Machine Translated by Google CONSOLIDATED LEGISLATION Royal Decree 840/2015, of September 21, which approves control measures for the risks inherent in serious accidents involving dangerous substances. Ministry of the Presidency «BOE» no. 251, of October 20, 2015 Reference: BOE-A-2015-11268 CONSOLIDATED TEXT Last modified: no modifications Royal Decree 1254/1999, of July 16, approving control measures for the risks inherent in serious accidents involving dangerous substances, and its amendments, incorporated Directive 96/82/ CE of the Council, of December 9, 1996, relative to the control of the risks inherent to serious accidents involving dangerous substances, as well as Directive 2003/105/CE of the Parliament and of the Council, of December 16, 2003 , which modifies Directive 96/82/ CE, of December 9, 1996. Royal Decree 1196/2003, of September 19, which approves the Basic Civil Protection Directive for control and planning in the face of the risk of serious accidents involving dangerous substances, developed the main novelties introduced by the Royal Decree 1254/1999, of July 16, also adapting to the provisions of Royal Decree 407/1992, of April 24, which approves the Basic Civil Protection Standard, which constitutes the fundamental framework for the preparation and integration of the different civil protection plans and which contemplates the chemical risk as an object of special planning. In accordance with all this, the State Civil Protection Plan against chemical risk was developed, approved by Royal Decree 1070/2012, of July 13, which aims to establish the organization and action procedures of those resources and services. of the State and, where appropriate, of other public and private entities, that are necessary to ensure an effective response from all Public Administrations, in the face of different emergency situations due to accidents with dangerous substances, in which the national interest is present , as well as the support mechanisms for the plans of autonomous communities in the cases that require it. At the European level and through Regulation (EC) No. 1272/2008 of the European Parliament and of the Council, of December 16, 2008, on the classification, labeling and packaging of substances and mixtures, the European Union adopted the Global Harmonized System of the United Nations on the classification and labeling of substances and mixtures, which introduced new hazard classes and categories that do not fully correspond to those used in Council Directive 96/82/CE of December 9, 1996 . In order to adapt to the new classification system, the European Commission considered necessary a fundamental review of this Directive that would also take into account a harmonization with other Directives, improve its understanding and contribute to a more consistent application of it. Page 1 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION Thus, Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012, was approved on the control of the risks inherent in serious accidents involving dangerous substances and by which it is modified and subsequently repeals Directive 96/82/EC. By means of Order PRE/1206/2014, of July 9, by which Annex I of Royal Decree 1254/1999, of July 16, is modified, compliance with the provisions of this last Directive only regarding the introduction of 'heavy fuel oils' as petroleum products. Through this royal decree, the remaining provisions of Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012, are transposed into our internal legal system. This provision is issued in development of Law 2/1985, of January 21, on civil protection, which, in its articles 5, 6 and 12, establishes the cataloging of activities that can cause emergencies and the inventory of centers, establishments and dependencies in which these are carried out, as well as the obligation of their owners to have a self-protection organization and an internal emergency plan for risk prevention and immediate control of accidents that may occur. Likewise, it contemplates the power of the competent bodies and authorities to request information on certain issues and the capacity of the Public Administrations to develop an external emergency plan that, together with the aforementioned internal emergency plan, constitute a single and integrated action plan. . On the other hand, Law 21/1992, of July 16, on Industry, contemplates in chapter I, "Industrial safety", of its title III, the provisions of Law 2/1985, of January 21, and typifies in its title V, «Infringements and sanctions», non-compliance with the security measures provided for in this law and in the implementing regulations. With respect to the previous regulation, this royal decree presents important changes, such as the alignment of the categories of substances in its annex I with those corresponding to the new European system of classification of substances and mixtures. Likewise, a correction mechanism is included in this annex to provide for subsequent adaptations to the classification system that could have an impact on substances for which it is demonstrated that they do not present a risk of serious accident. The provisions related to public access to information on the application of the royal decree are reinforced, with the effective participation of the interested public in decision-making and with the public's rights to appeal to the courts. All this in accordance with Law 27/2006, of July 18, which regulates the rights of access to information, public participation and access to justice in environmental matters. With this royal decree, the mechanisms for the collection of information, the exchange of information between the competent authorities and the European Commission and its dissemination and availability to the public are strengthened. In accordance with the provisions of Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012, regarding the procedures for consulting industrialists and public participation in the framework of territorial planning policies and other pertinent ones, this Royal Decree provides for the coordination of said procedures with those existing in other regulations. Due to the fact that its scope of application does not coincide, and due to the confluence of these at the state and sector level, the aforementioned coordination is contemplated in a general way, entrusting the General State Administration to promote the necessary actions to coordinate the procedures and controls in question. It should be remembered that industrial operators may in any case make use of the protection mechanisms for economic operators in chapter VII of Law 20/2013, of December 9, on the guarantee of market unity, when they understand that a breach has been made. any principle or provision of the aforementioned law, among them, the principle of simplification of charges, as a result of duplicate procedures or lack of coordination in the administrative actions in application of this Royal Decree and other regulations. With regard to the inspections of the establishments affected by this royal decree, stricter criteria are introduced, in order to ensure compliance with the Page 2 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION safety standards, as well as an effective implementation of the control measures considered. Likewise, this royal decree contemplates the general structure of the Civil Protection Planning against special risks, integrated by the State Plan, the autonomous community plans and, within the latter, the Municipal Action Plans, which constitute the integrated national model to make possible a joint coordination and action of the different services of the administrations in the face of serious accidents with dangerous substances. Taking into account the special distribution of powers between public administrations with regard to explosives, pyrotechnic material and ammunition, this royal decree is limited to regulating, for establishments in which said products are handled or stored, aspects related to external planning of emergencies and information to the affected public, the ordering of the territory, the prompt notification of accidents and the consultation and public participation in works projects in the vicinity of the establishments; The other aspects contemplated in Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012, are regulated in specific regulations. This royal decree was favorably reported by the Plenary of the National Civil Protection Commission at its meeting on October 20, 2014, as well as by the Permanent Interministerial Commission on Weapons and Explosives at its meeting on April 15, 2015. It has been submitted to the public information procedure provided for in article 24.1 c) of Law 50/1997, of November 27, of the Government. By virtue of this, at the proposal of the Ministers of the Interior, Development, Employment and Social Security, Industry, Energy and Tourism, Agriculture, Food and Environment, and Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administration, in accordance with the Council of State and after deliberation by the Council of Ministers at its meeting on September 18, 2015, I HAVE: Article 1. Object. The purpose of this royal decree is to prevent serious accidents involving dangerous substances, as well as to limit their consequences on human health, property and the environment. Article 2. Scope of application. 