Machine Translated by Google Ordinary supplement to the "Official Journal" n. 73 of 28 March 2014 - General Series Shipping b abb. Shipping post. abb. 45% post. - art. - art. 2, paragraph 1, paragraph 1 20 / Law 02/27/2004, Law 23-12-1996, n. n. 46 662- Rome - Romebranch branch OFFICIAL JOURNAL OF THE ITALIAN REPUBLIC ALL PUBLISHED PART ONE Rome - Friday, March 28, 2014 NON-HOLIDAY DAYS MANAGEMENT AND DRAFTING AT THE MINISTRY OF JUSTICE - OFFICE FOR PUBLICATION OF LAWS AND DECREES - VIA ARENULA, 70 - 00186 ROME ADMINISTRATION AT THE POLYGRAPHIC INSTITUTE AND STATE ZECCA - VIA SALARIA, 1027 - 00138 ROME - CENTRALINO 06-85081 - STATE LIBRARY PIAZZA G. VERDI, 1 - 00198 ROME No. 30/L LEGISLATIVE DECREE March 14, 2014, n. 49. Implementation of Directive 2012/19 / EU on waste electrical and electronic equipment (WEEE). Machine Translated by Google Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 SUMMARY LEGISLATIVE DECREE March 14, 2014, n. 49. Implementation of Directive 2012/19 / EU on waste from electrical equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and electronics (WEEE). (14G00064) . . Pag. 1 ANNEX I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 18 ANNEX II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 19 ANNEX III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 24 ANNEX IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 25 ANNEX V. _ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 28 ANNEX VI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 30 ANNEX VII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 32 ANNEX VIII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 36 ANNEX IX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 38 ANNEX X . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . » 39 — III — Machine Translated by Google Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 LAWS AND OTHER REGULATORY ACTS LEGISLATIVE DECREE March 14, 2014 , n. 49 . E MANA the following legislative decree: Implementation of Directive 2012/19 / EU on waste from electrical and electronic equipment (WEEE). TITLE I. GENERAL PRINCIPLES THE PRESIDENT OF THE REPUBLIC Art. 1. Having regard to articles 76 and 87 of the Constitution; Purpose Having regard to the law of 24 December 2012, n. 234, laying 1. This legislative decree establishes measures and procedures down general rules on Italy's participation in the formation and aimed at protecting the environment and human health: a) by implementation of Unio regulations and policies preventing or reducing the negative impacts deriving from not European; the design and production of electrical and electronic equipment and from the production and management of waste from electrical Having regard to the law of 6 August 2013, n. 96, delegating to and electronic equipment; b) reducing negative impacts and the Government for the transposition of European directives and improving the effectiveness of the use of resources to achieve the implementation of other European Union acts - 2013 European sustainable development objectives, in application of the Delegation Law, and, in particular, attachment B ; principles and criteria set out in articles 177, 178, 178 -bis , 179, 180, 180 - Having regard to Directive 2012/19 / EU of the European bis and 181 of the legislative decree 3 April 2006, n. 152, and Parliament and of the Council, of 4 July 2012, on Waste from subsequent amendments. electrical and electronic equipment (WEEE); Art. 2. Given the legislative decree of 25 July 2005, n. 151, implementing directive 2002/96 / EC and directive 2003/108 / EC, Scope of relating to the reduction of the use of hazardous substances in 1. The provisions of this legislative decree apply: a) to electrical electrical and electronic equipment, as well as the disposal of waste; and electronic equipment falling within the categories referred to in Annex I and listed by way of example in Annex II, from the date of entry into force of this legislative decree until to 14 Aug Given the legislative decree 3 April 2006, n. 152, and subsequent 2018; b) to all electrical and electron equipment which, as classified amendments, containing rules on environmental matters and, in in the categories of Annex III and listed by way of example in Annex IV from 15 August 2018. particular, Part Four containing rules on the management of waste and the reclamation of polluted sites; Given the preliminary resolution of the Council of ministers, adopted at the meeting of 13 December 2013; 2. This legislative decree does not affect the application of the Having acquired the opinion of the unified Conference referred national legislation transposing the European provisions on safety, health, chemicals, as well as Regulation (EC) no. 1907/2006 of the to in article 8 of legislative decree no. 281, made in the session of European Parliament and of the Council, of 18 December 2006, February 6, 2013; concerning the registration, evaluation, authorization and restriction of chemical substances (REACH), of the legislative decree 16 Having acquired the opinions of the competent commissions of the February 2011, n. 15, transposing Directive 2009/125 / EC of the Chamber of Deputies and the Senate of the Republic; European Parliament and of the Council, of 21 October 2009 on the eco-friendly design of energy-related products, of the national Having regard to the resolution of the Council of Ministers, legislation for the transposition of Directive 2011/65 / EU of the adopted at the meeting of 14 March 2014; European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical On the proposal of the President of the Council of Ministers and and electronic equipment and of Part Four of the Legislative Decree the Minister of the Environment and Land Protection e of 3 April 2006, n. 152, and subsequent amendments. of the sea, in agreement with the Ministers of Foreign Affairs, Justice, Economy and Finance, Economic Development, Health and Regional Affairs; —1— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 Art. 3. c) 'large-scale fixed installations' means a large-scale Exclusions combination of various types of equipment and possibly other devices, which: 1) are assembled, installed and uninstalled by 1. They are excluded from the scope of this professionals; 2) they are intended for permanent use legislative decree: a) as part of a building or structure in a predetermined and specific equipment necessary for the protection of the essential place; 3) can only be replaced with interests of national security, including weapons, ammunition and war material, provided that they are intended for specifically military purposes; b) equipment specifically designed and installed as part same specially designed equipment; of other equipment that is excluded or does not fall within the scope of this legislative decree, provided that it can perform its (d) 'non-road mobile machinery' means machinery function only as part of that equipment; c) incandescent lamps. equipped with an on-board power source, the operation of which requires continuous or semi-continuous mobility or movement during work, between a series of fixed workstations; e) 'waste of electrical and electron equipment which' or 'WEEE': 2. Starting from 15 August 2018 they are also excluded from the electrical equipment or electrons which are waste scope of this legislative decree: pursuant to article 183, paragraph 1, letter a) , of legislative decree 3 April 2006, n. 152, including all components, subsets a) equipment intended to be sent into space; b) large- and consumable materials product that the at the time are holder an integral part of discards the it and sized fixed industrial tools; (c) large fixed installations, with intends or is obliged to discard them; f) 'WEEE of very small the exception of equipment which is not specifically dimensions': WEEE with external dimensions of less than 25 designed and installed to be part of such installations; cm; g) 'producer': the natural or , thelegal person sales who, used, technique whatever including remote communication, pursuant to Section II, Chapter I, Title III of Legislative Decree 6 September 2005, n. 206, concerning the protection of consumers in respect d) means of transport for persons or goods, excluding non-approved two-wheeled electric vehicles; e) non-road mobile of distance contracts: machinery intended for professional use only; f) equipment specifically designed for research and development, available only in the context of business-to-business relationships; g) medical devices and in vitro diagnostic-medical devices if there is a risk that such devices are infected, pursuant to the 1) is established in the national territory and factory decree of the President of the Republic of 15 July 2003, EEE bearing its name or trademark or commissions the design n. 254, before the end of their life cycle and active implantable or manufacture of EEE and markets them on the national medical devices. market by affixing its name or trademark; 2) is established in the national territory and resells on the national market, with its name or trademark, equipment produced by other Art. 4. suppliers; the reseller is not considered a 'manufacturer', if the equipment bears the manufacturer's mark in accordance with Definitions number 1); 1. For the purposes of this legislative decree, the following 3) is established in the national territory and places on definitions apply: a) 'electrical and electronic equipment' the national market, as part of a professional activity, EEE from or 'EEE': equipment that depends, for proper operation, on a third country or from another member state of the European electric currents or electromagnetic fields and generation Union; equipment, transferring and measuring these currents and fields and designed for use with a voltage not exceeding 1000 4) is established in another Member State of the volts for alternating current and 1500 volts for direct current; European Union or in a third country and sells on the national market (b) 'large fixed industrial tools' means a large set of machines, EEE by means of remote communication techniques directly equipment and components, or both that work together for a to private households or to users other than households; specific application, installed and permanently installed by professionals in a given located and used and operated by h) 'distributor': natural or legal person registered in the professionals at an industrial production facility or research and Business Register pursuant to law no. 580, and subsequent development center; amendments, which, operating in the supply chain, makes an EEE available on the market. This definition does not preclude a distributor from being at the same time a manufacturer within the meaning of letter g) ; —2— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 (i) 'retail distributor' means a natural or legal person z) 'dangerous waste': waste that has the as defined in point ( h) , who makes to anthe EEEend available user; l) characteristics indicated in article 183, paragraph 1, letter 'WEEE from private households': WEEE originating from b) , of legislative decree no. 152; households and WEEE from commercial, industrial, aa) 'prevention': the measures indicated in article institutional and other types, similar in nature and quantity 183, paragraph 1, letter m) , 2006,of legislative n. 152; decree 3 April to those originating from households. Waste from EEE which could be used both by private households and by bb) 'collection': the operations defined in article 183, users other than private households are in any case paragraph 1, letter o)2006, , of the n. legislative 152, includingdecree 3 April sorting and considered WEEE from private households; m) preliminary deposit for collection and management of the 'Professional WEEE': WEEE other than those collection centers referred to in letter mm) ; cc) 'pre- collection deposit': the temporary deposit referred to in Article 3, paragraph 1, point 10, and in the notes to coming from the households referred to in letter l) ; point D15 of Annex I and point R13 of Annex II of n) 'WEEE equivalent': WEEE collected in connection Directive 2008/98 / EC of the European Parliament and with the supply of new equipment, which have performed of the Council of 19 November 2008; the same function as the equipment supplied; o) 'Historical WEEE': WEEE deriving from electrical dd) 'separate collection': the collection defined in and electronic equipment placed on the market before article 183, paragraph 1, letter p) , of the legislative decree 3 April 13 August 2005; p) 'financial agreement' means any 2006, n. 152; ee) 'reuse': the operations indicated in loan, lease, lease or deferred sale agreement or article 183, paragraph 1, letter r) , of legislative agreement relating to any equipment, regardless of decree 3 April 2006, n. 152;the ff) 'preparation for re-use': operations indicated in article 183, paragraph 1, letter q) , of the legislative whether the terms of such agreement or agreement or any ancillary agreement or agreement provide for the decree 3 April 2006, n. 152; transfer or the possibility of transferring ownership of such equipment; q) 'making available on the market': the supply of a product for distribution, consumption or use gg) 'recovery': the operations indicated in article on the national market in the course of a commercial 183, paragraph 1, letter t) , April of the2006, legislative n. 152;decree 3 activity, whether in return for payment or free of charge; r) 'placing on the market' means the first making available hh) 'money laundering': the recovery operations of a product on the national market as part of a indicated in article 183, paragraph 1, letter u) , ofdecree legislative professional activity; no. 152; ii) 'disposal': the operations indicated in article 183, paragraph 1, letter z) , of legislative decree 3 April 2006, n. 152; s) 'removal': the manual, mechanical, chemical or metallurgical operation whereby hazardous substances, ll) 'treatment': the operations indicated in article mixtures and components are confined in an identifiable 183, paragraph 1, letter s) , 2006, of legislative n. 152;decree 3 April flow or are an identifiable part of a flow in the process of treatment. A substance, mixture or component is mm) 'WEEE collection center': collection center identifiable if it can be monitored to verify that the defined and regulated pursuant to article 183, paragraph treatment is safe for the environment; t) 'medical device': 1, letter mm) , of legislative decree subsequent no. 152, and amendments, from which a medical device or accessory within the meaning of the various types of WEEE are collected through letters a) or b) respectively differentiated grouping; nn) 'trademark': image, symbol or inscription affixed to the electrical and electronic of article 1, paragraph 2, of legislative decree February equipment pursuant to article 28, which allows the 24, 1997, n. 46, implementing Directive 93/42 / identification of the manufacturer; oo) 'grouping': each of EEC, of the Council of 14 June 1993, on medical devices, the WEEE groupings defined in Annex 1 of regulation which constitutes an EEE; u) 'in vitro diagnostic medical no. 185; pp) 'grouping place': deposit prior to the device': an in vitro diagnostic device or an accessory collection of domestic WEEE organized by pursuant to letters b) or c) , respectively, of article 1, distributors pursuant to article 11; qq) 'waste deriving paragraph 1, of legislative decree no. 37, implementing Directive from photovoltaic panels': WEEE from households is 98/79 / EC of the European Parliament and of the considered to be waste originating from photovoltaic Council, of 27 October 1998, relating to in vitro diagnostic panels installed in systems with a nominal power of less medical devices which constitutes an EEE; v) 'active than 10 KW. These panels must be given to the implantable medical device': an active implantable "Collection Centers" in group n. 4 of Annex 1 of the medical device pursuant to article 1, paragraph 2, letter decree 25 September 2007, n. 185; c) , of legislative decree no. 507, which constitutes an EEE; —3— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 all waste deriving from photovoltaic panels installed in systems with 2. Where it is not possible to comply with the priority criteria a nominal power greater than or equal to 10 KW are considered referred to in paragraph 1, the WEEE collected separately is sent professional WEEE. for recovery according to the procedures referred to in Article 18. 2. A 'producer' within the meaning of letter g) is anyone who provides financing solely on the basis or under a financial Art. 7. arrangement, unless he is acting as a producer within the meaning Preparation for reuse and reuse of numbers 1) to 4) of letter g) . 1. The WEEE is primarily sent to the accredited preparation 3. In the case of electrical and electronic equipment intended centers for reuse, set up in compliance with the decree referred to for export, the producer is considered as such only for the purposes in article 180 -bis but 2, of the legislative decree 3 April 2006,, n. 152, with of Articles 5, 26, 28 and 29. prior to separation from WEEE destined for treatment pursuant to article 18. Art. 5. Product design 2. Special areas are identified in the collection centers for the "preliminary deposit for collection" of domestic WEEE destined for 1. In line with the measures provided for in the national waste preparation for re-use. prevention program referred to in article 180, paragraph 1 - bis of the legislative decree , 3 April 2006, TITLE II n. 152, and subsequent amendments, the Minister of the Environment and the Protection of the Territory and the Sea, in WEEE MANAGEMENT agreement with the Minister of Economic Development, regulates the measures aimed at: (a) to promote cooperation between producers and operators Chapter I of treatment, recovery and recycling plants; b) encourage the eco- WEEE MANAGEMENT SYSTEMS friendly design and production of EEE, in order to facilitate the disassembly, repair operations, as well as the operations of Art. 8. preparation for reuse, reuse, recovery and disposal of Obligations of EEE producers WEEE, their components and materials, with particular regard to those products that introduce innovative solutions for the reduction 1. Producers must achieve minimum targets of environmental loads associated with the life cycle; for recovery and recycling referred to in Annex V. 2. Producers fulfill their obligations deriving from the provisions c) support the market for recycled materials also for the of this legislative decree by means of individual or collective production of new EEE. management systems, operating uniformly throughout the national territory. 2. The measures referred to in paragraph 1 take into account the entire life cycle of the equipment and the best techniques 3. The producers of EEE, through one of the management available, and are aimed, in particular, at favoring the correct systems referred to in paragraph 2, annually determine and application of the ecological design requirements referred to in the communicate to the Ministry of the environment and the protection legislative decree February 16, 2011, n. 15, as well as to avoid that of the territory and the sea the amount of the contribution necessary the specific characteristics of the design or the manufacturing to fulfill, in the calendar year of reference, to the collection, treatment, processes may hinder or limit the reuse and treatment of WEEE, recovery and disposal obligations imposed by this legislative decree, unless they present advantages of primary importance in relation to to an extent that does not exceed the best estimate of the costs interests of constitutional importance, such as the protection actually incurred. When an EEE is made available on the national environment and safety. market, the producer may apply the levy on the sale price of the same, indicating it separately in his sales invoices to distributors. 3. For the purposes referred to in paragraph 1, the Minister for The presence of the contribution can be made known in the the Environment and for the Protection of the Territory and the Sea, indication of the price of the product to the end user. in agreement with the Ministers of Economic Development and the Economy and Finance, identifies and promotes and incentives, within the limits of the ordinary budget allocations envisaged. Art. 9. Art. 6. Individual systems Priority criteria in the management of WEEE 1. Producers who intend to fulfill their obligations individually 1. The management of WEEE must favor the reuse and organize a self-sufficient system operating uniformly throughout the preparation operations for the reuse of WEEE, their components, national territory for the management of WEEE deriving from the subsets and consumables in implementation of the principles of consumption of their EEE and apply for recognition to the Ministry precaution and prevention, and in order to allow an efficient use of of environment and protection of the territory e the resources. —4— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 of the sea. The application is accompanied by a descriptive 2. The collective systems are organized in consortium form project, suitable for demonstrating that the system: a) is pursuant to articles 2602 and following of the civil code as organized according to criteria of efficiency, effectiveness, applicable and except for the provisions of this legislative decree. cost-effectiveness and transparency; b) is effectively able to operate throughout the national territory and to achieve, 3. The consortia referred to in paragraph 2 have independent within the scope of the activities carried out, the recovery and legal personality under private law, have no profit and operate recycling objectives referred to in Annex V; under the supervision of the Ministry of the Environment and the Protection of the Territory and the Sea and the Ministry of c) operates through suitable management methods to Economic Development, that within 6 months of the entry into ensure that end users are adequately informed about the operating methods of the system and the methods for collecting force of this legislative decree approve the standard statute. WEEE. 2. A collection plan is an integral part of the project referred 4. Each collective system must guarantee the collection of to in paragraph 1, certifying that the proposed system is able to WEEE from municipal collection centers throughout the national intercept all the WEEE generated by its EEE throughout the territory according to the indications of the Coordination Center. national territory, according to one of the following methods: a) the preparation of an efficient system of remains 5. The existing and newly established consortia conform their tuction of WEEE generated by its own EEE; activities to the directive criteria of the management systems b) the stipulation of specific agreements with the subjects referred to in article 237 of the legislative decree 3 April 2006, n. responsible for collection throughout the national territory, to be 152, and their statute to the standard statute, according to the drawn up in order to ensure that the contracting producer collects procedures indicated in paragraphs 6, 7 and 8. only the WEEE deriving from its own collection centers and other 6. Existing collective systems adapt their statutes within 90 gathering places EEE placed on the market, identified by the trademark referred to in Article 28 and specially selected. days of approval of the standard statute and send it within 15 days to the Ministry of the Environment and Land and Sea Protection for approval. 3. The recognition by the Ministry of the environment and the protection of the territory and the sea takes place within 90 days of the submission of the project and is an essential requisite for 7. The newly established collective systems shall transmit registration in the National Register referred to in Article 29 of the statute to the Minister of the Environment and the Protection this legislative decree. . If the recognition of an individual system is requested following withdrawal from a collective system, such of the Territory and the Sea within 15 days of their adoption, for the purpose of approval. withdrawal takes effect only from the date indicated in the system recognition provision. The recognized systems annually transmit 8. The statute is approved within 90 days of the transmission, to the Ministry of the Environment and Land and Sea Protection by decree of the Minister of the Environment and of the Protection a specific management program for their WEEE relating to the of the Territory and the Sea in agreement with the Minister of following calendar year, together with the financial statements Economic Development, unless justified observations which the accompanied by a management report relating to the year. previous calendar with an indication of the objectives achieved. consortium is required to comply with in the next 60 days. The revocation of the recognition ordered in the event that the Approval of the statute is an essential condition for registration recovery objectives established in article 19 are not achieved in the National Register. results in automatic cancellation from the National Register and 9. The collective systems annually transmit to the Ministry of the application of the sanction referred to in article 38, paragraph the Environment and the Protection of the Territory and the Sea 7, of this legislative decree. . The systems must demonstrate, for the purposes of recognition, that they are in possession of the the prevention and management plan relating to the following ISO 9001 and 14001, EMAS, or other equivalent quality calendar year, including a prospectus relating to the economic management system audited and which also includes the resources that will be used and a copy of the financial statements treatment processes and internal monitoring. to the company. accompanied by a management report relating to the previous calendar year with an indication of the objectives achieved. 10. Collective systems are required to guarantee the Art. 10. equilibrium of their financial management and any management surpluses do not contribute to the formation of income and Collective systems cannot be divided among the consortium members. The systems 1. Producers who fail to fulfill their obligations through an must demonstrate that they are in possession of ISO 9001 and individual system must join a collective system. Distributors, 14001, EMAS, or other equivalent quality management system collectors, transporters, recyclers and recoverers can participate audited and which also includes the treatment processes and in collective systems, subject to agreement with the EEE internal monitoring of the company. producers. —5— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 Chapter II and from the action of the wind by means of special DEPOSIT PRELIMINARY TO COLLECTION, COLLECTION, covering systems, including mobile, and are grouped taking APPROPRIATE TREATMENT AND RECOVERY care to keep hazardous waste separate, in compliance with the provision referred to in article 187, paragraph 1, of the legislative decree 3 April 2006, n. 152. It is necessary to Art. 11. guarantee the integrity of the equipment, adopting all precautions to avoid its deterioration and the release of Preliminary deposit for collection with distributors dangerous substances. 1. Distributors shall ensure, upon supply of new electrical 3. Distributors may carry out the free collection of and electronic equipment intended for a household, the WEEE from very small households delivered by end users free one-to-one collection of used equipment of an within the premises of their own point of sale or in the equivalent type. Distributors, including those who carry out immediate vicinity of them, without the obligation to teleshopping and electronic sales, are obliged to inform purchase EEE of the type equivalent. This activity is consumers about the free collection in a clear and mandatory for distributors with retail EEE sales area of at immediate way, also by means of notices placed in least 400 square meters. The aforementioned collection commercial premises with easily legible characters or by points are not subject to the registration or authorization means of an indication in the website. requirements referred to in articles 208, 212, 213 and 216 of the legislative decree 3 April 2006, n. 152. Pending the 2. It is part of the collection phase, as defined in article adoption of the decree referred to in paragraph 4, the 183, paragraph 1, letter o) , of the legislative April 2006,decree n. 152,3 the separate collection of lighting WEEE from the other preliminary deposit for the collection of WEEE carried out categories of WEEE must be guaranteed by means of by distributors at the premises of their point of sale and at special containers, suitable for the safe collection of the other places resulting from the communication referred to WEEE provided, in order to preserve its integrity also in article 3 of the decree of the Minister for the environment during the transport phase up to their delivery to the and protection of the territory and the sea 8 March 2010, n. treatment plants. 65, at the end of their transport to the collection centers 4. By decree of the Ministry of the Environment and of built and managed on the basis of the provisions adopted Territorial and Sea Protection, in agreement with the in implementation of article 183, paragraph 1, letter mm) , Ministry of Economic Development, the simplified of the legislative decreeauthorized collection 3 April 2006, 152, ortotoarticles pursuant the 208, procedures for the free collection activity by the distributors 213 and 216 of the legislative decree 3 April 2006, n. 152, referred to in paragraph 3 are regulated. on the basis of or at plants authorized for adequate treatment. The the one against zero, as well as the technical requirements preliminary deposit for collection consists in the grouping for carrying out the preliminary deposit for collection at the of WEEE from private households carried out in compliance distributors and for transport. with the following conditions: Art. 12. a) WEEE collected by distributors must be sent to the collection centers built and managed on the basis of Separate collection of domestic WEEE the provisions adopted in implementation of article 183, paragraph 1, letter mm) , of and n. 152, legislative decreeamendments subsequent 3 April 2006, 1. In order to minimize the disposal of WEEE from and those authorized pursuant to articles 208, 213 and 216 private households as mixed urban waste, by achieving a of the same legislative decree, according to one of the high level of separate collection suitable for achieving the following alternative methods chosen by the distributor: objectives indicated in Article 14, and to submit the WEEE every three months or when the quantity withdrawn and collected under the adequate treatment referred to in article deposited reaches a total of 3,500 kilograms. In any case, 18, the following measures and actions must be activated : even if 3,500 kilograms have not been reached, the duration and accessibility to the relative collection centers, in order of the deposit must not exceed one year. This quantity is to allow the final holders, distributors, installers and raised to 3,500 kilograms for each of the groupings 1, 2 managers of WEEE technical assistance centers to deliver and 3 of Annex 1 to regulation no. 185, and a total of 3,500 free of charge the WEEE produced in their territory or held kilograms for groupings 4 and 5 referred to in the same in places of grouping organized by distributors in their Annex 1, only in the event that the WEEE is collected for territory. The delivery of waste produced in other subsequent transport to the collection centers or suitable municipalities is permitted only after signing a specific treatment plants by transporters registered in the Register agreement with the municipality of destination. This of environmental managers pursuant to article 212, agreement is mandatory for municipalities that have not set paragraph 5, of legislative decree no. 152; b) the deposit up a collection center suitable for receiving WEEE. prior to collection is carried out in a suitable place, not accessible to third parties, paved and where the WEEE is protected from rainwater —6— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 b) without prejudice to the provisions of letter a) and calculated on the basis of the total weight of WEEE collected paragraphs 1 and 3 of article 11, producers, individually or in accordance with the provisions of this decree in a given year through the collective systems to which they adhere, may and expressed as a percentage of the average weight of EEE organize and manage systems for the collection or return of placed on the market in the previous three years. WEEE from households domestic to achieve the objectives In the period from 1 January 2016 to 31 December 2018, the defined by this legislative decree. quantity of WEEE collected must gradually increase until the 2. The construction and management of collection centers final collection rate referred to in letter c) is reached ; c) as of referred to in letters a) and b) is carried out in the manner 1 January 2019 a minimum collection rate of 65 per cent of the provided for by the provisions adopted in implementation of average weight of EEE placed on the market in the article 183, paragraph 1, letter mm)2006, 3 April , of the legislative n. 152, decree or, alternatively, previous three years must be achieved or, alternatively, a with the modalities provided for in articles 208, 213 and 216 of minimum collection rate of 85 must be achieved percent of the the legislative decree 3 April 2006, n. 152. weight of WEEE produced in the national territory. 3. Separate collection must primarily concern temperature exchange equipment containing substances that deplete the 2. While waiting for the Commission to define a common ozone layer and fl uorinated greenhouse gases, fl uorescent methodology for calculating the volume measured on the basis lamps containing mercury, photovoltaic panels and small sized of the weight of WEEE produced, the Minister for the equipment. referred to in categories 5 and 6 of Annex III. Environment and for the Protection of the Territory and the Sea, having consulted ISPRA, and certainly with Minister of Economic Development, may define a methodology for 4. Taking into account the current provisions on the calculating the total weight of the WEEE produced to be protection of the health and safety of workers, the free applied throughout the national territory, taking into due withdrawal of an electrical and electronic equipment pursuant consideration the different life and reuse cycles of EEE and in to paragraphs 1 and 3 of article 11 of this legislative decree compliance with the best available techniques. may be refused in the event where there is a risk of 3. Monitoring of the achievement of the rate of rec contamination of the personnel responsible for the same cultured referred to in this article is entrusted to ISPRA. collection or if it is evident that the equipment in question does not contain its essential components or contains waste other than WEEE. In order to ensure the correct disposal of such Art. 15. WEEE, they must be delivered by the final holder to the Collection of WEEE delivered to collection centers collection centers, which manage them on the basis of the methods agreed pursuant to article 15, paragraph 3, letter c). . 1. Producers ensure the collection throughout the national territory of WEEE deposited in the collection centers referred to in Article 12, paragraph 1, letter a) , on the methods basis of the defined: Art. 13. a) by specific agreements stipulated pursuant to article Separate collection of professional WEEE 9, paragraph 2, letter b) , in the case of individual by the Coordination systems; b) Center, in the case of collective systems. 1. Without prejudice to the provisions of article 24 of this decree, producers, individually or through the collective systems to which they belong, organize and manage professional WEEE separate collection systems, supporting 2. The trade associations representing the producers the related costs. To this end, they can make use of the enrolled in the Coordination Center, the trade associations at structures referred to in article 12, paragraph 1, letter a) , national level of the enterprises that carry out the collection, subject to an agreement with the Municipality concerned, at each through a single delegate, the National Association of their own expense. Italian Municipalities (ANCI) and the Center of coordination enter into a Program Agreement, valid for three years, within Art. 14. six months of the entry into force of this legislative decree. This agreement is renewed by the deadline of 31 December Separate collection rate which precedes the expiry of the first three years. 1. The following separate collection objectives must be achieved every year: 3. The agreement referred to in paragraph 2 governs the a) up to 31 December 2015, an average separate methods and times for collecting WEEE from the collection collection rate for WEEE from private households must be centers, the organization of collection in a homogeneous achieved of at least 4 kilograms per year per inhabitant; b) manner throughout the national territory and the charges for from 1 January 2016 a minimum collection rate of at least 45 carrying out the related activities, with particular reference to: per cent must be achieved, a) general conditions for collection by collective systems of WEEE delivered to municipal collection centers; —7— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 b) necessary procedures so that the withdrawal is carried out b) the methods of support to distributors, by the Coordination in a rational and homogeneous way throughout the national territory; Center, for the purpose of carrying out the administrative procedures c) methods of managing the waste referred to in paragraph 4 of referred to in Part Four of the legislative decree 3 April 2006, n. 152. article 12, conferred to the collection centers, through the identification of suitable plants, with charges to be borne by the 3. The agreement is valid for three years, is stipulated within six producers; d) efficiency bonuses, or the amounts that producers are months of the entry into force of this legislative decree and renewed required to pay to municipal collection centers upon the occurrence by the deadline of December 31st which precedes the expiry of the first three years. Paragraph 5 of article 15 applies. of good operating conditions, based on the quantities of WEEE withdrawn from collective systems; e) the adaptation and implementation of municipal collection centers. Art. 17. Transport and start of treatment of collected WEEE 1. Separate collection and transport of WEEE must be carried 4. These conventions do not give rise to any exclusive right in out in such a way as not to jeopardize preparation for reuse or favor of producers. recycling and in such a way as to guarantee the integrity of WEEE 5. In the event of failure to stipulate the agreement referred to in in order to allow the confinement of hazardous substances to be paragraph 2 within the terms provided, the Minister for the effected in optimal conditions. Environment and for the Protection of the Territory and the Sea invites the parties to find an agreement within sixty days, after which, 2. The WEEE collected separately in accordance with the without If the outcome is positive, it acts directly in consultation with procedures referred to in articles 11 and 12 are sent to adequate the Minister of Economic Development. Pending the signing of the treatment plants or to operations for preparation for re-use provided first agreement, the program agreements already stipulated remain that such re-use does not constitute an avoidance of the obligations valid between the parties. established pursuant to article 18, paragraph 2. 3. It is forbidden to dispose of collected WEEE that has not yet been subjected to Art. 16. adequate treatment, also pursuant to and for the purposes of article 7, paragraph 1, of legislative decree no. 36. Collection and transport of WEEE conferred to distributors 1. WEEE coming from private households and delivered to the Art. 18. grouping places managed by distributors are transported by distributors: a) to the collection centers referred to in Article 12, Adequate treatment paragraph 1, letter a) , in the manner indicated in the regulation 1. All separately collected WEEE must undergo adequate 25 September 2007, n. 185; treatment. 2. Adequate treatment and recovery and recycling operations, b) adequate treatment plants or collection centers referred to except in the case of waste sent to be prepared for reuse, include at in article 12, paragraph 1, letter b) , in compliance with the formalities least the elimination of all liquids and selective treatment carried out and April obligations envisaged 2006, n. 152. by Part Four of the legislative decree 3 in plants compliant with the provisions in force on the matter. , as well as the technical requirements and the management and storage methods established in Annexes VII and VIII. To this end, producers 2. The most representative trade associations at the national set up systems for the adequate treatment of WEEE, using the best level of distribution, the most representative trade associations at available treatment, recovery and recycling techniques. the national level of the companies that carry out the collection and the trade associations representative of the producers registered in the Coordination Center, each through a single delegate, the 3. In the case of WEEE containing ozone depleting substances, National Association of Italian Municipalities (ANCI) and the the provisions of Regulation (EC) no. 1005/2009 of the European Coordination Center, after consulting the Steering Committee, define Parliament and of the Council of 16 September 2009 on substances with a program agreement the methods of collection and collection that deplete the ozone layer, as well as of Regulation (EC) no. of WEEE given to distributors pursuant to article 11, paragraphs 1 842/2006, of the European Parliament and of the Council, of 17 May and 3, and the respective charges, with particular reference to: a) 2006, on certain fl uorure gases with a greenhouse effect. the efficiency bonuses, or the amounts that the producers are required to disburse to the distributors upon the occurrence of conditions of good operation of the group, based on the 4. The Minister for the Environment and for the Protection of the quantities of WEEE withdrawn from collective systems; Territory and the Sea, making use of the Coordination Center and ISPRA, determines by decree the criteria and technical methods of treatment other than those contained in Annexes VII and VIII, and the related verification procedures, —8— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 in compliance with the minimum quality standards defined by in article 190, paragraph 1, of the legislative decree 3 April the European Commission pursuant to the provisions of Article 2006, n. 152, the weight of WEEE, their components, incoming 8, paragraph 5, of Directive 2012/19 / EU, within three months materials and substances (input) and the weight of WEEE, of their adoption. their components, materials and substances, i.e. the weight of 5. Within three months of the adoption of the ministerial the products and materials actually recovered in output (output) decree referred to in paragraph 4, the subjects who carry out from the plants. the processing operations must present an application for the 6. On the basis of the information acquired in fulfillment of adaptation of the authorization, and within the following four the obligations referred to in paragraphs 4 and 5, the owners months the Region or the delegated Province shall issue the of the plants annually communicate the data relating to the provision. In any case, until the adoption of the provision by quantities of WEEE managed through the single environmental the Region or the delegated Province, the applicants can clarification model pursuant to the law of 25 January 1994, n. continue the activity. 70, which is appropriately modified. The Chambers of Commerce communicate the data relating to the WEEE 6. Following the adoption of the ministerial decree referred to in paragraph 4 and by reason of the provisions thereof, the collected pursuant to articles 11 and 12 to the telematic Coordination Center proceeds to adapt the program agreements cadastre referred to in article 189 of the legislative decree 3 stipulated pursuant to article 33, paragraph 5, letter g) . April 2006, n. 152, pursuant to law no. 70. 