Machine Translated by Google 813.11 Ordinance on protection against dangerous substances and preparations (Chemicals Ordinance, ChemO) of June 5, 2015 (Status on February 1 , 2016) The Swiss Federal Council, having regard to the law of 15 December 2000 on chemical products (LChim)1, having regard to arts. 26, para. 3, 29, 30a to 30d, 38, para. 3, 39, par. 1, 41, par. 3, 44, par. 2 and 3, 46, para. 2 and 3, and 48, para. 2, of the law of October 7, 1983 on the protection of the environment (LPE)2, given the arts. 9 para. 2 let. c, 27, para. 2, and 48, para. 2, of the federal law of January 24, 1991 on the protection of waters3, in execution of the federal law of October 6, 1995 on technical barriers to trade4, stopped: Title 1 General provisions Art. 1 Purpose and scope 1 This Ordinance regulates: a. the analysis and assessment of the dangers and risks that substances and preparations may pose to human life and health and to the environment; b. the conditions relating to the placing on the market of substances and preparations liable to endanger human beings or the environment; the use of substances and preparations likely to c. endanger human beings or the environment; d. the processing by the enforcement authorities of data relating to substances and preparations. 2 This Ordinance applies to biocidal products and their active substances as well as to phytosanitary products, their active substances and their co-formulants, insofar as the Ordinance of 18 May 2005 on biocidal products5 or the Ordinance of May 12, 2010 on phytosanitary products6 refers to it. RO 2015 1903 1 RS 813.1 2 RS 814.01 3 RS 814.20 4 RS 946.51 5 RS 813.12 6 RS 916.161 1 Machine Translated by Google 813.11 Chemical products 3 This Ordinance applies to radioactive substances and preparations insofar as there are no effects attributable to the radioactivity of these substances and preparations. 4 Only arts. 5 to 7 and 81 of this ordinance apply to cosmetics and insofar as it concerns the interests of environmental protection and the classification or assessment of substances and preparations.7 5 This Ordinance does not apply: a. the transport of substances and preparations by road, rail, waterway, air or by pipeline; art. 10, para. 1 let. b, is reserved; b. the transit under customs supervision of substances and preparations, provided that they do not undergo any treatment or transformation; vs. substances and preparations in the form of finished products intended for professional or private users and belonging to the following categories: 1. foodstuffs within the meaning of art. 3 of the law of October 9, 1992 on foodstuffs (LDAl)8, 2. medicines within the meaning of Art. 4 para. 1 let. a, and medical devices within the meaning of art. 4 para. 1 let. b, of the law of 15 December 2000 on therapeutic products9, 3. animal feed within the meaning of art. 3 para. 1, of the order of 26 October 2011 on animal feed10; d. weapons and ammunition within the meaning of art. 4 para. 1 and 5, of the law of 20 June 1997 on weapons11; e. substances, preparations and objects considered as waste in the meaning of art. 7, al. 6, LPE. 6 Only art. 13 applies to dangerous substances and preparations imported and exported after modification of their labelling. Art. 2 Definitions and applicable law 1 For clarification in relation to the LChim, the following terms mean: has. substance: any chemical element and its compounds, in their natural state or obtained by a manufacturing process, including any additive necessary to preserve its stability and any impurity resulting from the process used, with the exception of any solvent which can be separated without affecting the stability of the substance or changing its composition; 7 Erratum du 8 sept 2015 (RO 2015 3017). 8 RS 817.0 9 RS 812.21 10 RS 916.307 11 RS 514.54 2 Machine Translated by Google 813.11 O on chemicals b. fabricate 1. any natural or legal person having his domicile, his registered office or a branch in Switzerland and who, on a professional or commercial basis, manufactures, produces or imports substances, preparations or objects, 2. A manufacturer is also deemed to be anyone who obtains substances, preparations or objects in Switzerland and who supplies them commercially, without modifying their composition: – under his own name without indicating the name of the manufacturer original, – under its own trade name, – in packaging different from that provided by the original manufacturer, or – for a different use; if a person has a substance, preparation or object manufactured in Switzerland by a third party, he is deemed to be a manufacturer in his own right if he has his 3. domicile, registered office or branch in Switzerland. 2 In addition, the following terms mean: a. professional user: 1. any natural or legal person who obtains substances, preparations or objects in Switzerland with a view to using them for profit, 2. is also deemed to be a professional user: – any natural or legal person who obtains substances, preparations or objects in Switzerland with a view to using them in the context of training or for research purposes, – any legal person who obtains substances in Switzerland, preparations or objects with a view to using them in the context of an activity of general interest; b. private user: any natural person who obtains or uses substances, preparations or objects for non-profit purposes; vs. trader: any natural or legal person who obtains substances, preparations or objects in Switzerland and supplies them for commercial purposes without modifying them; d. exclusive representative: any natural or legal person authorized by a manufacturer whose domicile or registered office is abroad to notify a substance in Switzerland and to represent several importers designated by him; e. object: product composed of one or more substances or preparations, which, during manufacture, has a specific shape, surface or consistency and whose use is determined more by its nature physical than by its chemical composition; 3 Machine Translated by Google 813.11 Chemical products f. existing substance: any substance listed in the European Inventory of Existing Chemicals12 of 15 June 1990 (EINECS)13; g. polymer: substance consisting of molecules characterized by a sequence of one or more types of monomer units: 1. containing a simple majority by weight of molecules comprising at least three monomer units linked by covalent bond to at least one other monomer unit or another reactive substance, and 2. containing less than a simple weight majority of molecules having the same molecular weight; these molecules must be distributed over a range of molecular weights, the differences in molecular weight being due essentially to differences in the numbers of monomer units; h. monomer: substance capable of forming covalent bonds with a sequence of other similar or dissimilar molecules, under the conditions of the reaction forming the polymer relevant for the particular process; i. monomer unit: reacted form of a monomer substance in a poly mother; d. intermediate product: any substance manufactured and used exclusively for chemical transformation processes during which it is transformed into one or more other substances; k. secondary product: any substance which is formed by chemical or biochemical transformation during storage, use or disposal of a substance or preparation; I. scientific research and development: any activity involving scientific experimentation, analysis or chemical research carried out under controlled conditions and relating to quantities of less than 1 tonne per year; Mr. research and development activities focused on products and processes: any scientific development linked to the development of products or the further development of a substance, on its own or contained in a preparation or an object, in in which a pilot plant or production trials are used to define the production process or to test the fields of application of the substance; not. robust study summary: a detailed summary of the objectives, methods, results and conclusions of a full test report, containing sufficient information to allow an independent evaluation of the test and reducing at least the need to read the complete test report; 12 The inventory can be consulted free of charge on the Internet from the European Agency (ECHA) under: www.echa.europa.eu > information on chemicals > EC Inventory European inventory of existing commercial chemical substances . 13 4 Machine Translated by Google O on chemicals 813.11 y. exposure scenario: the set of conditions, including operational conditions and risk management measures, describing how the substance is manufactured or used during its life cycle and how the manufacturer controls or recommends to professional users to control human and environmental exposure; an exposure scenario can also cover a specific process or, where appropriate, several processes or uses; p. hazard class: the nature of the physical hazard, health hazard human or environmental hazard; q. nanomaterial: material containing free particles, in the form of aggregate or agglomerate, one or more external dimensions of which are between 1 and 100 nanometers or a material having a specific surface area by volume greater than 60 m2/cm3. A material is considered to be a nanomaterial when it is produced intentionally in order to exploit the properties deriving from the external dimensions of its particles or from the specific volume surface mentioned above. Fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external dimensions less than 1 nanometer are considered nanomaterials. 3 In addition, the terms defined differently in the laws on which this ordinance is based are understood here within the meaning of the LChim. 4 The equivalences contained in appendix 1, ch. 1, apply for the correct interpretation of the expressions appearing in Regulation (EC) No 1907/2006 (EU-REACH Regulation)14, Regulation (EC) No 1272/2008 (EU-CLP Regulation)15 and Directive tive 75/324/EEC16 to which this order refers. 5 Where this Ordinance refers to provisions of the EU REACH Regulation, EU-CLP Regulation or Directive 75/324/EEC, which themselves refer to other provisions of those legal acts, those other provisions also apply. In this case, the version mentioned in the footnote to s. 4 applies, or, in case of reference to the annexes of the EU-CLP regulation or the EU-REACH regulation, the version defined in annex 2, ch. 1, respectively 14 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH), establishing a Euro Agency chemicals, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 and Directive 76/769/EEC of Council and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1; last amended by Regulation (EU) 2015/326, OJ L 58 of 3.3.2015, p. 43. 15 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006, OJ L 353 of 31.12.2008, p. 1; last amended by Regulation (EU) 2015/491, OJ L 78 of 24.3.2015, p. 12. 16 Council Directive 75/324/EEC of 20 May 1975 on the approximation of laws of the Member States relating to aerosol dispensers, OJ L 147, 9.6.1975, p. 40; last amended by Directive 2013/10/EU, OJ L 77 of 20.3.2013, p. 20. 5 Machine Translated by Google 813.11 Chemical products in annex 4, c. 3, applies. Exceptions are the successive references to the provisions of the EU- REACH regulation and the EU-CLP regulation mentioned in annex 1, ch. 2; in this case, the Swiss provisions mentioned in annex 1, ch. 2, apply. 6 Where this Ordinance refers to provisions of the EU REACH Regulation or the EU-CLP Regulation which themselves refer to other provisions of EU law, the Swiss law mentioned in Annex 1, c. 3, applies instead of these EU provisions. 7 For the marketing of substances and preparations whose development is based on the use of genetic resources or traditional knowledge associated with them, the provisions of the Nagoya Ordinance of 11 December 201517 are reserved.18 Art. 3 Dangerous substances and preparations Substances and preparations are deemed to be dangerous when they meet the classification criteria cited in the technical requirements of annex 2, ch. 1, relating to physical hazards, health hazards, environmental hazards or other hazards; Art. 4 Persistence, bioaccumulation and toxicity Are deemed persistent, bioaccumulative and toxic (PBT) substances that meet the criteria defined in annex XIII, ch. 1.1.1 to 1.1.3, of the EU-REACH regulation19. Are considered very persistent and very bioaccumulative (vPvB) substances that meet the criteria defined in annex XIII, c. 1.2.1 and 1.2.2, of the EU-REACH regulation. Title 2 Marketing conditions Chapter 1 Autonomous Control Section 1 Principles Art. 5 1 By virtue of the autonomous control established by art. 5 LChim and 26 LPE, the manufacturer must assess whether the substances or preparations may endanger human life or health or the environment. He must, in accordance with the provisions of this Ordinance, classify, package and label substances and preparations for this purpose; as well as drawing up exposure scenarios and compiling a safety data sheet relating to them. 17 RS 451.61 18 Introduced by ch. 2 of the appendix to the O of Nagoya of 11 Dec. 2015, in force since 1st Feb. 2016 (AS 2016 277). 19 See note on Art. 2 para. 4. 6 Machine Translated by Google O on chemicals 813.11 2 In the case of objects containing dangerous substances, substances assessed as PBT or vPvB or substances listed in appendix 3, the manufacturer must, under the autonomous control established by art. 26 LPE, assess whether these substances can endanger the environment or indirectly the human being when the said objects are used in accordance with the intended or foreseeable use or when they are disposed of in accordance with the relevant regulations. 3 In the case of objects containing substances listed in Annex 3, the manufacturer must assess whether these substances may endanger human health when the said objects are used in accordance with the intended or foreseeable use or when they are disposed of in accordance with the relevant regulations. 4 The manufacturer must collect all the available data which make it possible to fulfill the obligations referred to in paras. 1 and 2. 5 Any person who, on a professional or commercial basis, imports substances, preparations or objects containing dangerous components must have fulfilled the obligations referred to in paras. 1 and 2 at the latest before the first transfer to third parties or, in the case of personal use, before the first use. Section 2 Classification of substances and preparations Art. 6 Classification of substances 1 The manufacturer must classify substances according to Art. 5, 7 to 13 and 15 of the EU-CLP20 regulation. 2 If a harmonized classification for a substance is set out in Annex VI of the EU-CLP Regulation, in the version prescribed in Annex 2, ch. 1, of this ordinance, the manufacturer must also classify this substance according to art. 4 para. 3, of the EU-CLP Regulation. 3 The classification must be based on: has. for existing substances: on data collected pursuant to Art. 5, al. 4; b. for new substances: on the data of the technical file within the meaning of art. 27, al. 2, let. b. 4 The Federal Department of the Interior (DFI) may, in agreement with the Federal Department of Economic Affairs, Education and Research (DEFR) and with the Federal Department of the Environment, Transport, Energy and Communication (DETEC), prescribe a harmonized classification of certain hazard classes of a defined substance as well as the corresponding labelling, when Annex VI of the EU-CLP Regulation in the version prescribed in the Annex 2, ch. 1, does not contain any harmonized classification of the substance regarding these hazard classes. 20 See note on art. 2 para. 4. 7 Machine Translated by Google 813.11 Chemical products Art. 7 Classification of preparations The manufacturer must classify the preparations according to art. 6 to 15 of the EU CLP21 regulation. Section 3 Packaging and labeling of substances and preparations Art. 8 Packaging The manufacturer who makes available to third parties or hands over dangerous substances or preparations to third parties must package them in accordance with Art. 35 of the EU-CLP22 regulation. Art. 9 Packaging of aerosol dispensers Aerosol generators that do not fall under the LDA23 are governed, in addition to the provisions of this ordinance, by arts. 1 and 2 and ch. 2.1, 2.3, 3, 4, 5 and 6 of the Annex to Directive 75/324/ EEC24. Art. 10 Labeling 1 Manufacturers who make dangerous substances or preparations available to third parties or supply them to third parties must label them in accordance with the following provisions: has. the arts. 17, para. 1, 18, except s. 2, last sentence, 19 to 23, 25, para. 1, 3 and 4, 26 to 28, 29, par. 1 to 4, 31, 32, par. 1 to 5 and 33 of the EU-CLP25 regulation; b. the rules concerning the labeling of outer packaging, inner packaging and single packaging according to art. 33, of the EU-CLP Regulation. 