1. The provisions of this royal decree shall apply to establishments as defined in article 3. 2. These provisions shall not apply to: a) The establishments, facilities or storage areas belonging to the Armed Forces and the Security Forces and Bodies; b) The dangers created by ionizing radiation originating from substances; c) The transport of dangerous goods by road, rail, inland waterway and sea or air and intermediate temporary storage directly related to it; as well as loading and unloading activities and the transfer to and from other types of transport destined for docks, piers or railway logistics facilities or railway terminals outside the establishments contemplated in this royal decree; d) The transport of dangerous substances through pipelines, including pumping stations, that are outside the establishments referred to in this royal decree; e) The exploitation of minerals in mines, quarries and through drilling; specifically to the activities of exploration, extraction and treatment of the same; f) The offshore exploration and exploitation of minerals, including hydrocarbons; g) The storage of gas in offshore underground sites, both in those specifically dedicated to storage, and in those that also carry out mineral exploration and extraction activities, including hydrocarbons; Page 3 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION h) Waste dumps, including their underground storage. 3. Notwithstanding the provisions of the previous section, letters e) and h), they will be included within the scope of application of this royal decree: a) Operational mining waste disposal facilities, including dams and sterile rafts, which contain dangerous substances; b) The underground terrestrial storage of gas in natural strata, aquifers, salt cavities and disused mines, as well as thermal and chemical treatment activities and storage linked to these operations involving hazardous substances; c) Temporary storage of metallic mercury considered waste referred to in article 3 of Regulation (EC) 1102/2008 of the European Parliament and of the Council, of October 22, 2008, regarding the prohibition of the export of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury. 4. The establishments in which explosives, pyrotechnic material or ammunition are processed, handled or stored, regulated respectively by the Explosives Regulation, approved by Royal Decree 230/1998, of February 16, and by the Regulation of pyrotechnic articles and ammunition. , approved by Royal Decree 563/2010, of May 7, will be governed by its specific regulations, except in relation to: a) External emergency planning, which will be governed by the provisions of the article 13. b) Land use planning, to which the provisions of Article article 14. c) Information to the affected public, which will be governed by the provisions of article 15.2.a). d) Consultation and public participation in projects for the execution of works in the vicinity of establishments referred to in article 16.1.c) to which the provisions of article 16 will apply. e) Prompt notification of accidents, which will be subject to the provisions of article 17.1. For these purposes, the Government Delegations in the autonomous communities where such establishments are located and the corresponding competent bodies of the autonomous communities, will provide each other with all the necessary information to guarantee the proper fulfillment of the functions and powers attributed to them. Article 3. Definitions. For the purposes of this royal decree, it will be understood as: 1. Serious accident: any event, such as an emission in the form of a leak or spill, a major fire or explosion, resulting from an uncontrolled process during the operation of any establishment to which this royal decree applies, which involves a serious risk, immediate or deferred, to human health, property, or the environment, inside or outside the establishment and involving one or more dangerous substances. 2. Storage: the presence of a certain amount of dangerous substances for storage, escrow or reserve purposes. 3. Domino effect: the concatenation of effects that multiplies the consequences of an accident, due to the fact that the dangerous phenomena can affect, in addition to the external vulnerable elements, other containers, pipes or equipment of the same establishment or of other nearby establishments, of in such a way that a new leak, fire, explosion or burst occurs in them, which in turn generates new dangerous phenomena. 4. Establishment: the entire site under the control of an industrialist in which hazardous substances are found in one or more installations, including those Page 4 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION common or related infrastructures or activities; the establishments will be lower level or higher level. 5. Lower-tier establishment: an establishment in which hazardous substances are present in quantities equal to or greater than those specified in column 2 of Part 1 or Part 2 of Annex I, but less than the quantities specified in column 3 of part 1 or part 2 of annex I. All this using, when applicable, the rule of the sum of note 4 of annex I. 6. Upper level establishment: an establishment in which hazardous substances are present in amounts equal to or greater than those specified in column 3 of part 1 or part 2 of annex I. All this using, when applicable, the rule of the sum of note 4 of annex I. 7. Existing establishment: an establishment that until the date of entry into force of this royal decree is included in the scope of application of Royal Decree 1254/1999, of July 16, and that from said date of entry into force remains included in the scope of application of this royal decree without changing its classification as a lower-level establishment or a higher-level establishment. 8. New establishment: a) An establishment that comes into operation or is built from the date of entry into force of this royal decree, or b) an operational location that becomes included in the scope of application of this royal decree, or a lower-level establishment that becomes a higher-level establishment or vice versa, from the date of entry into force of this royal decree, due to modifications in its facilities or activities that give rise to a change in its inventory of dangerous substances. 9. Neighboring establishment: an establishment whose proximity to another establishment increases the risk or consequences of a serious accident. 10. Other establishment: an operational location that is included in the scope of application of this royal decree, or a lower level establishment that becomes a higher level establishment or vice versa, from the date of entry into force of this royal decree, due to reasons other than those mentioned in section 8.b). 11. Industrialist: any natural or legal person who operates or controls an establishment or facility or to whom, when the regulations so provide, the decisive economic or decision-making power over the technical exploitation of the establishment or facility has been delegated. 12. Inspection: any action, including on-site visits, controls of internal measures, monitoring systems, reports and documents and any necessary subsequent verification, carried out by the competent bodies in each case, or on their behalf, in order to review and promote compliance of establishments with the requirements of this royal decree. 