7. From the date of entry into force of this legislative decree 7. By decree of the Minister of the Environment and of the and until 15 August 2018, the annotations referred to in Protection of the Territory and the Sea, in agreement with the paragraphs 4 and 5 of this article are made on a section of the Ministers of Economic Development, Health and the Economy register divided into the categories referred to in Annex I. A and Finance, to be adopted within three months from the date starting from 16 August 2018, the annotations referred to in of entry in force of this decree, within the limits of the ordinary paragraphs 4 and 5 of this article are made on a section of the budget allocations envisaged for the purposes referred to in register divided into the categories referred to in Annex III. this article, measures are defined to encourage the voluntary introduction, in companies that carry out WEEE treatment 8. The control system for the traceability of waste (SISTRI) operations, of systems certificates - referred to in article 188 -ter of the legislative decree 3 April environmental management categories governed by Regulation 2006, n. 152, applies to the management of WEEE with (EC) no. 1221/2009 of the European Parliament and of the specific reference to the fulfilments referred to in paragraph 7, Council of 25 November 2009 on the voluntary participation of only if provided for by the sector regulations, within the limits organizations in a Community eco-management and audit and in the manner governed by the same. scheme (EMAS). 9. ISPRA ensures the monitoring of the achievement of the objectives referred to in Annex V and annually sends a report Art. 19. to the Ministry of the Environment and Land and Sea Protection on the basis of the information acquired pursuant to paragraph Recovery goals 6. 1. To achieve the minimum recovery objectives set out in 10. The Minister for the Environment and for the Protection Annex V, producers are required to initiate appropriate of the Territory and the Sea, by decree in agreement with the treatment and recovery of collected WEEE, prioritizing Ministers of Economic Development, Health and the Economy preparation for re-use. and Finance, after consulting the unified Conference, defines, 2. The achievement of the recovery objectives referred to in within the limits of the ordinary budget allocations foreseen for Annex V is calculated, for each category, by dividing the weight the purposes referred to in this article, measures aimed at of WEEE entering the recovery, recycling or preparation for promoting the development of new recovery, recycling and reuse plant, after having carried out the appropriate treatment treatment technologies. pursuant to Article 18, with regard to recovery or recycling, for the weight of all WEEE collected separately for each category, Capo III expressed as a percentage. AUTHORIZATIONS, SHIPPING AND DISTANCE SELLING 3. Preliminary activities including sorting and storage that precede recovery are not considered for the purpose of Art. 20. achieving these objectives. Authorizations 4. The owners of the collection centers make a note in the appropriate section of the register referred to in article 190, 1. The plants or companies that carry out WEEE treatment paragraph 1, of the legislative decree 3 April 2006, n. 152, the operations must be authorized pursuant to article 208 of the weight of WEEE, their components, materials and substances legislative decree 3 April 2006, n. 152. The authorization leaving the collection centers (output). guarantees the use of the best techniques for adequate 5. The owners of adequate treatment, recovery, recycling treatment, recovery and recycling available and establishes or preparation for re-use of WEEE shall make a note in a the conditions necessary to ensure compliance with the specific section of the register referred to required requirements. —9— Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 Article 18 for the appropriate treatment and for the Art. 22. achievement of the recycling and recovery targets set out in Obligations inherent in distance selling Annex V. 2. By decree adopted pursuant to article 214 of legislative 1. The producer who supplies EEE on the national decree no. 152, the recovery operations of non-hazardous territory by means of remote communication techniques, in WEEE are regulated, subject to simplified procedures the event that he is not based in the Italian territory, shall pursuant to article 216 of said legislative decree. register himself in the national register referred to in article 29 or through an authorized representative pursuant to of article 30 of this legislative decree. In this case, the 3. The preventive visit referred to in the first paragraph authorized representative is also responsible for organizing of article 216 of the legislative decree 3 April 2006, n. 152, must also verify the compliance of the recovery activities the collection of equivalent WEEE, on a one-to-one basis, throughout the national territory. with the technical prescriptions established by Annexes VII 2. Distributors who sell by means of remote communication and VIII and with the technical prescriptions and safety measures envisaged by the provisions adopted in techniques, including telesales and electronic sales, in order implementation of the legislative decree 3 April 2006, n. 152. to fulfill the obligation of free collection of equipment of an equivalent type pursuant to Article 11, paragraph 1 , clearly 4. For plants authorized according to the ordinary indicate: procedure, the inspection by the competent bodies is carried out, after the start of the activity, at least once a year. For plants authorized through the procedures referred a) its own grouping places or the con ventioned places to in article 216 of the legislative decree 3 April 2006, n. where the end user can deliver the WEEE of an equivalent 152, the competent Provinces transmit, according to the type free of charge, without greater burdens than those that method defined by them and, in any case, at least once a he would reasonably bear in the event of non-remote sales, year, the results of the inspections carried out pursuant to or; b) the methods of collection at the same place of delivery, this article to ISPRA, which processes them and transmits free of charge and without greater costs than those them to the Ministry of environment and land and sea that the same would reasonably bear in case of non-remote protection for subsequent communication to the European sales. Commission. 3. This indication constitutes an essential element of the Art. 21. sales contract, under penalty of nullity of the same and its absence gives the right to request the full refund of the sum Shipping of WEEE paid. 1. The treatment operation can be carried out outside the national territory provided that the shipment of WEEE TITLE III complies with regulation (EC) no. 1013/2006 of the European FINANCING OF WEEE MANAGEMENT Parliament and of the Council, of 14 June 2006, relating to shipments of waste, and to Regulation (EC) no. 1418/2007 Art. 23. of the Commission, of 29 November 2007, relating to the export of certain waste destined for recovery, listed in Annex Methods of financing WEEE III or III A to Regulation (EC) no. 1013/2006 to some from households countries to which the decision of the Organization for Economic Cooperation and Development (OECD) on the 1. For historical WEEE, the financing of the collection control of cross-border movements of waste does not apply. and transport operations of domestic WEEE delivered to the collection centers, as well as the operations of adequate 2. Exported WEEE shall be taken into consideration for treatment, recovery and environmentally compatible disposal the purposes of fulfilling the obligations and achieving the of the same, is borne by the producers present on the objectives referred to in Article 19 only if the exporter, in market in the same year in which the respective costs occur, accordance with Regulation (EC) no. 1013/2006 and with in proportion to the respective market share, calculated on regulation (EC) no. 1418/2007 can demonstrate that the the basis of the weight of EEE placed on the market for processing took place under conditions that are equivalent each type of equipment or for each grouping, in the reference to the requirements established by this decree. calendar year. 3. Shipments abroad of used EEE are carried out in 2. For WEEE deriving from EEE placed on the market compliance with the minimum requirements set out in Annex VI. The costs for analyzes and inspections relating to shipments after 13 August 2005, the financing of the collection and of used EEE suspected of being WEEE, including storage transport operations of domestic WEEE disposed of in the costs, are borne by the parties responsible for the shipment collection centers, as well as the operations of adequate of used EEE suspected of being WEEE. treatment, recovery and environmentally compatible disposal of the same, is the responsibility of the producers — 10 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 hear on the market in the year in which the respective of the territory and the sea, in agreement with the Ministers costs occur, which they can fulfill according to the following of Economic Development and the Economy and Finance. methods: a) individually, with reference only to the WEEE The adoption of the decree does not entail new or greater burdens, or lower revenues for public finance. deriving from the consumption of their own EEE; b) through a collective system, in proportion to the respective TITLE IV market share, calculated on the basis of the weight of EEE placed on the market for each type of equipment or INFORMATION AND MONITORING for each grouping, in the reference calendar year. Art. 26. 3. The Minister for the Environment and for the Protection Information to users of the Territory and the Sea defines the necessary measures to ensure that appropriate mechanisms or procedures for 1. The manufacturer of EEE provides, within the reimbursement of contributions to producers are developed instructions for use of the same, adequate information if the EEE is not transferred for placing on the market concerning: outside of the national territory or if the same are sent for a) the obligation not to dispose of WEEE as mixed processing outside the systems referred to in Article 8, urban waste and to carry out separate collection for said paragraph 2. waste; 4. The financing of the management of WEEE falling b) the WEEE collection or collection systems, as well within the categories referred to in point 5 of Annex I, is as the possibility and methods of delivery to the distributor borne by the producers regardless of the date of placing of the WEEE equivalent to the purchase of a new EEE said equipment on the market and of its domestic or pursuant to article 11, paragraph 1, or of the transfer free professional origin, according to the procedures identified of charge with no obligation to purchase for very small by the provisions adopted pursuant to article 10, paragraph 4, of legislative decree no. 151. WEEE pursuant to article 11, paragraph 3; c) the potential effects on the environment and on human health due to the Art. 24. possible presence of dangerous substances in electrical and electronic equipment and to improper Methods of financing the management management of the same; (d) the role of purchasers in of professional WEEE contributing to the reuse, recycling and other forms of 1. The financing of the operations of collection, transport, WEEE recovery; e) the meaning of the symbol shown adequate treatment, recovery and environmentally in Annex IX. compatible disposal of professional historical WEEE is borne by the producer in the case of supply of new electrical 2. In the event that, taking into account the type of EEE, and electronic equipment in substitution of a type product the provision of instructions is not envisaged, the information equivalent or is charged to the holder in other cases. referred to in paragraph 1 is provided by the retail distributor at the point of sale through appropriate publications or the 2. The financing of the operations of collection, transport, display of information material, pursuant to article 11, adequate treatment, recovery and environmentally paragraph 1. compatible disposal of professional WEEE originating from 3. The manager of the public collection service informs electrical and electronic equipment placed on the market the end users about: a) the measures adopted by the Public after 13 August 2005 is borne by the producer who bears Administration to ensure that end users contribute to the burden. for EEE that it has placed on the market starting the collection of WEEE and facilitate the treatment process from the aforementioned date. of the same; b) the role of the end user in preparing for 3. Producers can sign voluntary agreements with users reuse, recycling and other forms of recovery of WEEE. other than private households in order to provide alternative ways of financing the management of professional WEEE, provided that the purposes and requirements of this decree are respected. Art. 27. Art. 25. Information to treatment plants Financial guarantees 1. When the producer places an EEE on the market, he 1. To facilitate maintenance, modernization and repair, gives an adequate financial guarantee. The guarantee is as well as preparation for reuse and treatment of WEEE, provided by the single producer, in the event that he fulfills manufacturers provide adequate treatment and recycling his obligations individually, or by the collective system to facilities, as well as accredited preparation for reuse centers which the producer adheres, in accordance with the in con compliance with the decree referred to in article 180 provisions of article 1 of the law of 10 June 1982, n. 348, -bis paragraph 2, of the legislative decree 3 April 152, , 2006,free n. and according to equivalent procedures defined within six information on preparation for reuse and proper treatment. months from the date of entry into force of this legislative decree by the Minister for the environment and protection — 11 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 2. For each new type of EEE placed on the market for the Art. 29. first time and falling within the scope of this decree, the National register of obliged entities information must be provided within one year from the date of placing on the market. to the financing of WEEE management systems 3. To allow the preparation centers for re-use and the 1. The National Register of subjects obliged to fi nish the treatment and recycling plants to comply with the provisions WEEE management systems, established and functioning of this decree, the information referred to in paragraph 1 of pursuant to regulation no. 185, guarantees the collection and this article indicates at least the different components and keeping of the information necessary to verify compliance materials of the EEE, as well as the point of the EEA where with the provisions of this legislative decree and the correct the dangerous substances and mixtures are located. treatment of WEEE, as well as suitable for allowing the definition of the market shares referred to in Article 35, paragraph 1, letter c) . 4. The information is made available to preparation centers for re-use and treatment and recycling facilities by EEE 2. Producers are required to register in the National producers in the form of manuals or through electronic tools Register before they start operating in the Italian territory, in (e.g. CD-Roms and online services), including through the accordance with the procedures indicated in article 1 of the database prepared by the Coordination Center. regulation no. 185. 3. Within this Register, in addition to the section relating Art. 28. to the collective management systems of domestic WEEE, a special section relating to the systems identified as recognized pursuant to article 9 has been set up. Manufacturer's identification mark 4. The EEE producer subject to the obligations referred to 1. The manufacturer affixes a mark to the electrical and in paragraph 1 may place such equipment on the market only electronic equipment to be placed on the market. The mark following registration with the competent Chamber of affixed must make it possible to unequivocally identify the Commerce. When registering, the producer must indicate, if manufacturer of the EEE and that they were placed on the the activity code does not explicitly identify the nature of market after 13 August 2005. producer of AAE, also the specific activity code that identifies it as such, as well as the system through which it intends to comply with the obligations of financing for the management 2. The mark referred to in paragraph 1, in accordance with of WEEE and of guarantee provided for by this decree. the provisions of the technical standard CEI EN 50419: 2006- 05, which adopts without any modification the European 5. Enrollment in the register, with the indication of the standard CENELEC EN 50419: 2006-03, must contain at relevant information, is carried out exclusively by telephone least one of the following indications: name of the producer, by the producer or by the authorized representative pursuant logo of the producer (if registered), registration number in the to article 30, according to the procedures indicated in article National Register referred to in article 29. 3 of the 25 September regulation. 2007, n. 185. In the event 3. In addition to one of the marking options referred to in that the registration is carried out by the authorized paragraph 2, the manufacturer may use radio frequency representative, this subject is liable for the obligations imposed identification systems (RFID), subject to communication and on the producer who has appointed him, also with reference approval by the Supervisory and Control Committee. to the registration fees referred to in this paragraph. 6. Upon registration in the National Register, the 4. The trademark must be visible, legible and indelible. To manufacturer or his authorized representative shall provide check if the marking is durable, it must be legible after the the information provided for in Annex X and undertake to procedure indicated by the technical standard CEI EN 50419: update them appropriately. 2006-05, at point 4.2. 7. To facilitate registration in other countries, the National Register prepares, within its institutional website, specific 5. To ensure that WEEE is not disposed of as mixed urban waste and to facilitate its separate collection, the manufacturer references (links) to the other national registers. affixes the symbol shown in Annex IX to the equipment. 8. For the purposes of preparing and updating the Register, the Chambers of Commerce, Industry, Crafts and Agriculture 6. The mark and symbol are affixed to the surface of the communicate to the Supervisory and Control Committee the EEE, or to a visible surface after the removal of a cover or of list of companies registered in the Register as producers of a component of the equipment itself. However, this operation EEE. must be able to be carried out without the use of tools. Art. 30. 7. If it is not possible, due to the size or function of the Authorized Representative product, to affix the mark and symbol to the electrical and electronic equipment, they shall be affixed to the packaging 1. The producer having its registered office in another and instructions for use of the electrical equipment and Member State of the European Union may, notwithstanding electronics. the provisions of Article 4, paragraph 1, letter g)from , numbers 1) — 12 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 a 3), to designate with a written mandate an authorized TITLE V representative, understood as a legal person established in the COORDINATION, CONTROL AND SUPERVISION Italian territory or an individual, as the legal representative of a company established in the Italian territory, responsible for the fulfillment of the obligations falling on the producer, pursuant to Art. 33. this legislative decree. Coordination Center 2. The producer referred to in Article 4, paragraph 1, letter g) , number another 4), established Member State in the of national the European territory, Union whoinsells whichEEE he in is 1. The Coordination Center, established and regulated pursuant not established, must appoint a representative authorized in that to articles 9, paragraphs 1 and 3, 11 and 12 of regulation no. 185, State, responsible for the fulfillment of the obligations falling on has the form of a consortium with legal personality under private the producer pursuant to the regulations of the State in which the law and is governed pursuant to article 2602 and following of the sale is made. civil code as applicable and subject to the provisions of this legislative decree. The consortium is made up of all the collective systems for the management of WEEE from private households, Art. 31. which adhere to it within 30 days of their constitution, and of two components appointed respectively by the Ministry of the Monitoring and communications Environment and the Protection of the Territory and the Sea and by the Ministry of Economic Development. 1. ISPRA ensures the monitoring of the achievement of the objectives indicated in Annex V and annually transmits to the Ministry of the Environment and the Protection of the Territory and the Sea a report containing information, including detailed 2. Within six months from the date of entry into force of this estimates, on the quantities and categories of EEE placed on the decree, the Coordination Center prepares a specific list, in which market, collected through all channels, prepared for reuse, the owners of the WEEE treatment plants are required to register by simple communication and without further charges, and to recycled and recovered, as well as on WEEE collected separately and exported, by weight. annually communicate the quantities of WEEE treated by 30 April of each year. 2. The Ministry of the Environment and Land and Sea Protection sends the European Commission every three years a report on 3. Individual management systems for domestic WEEE, as the implementation of Directive 2012/19 / EU and on the well as individual and collective management systems for information referred to in paragraph 1. The report on the professional WEEE, may also participate in the coordination implementation is drawn up on the basis of a questionnaire center. referred to in Commission Decisions 2004/249 / EC and 2005/369 / 4. The Coordination Center adapts the statute to the provisions THERE IS. The report shall be sent to the Commission within nine of this legislative decree within 90 days of its entry into force. The months of the end of the three-year period examined therein. The statute and subsequent amendments which are approved by first report covers the period from 14 February 2014 to 31 decree of the Minister of the Environment, Land and Sea Protection December 2015. in agreement with the Minister of Economic Development and the Minister of Economy and Finance, within 60 days of presentation. Art. 32. Administrative collaboration 5. The Coordination Center optimizes, by standardizing the and exchange of information relative methods and conditions, the collection, collection and management of WEEE in a homogeneous way throughout the 1. In implementing this legislative decree, the competent national territory by the collective systems for delivery to treatment national authorities collaborate with each other, with the competent plants. In particular, the Coordination Center has the task of: a) authorities of the other Member States of the European Union, as guaranteeing the collection of WEEE delivered to municipal well as with those of the European Union itself, to establish an adequate flow of information aimed at ensuring that producers collection centers in a homogeneous way throughout the comply with the provisions of this decree. Administrative national territory by each collective system, in compliance with the cooperation and the exchange of information, in particular between principle of competition and non-discrimination , in order to national registries, include the use of electronic means of increase the collection of WEEE by the Municipalities and to communication. achieve the differentiated collection, recycling and recovery objectives established by this legislative decree; b) collaborate in the definition of the methodology of 2. Cooperation also includes the right of access to documents and relevant information, including the outcome of inspections, subject to the legislative provisions on the protection of personal referred to in the ministerial decree of article 18, paragraph 4; data applicable in the Member State of the European Union in which the authority whose cooperation is requested operates. c) support the Supervisory Committee in defining objective criteria for quantifying the shares of — 13 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 market, promoting studies by scientific and research institutes paragraph 1, of the legislative decree 25 July 2005, n. 151, for this purpose; d) ensure timely responses to collection and redefined by article 19 of legislative decree 20 November requests by collection centers, using telematic methods 2008, n. 188, carries out the following tasks: for this purpose; e) collect and report data relating to the a) prepares and updates the National Register referred collection and processing on the basis of the information to in Article 29, on the basis of the communications of the acquired pursuant to article 34; Chambers of commerce provided for in the same article 29, paragraph 8; b) collects, exclusively in electronic format, the data relating to the products placed on the market and f) annually transmit to ISPRA the information referred the financial guarantees that producers are required to to in letter d) for the purpose of preparing the report referred communicate to the National Register pursuant to article 29, to in article 31, paragraph 1; g) to stipulate specific paragraph 6; c) calculates, on the basis of the data referred agreements with the trade associations of the recovery to in letter b) , the respective market shares of the subjects, after consulting the Steering Committee, in order producers; d) plans and arranges, on the basis of a specific to ensure adequate and homogeneous levels of treatment and qualification of the companies in the sector; h) ensure plan, inspections on producers who do not carry out the monitoring of the fl ows of WEEE separated by the communications referred to in letter b) and, on a sample category referred to in Annexes I and III of this legislative basis, on the communications provided for in letter b) ; decree sorted to collective systems on the basis of procedures to be defined in agreement with ISPRA and the e) ensures that equipment placed on the market after Supervisory and Control Committee ; i) prepare an annual 13 August 2005 bears the identification of the manufacturer prevention and activity program for each grouping of and the symbol referred to in Annex IX and that manufacturers WEEE to be transmitted to the Supervisory and Control supplying electrical and electronic equipment by means of Committee. This program must contain specific indications remote communication techniques inform the Registry of also with regard to the WEEE recovery objectives established compliance with the provisions referred to in Article 29; for each category; l) coordinate and ensure the correct transfer of the information referred to in Article 27 provided f) ensures the monitoring of the implementation of this by producers to the preparation plants for reuse, legislative decree; treatment and recycling through electronic tools, through the preparation of a specific database. g) acts as a reference point for the representation of various problems by the interested parties, and by the Coordination Center and in particular, in the absence of a specific assessment at European level, it expresses itself on 6. The Coordination Center may also carry out its tasks the applicability or otherwise of this legislative decree to through the use of service companies and other external types of EEE not listed in Annexes II and IV; h) favors the subjects as long as the confidentiality of the data processed adoption of initiatives aimed at guaranteeing the uniform is guaranteed. application of this legislative decree and its implementing Art. 34. measures, also by submitting any proposals for changes to the legislation to the competent Ministries; i) provide the Information to the Coordination Center Ministry of the Environment and the Protection of the 1. For the purposes of carrying out the duties referred to Territory and the Sea with the information in its possession in Article 33, the Coordination Center acquires the following that is necessary for the purposes of preparing the information annually: a) data relating to the WEEE managed reports referred to in Article 31, paragraph 2. by the treatment plants; b) data relating to WEEE received from distributors. 2. With a specific resolution, the Committee defines the 2. This information may also be used for the purpose of criteria for determining the market shares referred to in letter transmitting information to the other Member States of the c) of paragraph 1, also in consideration, where possible, of European Union pursuant to Article 7, paragraph 2, of the different environmental impact of the individual types of Directive 2012/19 / EU. EEE. To this end, the Committee evaluates the life cycle analysis of the goods that can optionally be presented by Art. 35. each manufacturer with reference to their own electrical and Supervisory and control committee electronic equipment. The quotas are communicated to the producers of EEE through the website www.registroraee.it, 1. The Supervisory and Control Committee on the following a notice published in the Official Journal. For the management of WEEE and batteries, accumulators and purpose of defining the Committee market shares, . makes use the Supervisory of the Coordination related waste, already established at the Ministry of the Center. Environment and Land and Sea Protection pursuant to Article 15, — 14 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 3. For the purposes referred to in paragraph 1, the Committee Art. 37. makes use of ISPRA and, in particular, for the inspections referred to in paragraph 1, letter d) the, collaboration the Committee ofmay the Guardia also avail di itself Finanza. of Inspection and monitoring 1. The competent authorities carry out inspections and 4. The activities and functioning of the Committee are governed monitoring to verify the correct implementation of this decree. These by internal regulations adopted by the Committee itself, in inspections include at least: a) the information provided by the compliance with the provisions of this decree. The Secretariat of producer to the National Register during the registration phase the Committee is ensured by ISPRA. and in the annual communication phase; Art. 36. b) shipments, in particular exports of WEEE outside the European Union, in accordance with Regulation (EC) no. 1013/2006 Steering committee on the management of WEEE and with regulation (EC) no. 1418/2007; 1. The Steering Committee on the management of WEEE set c) the operations carried out at the treatment plants, as up and governed pursuant to articles 13 and 15 of regulation no. required by Directive 2008/98 / EC and by Annex VII to the same 185, is reconstituted within 180 days from the date of entry into directive. force of this legislative decree and operates on the basis of the provisions of regulation no. 185, except as provided by this decree. TITLE VI SANCTIONS, PROVISIONS 2. The Committee is made up of thirteen members, of which: TRANSITIONAL AND FINAL a) three designated by the national industry organizations chosen from the most representative categories, of which at least Art. 38. one representing the recovery and treatment sector; Sanctions b) two designated by the national organizations of the 1. A distributor who, in the hypothesis referred to in Article 11, categories of commerce; paragraphs 1 and 3, does not unlawfully collect, free of charge, an EEE is subject, where the fact does not constitute a crime, to a c) one from the national organizations of the craft categories; pecuniary administrative sanction from 150 euros to 400 euros, for each equipment not collected or withdrawn for consideration. d) one from the national organizations of the categories of cooperation; e) two from the Regions; f) one from ANCI; g) one from 2. Unless the fact constitutes a crime, the producer: a) fails to UPI; h) one from Confservizi; i) one from the consumer organize the separate collection system for professional WEEE referred to in article 13, and the systems for collection and associations. sending, treatment and recovery of WEEE referred to in articles 18, paragraph 2, and 19, paragraph 1, and to finance the related operations, in the hypothesis and in the manner referred to in articles 23 and 24, without prejudice, for the latter operations, to any agreements you concluded pursuant to article 24, paragraph 3, is subject to a pecuniary administrative sanction from € 30,000 to € 3. The members of the Committee remain in office for four years. 100,000; b) that, when placing an electrical or electronic equipment 4. The Steering Committee on the management of WEEE carries on the market, does not provide the financial guarantee referred to out a task of supporting the Supervisory and Control Committee in Article 25, is subject to a pecuniary administrative sanction and the Coordination Center. from 200 to 1,000 euros for each equipment placed on the market; the sanctioning of identical conduct committed after 10 July 2010 5. In particular, the Steering Committee: remains valid; c) who does not provide the information referred to in a) monitors operations, logistic functionality and article 26 in the instructions for use of EEE, is subject to a pecuniary the cost-effectiveness of the WEEE management system; administrative sanction ranging from € 2,000 to € 5,000; d) that, within one year from the placing on the market of any type of new b) acts as a point of reference for the interests of the categories represented; c) carries out a coordination function EEE, does not make the information referred to in Article 27 available to the treatment plants, is subject to a pecuniary between the interests of the categories represented in it and administrative sanction ranging from 5,000 to 30,000 euros; the activity of the Coordination Center and the Supervisory and Control Committee, through the transmission of policy documents; d) annually submits to the Ministry of the Environment a report on the progress of the WEEE collection, recovery and recycling system. — 15 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 e) who, after the deadline referred to in Article 40, Art. 39. paragraph 4, places on the market EEE without the trademark referred to in Article 28, is subject to a pecuniary administrative Amendment of annexes sanction from € 200 to € 1,000 for each equipment placed on the market; 1. By decree of the Minister of the Environment and of the Protection of the Territory and the Sea, after consulting f) who places on the market EEE without the symbol the Ministers of Health and Economic Development, the referred to in article 28, paragraph 5, is subject to a pecuniary technical directives for the modification of the annexes are administrative sanction from 100 to 500 euro for each implemented, in order to implement subsequent European provisions. equipment placed on the market; the sanctioning of identical conduct committed after 31 December 2010 remains valid; 2. If these technical directives provide for discretionary powers for their implementation, the provision is issued in agreement with the Ministers of health and economic g) who, without having registered with the Chamber of development, after consultation with the unified Conference. Commerce pursuant to article 29, paragraph 8, places EEE on the market, is subject to a pecuniary administrative Art. 40. sanction ranging from € 30,000 to € 100,000; Transitional and final provisions h) that, within the term established by article 29, paragraph 2, does not register in the National Register or 1. Until the approval by the Ministry of the Environment does not communicate the information therein, or and the Protection of the Territory and the Sea of the statutes communicates it in an incomplete or inaccurate manner, is of the existing and operating collective systems, subject to subject to the administrative sanction pecuniary from € 2,000 adaptation pursuant to Article 10, paragraph 6, the collective to € 20,000. systems continue to operate in accordance with the previous procedures. 3. Failure to register the treatment plants in the register prepared by the Coordination Center pursuant to article 33, 2. Up to the adoption of the ministerial decree referred to paragraph 2, entails the application of a pecuniary in article 25, paragraph 1, the guarantee can take the form of administrative sanction from € 2,000 to € 20,000. In case of the producer joining one of the existing collective systems. failure to register, the authority diffi from to provide within and no later than 30 days, after which the authorization is uselessly 3. The financing of the management of waste deriving revoked. from photovoltaic panels placed on the market before the 4. The violation of the communication obligation referred entry into force of this legislative decree, takes place according to in article 33, paragraph 2, entails the application of a to the procedures defined in articles 23, paragraph 1, and 24, pecuniary administrative sanction from € 2,000 to € 20,000. paragraph 1, without prejudice to the division of burdens The incorrect or incomplete communication of the same data which may have already been defined in compliance with the entails the application of the aforementioned administrative provisions of article 25, paragraph 10, of legislative decree sanctions reduced by half. The violation of the obligation to no. 28. For the management of waste produced by photovoltaic communicate information by the individual and collective panels which benefit from the incentive mechanisms referred systems for two years, even if not consecutive, in a three-year to in legislative decree no. 387, and subsequent decrees and period entails the cancellation of the office from the National implementing resolutions, in order to guarantee the financing Register referred to in Article 29. Individuals and legal entities of the operations of collection, transport, adequate treatment, canceled due to the violation of the obligation to communicate recovery and environmentally compatible disposal of the cannot be registered in the national register referred to in waste produced by these photovoltaic panels, the Energy article 29 for the following two years. Services Manager (GSE) withholds from the incentive mechanisms in the last ten years of entitlement to the incentive 5. Failure to comply with the obligation referred to in article a quota aimed at guaranteeing coverage of the management 30, paragraph 2, entails the imposition of a pecuniary costs of the aforementioned waste. The amount withheld, administrative sanction from 200 to 1,000 euro for each determined on the basis of the average costs of joining the equipment placed on the foreign market. consortia provided for by the ministerial decrees of 5 May 2011 and 5 July 2012, is returned to the holder, where it is 6. In the cases referred to in Article 21, if the shipment of ascertained that the obligations provided for by this decree used EEE suspected of being WEEE does not comply with have been fulfilled, or if, following for the supply of a new the provisions of Annex VI, the sanctions referred to in Articles panel, the responsibility lies with the manufacturer. Otherwise, 259 and 260 of the Legislative Decree 3 April are applied. the GSE provides directly, using the amounts withheld. Within 2006, n. 152. one year from the date of entry into force of this legislative 7. The provisions of articles 262 and 263 of the legislative decree, the GSE defines the method of calculating the quota decree 3 April 2006, n. 152. to be withheld and the relative operating methods to guarantee the total management of waste from photovoltaic panels. — 16 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 4. The provisions of article 28 become binding for producers Art. 42. after 180 days from the entry into force of this legislative decree. Repeals 5. The financing methods provided for in articles 23, paragraph 2, and 24, paragraph 2, also for the purposes of 1. From the date of entry into force of this decree, any the provisions of article 38, paragraph 2, letter b)article , and by 35, reference to Directive 2002/96 / EC of the European Parliament paragraph 1 , letter e) , are understood indicated in toarticle refer to20, theparagraph term and of the Council of 27 January 2003 on waste from electrical 4 of the legislative decree 25 July 2005, n. 151. and electronic equipment (WEEE), in any legislative act contained in Directive 2012/19 / EU, of the European 6. Pending the adoption of the decree referred to in Parliament and of the Council, of 4 July 2012, on waste from paragraph 2 of article 20, for the purposes of applying the electrical and electronic equipment (WEEE). simplified procedures referred to in articles 214 and 216 of legislative decree no. 152, for WEEE managed as part of the recovery operations indicated in Annex 1, sub annex 1 of the 2. From the date of entry into force of the present decree of the Minister of the Environment February 5, 1998, the decree are repealed: published in the Official Gazette no. 88 of 16 April 1998, with a) the legislative decree 25 July 2005, n. 151, and typologies n. 5.6, 5.7, 5.8, 5.9, 5.16, 5.19, 6.2, 7.20 and 13.20, subsequent amendments, with the exception of article 6, the notice of commencement of activity contains an indication of the measures adopted to ensure adequate treatment paragraph 1 -bisparagraph , of article 10, 8, ofparagraph article 15,4,paragraphs of article 13, 1 and 4, pursuant to article 18, as well as compliance with the and of article 20 , paragraph 4; established technical requirements to Annexes VII and VIII and the requisites necessary to guarantee the achievement of b) article 9, paragraphs 2 and 4, article 10, article 13, the objectives referred to in Annex V. paragraph 2, and article 14 of regulation no. 185; Art. 41. c) paragraph 1 of article 21 of law no. 96; Financial provisions d) article 22 of law no. 97. 1. The implementation of this decree must not result in new or greater charges for public finance. This decree, bearing the seal of the State, will be included in the Official Collection of Regulatory Acts of the Italian 2. The competent public administrations provide for the Republic. It is mandatory to anyone who is responsible for fulfilments envisaged by this decree with the human, observe it and have it observed. instrumental and financial resources available under current legislation. Given in Rome, on March 14, 2014 3. The charges for carrying out the preventive visit and inspections referred to in Article 20, paragraphs 3 and 4, as NAPOLITANO well as those deriving from the performance of the services and checks carried out by the territorial public offices in application of this decree are imposed charged to the recipients RENZI, President of the Council of these services and controls, on the basis of the actual cost of Ministers of the service, according to rates to be established with GALLETTI, Minister for the regional provisions. environment and for the 4. The charges relating to the monitoring activities referred protection of the territory and the sea to in Article 14, paragraph 3, and 19, paragraph 9, as well as MOGHERINI, Minister of Foreign the operating costs of the Supervisory and Control Committee, Affairs the Steering Committee on the management of WEEE and keeping the Register national level referred to in Article 29 are ORLANDO, Minister of Justice borne by the producers of EEE on the basis of their respective market shares. PADOAN, Minister of Economy 5. By decree of the Minister of the Environment and of and Finance Territorial and Sea Protection, in agreement with the Minister of Economy and Finance, to be adopted within sixty days from GUIDI, Minister of Economic the date of entry into force of this decree, the tariffs for covering Development the charges referred to in paragraph 4, as well as the relative LORENZIN, Minister of Health payment methods. With regional provisions, having consulted the local authorities LANZETTA, Minister for Regional concerned, the tariffs for covering the charges referred to in Affairs paragraph 3, as well as the relative payment methods, are determined. Seen, the Keeper of Seals: ORLANDO — 17 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX I Categories of EEE falling within the scope of application of this decree in the period indicated in article 2, paragraph 1, letter a). 