2 Preparations presenting particular dangers, mentioned in Art. 4 para. 7, of the EU-CLP regulation, must additionally be labeled in accordance with art. 25, par. 6, of the EU-CLP Regulation. 3 In addition to paras. 1 and 2, the labeling must meet the following requirements: has. include the manufacturer's name, address and telephone number; where the substance or preparation is imported from a Member State of the European Economic Area (EEA) and is not intended to be handed over to a private user, the name of the manufacturer may be replaced by the name of person responsible for placing on the market in the EEA; 21 See note on art. 2 para. 4. 22 See note on Art. 2 para. 4. 23 SR 817.0 24 See note on art. 2 para. 4. 25 See note on art. 2 para. 4. 8 Machine Translated by Google O on chemicals 813.11 b. be formulated in at least two official languages; a substance can be labeled in only one official language or in English for delivery to a professional user in accordance with it. 4 The labeling elements resulting from the requirements laid down in other legislative acts must be placed in the section reserved for the additional information referred to in art. 25 of the EU- CLP Regulation. 5 When the name of the IUPAC nomenclature26 of a substance exceeds 100 characters, another name may be used, provided that the communication according to art. 49 includes both the name fixed in the IUPAC nomenclature and the name used. 6 The requirements of s. 1 are considered fulfilled when the inner packaging is labeled before or immediately after the removal of the outer packaging. The responsibility for packaging and labeling lies with the manufacturer. Art. 11 Labeling of aerosol generators 1 Aerosol dispensers that do not fall under the LDAI27 are governed, in addition to the provisions of this ordinance, by arts. 1, 2 and 8, par. 1a, ch. 1.8, 1.9 and 1.10, the introductory provision of ch. 2, and by ch. 2.2 and 2.3 of the annex to Directive 75/324/EEC28. 2 Aerosol generators which are not dangerous within the meaning of art. 3 must contain the name and address of the manufacturer. When importing aerosol dispensers from an EEA Member State, it is possible to replace the name of the manufacturer with the name of the person responsible for placing it on the market in the EEA. Art. 12 Derogations from labeling requirements 1 The notification receiving body may, in agreement with the assessment bodies, grant derogations from the labeling conditions for certain substances or preparations or certain groups of substances or preparations and authorize the absence of labeling or labeling in another suitable form, when: has. the packaging is too small or otherwise ill-suited for proper labeling to art. 10; b. the substance or preparation is supplied in such small quantities that it presents no risk either to human beings or to the environment due to its dangerous properties; or the substance or preparation does not fall within the scope of the EU-CLP29 regulation. c. 26 System for naming chemical substances developed by the International Union of Pure and Applied Chemistry (IUPAC): www.iupac.ch. 27 SR 817.0 28 See the note relating to art. 2 para. 4. 29 See note on Art. 2 para. 4. 9 Machine Translated by Google 813.11 Chemical products 2 It issues a decision on a duly substantiated request or issues a decision of general application. 3 It draws up a list of permitted exceptions and publishes it on its website. Art. 13 Labeling of dangerous substances and preparations intended for export 1 Any person who exports dangerous substances or preparations must label them taking into account the relevant international standards and mentioning at least the following information: has. the name of the manufacturer; b. chemical designation or trade name; vs. the dangers for humans and the environment as well as the corresponding protective measures. 2 The labeling language should be in accordance with the practice of the importing country. Art. 14 Use of an alternate chemical name 1 The manufacturer of a preparation may use an alternative chemical name for a substance: has. if he proves that the disclosure of the name of a substance on the label or on the safety data sheet presents a risk for the confidentiality of his professional activity, in particular for his intellectual property rights; and b. if the substance meets the criteria referred to in annex I, section 1.4, of the EU-CLP Regulation in the version defined in annex 2, ch. 1. 2 The alternative chemical name is a name expressing the main functional groups or a substitute name. 3 The manufacturer wishing to use an alternative chemical name must submit a written request to the notification authority. 4 The use of an alternative chemical name of a substance may be required for a preparation: has. whose composition is given; b. bearing a given trade name or designation; etc. reserved for specific uses. 5 Permission to use an alternate chemical name is granted to the manufacturer and is non- transferable. 6 Authorization for the use of an alternative chemical name is not required within 6 years of notification of a new substance. Thereafter, either the chemical designation mentioned in Art. 18, para. 2, from 10 Machine Translated by Google O on chemicals 813.11 EU-CLP30 regulation, or file a request for the use of a replacement chemical name. Art. 15 Request to use an alternative chemical name 1 The request for the use of an alternative chemical name of a substance in a preparation must be drawn up in one of the official languages or in English and submitted in the electronic format requested by the notification receiving body. The cover letter must be written in one of the official languages. 2 The request must include: the a. name, address and telephone number of the manufacturer; b. the data concerning the substances whose identity must remain confidential on the labelling: 1. the chemical designation, 2. the number fixed by the Chemical Abstract Service ( CAS no)31, 3. the EC no ; the substitute name; d. the reasons justifying the request; the trade name or designation of the preparation; the composition of the preparation in accordance with the provisions relating to the safety data sheet; the c. classification of the preparation; and. f. g. h. the labeling of the preparation; i. intended uses; d. the physical preparation; state of k. the if applicable, the safety data sheet. 3 The notification reception body decides on the request, in agreement with the evaluation bodies. Section 4 Exposure scenarios and safety data sheet for substances and preparations Art. 16 Obligation to establish an exposure scenario 1 The manufacturer of an existing substance meeting the criteria of Art. 14, para. 4, of the EU- REACH32 regulation and handing over to third parties as such in total quantity 30 See note on Art. 2 para. 4. 31 The CAS RN can be consulted free of charge on the Internet from ECHA under: www.echa.europa.eu > information on chemicals > EC Inventory 11 Machine Translated by Google 813.11 Chemical products equal to or greater than 10 tonnes per year, is required to establish an exposure scenario for each identified use of the substance. 2 Anyone who obtains a substance for which exposure scenarios have been established and who supplies it to third parties on a commercial basis, as such or in a preparation, in a quantity equal to or greater than one tonne per year, for a use not described in the safety data sheet, must establish an exposure scenario for this use. 3 s. 2 does not apply where: has. the exposure scenario for the new use includes only the conditions described in the exposure scenario of the safety data sheet; b. the substance is present in the preparation in a concentration lower than the limits mentioned in art. 27, para. 3; or vs. the substance is used for product and process oriented research and development. Art. 17 Requirements for drawing up an exposure scenario Exposure scenarios must be drawn up in accordance with the provisions of Annex I, section 5.1, of the EU-REACH regulation33. Art. 18 Purpose of the safety data sheet The safety data sheet is intended to inform professional users and traders so that they can take the necessary measures in terms of health protection, occupational safety and environmental protection. . Art. 19 Obligation to draw up a safety data sheet In the cases provided for in art. 21, the manufacturer is required to draw up and provide a safety data sheet for: a. dangerous substances and preparations; b. PBT or vPvB substances; vs. substances listed in Schedule 3; d. preparations which are not dangerous within the meaning of art. 3 and which contain at least one of the following substances: 1. a substance hazardous to health or the environment in an individual concentration ÿ 1.0% by weight for non-gaseous preparations, and ÿ 0.2% by volume for gaseous preparations, 32 See note on Art. 2 para. 4. 33 See note on Art. 2 para. 4. 12 Machine Translated by Google O on chemicals 813.11 2. a PBT or vPvB substance in an individual concentration ÿ 0.1% by weight, 3. a substance listed in Annex 3 in an individual concentration ÿ 0.1% by weight, 4. a substance for which Directives 2000/39 /EC34, 2006/15/EC35 or 2009/161/EU36 set an occupational exposure limit value. Art. 20 Requirements for the preparation of the safety data sheet 1 The safety data sheet must be drawn up in accordance with the technical requirements of appendix 2, ch. 3. 2 The exposure scenarios established according to Art. 16 or appearing in the chemical safety report (art. 28) must be annexed to the safety data sheet; the information in sections 1, 7, 8 and 13 of the safety data sheet must correspond to the uses listed in the exposure scenarios. 3 The DFI may, in agreement with the DEFR and the DETEC, define the professional qualifications required for the establishment of safety data sheets. Art. 21 Obligation to provide a safety data sheet 1 Any person who provides commercially the substances or preparations referred to in art. 19 to professional users or traders must provide them with an up-to-date safety data sheet. In the retail trade, the safety data sheet only needs to be provided on request. 2 The safety data sheet must be provided: has. for substances and preparations within the meaning of art. 19 let. a to c: at the latest on the first submission and, on request, on subsequent submissions; b. for preparations within the meaning of art. 19 let. d to g: on request when delivery. 3 The safety data sheet must be provided: has. free; 34 Commission Directive 2000/39/EC of 8 June 2000 on the establishment of indicative occupational exposure limit values pursuant to Council Directive 98/24/ EC on the protection of health and safety of workers from the risks related to chemical agents at work, OJ L 142, 16.6.2000, p. 47; last amended by Directive 2009/161/EU, OJ L 338 of 19.12.2009, p. 87. 35 Commission Directive 2006/15/EC of 7 February 2006 establishing a second list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000 /39/EC, OJ L 38 of 9.2.2006, p. 36. 36 Commission Directive 2009/161/EU of 17 December 2009 establishing a third list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Directive 2000/39/EC of the Commission, OJ L 338, 19.12.2009, p. 87. 13 Machine Translated by Google 813.11 Chemical products b. in the official languages desired by the professional user or the trader or, by agreement between the two parties, in another language; the annex to the safety data sheet can be formulated in English; vs. in printed or electronic form; at the request of the professional user or trader, the safety data sheet must be provided in printed form. Art. 22 Safety data sheet update 1 The manufacturer must update the safety data sheet without delay in the event of important new information concerning the substance or the preparation. 2 The remitter must provide the updated safety data sheet to the professional users and traders to whom he has remitted the substance or preparation in question during the last twelve months. 3 s. 2 does not apply when the safety data sheet has been supplied through the retail trade. Art. 23 Obligation to keep the safety data sheet The professional user or trader is required to keep the safety data sheet for as long as he uses the substance or preparation concerned. Chapter 2 Notification and declaration of new substances Section 1 Notification of new substances Art. 24 Duty to notify 1 The manufacturer of a new substance or his only representative must notify the said new substance to the notification receiving body before it is first placed on the market: has. as is; b. in a preparation; or c. into an object from which the new substance is intended to be released under normal or reasonably foreseeable conditions of use. 2 When a new substance is contained in a polymer, in the form of monomer or monomer units or as a chemically bound substance, para. 1 applies to the substance itself. 3 The notification receiving body may require the notification of a new substance contained in an object, when it has reason to suspect that the substance can be released under the conditions of use of the object. 14 Machine Translated by Google O on chemicals 813.11 Art. 25 Defining quantity of substance The determining quantity of substance to be taken into account for the values mentioned in art. 27, 31, 34, 46, 47 and in appendix 4 is fixed as follows mitten: a. if the substance is manufactured in the EEA: the total quantity manufactured per year in the EEA by a manufacturer part of whose production is supplied to the notifier; b. if the substance is manufactured in Switzerland, the greater of: 1. the quantity placed on the market per year in Switzerland, or 2. the greater quantity exported per year to the EEA for an importer determined having its registered office in the EEA; c. if the substance is manufactured outside Switzerland and outside the EEA and the notifier imports the substance directly from that country: the quantity imported per year into Switzerland; d. if the substance is manufactured outside Switzerland and outside the EEA and the notifier imports the substance from an EEA member country: the total quantity imported per year into the EEA by an importer, part of which is supplied to the notifier. Art. 26 Exceptions 1 Notification is not required: has. for polymers and substances contained in the form of monomer units or chemically bound to the polymer in a concentration of less than 2% by weight; b. for substances on the No-Longer Polymer list37 (list NLP); vs. for substances placed on the market in quantities of less than 1 tonne per an; d. for substances placed on the market by a manufacturer: 1. exclusively for the purpose of research and development activities focused on products and processes, 2. in strictly limited quantities for said purposes, and 3. for a maximum of five years; upon justified request, the notification receiving body may, in agreement with the assessment bodies, extend this period by a period of five or ten years; 37 The NLP list can be consulted free of charge on the Internet from ECHA under: www.echa.europa.eu > information on chemicals > EC Inventory and informa tion on chemicals > registered substances > registered substances informa tion. 15 Machine Translated by Google 813.11 Chemical products e. for substances which are used exclusively as raw materials, active ingredients or additives in foodstuffs, therapeutic products and animal feed; f. for substances acquired in Switzerland; g. for intermediates, unless they are mo substances nomers; h for substances defined in Annex V of the EU-REACH regulation38; i. for substances that have already been notified and exported by a manufacturer and imported again by the same manufacturer or another manufacturer in the same supply chain, provided that it can be demonstrated: 1. that it is the same substance, 2. that he has been provided with a safety data sheet in accordance with art. 20 for the exported substance, insofar as this is required by Art. 19. If there is reason to assume that a given substance, not subject to notification under para. 1, may endanger human beings or the environment, the notification body shall require the manufacturer, at the request of an assessment body, to submit test reports. For these test reports, it is not possible to require data going beyond those required for the technical file referred to in annex 4, ch. 8 let. a, 9, let. a, and 10, let. has. 3 Hazardous substances, PBTs and vPvBs not subject to notification according to par. 1 let. a to c, are subject to the reporting obligation of Art. 48. Art. 27 Form and content of notification 1 The notification must be drawn up in one of the official languages or in English and submitted in the electronic format requested by the body receiving notifications. The cover letter must be written in one of the official languages. 