13. Installation: a technical unit inside an establishment, regardless of whether it is located at ground level or underground, in which dangerous substances are produced, used, handled or stored; including all the equipment, structures, pipes, machinery, tools, private railway branches, docks, loading or unloading docks for its use, breakwaters, tanks or similar structures, whether afloat or not, necessary for the operation of that facility . 14. Mixture: A mixture or solution made up of two or more substances. 15. Danger: the intrinsic capacity of a dangerous substance or the potentiality of a physical situation to cause damage to human health, property or the environment. 16. Presence of Hazardous Substances: The current or anticipated presence of hazardous substances in the facility, or hazardous substances that may reasonably be expected to be generated as a result of loss of process control, including storage activities, at any facility where inside an establishment, in quantities equal to or greater than the threshold quantities indicated in parts 1 or 2 of Annex I. Page 5 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 17. Public: one or more natural or legal persons and, in accordance with legal provisions or common practices, associations, organizations or groups constituted by such persons. 18. Affected public: for the purposes of article 15.2, the staff of an establishment and the surrounding population who, according to the risk and consequence analysis studies, could suffer the effects of a possible serious accident on their health. 19. Interested public: the public that is or may be affected by the decisions adopted on any of the matters provided for in article 16.1, or that has an interest to invoke in making those decisions; For the purposes of this definition, non-governmental organizations that work for the protection of human health or the environment and that meet the relevant requirements of national legislation will be considered to have an interest. 20. Risk: The probability that a specific effect will occur in a given period of time or under given circumstances. 21. Dangerous substance: any substance or mixture included in part 1 or listed in part 2 of annex I, including those in the form of raw material, product, by-product, residue or intermediate product. Article 4. Major accident hazard assessment for a given hazardous substance. 1. Where appropriate or, in any case, on the basis of a notification by a Member State under paragraph 2, the European Commission shall assess whether it is impossible in practice for a particular hazardous substance included in Part 1 or listed in the part 2 of annex I results in a release of matter or energy that could cause a serious accident under normal or abnormal circumstances that can be reasonably foreseen. This evaluation will take into account the information referred to in section 3 and will be based on one or more of the following characteristics: a) The physical form of the hazardous substance under normal process conditions, tampering or an unforeseen loss of insulation. b) The inherent properties of the hazardous substance, particularly those related to dispersion behavior in a severe accident scenario, such as molecular mass and saturated vapor pressure. c) The maximum concentration of substances in the case of mixtures. For the purposes of the first subparagraph, the isolation and generic packaging of the dangerous substance or mixture should also be taken into account, in particular when covered by specific legislative provisions of the European Union. 2. When the competent body of an autonomous community or another represented in the National Civil Protection Commission considers that a dangerous substance does not present a serious accident hazard in accordance with section 1, it shall notify the Plenary of said Commission together with the corresponding justification, including the information referred to in section 3. 3. For the purposes of paragraphs 1 and 2, the information necessary to evaluate the properties of danger to health, physical or to the environment, of the dangerous substance in question, will include: a) An exhaustive list of properties needed to assess the potential of the dangerous substance to cause physical damage, health or the environment. b) Physical and chemical properties (such as molecular mass, saturated vapor pressure, inherent toxicity, boiling point, reactivity, viscosity, solubility, and other relevant properties). c) Properties (such as reactivity, flammability, toxicity, and other factors such as mode of attack on the body, injury-to-fatal ratio, and long-term effects, as well as other relevant properties) that may cause health hazards. health or physical hazards. d) Properties (such as ecotoxicity, persistence, bioaccumulation, potential for long-range environmental transport and other relevant properties) that may generate hazards to the environment. Page 6 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION e) When available, the classification by the European Union of the substance or mixture. f) Information on the specific process conditions of the substance (for example, temperature, pressure and other relevant conditions) under which the substance or mixture is stored, used and/ or may be present in the event of foreseeable abnormal operations or from an accident such as a fire. 4. After the favorable report of the National Civil Protection Commission, the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior will provide the European Commission with the corresponding documentation, who, as a result of the evaluation referred to in section 1 , will present, if appropriate, a legislative proposal to the European Parliament and the Council to exclude the hazardous substance in question from the scope of Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012. Article 5. General obligations of the industrialist. The industrialists to whose establishments this Royal Decree applies are obliged to: a) Adopt the measures provided for in this royal decree and as many as are necessary to prevent serious accidents and limit their consequences for human health, property and the environment. b) Collaborate with the competent bodies of the autonomous communities and demonstrate, at all times and, especially on the occasion of the controls and inspections referred to in article 21, that they have taken all the necessary measures provided for in this royal decree. Article 6. Competent authorities. 1. The following are considered competent authorities for the purposes of this royal decree: a) The Ministry of the Interior, through the General Directorate of Civil Protection and Emergencies, for: 1st Maintain a permanent relationship with the European Commission for the purposes provided for in Directive 2012/18/EU of the European Parliament and of the Council of July 4, 2012, and in particular for: Report, as soon as possible and according to the procedure specified in article 22, serious accidents that have occurred in Spanish territory and that meet the criteria of annex IV. Exchange information on the experience gained in preventing serious accidents and limiting their consequences and, specifically, on the measures provided for in this royal decree. Provide the Commission with a report every four years on the implementation of Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012, in the Spanish State. Provide the Commission with the information referred to in article 4. 2.º Maintain a permanent relationship with the corresponding Government Delegations, and with the competent bodies of the autonomous communities for the purposes provided for in this royal decree, and in particular for: Receive and review the data contained in article 22 and annex III on the affected establishments, through the National Chemical Risk Database referred to in the State Civil Protection Plan against chemical risk, approved by Royal Decree 1070 /2012, of July 13. Collect reports or questionnaires related to technical aspects and the implementation of this provision. Prepare periodic reports on the lessons learned from serious accidents occurred in Spain, according to the information contained in article 17. Page 7 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 3rd Inform, through the National Civil Protection Commission, about the initiatives, actions and exchange of experiences, generated by the technical groups constituted by the European Commission, as well as their results and their dissemination. 