1. Large appliances 2. Small appliances 3. IT and telecommunication equipment 4. Consumer equipment and photovoltaic panels 5. Lighting equipment 6. Electrical and electronic tools (except large stationary industrial tools) 7. Toys and equipment for leisure and sport 8. Medical devices (with the exception of all implanted and infected products) 9. Monitoring and control tools 10. Automatic dispensers — 18 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX II Indicative list of EEE falling within the categories of Annex I 1. LARGE APPLIANCES 1.1 Large refrigeration appliances 1.2 Refrigerators 1.3 Freezers 1.4 Other large appliances used for refrigeration, preservation and storage of food 1.5 Washing machines 1.6 Dryers 1.7 Dishwasher 1.8 Cooking appliances 1.9 Electric stoves 1.10 Electric hot plates 1.11 Microwave ovens 1.12 Other large household appliances used for cooking and further processing of foods 1.13 Electric heating appliances 1.14 Electric radiators 1.15 Other large appliances used to heat rooms, beds and seating furniture 1.16 Electric fans 1.17 Air conditioning appliances as defined by the implementing provisions of Commission Directive 2002/40 / EC of 8 May 2002 establishing the modalities from application of Council Directive 92/75 / EEC as regards labeling indicating the energy consumption of electric ovens for domestic use 1.18 Other ventilation, extraction and conditioning equipment 2. SMALL HOUSEHOLD APPLIANCES 2.1 Vacuum cleaner 2.2 Mechanical brooms 2.3 Other cleaning equipment — 19 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 2.4 Sewing machines, knitting machines, weaving machines and other processing machines of textiles 2.5 Irons and other equipment for ironing, pressing and further processing clothing 2.6 Toaster 2.7 Fryers 2.8 Blenders , electric coffee grinders and equipment used to open or seal containers or packages 2.9 Electric knives 2.10 Hair clippers, hair dryers, electric toothbrushes, electric razors, apparatus for massage and other body care 2.11 Alarm clocks, wrist or pocket watches and equipment for measuring, indicating and recording the weather 2.12 Balance sheet 3. COMPUTER AND TELECOMMUNICATIONS EQUIPMENT 3.1 Centralized data processing: 3.1.1. Mainframe 3.1.2 Minicomputer 3.1.3. Printers 3.2. Individual IT: 3.2.1. Personal computer (central unit, mouse, screen and keyboard included) 3.2.2. Laptops (central unit, mouse, screen and keyboard included) 3.2.3. Notebook 3.2.4 Electronic agendas 3.2.5 Printers 3.2.6 Copiers 3.2.7 Electric and electronic typewriters 3.2.8 Pocket and desktop calculators and other products and equipment for collecting, store, process, present or communicate information by electronic means 3.2.9 Terminals and user systems 3.2.10 Fax 3.2.11 Telex 3.2.12 Telephones — 20 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 3.2.13 Public pay telephones 3.2.14 Cordless phones 3.2.15 mobile phones 3.2.16 Telephone answering machines and other products or equipment to transmit sound, images or other information through telecommunication 4. CONSUMER EQUIPMENT AND PHOTOVOLTAIC PANELS 4.1 Radio equipment 4.2 Television sets 4.3 Cameras 4.4 Video registrars 4.5 Hi-fi recorders 4.6 Audio Amplifiers 4.7 Musical instruments 4.8 other products or equipment for recording or reproducing sound or images, including signals or other technologies for the distribution of sound and images other than telecommunication 4.9 Photovoltaic panels 5. LIGHTING EQUIPMENT 5.1 Chandeliers for fluorescent lamps with the exception of home chandeliers 5.2 Fluorescent tubes 5.3 Compact fluorescent lamps 5.4 High density discharge lamps, including high pressure sodium vapor lamps e metal halide lamps 5.5 Low pressure sodium vapor lamps 5.6 Other lighting equipment to diffuse or control light except of incandescent lamps 6. ELECTRICAL AND ELECTRONIC TOOLS (EXCEPT TOOLS FIXED INDUSTRIAL LARGE DIMENSIONS) 6.1 Drills 6.2 Saws — 21 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 6.3 Sewing machines 6.4 Equipment for turning, milling, sanding, grinding, sawing, cutting, shearing, drilling, boring, punching, bending, bending or similar procedures on wood, metal or other materials 6.5 Tools for riveting, nailing or screwing or removing rivets, nails and screws or use similar 6.6 Tools for welding, brazing or similar use 6.7 Equipment for spraying, spreading, dispersing or other treatment of substances liquid or gaseous by other means 6.8 Tools for lawn mowers or other gardening activities 7. TOYS AND EQUIPMENT FOR LEISURE AND SPORT 7.1 Electric trains or toy racing cars. 7.2 Handheld video game consoles 7.3 Video games 7.4 Computer for cycling, diving, running, rowing, etc. 7.5 Sports equipment with electrical or electronic components 7.6 Coin operated machines 8. MEDICAL DEVICES (EXCEPT ALL IMPLANTED PRODUCTS AND INFECTED) 8.1 Radiotherapy equipment 8.2 Cardiology equipment 8.3 Dialysis equipment 8.4 Pulmonary ventilators 8.5 Nuclear medicine devices 8.6 Laboratory equipment for in vitro diagnosis 8.7 Analyzers 8.8 Freezers 8.9 Fertilization test 8.10 Other equipment for diagnosing, preventing, monitoring, treating and alleviating disease, injuries or disabilities — 22 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 9. MONITORING AND CONTROL TOOLS 9.1 Smoke detectors 9.2 Heat regulators 9.3 Thermostats 9.4 Measuring, weighing or regulating equipment for domestic or laboratory use 9.5 Other monitoring and control tools used in industrial plants (e.g. in control panels) 10. AUTOMATIC DISTRIBUTORS 10.1 Vending machines, including machines for preparation and dispensing automatic or semiautomatic of foods or of: a) hot and cold drinks, bottles and cans; b) of solid products 10.2 Automatic cash dispensers 10.3 All vending machines of any type of product — 23 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX III Categories of EEE falling within the scope of this decree in the period indicated in article 2, paragraph 1 letter b). , 1. Temperature exchange equipment 2. Screens, monitors and equipment equipped with screens with an area greater than 100 cm2 3. Lamps 4. Large fixtures (with at least an external dimension greater than 50 cm), including, but not limited to: household appliances; computer and telecommunication equipment; consumer equipment; chandeliers; equipment for reproducing sound or images, musical equipment; electric and electronic instruments; toys and weather equipment free and sport; medical devices; monitoring and control tools; distributors automatic; electrical power generation equipment. This category does not include the equipment belonging to categories 1, 2 and 3. 5. Small equipment (with no external dimension greater than 50cm), including, but not limited to: household appliances; consumer equipment; chandeliers; equipment for reproducing sound or images, musical equipment; electric and electronic instruments; toys and equipment for leisure and sport; medical devices; tools of monitoring and control; vending machines; power generation equipment electric. This category does not include equipment belonging to categories 1, 2, 3 and 6. 6. Small IT and telecommunication equipment (with no external dimension greater than 50 cm). — 24 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX IV Non-exhaustive list of EEE falling within the categories set out in Annex III 1. Temperature exchange equipment 1.1 Refrigerators 1.2 freezers 1.3 appliances that automatically distribute cold products, 1.4 air conditioners, dehumidifiers, heat pumps, 1.5 oil radiators 1.6 other equipment for the exchange of temperature with fluids other than water. 2. Screens, monitors and equipment with screens having a surface greater than 100 cm2 2.1 Screens 2.2 televisions 2.3 LCD digital photo frames 2.4 monitor, 2.5 laptop, notebook. 3. Lamps 3.1 Fluorescent tubes 3.2 compact fluorescent lamps 3.3 fluorescent lamps 3.4 high density discharge lamps, including high pressure sodium vapor lamps and metal halide lamps, low pressure sodium vapor lamps 3.5 LED. 4. Large equipment 4.1 Washing machines 4.2 dryers 4.3 dishwasher 4.4. cooking appliances, electric stoves, electric hot plates 4.5 chandeliers 4.6 equipment for reproducing sound or images, musical equipment (excluding pipe organs installed in churches) — 25 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 4.7 sewing machines, knitting machines, 4.7 mainframe 4.6 large printers 4.9 large copiers 4.10 large coin operated machines 4.11 large medical devices 4..12 large monitoring and control tools 4.13 large devices that automatically distribute products and money 4.14 photovoltaic panels. 5. Small equipment 5.1 Vacuum cleaner 5.2 mechanical brooms 5.3 sewing machines 5.4 chandeliers 5.5 microwave ovens 5.6 electric fans 5.7 irons 5.8 toaster 5.9 electric knives 5.10 electric kettles 5.11 alarm clocks and watches 5.12 electric razors 5.13 balance sheet 5.14 hair clippers and body care appliances 5.15 calculators 5.16 radio sets 5.17 video cameras, video recorders 5.18 hi-fi apparatus, musical instruments, equipment for reproducing sound or images 5.19 electric and electronic toys 5.20 sports equipment, computer for cycling, diving, running, rowing, etc., 5.21.Smoke detectors, heat regulators, thermostats, small electrical tools and electronics, small medical devices, small monitoring and control instruments, — 26 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 5.22 small appliances that automatically distribute products 5.23 small appliances with integrated photovoltaic panels. 6. Small IT and telecommunication equipment (with no external dimension more than 50 cm) 6.1 Mobile phones 6.2 satellite navigators (GPS), 6.3 pocket calculators 6.4 router 6.5 PC 6.6 printers 6.7 telephony. — 27 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX V MINIMUM RECOVERY OBJECTIVES REFERRED TO IN ARTICLE 15 Part 1: Minimum targets applicable by category from until 14 August 2015 with reference to the categories listed in Annex I: a) for WEEE falling under categories 1 or 10 of Annex I, - 80% recovery, e - 75% recycling; b) for WEEE falling under categories 3 or 4 of Annex I, - 75% recovery, e - 65% recycling; c) for WEEE falling under categories 2, 5, 6, 7, 8 or 9 of Annex I, - 70% recovery, and - 50% recycling; d) for discharge lamps, recycling of 80%. Part 2: Minimum targets applicable by category from 15 August 2015 until 14 August 2018 with reference to the categories listed in Annex I: a) for WEEE falling under categories 1 or 10 of Annex I, - 85% recovery, e - preparation for reuse and recycling of 80%; b) for WEEE falling under categories 3 or 4 of Annex I, - 80% recovery, e - 70% preparation for reuse and recycling; c) for WEEE falling under categories 2, 5, 6, 7, 8 or 9 of Annex I, - 75% recovery, e - 55% preparation for reuse and recycling; d) for discharge lamps, recycling of 80%. Part 3: Minimum targets applicable by category from 15 August 2018 with reference to categories listed in Annex III: a) for WEEE falling under categories 1 or 4 of Annex III, - 85% recovery, e — 28 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 - preparation for reuse and recycling of 80%; b) for WEEE falling under category 2 of Annex III, - 80% recovery, e - 70% preparation for reuse and recycling; c) for WEEE falling under Annex III, categories 5 or 6, - 75% recovery, e - 55% preparation for reuse and recycling; d) for WEEE falling under category 3 of Annex III, recycling of 80%. — 29 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX VI MINIMUM REQUIREMENTS FOR SHIPMENTS 1. In order to distinguish EEE from WEEE, if the holder of the article declares that he wants to ship o to send used EEE and not WEEE, the holder in support of his declaration must attach the following documents: a) copy of the invoice and contract relating to the sale and / or transfer of ownership of the EEE, which certify that the equipment is fully functional and intended for direct use to reuse; b) evidence of the evaluation or tests conducted, in the form of copies of the documentation (test certificate, function test) on each item of the shipment and a protocol containing all the information indicated in point 3; c) a declaration from the holder who arranges the transport of the EEE, showing that no material or equipment of the shipment is classifiable as "waste" within the meaning of Article 3 (1) of Directive 2008/98 / EC, and d) adequate protection against damage during transport, loading and unloading, in particular through suitable packaging and adequate stacking of the cargo. 2. The documents indicated in point 1 of this annex under letters a) and b) and in point 3 are not required if it is documented by conclusive evidence that the shipment takes place in the context of a transfer agreement between companies and that: a) defective EEE is returned to the manufacturer or a third party acting on its behalf for repair under warranty or repair contract for reuse; or b) used EEE for professional use is returned to the manufacturer or to a third party acting on his behalf or to a third party facility in countries where Decision C (2001) applies 107 / fin. of the OECD Council on the revision of the OECD decision (92) 39 / fin. on control of transboundary movements of waste destined for recovery operations, for renewal or repair under a valid contract for reuse purposes; or c) Defective used EEE for professional use, such as medical devices and parts thereof, are returned to the manufacturer or a third party acting on its behalf for a root cause analysis based on a valid contract, in cases where this analysis can only be carried out by the manufacturer. 3. To prove that the items shipped are used EEE and not WEEE, it is necessary that the tests indicated in point 1 are carried out on the EEE to be shipped and that the documentation referred to in point 2: — 30 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 1. Prove a) Test the functionality and evaluate the presence of dangerous substances. The tests carried out depend on the type of EEE. A function test is sufficient for most EEE main. b) Record the results of the evaluation and tests. 2. Documentation a) The documentation must be firmly affixed, but not permanently fixed, on the EEE itself (if it is not packaged) or on the packaging, so that it can be read without unpack the equipment. b) The documentation contains the following information: - name of the item (name of the equipment if listed in Annex II or Annex IV, if applicable, and category set out in Annex I or Annex III, if applicable), - item identification number (matr. no.) where appropriate, - year of production (if available), - name and address of the company responsible for the functionality tests, - result of the tests referred to in point 1 (including the date of the functionality test), - type of tests carried out. 4. In addition to the documentation required in points 1, 2 and 3, each load (for example each container or truck) of used EEE must be accompanied by: a) relevant transport document, e.g. CMR, or waybill, b) declaration of the responsible person under his own responsibility. 5. In the absence of proof that an item is a used EEE and not a WEEE by means of the appropriate documentation referred to in points 1, 2, 3 and 4 and adequate protection against damage during the transport, loading and unloading, in particular through suitable packaging and adequate stacking of the load, which constitute obligations for the holder who organizes the transport, the Member State authorities consider the item to be WEEE and assume that the cargo contains an illegal shipment. In such circumstances, the competent authorities and the cargo is treated as required by articles 24 and 25 of Regulation (EC) no. 1013/2006. — 31 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX VII MANAGEMENT METHOD OF WEEE IN THE TREATMENT PLANTS REFERRED TO IN ARTICLE 18, PARAGRAPH 2 1. Methods of collection and conferment 1.1 The collection of WEEE to be subjected to treatment operations must be carried out by adopting criteria that guarantee the protection of discarded equipment during transport and during loading and unloading operations. 1.2 The equipment must not be damaged that could cause the release of polluting or dangerous substances for the environment or compromising subsequent operations recovery. 1.3 Injury to refrigeration circuits and walls must be avoided, in the case of refrigerators, for avoid the release of refrigerants or oils to the atmosphere, as well as to the cathode ray tubes, in the case of televisions and computers, The light sources referred to in point 5 of annex 1B, during the collection, storage and handling, must be kept intact to avoid the dispersion of dust and vapors contained in the equipment itself, also through the use of special containers that ensure their integrity. 1.4 They must be: a) suitable choices of lifting equipment; b) removed any residual substances that could be released during the handling of the equipment; c) the doors are closed and the moving parts are secured; the d) integrity of the seal with respect to liquids or gases contained in the circuits is maintained; and) avoid volumetric reduction operations before putting them into safety conditions; f) use conservative methods of loading the transport boxes. 2. Management of incoming waste 2.1 The materials to be treated must be characterized and separated for each individual typology in order to identify the specific treatment methodology. 2.2 a radioactivity detector at the entrance to the plant, even portable, must allow for identify any radioactive materials present in the waste. 3. Criteria for waste storage — 32 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 3.1. The storage of dismantled parts and waste must be carried out in such a way as not to modify them the characteristics compromising the subsequent recovery. 3.2. Fixed and mobile containers, including tanks and basins used for the storage of waste, they must possess adequate resistance requirements in relation to the chemical-physical properties and the dangerous characteristics of the waste itself. 3.3. The tanks containing the hazardous liquid waste must be equipped with suitable devices anti-overflow and containment devices. 3.4. Containers of volatile fluids must be watertight and maintained in conditions of controlled temperature. 3.5. If hazardous waste is stored in mobile containers, these must be provided from: a) suitable closures to prevent the leakage of the stored waste; b) devices suitable for carrying out filling and filling operations in safe conditions emptying; c) gripping means for making handling operations safe and easy. 3.6. Appropriate labeling must be affixed to fixed and mobile containers indicating the waste stored. 3.7. The storage of CFCs and HCFCs must take place in compliance with the provisions of implementing provisions of article 5 of the law of 28 December 1993, n. 549, containing measures a protection of stratospheric ozone. 3.8. The storage of waste oils must be carried out in compliance with the provisions of the legislative decree 27 January 1992, n. 95, and subsequent amendments, and by the decree of the Minister industry, trade and crafts 16 May 1996, n. 392. 3.9. The storage of cells and capacitors containing PCBs and other waste containing substances dangerous or radioactive must take place in suitable containers in compliance with the regulations that regulate the deposit of the dangerous substances contained therein. 3.10. The handling and storage of equipment and the resulting waste must take place in such a way that any contamination of the soil and surface receiving bodies is avoided e deep. 3.11. All precautions must be taken to prevent the formation of odors and the dispersion of aerosols and dust. 3.12. The discarded equipment storage sector must be organized in distinct areas for each type of treatment for which the equipment is intended. in the case of equipment containing hazardous substances, these areas must be marked with tables, — 33 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 clearly visible for size and location, indicating the rules for behavior, for the handling of waste and for the containment of risks to human health and the environment. 3.13. In the storage area of decommissioned equipment, procedures must be adopted for Avoid stacking equipment without proper safety measures for operators and for the integrity of the equipment itself. 4. Safety of WEEE 4.1. The activity consists of the complex of operations necessary to return the equipment environmentally safe and ready for subsequent operations. 4.2. The safety measures must include, in advance, the removal of all fluids and following substances, preparations and components: a) capacitors containing polychlorinated diphenyls (PCBs) to be treated pursuant to the decree legislative 22 May 1999, n. 209; b) mercury-containing components, such as switches or backlights; fleece; c) d) printed circuits of mobile phones in general and other devices if the surface of the printed circuit is greater than 10 cm2; and) toner cartridges, liquid and powder, and color toner; f) plastics containing brominated flame retardants; g) waste asbestos and components that contain asbestos; h) cathode ray tubes; i) colorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs), hydrofluoroclorocarbons (HFCs) or hydrocarbons (HC); L) discharge light sources; (m) liquid crystal displays, if applicable with coating, with an area exceeding 100 cm2 and all of them backlit by discharge light sources; n) external electrical cables; O) components containing refractory ceramic fibers described in directive 97/69 / EC of Commission of 5 December 1997 adapting the directive to technical progress 67/548 / EEC of the Council relating to the classification, packaging and labeling of dangerous substances; p) components containing radioactive substances, except for components that are beyond below the exemption thresholds provided for in Article 3 and Annex I to Directive 96/29 / EURATOM of the Council of 13 May 1996 establishing the basic safety standards relating to — 34 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 health protection of the population and workers against the dangers deriving from radiation ionizing; q) electrolytic capacitors containing potentially dangerous substances (height> 25 mm, diameter> 25 mm or proportionally similar in volume). 4.3 The substances and components listed are eliminated or recovered without creating health risks man and the environment. 4.4. The following components of separately collected WEEE must be treated as follows: cathode ray tubes: remove the fluorescent coating; b) equipment containing gases that deplete ozone or have a potential of global warming (GWP) greater than 15, present for example in foam and in the circuits of refrigeration: the gases must be extracted and treated appropriately. Gases that deplete ozone must be treated in accordance with Regulation (EC) no. 2037 of 2000 of the European Parliament and of Council of 29 June 2000 on substances that deplete the ozone layer and in compliance with the dispositions foreseen by the implementing provisions of article 5 of the law of 28 December 1993, n. 549, containing measures for the protection of stratospheric ozone; c) discharge light sources: remove mercury, avoiding the dispersion of dust e vapors. 5. Environmental safeguards 5.1 The WEEE treatment plants must be operated in such a way as to avoid any contamination of soil and superficial and / or deep receptor bodies. 5.2 All precautions must be taken to prevent the release of dangerous fluids, formation odors and the dispersion of aerosols and dust 5.3 In the event of the formation of gaseous emissions and / or dust, the system must be equipped with suitable system of collection and abatement of the same. 5.4 For treatment plants for equipment containing ozone depleting substances stratospheric emission limit values and related controls are provided for by the provisions of implementation of article 5 of law no. 549, containing measures for the protection of ozone stratospheric. — 35 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX VIII TECHNICAL REQUIREMENTS OF THE TREATMENT PLANTS REFERRED TO IN ARTICLE 18, PARAGRAPH 2 OF THIS DECREE 1.1 The treatment plants governed by this decree are not characterized by environmental impacts higher than those of any industrial plant and therefore do not involve particular precautions due to the nature of the materials treated. 1.2 The treatment plant must be delimited by a suitable fence along its entire length perimeter. The external protective barrier must be made with hedges, trees and screens mobile, designed to minimize the visual impact of the system. Maintenance must be ensured in the time of said environmental protection barrier. The plant must be suitably equipped per: a) treat the specific flow of discarded equipment; b) identify and manage the dangerous components that must be removed in advance at the treatment stage. 1.3 The presence of qualified and adequately trained personnel must be guaranteed to manage specific waste, avoiding releases into the environment, and able to promptly adopt emergency procedures in the event of accidents, based on current safety regulations at work. 1.4 At the closure of the plant, a restoration plan must be envisaged in order to guarantee the usability of the site in line with the urban destination of the area. 1.5 Organization and equipment of the treatment plant. 1.5.1 The plant must be equipped with areas for the temporary storage of WEEE, built in compliance with the requirements indicated in the legislative decree 13 January 2003, n. 36, implementing the Directive 1999/31 / EC on the landfill of waste. In the plant, the areas must be distinguished storage of incoming waste from those used for the storage of outgoing waste and materials to be sent for recovery. The plant must be organized in the following specific sectors corresponding, as applicable, to the respective processing phases: a) disposal and storage sector of decommissioned WEEE; b) safety sector; c) disassembly sector for reusable parts; d) carcass crushing sector; and) storage sector of environmentally critical components; f) storage sector of components and recoverable materials; — 36 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 g) storage sector of non-recoverable waste resulting from treatment operations from be destined for disposal 1.5.2 The storage and treatment plant must be equipped with: a) scales to measure the weight of the waste treated; b) adequate canalization system to protect external rainwater; c) adequate system of collection and removal of rainwater with separator of the first rain water, to be sent to the treatment plant; d) adequate waste collection system; n case of storage of waste they contain oily substances, the presence of decanters and detergents-degreasers must be guaranteed; and) surfaces resistant to chemical attack by waste; f) weatherproof cover for the delivery, safety and security areas storage of environmentally critical components and dismantled parts and intended materials to recovery. g) suitable containers for the storage of batteries, capacitors containing PCB / PCT and other waste as hazardous as radioactive waste 1.5.3. The sectors for the transfer and storage of discarded WEEE, for the safety and storage of environmentally critical components must be equipped with waterproof with a slope such as to convey any liquids in special channels and in collection wells. 1.5.4 The delivery area must be large enough to allow for easy handling of incoming and outgoing vehicles and equipment. 1.5.5 Treatment plants for equipment containing ozone depleting substances stratospheric must comply with the requirements provided for by the implementing provisions of article 5 of the law of 28 December 1993, n. 549, containing measures for the protection of stratospheric ozone. — 37 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX IX SYMBOL FOR MARKING ELECTRICAL EQUIPMENT ED ELECTRONICS REFERRED TO IN ARTICLE 28 The symbol indicating the separate collection of electrical and electronic equipment is a wheeled bin crossed out as shown below, accompanied by a solid bar horizontal which identifies electrical and electronic equipment placed on the market after August 13, 2005. The union of the symbol (bin and bar) must have a minimum height of 7 mm (a = 3.33 mm), while the height of the bar must be greater than 0.3 a or 1 mm. The bar must not contain any type of text. — 38 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 ANNEX X INFORMATION FOR REGISTRATION AND COMMUNICATIONS REFERRED TO IN ARTICLE 29 A. Information to be provided upon registration: 1. Name and address of the manufacturer or authorized representative, if designated by law Article 30 (postcode and town, street and house number, country, telephone and fax number, e-mail address as well as a contact person). In the case of a representative authorized as defined in Article 30, also the data relating to the producer who is represented. 2. National identification code of the producer, including the European or national tax number of the producer. 3. Category of EEE referred to in Annexes I and III, as well as the specific type of EEE indicated in Annex II and IV. 4. Type of EEE (equipment for domestic or other uses). 5. Trademark of the EEA. 6. Information on how the manufacturer fulfills its responsibilities: individually or through a collective scheme, including information on financial collateral. 7. Sales technique used (eg distance selling). 8. Declaration certifying that the information provided is true. B. Information to be provided for communications: 1. National identification code of the producer. 2. Reference period. 3. Category of EEE referred to in Annex I or Annex III, as well as the specific type of EEE indicated in Annexes II and IV. 4. Quantity of EEE released on the national market, by weight. 5. Quantity, by weight, of waste EEE separately collected, recycled (including prepared for re-use), recovered and disposed of within the Member State or shipped inside or outside of the Union. Note: the information referred to in points 4 and 5 must be provided by category. — 39 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 NOTE 2011/51 / EU of the European Parliament and of the Council of 11 May 2011 amending Council Directive 2003/109 / EC to extend its scope to WARNING: beneficiaries of international protection (deadline for transposition May 20, 2013); 2011/61 / EU of the European Parliament and of the Council, of 8 June - The text of the notes published here was drawn up by the administration competent for the matter pursuant to article 10, paragraphs 2 and 3 of the 2011, on alternative investment fund managers, amending Directives consolidated text of the provisions on the promulgation of laws, on the 2003/41 / EC and 2009/65 / EC and Regulations (EC) no. 1060/2009 and (EU) enactment of the decrees of the President of the Republic and on the official no. 1095/2010 (deadline for transposition 22 July 2013); publications of the Italian Republic, approved by decree of the President of the Republic 28 December 1985, n. 1092, for the sole purpose of facilitating the 2011/62 / EU of the European Parliament and of the Council of 8 June reading of the amended law provisions or to which the referral is made. The 2011 amending Directive 2001/83 / EC, laying down a Community code relating value and effectiveness of the legislative acts transcribed here remain to medicinal products for human use, in order to prevent the entry of falsified unchanged. medicines in the legal supply chain (deadline for transposition 2 January 2013); - For the EEC directives, the publication details are provided in the Official Journal of the European Communities (GUCE). 2011/65 / EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) (transposition deadline 2 January 2013); Notes to the premises: 2011/70 / Euratom of the Council of 19 July 2011 establishing a Community - Art. 76 of the Constitution establishes that the exercise of the legislative framework for the responsible and safe management of spent nuclear fuel and function cannot be delegated to the Government except with the determination radioactive waste (transposition deadline 23 August 2013); of guiding principles and criteria and only for a limited time and for defined objects. 2011/76 / EU of the European Parliament and of the Council of 27 - Art. 87 of the Constitution confers, among other things, the President of September 2011 amending Directive 1999/62 / EC on the taxation of heavy the Republic the power to promulgate laws and to issue decrees having the goods vehicles used for the carriage of goods by road for the use of certain force of law and regulations. infrastructures ( deadline for transposition 16 October 2013); - The law of 24 December 2012, n. 234 (General rules on Italy's 2011/77 / EU of the European Parliament and of the Council, of 27 participation in the formation and implementation of European Union legislation September 2011, amending Directive 2006/116 / EC concerning the duration and policies) is published in the Official Journal of 4 January 2013, no. 3. of protection of copyright and certain related rights (transposition deadline 1 ° November 2013); - The text of annex B of the law 6 August 2013, n. 96 (Delegation to the 2011/82 / EU of the European Parliament and of the Council, of 25 Government for the transposition of European directives and the implementation October 2011, aimed at facilitating the cross-border exchange of information on of other European Union acts - European delegation law 2013), published in road safety offenses (transposition deadline 7 November 2013); the Official Journal no. 194, reads as follows: 2011/83 / EU of the European Parliament and of the Council, of 25 "Annex B (Article 1, paragraphs 1 and 3) October 2011, on consumer rights, amending the directive Effective from 4 September 2013 93/13 / EEC of the Council and of Directive 1999/44 / EC of the European Parliament and of the Council and repealing Council Directive 85/577 / EEC 2009/101 / EC of the European Parliament and of the Council, of 16 and Directive 97/7 / EC of the European Parliament and of the Council (term September 2009, aimed at coordinating, in order to make them equivalent, the transposition of 13 December 2013); guarantees that are required, in the Member States, of companies pursuant to Article 48, second paragraph, of Treaty to protect the interests of shareholders 2011/85 / EU of the Council of 8 November 2011 on the requirements for and third parties (without deadline for transposition); the budgetary frameworks of the Member States (transposition deadline 31 December 2013); 2009/102 / EC of the European Parliament and of the Council, of 16 September 2009, in the matter of company law, relating to limited liability 2011/89 / EU of the European Parliament and of the Council, of 16 companies with a single shareholder (without deadline for transposition); November 2011, amending Directives 98/78 / EC, 2002/87 / EC, 2006/48 / EC and 2009/138 / EC as regards the supplementary supervision of financial 2009/158 / EC of the Council, of 30 November 2009, on the animal health firms belonging to a financial conglomerate (transposition deadline 10 June rules for intra-community trade and imports from third countries of poultry and 2013); hatching eggs (without transposition deadline); 2011/93 / EU of the European Parliament and of the Council of 13 December 2011 on the fight against the sexual abuse and sexual exploitation 2010/32 / EU of the Council of 10 May 2010, which implements the of minors and child pornographers, and which replaces the framework decision framework agreement, concluded by HOSPEEM and EPSU, on the prevention 2004/68 / JHA of the Council (deadline for transposition 18 December 2013); of stabbing or stabbing injuries in the hospital and health sector (deadline for transposition 11 May 2013); 2011/95 / EU of the European Parliament and of the Council, of 13 December 2011, laying down rules on the attribution, to nationals of third 2010/63 / EU of the European Parliament and of the Council, of 22 countries or stateless persons, of the qualification of beneficiary of international September 2010, on the protection of animals used for scientific purposes protection, on a uniform status for refugees or for persons entitled to benefit (transposition deadline 10 November 2012); from subsidiary protection, as well as on the content of the recognized protection 2010/64 / EU of the European Parliament and of the Council of 20 (recast) (transposition deadline 21 December 2013); October 2010 on the right to interpretation and translation in criminal 2011/98 / EU of the European Parliament and of the Council, of 13 proceedings (transposition deadline 27 October 2013); December 2011, relating to a single application procedure for the issue of a 2010/75 / EU of the European Parliament and of the Council of 24 single permit allowing third-country nationals to reside and work in the territory November 2010 on industrial emissions (integrated pollution prevention and of a Member State and to a common set of rights for third country workers reduction) (recast) (transposition deadline 7 January 2013); legally residing in one Member State (transposition deadline 25 December 2013); 2011/16 / EU of the Council of 15 February 2011, relating to administrative 2011/99 / EU of the European Parliament and of the Council, of 13 cooperation in the tax sector and repealing the directive December 2011, on the European protection order (transposition deadline 11 77/799 / EEC (transposition deadline 1 January 2013); January 2015); 2011/24 / EU of the European Parliament and of the Council, of 9 March 2012/4 / EU of the Commission, of 22 February 2012, amending Directive 2011, concerning the application of patients' rights relating to cross-border 2008/43 / EC, on the establishment, pursuant to Directive healthcare (transposition deadline 25 October 2013); 93/15 / EEC of the Council, of a system for the identification and traceability of explosives for civil use (transposition deadline 4 April 2012); 2011/36 / EU of the European Parliament and of the Council of 5 April 2012/12 / EU of the European Parliament and of the Council of 19 April 2011 on the prevention and repression of trafficking in human beings and the 2012 amending Council Directive 2001/112 / EC concerning fruit juices and protection of victims, and which replaces the Council Framework Decision other similar products intended for human consumption (transposition deadline 2002/629 / JHA (deadline transposition 6 April 2013); 28 October 2013); — 40 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 2012/13 / EU of the European Parliament and of the Council, of 22 May 4. Waste is managed without endangering human health and without using 2012, on the right to information in criminal proceedings (transposition deadline processes or methods that could harm the environment and, in particular: a) 2 June 2014); without creating risks for water, air, soil, as well as for fauna and flora; b) without 2012/18 / EU of the European Parliament and of the Council, of 4 July causing inconvenience from noise or odors; c) without damaging the 2012, on controlling the danger of major accidents connected with dangerous landscape and sites of particular interest, protected according to current substances, amending and subsequently repealing Council Directive 96/82 / EC legislation. (deadline for transposition 31 May 2015; for Article 30, transposition deadline 14 February 2014); 2012/19 / EU of the European Parliament and of the Council, of 4 July 5. To achieve the purposes and objectives referred to in paragraphs 1 to 2012, on waste from electrical and electronic equipment (WEEE) (recast) 4, the State, the regions, the autonomous provinces and the local authorities (transposition deadline 14 February 2014); exercise the powers and functions of their respective competence in the field of 2012/26 / EU of the European Parliament and of the Council, of 25 waste management in compliance to the provisions referred to in part four of this October 2012, amending Directive 2001/83 / EC as regards pharmacovigilance decree, adopting all appropriate actions and making use, where appropriate, by (transposition deadline 28 October 2013); means of agreements, program contracts or memoranda of understanding, 2012/27 / EU of the European Parliament and of the Council, of 25 including experimental ones, of public or private subjects. October 2012, on energy efficiency, amending Directives 2009/125 / 6. The subjects referred to in paragraph 5 also constitute a complete and CEe 2010/30 / UE and repeals Directives 2004/8 / EC and 2006/32 / EC (final synergistic system which harmonises, in a unitary context, in relation to the transposition deadline 5 June 2014); objectives to be pursued, the drafting of technical standards, accreditation systems and certification systems relating to directives. environmentally or 2012/28 / EU of the European Parliament and of the Council, of 25 indirectly, with particular reference to the management of waste, according to October 2012, on certain permitted uses of orphan works (transposition deadline the criteria and methods referred to in Article 195, paragraph 2, letter a) , and in 29 October 2014); compliance with the information proceduresthe in the technical sector regulations of regulations andand rules of 2012/29 / EU of the European Parliament and of the Council of 25 October relating to information society services, provided for by the Community directives 2012 establishing minimum standards on the rights, assistance and protection and related implementation rules, with particular reference to the law of 21 June of victims of crime and replacing the framework decision 1986, no. 317. 2001/220 / JHA (transposition deadline 16 November 2015); 2012/33 / EU of the European Parliament and of the Council of 21 7. The regions and autonomous provinces adapt their respective November 2012 amending Council Directive 1999/32 / EC on the sulfur content regulations to the provisions for the protection of the environment and the of marine fuels (transposition deadline 18 June 2014); ecosystem contained in part four of this decree within one year from the date of entry into force of this provision. 2012/34 / EU of the European Parliament and of the Council, of 21 8. For the purpose of implementing the principles and objectives November 2012, establishing a single European railway area (recast) established by the provisions referred to in part four of this decree, the Minister (transposition deadline 16 June 2015); for the Environment and for the Protection of the Territory and the Sea may make use of the technical support of the Higher Institute for environmental 2012/52 / EU of the Commission, of 20 December 2012, involving many protection and research (ISPRA), without new or increased burdens for public finance. " measures aimed at facilitating the recognition of medium prescriptions issued in another Member State (transposition deadline 25 October 2013); 2013/1 / EU “Art. 178. (Principles) of the Council, of 20 December 2012, amending Directive 93/109 / EC relating 1. The management of waste is carried out in accordance with the to certain procedures for exercising the right of eligibility in elections to the principles of precaution, prevention, sustainability, proportionality, re sponsibility European Parliament for Union citizens residing in a State member of which they and cooperation of all those involved in the production, distribution, use and are not citizens (transposition deadline 28 January 2014). ". consumption of goods to be origin of the waste, as well as the polluter pays principle. To this end, waste management is carried out according to criteria of effectiveness, efficiency, cost-effectiveness, transparency, technical and economic feasibility, as well as in compliance with current regulations on - Directive 2012/19 / EU on waste from electrical and electronic equipment participation and access to environmental information. " (WEEE) (recast) is published in the OJEU 24 July 2012, no. L 197. "Art. 178 -BIS . (Extended producer responsibility) - The legislative decree of 25 July 2005, n. 151 (Implementation of Directive 2002/95 / EC, Directive 2002/96 / EC and Directive 2003/108 / EC, 1. In order to strengthen prevention and facilitate the efficient use of relating to the reduction of the use of hazardous substances in electrical and resources during the entire life cycle, including the phases of reuse, recycling electronic equipment, as well as the disposal of waste ) is published in the Official and recovery of waste, avoiding compromising the free movement of goods on Gazette of 29 July 2005, no. 175, SO. the market , may be adopted, after consulting the interested parties, with one or more decrees of the Minister for the Environment and for the Protection of the Territory and the Sea having a regulatory nature, having heard the unified - The legislative decree 3 April 2006, n. 152 (Environmental regulations), Conference referred to in Article 8 of Legislative Decree 28 August 1997, n. 281, is published in the Official Gazette of 14 April 2006, no. 88, SO n. 96. the methods and criteria for introducing the extended responsibility of the product producer, understood as any natural or legal person who professionally develops, manufactures, transforms, treats, sells or imports products, in the organization Note all’art. 1: of the waste management system , and in the acceptance of returned products and waste that remain after their use. For my purposes, the methods and criteria The text of articles 177, 178, 178 -bis , 179, 180, 180 -bis and 181 of the may be adopted with one or more decrees of the Minister for the Environment aforementioned legislative decree 3 April 2006, n. 152, it reads: and for the Protection of the Territory and the Sea in agreement with the Ministry "Art. 177. (Scope and purpose) of Economic Development: 1. Part four of this decree governs the management of waste and the remediation of polluted sites, also in implementation of Community directives, in a) management of waste and the related financial responsibility of the particular Directive 2008/98 / EC, providing for measures aimed at protecting producers of the product. The decrees of this letter are adopted in agreement the environment and human health, by preventing or reducing the negative with the Ministry of Economy and Finance; impacts of the production and management of waste, reducing the overall b) publicizing information relating to the extent to which the product is impacts of the use of resources and improving their effectiveness. reusable and recyclable; c) product design aimed at reducing their environmental impacts; d) product design aimed at reducing or eliminating waste during 2. The management of waste constitutes an activity of public interest. the production and subsequent use of the products, ensuring that the recovery 3. This is without prejudice to specific, particular or complementary and disposal of products that have become waste take place in compliance provisions, compliant with the principles set out in part four of this decree with the criteria set out in Articles 177 and 179; adopted in implementation of Community directives governing the management of certain categories of waste. — 41 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 e) aimed at favoring and encouraging the development, production and I'm 2005, n. 195, the use of economic tools, criteria for public tender procedures, marketing of products suitable for multiple use, technically durable, and which, and other necessary measures. after becoming waste, are suitable for adequate and safe recovery and disposal 8. The Administrations concerned shall fulfill the obligations referred to in this compatible with environment. article with the human, instrumental and financial resources available under current 2. The extended responsibility of the product manufacturer is applicable legislation, without new or greater charges for public finance. " without prejudice to the responsibility for the management of waste referred to in Article 188, paragraph 1, and without prejudice to existing legislation concerning "Art. 180. (Prevention of the production of waste) waste streams and specifi c products. 