2 It must include the following data and documents: has. the indication of the determining quantity of substance defined in art. 25 in specifying the case (Art. 25 let. a, b, c or d) applicable; b. a technical file containing the following information specified in Annex 4: 1. the identity of the notifier, 2. the identity of the substance, 3. information on manufacture and use, 4. classification and labeling, 5. advice on safe use, 6. the exposure assessment, 38 See note on Art. 2 para. 4. 16 Machine Translated by Google O on chemicals 813.11 7. robust test summaries and other data relating to physico-chemical properties, 8. robust test summaries referring to properties hazardous to health, 9. robust test summaries referring to hazardous properties for the environment; vs. when the determining quantity of substance defined in art. 25 equals or exceeds 10 tonnes per year: a chemical safety report referred to in art. 28; d. a proposal for a safety data sheet in the case of hazardous substances or PBT or vPvB; e. all the documents and information available concerning the exposure and the harmful effects of the substance on humans and the environment, insofar as these aspects are not already covered in the technical file referred to in let. b. 3 s. 2 let. c, does not apply to new substances placed on the market in the form of a preparation, if the concentration of the substance is below the following levels: a. the threshold value referred to in art. 11, para. 3, of the EU-CLP39 regulation; or b. 0.1% by weight if the substance is PBT or vPvB. 4 If, in the situations referred to in Art. 25 let. a or d, certain documents required in para. 2 are not available or if the notifier cannot obtain them under reasonable conditions, he must provide proof of this. 5 The notification authority may request test reports from the notifier which go beyond the scope of the technical file and which are relevant for the evaluation of the substance, provided that they are available and can be obtained. procure on reasonable terms. Art. 28 Chemical safety report The chemical safety report contains the chemical safety assessment drawn up in accordance with the provisions of annex I of the EU-REACH40 regulation. The chemical safety assessment contains: has. a human health hazard assessment; b. a physico-chemical hazard assessment; vs. an environmental hazard assessment; d. an assessment of PBT and vPvB characters; e. when the substance meets the criteria of art. 14, para. 4, of the regulations UE-REACH: 39 See note on Art. 2 para. 4. 40 See note on Art. 2 para. 4. 17 Machine Translated by Google 813.11 Chemical products 1. an exposure assessment covering all uses identified, 2. a characterization of the risks covering all the uses identified. Section 2 Use of previous notifier files and duration of data protection Art. 29 Use of data from previous notifiers 1 The notification office waives the data of the notifier and resorts to the data of a previous notifier: has. where the notifier produces a letter of access from a previous notifier proving that the latter consents to the notification authority referring to his data; or b. when the data protection period has expired. 2 The notifier may under no circumstances refer to the data of a previous notifier with regard to: has. the identity, purity level and identity of impurities of a substance; b. the possibilities of neutralization specific to this substance. 3 The provisions of this section are without prejudice to the rules of competition law and intellectual property law. Art. 30 Duration of data protection 1 Data is protected for ten years. 2 Data subsequently submitted pursuant to Art. 47 are protected for five years. If the term of protection referred to in para. 1 has not yet expired at the end of these five years, the protection of data submitted subsequently is extended accordingly. Art. 31 Obligation to submit a prior application for testing on vertebrates 1 Before undertaking tests on vertebrates for the purpose of submitting a notifi cation, the notifier must ask the notification receiving body in writing whether there are already data from such tests (art. 12 ChemA). 2 The prior request must mention: has. data relating to the identity of the substance in accordance with Art. 27, al. 2, let. b, ch. 2; b. the data relating to the determining quantity of substance according to Art. 25. 18 Machine Translated by Google 813.11 O on chemicals Art. 32 Use of results from previous tests on vertebrates 1 If the notification receiving body has sufficient results from previous tests on vertebrates, it informs the notifier to what extent these data make it possible to avoid new tests on vertebrates for the notification envisaged. 2 If these results come from tests carried out by previous notifiers and this data is still protected, the body receiving notifications takes the following measures: a. he communicates to previous notifiers: 1. the data he intends to reuse for the benefit of the new notifier, and 2. the address of the new notifier; b. he communicates to the new notifier the address of the previous notifiers. 3 Previous notifiers may object within 30 days to the immediate reuse of their data and request that access to this data be postponed. 4 If no request for postponement is filed, the notification reception body issues a decision validating the reuse of the data. 5 If a request for deferral is filed, the notification receiving body issues a decision setting: a. data from previous notifiers that he intends to reuse; b. the postponement affecting the notification of the substance, equivalent to the time that the new notifier would take to obtain its own results. 6 The notification reception body establishes, at the request of the new notifier, a summary of the results used; the provisions relating to confidential data within the meaning of art. 73 are reserved. Art. 33 Compensation to previous notifiers for re-use of their vertebrate test results 1 Previous notifiers are entitled to fair compensation from the new notifier for the reuse of results from tests on vertebrates when these data are still protected under Art. 30. 2 If the notifiers do not reach an agreement on compensation within a period of six months, the notification reception body issues, at the request of one of the notifiers, a decision fixing the amount of the compensation. In particular, it takes into account the following factors: a. expenditures for the acquisition of test results; b. the remaining period of protection enjoyed by the data concerned; the number of notifiers c. entitled to compensation. 3 Previous notifiers may ask the notification receiving body to prohibit the marketing of the substance until the new applicant has paid them the compensation due. 19 Machine Translated by Google 813.11 Chemical products Section 3 Notification of new substances for product and process oriented research and development Art. 34 Obligation to declare Before its first placing on the market, the manufacturer of a new substance not subject to notification under Art. 26, para. 1 let. d, or its exclusive representative, is required to declare to the notification body the said substance, as such or contained in a preparation or in an object from which the substance is intended to be released under normal or reasonably foreseeable conditions of use when the determining quantity according to Art. 25 equals or exceeds one tonne per year. Art. 35 Form and content of the declaration 1 The declaration must be drawn up in one of the official languages or in English and submitted in the electronic format requested by the body receiving notifications. The cover letter must be written in one of the official languages. 2 It must include the following data and documents: a. the name and address of the manufacturer; b. the name and address of the foreign manufacturer if the substance is imported; vs. essential data concerning the identity of the substance; d. intended use; e. the annual quantity of substance that the manufacturer intends to place on the market in Switzerland; the classification and labeling provided; the research program and the list of persons to whom it is intended to hand over the substance; f. g. h. a proposal for a safety data sheet if it is a dangerous substance or PBT or vPvB. 3 The notification authority may request from the manufacturer or the only representative the test reports relevant for the evaluation of the substance, provided that they are available and can be obtained under certain conditions. reasonable. 20 Machine Translated by Google 813.11 O on chemicals Section 4 Procedure applying to notifications and declarations Art. 36 Confirmation of receipt and transmission of the file 1 The notification reception body confirms to the manufacturer or the only representative the date of receipt of the notification or declaration. 2 If the notification or declaration file does not present any obvious shortcomings, the notification reception body forwards it to the assessment bodies. Art. 37 Examination of the notification or declaration file 1 The evaluation bodies verify in their field of competence: a. whether the file is complete or, if not, whether the reasons given by the notifier are valid; b. whether the data is scientifically plausible; c. if the test reports are based on tests meeting the requirements specified in art. 43. 2 If an assessment body finds, during the study of the notification file, that the substance presents a particular risk for human health or the environment, due to its dangerousness, its properties, its probable use or of the quantity placed on the market, it may carry out a targeted risk assessment before accepting the notification. 3 The evaluation bodies transmit the result of their examination to the notification reception body. Art. 38 Additions and corrigenda 1 If the notification office finds that the dossier has obvious shortcomings, it shall immediately report this to the manufacturer or the exclusive representative. 2 If an assessment body finds that the file contains gaps or errors, or even that additional data or tests are necessary for the assessment of the dangers and risks associated with the substance in question, it shall communicate this to the notification receiving body. This requires the manufacturer or the only representative to complete or correct his file accordingly. 3 When a substantial test summary referred to in art. 27, para. 2 let. b, c. 7 to 9, does not allow an independent evaluation of a given test, the notification body may require the complete test report. 4 The notification receiving body confirms to the manufacturer or the exclusive representative the date of receipt of the additions or corrections. Art. 39 Acceptance of notification or declaration 1 In agreement with the assessment bodies, the notification receiving body shall accept the notification or declaration by decision if, after examination, the 21 Machine Translated by Google 813.11 Chemical products dossier is complete and sufficient for the assessment of the hazards and risks associated with the substance in question. 2 If a targeted risk assessment is carried out, the decision includes the prescribed measures to reduce the risks. Section 5 Marketing Authorization Art. 40 Placing on the market of substances subject to notification A substance subject to notification may be placed on the market: has. if the notification authority has accepted its notification by way of decision; Where b. if the body receiving notifications has not issued an opinion within 60 days after the confirmed date of receipt of the notification and, where applicable, any additional information or corrections required afterwards. Art. 41 Marketing of substances subject to declaration A reportable substance can be placed on the market: has. whether the notification authority has accepted its declaration by way of decision; Where b. if the notification reception body has not issued an opinion within 30 days after the confirmed date of receipt of the declaration and, where applicable, of the additions or corrections required afterwards. Chapter 3 Testing Requirements Art. 42 Principles 1 The manufacturer must ensure that the tests required for the estimation of the dangers and risks represented by the substances and preparations, the test methods and the evaluation of the test results correspond to the state of scientific knowledge. fics and techniques. 2 The DFI, the DEFR and the DETEC may define technical procedures in their respective fields. Art. 43 Requirements 1 Tests to determine the properties of substances and preparations must be carried out according to the test methods of the technical requirements of appendix 2, ch. 2. 2 Other test methods may be applied if: has. no method is prescribed pursuant to para. 1; 22 Machine Translated by Google O on chemicals 813.11 b. the manufacturer can demonstrate that a prescribed method is not adequate to determine a given physico-chemical property; or that the method is recognized in the EU in c. accordance with Art. 13, para. 3, of the EU-REACH41 regulation. 3 If other test methods are applied, the manufacturer must demonstrate: has. that these methods deliver valid results; and B. that these methods take due account of the protection of animals in animal test cases. 4 Non-clinical tests aimed at determining the properties dangerous to health or the environment must be carried out in accordance with the principles of good laboratory practice (GLP) in accordance with the ordinance of 18 May 2005 on good laboratory practice42 . 5 If certain tests do not comply, or do not fully comply, with the principles of GLP, the person submitting the test reports must justify this. The notification receiving body decides, in agreement with the evaluation bodies, whether to accept the said test results. Title 3 Obligations of the manufacturer subsequent to placing on the market Chapter 1 Consideration of new critical facts for assessment, classification and labeling Art. 44 Re-evaluation of substances, preparations and objects The manufacturer must carry out a new evaluation of substances, preparations and articles containing dangerous components, or complete their evaluation and, if necessary, carry out their reclassification, re-labelling and re-packaging: a. when they are intended to be given for another purpose; b. when they are intended for use in another way; vs. when they are intended to be used in significantly higher quantities; d. when differences in the nature and quantity of the impurities may adversely affect the risks they represent for human beings or the environment; e. when the risks they represent for human beings or the environment must be reassessed in the light of practice, new information or new knowledge. 41 See note on Art. 2 para. 4. 42 RS 813.112.1 23 Machine Translated by Google 813.11 Chemical products Art. 45 Updating and keeping the evaluation file 1 The manufacturer is required to update and complete the assessment dossier on the basis of new information that is relevant to human health and the environment, for as long as he places the substance, preparation or object containing hazardous components. 