4th Make available to other Member States of the European Union, which could be affected by the potential cross-border effects of a serious accident produced in an establishment located in Spanish territory, sufficient information so that the affected Member State can adopt the necessary measures. timely prevention and protection. Likewise, transfer to the competent authorities of the autonomous communities the information received from other Member States in relation to serious accidents produced in establishments of the aforementioned nature, located outside Spanish territory, which could potentially affect their geographical scope. All this, in accordance with the Convention on the Transboundary Effects of Industrial Accidents, of the United Nations Economic Commission for Europe (UNECE). 5th Make available to the Member States affected, the decision that an establishment close to its territory cannot present any danger of serious accident outside its perimeter and does not require an external emergency plan in accordance with article 13.4, as well as transfer to the competent bodies of the autonomous communities the decision by other Member States close to their territory not to draw up the external emergency plan. 6th Inform and transfer to the National Civil Protection Commission, the proposal for approval of external emergency plans that have been prepared and approved by the competent bodies of the autonomous communities, as well as their successive reviews. 7th Participate in the execution of the State Civil Protection Plan against chemical risk, approved by Royal Decree 1070/2012, of July 13, in emergency situations in which the national interest is present, as well as in the capacity of support for external emergency plans of autonomous communities in cases that require it. 8th Manage and maintain in collaboration with the competent bodies of the autonomous communities, the National Chemical Risk Database. b) The competent bodies of the autonomous communities, to: 1st Receive, evaluate and use the information referred to in articles 7 to 13 and, where appropriate, the information referred to in article 17, as well as collect as much data as it deems appropriate in the exercise of its powers. . 2nd Prepare, approve and submit to the National Civil Protection Commission, for its corresponding approval, the external emergency plans of higher level establishments, as provided for in article 13. 3.º Order the application of external emergency plans and direct them, in accordance with the Basic Civil Protection Directive for control and planning in the event of the risk of serious accidents involving dangerous substances, approved by Royal Decree 1196/ 2003, of September 19. 4.º Inform the corresponding Government Delegation or Sub-delegation and the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior through the National Emergency Room as soon as there is news of a serious accident. 5th Prepare and submit to the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior the reports that the European Commission requests on the application of this royal decree. 6th Apply the control requirements of land use referred to in the Article 14, through the territorial planning instruments developed in this regard. 7.º Ensure compliance with the obligations established in this royal decree, through the exercise of the corresponding powers of inspection and sanction, in accordance with the legal system. 8. Submit to public consultation and articulate the participation of the interested public, in accordance with article 16, in the projects, plans and programs in which establishments are involved. page 8 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 9. Keep updated, in collaboration with the General Directorate of Civil Protection of the Ministry of the Interior, the National Database on Chemical Risk. c) The Government Delegates in the autonomous communities or, where appropriate, the Sub-delegates of the Government, in accordance with the provisions of Law 6/1997, of April 14, of Organization and Operation of the General State Administration and other applicable regulations, for: 1st Collaborate with the competent bodies of the autonomous communities in the preparation of external emergency plans. 2nd Provide the necessary information to the competent body in matters of civil protection of the autonomous community for the preparation of the corresponding external emergency plans of the establishments affected by the Regulation of explosives or by the Regulation of pyrotechnic articles and ammunition. 3rd Receive the information provided for in article 22 and annex III through the Database national chemical hazard data. 4th Collect as many data, studies, reports as are considered necessary in order to exercise the competences, functions and faculties recognized by their regulatory provisions. 5th Assume the functions that in case of emergency are attributed to them in the State Plan civil protection against chemical risk. d) Municipalities or other local entities, where appropriate, to: 1st Collaborate with the competent bodies of the autonomous community, in the preparation of external emergency plans that affect their municipal area, providing the necessary information, which will include data related to population censuses, cartography municipal, identification of evacuation routes, organization of municipal civil protection and other equivalents. 2.º Prepare and update the municipal or local Action Plan, following the guidelines of the external emergency plans; participate in the execution of the latter, directing and coordinating the measures and actions contemplated in the former, such as warnings to the population, activation of the necessary protection measures and carrying out civil protection exercises and drills. 3. Approve the municipal or local Action Plan and send it to the Autonomous Commission of Civil Protection for approval. 4th Immediately inform the competent body of the autonomous community about serious accidents that originate in their municipal area, as well as any incident that could lead to their unleashing, regardless of the alert systems that are determined in the outdoor emergency plan 5th Apply in its urban planning instruments, the control requirements of land use referred to in article 14. 2. The competent authorities and the rest of the Public Administrations, in compliance with the provisions of this royal decree, will act in accordance with the principles of coordination and collaboration and will ensure that the information of interest obtained by virtue of this royal decree is available. disposal of the competent authorities in each case, in matters of civil protection, prevention of risks to human health, prevention of occupational risks, safety and industrial quality, protection of the environment, land use planning and urban planning and ports. In this regard, the National Civil Protection Commission, in accordance with Royal Decree 967/2002, of September 20, which regulates its composition and operating regime, constitutes the body for coordination and cooperation between the bodies of the General State Administration and the Administrations of the autonomous communities for the implementation of this royal decree. Likewise, in the territorial scope of the autonomous communities, the autonomous civil protection commissions, represented by the peripheral State Administration, the autonomous community bodies and local corporations, will be the coordination nucleus for the application of this royal decree. 3. The competent authorities referred to in section 1 of this article will accept the equivalent information that, in compliance with articles 7 to 13, they present. Page 9 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION industrialists in accordance with other relevant national legislation. In such cases, the competent authorities will ensure that all the requirements of this royal decree are met. Article 7. Notification. 