1. In order to promote as a priority the prevention and reduction of the 3. The decrees referred to in paragraph 1 may also provide that the costs of production and harmfulness of waste, the initiatives referred to in article 179 managing the waste are partially or entirely borne by the producer of the product concern in particular: a) the promotion of economic instruments, eco-balances, causing the waste. If the producer of the product participates partially, the distributor systems of environmental certification, use of the best available techniques, of the product competes for the difference up to the full coverage of these costs. analysis of the life cycle of products, information and consumer awareness actions, the use of quality systems, as well as the development of the eco-label system for 4. The implementation of this article must not result in new or greater burdens the purposes of correct assessment of the impact of a specific product on the on public finance. " environment during the entire life cycle of the product itself; "Art. 179. (Priority criteria in the management of waste) 1. Waste management takes place in compliance with the following hierarchy: a) prevention; b) preparation for re-use; c) recycling; d) other types of recovery, for b) the provision of clauses for calls for tenders or invitation letters that enhance the technical skills and competences in the field of preventing the example energy recovery; e) disposal. production of waste; c) the promotion of program agreements and contracts or memoranda of understanding, including experimental ones, aimed at preventing and reducing the quantity and danger of waste; d) . 1 -toThe Ministry of the Environment and the Protection of the Territory . 2. The hierarchy establishes, in general, an order of priority of what constitutes the best environmental option. In compliance with the hierarchy referred to in and the Sea shall adopt by 31 December 2012, in accordance with articles 177, paragraph 1, measures must be adopted to encourage the options that guarantee, 178, 178 -bis and 179, a national program for the prevention of waste and draw up in compliance with articles 177, paragraphs 1 and 4, and 178, the best overall indications so that this program is integrated into the waste management plans result, taking into account the health impacts, social and economic, including referred to in Article 199. In case of integration into the management plan, the technical feasibility and economic viability. waste prevention measures are clearly identified. By 31 December of each year, starting from 2013, the Ministry of the Environment and Land and Sea Protection shall submit to the Chambers a report updating the national waste prevention 3. With reference to individual streams of waste, exceptionally, it is permitted program and also containing the indication the results achieved and any criticalities to deviate from the order of priority referred to in paragraph 1 if this is justified, in recorded in the pursuit of waste prevention objectives. compliance with the precautionary and sustainability principle, on the basis of a specific analysis of the overall impacts of the production and management of such waste both under the environmental and health profile, in terms of life cycle, and 1 - tue The programs referred to in paragraph 1 -bis set the prevention . under the social and economic profile, including technical feasibility and resource protection. objectives. The Ministry describes the existing prevention measures and evaluates the usefulness of the examples of measures listed in Annex L or other appropriate 4. With one or more decrees of the Minister of the Environment and of Land measures. 1 -quater . and Sea Protection, in agreement with the Minister of Health, the options that The Ministry of the Environment and the Protection of the guarantee , in compliance with the provisions of paragraphs 1 to 3, the best result Territory and the Sea identifies the appropriate specific qualitative or quantitative in terms of protection of human health and the environment. parameters for the waste prevention measures, adopted to monitor and evaluate the progress made in the implementation of the prevention measures and can establish specific targets and qualitative or quantitative indicators. 1 -quinquies . 5. The public administrations pursue, in the exercise of their respective competences, initiatives aimed at encouraging compliance with the hierarchy of The Ministry of the Environment and Land and Sea Protection waste treatment referred to in paragraph 1, in particular by: a) promoting the ensures the availability of information on the best practices in the field of waste development of clean technologies, which allow a more rational use and prevention and, where appropriate, draws up guidelines to assist the regions in greater saving of natural resources; preparing the programs referred to in Article 199, paragraph 3, lett. r) . 1 -sexies . (b) the promotion of the technical development and the placing on the market The administrations concerned shall fulfill the obligations referred to in this article of products conceived in such a way as not to contribute or to contribute as little as with the human, instrumental legislation, andor without new financial greaterresources available charges for under current public finance. " possible, for their manufacture, use or disposal, to increasing the quantity or harmfulness of waste and pollution risks; c) promoting the development of appropriate techniques for the elimination of dangerous substances contained in waste in order to facilitate their recovery; d) the determination of contract "Art. 180 -bis . (Reuse of products and preparation for reuse of waste) conditions that provide for the use of materials recovered from waste and substances and objects produced, even if only in part, with materials recovered 1. Public administrations promote, in the exercise of their respective from waste in order to favor the market for said materials; competences, initiatives aimed at encouraging the reuse of products and the preparation for the reuse of waste. These initiatives may also consist of: a) use of economic instruments; b) e) the use of waste for the production of fuels and subsequent use and, logistical measures, such as the establishment and support of accredited more generally, the use of waste as another means of producing energy. repair / reuse centers and networks; c) adoption, as part of the procedures for awarding public contracts, of 6. In compliance with the waste treatment hierarchy, measures aimed at suitable criteria, pursuant to article 83, paragraph 1, letter e) , of legislative decree recovering waste through preparation for reuse, recycling or any other material no. 163, and letterprovision of the b) , and 69 conditions of the referred same decree; toto in end, this articles the68, paragraph Minister for the3, recovery operation are adopted with priority over the use of waste as a source of Environment and for the Protection of the Territory and the Sea implementing shall adopt the decrees power. referred to in Article 2 of the Minister for the Environment and Territorial Protection 7. Public administrations promote the analysis of the life cycle of products on within six months of the date of entry into force of this provision and del mare on the basis of uniform methodologies for all types of products established by ISPRA 11 April 2008, published in the Official Gazette no. 107 of 8 May 2008; guidelines, eco-balances, the disclosure of information also pursuant to legislative decree 19 needle — 42 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 d) definition of quantitative objectives; e) Note all’art. 2: educational measures; f) promotion of The Regulation (EC) 18-12-2006 n. 1907/2006 of the European Parliament program agreements. and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, 2. With one or more decrees of the Ministry of the Environment and the amending Directive 1999/45 / EC and repealing Regulation (EEC) no. 793/93 of Protection of the Territory and the Sea, in agreement with the Ministry of the Council and Regulation (EC) no. 1488/94 of the Commission, as well as Economic Development, having heard the unified Conference referred to in Council Directive 76/769 / EEC and Commission Directives 91/155 / EEC, 93/67 / Article 8 of Legislative Decree no. . 281, the additional measures necessary to EEC, 93/105 / EC and 2000/21 / EC, is published in the OJEU 30 December promote the reuse of products and the preparation of waste for reuse are 2006, n. L 396. adopted, also through the introduction of the extended responsibility of the product manufacturer. With one or more decrees of the Ministry of the environment and the protection of the territory and the sea, having heard the The legislative decree of 16 February 2011, n. 15 (Implementation of unified Conference referred to in article 8 of the legislative decree 28 August Directive 2009/125 / EC relating to the establishment of a framework for the 1997, n. 281, to be adopted within six months from the date of entry into force of development of ecodesign specifications for energy-related products) is this provision, the operating procedures for the establishment and support of published in the Official Journal of 8 March 2011, accredited centers and networks referred to in paragraph 1, lett. b) , including n. 55. the definition products of simplified and product authorization waste thatprocedures can be subjected, and an exemplary respectively, catalog to re-of use or preparation for re-use. Directive 2011/65 / EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) (Text with relevance for the EEA) is published in the OJEU 1 July 2011, n. L 174. 3. The administrations concerned shall fulfill the obligations referred to in this article with the human, instrumental and financial resources available under The Fourth Part of the legislative decree 3 April 2006, n. 152, cited in the current legislation, without new or greater charges for public finance. " notes to the introduction, is entitled as follows: "Regulations on the management of waste and the remediation of polluted sites". "Art. 181. (Recycling and recovery of waste) 1. In order to promote high-quality recycling and to meet the necessary Note all’art. 3: quality criteria for the various recycling sectors, on the basis of the indications provided by the Ministry of the Environment and Land and Sea Protection, the The decree of the President of the Republic of 15 July 2003, n. 254 regions establish the criteria with which the municipalities carry out separate (Regulation governing the management of medical waste pursuant to Article 24 collection in accordance with the provisions of Article 205. The competent of Law no. 179 of 31 July 2002) is published in the Official Gazette of 11 authorities shall also carry out separate collection by 2015 at least for paper, September 2003, no. 211. metals, plastic and glass, and where possible, for wood, as well as take the necessary measures to achieve the following objectives: Note all’art. 4: a) by 2020, the preparation for reuse and recycling of waste such as, at a The text of article 183 of the legislative decree 3 April 2006, n. 152, cited minimum, paper, metals, plastics and glass from households, and possibly from in the notes to the premises, reads as follows: “Art. 183. (Definitions) other sources, to the extent that such streams of waste are similar to domestic ones, it will be increased overall to at least 50% in terms of weight; b) by 2020, 1. For the purposes of part four of this decree and without prejudice to the the preparation for reuse, recycling and other types of material recovery, including further definitions contained in the special provisions, the following definitions backfilling operations using waste to replace other materials, non-hazardous shall apply: a) "waste": any substance or object which the holder discards construction and demolition waste, excluding material in the natural state defined under item 17 05 04 of the waste list, it will be increased to at least 70 per cent or intends to or has an obligation to discard; in terms of weight. b) "dangerous waste": waste that has one or more characteristics referred to in Annex I of Part Four of this decree; (c) 'waste oils' means any industrial oil or lubricant, mineral or synthetic, 2. Until the European Commission defines the methods for implementing which has become improper for the use for which it was originally intended, such and calculating the objectives referred to in paragraph 1, the Ministry of the as waste oils from combustion engines and transmission systems, as well as Environment, Land and Sea Protection may adopt decrees determining these used oils for turbines and hydraulic controls; (d) 'organic waste' means methods. biodegradable waste from gardens and parks, food and kitchen waste from 3. With one or more decrees of the Ministry of the Environment and the households, restaurants, food service and retail outlets and similar waste from Protection of the Territory and the Sea, in agreement with the Ministry of the food industry collected in differentiated way; e) «self-composting»: composting Economic Development, having heard the unified Conference referred to in of the organic waste of one's own urban waste, carried out by domestic users, Article 8 of Legislative Decree no. . 281, measures are adopted to promote the for the purpose of on-site use of the material produced; f) "waste producer": recovery of waste in compliance with the priority criteria referred to in Article 179 and the procedures referred to in Article 177, paragraph 4, as well as measures the entity whose activity produces waste (initial producer) or whoever carries out aimed at promoting high-quality recycling, favoring separate collection, possibly pretreatment, blending or other operations that have changed the nature or even single material, of waste. composition of said waste (new producer) ; 4. To facilitate or improve recovery, waste is collected separately, where this is technically, economically and environmentally feasible, and is not mixed with other waste or other materials having different properties. (g) 'product producer' means any natural or legal person who professionally develops, manufactures, transforms, treats, sells or imports produced; 5. For the fractions of urban waste subject to separate collection destined for recycling and recovery, free circulation on the national territory is always permitted through entities or companies registered in the appropriate categories h) 'holder' means the producer of the waste or the natural or legal person of the national environmental managers register pursuant to the article 212, who is in possession of it; (i) "dealer" means any undertaking which acts as a paragraph 5, in order to favor their recovery as much as possible by favoring the buyer for the purpose of buying and subsequently selling waste, including principle of proximity to recovery plants. traders who do not take physical possession of the waste; l) "intermediary": any 6. In order to foster environmental education and contribute to the separate company that arranges for the recovery or disposal of waste on behalf of third collection of waste, separate waste collection systems for paper and plastic in parties, including intermediaries who do not acquire the material availability schools are exempted from the authorization requirement as they present low of the waste; (m) 'prevention' means measures taken before a substance, risks and are not managed on a professional basis. material or product becomes waste which reduce: 7. The administrations concerned shall fulfill the obligations referred to in this article with the human, instrumental and financial resources available under current legislation, without new or greater charges for public finance. ". 1) the quantity of waste, including through the reuse of products o the extension of their life cycle; — 43 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 2) the negative impacts of the waste produced on the environment and health 5) for some categories of waste, identified by decree of the Ministry of the Human; Environment and the Protection of the Territory and the Sea, in agreement with the 3) the content of hazardous substances in materials and products; (n) Ministry for Economic Development, the management methods of the temporary deposit are established; 'management' means the collection, transport, recovery and disposal of waste, including the control of such operations and subsequent actions to the closure of cc) «secondary solid fuel (CSS)»: solid fuel produced from waste that complies disposal sites, as well as operations carried out as a trader or intermediary; o) with the classification and specification characteristics identified in the UNI CEN / TS "collection": the collection of waste, including preliminary sorting and storage, 15359 technical standards and subsequent amendments and additions; without prejudice to the application of article 184 -ter secondary solid fuel is classified as including the management of the collection centers referred to in letter "mm", special waste; dd) "biostabilized , or anaerobicwaste": waste treatment obtainedwaste, of unsorted from thein biological compliance aerobic with for the purpose of transporting them to a treatment plant; specific technical standards, to be adopted by the State, aimed at defining its contents and uses compatible with environmental protection health and, in particular, to p) "separate collection": collection in which a stream of waste is kept separate define the degrees of quality; ee) "quality compost": product obtained from the on the basis of the type and nature of the waste in order to facilitate its specific composting of organic waste collected separately, which complies with the treatment; (q) 'preparation for re-use' means the inspection, cleaning, disassembly requirements and characteristics established in annex 2 of legislative decree no. 75, and repair operations by which products or components of products which have and subsequent amendments; become waste are prepared in such a way that they can be reused without further pre-treatment; r) "reuse": any operation whereby products or components which are not waste are reused for the same purpose for which they were conceived; ff) "quality digestate": product obtained from the anaerobic digestion of organic waste collected separately, which complies with the requirements contained in s) 'treatment' means recovery or disposal operations, including preparation technical standards to be issued by decree of the Ministry of the Environment, Land before recovery or disposal; and Sea Protection, in concert with the (t) 'recovery' means any operation the main result of which is to allow waste to Ministry of Agricultural, Food and Forestry Policies; gg) "emissions": play a useful role by replacing other materials that would otherwise have been used emissions into the atmosphere referred to in article 268, paragraph 1, letter b) ; to fulfill a particular function or to prepare them to fulfill that function, within the 'plant hh) «water discharges»: the immissions of waste water as per article 74, paragraph or in the economy in general. Annex C of part IV of this decree contains a non- 1, letter ff) ; ii) "atmospheric pollution": any atmospheric modification referred exhaustive list of recovery operations; to in article 268, paragraph 1, letter a) ; u) 'recycling': any recovery operation through which waste is treated to obtain products, materials or substances to be used for their original function or for other purposes. It includes the treatment of organic material but not energy recovery or ll) "integrated waste management": the set of activities, including street reprocessing to obtain materials for use as fuel or in filling operations; sweeping as defined in letter oo) , aimed at optimizing waste management; mm) "collection finance,center": area for the manned collection and set activity up, without through new or greater differentiated charges grouping forwaste of urban public for homogeneous fractions conferred by the holders for transport to the plants (v) 'regeneration of waste oils' means any recycling operation which makes it recovery and treatment. The regulation of the collection centers is given by decree of possible to produce base oils by refining waste oils, which involves in particular the the Minister for the environment and for the protection of the territory and the sea, separation of contaminants, oxidation products and additives contained in those oils; after hearing the unified Conference, as per legislative decree no. 281; nn) "best available techniques": best available techniques z) 'disposal': any operation other than recovery even when the operation has the secondary consequence of recovering substances or energy. Annex B to part IV of this decree contains a non-exhaustive list of disposal operations; as defined in article 5, paragraph 1, lett. l -ter ) of this decree; oo) "street sweeping": aa) 'storage': the disposal activities consisting of the preliminary deposit operations of waste referred to in point D15 of the annex method of collecting waste by cleaning the streets, public areas and private B to the fourth part of this decree, as well as the recovery activities consisting of the areas for public use, excluding the snow removal operations from the road and its operations of placing in reserve of waste referred to in point appurtenances, carried out for the sole purpose of guaranteeing their usability and R13 of Annex C to the same fourth part; transit safety; bb) "temporary storage": the grouping of waste carried out, before collection, in the place where they are produced or, for agricultural entrepreneurs referred to in pp) "organized collection circuit": system for the collection of specific types of article 2135 of the civil code, at the site that is available legal status of the agricultural waste organized by the consortia referred to in titles II and III of part four of this cooperative, including agricultural consortia, of which they are members, under the decree and sectoral legislation, or organized on the basis of a program agreement following conditions: stipulated between the public administration and nationally representative business associations, or their territorial articulations, or on the basis of a framework agreement stipulated between the same associations and the managers of the transfer platform, 1) waste containing persistent organic pollutants referred to in Regulation (EC) or of the waste transport company , showing the final destination of the waste. 850/2004, and subsequent amendments, must be deposited in compliance with the technical standards that regulate the storage and packaging of waste containing hazardous substances and managed in accordance with the aforementioned The program agreement or framework agreement must be followed by the signing of regulation; a service contract between the individual producer and the manager of the delivery 2) waste must be collected and sent for recovery or disposal operations platform, or of the waste transport company, in implementation of the aforementioned according to one of the following alternative methods, chosen by the waste producer: agreement or the aforementioned convention. ; at least quarterly, regardless of the quantities in storage; when the quantity of waste qq) «by-product»: any substance or object that satisfies the conditions referred in storage reaches a total of 30 cubic meters of which a maximum of 10 cubic meters to in article 184 -bis paragraph 1, or that complies with the criteria of paragraph 2. ". , of hazardous waste. In any case, when the quantity of waste does not exceed the established on the basis of article 184 -bis, aforementioned limit per year, the temporary deposit cannot last more than one year; 3) the «temporary storage» must be carried out for homogeneous categories of Section II, of Chapter I, of Title III of Legislative Decree 6 September 2005, n. waste and in compliance with the relative technical standards, as well as, for 206 (Consumer Code, pursuant to article 7 of law no.229 of 29 July 2003), published in the Official Journal dangerous waste, in compliance with the rules governing the storage of the 8 October 2005, n. 235, SO, is listed as follows: dangerous substances contained therein; "Section II Distance contracts". The law of 29 December 1993, n. 580 (Reorganization of the chambers of 4) the rules governing the packaging and labeling of dangerous substances commerce, industry, crafts and agriculture) is published in the Official Gazette 11 must be respected; January 1994, n. 7, SO. — 44 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 The text of article 1 of the legislative decree 24 February 1997, n. g) destination: the use for which the device is intended according 46 (Implementation of Directive 93/42 / EEC, concerning medical to the indications provided by the manufacturer on the label, in the devices), published in the Official Journal of 6 March 1997, no. 54, SO, package leaflet or in the advertising material; reads as follows: h) placing on the market: the first making available against payment "Art. 1. Definitions. or free of charge of devices, excluding those intended for clinical investigations, with a view to distribution or use on the Community 1. This decree applies to medical devices and related accessories. market, regardless of whether they are new or refurbished devices ; For the purposes of this decree, accessories are considered to be full- fledged medical devices. In this decree and its annexes, medical devices and their accessories are referred to as "devices". i) putting into service: phase in which the device has been made available to the end user as it is ready for the first use on the Community market according to its intended use; 2. For the purposes of this decree, the i- bis ) authorized representative: the natural or legal person following definitions apply: a) medical device: any instrument, established in the territory of the European Union who, after having apparatus, plant, software, substance or other product, used alone or been expressly designated by the manufacturer, acts and can be in combination, including software intended by the manufacturer to be consulted by the competent national authorities and Community bodies used specifically for diagnostic or therapeutic purposes and necessary in place of the manufacturer to as regards the obligations that this for the correct functioning of the device, intended by the manufacturer decree imposes on the latter; i -ter ) clinical data: information on safety to be used on humans for the purpose of diagnosis, prevention, control, or performance obtained from the use of a device. Clinical data therapy or mitigation of a disease; to diagnose, monitor, treat, alleviate comes from the following sources: or compensate for an injury or handicap; study, replacement or modification of anatomy or of a physiological process; intervention on conception, which product does not exert the main action, in or on the 1) clinical investigations relating to the device in question; human body, for which it is intended, by pharmacological or immunological or 2) clinical investigations or other studies published in the means or by metabolic process but whose function can be assisted by scientific literature relating to a similar device whose equivalence to the such means; b) accessory: product which, although not a device, is device in question can be demonstrated; or 3) published or unpublished specifically designed by the manufacturer to be used with a device reports on other clinical practices relating to the device in question to allow the use envisaged by the manufacturer; c) in vitro diagnostic or to a similar device for which equivalence to the device in question can medical device: any medical device consisting of a reagent, a reactive be demonstrated; i -quater ) device subcategory: series of devices with product, a calibrator, a control material, a kit, an instrument, an septum apparatus, equipment or a system, used alone or in combination, common use or with common technologies; intended by the manufacturer for use in vitro for examining samples from i -quinquies ) generic group of devices: series of devices for which the human body, including donated blood and tissue, solely or principally an identical or similar use is envisaged and which share the same for the purpose of providing information on a physiological state or technology, so that they can be classified in a generic way, without pathological, or on a congenital anomaly, or information that allows the taking into account specific characteristics; determination of safety and compatibility with potential recipients, or that i -sexies ) disposable device: device intended to be used only allows the control of therapeutic measures. The specimen containers are considered in vitro diagnostic medical devices. Sample containers once for a single patient. ". are devices, whether vacuum-packed or not, specifically intended by The text of article 1 of the legislative decree 25 January 2010, n. manufacturers to directly receive the sample from the human body and 37 (Implementation of Directive 2007/47 / EC which modifies Directives to store it for the purpose of an in vitro diagnostic test. 90/385 / EEC for the approximation of the laws of the Member States relating to active implantable medical devices, 93/42 / EEC concerning medical devices and 98/8 / EC relating to the placing on the market of biocidal products), published in the Official Journal no. 60, it says: Products intended for general laboratory use are not in vitro diagnostic medical devices unless, given their characteristics, they are not "Art. 1. Amendments and additions to the legislative decree no. specifically intended by the manufacturer for in vitro diagnostic tests; d) 507, implementing Directive 90/385 / EEC concerning the approximation custom-made device: any device specially manufactured, on the of the laws of the Member States relating to active implantable medical basis of the written prescription of a duly qualified physician and devices. indicating, under his responsibility, the specific design characteristics of 1. To the legislative decree 14 December 1992, n. 507, and the device and intended to be used only for a specific patient. The subsequent amendments, the following amendments are made: prescription can also be drawn up by another person who is authorized (a) wherever it occurs, the expression: "authorized representative to do so by virtue of his or her professional qualification. Devices established in the Community" is replaced by the following: "authorized manufactured by continuous or series manufacturing methods, which must be subsequently adapted, to meet a specific need of the physician representative"; (b) wherever it occurs, the term "designated body" or other professional user, are not considered to be tailor-made devices; is replaced by the following: "notified body"; c) wherever they occur, the terms: "Ministry of Health" or: "Minister of Health" are replaced respectively by the following: "Ministry of Health" or: "Minister of Health"; (e) devices for clinical investigations: a device intended to be d) wherever they occur, the expressions: "Ministry of Industry, Commerce made available to a duly qualified physician for carrying out the investigations referred to in point 2.1 of Annex X in an appropriate and Crafts" or: "Minister of Industry, Commerce and Crafts" are human clinical environment. For the execution of clinical investigations, replaced respectively by the following: "Ministry of Economic any other person who, on the basis of his or her professional qualification, Development" or: "Minister of Economic Development"; e) in article 1: 1) is authorized to carry out such investigations is assimilated to the duly in paragraph 2: 1.1. point ( a) is replaced by the following: ' (a) medical qualified doctor; device: any instrument, apparatus, plant, software, substance or other f) manufacturer: the natural or legal person responsible for the product, used alone or in combination, including accessories design, manufacture, packaging and labeling of a device with a view to including software intended by the manufacturer to be used placing it on the market in his own name, regardless of whether these specifically for diagnostic and / or therapeutic purposes and operations are carried out by him person or by a third party on its behalf. The obligations of this decree that are imposed on the manufacturer necessary for the correct functioning of the device itself, intended also apply to the physical or legal person who composes, packs, by the manufacturer to be used on humans for the purposes of: 1) processes, refurbishes, labels one or more prefabricated products or diagnosis, prevention, control, treatment or mitigation of diseases; assigns them the destination of device in sight. marketing in its own name. The aforementioned obligations do not apply to the person who, without being the manufacturer, composes or adapts devices already placed on the market according to their destination for a single patient; — 45 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 2) diagnosis, monitoring, treatment, alleviation or compensation of an injury or 6) the following paragraph is added at the end: «2 handicap; 3) study, replacement or modification of the anatomy or of a physiological process; -quinquies . This decree does not apply: a) to medicines 4) control of conception, which does not exert the main action it is intended for in or on covered by the legislative decree 24 April 2006, n. 219, which incorporates the the human body by pharmacological, immunological or metabolic means, but whose function Community code on medicinal products for human use; when establishing whether a specific can be assisted by such means; "; product falls within the scope of application of this decree or that of this decree, particular account is taken of the main mechanism of action of the product itself; (b) human blood, human blood products, plasma or blood cells of human origin, or devices which, at the time of placing on the market, contain such products derived from blood, plasma or cells, for example exception of the devices referred to in paragraph 2 -ter .1; c) to organs, 1.2. letters d) , e) and f) are replaced by the following: " d) custom- tissues or cells of human origin, or to products comprising or derived from tissues or cells of made device: any device specially manufactured on the basis of the written prescription human origin, with the exception of the devices referred to in paragraph 2 -ter .1; (d) to of a duly qualified doctor who specifies, under his own responsibility, the specific characteristics organs, tissues or cells of animal origin, unless the device is manufactured from rendered designed and intended to be used only for a particular patient; devices manufactured by mass non-viable animal tissues or non-viable products derived from animal tissues. '; f) in article 2: production methods that have to be adapted to meet a specific need of the doctor or other 1) paragraph 1 is replaced by the following: «1. The active implantable devices referred professional user are not considered to be tailor-made devices; (e) devices for clinical to in article 1, paragraph 2, letters c) and d) , may be placed on the market or put into service investigations: any device intended to be used by a physician duly qualified to carry out the only if they meet the requirements of this decree, are correctly supplied and installed, and are clinical investigations referred to in Annex 7, section 2.1, in an appropriate human clinical environment; for carrying out clinical investigations, any other person who, on the basis of subject to a adequate maintenance and are used in accordance with their intended purpose. '; professional qualifications, is authorized to carry out such investigations is assimilated to the duly qualified doctor; (f) intended use: the use for which the device is intended according to the indications provided by the manufacturer on the label, in the instructions for use and / or in advertising materials; '; 2) paragraph 3 is replaced by the following: «3. 1.3. the following letters are added at the end: 'g -quater ) Active implantable medical devices referred to in Article 1, paragraph 2, letters c) , d) agent: the natural or legal person established in the Community who, after having been and e) , hereinafter referred to as 'devices', Annex 1 which satisfyare theapplicable essential requirements to them, takingset into outaccount in expressly designated by the manufacturer, acts and can be consulted by the competent the destination of the devices in question. Where there is a risk to the health of patients, national authorities and bodies Community instead of the manufacturer as regards the operators or third parties, devices that are also machines within the meaning of Article 2, obligations that this decree imposes on the latter; letter a) , of Directive 2006/42 / EC of the European Parliament and of the Council of 17 May 2006, relating to machinery, also comply with the essential health and safety requirements g -queries ) clinical data: information on safety and / or performance obtained from the set out in Annex specific thanI the of this directive, essential if said essential requirements set outhealth and Isafety in Annex of therequirements this decree. ";are 3) more use of a device; the clinical data come from the following sources: 1) clinical investigations paragraph 5 is replaced by the following: «5. The placing on the market and putting into relating to the device in question; or 2) clinical investigations or other studies published in the service, in the Italian territory, of devices compliant with the provisions of this decree and bearing the CE marking referred to in Article 4, which indicates that they have been the scientific literature relating to a similar device whose equivalence to the device in subject of the evaluation procedure of the in accordance with article 5. "; question can be demonstrated; or (3) published and / or unpublished reports on other clinical practices relating to the device in question or to a similar device for which equivalence to the device in question can be demonstrated. '; 2) paragraph 2 -bis is replaced by the following: «2 -bis . When antoactive implantable administer medical a substance deviceas defined is aintended "medicine" pursuant to Article 1 of 4) after paragraph 5 the following are added: «5 -bis Legislative Decree no. 219, which acknowledges the Community code on medicinal products Devices intended for clinical investigations may be made available to doctors . for human use, this device is governed by this decree, without prejudice to the provisions of or duly authorized persons if they meet the conditions set out in Article 7 and Annex 6. the legislative decree no. 219, relating to the medicinal product. "; 3) paragraph 2 -ter is Custom-made devices may be placed on the market or put into service if they meet the replaced by the following: «2 -ter . When an active implantable medical device incorporates conditions set out in annex 6 and are accompanied by the declaration set out in said annex, as an integral part a substance which, if used separately, can be considered a medicinal which is made available to the specifically identified patient. These devices do not bear the product pursuant to article 1 of the legislative decree 24 April 2006, n. 219, and can CE marking. have effects latteron the be must human body with evaluated an accessory and authorized action to that in accordance of the with thisdevice, decree.the "; 4) the following is inserted after paragraph 2 -ter : «2 -ter .1. When a device incorporates as an 5 - tue The devices referred to in article 1, paragraph 2, letters c) , d) and e) , may be . integral part a substance, hereinafter referred to as: "human blood derivative", which, when presented at fairs, exhibitions and demonstrations, even if they do not comply with the rules used separately, can be considered a component of a medicinal product or a medicinal of this decree, provided that a clear notice visible, written in Italian, indicates their non- product derived from human blood or plasma within the meaning of 'article 1 of the legislative conformity and the impossibility of placing on the market or putting into service such devices decree 24 April 2006, n. 219, and can have effects on the human body with an accessory before the manufacturer or his authorized representative has made them compliant with the action to that of the device, the latter is evaluated and authorized on the basis of this provisions of the decree itself. "; g) Article 3 is replaced by the following: «Art. 3 (Presumption decree. "; 5) paragraph 2 -quater is replaced by the following: «2 -quater . The of conformity) - 1. Devices manufactured in compliance with the Community harmonized provisions contained in article 1, paragraph 4, of legislative decree no. 194, which technical standards and the national technical standards that implement them are acknowledges the community directives on electromagnetic compatibility, do not apply to presumed to comply with the essential requirements referred to in Article 2, paragraph devices governed by this decree. "; 3, and Annex 1. 2. References to national technical standards which incorporate Community harmonized technical standards are published in the Official Journal of the Italian Republic by decree of the Minister of Economic Development. 