2 He is required to keep or keep available the main documents used for the evaluation and classification, including the corresponding results, for at least ten years after the last marketing. He must keep the samples and specimens for as long as their condition allows an evaluation. Chapter 2 Additional information and test reports for new substances Art. 46 Further information 1 The notifier is obliged to inform the notification receiving body without delay and in writing: has. if the data referred to in art. 27, para. 2 let. b, c. 1 to 6, or art. 35, par. 2, change; b. if the determining quantity of substance according to Art. 25 has in all probability reached one of the quantitative thresholds set out in Art. 47, s. 1; in this case, the notifier indicates the tests he plans to carry out in order to obtain the additional data mentioned in art. 47, s. 1; vs. if the determining quantity according to Art. 25 has more than doubled or more than halved the last notified quantity; d. if he becomes aware of any new facts concerning the effects of the substance on humans or the environment; e. if he places the substance on the market for a new use or if he becomes aware that this substance is being used for purposes other than those which he has indicated to the notification authority; if he establishes or has established, for the substance in question, f. test reports going beyond the technical file referred to in art. 27, para. 2 let. b; if he is able to obtain, under reasonable conditions, other test reports going beyond the g. technical file referred to in art. 27, para. 2 let. b. 2 The additional information according to para. 1 must be written in one of the official languages or in English and presented in the electronic format requested by the notification authority. The cover letter must be written in one of the official languages. 3 The only representative must ensure that he has up-to-date data, in particular with regard to the quantities of substance imported annually by the importers he represents. 24 Machine Translated by Google 813.11 O on chemicals 4 Importers subrogated to an exclusive representative for the notification of a new substance must inform the latter of the quantities of substance imported annually. Art. 47 Information to be submitted according to the quantities 1 The notifier is obliged to submit to the notification receiving body the following additional data, depending on the determining quantity of substance according to Art. 25: has. quantity equal to or greater than 10 tonnes per year: the information mentioned in annex 4, ch. 9 let. b, and. 10 let. b, as well as a chemical safety report referred to in art. 28; b. quantity equal to or greater than 100 tonnes per year: the information mentioned in annex 4, ch. 8 let. b, 9, lit. c, and 10, let. c, as well as a chemical safety report referred to in art. 28; vs. quantity equal to or greater than 1000 tonnes per year: the information mentioned in annex 4, ch. 9 let. d, and 10, let. d, as well as a chemical safety report referred to in art. 28. 2 After receipt of the information referred to in art. 46, s. 1 let. b, the body for receiving notifications, pursuant to art. 32, informs the notifier of the data already available. 3 If the hazards associated with a given substance cannot be sufficiently assessed, the notification receiving body shall request from the notifier, at the request of an assessment body, additional information or tests for the substance in question or its secondary products. 4 The notification reception body, after consultation with the notifier and in agreement with the assessment bodies, draws up a timetable for carrying out the additional tests. 5 If the notifier fails to submit the additional test reports within the time limits set, the notification authority may have the required tests carried out at the expense of the notifier and, if necessary, prohibit the latter from placing on the market for the substance under consideration. Chapter 3 Obligation to communicate Art. 48 Substances and preparations subject to communication The manufacturer must notify the notification receiving body of the substances and preparations mentioned in Art. 19, independently of the obligation to draw up a safety data sheet, within three months after the first placing on the market. 25 Machine Translated by Google 813.11 Chemical products Art. 49 Content of communication The communication must contain the following data: has. the name and address of the manufacturer; b. the name of the person responsible for placing on the market in the EEA, defined in art 17, al. 1 let. a, of the EU-CLP43 regulation if the labeling does not mention the identity of the manufacturer; vs. for substances: 1. the chemical designation within the meaning of art. 18, para. 2 let. a to d, of the EU-CLP regulation, 2. the CAS number, 3. the EC number , 4. the classification and labeling, 5. the intended use, 6. for substances dangerous for the environment: the annual quantity that is planned to be placed on the market according to the following categories: less than 1 tonne, 1 to 10 tonnes, 10 to 100 tonnes, more than 100 tonnes, 7. for nanomaterials: the composition of the nanomaterial , the shape of the particles and their average size as well as, when this information is available, the particle size distribution, the specific surface area by volume, the crystalline structure, the state of aggregation, the surface coating and the surface functionalization, 8 .the indication whether the substance is deemed to be PBT or vPvB, 9. the chemical safety report available in the EEA, provided that the manufacturer can obtain it under reasonable conditions; d. for the preparations: 1. the trade name, 2. the data relating to the components, in accordance with the provisions applying to the safety data sheet, 3. the classification and labelling, 4. the intended use, 5. physical condition, 6. for preparations dangerous for the environment: the annual quantity which it is planned to place on the market according to the following categories: less than 1 tonne, from 1 to 10 tonnes, from 10 to 100 tonnes, more than 100 tonnes , 7. for preparations which contain nanomaterials: the composition of the nanomaterials, the shape of the particles and their average size as well as, when this information is available, the particle size distribution, the specific surface area by volume, the structure 43 See note on Art. 2 para. 4. 26 Machine Translated by Google 813.11 O on chemicals crystalline, state of aggregation, surface coating and surface functionalization. Art. 50 Extended communication With regard to dangerous preparations accessible to private users, the full composition must be communicated to the notification body. Components that are not dangerous within the meaning of Art. 3 may be designated by a name expressing the main functional groups or by a substitute name obtained in accordance with Art. 15. Art. 51 Form of communication and extended communication Communication and extended communication must be transmitted: has. in the electronic format requested by the notification receiving body; b. in one of the official languages or in English. Art. 52 Modifications 1 The changes affecting the data referred to in art. 49 and 50 must be communicated within three months. 2 If, in the case of substances and preparations dangerous for the environment, the annual quantity actually delivered does not correspond to the quantitative category previously announced, it is necessary to communicate, until March 31 of the following year , the quantity actually delivered during the previous year broken down according to the categories specified in art. 49 let. c, c. 6, and d, c. 6. Art. 53 Alternative forms of the obligation to communicate The obligation to communicate preparations pursuant to Art. 48 is deemed fulfilled when an application for the use of an alternative chemical name has been filed (Art. 15) and the notification receiving body has the information required by Art. 49 let. a, b and d, and, where applicable, in art. 50. Art. 54 Exceptions to the obligation to communicate The following are not subject to the communication regime within the meaning of this chapter: a. intermediate products, with the exception of new substances in the form of monomers; b. substances and preparations placed on the market exclusively for the purposes of analysis, research, teaching or which are themselves the subject of a research and development activity; substances and preparations used exclusively for foodstuffs, therapeutic products c. or animal feed; 27 Machine Translated by Google 813.11 Chemical products d. fertilizers which must be authorized by the Federal Office for Agriculture (FOAG) or notified to the FOAG, pursuant to the ordinance of 10 January 2001 on fertilizers44; e. explosives and pyrotechnic devices which are subject to authorization according to the Ordinance of 27 November 2000 on explosives45; f. substances acquired in Switzerland; g. preparations acquired in Switzerland and delivered in packaging other than that provided by the original manufacturer, provided that: 1. the trade name, composition and intended use are not modified trusted, and that 2. the name of the original manufacturer is also mentioned; h. gas mixtures composed exclusively of gases which have been the subject of a communication; preparations which are not dangerous within the meaning of art. 3 and packaged in i. packaging not exceeding 200 ml, when manufactured in Switzerland and delivered directly by the manufacturer to the professional or private user; preparations placed on the market in quantities of less than 100 kg per year and exclusively intended for professional users. j. Title 4 Rules of conduct when using substances, preparations and objects Chapter 1 General Provisions Art. 55 Observance of manufacturer's data 1 Substances, preparations and objects may, on a professional or commercial basis, be the subject of advertising promotion, offered for sale or handed over only for the uses and disposal methods provided for by the manufacturer. 2 The indications on the packaging, labeling and safety data sheet must be taken into account. Art. 56 Dispersion in the environment 1 Any direct release of substances or preparations into the environment must be limited to what is strictly necessary in relation to the intended use. 2 To this end, it is necessary: has. to use devices allowing correct and precise use; 44 RS 916.171 45 RS 941.411 28 Machine Translated by Google O on chemicals 813.11 b. to take all the necessary measures to ensure that the substances do not come unnecessarily into the neighborhood or into the waters; etc. to take all necessary measures so that animals, plants, their biocenoses and their biotopes are not unnecessarily threatened. 3 The direct dispersion of preparations in the environment is only permitted for the uses intended by the manufacturer. Art. 57 Storage 1 Substances and preparations should be stored in accordance with the instructions on the packaging, labeling and, where applicable, on the safety data sheet. 2 Dangerous substances and preparations and their containers must be protected against any dangerous deterioration, in particular of a mechanical nature. 3 Dangerous substances and preparations must be stored in a clear and orderly manner, separate from other goods. Any storage in the immediate vicinity of foodstuffs, animal feed or therapeutic products is prohibited. 4 Paras. 1 to 3 also apply to objects releasing substances or preparations in quantities likely to endanger human beings or the environment ment. 5 Substances and preparations liable to interact by causing dangerous reactions must be stored separately from each other. 6 Dangerous substances and preparations may only be transferred and stored in containers which comply with the following requirements: a. they must not be confused with packaging for foodstuffs, cosmetics, therapeutic products or animal feed; b. the name of the substance or preparation must appear on the labeling of the container; c. they must comply with the requirements of art. 35, para. 1 and 3, of the EU-CLP46 regulation; d. they must not have a shape or an aesthetic likely to attract or encourage the curiosity of children. Art. 58 Special obligations relating to the supply of substances and preparations Any person who supplies a substance or a preparation on a commercial basis and who must provide a safety data sheet, must know and be able to interpret the content of the data sheet. of security. 46 See note on Art. 2 para. 4. 29 Machine Translated by Google 813.11 Chemical products Art. 59 Contact person for chemicals 1 Companies and educational establishments must notify the cantonal enforcement authorities of the name of the contact person for chemicals pursuant to Art. 25, par. 2, LChem. 2 The DFI regulates the notification obligation provided for in para. 1. It fixes the form and content of the advertisement. 3 It lays down the requirements that the contact person for chemicals must meet, in particular with regard to the qualifications required at both technical and managerial level. Art. 60 Advertising 1 Advertising relating to substances, preparations and objects must not give rise to an erroneous impression as to the nature of the dangers which they represent for human beings and the environment or as to their eco-compatibility, and must not suggest either a nor improper or improper disposal. 2 Terms such as "degradable", "ecologically harmless", "eco-compatible" and "harmless to water" may only be used in advertising if they are simultaneously explained. 3 Any person who advertises dangerous substances or preparations which the private user has the possibility of purchasing without having seen the labeling beforehand must indicate their dangerous properties in an understandable and clearly legible or audible manner. 4 s. 3 also applies to preparations labeled according to art. 25, par. 6, of the EU-CLP47 regulation. 5 Substances and preparations may not be advertised for a use for which they may not be placed on the market. Chapter 2 Use of substances and preparations from groups 1 and 2 Art. 61 Substances and preparations of groups 1 and 2 1 Group 1 substances and preparations means substances and preparations: has. whose labeling according to the EU-CLP48 regulation mentions at least one element listed in appendix 5, ch. 1.1 of this order; Where 47 See note on Art. 2 para. 4. 48 See note on Art. 2 para. 4. 30 Machine Translated by Google 813.11 O on chemicals b. which are not yet labeled according to the EU-CLP regulation and whose labeling mentions at least one element listed in appendix 5, ch. 2.1, of this order. 2 Group 2 substances and preparations means substances and preparations: has. whose labeling according to the EU-CLP regulation mentions at least one element listed in appendix 5, ch. 1.2 of this order; or b. which are not yet labeled according to the EU-CLP regulation and whose labeling mentions at least one element listed in appendix 5, ch. 2.2, of this order. Art. 62 Storage 1 Art. 57 applies to the storage of substances and preparations of groups 1 and 2. 2 Any person who stores substances or preparations of groups 1 and 2 must ensure that they are inaccessible to unauthorized persons. 3 Substances and preparations in groups 1 and 2 may only be transferred and stored in containers labeled with the appropriate hazard symbols or hazard pictograms. Art. 63 Exclusion of sale in free-service 1 Group 2 substances and preparations intended for private users are excluded from self-service sales. 2 The prohibition within the meaning of para. 1 does not apply to motor fuels. Art. 64 Discount restrictions 1 Substances and preparations in group 1 may not be supplied on a commercial basis to private users. 2 Substances and preparations in groups 1 and 2 may only be distributed on a commercial basis to persons having the exercise of civil rights. 3 Substances and preparations in groups 1 and 2 may be given to minors, provided that they are capable of discernment and that they use such substances or preparations within the framework of their training or in a professional or commercial capacity. . 4 The restrictions on the delivery of ss. 1 and 2 do not apply to motor fuels. Art. 65 Specific obligations related to surrender 1 Any person who, on a commercial basis, supplies a substance or a preparation of group 1 to a professional user or to a trader must inform him expressly 31 Machine Translated by Google 813.11 Chemical products sow, when handing over, the necessary protective measures and the method of disposal in accordance with the regulations. 2 Any person who, on a commercial basis, hands over a substance or a preparation of group 2 to a private user must expressly inform him, when handing over, of the necessary protective measures and of the mode of disposal in accordance with the prescriptions. 3 The substances and preparations referred to in para. 2 can only be handed over to the user if the remitter can reasonably admit that he is capable of discernment and that he is able to meet the duty of care provided for in Art. 8 ChemA as well as the provisions of art. 28 EPLs. 4 The obligations referred to in paras. 