1. Industrialists, to whose establishments this Royal Decree is applicable, are obliged to send a notification to the competent body of the autonomous community where they reside, containing at least the following information: a) Name or business name of the industrialist, or both, and full address of the corresponding establishment; b) Registered office of the industrialist and full address. c) Name and position of the person in charge of the establishment, if it is a different person from the industrialist referred to in letter a). d) Sufficient information to identify the dangerous substances and the category of substances in question or that may be present. In any case: 1st Name of the substance, CAS number and UN number. 2nd Identification of hazards and classification according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council, of December 16, 2008, on classification, labeling and packaging of substances and mixtures. 3rd Composition and information on the components if it were a mixture. 4th Category to which it belongs in annex 1 part 1, of this royal decree. e) Quantity and physical form of the hazardous substance or substances in question. f) Activity carried out or activity planned in the facility or storage area. g) Immediate surroundings of the establishment and factors capable of causing a serious accident or aggravating its consequences, including, when available, details of neighboring establishments, locations that are outside the scope of application of this royal decree, areas and works that may cause or increase the risk or consequences of a serious accident and domino effect. When the establishments are located in the port public domain, this information will also be provided to the port authorities and competent maritime captaincies. 2. The notification referred to in section 1, or its update, must be sent by the industrialist: a) In the case of new establishments, within a reasonable time before starting construction or operation, or before modifications that give rise to a change in the inventory of hazardous substances. All this within the period determined by the competent body of the autonomous community, which in no case may exceed one year from the request for a building permit. b) In all other cases, within one year from the date on which this royal decree is applied to the establishment in question. 3. Sections 1 and 2 will not apply if the industrialist has already sent a notification to the competent authority in compliance with the requirements of Royal Decree 1254/1999, of July 16, before the date of entry into force of this Royal decree, and the information contained therein complies with the provisions of paragraph 1 and has not changed. 4. The industrialist will inform the competent body of the autonomous community in advance, in the following circumstances and will proceed, where appropriate, to update the notification: a) Significant increase or decrease in the amount or significant change in the characteristics or physical form of the hazardous substance present, indicated in the notification sent by the industrialist under section 1, or significant change in the processes where it is used, or b) Modification of an establishment or facility that may have consequences significant in terms of major accident hazards, or c) Definitive closure or dismantling of the establishment, or Page 10 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION d) Changes in the information referred to in section 1, letters a), b) or c). Article 8. Serious accident prevention policy. 1. The industrialists of all the establishments to which this royal decree is applicable must correctly define and implement their serious accident prevention policy as well as translate it into a written document. The implementation of this policy will aim to ensure a high degree of protection of human health, the environment and property and will be proportional to the major accident hazards of the establishment. It will include the general objectives and principles of action of the industrialist, the distribution of management tasks and responsibilities as well as the commitment to permanently improve the control of the risks of serious accidents and to guarantee a high level of protection. 2. The document that defines the serious accident prevention policy will be kept at the disposal of the competent bodies of the autonomous communities, with a view in particular to the application of article 5 b) and article 21, from the following dates: a) In the case of new establishments, from a reasonable date before construction or operation begins, or before modifications that give rise to a change in the inventory of hazardous substances. All this, within the specific period determined by the competent body of the autonomous community. b) In all other cases, one year from the date on which this royal decree applies to the establishment in question. Said document will be kept at the disposal of the port authorities and competent maritime authorities when the establishments are located in the port public domain. 3. For higher level establishments, the document that defines their serious accident prevention policy will form part of the safety report referred to in article 10. 4. Section 1 will not apply if the industrialist has established and implemented, before the date of entry into force of this Royal Decree, its policy for the prevention of serious accidents in accordance with Royal Decree 1254/1999, of July 16 , provided that it complies with the provisions of section 1 and has not changed. 5. Without prejudice to the provisions of article 11, the industrialist shall periodically review his serious accident prevention policy, at least every five years, and shall update it when necessary. The document that defines said updated prevention policy will be kept at the disposal of the competent bodies of the autonomous community. 6. The major accident prevention policy will be applied through a safety management system through appropriate means, structures and procedures in accordance with annex II and, in any case, in a manner proportionate to the major accident hazards and the complexity of the organization or activities of the establishment. Article 9. Domino effect. 1. The competent bodies of the autonomous communities, using the information provided by the industrialist under articles 7 and 10 or through a request for additional information or through inspections in accordance with article 21, will determine the higher level establishments and or groups of establishments in which the probability and consequences of a serious accident may be increased due to the geographical position and the proximity between said establishments, as well as the presence of dangerous substances in them. 2. When the competent bodies of the autonomous communities have additional information to that provided by the industrialist in accordance with article 7.1 g), they shall make said information available to the same, if it is necessary for the application of this article. 3. The competent bodies of the autonomous communities will establish communication protocols that ensure that the establishments thus determined: a) The data necessary to enable industrialists to take into consideration the nature and magnitude of the general accident risk are adequately exchanged. Page 11 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION serious in its policies for the prevention of serious accidents, safety management systems, safety reports and internal or self-protection emergency plans; b) Cooperate in providing information to the population and neighboring sites not included in the scope of application of this royal decree, as well as in providing information to the competent authority for the preparation of external emergency plans. 4. Accidents that may occur due to a domino effect between facilities of the same establishment must be considered in the safety reports referred to in article 10. Article 10. Security report. 