3. For the purposes of this decree, the reference to the harmonized technical standards also includes the monographs and the European Pharmacopoeia relating in particular to the interaction between medicinal products and materials used in — 46 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 devices containing these medicinal products, the references of which have been a clinical investigation, stating the reasons in the event of an early conclusion. In the published in the Official Journal of the European Union. '; h) in article 5: 1) in paragraph event of early termination of a clinical investigation for safety reasons, this notification 3 the following period is added: "The authorization has a renewable five-year shall be communicated to all Member States and to the Commission. The manufacturer or his authorized representative shall keep the report referred to in annex 7, point 2.3.7. duration and is revoked if the requisites referred to in paragraph 2 are no longer At the disposal of the Ministry of Health, for the times specified in annex 6, point 3 -bis valid, or if the serious or repeated irregularities on the part of the notified body. '; 2) 5. Clinical investigations are carried out in accordance with provisions of Annex 7. . paragraph 5 -quinquies is replaced by the following: «5 -quinquies . The decisions adopted by the notified bodies in accordance with Annexes 2, 3 and 5 have a maximum validity of five years and can be extended for the next five years at the most, upon 6. The use of the devices referred to in paragraph 1 is limited to public hospitals, request submitted within the deadline agreed in the contract signed by the two. university polyclinics, hospitals where the faculties of medicine and surgery are located, set off."; 3) the following are inserted after paragraph 5 -quinquies : «5 -quinquies .1. referred to in article 4 of the legislative decree 30 December 1992. , no. 502, of The notified body provides the Ministry of Health with all information on the certificates reorganization of the discipline in health matters, to the Institutes of hospitalization and issued, modified, integrated, suspended, withdrawn or refused and also informs the care of a scientific nature, to the Ecclesiastical Institutes and Bodies referred to in article other bodies, designated pursuant to paragraph 3, on the certificates suspended, 41 of the law 23 December 1978, n. 833, of the institution of the National Health Service, withdrawn. o refused and, upon request, on the certificates issued. It also makes as well as the hospitals managed on the basis of the regional provisions adopted all relevant additional information available upon request. pursuant to article 9 - bis of Legislative Decree no. 502 of 1992 and which have the requirements of the high specialty referred to in the decree of the Minister of Health of 29 January 1992, published in the Official Gazette no. 26 of February 1, 1992, according to the procedures and modalities established by decree of the Ministry of Health, after consulting the Higher Health Council. In the same way, the Ministry of Health can establish the conditions in compliance with which structures other than those of the 5 -quinquies .2. If a notified body finds that the relevant requirements of this previous period can use the devices referred to in paragraph 1. The costs deriving from decree have not been or are no longer satisfied by the manufacturer, or that a certificate the application of this paragraph shall be borne by the manufacturer. should not have been issued, it shall suspend, withdraw or limit the issued certificate, taking into account the principle of proportionality, unless compliance with these requirements is ensured through the application of appropriate corrective measures by the manufacturer. The notified body informs the Ministry of Health in the event of 7. The provisions referred to in paragraphs 1, 2 and 6 do not apply in the case of suspension, withdrawal or limitation of the certificate or in cases where the intervention clinical investigations carried out with medical devices bearing the CE mark, after of the Ministry is necessary. The Ministry of Health informs the other Member States obtaining the favorable opinion of the competent Ethics Committee and the communication and the European Commission. 5 -quinquies . 3. The notified body shall provide the of the start of the investigation to the Ministry of Health, according to procedures and Ministry of Health, upon its request, with all relevant information and documents, methods established by ministerial decree. The additional expenses with respect to including balance sheets, necessary to verify compliance with the requirements set out normal clinical practice, deriving from the application of this paragraph, are borne by the in Annex 8. "; manufacturer. The medical devices needed for clinical investigations, which have not already been acquired in compliance with the ordinary procedures for the supply of goods, are also the responsibility of the manufacturer. The provisions of Annex 7 remain applicable. This derogation does not apply if said clinical investigations concern a intended use of the devices other than that envisaged by the conformity assessment 4) paragraph 5 -sexies is replaced by the following: «5 procedure. -sexies The Ministry of Health authorizes, upon justified request, the placing . on the market and putting into service, in the national territory, of single devices for 8. By decree of the Ministry of Health, the composition, organization and which the procedures referred to in articles 5, paragraph 1, and 6, paragraph 1, do not functioning of the Ethics Committees in the field of clinical investigations of active have been completed or completed, the use of which is in the interest of health implantable medical devices are regulated, providing that the charges deriving from the protection. The application for authorization must contain a description of the device, remuneration eventually established for the members of the Committees and the the main action for which it is intended and the reasons for which the application was functioning of the same Committees, are placed in full charge of the promoters of the submitted. The Ministry of Health communicates, within thirty days, the provision clinical investigation. Until the adoption of the decree envisaged in the previous period, regarding the authorization. "; the decree of the Ministry of Health of 12 May 2006, published in the Official Gazette no. 194 of 22 August 2006, concerning the minimum requirements for the establishment 5) after paragraph 5 -sexies the following is inserted: «5 and functioning of ethics committees for trials. -sexies .1. For the treatment of individual patients, for compassionate purposes, in exceptional cases of necessity and urgency and in the manner established by a subsequent ministerial decree, the Ministry of Health authorizes the use of medical 9. The Ministry of Health adopts, where necessary, the appropriate measures devices for which the procedures indicated in articles 5, paragraph 1, and 6, paragraph tune to ensure public health and public order. '; m) after article 7 the 1, have not been completed. "; i) in article 6: 1) at the end of paragraph 1 the following following are inserted: «Art. 7 -bis (Registration of persons sentence is added: "This declaration is made available to the specifically identified responsible for placing on the market). - 1. The manufacturer who places on the patient."; market active implantable medical devices in his own name, according to the procedure referred to in Article 6, paragraph 1, and which has its registered office in the Italian territory, shall notify the Ministry of Health of his address and description of the devices 2) in paragraph 2, the following words are added: ", for the period indicated in in question. annex 2, point 6.1"; l) Article 7 is replaced by the following: "Art. 7 (Active implantable devices intended for clinical investigations). - 1. For active implantable devices 2. Upon request, the Ministry of Health informs the Member States and the Commission about the data referred to in paragraphs 1 and 3. intended for clinical investigations that the manufacturer or the authorized representative, at least sixty days before the scheduled start of the investigations, 3. The manufacturer who places active implantable medical devices on the notifies the declaration referred to in annex 6 to the Ministry of Health. market in his own name, according to the procedures referred to in article 5, paragraph 1, informs the Ministry of Health of all the data necessary to identify such devices together with the label and the instructions for use, when the devices are put into service 2. The subjects indicated in paragraph 1 may initiate clinical investigations which, in Italy. after sixty days from the notification, unless the Ministry of Health has communicated 4. If not based in a Member State, the manufacturer who places a device on the within said period a contrary decision for reasons of public health or public order. In the market in his own name, as referred to in paragraphs 1 or 3, shall appoint a single event of a contrary decision, the Ministry of Health consults the Higher Council of Health. representative in the European Union. The agent communicates to the Ministry of Health the information requested in paragraph 3 and, if it has its registered office in the Italian 3. The manufacturer or his authorized representative shall keep the documentation territory, the information referred to in paragraph 1. indicated in attachment 6 at the disposal of the Ministry of Health, for the times indicated Art. 7 -ter (European database). - 1. The Ministry of Health shall send the therein. following information to the European database: a) data relating to certificates issued, 4. The manufacturer or his authorized representative shall notify the Ministry of modified, integrated, suspended, Health and the competent authorities of the Member States concerned of the conclusion of withdrawn or refused according to the procedures set out in Annexes 2, 3, 4 and 5; — 47 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 b) the data obtained on the basis of the supervisory procedures defined in art. 11; signati, the information obligations provided for by this decree and the dissemination of c) data relating to clinical investigations referred to in Article 7. safety notices. 2. The following are not considered confidential: 2. The application of paragraph 1 does not involve charges to be borne by the a) information on the registration of the persons responsible for placing on the State budget. "; n) in article 8, paragraph 2, after the words: "or storage," the following market referred to in article 7 -bis ; b) information to users provided by the manufacturer, are inserted: "and, in the commissioning phase, at the plant and use sites,"; o) the the authorized representative or the distributor in relation to a measure provided following are added after article 8: «Art. 8 -bis (Special measures of health surveillance). for in Article 11; - 1. When the Ministry of Health considers that, to ensure the protection of health and safety and to ensure compliance with public health requirements, a device or group (c) the information contained in the certificates issued, modified, supplemented, suspended or withdrawn. '; of devices should be withdrawn from the market or that its placing on the market and its putting into service must be prohibited, limited or subject to particular conditions, r) Article 10 is replaced by the following: «Art. 10 it may take all necessary and justified transitional measures by informing the European (Sanctions). - 1. Manufacturers or their agents, health workers, legal representatives Commission and all other Member States and indicating the reasons for its decision. of health facilities or, if not mined, the contact persons for supervision, who violate the provisions of article 11, paragraphs 2, 3 or 7, are punished with imprisonment for up to six months and a fine ranging from 7,200 to 43,200 euros. 2. Anyone who violates the provisions adopted by the Ministry of Health in implementation of articles 8 -bis paragraph 1, and , arrest 8 -ter from paragraph six months 1, is punished , towith oneayear fine with and from Art. 8 -ter (Safeguard clause). - 1. The Ministry of Health, when it ascertains that a 10,000 to 100,000 EUR. When the violated prescriptions concern limitations or particular device referred to in Article 1, paragraph 2, letters c) or d) , even if installed and used conditions of placing on the market or putting into service, the penalty is not exceeded by correctly according compromise to itshealth intended andpurpose the safety andofsubject patients, to users regular ormaintenance, third parties, orders can one third. their withdrawal from the market at the expense of the manufacturer or his authorized representative, prohibits or limits their placing on the market or putting them into service, 3. Unless the fact constitutes a crime, anyone who markets or sells or puts into informing the Ministry of Economic Development . The Ministry of Health immediately service active implantable medical devices without CE marking of conformity or certificate communicates the measures adopted to the Commission of the European Communities, of conformity is subject to a pecuniary administrative sanction ranging from 21,400 euros indicating in particular whether the non-compliance of the device with this decree results to 128,400 euros. The same sanction is subject to anyone who violates the provisions of in: article 2, paragraph 5 -bis second sentence, and of article 11, paragraph 4, as well as the notified body that violates the provisions , of article 5, paragraph 5 -quinquies .2. a) the lack of the essential requirements referred to in Article 2; b) incorrect application of the technical standards referred to in article 3; 4. Unless the fact constitutes a crime, the manufacturer or his man diary who affixes the CE marking of conformity improperly, as it is a product that does not fall within c) a lacuna in the technical standards referred to in Article 3. the definition referred to in Article 1, paragraph 2, letter a) , or unduly, as the product does not meet all the essential requirementsthe provisions set out in of this article decree, 2, paragraph or whoever 1, violates is subject 2. When the Commission of the European Communities communicates that the to a pecuniary administrative sanction ranging from 21,400 euros to 128,400 euros. measures referred to in paragraph 1 are unjustified, the Ministry of Health may revoke them, unless it deems, based on the assessments of the technical consultation bodies, that the revocation could cause serious risk for the health or safety of patients, users or third parties. '; p) Article 9 is replaced by the following: «Art. 9 (Provisions of denial or 5. Unless the fact constitutes a crime, anyone who violates the provisions of article restriction). - 1. Without prejudice to the application of the sanctions referred to in Article 4, paragraph 6, first sentence, is subject to a pecuniary administrative sanction ranging from € 7,200 to € 43,200. 10, the Ministry of Health, when it ascertains the undue CE marking of medical 6. Unless the fact constitutes a crime, anyone who violates the provisions of articles devices, or the absence thereof, in violation of the provisions of this decree, orders 2, paragraphs 4 and 5 -ter ; 4, paragraphs 5, 6, second sentence, and 7, last sentence; the manufacturer or the authorized representative to take all appropriate measures to 5, paragraphs 5, 5 -quinquies .1, 5 -quinquies .3; 7, paragraph 3 and paragraph 4, last eliminate the infringement situation by setting a term not exceeding thirty days. sentence; 7 -bis paragraphs 1, 3 and 4,, is subject from to a pecuniary 500 euros to 3,000 administrative euros. sanction 7. Anyone who violates the provisions of article 8, paragraphs 2 and 3, hindering controls, is subject to an administrative fine ranging from 3,600 euros to 21,600 euros. Anyone who violates the provisions of article 2, paragraph 5 -bis , first sentence, of article 2. Once the term referred to in paragraph 1 has expired in vain, the Ministry of 4, paragraph 4, of article 6, paragraph 2, of article 7, paragraphs 1, 2,same 4, is sanction. subject tofirst the Health orders the immediate withdrawal from the market of the medical devices, at the and second sentence, and paragraph 5 and of article 11, paragraph 6. expense of the recipient of the order. 3. In the event that the infringement continues, the Ministry of Health will adopt the measures to guarantee withdrawal from the market, at the expense of the manufacturer with 8. Anyone who violates the obligations set out in article 9 -bis but 1 is , or the authorized representative. subject to a pecuniary administrative sanction ranging from 6,000 euros to 36,000 euros. 4. The provisions referred to in paragraphs 1, 2 or 3 apply even if the CE marking has been affixed on the basis of the procedures referred to in this decree, but improperly, 9. The verification of the violations and the contestation of the administrative on products that are not covered by the decree itself. sanctions, as per this article, are carried out by the supervisory bodies and the offices of the Ministry of Health, competent in the field of medical devices. This is without prejudice 5. Any measure of denial or limitation of the placing on the market, of the putting to the jurisdiction of the criminal judge to ascertain violations and the application of into service of a device, or of carrying out clinical investigations, or of withdrawal of the administrative sanctions for offenses committed in objective connection with a crime. devices from the market, must be motivated. The provision is notified to the interested party with an indication of the term within which a hierarchical appeal can be made to the If the payment of the reduced sanction has not been made, the competent authority to Minister of Health or a judicial appeal to the Regional Administrative Court. receive the report pursuant to article 17 of law no. 689, containing changes to the penal system, is the Prefect. "; s) Article 11 is replaced by the following: «Art. 11 (Supervision of accidents occurring after placing on the market). - 1. For the purposes of this decree, 6. Before the adoption of the measures referred to in paragraph 2, the manufacturer an accident is understood as: a) any malfunction or alteration of the characteristics or the authorized representative must be invited to present his counter-arguments, unless and performance of an active implantable medical device, as well as any inadequacy such consultation is made impossible by the urgency of the provision. " ; q) article 9 -bis in the labeling or instructions for use that may or may be states causing death or serious is replaced by the following: «Art. 9 -bis (Confidentiality). - 1. Anyone who carries out deterioration of the health conditions of a patient or user; activities related to the application of this decree is obliged to keep the information acquired confidential, without prejudice to the authorities and bodies of — 48 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 b) any technical or medical reason connected to the characteristics or taken the clinical profile of risks / benefi ts related to the incorporation of the performance of an active implantable medical device which, for the reasons substance into the device. When issuing the opinion, the authority or the EMEA referred to in letter a) , involves the systematic withdrawal of the devices of the shall take into account the manufacturing process and the data relating to the same type by the manufacturer. usefulness of incorporating the substance into the device as established by the 2. Public or private health workers who in the exercise of their activity notified body. When a device incorporates, as an integral part, a derivative of detect an accident, as defined in paragraph 1, letter a) , involving an active human blood, the notified body, after verifying the usefulness of the substance implantable the termsmedical device, and in the are required manner to notify established the Ministry with one or more of decrees. as part of the medical device and taking into account the destination of the Health, within ministerial device, asks the EMEA, which operates in in particular through its committee, a scientific opinion on the quality and safety of the substance, including the clinical profile, risks / benefits of the incorporation of the human blood derivative in the 3. The communication referred to in paragraph 2 is made directly or medical device. In issuing the opinion, the EMEA shall take into account the through the health facility where the reported incident occurs, in compliance with manufacturing process and the data relating to the usefulness of incorporating any regional provisions that require the presence of contact persons for the the substance into the device, as established by the notified body. Changes supervision of medical devices. made to an ancillary substance incorporated in a device, in particular those 4. The communication referred to in paragraphs 2 and 3 must be sent to related to the manufacturing process, are communicated to the notified body, the manufacturer or his authorized representative, also through the supplier of which consults the competent medicines authority (i.e. the one that participated the active implantable medical device. in the initial consultation ), to confirm the maintenance of the quality and safety 5. Without prejudice to the obligation of communication provided for in of the ancillary substance. The competent authority shall take into account the paragraph 4, the Ministry of Health ensures the communication to the data relating to the usefulness of incorporating the substance into the device as manufacturer or his authorized representative of the information received established by the notified body, in order to ensure that the changes have no negative pursuant to paragraphs 2 and 3, also through the supplier of the active implantable medical impact on the cost / profit profile. device. 6. Public or private healthcare professionals are required to communicate to the manufacturer or authorized representative, directly or through the healthcare facility to which they belong and, therefore, also through the supplier defined benefit relating to the inclusion of the substance in the medical device. of the active implantable medical device, any other inconvenience which, When the relevant competent medical authority, i.e. the one that participated in although by not integrating the characteristics of the accident referred to in the initial consultation, had information on the ancillary substance that could paragraph 1, letter a) , it may allow the adoption of measures to guarantee the have an impact on the risk profile / protection and health of patients and users. defined benefit relating to the inclusion of the substance in the device, it provides the notified body with an opinion in which it establishes whether or not this in 7. Within the terms and in the manner established by one or more formation has an impact on the defined risk / benefit profile relating to the ministerial decrees, the manufacturer or his agent are obliged to immediately addition of this substance in the device. The Notified Body shall take into account notify the Ministry of Health of any incidents, as defined in paragraph 1, of which the updated scientific opinion by reconsidering its assessment of the conformity aware, as well as of the field corrective actions taken to reduce the risk of death assessment procedure. '; 5) in point 14.2: a) the following words are added to or serious deterioration of the state of health associated with the use of an active implantable medical device. the first paragraph: "and name and address of the authorized representative if the manufacturer is not established in the Community"; 8. The Ministry of Health records the data relating to accidents, as defined in paragraph 1, concerning active implantable medical devices. b) the following paragraph is added at the end: "- in the case of a device 9. The Ministry of Health, after carrying out an assessment, if possible pursuant to article 1, paragraph 2 -ter .1, the indication that the device together with the manufacturer or his authorized representative, immediately incorporates a human blood derivative."; informs the European Commission and the other Member States of the measures 6) at the end of point 15, the following paragraph is added: "- taken or planned to minimize the recurrence of accidents, therein. including information on the incidents from which the assessment originated '; (t) in Annex date of issue of the latest version of the instructions for use."; u) in Annex I: 1) the following is added after point 5: '5 -a 2: 1) the third paragraph of point 2 is replaced by the following: "This declaration relates to one or more devices clearly identified by means of the product name, its code or other unambiguous reference and must be kept by the . Demonstration of compliance with the essential requirements manufacturer."; 2) in point 3.1 the words from: "- the manufacturer's commitment" it must include a clinical evaluation in accordance with Annex 7. '; 2) the fifth to: "after-sales surveillance" are replaced by the following: "- the manufacturer's commitment to replace and update an after-sales surveillance system comprising paragraph of point 8 is replaced by the following: "- risks associated with ionizing radiation from radioactive substances that are part of the the provisions set out in Annex 7. '; 3) in point 3.2: 3.1) the following is device, in compliance with the protection requirements established by the relative inserted after the third sentence: 'It includes in particular the corresponding implementing decrees;"; documents, data and records resulting from the procedures referred to in point ( c) .'; 3.2) the following paragraph is added to letter b) of the third sentence: "- 3) in point 9, seventh paragraph, the following sentence is added at the end: "For devices that incorporate software or constitute medical software in the methods for checking the efficiency of the quality system, and in themselves, the software is validated according to the state of the art, taking into particular the type and extent of the checks carried out on the third party, account the principles the development life cycle, risk management, validation in the case where a third party carries out the design, manufacture and / or final and verification "; 4. point 10 is replaced by the following: '10. When a device inspection and testing of the products or their components; '; incorporates as an integral part a substance which, if used separately, can be considered a medicine pursuant to article 1 of the legislative decree 24 April 2006, n. 219, which transposes the Community code on medicinal products for human use, and can have effects on the human body with an ancillary action to that of the device, It is necessary to verify the quality, safety and usefulness of the substance, applying by analogy the methods provided for in annex I of the legislative decree 24 April 2006, n. 219. In the case of substances referred to in the previous period, the notified body, after verifying the usefulness of the substance as part of the medical device and taking into account the intended 3.3) the following paragraphs are added to letter c) : "- a use of the device, asks one of the competent authorities designated by Member declaration indicating whether or not the device incorporates, as an integral States pursuant to Directive 2001/83 / EC, on the Community code on medicinal part, a substance or a derivative of human blood referred to in Annex 1, point products for human use, or to the European Medicines Agency (EMEA), which 10, fourth sentence , as well as the data relating to the relevant tests carried out, operates in particular through its committee in accordance with Regulation (EC) necessary to evaluate the safety, quality and usefulness of this substance or No. . 726/2004, establishing the European Medicines Agency, a scientific opinion human blood derivative, taking into account the intended use of the device; - the on the quality and safety of the substance, including preclinical evaluation; - the clinical evaluation referred to in Annex 7; '; — 49 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 4. the third sentence of point 3.3 is replaced by the 1.2) the fifth to eighth indents are replaced by the following: '- following: 'The assessment procedure shall include a visit to the the results of design calculations, risk analysis, investigations, manufacturer's premises and, in duly justified cases, to the premises of technical tests carried out and similar assessments carried out; - a the manufacturer's suppliers and subcontractors to check the manufacturing statement indicating whether or not the device incorporates, as an integral processes. "; 5) in point 4.2: 5.1) the first sentence is replaced by the part, a substance or a derivative of human blood referred to in Annex following: 'The design, manufacture and performance of the product 1, point 10, fourth sentence, as well as the data relating to the relevant in question are described in the application, which must include the tests carried out, necessary to evaluate the safety, quality and usefulness documents necessary to assess the conformity of the product with the of this substance or human blood derivative, taking into account the requirements of the this decree, in particular Annex 2, point 3.2, letters c) intended purpose of the device; - preclinical evaluation; - the clinical and d) . "; 5.2) the words: "clinical data" are replaced by the following: evaluation referred to in Annex 7; - the draft instructions for use. '; 2. point "clinical evaluation"; 6) point 4.3 is replaced by the following: '4.3 The 5 is replaced by the following: '5. If the type complies with the notified body examines the application and, if the product complies with the provisions of this decree applicable to it, it issues the applicant provisions of this decree, the notified body issues the applicant with with an EC design examination certificate. an EC certificate. This certificate contains the name and address of the manufacturer, the conclusions of the inspection, the conditions of validity of the certificate and the data necessary to identify the approved type. The notified body may request that the application be supplemented by additional tests or examinations to enable it to assess its compliance with the requirements of this decree. The certificate contains the conclusions of the examination, the conditions of validity, the data necessary to indicate the approved design, and, where necessary, the description of the The main parts of the documentation are attached to the certificate intended use of the product. Do not keep one copy of the known organism. In the case of the devices referred to in Annex 1, point 10, first In the case of the devices referred to in Annex 1, point 10, first period, before taking a decision, the notified body shall consult, as regards period, before taking a decision, the notified body shall consult, as regards the aspects covered by that point, one of the competent authorities the aspects covered by that point, one of the competent authorities designated by the Member States to under Directive 2001/83 / EC, designated by the Member States to under Directive 2001/83 / EC, containing the Community code on medicinal products for human use, or the EMEA. The opinion of the authority or the EMEA shall be drawn up containing the Community code on medicinal products for human use, or within 210 days of receipt of valid documentation. The scientific opinion of the EMEA. The opinion of the AIFA or the EMEA is drawn up within 210 the authority or the EMEA is included in the documentation concerning days of receipt of the valid documentation. The scientific opinion of AIFA the device. In taking the decision, the notified body shall take due account or the EMEA must be included in the documentation relating to the device. of the views expressed in the context of the consultation. It shall inform In taking its decision, the notified body shall take due account of the views the competent body concerned of its final decision. expressed in the context of the consultation. It informs the competent body concerned of its final decision. In the case of the devices referred to in In the case of devices referred to in Annex 1, point 10, fourth period, Annex 1, point 10, fourth sentence, the scientific opinion of the EMEA the scientific opinion of the EMEA must be included in the documentation must be included in the documentation concerning the device. The opinion concerning the device. The EMEA opinion is drawn up within 210 days of is drawn up within 210 days of receipt of valid documentation. In taking receipt of valid documentation. In taking its decision, the notified body the decision, the notified body shall take due account of the opinion of the shall take due account of the opinion of the EMEA. The notified body EMEA. The notified body cannot issue the certificate if the scientific cannot issue the certificate if the scientific opinion of the EMEA is opinion of the EMEA is unfavorable. unfavorable. It shall inform the EMEA of its final decision. '; 7) the second paragraph of point 5.2 is replaced by the following: "- the data foreseen in It shall inform the EMEA of its final decision. '; the part of the quality system relating to the design, such as results 3) in point 7.3, the words "five years" to "last device" are replaced by of analyzes, calculations, tests, preclinical and clinical evaluation, the following: "fifteen years from manufacture of the last product"; 4) point the follow-up plan -up post-sales clinical and, if applicable, the results of 7.4 is deleted; (z) in Annex 4: 1) in point 4, the words: "post-sales control the same; "; 8) point 6.1 is replaced by the following: '6.1. For at least system" are replaced by the following: "post-sales surveillance fifteen years after the last product has been manufactured, the system including the provisions set out in Annex 7"; 2. point 6.3 is manufacturer or his authorized representative shall keep at the replaced by the following: '6.3. The statistical control of the products disposal of the national authorities: is operated by attributes and variables, providing sampling systems with operational characteristics that guarantee a high level of safety and - the declaration of conformity; - performance corresponding to the state of the art. The sampling the documentation referred to in point 3.1, second indent, in systems are defined by the harmonized standards referred to in particular the documents, data and records referred to in point 3.2, second Article 3, taking into account the specific characteristics of the categories and third sentence; of products concerned. '; - the changes provided for in point 3.4; - the documentation referred to in point 4.2; - the decisions and reports from the notified body as referred to 3) the following point is added at the end: in points 3.4, 4.3, 5.3 and 5.4. '; 9) point 6.3 is deleted; 10) the following "6 -bis . Application to the devices referred to in article 1, paragraph point is added at the end: «6 -bis . Application to the devices referred 2 - ter . 1. - At the end of the manufacture of each batch of devices referred to in article 1, paragraph 2 - ter . 1. - At the end of the manufacture to in article 1, paragraph 2 -ter .1, the manufacturer informs the notified of eachthe batch of devicesinforms manufacturer referredthe to in articlebody notified 1, paragraph 2 -terof of the release .1, body of the release of this batch of devices and sends it the official release this batch of devices and sends it the official release certificate the batch certificate the batch of the human blood derivative used in this device, of the human blood derivative used in this device, issued by the Higher issued by the Higher Institute of Health. '; aa) in Annex 5: 1) in point 2, Institute of Health. '; first sentence, the words: "referred to in point 2" are replaced by the following: "referred to in point 1"; 2) in point 2, third sentence, the (v) in Annex 3: words: "specimens identifying the product and kept by the manufacturer" 1) in point 3: are replaced by the following: "manufactured devices, clearly identified with the name of the product, its code or other reference 1.1) the first indent is replaced by the following: unambiguous, and must be kept by the manufacturer '; '- A general description of the type, including variants envisaged, and its intended use;'; — 50 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 3) in point 3.1, sixth indent, the words: 'after-sales surveillance system' undertakes . With regard to evaluate to custom-made and documentdevices, the experience the manufacturer acquired3in-ter the are replaced by the following: 'after-sales surveillance system comprising the post-production phase, also on the basis of the provisions set out in Annex 7, provisions set out in Annex 7'; 4) in point 3.2 ( b) , the following indent is as well as to prepare suitable means for application any necessary corrective added: '- the methods for checking the efficiency in particular the type of andtheextent quality ofsystem, the actions. This undertaking must include the obligation for the manufacturer to checks carried out on the third party, in the event that a third party carries inform the competent authorities of the following incidents, as soon as he becomes aware of them, and of the relevant corrective actions: out the manufacture and the final inspection and testing of the products or their components; "; a) any malfunction or deterioration of the characteristics and / or 5) in point 4.2, the following indent is inserted after the first indent: '- the performance of a device, as well as any deficiency in the labeling or instructions technical documentation;'; 6) the following point is added at the end: «5 for use of a device which may cause or have caused death or serious -bis . Application to the devices referred to in article 1, paragraph 2 - ter . deterioration of the state of health of a patient or user; 1. - At the end1,ofparagraph article the manufacture ofthe 2 -ter .1, each batch of devices manufacturer referred informs to in the notified body of the release of this batch of devices and sends it the official release (b) the technical or medical reasons connected with the characteristics certificate the batch of the human blood derivative used in this device, issued or performances of a device which lead, for the reasons listed in point ( a) , to by the Higher Institute of Health. '; bb) in Annex 6: 1) in point 2.1: 1.1) the first the systematic withdrawalsame by thetype. manufacturer "; of the devices belonging to the indent is replaced by the following: '- the name and address of the manufacturer; - the information necessary for the identification of the product in question; '; cc) in Annex 7: 1) 1.2) in the third indent, the word: "doctor" is replaced by the following: point 1 is replaced by the following: '1. General provisions: 1.1. As a rule, the confirmation of compliance with the requirements relating to the characteristics and performances specified in points 1 and 2 of Annex 1 under normal conditions of use of the device and the assessment of the side effects and acceptability of the risk / benefit ratio of referred to in point 5 of Annex 1 must be based on clinical data. The evaluation of such data, hereinafter "Duly qualified doctor"; 1.3) the fourth referred to as "clinical evaluation", which takes into account where necessary indent is replaced by the following: 'the specific any relevant harmonized standards, follows a defined and methodologically valid procedure based alternatively on: characteristics of the product indicated by the requirement;'; 2. point 2.2 is replaced by the following: '2.2. For devices intended for clinical investigations 1.1.1. a critical analysis of the pertinent scientific literature currently referred to in Annex 7: - data enabling the device in question to be available on the issues of safety, performance, design characteristics and identified; - the program of clinical investigations; - the dossier for the intended use of the device if: - equivalence between the device in question investigator; - confirmation of the insurance of the parties involved; - the and the device is demonstrated documents used to obtain informed consent; - an indication as to whether or not the device incorporates as an integral part a substance or a human sitive to which the data refer e blood derivative referred to in Annex 1, point 10; - the opinion of the - the data adequately demonstrate compliance with the relevant ethics committee concerned as well as an indication of the aspects which essential requirements; were the subject of the opinion; - the name of the duly qualified doctor or 1.1.2. a critical analysis of all clinical investigations conducted; of another person 1.1.3. a critical analysis of the combined clinical data referred to in points 1.1.1 and 1.1.2. 1.2. Clinical investigations are conducted, unless it is duly justified to rely on existing clinical data. 1.3. The clinical evaluation and its outcome are documented. The technical documentation of the device contains these documents and / or their authorized, as well as the investigating institution; complete references. - the place, start date and duration envisaged for the investigations; 1.4. The clinical evaluation and related documentation are actively - an indication that the device in question complies with the essential updated with data deriving from post-sales surveillance. If post-sales clinical requirements, with the exception of the aspects that are the subject of the follow-up is not considered necessary as part of the post-sales surveillance investigations, and that, for the latter, all precautions have been taken to plan applied to the device, this conclusion must be duly justified and protect the health and safety of the patient. " ; (3) the first sentence of point documented. 3.1 is replaced by the following: 'For custom-made devices, the 1.5. If it is not considered appropriate to demonstrate compliance with documentation that indicates the place (s) of manufacture and allows an the essential requirements on the basis of clinical data, an appropriate understanding of the design, manufacture and performance of the product, justification for this exclusion should be provided based on the results of the including the expected performance in order to allow the assessment of the risk management, also taking into account the specificity of the interaction conformity of the product with the requirements of this decree. "; 4) in point between the device and body, expected clinical performance and manufacturer's 3.2: 4.1) the first indent is replaced by the following: '- a general description of claims. The adequacy of the demonstration of conformity with the essential the product and its intended uses;'; 4.2) the words: "a list of norms" are requirements which is based only on performance evaluation, bench tests and preclinical evaluation must be duly demonstrated. replaced by the ifs 1.6. All data must remain confidential unless disclosure is deemed essential. '; following: 'the results of the risk analysis and a list of standards'; 4.3) the 2. point 2.3.5 is replaced by the following: following is inserted after the fourth indent: '- if the device '2.3.5. All serious adverse events must be fully recorded and immediately incorporates as an integral part a substance or a human blood derivative reported to all competent authorities of the Member States where the clinical referred to in point 10 of Annex 1, the data relating to the relevant tests carried investigation is conducted. '; 3. point 2.3.6 is replaced by the following: '2.3.6. out, necessary to evaluate the safety, quality and usefulness of that substance or human blood derivative, taking into account the intended purpose of the Investigations should be carried out under the responsibility of a duly device; '; qualified physician or authorized person in an appropriate environment. 5) the following points are added at the end: «3 -bisdeclarations . The information contained required by this in the are kept for a period of at annex least fifteen years from the date of manufacture of the last product. The doctor in charge will have access to the technical data relating to the device. ».". — 51 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 The text of article 1 of the legislative decree 14 January 1992, n. 507 g -quater ) agent: the natural or legal person established in the (Implementation of Directive 90/385 / EEC concerning the approximation of the Community which, after having been expressly designated by the manufacturer, laws of the Member States relating to active implantable media devices), acts and can be consulted by the competent national authorities and by the published in the Official Journal no. 305, reads as follows: "Art. 1. Definitions. Community bodies in place of the manufacturer as regards the obligations that this decree imposes on the latter; g -queries ) clinical data: information on safety and / or performance obtained from the use of a device; the clinical data come from the following 1. This decree applies to active implantable medical devices. sources: 1) clinical investigations relating to the device in question; or 2) clinical investigations or other studies published in the scientific literature relating 2. For the purposes of this decree, the following definitions apply: a) to a similar device whose equivalence to the device in question can be medical device: any instrument, apparatus, implant, software, substance demonstrated; or 3) published and / or unpublished reports on other clinical or other product, used alone or in combination, including accessories including practices relating to the device in question or to a similar device for which software intended by the manufacturer to be used specifically for diagnostic and / equivalence to the device in question can be demonstrated. 