1 and 2 do not apply to the rebate of motor fuels. Art. 66 Technical knowledge required for handover 1 Anyone who, in a commercial capacity, delivers: has. substances or preparations of group 1 to a person who obtains them for professional purposes without placing them on the market in another form; b. group 2 substances or preparations to a private user. 2 The DFI can regulate: has. the criteria to be met, taking into account professional training and professional experience; b. the subject, duration and modalities of the courses enabling the acquisition of the technical knowledge required. 3 Arts. 10 and 11 of the Ordinance of 18 May 2005 on the reduction of risks linked to chemical products (ORRChim)49 apply by analogy. 4 s. 1 does not apply to the rebate of motor fuels. Art. 67 Theft, loss, placing on the market by mistake 1 In the event of the theft or loss of substances or preparations of group 1, the victim of the theft or the person who suffered the loss is obliged to notify the police immediately. 2 The police shall inform the cantonal authority responsible for applying this Ordinance as well as the Federal Office of Police. 3 Anyone who places a group 1 or 2 substance or preparation on the market by mistake is required to immediately notify the cantonal authority responsible for applying this Ordinance and communicate to it: a. all information enabling precise identification of the substance or preparation; 49 RS 814.81 32 Machine Translated by Google 813.11 O on chemicals b. a full description of the hazard posed by the substance or preparation tion; vs. all available information on the identity of the person who supplied him with the substance or preparation and the persons to whom he delivered it; d. the measures taken to prevent risks, such as warnings, interruption of sale, withdrawal from the market or recall. 4 The cantonal authority decides on the relevance of a warning against any possible danger and its form. Art. 68 Samples Substances and preparations in groups 1 and 2 may only be passed on for advertising purposes to professional users and traders. Art. 69 Substances and preparations intended for self-defense 1 Arts. 62, 64, s. 2 and 3, 65, para. 2 and 3, 66 par. 1 let. b, 67, para. 3 and 4, and 68 apply by analogy to the use of substances and preparations intended for self-defence. 2 Substances and preparations intended for self-defense are excluded from self-service sales. Chapter 3 Use of Substances of Very High Concern Art. 70 List of Substances of Very High Concern 1 Substances according to Art. 57 of the EU-REACH50 regulation are deemed to be of very high concern when they are included in appendix 3 (candidate list of substances). 2 The Federal Office for the Environment (FOEN) decides, in agreement with the Federal Office of Public Health (FOPH) and the State Secretariat for Economic Affairs (SECO), whether a substance on the list of substances candidates listed in appendix XIV of the EU-REACH regulation must be included in appendix 1.17 of the ORRChim51. Art. 71 Objects containing substances of very high concern 1 Any person who, on a commercial basis, delivers an object containing a substance of very high concern with a concentration greater than 0.1% by weight must provide the following information: a. the name of the substance; 50 See note on Art. 2 para. 4. 51 RS 814.81 33 Machine Translated by Google 813.11 Chemical products b. all the necessary information available to it to allow safe use of the object. 2 It must provide this information free of charge: has. spontaneously to the professional user and the trader; b. on request and within 45 days to the private user. Title 5 Data processing Art. 72 Register of products 1 The notification office keeps a register of substances and preparations which fall under the following legislative acts: a. this order; b. ORRChim52; vs. the order of 18 May 2005 on biocidal products53; d. the order of 12 May 2010 on phytosanitary products54. 2 The register is established according to the data: a. which have been collected or processed by a Swiss authority under one of the orders referred to in para. 1; b. which are transmitted by foreign authorities or by international organizations nationals. Art. 73 Confidential data 1 The enforcement authorities shall treat the data confidentially when maintaining secrecy presents an interest worthy of protection, unless an overriding public interest requires its dissemination. 2 The notification reception body defines, in agreement with the evaluation bodies, the confidential data. It defines them before transmitting them to the competent federal or cantonal authorities pursuant to art. 75, s. 2. 3 Is deemed worthy of protection, in particular the interest in the guarantee of business secrecy and manufacturing secrecy, including the indications concerning the complete composition and the quantities put on the market. 4 If the notification receiving body learns that data deemed to be confidential have otherwise been lawfully disclosed, these lose their confidential nature. 5 The following are in no way deemed confidential: 52 RS 814.81 53 RS 813.12 54 RS 916.161 34 Machine Translated by Google 813.11 O on chemicals a. trade name; b. the name and address of the person subject to the obligation to notify, declare or communicate; physico-chemical properties; c. d. proper disposal methods, recycling possibilities and pos neutralization abilities; and. summary of toxicological and ecotoxicological test results; the degree of purity of the f. substance under consideration and the identity of impurities and additives relevant for classification; recommendations on precautions for use and on emergency measures g. in the event of an accident; h. the information on the safety data sheet; i. analytical methods for determining the risk of exposure to humans and the risk of dispersion in the environment. 6 The notification body and the assessment bodies may publish the data contained in the product register, which is in no way deemed confidential. Art. 74 Transmission of data to the notification receiving body and the assessment bodies If the execution of this ordinance so requires, the notification authority or the assessment authorities may request the transmission of the following data on substances, preparations and objects: a. the data collected by the FOAG pursuant to: 1. the ordinance of 10 January 2001 on fertilizers55, 2. the ordinance of 26 October 2011 on animal feed56, 3. the ordinance of 12 May 2010 on phytosanitary products57; b. data on foreign substances and components present in foodstuffs as well as on substances present in everyday objects, collected by the Federal Office for Food Safety and Veterinary Affairs pursuant to the order of 23 November 2005 on foodstuffs and everyday objects58; data collected by the Federal Customs Administration through customs declarations; c. 55 RS 916.171 56 RS 916.307 57 RS 916.161 58 RS 817.02 35 Machine Translated by Google 813.11 Chemical products d. the data collected by SECO, by the Swiss National Accident Insurance Fund (CNA) or by the cantonal labor inspectorates in application of the legislation on the protection of workers; e. data collected by the toxicological information center (art. 79); f. the data collected by the bodies responsible for examinations and per my au sens de l'art. 12, al. 3, ORRChim59; g. the data collected by the cantons pursuant to this ordinance or any other legislative act governing the protection of human beings or the environment against the risks associated with substances, preparations and objects. Art. 75 Exchanges of data 1 The body for receiving notifications and the evaluation bodies mutually exchange, insofar as the exercise of their functions so requires, the data which they collect or cause to be collected pursuant to this ordinance or any other legislative act governing the protection of human beings or the environment against the risks associated with substances, preparations and objects. They may establish automated access procedures for this purpose. 2 They make available to the cantonal and federal authorities responsible for the execution of legislative acts governing the protection of human beings or the environment against the risks associated with substances, preparations and objects, the data necessary for the performance of their duties. 3 They may make available, by means of automated access procedures, to the authorities mentioned below, the data relating to the manufacturers and the substances or preparations which they have placed on the market, if these data are necessary for them. execution, namely: a. customs authorities; b. to the authorities mentioned in para. 2; vs. at the toxicological information center (art. 79). They can, in particular cases, transmit to the cantonal or federal services which are not referred to in para. 2 data relating to substances, preparations and objects, insofar as the exercise of their functions so requires. 5 In the case of confidential data relating to the composition of a preparation, the exchange of data provided for in paras. 2, 3 and 4 are only accepted if these data are required by a criminal prosecution authority, if it is a question of answering questions of a medical nature, in particular in an emergency, or if it is is to ward off a danger directly threatening human life and health or the environment. 6 The cantons inform the FOPH about the results of the readings and analyzes relating to the quality of the ambient air in the premises and send it the data they have on this subject. 59 RS 814.81 36 Machine Translated by Google O on chemicals 813.11 Art. 76 Transmission of data to foreign authorities and international organizations 1 The notification office and the evaluation bodies may forward non-confidential data to foreign authorities and institutions. 2 They may transmit confidential data: has. when international agreements or decisions issued by international bodies so require; Where b. when necessary to avert a danger directly threatening human life and health or the environment. Title 6 Execution Chapter 1 Confederation Section 1 Organisation Art. 77 Notification receiving body and management committee 1 The notification reception body is administratively attached to the FOPH. 2 The notification reception body is subordinate to a management committee made up of the directors of the following offices: a. FOPH; b. OFAG; vs. FOEN; d. SECO. 3 The management committee has the following tasks and powers: has. to appoint the management of the notification-receiving body; b. define the notification agency's strategy; vs. consult and amend the budget of the body receiving notifications tions. 4 The management committee decides unanimously. Art. 78 Evaluation bodies The evaluation bodies are: has. the FOPH, for aspects relating to the protection of life and health human; b. the FOEN, for aspects relating to the protection of the environment and, indirectly, of human beings; SECO, for aspects relating to the protection of workers. c. 37 Machine Translated by Google 813.11 Chemical products Art. 79 Toxicological information center 1 The toxicological information center provided for by art. 30 LChim is the Tox Info Switzerland. 2 The FOPH concludes an agreement with Tox Info Suisse setting the amount of compensation for the services that the latter provides under Art. 30, par. 2, LChem. Section 2 Review of Existing Substances Art. 80 1 The assessment bodies may review an existing substance: has. if it represents a particular risk for human life or health or for the environment because of the quantities manufactured or placed on the market, because of its dangerousness, its secondary products or its waste; or b. if it is subject to an international re-evaluation programme. 2 In the event of a review of an existing substance, the notification receiving body shall, at the request of an assessment body, require the following information from all manufacturers concerned: has. the name and address of the manufacturer and, if imported, the name and address of the foreign manufacturer; b. all the documents used for the analysis and establishment of the hazardous properties of the substance; vs. known uses; d. the quantities marketed by each manufacturer; e. the registration dossier submitted to the European Chemicals Agency, provided that it is available and that the manufacturer can obtain it under reasonable conditions. 3 At the request of an assessment body, the notification receiving body requires clarifications or additional analyzes from one of the manufacturers. The costs incurred by the latter shall be borne jointly by all the manufacturers concerned. Section 3 Autonomous Control Verification and Monitoring Art. 81 Autonomous control verification 1 The assessment bodies verify, in their respective fields, with regard to substances, preparations and objects: 38 Machine Translated by Google O on chemicals 813.11 has. assessment and classification; b. the information on the safety data sheet. 2 They may instruct the body receiving notifications: has. verify the composition and physico-chemical properties of substances, preparations and articles; b. to ask the cantonal enforcement authorities to take samples let's. 3 If there is reason to assume that the assessment or classification is lacking or that it has not been carried out correctly, the notification authority shall require the manufacturer concerned, at the request of a regulatory authority, to 'Evaluation: has. all documents used to assess or establish the hazardous properties of the substance; b. if applicable, the safety data sheet. 4 At the request of an evaluation body, the notification reception body requires the manufacturer to carry out additional tests or evaluations if there are indications that: has. that a substance or a preparation and its by-products or its waste can endanger human beings or the environment; b. that an object, its by-products or its waste can endanger the environment. 5 In addition, the enforcement authorities exercise the powers attributed to them by art. 42 ChemA and, in the event of danger to the environment, art. 41 LChem. 6 If a manufacturer does not comply with an official decision, the notification receiving body prohibits him, at the request of an assessment body, from continuing to supply the substances, preparations or objects concerned. 7 With regard to cosmetics as well as raw materials and additives which are exclusively intended for them, the competent service in the matter decides on the measures to be taken. The collaboration of the FOEN is governed by Art. 62a and 62b of the law of 21 March 1997 on the organization of government and administration60. Art. 82 Surveillance in the context of national defense In cases relating to national defence, the notification reception body verifies, in agreement with the evaluation bodies, whether the provisions of this ordinance have been complied with. Art. 83 Import and export monitoring 1 The customs offices shall check, at the request of the notification receiving body, whether the substances, preparations or objects comply with the provisions of this Ordinance. 60 RS 172.010 39 Machine Translated by Google 813.11 Chemical products 2 The evaluation bodies may ask the notification reception body to file a request in accordance with para. 1. 3 If there is a presumption of violation, the customs offices are authorized to confiscate the goods at the border and to appeal to the other enforcement authorities mentioned in this ordinance. These take the necessary steps and decide on the measures to be taken. Section 4 Adaptation of the technical requirements and the candidate list of substances Art. 84 In agreement with the FOEN and the SECO, the FOPH adapts the following annexes: has. appendix 2: 1. by defining the determining version of the annexes of the EU regulation CLP61, 2. taking into account amendments to the Organization for Economic Co-operation and Development (OECD) Guidelines for the testing of chemicals and defining the governing version of Regulation (EC) No 440/200862 and the Testing Manual United Nations Tests and Criteria for Recommendations on the Transport of Dangerous Goods63, 3. by defining the determining version of Annex II of the EU Regulation REACH 64; b. annex 3: it takes into account the modifications of the “list of substances identified with a view to inclusion in annex XIV of regulation (EC) no 1907/2006” mentioned in art. 59, para. 1, of the EU-REACH regulation; vs. appendix 4: it takes into account the modifications of annexes III and VII to XI of the EU-REACH regulation. 