1. The industrialists of the higher level establishments are obliged to elaborate a safety report, which aims to: a) Demonstrate that a serious accident prevention policy applied through a safety management system has been established in accordance with the elements that appear in Annex II. b) Demonstrate that the risks of accidents have been identified and evaluated, with special rigor in cases in which they can generate serious consequences, and that the necessary measures have been taken to prevent them and to limit their consequences on human health, the environment and assets. c) Demonstrate that the design, construction, operation and maintenance of all facilities, storage areas, equipment and infrastructure linked to their operation, which are related to the risk of a serious accident in the establishment, present sufficient safety and reliability . d) Demonstrate that internal emergency or self-protection plans have been drawn up and provide the necessary data to enable the drawing up of the external emergency plan in order to take the necessary measures in the event of a serious accident. e) Provide sufficient information to the competent authorities so that they can make decisions regarding the implementation of new establishments, or authorization of other types of projects in the vicinity of existing establishments. 2. The safety report will contain, at a minimum, the information contained in the Basic Civil Protection Guideline for control and planning against the risk of serious accidents involving dangerous substances, approved by Royal Decree 1196/2003, of 19 of September. The security report will expressly indicate the names of the relevant organizations that have participated in its preparation. In accordance with the provisions of article 6.3, the safety report and any other studies or reports of a similar nature that industrialists must carry out, by virtue of the applicable sectoral legislation, may be merged into a single document for the purposes of this article, when said merger makes it possible to avoid unnecessary duplication of information and the repetition of the work carried out by the industrialist or the competent authority, provided that all the requirements of this article and those required by the applicable sectoral legislation are met. In this regard, in the case of possible consequences for the environment, the environmental risk analyzes prepared in compliance with Law 26/2007, of October 23, on Environmental Responsibility may be used. 3. The industrialist will submit the safety report to the competent body of the autonomous community, respecting the following deadlines: a) In the case of new establishments, before starting their construction or operation or before the modifications that give rise to a change in the inventory of dangerous substances, all within the specific period determined by the competent body of the autonomous community. b) In the case of existing higher level establishments, before the term of a year from the date of entry into force of this royal decree. Page 12 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION c) In the case of other establishments, within two years from the date on which this royal decree is applied to the establishment in question. 4. Sections 1, 2 and 3 will not apply to the industrialist when he has already sent the safety report to the competent body of the autonomous community before the date of entry into force of this royal decree, in compliance with the requirements of the Royal Decree 1254/1999, of July 16, and the information contained therein complies with the provisions of sections 1 and 2 and has not changed. In order to comply with sections 1 and 2, the industrialist will present all the modified parts of the safety report in the manner prescribed by the competent body within the periods mentioned in section 3. 5. Every security report must be evaluated. For the evaluation of the safety reports, the competent body of the autonomous community may require, if it deems appropriate, the collaboration of the control bodies authorized in accordance with the provisions of the Regulation of the infrastructure for quality and industrial safety. , approved by Royal Decree 2200/1995, of December 28. 6. Once the safety report has been evaluated, the competent body of the autonomous community will decide within a maximum period of six months from its delivery, on the safety conditions of the establishment in terms of serious accidents, in any of the following ways: a) It will communicate to the industrialist its conclusions on the examination of the safety report, where appropriate, upon request for additional information and/or pertinent modifications. b) Prohibit the commissioning or continuation of the activity of the establishment of in question, in accordance with the powers and procedures set forth in article 20. 7. Without prejudice to the provisions of article 11, the industrialist must periodically review the safety report and update it, where appropriate, as follows: a) At least every five years. b) As a result of a serious accident in your establishment, when necessary. c) At any time, at the initiative of the industrialist or at the request of the competent authority, when justified by new data or in order to take into account new technical knowledge on safety. The updated safety report, or its updated parts, will be sent without delay to the competent body of the autonomous community. For the purposes of the provisions of article 22, the competent body of the autonomous community shall report such updates to the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior through the National Chemical Risk Database. 8. In the case of establishments located in the port public domain, the industrialist will also send a copy of the safety report and its subsequent updates to the port authority and competent maritime captaincies. Likewise, the competent body of the autonomous community will inform the port authority and maritime captaincy on the conclusions of the security report referred to in section 6. 9. The competent body of the autonomous community may require the industrialists of lower- level establishments to prepare and submit to said body certain aspects of the safety report that may be necessary for compliance with the provisions of articles 8 and 9. Article 11. Modification of a facility, establishment or storage area. 1. In the event of modification of an establishment, installation, storage area, process, or of the characteristics, physical form or quantities of dangerous substances, which may have significant consequences with regard to the risks of serious accident, or which may lead to a lower level establishment becoming a higher level establishment or vice versa, the industrial: a) Review and, if necessary, update the notification referred to in article 7, its serious accident prevention policy and the safety management system, the safety report, as well as the internal emergency plan or Page 13 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION self-protection, contemplated in articles 8, 10 and 12, within the terms provided in these precepts. b) It will inform the competent body of the autonomous community about said updates before proceeding with that modification. When the establishments are located in the port public domain, this information will also be provided to the port authorities. 2. In order to comply with the provisions of article 22, the competent body of the autonomous community will inform the General Directorate for Civil Protection and Emergencies of the Ministry of the Interior through the National Chemical Risk Database of said updates. 3. For the purposes of what is indicated in section 1, modifications will be considered that may have important consequences on the risks of serious accident, the following: a) The change in the level of affectation of the establishment, passing from a lower level to a higher level, or vice versa. b) The change of the physical state of any dangerous substance, or of the processes in which it intervenes, in such a way that the release of matter or energy that originates a risk of serious accident can be foreseen under certain conditions. c) The incorporation of new dangerous substances in amounts equal to or greater than the thresholds in column 2 of part 1 or part 2 of annex I. All this using, when applicable, the rule of the sum of note 4 of annex I. d) The increase in the quantities of dangerous substances present in amounts lower than the thresholds in column 3 of part 1 or part 2 of annex I, when said increase is equal to or greater than the thresholds in column 2 of the part 1 or part 2 of annex I. All using, when applicable, the addition rule of note 4 of annex I; e) The increase in the quantities of dangerous substances present in quantities equal to or greater than the thresholds in column 3 of part 1 or part 2 of annex I, when said increase is 30% or more of the quantity present and , at the same time, leads to an increase of more than double the thresholds in column 2 of Part 1 or Part 2 of Annex I. f) The sum of successive modifications not considered important when, in as a whole, meet any of the above conditions. The list of quantitative and qualitative criteria indicated in this section is non-limiting. In any case, the competent body of the autonomous community may set more restrictive criteria. Article 12. Internal or self-protection emergency plans. 