2 -bis . When or therapeutic purposes and necessary for the correct functioning of the device an active implantable medical device is intended to administer a substance itself, intended by the manufacturer to be used on humans for the purpose of: defined as a "medicine" pursuant to Article 1 of Legislative Decree no. 219, which incorporates the Community this device is governedcode ondecree, by this medicinal products without for human prejudice to theuse, 1) diagnosis, prevention, control, treatment or alleviation of disease; 2) provisions of the legislative decree 24 April 2006, n. 219, concerning the medicinal diagnosis, monitoring, treatment, alleviation or compensation of an injury or product. handicap; 3) study, replacement or modification of the anatomy or of a physiological process; 4) control of conception, which does not exercise in or on the human body the main action for which it is intended by pharmacological, 2 -ter . When an active implantable medical device incorporates as an immunological or metabolic processes, but whose function can be assisted by integral part a substance which, if used separately, can be considered a medicinal such means; product pursuant to article 1 of the legislative decree 24 April 2006, n. 219, and can have effects on the human body with an accessory action to that of the device, the latter must be evaluated and authorized in accordance with this decree. b) active medical device: any medical device connected for its operation to 2 -ter .1. When a device incorporates as an integral part a substance, a source of electrical energy or to any other source of energy other than that hereinafter referred to as: 'human blood derivative', which, when used separately, produced directly by the human body or by gravity; (c) active implantable medical can be considered a component of a medicinal product or a medicinal product device: any active medical device intended to be fully or partially implanted by derived from human blood or plasma within the meaning of article 1 of the legislative decree 24 April 2006, n. 219, and can have effects on the human body surgical or medical intervention in the human body or by medical intervention with an accessory action to that of the device, the latter is evaluated and in a natural orifice and intended to remain there after surgery; (d) custom-made authorized on the basis of this decree. device: any device specially manufactured on the basis of the written prescription of a duly qualified physician who specifies, under his own responsibility, the 2 -quater . The provisions contained in article 1, paragraph 4, of legislative specific design characteristics and is intended to be used only for a particular decree no. 194, which acknowledges the community directives on electromagnetic patient; devices manufactured by mass production methods that have to be compatibility, do not apply to devices governed by this decree. 2 -quinquies . adapted to meet a specific need of the doctor or other professional user are not considered to be tailor-made devices; (e) devices for clinical investigations: any This decree does not apply: a) to device intended to be used by a physician duly qualified to carry out the clinical medicines covered by the legislative decree 24 April 2006, n. 219, which investigations referred to in Annex 7, section 2.1, in an appropriate human clinical incorporates the Community code on medicinal products for human use; when environment; for carrying out clinical investigations, any other person who, on the establishing whether a specific product falls within the scope of application of this basis of professional qualifications, is authorized to carry out such investigations decree or that of this decree, particular account is taken of the main mechanism is assimilated to the duly qualified doctor; f) destination: the use for which the of action of the product itself; (b) human blood, human blood products, plasma or device is intended according to the indications provided by the manufacturer blood cells of human origin, or devices which, at the time of placing on the market, on the label, in the instructions for use and / or in advertising materials; g) contain such products derived from blood, plasma or cells, for example commissioning: making available to the medical body for implantation; g -bis ) exception of the devices referred to in paragraph 2 -ter .1; c) to organs, tissues or placing on the market: the first making available against payment or free of charge cells of human origin, or to products comprising or derived from tissues or cells of of devices, excluding those intended for clinical investigations, with a view to human origin, with the exception of the devices referred to in paragraph 2 -ter .1; distribution or use on the Community market, regardless of whether they are new d) organs, tissues or cells of animal origin, unless the device is manufactured or refurbished; g -ter ) manufacturer: 1) the natural person or legal using animal tissues rendered non-viable or non-viable products derived representative of the legal person responsible for the design, manufacture, from animal tissues. ”. packaging and labeling of a device with a view to placing it on the market in his own name or in his name the legal person represented, regardless of whether these transactions are carried out by the same natural or legal person or by a third party on his behalf; For the text of article 183 of the legislative decree 3 April 2006, n. 152 see in the notes to article 4. Directive 2008/98 / EC of the European Parliament and of the Council relating to waste and which repeals some directives (Text with relevance for the EEA) is published in the OJEU 22 November 2008, n. L 312. The text of Annex 1 of the decree of the Minister of the Environment and the Protection of the Territory and the Sea of 25 September 2007, n. 185 (Establishment and operating methods of the national register of subjects obliged to finance the management systems for waste electrical and electronic equipment (WEEE), establishment and operation of a coordination center for the optimization of competence of collective systems and establishment of the steering committee on the management of WEEE, pursuant to articles 13, paragraph 8, and 15, paragraph 4, of Legislative Decree no. 151 of 25 July 2005), published in the 2) the natural person or the legal representative of the legal person who Official Journal cial composes, packs, processes, refurbishes or labels one or more prefabricated 5 November 2007, n. 257, reads as products or assigns them the use of a device in view of being placed on the follows: "Annex 1 (article 9, market. name or in the name of the legal person represented, except for those who are not the manufacturer pursuant to n. 1) composes or adapts devices paragraph 3 and article 10 paragraph already placed on the market according to their destination for a single patient; 2, letters a and h) Groupings of WEEE to be carried out by the collection centers referred to in Article 6 of the Legislative Decree of 25 July 2005, — 52 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 n. 151, without prejudice to the provisions of article 187 of legislative decree d) the types of WEEE grouped together, with the indication of the relative no. 152, relating to the prohibition of mixing hazardous waste. codes of the waste list referred to in annex D to the fourth part of the legislative decree 3 April 2006, n. 152; Grouping 1 - Cold and climate: the following categories as per annex 1B e) compliance with the requirements referred to in article 1, paragraph 2, of the legislative decree 25 July 2005, n. 151: 1.1, 1.2, 1.3, 1.4, 1.17. letter c) of the place where the WEEE are grouped; f) the identification details and the technical suitability of any means to be used for the transport of Grouping 2 - Other great whites: this group includes the following WEEE; g) the payment of the annual registration fee referred to in paragraph 4. categories as per annex 1B of the legislative decree 5 July 2005, n. 151: from 1.5 to 1.16 and 1.18. 3. For the purposes of registration for the transport activities referred to Grouping 3 - TV and Monitor. in Article 2, third parties acting in the name of distributors submit a Grouping 4 - IT and Consumer electronics, lighting equipment (deprived communication to the regional or provincial section of the territorially competent of light sources). PED and other: the following categories as per annex 1B of Register in which they certify under their own responsibility, pursuant to article the legislative decree 25 July 2005, n. 151: 3 and 4, except those in grouping 21 of law no. 241 of 1990: 3, 5.1 and all categories not mentioned in the other groupings in this annex. a) the company's headquarters; b) the details of the distributor on behalf of whom the transport is carried out and the address of the point of sale or of the different Grouping 5 - Light sources: the following categories as per annex 1B of place where the WEEE awaiting transport is grouped; the legislative decree 25 July 2005, n. 151: from 5.2 to 5.5. ". c) the types of WEEE transported, with the indication of the relative codes of the list of waste as per annex D to the fourth part of the legislative decree 3 April 2006, n. 152; d) the identification details and the technical suitability of the Note all’art. 5: means to be used for the transport of WEEE; e) the payment of the annual For the text of article 180 of the legislative decree 3 April 2006, n. 152 registration fee referred to in paragraph 4. see in the notes to article 1. For the normative references of the legislative decree 16 February 2011, 4. The regional section of the Register issues the relative provision within n. 15, see in the notes to article 2. thirty days following the presentation of the communication referred to in paragraphs 2 and 3. For such registrations the provision of the financial Note all’art. 7: guarantees referred to in paragraph 7 of article 212 is not required. of the legislative decree 3 April 2006, n. 152. Enrollment must be renewed every five For the text of article 180 - bis of the legislative decree 3 April 2006, n. years and is subject to the payment of an annual enrollment fee of 50 euros, 152 see in the notes to article 1. which can be recalculated in accordance with article 21 of the decree of the Minister for the environment of 28 April 1998, n. 406. The company is required Note all’art. 10: to communicate any changes that occur after registration. ". The text of article 237 of the legislative decree 3 April 2006, n. 152, cited The text of articles 187, 208, 212, 213 and 216 of the legislative decree in the notes to the premises, reads as follows: tivo 3 April 2006, n. 152, cited in the notes to the premises, reads as follows: "Art. 237. (Guidelines for management systems) "Art. 187. (Prohibition of mixing hazardous waste) 1. It is 1. The management systems adopted must, in any case, be open to the forbidden to mix hazardous waste having different dangerous participation of all operators and designed in such a way as to ensure the characteristics or hazardous waste with non-hazardous waste. Mixing includes principle of transparency, non-discrimination, non-distortion of competition, free dilution of hazardous substances. circulation and maximum yield possible.". 2. Notwithstanding paragraph 1, the mixing of hazardous wastes that do not have the same dangerous characteristics, with each other or with other wastes, substances or materials, may be authorized pursuant to articles 208, Note all’art. 11: 209 and 211 provided that : For the text of article 183 of the legislative decree 3 April 2006, n. 152 a) the conditions referred to in Article 177, paragraph 4, are complied with see in the notes to article 4. and the negative impact of waste management on human health and the The text of article 3 of the decree of the Minister for the environment and environment is not increased; b) the blending operation is carried out by an the protection of the territory and the sea of 8 March 2010, n. 65 (Regulation entity or an undertaking which has obtained an authorization pursuant to containing simplified procedures for the management of waste from electrical Articles 208, 209 and 211; c) the mixing operation complies with the best and electronic equipment (WEEE) by distributors and installers of electrical and available techniques referred to in article 183, paragraph 1, letter nn) . electronic equipment (EEE), as well as by the managers of the technical assistance centers of such equipment), published in the Official Gazette of 4 May 2010, no. 102, reads as follows: 3. Without prejudice to the application of specific sanctions and in "Art. 3. Registration in the National Register of Environmental Managers particular those referred to in Article 256, paragraph 5, anyone who violates the for the collection and transport of domestic WEEE 1. The collection and prohibition referred to in paragraph 1 is required to proceed at their own transport of household WEEE referred to in articles 1 and 2 are carried expense to separate the mixed waste, if it is technically and economically out upon registration in a specific section of the National Register Environmental feasible and in compliance with the provisions of Article 177, paragraph 4. " Managers referred to in article 212 of the legislative decree 3 April 2006, n. 152. "Art. 208. (Single authorization for new waste disposal and recovery plants) 2. For the purposes of registering for the activities referred to in paragraph 1. Subjects who intend to build and manage new waste disposal or 1, the distributors shall submit to the regional or provincial section of the recovery plants, including dangerous ones, must submit a specific application territorially competent Register a communication in which they certify under to the region responsible for the territory, attaching the final design of the plant their own responsibility, pursuant to article 21 of the law 7 August 1990, n. 241: and the technical documentation required for the construction of the project itself by the provisions in force on urban planning, environmental protection, health, safety at work and public hygiene. If the plant must be subjected to the a) the company's environmental impact assessment procedure in accordance with current headquarters; b) the address of the point of sale where i legislation, the application is also accompanied by the communication of the WEEE awaiting transport; c) in project to the competent authority for the aforementioned purposes; the terms cases where the grouping referred to in Article 1 is carried out in a place referred to in paragraphs 3 and 8 remain suspended until the decision on other than the premises of the point of sale, the address of the place where the environmental compatibility is acquired pursuant to part two of this decree. WEEE are grouped awaiting transport, the native name or company name the owner of the area and the legal title on the basis of which the area is used; 2. The application of the national legislation implementing Directive 96/61 / EC on prevention and reduction remains valid — 53 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 integrated pollution, for plants falling within the scope of the same, with particular i) the emission limits into the atmosphere for the treatment processes reference to the legislative decree February 18, 2005, n. 59. thermal waste, even accompanied by energy recovery. 11 -bis . Authorizations for incineration or co-incineration with energy 3. Within thirty days of receipt of the application referred to in paragraph 1, recovery are subject to the condition that recovery takes place with a high level of the region identifies the person in charge of the procedure and convenes a special energy efficiency, taking into account the best available techniques. service conference. The heads of the competent regional offices and the representatives of the local authorities and local authorities on whose territory the 12. The authorization referred to in paragraph 1 is granted for a period of plant is built, as well as the applicant for authorization or an his representative in ten years and is renewable. For this purpose, at least one hundred and eighty order to acquire documents, information and clarifications. Within the same term days before the expiry of the authorization, a specific application must be of 20 days, the documentation referred to in paragraph 1 is sent to the members submitted to the region which decides before the expiry of the authorization itself. of the service conference. The decision of the conference of services is taken by In any case, the activity can be continued until the express decision is made, majority and the relative decisions must provide adequate motivation with respect subject to the extension of the financial guarantees given. The authorization to the dissenting opinions expressed during the conference. requirements may be modified, before the expiry date and after at least five years from issue, in the case of critical environmental conditions, taking into account the evolution of the best available technologies and in compliance with the procedural guarantees referred to in law n. 241 of 1990. 4. Within ninety days of its convocation, the Conference of Services: 13. Without prejudice to the application of the sanctioning rules referred to a) evaluates the projects; b) acquires and in Title VI of Part Four of this decree, in the event of non-compliance with the evaluates all elements relating to compatibility requirements of the authorization, the competent authority shall proceed, according of the project with the provisions of article 177, paragraph 4; to the seriousness of the infringement: c) acquires, where required by current legislation, the environmental a) diffi da, establishing a deadline within which non-compliance must be compatibility assessment; d) transmits its conclusions with the related documents eliminated; to the region. b) the diffi da and contextual suspension of the authorization for a fixed period, in the event of situations of danger for public health and the environment; 5. For the technical investigation of the application, the regions can avva c) the revocation of the authorization in the event of failure to comply with the complaints of the Regional Agencies for the Protection of the Environment. provisions imposed with the diffi da and in the event of repeated violations 6. Within 30 days of receipt of the conclusions of the Con ference of that cause a situation of danger to public health and the environment. services, evaluating the results of the same, the region, in the event of a positive evaluation of the project, authorizes the construction and management of the plant. The approval replaces visas, opinions, authorizations and concessions of regional, provincial and municipal bodies for all purposes, constitutes, where 14. The control and authorization of the operations of loading, unloading, necessary, a variant to the urban planning instrument and involves the declaration transshipment, storage and handling of waste in port areas are governed by the of public utility, urgency and non-postponement of the works. specific provisions of law no. 84 and referred to in Legislative Decree 24 June 2003, n. 182 of implementation of Directive 2000/59 / EC on waste produced on ships and other provisions on the subject by current legislation. In the case of 7. In the event that the project concerns restricted areas pursuant to cross-border transport of waste, the authorization for embarkation and legislative decree no. 42, the provisions of article 146 of this decree on disembarkation operations cannot be issued if the applicant does not prove that authorization apply. he has complied with the requirements referred to in Article 193, paragraph 1, of 8. The investigation is concluded within one hundred and fifty days from this decree. the presentation of the application referred to in paragraph 1 with the issue of the single authorization or with the motivated refusal of the same. 15. Mobile disposal or recovery plants, excluding mobile plants that 9. The terms referred to in paragraph 8 are interrupted, for one time only, dehydrate the sludge generated by purification plants and re-introduce the water by any inquiries made by the person in charge of the procedure to the interested at the head of the de purative process in which they operate, and excluding cases party and start again from receipt of the information provided by the interested in which it is to the volumetric reduction and separation of extraneous fractions party. only, they are definitively authorized by the region where the interested party has 10. Without prejudice to the assessment of any responsibilities pursuant to its registered office or the foreign company that owns the plant has its current legislation, if the competent authority fails to conclude the procedure for representative office. To carry out the individual activity campaigns on the national issuing the single authorization within the terms provided for in paragraph 8, the territory, the interested party, at least sixty days before the installation of the substitute power referred to in ar article 5 of the legislative decree 31 March 1998, system, must communicate to the region in whose territory the chosen site is n. 112. located the detailed specifications relating to the activity campaign, attaching the authorization referred to in paragraph 1 and the registration in the national register 11. The authorization identifies the conditions and requirements necessary of environmental managers, as well as the additional documentation required. to ensure the implementation of the principles referred to in Article 178 and The region can adopt additional prescriptions or it can prohibit the activity with a contains at least the following elements: a) the types and quantities of waste that justified measure if the carrying out of the same in the specific site is not can be treated; b) for each type of authorized operation, the technical compatible with the protection of the environment or public health. requirements with particular reference to the compatibility of the site, the equipment used, the types and maximum quantities of waste and the methods of verification, monitoring and control of the conformity of the plant to the approved 16. The provisions of this article also apply to proceedings in progress at project; c) the precautionary and safety measures to be adopted; d) the location the date of entry into force of the fourth part of this decree, except for those for of the authorized plant; e) the method to be used for each type of transaction; f) which the environmental impact assessment procedure has been completed. the provisions relating to closure and subsequent interventions 17. Without prejudice to the obligation to keep the registers of loading and unloading by the subjects referred to in article 190 and the prohibition of mixing referred to in article 187, the provisions of this article do not apply to the temporary deposit made in compliance with the conditions established by article 183, ceased that prove necessary; paragraph 1, letter m) . 17 -bis . The authorization referred to in this article must g) the required financial guarantees, which must be provided only when the be communicated, Land Registry by of the administration waste referred toresponsible forthrough in Article 189 issuing the it, totelematic the plant is actually started up; the financial guarantees for the management of the Land Registry and according to the standards agreed with ISPRA which takes landfill, also for the phase following its closure, must be provided in accordance care of the inclusion in a national list, accessible to the public, of the following with the provisions of article 14 of legislative decree no. 36; (674) (683) h) the identifying elements, without new or greater burdens for public finance: a) expiry date of the authorization, in compliance with the provisions of paragraph 12; company name; — 54 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 b) registered office of the authorized company; c) 5. Registration in the Register is a prerequisite for carrying out the activities of location of the authorized plant; d) authorized collection and transport of waste, site reclamation, reclamation of goods containing asbestos, trade and brokerage of waste without holding waste themselves. The organizations management activities; e) the waste object of the referred to in articles 221, paragraph 3, letters a) and c) , 223, 224, 228, 233, 234, 235 and management activity; f) authorized quantities; g) 236, of the legislative decree of 20 November 2008, are exempt from the obligation referred expiry of the authorization. 17 -ter The communication to in this paragraph , n. 188, and the legislative decree 25 July 2005, n. 151, limited to the of the data referred to in paragraph 17 -bis must take activity of intermediation and trade without the possession of waste objects provided for in the aforementioned articles. For special companies, consortia of municipalities and public place without finance . newbetween and greater the existing chargesregional for public information systems, and the service management companies referred to in Legislative Decree 18 August 2000, n. 267, telematic cadastre according to shared standards. registration in the Register is carried out with a specific communication from the municipality or consortium of municipalities to the regional section with territorial jurisdiction and is valid for the management services of urban waste produced in the same municipalities. 18. In the event of events affecting the authorization, these are communicated, with prior notice to the interested party, to the Land Registry of waste referred to in article 189. The registrations referred to in this paragraph, already made on the date of entry into force 19. The procedures referred to in this article are also applied for the realization of of this provision, remain effective until their natural expiry. substantial changes during construction or operation that involve changes as a result of which the plants no longer comply with the authorization issued. 6. Registration must be renewed every five years and constitutes a title for the “ exercise of waste collection, transport, trade and intermediation activities; for other activities, 20. registration enables them to carry out the same activities. "Art. 212. (National Register of Environmental Managers) 1. The National Register of Environmental Managers, hereinafter referred to as 7. Entities and companies registered in the Register for the collection and transport Register, is set up at the Ministry of the Environment and Protection of the Territory and of hazardous waste are exempted from the obligation to register for the collection and the Sea, divided into a National Committee, based at the same Ministry, and in regional and transport of non-hazardous waste, provided that this last activity does not involve change in provincial Sections, established at the Chambers of Commerce, Industry, Crafts and the class for which the companies are registered. Agriculture of the regional capitals and of the autonomous provinces of Trento and Bolzano. The members of the National Committee and of the regional and provincial Sections 8. The initial producers of non-hazardous waste who carry out operations of remain in office for five years. collection and transport of their own waste, as well as the initial producers of hazardous 2. By decree of the Ministry of the Environment and the Protection of the Territory waste who carry out operations of collection and transport of their own hazardous waste in and the Sea, special sections of the National Committee are established for each individual quantities not exceeding thirty kilograms or thirty liters per day, are not subject to the activity subject to registration in the Register, without new or greater charges for public provisions of paragraphs 5, 6, and 7 provided that these operations are an integral and finance, and composition and skills are fixed. The National Committee of the Register has accessory part of the organization of the company from which the waste is produced. These decision-making power and is made up of nineteen effective members with proven and subjects are not required to provide financial guarantees and are registered in a specific documented technical-economic or legal experience in environmental matters appointed by section of the Register based on the presentation of a communication to the regional or decree of the Minister for the Environment and Territorial Protection and designated provincial section of the territorially competent Register which issues the relative provision respectively: within the following thirty days. . With the communication, the interest attests under his responsibility, pursuant to article 21 of law no. 241 of 1990: a) two by the Minister of the Environment and Land and Sea Protection, one of which with the role of President; b) one from the Minister of Economic Development, with the functions of Vice-President; a) the seat of the undertaking, the business or activities from which the waste is c) one from the Minister of Health; d) produced; b) the characteristics, the nature of the waste produced; c) the identification one from the Minister of Economy and Finance; e) one from the details and the technical suitability of the means used for the transport of the waste, Minister of Infrastructure and Transport; f) one from the Minister of also taking into account the methods of carrying out the transport itself; d) the payment of the annual registration fee of 50 euros, which can be re-determined pursuant to the Interior; g) three from the regions; h) one from the Italian Union article 21 of the decree of the Minister of the Environment no. 406. of Chambers of Commerce, Industry, Crafts and Agriculture; i) eight by the business organizations most representative of the economic categories concerned, of which two by the organizations representing the category of road hauliers and two by the organizations representing waste managers and one of the Registration must be renewed every 10 years and the company is required to organizations representative of the companies carrying out waste disposal activities sites communicate any changes that have occurred after registration. The registrations referred and reclamation of goods containing asbestos. An alternate member is appointed for each effective member. to in this paragraph, made by April 14, 2008 pursuant to and for the purposes of the legislation in force on that date, must be updated within one year from the date of entry into force of this provision. 3. The Regional and Provincial Sections of the Register are established by decree of 9. The companies referred to in paragraphs 5 and 8 required to adhere to the waste the Minister of the Environment and the Protection of the Territory and the Sea and are traceability control system (SISTRI) referred to in article 188 - bis paragraph 2, lett. a) , in composed of: a) by the President of the Chamber of Commerce, Industry, Crafts and relation , to each of fulfillment vehicle used for the the obligations collectionby established and transport article of waste,6,proceed 3, paragraph letter c)with the , of the Agriculture or by a member of the Chamber Council designated for this purpose by decree of the Minister for the environment and the protection of territory and the sea on 17 the same, with the functions of President; December 2009. The Regional Section of the Register proceeds, upon first within application two months from the date of entry into force of this provision, with the suspension of office from the Register of auto vehicles for which the obligation referred to in the previous period has not b) by an official or manager with proven experience in environmental matters designated by the region or autonomous province, acting as vice-president; been fulfilled. After three months from the suspension without the above obligation having been fulfilled, the vehicle is by right and with immediate effect canceled from the Register. c) by an official or manager with proven experience in environmental matters, designated by the regional union of provinces or by the autonomous province; d) by an expert with proven experience in environmental matters, appointed by the Minister for the environment and for the protection of the territory and the sea; [e) by two 10. Enrollment in the Register for the collection and transport of hazardous waste, experts designated by the most representative organizations of the economic categories;] for the intermediation and trade of waste without detention of the same, is subject to the provision of suitable financial guarantees in favor of the State. the amounts and methods of which are established by one or more decrees of the Minister for the Environment and for the Protection of the Territory and the Sea, in agreement with the Ministry for the Economy f) . and Finance. These guarantees are reduced by fifty percent 4. — 55 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 companies registered pursuant to Regulation (EC) no. 1221/2009, and forty percent in the determined by decree of the Minister for the Environment and for the Protection of the case of companies in possession of environmental certification pursuant to the Uni En Iso Territory and the Sea, in agreement with the Minister for the Economy and Finance. Until 14001 standard. Minister of the Environment on 8 October 1996, published in the Official the adoption of the aforementioned decree, the provisions referred to in the decree of the Gazette no. 1 of 2 January 1997, as modified by the decree of the Minister of the Minister for the environment on 29 December 1993, and subsequent amendments, and the Environment on 23 April 1999, published in the Official Gazette no. 148 of 26 June 1999. provisions referred to in the decree of the Minister for the environment on 13 December 1995 are applied, published in the Official Journal - cial no. 51 of 1 March 1995. The sums referred to in article 7, paragraph 7, of the decree of the Minister of the Environment of 29 December 1993 are paid to Chapter XXXII, chapter 11. The companies that carry out site remediation activities and the remediation of 2592, article 04, of the income of the State Budget, for be reassigned, by decree of the assets containing asbestos must provide suitable financial guarantees in favor of the region Minister of the Economy and Finance, to Chapter 7082 of the forecast of the Ministry of the with territorial jurisdiction for any remediation intervention in compliance with the general Environment and the Protection of the Territory and the Sea. criteria referred to in Article 195, paragraph 2, letter g) . These guarantees are reduced by fifty percent for 18. The remuneration to be paid to the members of the National Committee of the companies registered pursuant to Regulation (EC) no. 761/2001, and forty percent in the Register and of the Regional Sections of the Register are determined pursuant to article 7, case of companies in possession of environmental certification pursuant to the Uni En Iso paragraph 5, of the decree of the Minister for the environment of 28 April 1998, 406. 14001 standard. 12. Companies and logistic operators at railway stations, freight ports, terminal 19. The regulatory discipline of cases in which, pursuant to articles 19 and 20 of the systems, freight terminals and ports to which, in the context of intermodal transport, are law of 7 August 1990, no. 241, the exercise of a private activity can be undertaken on the entrusted with waste awaiting collection are registered in the Register. in charge of the basis of the notification of the start of the activity does not apply to applications for same by the railway or naval company or by the company carrying out the subsequent registration and to the acts of competence of the Register. transport, in the case of ship transport, the shipping agent referred to in the law of 4 April 1977, n. 135, is delegated by the shipowner or charterer, who carry out the transport, for 19 -bis .The agricultural entrepreneurs referred to in Article 2135 of the Civil Code, the obligations relating to the waste traceability control system (SISTRI) referred to in article initial producers of waste, for the transport of their waste carried out within the provincial or 188 -bis ta every five years and is not subject to the performance financial guarantees. regional territory where the company has its registered office for the purpose of conferment of the same within the organized collection circuit referred to in letter pp) of paragraph 1 of , paragraph 2, lett. a) . Membership must be renewed article 183. 13. Enrollment in the Register and the measures for suspension, withdrawal, 20. forfeiture and cancellation of enrollment, as well as the acceptance, revocation and release 21. of the financial guarantees that must be provided in favor of the State are approved by the Regional Section of the Register of the region where the company concerned has its 22. registered office, on the basis of current legislation and the directives issued by the National 24. Committee. 25. 14. Against the provisions of the Regional Sections of the Register, the interested 26. parties may propose, within the deadline of thirty days from the notification of the measures 27. themselves, an appeal to the National Committee of the Register. ” 28. 15. By decree of the Minister for the Environment and for the Protection of the "Art. 213. (Integrated environmental authorizations) Territory and the Sea, in agreement with the Ministers of Economic Development, 1. The integrated environmental authorizations issued pursuant to the legislative Infrastructure and Transport, having heard the opinion of the National Committee, to be decree February 18, 2005, n. 59, replace for all purposes, according to the procedures adopted within ninety days from the date of entry into force of the fourth part of this decree, provided for therein: a) the authorizations referred to in this chapter; b) the communication the powers and organizational methods of the Register are defined, the technical and financial requirements of the companies, the requirements of the technical managers of the referred to in article 216, limited to activities not falling under category 5 of Annex I of same, the terms and methods of registration, the rights annual enrollment. Until the adoption legislative decree no. 59, which, if carried out in a simplified procedure, are excluded of the aforementioned decree, the provisions of the decree of the Minister for the from the integrated environmental authorization, without prejudice to the possibility of Environment of 28 April 1998, n. 406, and the resolutions of the National Committee of the subsequently using the simplified procedures provided for in chapter V. 2. Register. The decree referred to in this paragraph is based on the following principles: ” a) identification of registration requirements, valid for all sections, in order to standardize procedures; b) coordination with current legislation on road transport, rail "Art. 216. (Recovery operations) transport, transport by sea and inland waterway, in line with the purpose referred to In force since 25 December 2010 1. in letter a) ; Provided that the technical standards and specific prescriptions referred to in Article 214, paragraphs 1, 2 and 3 are respected, the exercise of waste recovery operations can c) effective coverage of expenses through secretarial fees and annual registration be undertaken after ninety days from the communication of the commencement of activity fees; to the territorially competent province. In the event of electrical and electronic waste referred d) redefinition of annual registration fees relating to companies to in Article 227, paragraph 1, letter a) , of end-of-life vehicles referred to in Article 227, transport of waste registered in the national register of environmental managers; paragraph 1, letter c) , and of co-incineration plants, carrying the ofout theofactivities a preventive is subject visit, by to the e) interconnection and interoperability with public administrations province competent for the territory, to bepresentation carried outofwithin the aforementioned six holy days from communication. the competent actions to keep public registers; f) reformulation of the disciplinary-sanctioning system of the Register and of the causes for cancellation of registration; 2. The conditions and technical standards referred to in paragraph 1, in relation to g) definition of the responsibilities and responsibilities of the respon each type of activity, provide in particular: a) for non-hazardous waste: 1) the maximum technician. quantities that can be used; 2) the origin, the types and characteristics of the waste 16. Pending the issuance of the decrees referred to in this article, the provisions governing the national register of companies that manage waste in force on the date of that can be used as well as the specific conditions under which the activities entry into force of part four of this decree continue to apply, whose repeal is deferred upon themselves are subject to the regulations provided for in this article; 3) the provisions publication of the aforementioned decrees. necessary to ensure that, in relation to the types or quantities of waste and the methods of recovery, the waste itself is recovered without endangering human health and without using 17. The expenses for the functioning of the National Committee and of the regional procedures or methods that could cause harm to the environment; and provincial Sections are provided with the revenues deriving from the secretarial rights and the annual registration fees, according to the provisions, also relating to the methods of payment and use, which they will be — 56 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 b) for hazardous waste: 1) storage centers for non-hazardous waste not located in the plants where the recycling the maximum quantities that can be used; and recovery operations are carried out, as identified in points R1 to R9 of Annex C in part four of this decree, as well as the methods of storage and maximum terms within 2) the origin, types and characteristics of the waste; 3) the which waste must be sent to the aforementioned operations. specific conditions referring to the limit values of dangerous substances contained in the waste, the emission limit values for each type of waste and the type of 9. activity and plant used, also in relation to the other emissions present on site; 10. 11. 4) the other requisites necessary to carry out different forms of recovery; 5) the 12. requirements necessary to ensure that, in relation to the type and quantity of dangerous 13. substances contained in the waste and the methods of recovery, the waste itself is recovered without endangering human health and without using procedures and 14. methods that could harm the environment. 15. “. For the text of Annex 1 of the decree of the Minister of the Environment and the Protection of the Territory and the Sea of 25 September 2007, n. 185, see in the notes 3. The province registers the companies that communicate the commencement to article 4. of activities and, within the term referred to in paragraph 1, the office verifies the existence of the conditions and requisites required in a special register. To this end, a Note all’art. 12: report is attached to the communication of the start of business, signed by the legal representative of the company, showing: For the text of article 183 of the legislative decree 3 April 2006, n. 152 see in the notes to article 4. a) compliance with the technical standards and specific conditions referred to in The text of articles 208, 213 and 216 of the legislative decree 3 April 2006, n. paragraph 1; b) possession of the subjective requisites required for waste management; 152, cited in the notes to the introduction, see the notes to article 11. c) the recovery activities to be carried out; d) the establishment, the recovery capacity and the treatment or combustion cycle in which the waste is destined to be Note all’art. 16: recovered, as well as the use of any mobile plants; e) the product characteristics For the normative references of the decree of the Minister of the environment of the products deriving from the recovery cycles. and the protection of the territory and the sea of 25 September 2007, n. 185, see in the notes to article 4. The Fourth Part of the legislative decree 3 April 2006, n. 152, quoted in the notes to the introduction, it is cited in the notes to article 2. 4. If the province ascertains the non-compliance with the technical regulations Note all’art. 17: and the conditions referred to in paragraph 1, it shall, with a justified provision, prohibit the beginning or the continuation of the activity, unless the interested party does not The text of article 7 of the legislative decree 13 January 2003, n. 36 comply to the current legislation said activity and its effects within the term and (Implementation of Directive 1999/31 / EC relating to landfills of waste), published in according to the prescriptions established by the administration. the Official Journal of 12 March 2003, no. 59, SO, reads as follows: “Art. 7. Waste used in landfills. 5. The communication referred to in paragraph 1 must be renewed every five years and in any case in the event of substantial modification of the recovery operations. 1. Waste may only be landfilled after treatment. This provision does not apply: a) to inert waste whose treatment is not technically feasible; b) waste whose treatment 6. The simplified procedure referred to in this article replaces, limited to the does not contribute to the achievement of the purposes referred to in article 1, qualitative and quantitative variations of the emissions determined by the waste reducing the quantity of waste or the risks to human health and the environment, identified by the technical standards referred to in paragraph 1, which already set the and is not indispensable for the purposes of complying with the limits fixed by current emission limits in relation to the activities of recovery of themselves, the authorization legislation. referred to in Article 269 in the event of a substantial modification of the plant. 