61 See note on Art. 2 para. 4. 62 Commission Regulation (EC) No 440/2008 of 30 May 2008 establishing test methods in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), OJ L 142, 31.5.2008, p. 1; last amended by Regulation (EU) No 900/2014, OJ L 247, 21.8.2014, p. 1. 63 The manual, 5th revised edition, 2013, can be consulted free of charge on the United Nations website at the following address: www.unece.org/fileadmin/DAM/trans/danger/publi/manual/Rev5/English/ST-SG-AC10- 11-Rev5-EN.pdf 64 See note on art. 2 para. 4. 40 Machine Translated by Google O on chemicals 813.11 Section 5 Delegation of tasks and powers to third parties Art. 85 1 The competent federal services may delegate to corporations governed by public law or to individuals all or part of the tasks and powers conferred on them by this Ordinance. 2 With regard to the provisions on the protection of health, they may only delegate: a. verification of autonomous control; b. assessment in the context of the review of notifications and information complementary; c. information activities within the meaning of art. 28 LChem; d. the risk assessment within the meaning of art. 16 LChem. Section 6 Emoluments Art. 86 The system and the calculation of the fees for the administrative acts carried out by the federal enforcement authorities under this ordinance are governed by the ordinance of 18 May 2005 on the fees levied in application of the legislation on chemical products65. Chapter 2 Cantons Section 1 Subsequent control Art. 87 Tasks of the cantonal enforcement authorities 1 The cantonal enforcement authorities check the substances, preparations and objects placed on the market by sampling. 2 As part of these checks, they verify: a. that the obligation to notify, declare or communicate (Art. 24, 34, 48, 52, 53) and the provisions governing additional information (Art. 46) are complied with; b. that the packaging complies with the relevant provisions (ss. 8 and 9); vs. that the labeling complies with the relevant provisions (ss. 10 to 13); 65 RS 813.153.1 41 Machine Translated by Google 813.11 Chemical products d. that the requirements on the provision, updating and storage of safety data sheets (art. 21 to 23) are complied with and that the information given in the safety data sheets is not manifestly incorrect ; e. that the regulations on advertising (Art. 60) and on samples (Art. 68) are complied with; f. that the obligation to provide information when handing over an object containing a substance of very high concern (Art. 71) is complied with. Art. 88 Collaboration between cantonal and federal enforcement authorities 1 The notification receiving body invites, on its own initiative or at the request of an assessment body, the cantonal enforcement authorities to carry out targeted checks on substances, preparations or objects, in particular under art. 81, s. 1. 2 The cantonal enforcement authorities take samples at the request of the notification reception body. 3 If the checks give rise to major disputes, the authority which carried out the check informs the notification reception body and the cantonal authorities responsible for decisions under Art. 89. 4 In the event of a well-founded suspicion of incorrect classification, the authority which carried out the inspection shall inform the notification reception body. Art. 89 Decisions of cantonal enforcement authorities If the control reveals violations against the provisions mentioned in art. 87, s. 2, and 88, para. 1, the authority of the canton in which the accused person has his domicile or his head office decides on the measures to be taken. Section 2 Monitoring usage and encouraging environmentally friendly behavior Art. 90 1 The cantonal enforcement authorities monitor compliance with the specific provisions governing the use of chemicals (arts. 55 to 59, 61 to 67 and 69). Art. 25, para. 1, 2nd sentence, LChim, applies by analogy. 2 The cantons encourage environmentally compatible behavior. 42 Machine Translated by Google O on chemicals 813.11 Title 7 Final provisions Chapter 1 Repeal and amendment of other acts Art. 91 Repeal of another act The Ordinance of 18 May 2005 on chemicals66 is repealed. Art. 92 Modification of other acts Amendments to other acts are regulated in Annex 6. Chapter 2 Transitional Provisions Art. 93 For preparations labeled and packaged before the entry into force of this order, in accordance with art. 35 to 50 of the Ordinance of 18 May 2005 on chemicals67, the following transitional provisions apply: a. they can be submitted until May 31, 2017, if a safety data sheet within the meaning of art. 19 of this order has been established and that a communication within the meaning of art. 48 of this order has been made; in the case of liquid laundry detergents intended for private users and packaged in soluble packaging, which do not meet the requirements of Regulation (EU) No 1297/201468, they may only be handed over until 31 December 2015; b. double labeling according to art. 35 to 50 of the Ordinance of May 18, 2005 on chemical products and according to art. 10 of this order is not permitted; the provisions of Title 4 of this Ordinance apply to the use of these preparations. c. 2 Aerosol generators labeled and packaged before the entry into force of this order, which do not fall under the LDAl69 and which do not meet the requirements of art. 9 and 11, can be submitted until May 31, 2017. If a preparation labeled before the entry into force of this order, in accordance with art. 39 to 50 of the Ordinance of May 18, 2005 on chemicals in its version of December 1 , 2012, is decanted from its packaging 66 [RO 2005 2721, 2007 821, 2009 401 805, 2010 5223, 2011 5227, 2012 6103, 2013 201 3041 ch. I 3, 2014 2073 annexe 11 ch. 1 3857] 67 [RO 2005 2721, 2007 821, 2009 401 805, 2010 5223, 2011 5227, 2012 6103, 2013 201 3041 ch. I 3, 2014 2073 annexe 11 ch. 1 3857] 68 Commission Regulation (EU) No 1297/2014 of 5 December 2014 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures, OJ L 350, 6.12.2014, p. 1. 69 RS 817.0 43 Machine Translated by Google 813.11 Chemical products original to smaller packaging, without the composition or the intended use being modified, it can, until May 31, 2017, also be returned in these smaller packages with the old labelling. 4 The manufacturer must meet, until June 1 , 2018, the obligation referred to in art. 16 to develop exposure scenarios for substances placed on the market in a total quantity of 10 to 100 tonnes per year. Chapter 3 Entry into force Art. 94 This Ordinance comes into force on July 1 , 2015. 44 Machine Translated by Google O on chemicals 813.11 Annex 170 (art. 2, para. 4, 5 and 6) Equivalences of expressions and applicable law 1 In order to correctly interpret the expressions appearing in the EU Regulation REACH71, the EU-CLP72 regulation and directive 75/324/EEC73 to which this ordinance refers, the following equivalences will be taken into account: UE Suisse has. French expressions: manufacturer, supplier, importer, manufacturer according to art. 2 para. 1 let. b downstream user marketing placing on the market according to art. 4 para. 1 let. i, LChim preparation object ,mixed intermediate product according to art. 2 article para. 2 let. intermediate consumer private user Tox official advisory body Info Switzerland (Art. 79) b.Expressions en anglais: manufacturer, supplier, importer, Manufacturer according to Article 2 paragraph 1 downstream user placing on the letter b market Placing on the market in accordance with Article 4 paragraph 1 Letter i ChemG mixture Preparation product Object intermediate Intermediate according to Article 2 paragraph 2 letter j private user Tox Info Suisse (Art. 79) consumer Public advice center 70 Update according to ch. 3 of appendix 6 to O of 4 Dec. 2015 on waste, in force since Jan. 1 , 2016 (RO 2015 5699). 71 See note on Art. 2 para. 4. 72 See note on Art. 2 para. 4. 73 See note on Art. 2 para. 4. 45 Machine Translated by Google 813.11 Chemical products UE Suisse c. Expressions en italien: Manufacturer, supplier, importer, Manufacturer pursuant to Article 2 downstream user paragraph 1 letter b Placing on the market Placing on the market in accordance with Article 4 paragraph 1 letter i LPChim Blend Prepared Item Object Intermediate substance Intermediate product within the meaning of Article 2 paragraph 2 letter j Private user Tox Consumer Info Suisse (Article 79) Official advisory body 2 Where this Ordinance refers to provisions of the EU Regulation REACH or the EU-CLP Regulation, which themselves refer to one of the provisions below of these legal acts, the following provisions of Swiss law apply instead: Provision of EU-REACH Regulation or Regulation Provisions of Swiss law UE-CLP art. 13 of the EU-REACH regulation art. 43, para. 2, of this ordinance art. 20 art. 31 of the EU-REACH regulation of this order appendix 3 of this order art. art. 59 of the EU-REACH regulation 10, para. 3 let. b, of this order art. 17, para. 2, of the EU-CLP Regulation art. 23 let. e, of the EU-CLP regulation explosives legislation art. 24 of the EU-CLP Regulation art. 14 of this order 3 Where this Ordinance refers to provisions of the EU Regulation REACH or the EU-CLP Regulation, which themselves refer to other provisions of EU law, the following provisions of Swiss law apply instead: 46 Machine Translated by Google 813.11 O on chemicals European law Swiss law Council Directive 86/609/EEC of 24 Federal law of December 16, 2005 on the November 1986 on the approximation of protection of animals74 the laws, regulations and administrative provisions of the Member States relating to the protection of animals used for experimental or other scientific purposes, OJ L 358 of 18.12. 1986, p. 1 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on ordinance of 18 May 2005 on biocidal the market and use of biocidal products, OJ products75 L 167, 27.6.2012, p. 1 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives ordinance of 12 May 2010 on 79/117/EEC and 91/414/EEC, OJ L 309, phytosanitary products76 24.11.2009, p. 1 regulations on the transport of dangerous goods provisions governing transport by post, rail, road, air, waterway and pipeline art. 50, par. 3, of the ordinance of 19 December 1983 on Commission Decision of 12 July the prevention of accidents77 1995 on the creation of a scientific committee on occupational exposure limits for chemical agents, OJ L 188, 9.8.1995, p. 14 Council Directive 98/24/EC of 7 April worker protection legislation 998 on the protection of the health and safety of workers from the risks related to chemical agents at work, OJ L 131, 5.5.1998, p. 11 74 RS 455 75 RS 813.12 76 RS 916.161 77 RS 832.30 47 Machine Translated by Google 813.11 Chemical products European law Swiss law Directive 2004/37/EC of the European worker protection legislation Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, OJ L 158 of 30.4.2004, p. 50 National Occupational Exposure Limits Council Directive 89/686/EEC, of the OrdinanceCNA list of workplace exposure limit of 19 May 2010 on the safety of 21 December values78 1989, concerning the products79 approximation of the laws of the Member States relating to personal protective equipment, OJ L 399, 30.12.1989, p. 18 Directive 2008/98/EC of the European Ordinance of 4 December 2015 on waste80 Parliament and of the Council of 19 and ordinance of 22 June 2005 on the November 2008 on waste and repealing movement of waste81 certain directives, OJ L 312 of 22.11.2008, p. 3 Regulation (EC) No 1005/2009 of the European Parliament and of the Council of annexe 1.4 ORRChim82 16 September 2009 on substances which deplete the ozone layer, OJ L 286, 31.10.2009, p. 1 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent annexes 1.1, 1.9 and 1.16 ORRChim organic pollutants and amending Directive 79/117/EEC, OJ L 158 of 30.4.2004, p. 7 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of dangerous chemicals, OJ L 201 of PIC order of 10 November 200483 27.7.2012, p. 60 78 The list of workplace exposure limit values can be downloaded from the CNA website: www.suva.ch > Prevention > Work > Occupational medicine > “Workplace exposure limit values” 79 RS 930.111 80 RS 814.600 81 RS 814.610 82 RS 814.81 83 RS 814.82 48 Machine Translated by Google 813.11 O on chemicals European law Swiss law directive 2012/18/EU of the European Parliament order of 27 February 1991 on major accidents and of the Council of 4 July 201284 on the control of major-accident hazards involving dangerous substances, amending and then repealing Council Directive 96/82/ EC, OJ L 197, 24.7.2012, p. 1 Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the law of 17 June 2011 on metrology85 and Member States relating to units of related ordinances in the field of weights and measurement and repealing Directive 71/354/ measures EEC, OJ L 39, 15.2.1980, p. 40 Regulation (EC) No 648/2004 of annexes 2.1 and 2.2 ORRChim the European Parliament and of the Council of 31 March 2004 on detergents, OJ L 104 of 8.4.2004, p. 1 84 RS 814.012 85 RS 941.20 49 Machine Translated by Google 813.11 Chemical products Appendix 286 (art. 2, para. 5, 3, 6, para. 2 et 4, 14, para. 1, letter b, 20, para. 1, 43, para. 1, et 84, letter a) List of governing technical requirements 1 Technical requirements for the classification, labeling and packaging of substances and preparations Annexes I to VII of the EU-CLP87 regulation apply for the classification, labeling and packaging of substances and preparations. 2 Test methods for the properties of substances and preparations Tests to determine the properties of substances and preparations must be carried out: has. according to the test methods defined in Regulation (EC) No 440/200888; or b. according to the OECD Guidelines for the Testing of Chemicals in their version of July 28, 201589, or c according to the test methods of the United Nations Manual of Tests and Criteria for Recommendations on the Transport of Dangerous Goods90. 86 Update according to ch. I of the O of the FOPH of 2 Nov. 2015, in force since 1 Dec. 2015 (AS 2015 4429). 87 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006, OJ L 353 of 31.12.2008, p. 1; last amended by Regulation (EC) 2015/1221, OJ L 197 of 25.7.2015, p. 10. 88 Commission Regulation (EC) No 440/2008 of 30 May 2008 establishing test methods in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the registration, evaluation and authorization of chemical substances and the restrictions applicable to these substances (REACH), OJ L 142, 31.5.2008, p. 1; last amended by Regulation (EU) No 900/2014, OJ L 247, 21.8.2014, p. 1. 89 The OECD guidelines for the testing of chemicals can be freely available at: www.oecd-ilibrary.org/environment/oecd guidelines-for-the-testing-of- chemicals_chem_guide_pkg-en 90 The manual, 5th revised edition, 2013, can be consulted free of charge on the UN website at the following address: www.unece.org/fileadmin/DAM/trans/danger/publi/manual/Rev5/ French/ST -SG-AC10- 11-Rev5-FR.pdf 50 Machine Translated by Google O on chemicals 813.11 3 Safety Data Sheet Requirements 3.1 The safety data sheet must meet the requirements of annex II of the EU-REACH91 regulation. 3.2 Annex 1 equivalences should be taken into account for the information to be provided according to Annex II, sections 1, 7, 8, 13 and 15 of the EU REACH Regulation. 4 Transitional provisions 4.1 Preparations, packaged and labeled before the entry into force of this Ordinance which do not meet the requirements of Regulation (EU) No 286/201192 (2nd adaptation of the EU-CLP Regulation to technical progress [ATP]), may be submitted until May 31, 2017. 4.2 Substances and preparations, packaged and labeled before the entry into force of this Ordinance, which do not meet the requirements of Regulation (EU) No 487/201393 [4th ATP] and Annex I of Regulation ( EU) No 944/201394 [5th ATP], can be submitted as follows: substances: until 30 November 2016; a. b. preparations: until 31 May 2017. 4.3 The “pitch, coal tar, high-temp. ( EC No 266-028-2)' and preparations containing it, the classification and labeling of which do not meet the requirements of Regulation (EU) No 944/2013, may be surrendered until 31 March 2016. 91 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation and authorization of chemical substances and the restrictions applicable to these substances (REACH), establishing an agency chemicals, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 and Directive 76/769/ EEC of the Council and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1; last amended by Regulation (EU) No 2015/830, OJ L 132 of 29.5.2015, p. 8. 