1. In all establishments subject to the provisions of this royal decree, the industrialist must prepare an internal emergency or self-protection plan, in which the organization and set of means and procedures of action are defined, in order to prevent accidents. of any kind and, where appropriate, limit the effects inside the establishment. Its content will comply with that specified in the Basic Civil Protection Guideline for control and planning in the face of the risk of serious accidents involving dangerous substances, approved by Royal Decree 1196/2003, of September 19, and the regulations in force in terms of self-protection. They will be drawn up after consultation with the staff of the establishment and the workers of subcontracted companies or long-term subcontractors; complying, in any case, with the provisions of article 18, regarding the information, consultation and participation of workers, of Law 31/1995, of November 8, on the Prevention of Occupational Risks. 2. The competent bodies of the autonomous communities will establish the appropriate regulations so that industrialists keep the internal emergency or self-protection plans updated, by modifying them in accordance with the changes that have occurred in the establishments and, in any case, for periods not exceeding three years. The revision will take into account the changes that have occurred in Page 14 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION the corresponding establishments, as well as new technical knowledge and knowledge about the measures to be taken in the event of a serious accident. 3. Within the framework of the obligations derived from the coordination of business activities referred to in article 24 of Law 31/1995, of November 8, developed by Royal Decree 171/2004, of January 30, in Regarding the coordination of business activities, the business owner of the establishment must inform the content of the internal emergency or self-protection plan to those subcontracted and self-employed companies that carry out their activity in said establishment, and all of them must comply with the duty of cooperation and with the other obligations established in the aforementioned royal decree. 4. The internal or self-protection emergency plan will be sent to the competent body of the autonomous community, as well as to the competent port authorities and maritime captaincies when the establishments are located in the port public domain: a) For new establishments, before their operation begins or before the modifications that give rise to a change in the inventory of dangerous substances; all this within the period established by the autonomous community. b) For existing establishments, no later than one year from the date of entry into force of this Royal Decree, unless the plan prepared in compliance with the requirements of Royal Decree 1254/1999, of July 16, before that date and the information contained therein, already comply with the provisions of this article and have not changed. c) For other establishments, within two years from the date on which this royal decree applies to the establishment in question. 5. The industrialists of higher level establishments will provide, in the terms and deadlines indicated in section 4, the necessary information so that the competent authority in matters of civil protection of the corresponding autonomous community develops external emergency plans. Article 13. External emergency plans. 1. For higher level establishments, including those regulated by the Regulation on Explosives, and by the Regulation on pyrotechnic articles and ammunition, the competent bodies in matters of civil protection of the autonomous communities will prepare, with the collaboration of the industrialists. , an external emergency plan to prevent and, where appropriate, mitigate the consequences of possible serious accidents previously analyzed, classified and evaluated, in which the most suitable protection measures, the necessary human and material resources and the scheme are established. coordination of the authorities, bodies and services called upon to intervene. Its content and homologation procedure will comply with what is specified in the Basic Civil Protection Directive for the control and planning in the face of the risk of serious accidents involving dangerous substances, approved by Royal Decree 1196/2003, of September 19. The term for its elaboration and approval will be two years from the receipt of the safety report and the information referred to in article 12.5. 2. To elaborate or substantially modify the external emergency plans, the competent bodies of the autonomous communities will establish consultation mechanisms so that the interested public has the possibility of giving its opinion from an early stage. 3. The competent bodies of the autonomous communities will organize a system that guarantees the periodic review, updating, testing and, where appropriate, modification of all external emergency plans at appropriate intervals that should not exceed three years. It will take into account both the changes that have occurred in the corresponding establishments and in the organization of the emergency services called to intervene, as well as new technical knowledge and knowledge about the measures to be taken in the event of a serious accident. Page 15 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION This system will guarantee that all the Administrations, organizations and services involved have timely updates, tests and reviews carried out in the external emergency plans. Likewise, the competent authority of the autonomous community will request a new homologation from the National Civil Protection Commission, if it deems it appropriate, based on periodic reviews, extensions, substitutions or other modifications that vary the conditions in which the homologation was carried out. initial. 4. The competent authority of the autonomous community may decide, in view of the information contained in the safety report, that the provisions of section 1 relating to the obligation to establish an external emergency plan do not apply; as long as it is shown that the impact of the accidents foreseen in the safety report does not have consequences abroad. This justified decision must be communicated to the National Civil Protection Commission for the purposes provided for in article 6. 5. In relation to those establishments that are located in the port public domain, the port authorities and competent maritime captaincies will collaborate with the competent bodies of the autonomous communities in the preparation of the external emergency plan. Article 14. Land use planning. 1. The competent bodies of the autonomous communities will ensure that the objectives of preventing serious accidents and limiting their consequences for human health, property and the environment are taken into account in their territorial and urban planning instruments and in other pertinent They shall seek to achieve these objectives by controlling: a) The location of new establishments. b) The modifications of the establishments contemplated in article 11. c) New works, such as communication routes, places for public use and housing areas, carried out in the vicinity of the establishments, when the location or the works carried out may cause or increase the risk or consequences of a serious accident. 