2. Only inert waste that meets the criteria of current legislation may be admitted 7. The ordinary rules for recovery and disposal are fully applied to the activities to landfills for inert waste. referred to in this article if the waste is not effectively destined for recovery. 3. The following waste may be admitted to landfills for non-hazardous waste: a) urban waste; b) non-hazardous waste of any other origin satisfying i 8. Without prejudice to compliance with the emission limits into the atmosphere referred to in article 214, paragraph 4, letter b) , and emissions the limitsestablished of other polluting by current provisions and without prejudice to compliance with the other restrictions for the protection of health and environmental profiles, within sixty days from the date of entry criteria for the admission of waste provided for by current legislation; into force of the fourth part of this decree, the Minister of the Environment and of the c) stable and non-reactive hazardous waste that meets the admission criteria set Protection of the Territory and the Sea, in agreement with the Minister of Productive out in the decree referred to in paragraph 5. Activities, determines methods, conditions and measures relating to the granting of 4. Only hazardous waste that meets the criteria set by current legislation may financial incentives provided for by laws in force in favor of the use of waste as a be admitted to landfills for hazardous waste. priority in recycling and recovery operations to obtain materials, substances, objects, as well as as a fuel to produce electricity, also taking into account the prevailing public 5. The criteria for admission to landfills are defined by decree of the Minister of interest in energy recovery in power plants of urban waste subjected to preventive the Environment and Territorial Protection, in agreement with the Ministers of Productive operations the treatment aimed at the production of fuel from waste and the provisions Activities and Health, having heard the Permanent Conference for relations between of Legislative Decree 29 of December 2003, n. 387, and subsequent amendments, as the State, the regions and autonomous provinces. ". well as by Directive 2009/28 / EC and the related transposition provisions. 8 -bis . The operations for placing hazardous waste identified in accordance with this article in reserve are subject to the simplified procedures for communicating the start of activities Note all’art. 18: only if carried out at the plant where the recycling and recovery operations envisaged The Regulation (EC) 16-9-2009 n. 1005/2009 of the European Parliament and in points from R1 to R9 of Annex C to the fourth part of this decree. of the Council on substances that deplete the ozone layer (recast) (Text with relevance for the EEA) is published in the OJEU 31 October 2009, n. L 286. The Regulation (EC) 17-5-2006 n. 842/2006 of the European Parliament and of the Council on certain fl uorinated greenhouse gases is published in the OJEU 14 June 2006, no. L 161. 8 - tue. Without prejudice to the provisions of paragraph 8, the technical standards For the regulatory references to Directive 2012/19 / EU, see the notes to the referred to in paragraphs 1, 2 and 3 establish the plant characteristics of the introduction. — 57 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 The Regulation (EC) 25-11-2009 n. 1221/2009 of the European Parliament issuing of the same, which annotate the expected data on a monthly basis, and of the Council on voluntary participation by organizations in a Community keeping a copy of the transmitted data at the company headquarters. eco-management and audit scheme (EMAS), which repeals regulation (EC) no. 761/2001 and Commission decisions 2001/681 / EC and 2006/193 / EC is 4. The information contained in the loading and unloading register is made published in the OJEU 22 December 2009, n. L 342. available at any time to the supervisory authority upon request. Note all’art. 19: 5. The loading and unloading registers are numbered, endorsed and The text of article 190 of the legislative decree 3 April 2006, n. 152, cited managed with the procedures and methods established by the legislation on in the notes to the premises, reads as follows: “Art. 190. (Loading and unloading VAT registers. The obligations connected with the keeping of the loading and registers) unloading registers are understood to be correctly fulfilled even if A4-size paper, regularly numbered, is used. The registers are numbered and endorsed by the 1. The following are obliged to compile and keep the waste loading and unloading registers: territorially competent Chambers of Commerce. 6. The national regulations relating to the loading and unloading registers a) the initial bodies and enterprises producing hazardous special waste are those referred to in the decree of the Minister of the Environment 1 April and the initial producing entities and enterprises of special non-hazardous 1998, n. 148, as amended by paragraph 7. waste referred to in letters c) and d) of paragraph 3 of article 184 and non- hazardous special from purification and other water treatments referred to in 7. In Annex C1, section III, letter c) , of the decree of the Minister of the letter g) of paragraph 3 of article 184; b) other waste holders, such as entities Environment 1 April 1998, n. 148, after the words: "in liters" the conjunction: "and" is replaced by the disjunction: "or". and companies that collect and transport waste or that carry out operations for preparation for reuse and treatment, recovery and disposal, including new 8. Producers of hazardous waste who are not part of a corporate or producers and, in the case of intermodal transport, subjects to whom the special business organization are subject to the obligation to keep the loading and waste is entrusted pending the taking over of the same by the ship or railway unloading register and fulfill this by keeping, in chronological order, copies of company or the company that carries out the subsequent transport pursuant to the cards of the control system for the traceability of waste (SISTRI) referred to article 188 -ter in article 188 -bis paragraph 2, lett. a) , of the waste itself. , paragraph 1, last sentence; , relating to the waste produced, issued by the transporter c) intermediaries and waste dealers. 1 -bis . The following are excluded from the obligation to keep loading and unloading registers: 9. The management operations of the collection centers referred to in article 183, paragraph 1, letter mm)article , are excluded limited to from the obligations non-hazardous of this waste. For hazardous waste, the loading and unloading can be registered at the same time a) entities and companies that are obliged or that voluntarily adhere to as the waste leaves the collection center and cumulatively for each code in the the waste traceability control system (SISTRI) referred to in Article 188 -bis waste list. ". paragraph 2, letter a) , from the date of effective use , operating of said system; b) The law 25 January 1994, n. 70 (Rules for the simplification of the activities of collection and transport of own special waste not environmental, health and public safety obligations, as well as for the hazards carried out by the initial producer entities and enterprises. implementation of the eco-management and environmental audit system) is 1 -ter . The agricultural entrepreneurs referred to in Article 2135 of the published in the Official Gazette of January 31, 1994, no. 24. Italian Civil Code, initial producers of hazardous waste, fulfill the obligation to The text of article 189 of the legislative decree 3 April 2006, n. 152, cited keep the loading and unloading registers in one of the following two ways: a) in the notes to the premises, reads as follows: “Art. 189. (Land registry of waste) with the progressive conservation for three years of the identification pursuant to article 193, paragraph 1, relating to the transport of waste, or the copy 1. The waste register, established by article 3 of the decree-law 9 of the card of the waste traceability control system (SISTRI) referred to in article September 1988, n. 397, converted, with modifications, by the law 9 November 188 -bis paragraph 2, letter a ) ; b) with the conservation for three years of the 1988, n. 475, is divided into a National Section, which is based in Rome at the document conferring dangerous waste produced by agricultural ,by the person activities, whoissued Higher Institute for Environmental Protection and Research (ISPRA), and in collects said waste in the context of the organized collection circuit referred Regional Sections or the Autonomous Provinces of Trento and Bolzano at the to in article 183, paragraph 1, letter pp) . corresponding Regional Agencies and autonomous provinces for environmental protection. 2. The Land Registry ensures a complete and constantly updated 1 -quater . The information on the qualitative and quantitative characteristics cognitive picture of the data acquired through the waste traceability control of the waste produced or subjected to the various treatment activities governed system (SISTRI) referred to in article 188 -bis paragraph 2, lett. a) , and information ,the by this Part Four must be recorded in the loading and unloading register. The referred to activities. in paragraph 3, also for the purposes of planning waste management annotations must be made: a) for initial producer entities and enterprises, within ten working days of 3. The municipalities or their consortia and the mountain communities production and unloading; b) for entities and businesses that carry out operations communicate annually to the Chambers of Commerce, Industry, Crafts and to prepare for reuse, within ten working days of taking charge of the waste Agriculture, in accordance with the procedures established by law no. 70, the and unloading the waste originating from said activity; following information relating to the previous year: a) the quantity of urban waste collected in its territory; b) the quantity of special waste collected in its own c) for entities and companies that carry out processing operations, within territory two working days from taking charge and from the conclusion of the processing following a specific agreement with public or private entities; operation; c) the subjects who managed the waste, specifying the operations carried d) for intermediaries and traders, at least two working days before the out, the types and quantity of waste managed by each one; start of the operation and within ten working days of the conclusion of the operation. d) the management costs and the technical and financial depreciation of 2. The loading and unloading registers are kept at each production plant investments for waste management activities, as well as the proceeds from the or, if this is excessively burdensome, at the production site, and integrated with tariff referred to in article 238 and the proceeds from consortia aimed at the identification forms referred to in article 193, paragraph 1, relating to the recovering waste; e) data relating to separate collection; f) the quantities transport of waste, or with the copy of the card of the waste traceability control system (SISTRI) referred to in article 188 -bis paragraph 2, lett. a) , transmitted collected, broken down by materials, in implementation of the agreements by the plant of destination ofthe , thelast waste, are kept for five years from the date of registration. with the consortia aimed at recovering waste. 4. The provisions referred to in paragraph 3 do not apply to the 3. The initial producers of special non-hazardous waste referred to in municipalities of the Campania region, required to adhere to the control system paragraph 1, letter a) , whose not exceed annual tenproduction tonnes ofof non-hazardous non-hazardous waste, wastemay does for the traceability of waste (SISTRI) referred to in article 188 -bis paragraph ,lett. a) . 2, fulfill the obligation of keeping records of loading and unloading of waste also The information referred to in paragraph 3, letter d) , to ISPRA, are transmitted through direct through the interested business associations or direct service companies interconnection between the Land Registry of waste and the traceability system of waste in the Campania region referred to in — 58 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 article 2, paragraph 2 - bis of the decree-law 6 November 2008, n. 172, , ciability of waste (SISTRI) referred to in article 188 -bis paragraph 2, lett. a) , , converted, with amendments, by law no. 210 (YES BETWEEN). The activities the no. procedures relating 1013/2006, to shipmentsamendments, and subsequent of waste pursuant to Regulation including (EC) the adoption of referred to in this paragraph are carried out within the limits of the human, a data exchange system provided for by article 26, paragraph 4, of the instrumental and financial resources available under current legislation, aforementioned regulation. Pending the adoption of the aforementioned without new or greater charges for public finance. decrees, without prejudice to the obligations established by the decree of the 5. The provisions referred to in paragraph 3, except for the information Minister for the Environment and for the Protection of the Territory and the Sea on 17 December 2009, relating to the section of the national territory referred to in letter d) , also do not article apply188 to the -termunicipalities paragraph 2, referred lett. e) who to in adhere to the waste traceability , control system 188 -bis paragraph 2, lett.(SISTRI) a) . referred to in article affected by cross-border transport. , 7. With one or more regulations, pursuant to article 17, paragraph 2, of 6. The regional and provincial sections of the Land Registry shall law no. 400, and subsequent amendments, the provisions are recognized, process the data referred to in article 188 -ter paragraphs 1subsequently ,and 2, and including those of this decree, which, starting from the date of entry into force transmit them, within thirty days of receipt of the same, to the National of the aforementioned ministerial decrees, are repealed. Section which, in turn, provides , to the dispatch to the regional and provincial administrations competent in the matter of waste. 8. In relation to the organizational and operational needs of the Armed The Higher Institute for Environmental Protection and Research (ISPRA) Forces, Police Forces and the National Fire Brigade Corps, connected, processes the data annually and ensures their publicity. The Administrations respectively, to the defense and military security of the State, to the protection concerned shall fulfill the obligations referred to in this paragraph with the of public order and security , to public aid and civil defense, the procedures human, instrumental and financial resources available under current and methods by which the waste traceability control system (SISTRI) is legislation, without new or greater charges to be borne by public finance. applied to the corresponding central administrations are identified with a 7. For communications relating to packaging waste, the provisions of decree of the Minister for the Environment and for the Protection of the article 220, paragraph 2 apply. " Territory and of the sea and the Minister of Economy and Finance and, to the The text of article 188 -ter of the legislative decree 3 April 2006, n. 152, extent of their respective competence, the Minister of Defense and the cited in the notes to the premises, reads as follows: “Art. 188 -ter . (Waste Minister of the Interior, to be adopted within 120 days from the date of entry traceability control system - SISTRI) into force of this provision. 1. Entities and initial producers of special hazardous waste and entities 9. By decree of the Minister for the Environment and for the Protection or companies that collect or transport special hazardous waste on professional , a basis, of the Territory and the Sea, simplified procedures for registering the including foreign carriers operating on the national territory, or carrying out producers of hazardous waste in the control system for the traceability of operations for the treatment, recovery, disposal, trade and intermediation of waste (SISTRI) referred to in Article 188 -bis paragraph 2, lett. a) ., urban and special hazardous waste, including new producers which process or produce hazardous waste. 10. In the case of accidental production of dangerous waste, the manufacturer is required to proceed with the request for membership of SISTRI within three working days of ascertaining the dangerousness of the waste. ". In the case of intermodal transport, the subjects who are entrusted with the special dangerous waste pending the taking over of the same by the naval Note all’art. 20: or railway company or the company that carries out the same are also required to adhere to SISTRI. the subsequent transport. Within sixty days For the text of articles 208 and 216 of legislative decree 3 April 2006, from the date of entry into force of this provision, with one or more decrees n. 152, cited in the notes to the introduction, see the notes to article 11. of the Minister of the Environment and of the Protection of the Territory and the Sea, after consulting the Minister of Economic Development and the Minister of Infrastructure and Transport, are defined the procedures for The text of article 214 of the legislative decree 3 April 2006, n. 152, applying the SISTRI fully operational to intermodal transport. cited in the notes to the premises, reads as follows: “Art. 214. (Determination 2. Producers , managers and intermediaries and traders of waste other of the activities and characteristics of refusals for admission to simplified than those referred to in paragraph 1. , procedures) 1. The simplified procedures referred to in this chapter must in any case guarantee a high level of environmental protection and effective 3. With one or more decrees of the Minister of the Environment and of controls pursuant to and in compliance with the provisions of article 177, the Protection of the Territory and of the Sea, after consulting the Minister of paragraph 4. Economic Development and the Minister of Infrastructure and Transport, the 2. By decrees of the Minister for the Environment and for the Protection categories of subjects referred to in paragraph 1 and further categories of of the Territory and the Sea, in agreement with the Ministers of Economic persons to whom it is necessary to extend the waste traceability system Development, Health and, for agricultural waste and activities that generate referred to in article 188 -bis are identified within the bodies or companies that carry out waste treatment . fertilizers, with the Minister of agricultural and forestry policies, regulations are adopted for each type of activity, which fix the types and quantities of 4. They are required to adhere to the traceability control system, waste and the conditions under which the activities of disposal of non- of waste (SISTRI) referred to in article 188 -bis paragraph 2, lett. a)commu , , the hazardous waste carried out by producers in the production sites of and the and the transport companies of urban waste in the Campania region. recovery activities referred to in Annex C in the fourth part of this decree are subject to the simplified procedures referred to in articles 215 and 216. The [5. With one or more decrees of the Minister of the Environment and of aforementioned technical standards and conditions are updated with the the Protection of the Territory and the Sea, in agreement with the Minister of same procedure. Infrastructure and Transport, the obligation to register in the control system 3. The rules and conditions referred to in paragraph 2 and the simplified for the traceability of waste can be extended (SISTRI ) referred to in article , procedures must ensure that the types or quantities of waste and the 188 -bis paragraph paragraph 2, lett. a) , to thethe 2 to categories producersofofsubjects special referred to inwaste dangerous procedures and methods of disposal or recovery are such as not to constitute who are not part of an organization or corporate body, as well as to the a health hazard. man and not to harm the environment. In particular, without subjects referred to in the decree provided for in article 6, paragraph 1 -bis of prejudice to the discipline of the legislative decree 11 May 2005, n. 133, to the legislative decree 25 July 2005,forn.the , 151, containing simplified management procedures of waste from electrical access the simplified procedures, the heat treatment and energy recovery and electronic equipment (WEEE) by distributors and installers of electrical activities must also comply with the following conditions: and electronic equipment (EEE), as well as by the managers of the technical assistance centers of such equipment. ] a) fuels from municipal waste or special waste identified for homogeneous fractions are used; 6. With one or more decrees of the Minister of the Environment and Land and Sea Protection, in agreement with the Minister of Infrastructure and b) the emission limits are not higher than those established for waste Transport, within three months from the date of entry into force of this incineration and co-incineration plants by the regulations in force, with provision, are established, in compliance of Community rules, the criteria and particular reference to legislative decree no. 133; conditions for the application of the trac control system — 59 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 c) the production of a minimum rate of transformation of the calorific value of if not already authorized pursuant to the previous period, the regime referred to in the waste into useful energy is guaranteed, calculated on an annual basis; d) the articles 22 and 23 of the consolidated text of the legislative and regulatory provisions conditions, technical standards and specific prescriptions referred to in articles 215, on construction, referred to in the decree of the President of the Republic of 6 June paragraphs 1 and 2, and 216, paragraphs 1, 2 and 3 are complied with. 2001, no. 380, and subsequent amendments. ". 4. Until the adoption of the decrees referred to in paragraph 2 relating to recovery Note all’art. 21: activities, the provisions of the decrees of the Minister for the Environment of February 5, 1998, published in the SO in the Official Gazette no. 88 of 16 April 1998 and 12 The Regulation (EC) 14-6-2006 n. 1013/2006 of the European Parliament and June 2002, n. 161. of the Council relating to shipments of waste is published in the OJEU 12 July 2006, 5. The adoption of the rules and conditions referred to in paragraph 2 must first no. L 190. of all concern the waste indicated in the green list referred to in Annex III of Regulation The Regulation (EC) 29-11-2007 n. 1418/2007 of the Commission on the export (EC), no. 1013/2006. of certain waste destined for recovery, listed in Annex III or III A of Regulation (EC) no. 6. For the keeping of the registers referred to in articles 215, paragraph 3, and 1013/2006 of the European Parliament and of the Council, to some countries to which 216, paragraph 3, and for carrying out periodic checks, the interested party is required the OECD decision on the control of cross-border movements of waste does not apply to pay to the territorially competent province an annual registration fee determined with is published in the OJEU 4 December 2007, n. L 316. decree of the Minister for the Environment and for the Protection of the Territory and the Sea, in agreement with the Ministers of Economic Development and the Economy and Finance. Pending the issuance of the aforementioned decree, the provisions of Note all’art. 23: the decree of the Minister of the Environment 21 July 1998, n. 350. The provinces shall provide for the implementation of the tasks indicated in this paragraph with the human, The text of article 10 of the legislative decree 25 July 2005, n. 151, cited in the instrumental and financial resources available under current legislation, without new or notes to the premises, reads as follows: “Art. 10. Financing methods and guarantees greater charges for public finance. for the management of historical WEEE from private households. 7. The construction of plants that recover waste in compliance with the 1. The financing of the transport operations from the centers established conditions, requirements and technical standards referred to in paragraphs 2 and 3 is pursuant to Article 6, as well as the treatment, recovery and environmentally compatible governed by national and EU legislation on air quality and atmospheric pollution from disposal operations referred to in Articles 8 and 9 of historic WEEE, originating from industrial plants. strial and other provisions governing the construction of industrial private households is a load of the producers present on the market in the calendar plants. year in which the respective costs occur, in proportion to the respective market share, calculated on the basis of the number of pieces or by weight, if specifically indicated in The authorization to carry out recovery operations of waste not identified Annex 1B, by type of equipment, in the reference calendar year. Producers fulfill the pursuant to this article in the aforementioned plants remains in any case subject to the aforementioned obligation by setting up collective WEEE management systems. provisions of articles 208, 209 and 211. 8. The provisions relating to private activities subject to the discipline of articles 19 and 20 of the law of 7 August 1990, n. 241. The provisions of article 21 of the law 2. The producer may explicitly indicate to the purchaser, at the time of the sale of 7 August 1990, no. 241. Provided that the conditions, technical standards and of new products, the costs incurred for the collection, treatment, recovery and disposal specific prescriptions adopted pursuant to paragraphs 1, 2 and 3 of article 216 are of historical WEEE. In this case, the distributor indicates separately to the final respected, the execution of waste recovery operations can be undertaken after ninety purchaser the price of the product and the cost, identical to that identified by the days from the communication of the start of business to the province. manufacturer, for the management of historical waste. The costs indicated by the manufacturer cannot exceed the costs actually incurred for treatment, recovery and disposal. 9. The provinces communicate to the land registry of waste referred to in article 3. Manufacturers who supply electrical and electronic equipment using the 189, through the telematic land registry and according to the standards agreed with means of remote communication referred to in the aforementioned legislative decree ISPRA, which takes care of the inclusion in a national list, accessible to the public, of 22 May 1999, n. 185, comply with the obligations of this article also with regard to the the following identifying elements of the companies registered in the registers referred equipment supplied in the Member State in which the purchaser of the same resides, to in articles 215, paragraph 3, and 216, paragraph 3: a) company name; b) registered according to procedures defined by decree of the Minister for the environment and the office of the company; c) site of the plant; d) type of waste object of the protection of the territory, in agreement with the Minister of Productive Activities, in management activity; e) relative quantities; f) management activities; g) date of compliance with the provisions adopted at Community level. registration in the registers referred to in articles 215, paragraph 3, and 216, 4. The financing of the management of waste from equipment falling within the paragraph 3. category referred to in point 5 of annex 1A is borne by the producers regardless of the date of placing said equipment on the market and of domestic or professional origin, according to modalities identified by the Ministry of the Environment and Territorial Protection, with its own decree, in agreement with the Ministers of Productive Activities, Economy and Finance, to be adopted within six months from the date of entry into force of this decree. " . 10. The communication of the data referred to in paragraph 9 must take place without new and greater charges for public finance between the existing regional information systems, and the telematic cadastre according to shared standards. Note all’art. 25: 11. With one or more decrees, issued pursuant to article 17, paragraph 2, of The text of article 1 of the law of 10 June 1982, n. 348 (Constitutions of sureties law no. 400, and subsequent amendments, on the proposal of the Minister of the with surety policies to guarantee obligations towards the State and other public bodies), Environment and of the Protection of the Territory and the Sea, after consulting the published in the Official Journal Minister of Economic Development, the conditions under which the use of an alternative June 14, 1982, n. 161, reads as follows: fuel, in part the replacement of fuels, are identified traditional fossils, in plants subject "Art. 1. In all cases in which the provision of a security in favor of the State or to the regime referred to in Title III - bis of Part II, with certification of environmental other public body is envisaged, this can be constituted in one of the following ways: quality, both to be qualified, for all purposes, as a non-substantial modification. The aforementioned decrees may establish, in compliance with article 177, paragraph 4, a) by real and valid security, pursuant to article 54 of the regulation for the the appropriate procedures for integrating and unifying the procedures, including administration of assets and for the general accounting of the State, approved by Royal prerequisites, for updating the integrated environmental authorization, with the effect Decree no. 827 subsequent amendments; , and of absorption and replacement of any other prescribed act of consent. To any necessary structures, including those for the storage and supply of alternative fuel, built within the site of the b) bank surety issued by credit companies referred to to article 5 of the royal decree-law 12 March 1936, n. 375 sive , e success modifications and additions; — 60 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 c) by an insurance policy issued by insurance companies duly authorized d) information on the collection centers organized and managed pursuant to to exercise the surety branch and operating in the territory of the Republic under article 6, paragraph 1, letter c) and paragraph 3 of the legislative decree 25 July the freedom of establishment or freedom to provide services. ". 2005, n. 151, specifying whether the organization is on an individual or collective basis; e) the possible registration in the registers of other member states of the European Union; f) information relating to the extent and methods of Note all’art. 27: presentation of the financial guarantees pursuant to articles 11 and 12 of legislative For the text of article 180 - bis of legislative decree 3 April 2006, n. 152, decree no. 151; g) for each category of electrical and electronic equipment cited in the notes to the introduction, see the notes to article 1. placed on the market, the system or systems through which it intends to fulfill its WEEE financing obligations. In the case of a collective system, the manufacturer must indicate the name of the chosen system. Note all’art. 29: The text of articles 1 and 3 of the decree of the Minister for the environment and the protection of the territory and the sea of 25 September 2007, n. 185, cited in the notes to article 4, reads as follows: 6. Actual weight of electrical and electronic equipment means the weight of "Art. 1. Establishment of the Register and organizational structure. the product, including all electrical and electronic accessories, excluding packaging, 1. The National Register of subjects obliged to fi nish the management manuals, removable batteries and non-electrical or electronic accessories. systems for waste electrical and electronic equipment, hereinafter referred to as WEEE, is set up at the Ministry of the Environment and Land and Sea Protection. 7. If the producer does not have actual data on the division of EEE into article 14 of the legislative decree 25 July 2005, n. 151. domestic and professional at the time of registration, he shall provide an estimate of this division under his own responsibility. 2. Producers of electrical and electronic equipment are required to register in the Register, as defined in Article 3, paragraph 1, letter m) , of Legislative 8. Once the registration has been made, each producer is issued a Decree no. 151. registration number through the computer system of the chambers of commerce. 3. The Register contains a section containing the following information: a) the data communicated by the obliged subjects upon registration in the 9. Within thirty days of its issue, the registration number must Register at the Chamber of Commerce, pursuant to article 14, paragraph 2, of the be indicated by the manufacturer in all commercial documents. ". legislative decree 25 July 2005 , no. 151; b) the data communicated by the obliged subjects pursuant to article 13, Note all’art. 31: paragraphs 6 and 7 of the legislative decree 25 July 2005, n. 151. For the regulatory references of Directive 2012/19 / EU, see the notes to the 4. The Register also contains a section dedicated to collective or mixed introduction. systems set up for the financing of the management of WEEE referred to in articles The decision 11-3-2004 n. 2004/249 / EC of the Commission relating to the 10, paragraph 1, 11, paragraph 1 and 12, paragraph 4, of the legislative decree of questionnaire for use by Member States on the implementation of Directive 25 July 2005, n. 151, which contains the list of the aforementioned systems as 2002/96 / EC of the European Parliament and of the Council on waste electrical well as the information referred to in Article 7, paragraph 1. " and electronic equipment (WEEE) is published in the OJEU 16 March 2004 , no. "Art. 3. Registration of producers in the register. L 78. 1. Registration in the Register is carried out by the manufacturer at the The decision 3-5-2005 n. 2005/369 / EC of the Commission which Chamber of Commerce in whose district the registered office of the company is establishes the procedures for monitoring compliance with the obligations located. In the event that the producer is not established in the Italian territory, he incumbent on Member States and defines the formats for the presentation of data enters the Register through his own representative in Italy, in charge of all the for the purposes of Directive 2002/96 / EC of the European Parliament and of the formalities required by the legislative decree 25 July 2005, n. l51. In this case, Council on waste use of electrical and electronic equipment is published in the registration is made at the Chamber of Commerce in whose district the registered OJEU 11 May 2005, n. L 119. office of the representative is located. Note all’art. 33: 2. Registration is made within ninety days from the date of entry into force of The text of articles 9, 11 and 12 of the decree of the Minister for the this regulation or in any case before the manufacturer begins to operate on the Environment and the Protection of the Territory and the Sea of 25 September Italian market. 2007, cited in the notes to article 4, no. 185, reads as follows: “Art. 9. Coordination 3. Registration takes place exclusively electronically. The registration form center for the optimization of activities is signed by digital signature affixed by the legal representative or his delegate, or within the competence of collective systems. by the authorized representative pursuant to paragraph 1. 1. The collective management systems of WEEE from private households established within the thirtieth day from the date of entry into force of this regulation 4. Producers of EEE intended for private households required to finance the shall, within ninety days from the same date of entry into force, establish the management of WEEE through collective systems pursuant to articles 10, Coordination Center referred to in 'article 13, paragraph 8, of the legislative decree paragraph 1, and 20, paragraph 4, of legislative decree 25 July 2005, no. 151, are 25 July 2005, n. 151. registered in the Register after joining one or more collective systems, relating to the category of electrical and electronic equipment placed on the market; to this 2. The Coordination Center referred to in paragraph 1 is constituted in the end, the information system of the Register guarantees, at the time of registration, form of a consortium having legal personality under private law, in which all the the automatic verification of adherence to the collective system. collective management systems for WEEE from private households participate, which join the Center within thirty days of their constitution. 5. Upon registration in the Register, the producer must indicate: a) membership of one or more of the types of activities defined in Article 3, 3. If for one or more groupings of domestic WEEE referred to in Annex 1, a paragraph 1, letter m) , of Legislative Decree 25 July 2005, no. . 151; single collective system is established which operates throughout the national territory and which guarantees the performance of the services provided by the b) the specific ISTAT code of activity which identifies him as pro Coordination Center on its own, this system can be, upon evaluation of the doctor of electrical and electronic equipment (AEE); Supervisory and Control Committee referred to in Article 15 of Legislative Decree 25 July 2005, no. 151, exempted from the obligation to participate in the c) for each category of equipment referred to in Annex 1A of Legislative Coordination Center. In this case, the single collective system is required to submit Decree 25 July 2005, no. 151, as further divided into Annex 1B of the same to the Supervisory and Control Committee and the Coordination Center an annual legislative decree, the number and the actual weight, or only the actual weight, of prevention and activity program relating to the group or groups of WEEE managed. the equipment placed on the market in the previous calendar year, divided between domestic and professional equipment. This last subdivision does not apply to lighting equipment in compliance with the provisions of article 10, paragraph 4, of 4. Systems can also participate in the Coordination Center legislative decree no. 151; collective management of professional WEEE. " "Art. 11. Organization of the Coordination Center. — 61 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 1. The organs of the Center 2. For the purposes referred to in paragraph 1, the Committee makes use of are: a) the Assembly, made up of a representative from each collective the APAT and, in particular, for the inspections referred to in paragraph 1, the letter d) , system; b) the Executive Committee, made up of five members, including the Committee may also avail itself of the collaboration of the Guardia di Finanza. President; c) the President; d) the Board of Auditors. 3. 4. With the decree provided for in article 13, paragraph 8, the Steering Committee on the management of WEEE is also set up at the Ministry of the Environment and Territory and its composition has been defined. and the operating 2. The President and the Executive Committee appointed in the constitution regulations. This committee supports the Committee referred to in paragraph 1 in of the Center remain in office for twelve months starting from the constitution of the carrying out the tasks assigned to it. ". Center. 3. The members of the Board of Auditors are appointed from among those The text of article 19 of the legislative decree 20 November 11 2008, n. 188 enrolled in the Register of Auditors. (Implementation of Directive 2006/66 / EC concerning batteries, accumulators and 4. The statute of the Coordination Center is approved by the assembly and related waste and which repeals Directive 91/157 / EEC), published in the Official Journal of 3 December 2008, no. 283, SO, reads as follows: must be approved by decree of the Minister of the Environment and of the Protection of the Territory and the Sea, in agreement with the Minister of Economic Development and the Minister of Economy and finances. "Art. 19. Supervisory and control committee 1. 5. The Coordination Center adopts one or more operating regulations. " The Supervisory and control committee already established pursuant to article 15 of decree no. 151 of 2005, also assumes the functions of the Supervisory "Art. 12. Financing of the activities of the Coordination Center. and Control Committee on the management of batteries and accumulators and 1. The financial means for the functioning of the Coordination Center consist related waste referred to in this decree. of the contributions of the participating subjects, to be disbursed according to the 2. The operating costs of the Committee referred to in paragraph 1 are equally procedures established in the Statute. charged to the producers of electrical and electronic equipment and batteries and 2. If a single collective system is established for one or more groupings of accumulators. The producers of electrical and electronic equipment share the WEEE which operates throughout the national territory and which, following a charges referred to in this paragraph on the basis of market shares as identified by favorable opinion from the Control and Supervisory Committee as established in article 15, paragraph 1, letter c) , of decree no. 151 of 2005. The producers of Article 9, paragraph 3, of this Regulation, is exempted from the obligation to batteries and accumulators according share theto the expenses criteriareferred established to inby thisthe paragraph Coordination participate in the Coordination Center this collective system is also exempted from Center referred to in article 16, approved by the Supervisory Committee referred to the funding obligations of the Coordination Center. in this article. 3. If a single collective system is established for one or more groupings of 3. The Committee referred to in paragraph 1 is made up of eight members, WEEE which operates throughout the national territory and which, while participating three of which are designated by the Minister for the Environment and for the in the Coordination Center, demonstrates that it carries out some of its management Protection of the Territory and the Sea, one of whom with the function of president, activities without resorting to its services, this system is exempt from the Centre's one of which by the Minister of Economic Development, with the function as Vice- funding obligations as regards such activities. ". President, one by the Minister of Economy and Finance, one by the Minister of Labor, Health and Social Policies, one by the Minister for Public Administration and Innovation and one by the Unified Conference, appointed by decree of the Minister Note all’art. 34: the environment and the protection of the territory and the sea within sixty days For the regulatory references of Directive 2012/19 / EU, see the notes to the from the date of entry into force of this decree. Until the adoption of the decree introduction. appointing the new members, the carrying out of institutional activities is guaranteed by the members in office on the date of entry into force of this decree. Note all’art. 35: 4. The accounting system, the activities and the functioning of the Committee The text of article 15 of the legislative decree 25 July 2005, n. 151, cited in are governed by an internal regulation adopted by the Committee itself. The the notes to the premises, reads as follows: “Art. 15. Supervisory and control Secretariat of the Committee is ensured by ISPRA. For the examination of specific committee and steering committee on the management of WEEE. problems, experts who are particularly qualified in the subjects to be dealt with may be invited to the meetings of the Committee. 