92 Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures, version of OJ L 83, 30.3.2011, p. 1. 93 Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures, version of OJ L 149, 1.6.2013, p. 1. 94 Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures, version of OJ L 261, 3.10.2013, p. 1. 51 Machine Translated by Google 813.11 Chemical products 4.4 Substances which are listed in Regulation (EU) No 605/201495 [6th ATP] as well as preparations containing them, the classification and labeling of which do not meet the requirements of this Regulation, may be surrendered until 31 December 2015. 4.5 Liquid laundry detergents intended for private users and packaged in soluble packaging, which do not meet the requirements of Regulation (EU) No 1297/201496 can be returned until 31 December 2015. 5 Transitional provisions of the amendment of November 2, 2015 5.1 Substances and preparations whose German labeling does not meet the requirements of the EU-CLP regulation according to the corrigendum of April 10, 201597, can be surrendered until October 10, 2016. 5.2 Substances which are listed in Regulation (EU) 2015/122198 (7th ATP), as well as preparations containing them, the classification and labeling of which do not meet the requirements of this Regulation, may be surrendered until 31 December 2016. 5.3 For substances and preparations for which a safety data sheet was drawn up according to the old law before the entry into force of the amendment of 2 November 2015, a safety data sheet in accordance with Annex II of the EU-REACH regulation must be established by 1 June 2017 at the latest. 95 Commission Regulation (EU) No 605/2014 of 5 June 2014 amending, for the purpose of adding hazard statements and precautionary statements in the Croatian language and for the purpose of adapting it to scientific and technical progress, Regulation (EC ) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures, version of OJ L 167, 6.6.2014, p. 1. 96 Commission Regulation (EU) No 1297/2014 of 5 December 2014 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures, version of OJ L 350 of 6.12.2014, p. 1. 97 Corrigendum to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No ° 1907/2006. OJ L 94 of 10.4.2015, p. 9 of the German version. 98 Commission Regulation (EU) 2015/1221 of 24 July 2015 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures for the purposes of its adaptation to scientific and technical progress, version of OJ L 197, 25.7.2015, p. 10. 52 Machine Translated by Google O on chemicals 813.11 Annex 399 (art. 70, para. 1, et 84, let. b) List of substances of very high concern (“candidate list”) This list was last updated on September 1, 2015 and includes 163 substances. Substance name Additional substance In the EC CAS# Reason for listing information 1,2,3-Trichloropropane 202-486-1 96-18-4 Carcinogenic and toxic for reproduction 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl 276-158-1 71888-89-6 Toxic for reproduction esters, C7-rich 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl with ÿ 0.3% of dihexyl phthalate (EC 271-094-0, 68515-51-5; Toxic for reproduction esters; 1,2-Benzenedicarboxylic acid, mixed de cyl No. 201-559-5) 272-013-1 68648-93-1 and hexyl and octyl diesters 1,2-Benzenedicarboxylic acid, di-C7-11-branched and 271-084-6 68515-42-4 Toxic for reproduction linear alkyl esters 1,2-Benzenedicarboxylic acid, dihexyl ester, 271-093-5 68515-50-4 Toxic for reproduction branched and linear 1,2-Benzenedicarboxylic acid, dipentylester, 284-032-2 84777-06-0 Toxic for reproduction branched and linear 1,2-bis(2-methoxyethoxy)ethane (TEGDME; 203-977-3 112-49-2 Toxic for reproduction triglyme) 1,2-dichloroethane 203-458-1 107-06-2 Carcinogenic 1,2-Diethoxyethane 211-076-1 629-14-1 Toxic for reproduction 1,2-dimethoxyethane; ethylene glycol dimethyl ether 203-794-9 110-71-4 Toxic for reproduction (EGDME) 99 Updated according to the erratum of September 8, 2015 (RO 2015 3017) and ch. I of the O of the FOPH of 2 Nov. 2015, in force since 1 Dec. 2015 (AS 2015 4429). 53 Machine Translated by Google Chemical products 813.11 Substance name Additional substance In the EC CAS# Reason for listing information 1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane 2,4,6- 219-514-3 2451-62-9 Mutagenic trione (TGIC) 1,3,5-tris[(2S and 2R)-2,3- epoxypropyl]-1,3,5- 423-400-0 59653-74-6 Mutagenic triazine-2,4,6-(1H,3H,5H)-trione (ÿ-TGIC) 1-bromopropane (n-propyl bromide) 203-445-0 106-94-5 Toxic for reproduction 1-Methyl-2-pyrrolidone 212-828-1 872-50-4 Toxic for reproduction 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol 247-384-8 25973-55-1 PBT and vPvB (UV-328) 2-benzotriazol-2-yl-4,6-di-tert-butylphenol 223-346-6 3846-71-7 PBT and vPvB (UV-320) 2,2’-dichloro-4,4’-methylenedianiline 202-918-9 101-14-4 Carcinogenic 2,4-Dinitrotoluene 204-450-0 121-14-2 Carcinogenic 2-Ethoxyethanol 203-804-1 110-80-5 Toxic for reproduction 2-Ethoxyethyl acetate 2- 203-839-2 111-15-9 Toxic for reproduction ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa 3,5-dithia-4- 239-622-4 15571-58-1 Toxic for reproduction stannatetradecanoate (DOTE) 2-Methoxyaniline; o-Anisidine 201-963-1 90-04-0 Carcinogenic 2-Methoxyethanol 3- 203-713-7 109-86-4 Toxic for reproduction ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine 4-(1,1,3,3- 421-150-7 143860-04-2 Toxic for reproduction tetramethylbutyl)phenol 205-426-2 140-66-9 Equivalent level of concern having probable serious effects to the environ ment 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated covering well-defined substances and Equivalent level of concern having UVCB substances, polymers and probable serious effects to the environ ment homologues 4,4’-Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Carcinogenic 54 Machine Translated by Google O on chemicals 813.11 Substance name Additional substance information In the EC CAS# Reason for listing 4,4’-bis(dimethylamino)-4’’-(methylamino)trityl alcohol with ÿ 0.1 % of Michler’s ketone (EC No. 209-218-2 561-41-1 Carcinogenic 202-027-5) or Michler’s base (EC No. 202-959-2) 4,4’-bis(dimethylamino)benzophenone (Michler’s 202-027-5 90-94-8 Carcinogenic ketone) [4-[4,4’-bis(dimethylamino) benzhydrylide with ÿ 0.1 % of Michler’s ketone (EC No. 208-953-6 548-62-9 Carcinogenic ne]cyclohexa-2,5-dien-1-ylidene]dimethylam monium 202-027-5) or Michler’s base (EC No. chloride (C.I. Basic Violet 3) [4-[[4-anilino-1-naphthyl][4- 202-959-2) with ÿ 0.1 % of Michler’s (dimethylamino) phenyl]methylene]cyclohexa-2,5-dien-1- ketone (EC No. 202-027-5) or Michler’s 219-943-6 2580-56-5 Carcinogenic ylidene] dimethylammonium chloride (C.I. Basic Blue 26) base (EC No. 202-959-2) 4,4’-methylenedi-o-toluidine 4,4'- 212-658-8 838-88-0 Carcinogenic oxydianiline and its salts 202-977-0 101-80-4 Carcinogenic; Mutagenic 4-Aminoazobenzene 200-453-6 60-09-3 Carcinogenic 4-methyl-m-phenylenediamine (toluene-2,4- 202-453-1 95-80-7 Carcinogenic diamine) 4-Nonylphenol, branched and linear substances with a linear and/or Equivalent level of concern having probable branched alkyl chain with a carbon number serious effects to the environ ment of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substanc es which include any of the indi vidual isomers or a combination thereof 55 Machine Translated by Google Chemical products 813.11 Substance name Additional substance In the EC CAS# Reason for listing information 4-Nonylphenol, branched and linear, ethoxylated substances with a linear and/or branched alkyl chain Equivalent level of concern having with a carbon number of 9 covalently probable serious effects to the environ ment bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homo logues, which include any of the individual isomers and/or combina tions thereof] covering any of the individual stereoisomers of [1] and [2] or any combination thereof 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5- – – vPvB methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6- dimethylcyclohex-3-en-1-yl)-5-methyl-1,3- dioxane [2] 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 6-methoxy- 201-329-4 81-15-2 vPvB m-toluidine (p-cresidine) 204-419-1 120-71-8 Carcinogenic Acetic acid, lead salt, basic 257-175-3 51404-69-4 Toxic for reproduction Acids generated from chromium trioxide and their oligomers. 231-801-5, 7738-94-5, Carcinogenic Names of the acids and their oligomers: Chromic acid, 236-881-5 13530-68-2 Dichromic acid, Oligomers of chro mic acid and dichromic acid. Acrylamide 201-173-7 79-06-1 Carcinogenic and mutagenic Alkanes, C10-13, chloro (Short Chain 287-476-5 85535-84-8 PBT and vPvB Chlorinated Paraffins) 56 Machine Translated by Google O on chemicals 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number – Extracted from Carcinogenic 650-017-00-8 in Annex VI, part 3, table 3.2 Index no.: of Regulation (EC) No 1272/2008 of the 650-017-00-8 European Parlia ment and of the Council of 16 December 2008 on classification, labelling and packaging of sub stances and mixtures, and fulfil the two following conditions: a) Al2O3 and SiO2 are present within the following concentration rang es:Al2O3: 43.5–47 % w/w, and SiO2: 49.5– 53.5 % w/w, or Al2O3: 45.5–50.5 % w/w, and SiO2: 48.5–54 % w/w,b) fibres have a length weighted geometric mean diameter less two standard geomet ric errors of 6 or less micrometres (µm). Ammonium dichromate 232-143-1 7789-09-5 Carcinogenic, mutagenic and toxic for reproduction Ammonium pentadecafluorooctanoate (APFO) 223-320-4 3825-26-1 Toxic for reproduction; PBT Anthracene 204-371-1 120-12-7 PBT Anthracene oil 292-602-7 90640-80-5 Carcinogenic[1], PBT and vPvB Anthracene oil, anthracene paste 292-603-2 90640-81-6 Carcinogenic[2], mutagenic[3], PBT and vPvB Anthracene oil, anthracene paste, anthracene fraction 295-275-9 91995-15-2 Carcinogenic[2], mutagenic[3], PBT and vPvB 57 Machine Translated by Google Chemical products 813.11 Substance name Additional substance information In the EC CAS# Reason for listing Anthracene oil, anthracene paste,distn. lights 295-278-5 91995-17-4 Carcinogenic[2], mutagenic[3], PBT and vPvB Anthracene oil, anthracene-low 292-604-8 90640-82-7 Carcinogenic[2], mutagenic[3], PBT and vPvB Arsenic acid 231-901-9 7778-39-4 Carcinogenic Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Toxic for reproduction Biphenyl-4-ylamine 202-177-1 92-67-1 Carcinogenic Bis (2-ethylhexyl)phthalate (DEHP) 204-211-0 117-81-7 Toxic for reproduction Equivalent level of concern having probable serious effects to the environ ment Bis (2-methoxyethyl) ether 203-924-4 111-96-6 Toxic for reproduction Bis (2-methoxyethyl) phthalate 204-212-6 117-82-8 Toxic for reproduction Bis(pentabromophenyl) ether (decabromodiphenyl ether) 214-604-9 1163-19-5 PBT; (DecaBDE) vPvB Bis(tributyltin)oxide (TBTO) 200-268-0 56-35-9 PBT Boric acid 233-139-2/ 10043-35-3/ Toxic for reproduction 234-343-4 11113-50-1 Cadmium 231-152-8 7440-43-9 Carcinogenic; Equivalent level of concern having probable serious effects to human health Cadmium chloride 233-296-7 10108-64-2 Carcinogenic, Mutagenic, Toxic for reproduction and Equivalent level of concern having probable serious effects to human health 58 Machine Translated by Google O on chemicals 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Cadmium fluoride 232-222-0 7790-79-6 Carcinogenic, Mutagenic, Toxic for reproduction and Equivalent level of concern having probable serious effects to human health Cadmium oxide 215-146-2 1306-19-0 Carcinogenic; Equivalent level of concern having probable serious effects to human health Cadmium sulphate 233-331-6 10124-36-4; Carcinogenic, 31119-53-6 Mutagenic, Toxic for reproduction and Equivalent level of concern having probable serious effects to human health Cadmium sulphide 215-147-8 1306-23-6 Carcinogenic; Equivalent level of concern having probable serious effects to human health Calcium arsenate 231-904-5 7778-44-1 Carcinogenic Chromium trioxide 215-607-8 1333-82-0 Carcinogenic and mutagenic Cobalt dichloride 231-589-4 7646-79-9 Carcinogenic and toxic for reproduction Cobalt(II) carbonate 208-169-4 513-79-1 Carcinogenic and toxic for reproduction Cobalt(II) diacetate 200-755-8 71-48-7 Carcinogenic and toxic for reproduction Cobalt(II) dinitrate 233-402-1 10141-05-6 Carcinogenic and toxic for reproduction Cobalt(II) sulphate 233-334-2 10124-43-3 Carcinogenic and toxic for reproduction 59 Machine Translated by Google Chemical products 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Cyclohexane-1,2-dicarboxylic anhydride [1], cis- The individual cis- [2] and trans- [3] 201-604-9; 85-42-7; Equivalent level of concern having isomer substances and all possible 236-086-3; 13149-00-3; probable serious effects to human health cyclohexane-1,2-dicarboxylic anhydride [2], trans- combinations of the cis and trans- cyclohexane-1,2-dicarboxylic anhydride [3] 238-009-9 14166-21-3 isomers [1] are covered by this entry Diarsenic pentaoxide 215-116-9 1303-28-2 Carcinogenic Diarsenic trioxide 215-481-4 1327-53-3 Carcinogenic Diazene-1,2-dicarboxamide (C,C’- 204-650-8 123-77-3 Equivalent level of concern having azodi(formamide)) probable serious effects to human health Diboron trioxide 215-125-8 1303-86-2 Toxic for reproduction Dibutyl phthalate (DBP) 201-557-4 84-74-2 Toxic for reproduction Dibutyltin dichloride (DBTC) 211-670-0 683-18-1 Toxic for reproduction Dichromium tris(chromate) 246-356-2 24613-89-6 Carcinogenic Diethyl sulphate 200-589-6 64-67-5 Carcinogenic; Mutagenic Dihexyl phthalate 201-559-5 84-75-3 Toxic for reproduction Diisobutyl phthalate 201-553-2 84-69-5 Toxic for reproduction Diisopentyl phthalate 210-088-4 605-50-5 Toxic for reproduction Dimethyl sulphate 201-058-1 77-78-1 Carcinogenic Dinoseb (6-sec-butyl-2,4-dinitrophenol) 201-861-7 88-85-7 Toxic for reproduction Dioxobis (stearate) trilead 235-702-8 12578-12-0 Toxic for reproduction Dipentyl phthalate (DPP) 205-017-9 131-18-0 Toxic for reproduction Disodium 3,3’-[[1,1’-biphenyl]-4,4’- 209-358-4 573-58-0 Carcinogenic diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28) 60 Machine Translated by Google O on chemicals 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Disodium 4-amino-3-[[4’-[(2,4- 217-710-3 1937-37-7 Carcinogenic diaminophenyl)azo][1,1’-biphenyl]-4-yl]azo] -5- hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38) Disodium tetraborate, anhydrous 215-540-4 1303-96-4/ Toxic for reproduction 1330-43-4/ 12179-04-3 Fatty acids, C16-18, lead salts 292-966-7 91031-62-8 Toxic for reproduction Formaldehyde, oligomeric reaction products with 500-036-1 25214-70-4 Carcinogenic aniline Formamide 200-842-0 75-12-7 Toxic for reproduction Open 203-727-3 110-00-9 Carcinogenic Henicosafluoroundecanoic acid 218-165-4 2058-94-8 vPvB Heptacosafluorotetradecanoic acid 206-803-4 376-06-7 vPvB Hexabromocyclododecane (HBCDD) and all Alpha-hexabromocyclododecane 247-148-4 and 25637-99-4/ PBT major diastereoisomers identified: 221-695-9 3194-55-6/ Beta-hexabromocyclododecane Gamma-hexabromocyclododecane (134237-50-6)/ (134237-51-7)/ (134237-52-8) Hexahydromethylphthalic anhydride [1], The individual isomers [2], [3] and 247-094-1, [4] 25550-51-0, Equivalent level of concern having Hexahydro-4-methylphthalic anhydride [2], (including their cis- and trans stereo isomeric forms) 243-072-0, 9438-60-9, probable serious effects to human health and all possible combinations of the isomers [1] are Hexahydro-1-methylphthalic anhydride [3], covered by this entry 256-356-4, 48122-14-1, Hexahydro-3-methylphthalic anhydride [4] 260-566-1 7110-29-9 Hydrazine 206-114-9 302-01-2/ Carcinogenic 7803-57-8 61 Machine Translated by Google Chemical products 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Imidazolidine-2-thione (2-imidazoline-2-thiol) 202-506-9 96-45-7 Toxic for reproduction Lead bis(tetrafluoroborate) 237-486-0 13814-96-5 Toxic for reproduction Lead chromate 231-846-0 7758-97-6 Carcinogenic and toxic for reproduction Lead chromate molybdate sulphate red (C.I. 235-759-9 12656-85-8 Carcinogenic and toxic for reproduction Pigment Red 104) Lead cyanamidate 244-073-9 20837-86-9 Toxic for reproduction Lead di(acetate) 206-104-4 301-04-2 Toxic for reproduction Lead diazide, Lead azide 236-542-1 13424-46-9 Toxic for reproduction Lead dinitrate 233-245-9 10099-74-8 Toxic for reproduction Lead dipicrate 229-335-2 6477-64-1 Toxic for reproduction Lead hydrogen arsenate 232-064-2 7784-40-9 Carcinogenic and toxic for reproduction Lead monoxide (lead oxide) 215-267-0 1317-36-8 Toxic for reproduction Lead oxide sulfate 234-853-7 12036-76-9 Toxic for reproduction Lead styphnate 239-290-0 15245-44-0 Toxic for reproduction Lead sulfochromate yellow (C.I. Pigment Yellow 215-693-7 1344-37-2 Carcinogenic and toxic for reproduction 34) Lead titanium trioxide 235-038-9 12060-00-3 Toxic for reproduction Lead titanium zirconium oxide 235-727-4 12626-81-2 Toxic for reproduction Lead(II) bis(methanesulfonate) 401-750-5 17570-76-2 Toxic for reproduction Methoxyacetic acid 210-894-6 625-45-6 Toxic for reproduction Methyloxirane (Propylene oxide) 200-879-2 75-56-9 Carcinogenic; Mutagenic N,N,N’,N’-tetramethyl-4,4’-methylenedianiline 202-959-2 101-61-1 Carcinogenic (Michler's base) N,N-dimethylacetamide 204-826-4 127-19-5 Toxic for reproduction N,N-dimethylformamide 200-679-5 68-12-2 Toxic for reproduction 62 Machine Translated by Google O on chemicals 813.11 Substance name Additional substance information In the EC CAS# Reason for listing N-methylacetamide 201-182-6 79-16-3 Toxic for reproduction N-pentyl-isopentylphthalate o- – 776297-69-9 Toxic for reproduction aminoazotoluene 202-591-2 97-56-3 Carcinogenic Orange lead (lead tetroxide) o- 215-235-6 1314-41-6 Toxic for reproduction Toluidine 202-429-0 95-53-4 Carcinogenic Pentacosafluorotridecanoic acid 276-745-2 72629-94-8 vPvB Pentadecafluorooctanoic acid (PFOA) 206-397-9 335-67-1 Toxic for reproduction; PBT Pentalead tetraoxide sulphate 235-067-7 12065-90-6 Toxic for reproduction Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Carcinogenic Phenolphthalein [Phthalato(2-)]dioxotrilead 201-004-7 77-09-8 Carcinogenic Pitch, coal tar, high temp. 273-688-5 69011-06-9 Toxic for reproduction 266-028-2 65996-93-2 Carcinogenic, PBT and vPvB Potassium chromate 232-140-5 7789-00-6 Carcinogenic and mutagenic Potassium dichromate 231-906-6 7778-50-9 Carcinogenic, mutagenic and toxic for reproduction Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 Carcinogenic Pyrochlore, antimony lead yellow reaction 232-382-1 8012-00-8 Toxic for reproduction - - mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl 7-oxo-8-oxa-3,5- Toxic for reproduction dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2- [(2-ethylhexyl)oxy]-2- oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate (reaction mass of DOTE and MOTE) 63 Machine Translated by Google Chemical products 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Silicic acid (H2Si2O5), barium salt (1:1), lead-doped with lead (Pb) content above the applicable 272-271-5 68784-75-8 Toxic for reproduction generic concentration limit for ’toxicity for reproduction’ Repr. 1A (CLP) or category 1 (DSD); the substance is a member of the group entry of lead com pounds, with index number 082- 001-00-6 in Regulation (EC) No 1272/2008 Silicic acid, lead salt 234-363-3 11120-22-2 Toxic for reproduction Sodium chromate 231-889-5 7775-11-3 Carcinogenic, mutagenic and toxic for reproduction Sodium dichromate 234-190-3 7789-12-0/ Carcinogenic, mutagenic and toxic for 10588-01-9 reproduction Sodium perborate; perboric acid, sodium; salt 239-172-9; Toxic for reproduction – 234-390-0 Sodium peroxometaborate 231-556-4 7632-04-4 Toxic for reproduction Strontium chromate 232-142-6 7789-06-2 Carcinogenic Sulfurous acid, lead salt, dibasic 263-467-1 62229-08-7 Toxic for reproduction Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-1 Toxic for reproduction Tetraethyllead 201-075-4 78-00-2 Toxic for reproduction Tetralead trioxide sulphate 235-380-9 12202-17-4 Toxic for reproduction Trichloroethylene 201-167-4 79-01-6 Carcinogenic Trichosafluorododecanoic acid 206-203-2 307-55-1 vPvB Triethyl arsenate 427-700-2 15606-95-8 Carcinogenic Trilead bis(carbonate)dihydroxide 215-290-6 1319-46-6 Toxic for reproduction Trilead diarsenate 222-979-5 3687-31-8 Carcinogenic and toxic for reproduction 64 Machine Translated by Google O on chemicals 813.11 Substance name Additional substance In the EC CAS# Reason for listing information Trilead dioxide phosphonate 235-252-2 12141-20-7 Toxic for reproduction Tris(2-chloroethyl)phosphate 204-118-5 115-96-8 Toxic for reproduction Trixylyl phosphate 246-677-8 25155-23-1 Toxic for reproduction Zirconia Aluminosilicate Refractory are fibres covered by index – Extracted from Carcinogenic Ceramic Fibres number 650-017-00-8 in Annex Index no. VI, part 3, table 3.2 of Regulation 650-017-00-8 (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the two follow ing conditions: a) Al2O3, SiO2 and ZrO2 are present within the follow ing concentration ranges: Al2O3: 35–36 % w/ w, and SiO2: 47.5–50 % w/w, and ZrO2: 15–17 % w/w, b) fibres have a length weighted geometric mean diameter less two standard geomet ric errors of 6 or less micrometres (µm). with ÿ 0.1 % of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2) ÿ,ÿ-Bis[4-(dimethylamino)phenyl]-4- 229-851-8 6786-83-0 Carcinogenic (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [*] The EC number includes both anhydrous and hydrated forms of a substance and consequently the entries cover both these forms. The CAS number included may be for the anhydrous form only, and therefore the CAS number shown does not always describe the entry accurately. [1] The substance does not meet the criteria for identification as a carcinogen in situations where it contains less than 0.005 % (w/w) benzo[a]pyrene (EINECS No 200-028-5) 65 Machine Translated by Google Chemical products 813.11 Substance name Additional substance In the EC CAS# Reason for listing information [2] The substance does not meet the criteria for identification as a carcinogen in situations where it contains less than 0.005 % (w/w) benzo[a]pyrene (EINECS No 200-028-5) and less than 0,1 % w/w benzene (EINECS No 200-753-7).] 66 Machine Translated by Google O on chemicals 813.11 Annex 4 (art. 2, para. 5, 25, 26, para. 2, 27, para. 2, letter b, 47, para. 1, and 84, letter c) Technical file 1 General 1.1 Technical dossier information may be submitted in a form accepted by the European Chemicals Agency. In this case, some expressions may be different from those mentioned in this appendix. 1.2 The information required in ch. 7 to 10 depend on the determining quantity of substance according to Art. 25. 2 General information on the notifier 1.1 The identity of the notifier must be indicated, in particular: has. his name, address, telephone number and e-mail address; b. the contact person; vs. where applicable, the geographical location of the notifier's production sites; 1.2 In addition, if the notifier is an exclusive representative, it is necessary to provide: a. the name and address of the foreign manufacturer; b. the geographical location of the production sites; vs. a power of attorney from the foreign manufacturer certifying that he has appointed the notifier as exclusive representative; d. the names and addresses of the importers represented; e. the annual quantities that each importer intends to import. 3 Substance identification The following information on the substance must be provided: a. the data in accordance with Annex VI, Section 2, of the EU Regulation REACH100; b. for nanomaterials: data relating to the composition and, where applicable, to the surface coating and to the surface functionalization. 100 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH), establishing a Euro Agency chemicals, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 and Directive 76/769/EEC of Council and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1; last amended by Regulation (EU) 2015/326, OJ L 58 of 3.3.2015, p. 43. 67 Machine Translated by Google 813.11 Chemical products 4 Information on manufacture and use The following information should be provided: a. the total quantity which the notifier intends to place on the market during the calendar year of notification; b. the amount used for its own uses; vs. the form or physical state in which the substance is supplied; d. a brief description of the identified use(s); e. data on the quantities of waste and the composition of the waste resulting from the manufacture of the substance, the use in objects and the identified uses; f. uses advised against (section 1.2 of the safety data sheet). 5 Classification and labeling It is necessary to indicate: has. the classification of the substance in accordance with art. 6 para. 1, for all hazard classes and categories of the EU-CLP101 regulation; if no classification is given for a hazard class or a differentiation of a hazard class, the reasons should be given; b. the labeling of the substance according to the provisions of art. 10; vs. any specific concentration limits resulting from the application of Art. 10 of the EU-CLP Regulation. 6 Tips for safe use The following information must be indicated, which must be consistent with that appearing on the safety data sheet, in the event that the latter is required according to art. 19: has. first aid (section 4 of the safety data sheet); b. fire-fighting measures (Section 5 of the safety data sheet); vs. measures to be taken in the event of accidental release (ch. 6 of the data sheet for security); d. handling and storage (section 7 of the safety data sheet); e. transport information (ch. 14 of the safety data sheet rite); f. exposure control and personal protection (ch. 8 of the donation form safety locks); 101 See note on annex 2, ch. 1. 68 Machine Translated by Google 813.11 O on chemicals g. stability and reactivity (chap. 10 of the safety data sheet); h. disposal considerations. Information on recycling and methods of disposal for professional and private users (chap. 13 of the safety data sheet). 7 Exposure information (1 to 10 tons per year) For substances whose determining quantity according to Art. 25 is between 1 and 10 tonnes per year, the following exposure information should be provided: has. main categories of use: 1. professional use, 2. commercial use, 3. private use; b. specifications for professional and commercial use: 1. use in a closed system, 2. use resulting from inclusion in or on a matrix, 3. non-dispersive use, 4 dispersive use; vs. Significant routes of exposure: 1. human exposure: oral, dermal and inhalation, 2. environmental exposure: water, air, solid waste and soil, 3. exposure pattern: accidental/infrequent, occasional or continuous / frequent. 8 Information on physico-chemical properties The following information should be provided: a. for the determining quantities according to Art. 25 equal to or greater than 1 tonne per year: 1. robust test summaries relating to the information mentioned in Annex VII, section 7, of the EU-REACH Regulation, 2. for nanomaterials: the shape of the particles and their size average, as well as, where this information is available, the particle size distribution, the specific surface area by volume and the state of aggregation; b. for the determining quantities according to Art. 25 equal to or greater than 100 tonnes per year: in addition to the information required by let. a, robust test summaries relating to the information mentioned in Annex IX, section 7, of the EU-REACH Regulation. 69 Machine Translated by Google 813.11 Chemical products 9 Toxicological information Robust test summaries of the following information should be provided: has. for quantities equal to or exceeding 1 tonne per year: the information mentioned in Annex VII, section 8, of the EU-REACH Regulation; b. for quantities equal to or exceeding 10 tonnes per year: in addition to the information required in let. a, the information referred to in Annex VIII, Section 8 of the EU-REACH Regulation; vs. for quantities equal to or exceeding 100 tonnes per year: in addition to the information required in let. a and b, the information mentioned in Annex IX, section 8, of the EU- REACH Regulation; d. for quantities equal to or exceeding 1000 tonnes per year: in addition to the information required in let. a to c, the information mentioned in Annex X, section 8, of the EU- REACH regulation. 10 Ecotoxicological information Robust test summaries of the following information should be provided: has. for quantities equal to or exceeding 1 tonne per year: the information mentioned in Annex VII, section 9, of the EU-REACH Regulation; b. for quantities equal to or exceeding 10 tonnes per year: in addition to the information required in let. a, the information referred to in Annex VIII, Section 9, of the EU-REACH Regulation; vs. for quantities equal to or exceeding 100 tonnes per year: in addition to the information required in let. a and b, the information mentioned in Annex IX, section 9, of the EU- REACH Regulation; d for quantities equal to or exceeding 1000 tonnes per year: in addition to the information required in let. a to c, the information mentioned in Annex X, section 9, of the EU- REACH regulation. 11 Possibility to waive certain tests It is possible to waive certain tests mentioned in ch. 8 to 10 when, in application of the criteria established in Annex XI of the EU-REACH Regulation: has. the tests do not appear to be necessary from a scientific point of view stay; b. testing is technically impossible; vs. the exposure assessment makes it possible to dispense with certain tests. 70 Machine Translated by Google O on chemicals 813.11 Schedule 5 (s.61) Substances and preparations of groups 1 and 2 1 Substances and preparations labeled according to the regulation UE-CLP102 1.1 Group 1 a. H300103: Fatal if swallowed, or H310: Fatal in contact with skin, or H330: Fatal if inhaled, or in relationship with combination of the above hazard statements. b. vs. Substances and preparations according to Annex 1.10 ORRChim104 labeled with: H340: May cause genetic defects, or H350: May cause cancer (if inhaled), or H360: May damage fertility or the unborn child in relationship with 1.2 Group 2 a. H301: Toxic if swallowed, or H311: Toxic in contact with skin, or H331: Toxic if inhaled, or combination of the in relationship with hazard statements above. b. H370: Causes damage to organs, or H372: Causes damage to organs through prolonged or repeated exposure. in relationship with 102 See note on Art. 2 para. 4. 103 The H-phrase number does not need to appear on the label. 104 RS 814.81 71 Machine Translated by Google 813.11 Chemical products c. H314: Causes severe skin burns and eye damage. in relationship with d. Container over 1 kg labeled with: H410: Very toxic to aquatic organisms with long lasting effects. in relationship with and. H250: Catches fire spontaneously if exposed to air, or H260: In contact with water releases flammable gases which may ignite spontaneously, or in relationship with H261: In contact with water releases flammable gases. f. H230: May explode even in the absence of air, or H231: May explode even in the absence of air at elevated pressure and/or temperature or EUH019: May form explosive peroxides, or EUH029: Contact with water liberates toxic gas, or EUH031: Contact with acids liberates toxic gas, or EUH032: Contact with acids liberates very toxic gas. 2 Substances and preparations that are not yet labeled according to EU-CLP 2.1 Group 1 a. R28105: Very toxic if swallowed, or R27: Very toxic in contact with skin, or R26: Very toxic by inhalation, or in relationship with combination of the R phrases above. b. 105 The R-phrase number does not need to appear on the label. 72 Machine Translated by Google O on chemicals 813.11 vs. Substances and preparations according to Annex 1.10 ORRChim labeled with: R46: May cause heritable genetic damage, or R45: May cause cancer, or in relationship with R49: May cause cancer by inhalation, or R60: May impair fertility, or R61: Risk during pregnancy of harmful effects for the child. 2.2 Group 2 a. R25: Toxic if swallowed, or R24: Toxic in contact with skin, or R23: Toxic by inhalation, or in relationship with combination of the R phrases above. b. R39: Danger of very serious irreversible effects, or R48: Danger of serious damage to health by prolonged exposure. in relationship with c. R35: Causes severe burns, or R34: Causes burns. in relationship with d. Container over one kilo labeled with: R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. in relationship with and. R17: Spontaneously flammable in air, or R15: Contact with water liberates extremely flammable gases. in relationship with f. R6: Danger of explosion with or without contact with air, or R19: May form explosive peroxides, or R29: Contact with water liberates toxic gas, or R31: Contact with acids liberates toxic gas, or R32: Contact with acids liberates very toxic gas. 73 Machine Translated by Google 813.11 Chemical products Schedule 6 (s.92) Modification of other acts …106 106 mods. can be consulted in RO 2015 1903. 74