1. By decree of the Minister of the Environment and Territorial Protection, to 5. The Supervisory and Control Committee ensures the unitary direction and be adopted within six months from the date of entry into force of this decree, the coordination of the management of waste batteries and accumulators and reports Committee of supervision and control over the management of WEEE, with the annually to the Ministry of the Environment and Land and Sea Protection. following tasks: a) preparing and updating the register referred to in Article 14, paragraph 1, on the basis of the communications from the Chambers of Commerce provided for in the same Article 14, paragraph 3; 6. The Supervisory and Control Committee is also responsible for: a) the development and permanent updating of the rules necessary for the preparation and cooperation between collection centers / collection points for b) collect, exclusively in electronic format, the data relating to the products batteries and accumulators and / or local authorities ; placed on the market and the financial guarantees that the producers are required b) ensure monitoring of the implementation of this legislative decree; to this to communicate to the Registry pursuant to article 13, paragraphs 6 and 7; end, it makes use of the register referred to in article 14, of the lists and data referred to in article 15, paragraphs 2 and 3, prepared and made available by ISPRA; c) calculate, on the basis of the data referred to in letter b) , the respective market shares of the producers; c) ensure the examination and evaluation of the problems presented by the d) planning and arranging, on the basis of a specific plan, inspections on categories concerned and by the collection systems, in particular, in the absence of producers who do not carry out the communications referred to in letter b) and, on a specific evaluation at Community level, it expresses itself on the applicability or a sample basis, on the communications provided for in letter b) ; e) ensure that the otherwise of this decree; equipment placed on the market after 13 August 2005 bear the identification of the manufacturer and the trademark referred to in Article 13, paragraph 4, and d) encourage the adoption of initiatives aimed at guaranteeing the uniform that the manufacturers who supply electrical and electronic equipment using remote application of this legislative decree and its implementing measures, also by communication inform the register of compliance with the provisions referred to in submitting any proposals for amendments to the legislation to the competent Article 10, paragraph 3; Ministries; e) planning and arranging, on the basis of a specific plan, inspections of producers who do not carry out the communications referred to in articles 14, f) process the data relating to the recovery objectives referred to in the article paragraph 2, and 15, paragraph 3, using ISPRA and the Guardia di Finanza. ". 9, paragraph 2, and prepare the reports provided for in article 17. — 62 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 Note all’art. 36: 4. The judge, with the sentence of conviction or with that issued pursuant to article 444 of the code of criminal procedure, orders the restoration of the The text of articles 13 and 15 of the decree of the Minister for the environment state of the environment and can make the granting of the conditional suspension and the protection of the territory and the sea of 25 September 2007, n. 185, cited of the sentence subject to the elimination of the damage. or the danger to the in the notes to article 4, reads as follows: environment. " "Art. 13. Establishment of the Steering Committee on the management of "Art. 262. (Jurisdiction and jurisdiction) WEEE. 1. Without prejudice to the other provisions of law no. 689 in the matter of 1. The Steering Committee on the management of WEEE referred to in ascertaining administrative offenses, the provincial in whose territory the violation article 15, paragraph 4, of the legislative decree 25 July 2005, n. 151. was committed shall provide for the imposition of the administrative pecuniary sanctions provided for in part four of this decree, with the exception of the sanctions provided for in Article 261, paragraph 3 , in relation to the prohibition 2. The Committee is composed of thirteen members, of which: 3 designated referred to in article 226, paragraph 1, for which the municipality is competent. by the national organizations of the industrial categories of which at least one representing the recovery sector, 1 designated by the national organizations of 2. The opposition judgment provided for by article 22 of law no. 689. the commercial categories, 1 by the national organizations of the craft categories, 1 from the national organizations of the cooperation categories, 2 from the Regions, 1 from ANCI, 1 from UPI, 1 from Confservizi, 1 from environmental associations and 1 from consumer associations. 3. For criminal proceedings pending on the date of entry into force of the fourth part of this decree, the judicial authority, if it does not have to issue an archiving decree or an acquittal sentence, orders the transmission of the 3. The members of the Committee remain in office for four years. " documents to the bodies indicated in paragraph 1 for the purposes the application "Art. 15. Functioning of the Steering Committee on the management of of administrative sanctions. " WEEE. "Art. 263. (Proceeds from administrative pecuniary sanctions) 1. The Steering Committee meets at least twice a year and whenever 1. The proceeds of the administrative pecuniary sanctions for the requested by the majority of its members or by the Supervisory and Control violations referred to in the provisions of the fourth part of this decree are Committee. devolved to the provinces and are intended for the exercise of the control 2. The Steering Committee may request, by a majority of its members, functions in environmental matters, without prejudice to the proceeds of the the convening of the Supervisory and Control Committee for the discussion of administrative pecuniary sanctions of referred to in article 261, paragraph 3, in the proposals formulated pursuant to article 14 and for the discussion of any relation to the prohibition referred to in article 226, paragraph 1, which are devolved to the munic problems. 3. The secretariat of the Steering Committee is ensured by the secretariat Note all’art. 40: of the Supervisory and Control Committee. The text of article 25 of the legislative decree 3 March 2011, n. 28 4. Pursuant to article 19, paragraph 3, of legislative decree no. 151, the (Implementation of Directive 2009/28 / EC on the promotion of the use of energy charges relating to the functioning of the Steering Committee are borne by the from renewable sources, amending and subsequently repealing Directives producers of electrical and electronic equipment in proportion to their respective 2001/77 / EC and 2003/30 / EC) published in the Official Gazette 28 March market shares by type of equipment; these charges are identified with the decree 2011, n. 71, SO, reads as follows: “Art. 25. Transitional provisions and referred to in article 19, paragraph 4, of legislative decree no. 151 of 2005, which also establishes the payment methods. ". abrogations 1. The production of electricity from plants powered by renewable sources, which came into operation by 31 December 2012, is encouraged with the mechanisms in force at the date of entry into force of this Note all’art. 37: decree, with the corrective referred to in the following paragraphs. For the normative references to the regulations (EC) n. 1013/2006 and n. 1418/2007, see in the notes to article 21. 2. Electricity imported starting from 1 January 2012 is not subject to the obligation pursuant to article 11, paragraphs 1 and 2, of legislative decree no. For the regulatory references to Directive 2008/98 / EC, see the notes to 79, exclusively in the event that it contributes to the achievement of the national article 4. objectives referred to in Article 3. Note all’art. 38: 3. Starting from 2013, the compulsory quota referred to in article 11, paragraph 1, of legislative decree no. 79, decreases linearly in each of the The text of articles 259, 260, 262 and 263 of the legislative decree following years, starting from the value assumed for the year 2012 on the basis 3 April 2006, n. 152, cited in the notes to the premises, reads as follows: of current legislation, until it is canceled out for the year 2015. “Art. 259. (Illicit trafficking of waste) 4. Without prejudice to the provisions of article 2, paragraph 148, of law 1. Anyone who makes a shipment of waste constituting lawful trafficking no. 244, the GSE annually withdraws the green certificates issued for production pursuant to Article 26 of Regulation (EEC) 1 February 1993, n. 259, or makes a from renewable sources for the years 2011 to 2015, possibly exceeding those shipment of waste listed in Annex II of the aforementioned regulation in violation necessary for compliance with the mandatory quota. The withdrawal price of the of article 1, paragraph 3, letters a) , b) , c) and d) , of the regulation itself is aforementioned certificates is equal to 78 per cent of the price referred to in the punished with the penalty to twenty-six thousandof 'fine eurosfrom andonewiththousand the arrestfive hundred of up to twoand fiftyThe years. euros aforementioned paragraph 148. The GSE also withdraws the green certificates, penalty is increased in case of shipment of dangerous waste. issued for the productions referred to in the same years, relating to the cogeneration plants combined with district heating referred to in article 2, paragraph 3, letter a) , of the decree of October the Minister 2005,of published ProductiveinActivities the ordinary of 24 2. To the sentence of conviction, or that issued pursuant to article 444 of Supplement of the Official Gazette of 14 November 2005, no. 265. The the criminal procedure code, for the offenses relating to illicit trafficking referred withdrawal price of the certificates referred to in the previous period is equal to to in paragraph 1 or to illicit transport referred to in articles 256 and 258, the average market price recorded in 2010. Consequently, from the date of entry paragraph 4 , compulsorily follows the confiscation of the means of transport. " into force of this decree, paragraphs 149 and 149-bis are repealed "Art. 260. (Organized activities for the illicit traffi c of waste) of article 2 of the law of 24 December 2007, n. 244. 1. Anyone who, in order to achieve an unjust profit, with more operations 5. For the sole purpose of recognizing the tariff referred to in row 6 of table and through the setting up of organized means and continuous activities, 3 attached to law no. 244 slaughter residues, as well as the by-products of transfers, receives, transports, exports, imports, or in any case illegally manages agricultural, agri-food and forestry activities, are not considered liquid even if large quantities of waste is punished with imprisonment from one to six years. they undergo a liquefaction treatment or mechanical extraction. 2. In the case of highly radioactive waste, the penalty of imprisonment from three to eight years is applied. 3. The accessory penalties pursuant to articles 28, 30, 32 -bis and 32 - ter 6. The all-inclusive fixed tariffs provided for by article 2, paragraph 145, of of the criminal code follow, with the limitation referred to in article 33 of the same law no. 244 remain constant for the entire period of entitlement and remain code. unchanged at the values established in table 3 — 63 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 attached to the same law for all plants that come into operation by 31 December The text of article 20 of the legislative decree 25 July 2005, n. 151, cited in 2012. the notes to the premises, reads as follows: “Art. 20. Transitional and final provisions. 7. The multiplying factors referred to in article 2, paragraph 147, of law no. 244 and article 1, paragraph 382 -quater , of the law 27 December 2006, n. 296, 1. The owners of WEEE storage, treatment and recovery facilities authorized remain constant for the entire legal period and remain unchanged at the values pursuant to articles 27 and 28 of legislative decree no. 22 of 1997, in operation on established by the aforementioned standards for all plants that come into operation the date of entry into force of this decree, submit, if necessary, an application for by 31 December 2012. adaptation to the requirements set out in annexes 2 and 3, within three months of 7th to . the entry into force of this decree, and adapt the systems within 12 months of 7th _ . submitting the application. Pending the adjustment, the continuation of the activity is permitted. 7 -quater . 8. The reference value referred to in article 2, paragraph 148, of law no. 244 2. In order to verify compliance with the provisions of this decree, the remains unchanged at the value set by the aforementioned regulation for all plants province competent for the territory shall, within three months from the date of entry that come into operation by 31 December 2012. into force of this decree, inspect the plants in operation on the same date that they carry out the treatment and recovery of WEEE pursuant to articles 31 and 33 of 9. The provisions of the decree of the Minister of Economic Development of legislative decree no. 22 of 1997. The province, if necessary, establishes the 6 August 2010, published in the Official Gazette no. 197 of 24 August 2010, apply methods and times for complying with these prescriptions, which in any case to the production of electricity from solar photovoltaic systems that come into cannot exceed 12 months, allowing the continuation of the activity pending the operation by 31 May 2011. adaptation. In the event of failure to comply with the established methods and 10. Without prejudice to the provisions of article 2 -sexies of the decree law terms, the activity is interrupted. no. 3, converted, with amendments, by law 22 March 2010, n. 41, the incentive for the production of electricity from photovoltaic solar plants that come into operation 3. The producers of electrical and electronic equipment present on the after the deadline referred to in paragraph 9 is governed by a decree of the Minister market on the date of entry into force of the decree referred to in article 13, of Economic Development, to be adopted, in agreement with the Minister for the paragraph 8, shall make, within ninety days from the same date, the registration environment. and the protection of the sea, having consulted the unified Conference provided for in paragraph 2 of the aforementioned article 14. referred to in article 8 of legislative decree no. 281, by 30 April 2011, based on the 4. Pending the definition of a European system for the identification of following principles: producers, as indicated in Article 11, paragraph 2, of Directive 2002/96 / EC and, in any case no later than 31 December 2010, the the financing of the operations a) determination of an annual limit of cumulative electrical power of the referred to in article 11, paragraph 1, is carried out by the producers in the manner photovoltaic systems that can obtain the incentive tariffs; established in article 10, paragraph 1 and the financing of the operations referred to in article 12, paragraph 1, is carried out by the producers in the manner b) determination of the incentive tariffs taking into account the reduction of established in article 12, paragraph 2. technology costs and installation costs and incentives applied in the Member States of the European Union; c) provision of incentive tariffs and differentiated quotas 5. The subjects required to fulfill the obligations referred to in articles 6, based on the nature of the site area; d) application of the provisions of article paragraphs 1 and 3, 7, paragraph 18, paragraph 19, paragraph 1, 10, 11, 12 and 7 of the legislative decree no. 387, as they are compatible with the present 13 shall comply with the provisions of the same articles within one year from the date of entry in force of this decree. 6. The provisions referred to in articles 44 and 48 of legislative decree no. comma. 22 of 1997 do not apply to electrical and electronic equipment falling within the 11. Without prejudice to the acquired rights and the effects produced taking scope of this decree. ". into account the provisions of article 24, paragraph 5, letter c) , the following are abrogated: a) with For the text of article 214 of the legislative decree 3 April 2006, n. 152, cited effect from 1 January 2012, paragraph 3 of article 20 of the decree legislative in the notes to the introduction, see the notes to article 20. 29 December 2003, n. 387; b) with effect from 1 January 2013: 1) paragraphs 143, For the text of article 216 of the legislative decree 3 April 2006, n. 152, cited 144, 145, 150, 152, 153, letter a) , of article 2 of law no. 244; 2) paragraph 4 in the notes to the introduction, see the notes to article 11. -bis of article 3 of the decree-law of 1 July 2009, n. 78, converted, amendments, with The text of annex 1 of the decree of the Minister of the Environment February by law 3 August 2009, n. 102; 3) Article 7 of Legislative Decree 29 December 2003, 5, 1998 (Identification of non-hazardous waste subjected to simplified recovery n. 387; c) starting from 1 January 2016: 1) paragraphs 1, 2, 3, 5 and 6 of procedures pursuant to articles 31 and 33 of Legislative Decree no. 22), published article 11 of legislative decree no. 79; 2) article 4 of the legislative decree n. 387 of in the Official Journal of 16 April 1998, no. 88, SO, reads as follows: "General technical standards for the recovery of material from non-hazardous waste Annex 2003, with the exception of the last sentence of paragraph 1, which is 1 Sub-annex 1 1. Paper waste 1. Paper, cardboard and paper products waste repealed from the date of entry into force of this decree; 1.1 Type: paper waste , cardboard and cardboard, including polyac 3) paragraphs 382, 382 -bis 382 -quater , 382 -quinquies , 382 -sexies 382 , , -septies , 383 of article article 1 of 2 of law law no. no. 296; 4) paragraphs 147, 148, 155 and 156 of 244. coupled, including packaging [150101] [150105] [150106] [200101]. 1.1.1. Origin: production activities, waste separation, other forms of collection in special containers on private surfaces; service activities. 12. The incentives for the production of electricity from renewable sources referred to in paragraphs 382 to 382 - queries of article 1 of law no. 296 and 1.1.2. Characteristics of the waste: waste, consisting of: paper from separate paragraph 145 of article 2 of law no. 244 also apply to bio-gas plants owned by collection, waste from paper and cardboard that does not meet the specifications agricultural companies or managed in connection with agricultural, agro-food, of the UNI-EN 643 standards. livestock and forestry companies, which entered into commercial operation before 1.1.3. Recovery activities: a) January 1, 2008. The residual period of the incentives is calculated by subtracting from the duration of the incentives the time elapsed between the date of entry into direct reuse in the paper industry [R3]; b) reserve commercial operation of the biogas plants and 31 December 2007. ". [R13] for the production of secondary raw material for the paper industry through selection, elimination of impurities and contaminated materials, compaction in accordance with the following specifications [R3]: impurities such as metals, The legislative decree of 29 December 2003, n. 387 (Implementation of sands and materials building materials, synthetic materials, glass, papers produced Directive 2001/77 / EC relating to the promotion of electricity produced from with synthetic fibers, textiles, wood, as well as other foreign materials, max renewable energy sources in the internal electricity market) is published in the 1% as a total sum; Official Journal of 31 January 2004, no. 25, SO. — 64 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 carbon paper, no bituminized papers; individual or collective, collection systems for WEEE from households that comply formaldehyde not exceeding 0.1% by weight; phenol with the objectives of this decree. 1 -bis . By decree of the Minister for the Environment and for the Protection of not exceeding 0.1% by weight; PCB + PCT <25 ppm the Territory and the Sea, in agreement with the Ministers of Economic Development 1.1.4. Characteristics of the raw materials and / or and Health, to be adopted by February 28, 2008, after hearing the unified Conference, products obtained: a) paper, cardboard and cardboard in the forms usually they are identified, in compliance with the provisions community and also in derogation marketed; b) secondary raw materials for the paper industry complying with from the provisions of the fourth part of the legislative decree 3 April 2006, n. 152, specifi c simplified procedures for the collection and transport to the centers referred to in paragraph 1, letters a) and c) , of domestic WEEE and professional WEEE collected by distributors pursuant to paragraph 1, letter b) , as well as for the specifications of the UNI-EN 643 standards. construction and management of thereferred centers to themselves. in paragraphThe 1,withdrawal obligation letter b) , starts from 1.2. Typology: waste from diapers and sanitary napkins [150200]. the thirtieth day following the date of entry into force of this decree. 1.2.1. Origin: production activity. 1.2.2. Characteristics of the waste: waste consisting of cellular fiber, polyethylene film and cellulose wadding. 2. Taking into account the current provisions on the protection of the health and 1.2.3. Recovery activities: a) safety of workers, the free collection of electrical and electronic equipment provided for in paragraph 1, letters a) and b) , may be refused in the event that is a risk of direct reuse in paper mills [R3]; b) reserve contamination of the personnel responsible for the same collection or in the event [R13] for the production of secondary raw material for the paper industry that it is evident that the equipment in question does not contain its essential through selection, elimination of impurities and contaminated materials, compaction components or contains waste other than WEEE. In the aforementioned cases, the in accordance with the following specifications [R3]: impurities such as metals, sands disposal of WEEE is the responsibility of the holder who confers, at his own expense, and materials construction materials, synthetic materials, glued paper and cardboard, the WEEE to an operator authorized to manage said waste. glass, papers produced with synthetic fibers, textiles, wood, vegetable parchment and parchment as well as other foreign materials, max 1% as a total sum; 3. Without prejudice to the provisions of Article 12, producers or third parties acting on their behalf organize and manage, on an individual or collective basis, supporting the related costs, adequate systems for the separate collection of carbon paper, waxed and paraffin paper and cardboard, absent bituminous professional WEEE. To this end, they may make use of the structures referred to in papers; formaldehyde not exceeding 0.1% by weight; phenol not exceeding 0.1% by paragraph 1, letter a) , subject to an agreement with the municipality concerned, the costs of which are borne by the producers themselves or third parties acting in their weight; PCB + PCT <25 ppm 1.2.4. Characteristics of the raw materials and / name. " or products obtained: a) paper and cardboard in the forms usually marketed. b) "Art. 13. Information obligations. secondary raw materials for the paper industry complying with the specifications The manufacturer of electrical and electronic equipment provides, within the of the UNI-EN 643 standards. ". instructions for use of the same, adequate information concerning: a) the obligation not to dispose of WEEE as urban waste and to carry out separate collection for said waste; b) the WEEE collection systems, as well as the possibility of returning the equipment to the distributor when purchasing one Note all’art. 42: Directive 2002/96 / EC of the European Parliament and of the Council of 27 new; January 2003 on waste electrical and electronic equipment (WEEE) - Joint Declaration c) the potential effects on the environment and human health due to the of the European Parliament, the Council and the Commission relating to Article 9 is presence of dangerous substances in electrical and electronic equipment or to published in the OJ L 37 of 13.2.2003. improper use of the equipment itself or parts thereof; d) the meaning of the symbol shown in attachment 4; e) the penalties provided for in the event of illegal disposal of For the regulatory references of Directive 2012/19 / EU, see the notes to the said waste. introduction. The text of articles 6 and 13 of the legislative decree 25 July 2005, n. 151, cited in the notes to the premises, reads as follows: “Art. 6. Separate collection. 2. In the event that, taking into account the type of electrical and electronic equipment, the supply of instructions is not envisaged, the information referred to in paragraph 1 is provided by the distributor at the point of sale through appropriate 1. By the date referred to in article 20, paragraph 5, in order to create an publications or the display of informative material. organic management system for WEEE that minimizes their disposal together with mixed urban waste and, in particular, in order to guarantee , by 31 December 2008, 3. Without prejudice to the provisions in force regarding industrial secrecy, the the achievement of a separate collection rate for WEEE from private households manufacturer of electrical and electronic equipment shall make the information equal to at least 4 kg on average per inhabitant per year: system of separate collection available to reuse centers, treatment and recycling plants, in paper or electronic form systems for WEEE from households set up pursuant to the provisions in force on the or on electronic support. reuse and treatment for each type of new equipment placed separate collection of urban waste, so as to allow final holders and distributors on the market, within one year of the same placing. This information indicates the to deliver waste to the collection center free of charge products in their territory; the various components and materials of electrical and electronic equipment, as well as delivery of waste produced in other municipalities is permitted only after signing a the point at which the dangerous substances and preparations are found within the specific agreement with the municipality of destination (7); b) distributors ensure, at equipment itself, insofar as this is necessary to allow reuse centers and treatment the time of supply of new electrical and electronic equipment intended for a household, and recycling plants to comply with the provisions of this decree. the free one-to-one collection of the used equipment, provided that it is of an equivalent type and has performed the same functions as the new equipment supplied; they also ensure, pursuant to article 1, paragraph 1, letters a) and b) , to verify the possible reuse of the equipment collected and to transport to the 4. The electrical and electronic equipment falling within the scope of this centers established pursuant to letters a) and c) of those assessed not susceptible to decree, placed on the market starting from 13 August 2005, shall bear, by and under re-use; c) without prejudice to the provisions of letters a) and b) , producers or third the responsibility of the manufacturer, in a clear, visible and indelible way, an parties acting on their behalf may organize and manage, on a indication that allows to identify the same manufacturer and the symbol shown in attachment 4. This symbol indicates, unequivocally, that the equipment was placed on the market after 13 August 2005 and that it must be disposed of separately. By decree of the Minister for the Environment and for the Protection of the Territory, in agreement with the Minister for Production Activities, the methods for identifying the producer are defined in accordance with Community provisions. — 65 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 5. In the event that the affixing of the symbol referred to in paragraph 4 is c) stipulates specific agreements with the trade associations of the made impossible by the size or function of the equipment, the trademark itself recovery subjects, in order to ensure adequate and homogeneous levels of is visibly affixed on the packaging, on the instructions and on the guarantee treatment and qualification of the companies in the sector; sheet. d) ensures the necessary cooperation between the various collective 6. Producers communicate to the Register referred to in article 14, on an systems, in particular those that manage the same category of WEEE as per annual basis and with the methods to be identified pursuant to the same article Annex 1A to the legislative decree 25 July 2005, n. 151; 13, paragraph 8, the quantity and categories of electrical and electronic e) optimizes the collection system by standardizing the relative methods equipment placed on the market, collected through all channels, reused, and conditions, ensuring the collection of WEEE from the collection centers recycled and recovered, without prejudice to the provisions in force on trade referred to in Article 6 of Legislative Decree 25 July 2005, n. 151 and the secrets, the quantity of waste collected and exported expressed in weight or, if sorting to the competent collective system for the transfer to the treatment not possible, in number, as well as the relative indications to the financial plants; f) ensures the timeliness in the collection of collection requests by the guarantee provided for in this decree. collection centers, using telematic technologies for this purpose; g) ensures the monitoring of the fl ows of WEEE, broken down by category as per 7. Producers who supply electrical or electron equipment that using the Annex 1A of the legislative decree 25 July 2005, n. 151, sorted to means of distance communication referred to in Legislative Decree no. 185 of collective systems, on the basis of procedures to be defined in agreement with 1999, on an annual basis and with the methods referred to in paragraph 6, APAT and the Supervisory and Control Committee referred to in Article 15 of communicate to the Register provided for in Article 14, the quantities and Legislative Decree no. 151; h) prepares an annual prevention and activity categories of electrical and electronic equipment placed on the market of the program for each group of WEEE referred to in Annex 1 and sends it to the State in which the purchaser resides, as well as the methods of fulfilling the obligations set out in article 10, paragraph 3. Supervisory and Control Committee. This program must contain specific indications also with regard to the WEEE recovery objectives established for 8. By decree of the Minister for the Environment and Territorial Protection, each category by article 9 of legislative decree 25 July 2005, no. 151. in agreement with the Ministers of Productive Activities and the Economy and Finance, after hearing the unified Conference, to be adopted within six months from the date of entry into force of this decree, the procedures for the functioning of the Register referred to in Article 14, for registration in the same, 3. The Coordination Center annually transmits the data referred to in for the communication of the information referred to in paragraphs 6 and 7, as well as for the establishment and operation of a coordination center are letter f) to the Supervisory and Control Committee and to APAT for the purpose defined. , financed and managed by the producers, for the optimization of the of preparing the annual report referred to in Article 9, paragraph 5, of the activities pertaining to the collective systems, to guarantee homogeneous Legislative Decree 25 July 2005 , no. 151. municipalities and uniform operating conditions. 4. The Coordination Center may also carry out its tasks through the use of service companies and other external subjects, as long as the confidentiality 9. The manager of the public collection service informs consumers are: of the data processed is guaranteed. " "Art. 14. Tasks of the Steering Committee on the management of a) the measures adopted by the public administration to ensure that WEEE. consumers contribute both to the collection of WEEE and to facilitate the process of reuse, treatment and recovery of the same; 1. The Steering Committee on the management of WEEE carries out a task of supporting the Supervisory and Control Committee as per article 15 of b) the role of the consumer himself in the reuse, recycling and other the legislative decree 25 July 2005, no. 151. In particular, the Steering forms of recovery of WEEE. ". Committee monitors the operation, logistical functionality and cost-effectiveness, For the text of article 10 of the legislative decree 25 July 2005, n. 151, as well as the communication activity, of the WEEE management system, cited in the notes to the introduction, see the notes to article 23. forwarding its assessments and proposals to the Supervisory and Control For the text of article 15 of the legislative decree 25 July 2005, n. 151, Committee for improvement. ". cited in the notes to the introduction, see the notes to article 35. The text of article 21 of law no. 96 (Provisions for the fulfillment of obligations deriving from Italy's membership of the European Communities - For the text of article 20 of the legislative decree 25 July 2005, n. 151, Community law 2009), published in the Official Journal no. 146, SO, reads as cited in the notes to the introduction, see the notes to article 40. follows: For the text of article 9 of the decree of the Minister of the Environment "Art. 21. (Simplification in the matter of information charges for the and the Protection of the Territory and the Sea of 25 September 2007, cited in waste management of electrical and electronic equipment) the notes to article 4, no. 185, see in the notes to article 33. 1. The communication referred to in article 3, paragraph 4, of the decree For the text of article 13 of the decree of the Minister of the Environment of the Minister for the environment and the protection of the territory and the and the Protection of the Territory and the Sea of 25 September 2007, cited in sea of 12 May 2009, published in the Official Gazette no. 151 of 2 July 2009, the notes to article 4, n. 185, see in the notes to article 36. relating to the methods of financing the management of waste from lighting The text of articles 10 and 14 of the decree of the Minister of the equipment by the manufacturers of the same, is provided by the manufacturers Environment and the Protection of the Territory and the Sea of 25 September of lighting fixtures with reference to the fixtures placed on the market in 2007 2007, cited in the notes to article 4, n. 185, reads as follows: “Art. 10. Tasks of and 2008 , within the deadline of 30 June 2010. The market shares calculated the coordination center. by the Supervisory and Control Committee on the management of waste from electrical and electronic equipment are communicated to manufacturers of 1. The Coordination Center has the task of optimizing the activities of electrical and electronic equipment through the website www.registroaee.it, the collective management systems of WEEE to guarantee common, prior notice published in the Official Gazette 2. Legislative decree no. 151, the homogeneous and uniform operating conditions and with a view to maximizing following changes are made: a) to article 8, paragraph 2, the words: "annex 2" . the recycling / recovery of such waste. are replaced by the following: "annex 3, point 4"; 2. In particular, the Coordination Center performs the following functions: a) defines with the ANCI, through a program agreement, the general conditions for the collection by the competent collective systems of WEEE collected within the domestic circuit pursuant to article 6 of the legislative b) in article 9, paragraph 2, letter d) , the words: "fl uorescent light sources" are replaced by the following: "discharge lamps"; decree 25 July 2005 , no. 151, and, without prejudice to the provisions of article 187 of the legislative decree 3 April 2006, n. 152, relating to the prohibition of c) in article 11, paragraph 1, second sentence, the words: "or mixed mixing hazardous waste, grouped according to what is indicated in Annex I, suitable" are replaced by the following: "adequate, through the following ensuring the rationalization and homogeneity of the intervention at the territorial methods: level; a) individually, through the signing of contracts with all the subjects b) defines with the ANCI and with the national distribution trade responsible for the collection on the entire national territory of associations, through a program agreement, the conditions under which the WEEE under the responsibility of the contracting producer, which undertake withdrawal by the competent collective systems of the WEEE collected by the same subject to carry out, on behalf of the same producer, the selection of distributors pursuant to article 6, paragraph 1, letter b) , is carried out at the directly all the WEEE deriving from the equipment placed on the market for which the distributors themselves; same is defined as a producer pursuant to article 3 , — 66 — Machine Translated by Google 28-3-2014 Ordinary supplement n. 30 / L to the OFFICIAL JOURNAL General series - n. 73 paragraph 1, letter m) ; this contract must, among other things, provide the identification of Italy to the European Union - European Law 2013) published in the Official Journal cation of the producer, in accordance with the provisions of article 13, paragraph 4, as no. 194, reads as follows: well as the procedures for selecting the related WEEE. The producer, within ninety days "Art. 22. Amendments to the legislative decree 25 July 2005, n. 151, relating to from the assumption of the same qualification, or from the withdrawal from even one of the reduction of the use of hazardous substances in electrical and electronic equipment, the collective systems, must ask the Committee referred to in article 15 for recognition as well as the disposal of waste. Infringement procedure 2009/2264. of the system adopted; this withdrawal is valid only following approval by the aforementioned Committee; b) participating in one of the collective WEEE management 1. Annex 1B of the legislative decree 25 July 2005, n. 151, the following changes systems, established pursuant to Article 10, in proportion to the respective market are made: a) to number 1, the words: "(with the exclusion of large fixed ones)" are share, calculated on the basis of the number of pieces or by weight, if specifically deleted; b) at number 1.18 the following words are added: "and for conditioning"; indicated in Annex 1B, by type of equipment, in the reference year "; d) in article 11, c) the following is inserted after number 8.9: «8.9 -bis . Fertilization test ». paragraph 2, after the word: "producer", the following are inserted: "who opts for the method referred to in paragraph 1, letter a) ,"; after the words: "Minister of the environment and protection of the territory" the following are inserted: "and of the sea"; the words: "of productive activities" are replaced by the following: "of economic development" and after the words: "and of the economy and finances," the following are inserted: "after hearing the Committee referred to in Article 15 , "; e) in article 13, 2. It is part of the collection phase, as defined by article 183, paragraph 1, letter paragraph 6, after the words: "regarding industrial secrecy," the following are inserted: o) , of the legislative decreeand3 April 2006, n. electronic 152, the grouping equipment of waste (WEEE) aimed from transport at their electrical "the quantity of waste collected and exported expressed in weight or, if not possible, in to the collection centers referred to in article 6, paragraph 1, of legislative decree no. number," . 151, carried out by distributors at the premises of their point of sale or at another place resulting from the communication referred to in article 3 of the regulation referred to in the decree of the Minister for the environment and protection of the territory and the sea 8 March 2010, n. 65, in compliance with the following conditions: 3. For the purposes of the elaboration of the market shares referred to in article 15 of the legislative decree 25 July 2005, n. 151, and subsequent amendments - cations, as well as to allow the fulfillment of the communication obligations to the a) the grouping exclusively concerns the WEEE governed by the legislative European Commission referred to in article 17, paragraph 1, of the same legislative decree n. 151 of 2005 from private households; b) the WEEE referred to in letter a) are decree n. 151 of 2005, by 30 June 2010 the producers of electrical and electronic transported to the collection centers referred to in Article 6, paragraph 1, of equipment communicate to the National Register of subjects obliged to finance the Legislative Decree no. 151 of 2005 on a monthly basis and, in any case, when the waste management systems of electrical and electronic equipment, in accordance with aggregated quantity reaches a total of 3,500 kilograms. The quantity of 3,500 kilograms the procedures set out in article 3 of the regulation referred to in the decree of the refers to each of the groups 1, 2 and 3 of annex 1 to the regulation referred to in the Minister of the environment and the protection of the territory and the sea 25 September decree of the Minister for the Environment and for the Protection of the Territory and 2007, n. 185, the data relating to the quantities and categories of electrical and electronic the Sea of 25 September 2007, no. 185, and a total of 3,500 kilograms for groupings 4 equipment placed on the market in 2009. The market shares calculated by the and 5 referred to in the same annex; c) the grouping of WEEE is carried out at the Supervisory and Control Committee on the management of waste electrical and distributor's point of sale or at another place resulting from the communication referred electronic equipment (WEEE) are communicated to the producers of the same to in article 3 of the regulation referred to in the decree of the Minister for the Environment equipment through the website www.registroaee.it, subject to notice published in the and for the Protection of the Territory and the Sea 8 March 2010, n. 65, in a Official Journal . To allow the fulfillment of the communication obligations to the suitable place, not accessible to third parties and paved. WEEE is protected from European Commission referred to in article 17, paragraph 1, of the legislative decree rainwater and the action of the wind by means of suitable covering systems, including no.professional 151, the collective management electrical systems and electronic of WEEE equipment or, in theto not adhering case of producers collective of systems, mobile ones, and grouped taking care to keep hazardous waste separate, in compliance the individual producers communicate by 30 June 2010 to the National Register of with the provision referred to in Article 187, paragraph 1, of the legislative decree 3 April subjects obliged to finance the systems of management of waste from electrical and 2006, n. 152. It is necessary to guarantee the integrity of the equipment, taking all electronic equipment, in accordance with the procedures set out in article 3 of the precautions to prevent its deterioration and the release of dangerous substances. regulation referred to in the decree of the Minister for the environment and the protection of the territory and the sea of 25 September 2007, no. 185, the data relating to the weight of electrical and electronic equipment collected through all channels, exported, reused, recycled and recovered in 2009, divided according to the categories referred to in Annex 1A annexed to Legislative Decree 25 July 2005, n. 151, and, as regards the collection, in domestic and professional. Within the same term, the producers of 3. In article 2, paragraph 1, letter d) , of the regulation referred to in the decree of electrical and electronic equipment communicate to the National Register of subjects the Minister for the environment and for the protection of the territory and the sea no. obliged to finance the waste management systems for electrical and electronic 65, the words from: «, carried out» up to: «6,000 kg» are deleted. equipment, in accordance with the procedures set out in article 3 of the regulation referred to in the decree. of the Minister of the Environment and of the Territory and the Sea of 25 September 2007, n. 185, the information relating to the quantity of waste 4. The construction and management of collection centers referred to in article collected and exported expressed in weight or, if it is not possible, in number, referred 6, paragraph 1, letters a) and c) , of legislative decree the manner no. 151for provided of 2005 by thetakes place decree in of the to in article 13, paragraph 6, of the legislative decree 25 July 2005, n. 151, as amended Minister for the Environment and for the Protection of the Territory and the Sea of 8 by paragraph 2, letter e) , of this article, in the years 2006, 2007 and 2008. ". April 2008, published in the Official Gazette no. 99 of 28 April 2008, and subsequent amendments, or, alternatively, with the methods provided for by articles 208, 213 and 216 of the legislative decree 3 April 2006, n. 152. 5. Paragraph 2 of article 1 and article 8 of the regulation referred to in the decree of the Minister for the environment and the protection of the territory and the sea no. 65. The text of article 22 of law no. 97 (Provisions for the fulfillment of the obligations deriving from membership 14G00064 LOREDANA COLECCHIA, editor DELIA CHIARA, deputy editor (WI-GU-2014-SOL-006) Rome, 2014 - Polygraphic Institute and State Mint SpA — 67 — Machine Translated by Google € 5,00 *45-410201140328*