2. The instruments of land allocation or use and other pertinent ones, as well as the procedures for their application, will take into account the need, in the long term: a) To maintain adequate distances between, on the one hand, the establishments contemplated in this royal decree, and, on the other, housing areas, areas frequented by the public, recreational areas and, to the extent possible, the great transportation routes. For establishments also affected by the Explosives Regulation or by the Pyrotechnic Articles and Ammunition Regulation, these distances may in no case be less than the minimum distances to be observed for the location of factories, workshops and warehouses established in Complementary Technical Instruction No. 10 of the Explosives Regulations, approved by Order PRE/ 252/2006, of 6 February, and in the Complementary Technical Instruction n.o 10 of the Regulation on pyrotechnic articles and cartridges. b) To protect areas of particular natural interest or of a particularly sensitive nature in the vicinity of establishments, maintaining, where appropriate, the appropriate safety distances or other pertinent measures. c) In the case of existing establishments, to take additional technical measures, in accordance with article 5, so as not to increase the risks to human health and the environment. 3. The bodies empowered to make decisions in this area will establish adequate consultation procedures to facilitate the application of the policies adopted in accordance with section 1. The procedures will be such that, at the time of making decisions of an urban nature, sufficient information provided by the industrialists on the risks linked to the establishment and a technical opinion in this regard, based on the study of specific cases or on general criteria. page 16 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION In order to avoid duplication, the public information and consultation phase will be joint for all those procedures established in the regulations that, being applicable to the approval or authorization of the plan, program or project, require this phase. 4. The industrialists of the lower-level establishments, at the request of the competent bodies of the autonomous community, will provide the information on the risks linked to the establishment that is necessary for the purposes of land occupation planning. Article 15. Information to the public. 1. The competent authority in each case, will make available to the public permanently and also in electronic format, the information mentioned in Annex III. The information will be updated when necessary, also due to the modifications contemplated in article 11. 2. In the case of higher level establishments, the competent authority in collaboration with the industrialists of the establishments, will also ensure that: a) The affected public, including those who are in all buildings and areas for public use, such as schools and hospitals, and in all those located in the vicinity, for the purposes provided in article 9, periodically receive, by means of most appropriate and without their having to request it, clear and understandable information on the safety measures and the behavior to be adopted in the event of a serious accident. This information will include at least the data referred to in annex III, being provided at least every five years and being updated when necessary, also on the occasion of the modifications contemplated in article 11. b) The security report is available to the public when requested, without prejudice to the provisions of article 23.3. For this purpose, a modified report will be made available to the public, for example in the form of a non-technical summary, which will include general information on the dangers of a major accident and its potential effects on human health, property and the environment in the event of a major accident. of serious accident; c) The inventory of dangerous substances is available to the public when requested, without prejudice to the provisions of article 23.3. 3. For the purposes of the provisions of article 22, the competent body of the autonomous community will incorporate the information corresponding to section 2 to the National Chemical Risk Database. Article 16. Public consultation and participation in decision-making. 1. The specific projects relating to: a) The planning of new establishments, in accordance with article 14. b) The significant modifications of the establishments referred to in article 11, when they are subject to the requirements of article 14. c) The execution of works in the vicinity of establishments, when the location or the works carried out may increase the risk or the consequences of a serious accident, in accordance with article 14. 2. In relation to the specific projects indicated in section 1, the competent authority in each case will inform the public, by means of an announcement published in the corresponding official gazette for at least 15 business days, without prejudice to its possible publication on a web page. officer during the same period, of the following matters: a) The purpose of the specific project. b) When applicable, the circumstance that a project is subject to an evaluation of the environmental impact, or to consultations between Member States. c) Data on the competent bodies responsible for making the decision, from which pertinent information can be obtained and to which observations or questions can be made, as well as the deadlines for doing so. d) The nature of the possible decisions or, where appropriate, of the decision project. Page 17 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION e) An indication of the dates and places where the pertinent information will be provided, as well as the means used to do so. 3. The competent authority in each case, will likewise make the following elements available to the interested public regarding the specific projects referred to in section 1: a) The main reports and opinions sent to the competent authority in the when the public was informed in accordance with paragraph 2. b) Any information other than that referred to in section 2, which is relevant to the decision in question and which can only be obtained after the public has been informed in accordance with the aforementioned section. The interested public consulted must make a statement within a maximum period of 30 calendar days from receipt of the request to participate. Once this period has elapsed without the decision having been received, the procedure will continue. 4. When the pertinent decisions are made, the competent authority will inform and make available to the public, through public notices or other appropriate means such as electronic ones when they are available, and within a period of three months from the receipt of the notification and the documents that must accompany it: a) The content of the decision and the reasons that justify it, including, where appropriate, subsequent updates. b) The results of the consultations held before making the decision and a explanation of how they were taken into account to arrive at it. 5. So that the interested public has the possibility from an early stage to give its opinion on plans or programs related to the matters mentioned in section 1, letters a) or c): a) The competent authority in each case will consult the interested public, putting provision of the draft plan or program. b) The interested public consulted must make a statement within a maximum period of forty-five business days from receipt of the draft. Once this period has elapsed without the decision having been received, the procedure will continue. c) The competent authority in each case will make the corresponding decision within the term four months from the start of the consultation process. This section will not apply to plans and programs for which a participation procedure is carried out in accordance with Law 21/2013, of December 9, on environmental assessment. Article 17. Information that the industrialist must provide in the event of a serious accident. 1. As soon as an incident or accident capable of causing a serious accident occurs according to the definition given in article 3 and using the most appropriate means, the industrialists of the establishments included in the scope of application of this real decree will be obliged to immediately inform the competent body of the autonomous community in matters of civil protection. The industrialists of the establishments regulated by the Regulation of explosives and by the Regulation of pyrotechnic articles and cartridges, will also do so to the Delegation or Sub-delegation of the corresponding Government. When the establishments are located in the port public domain, this information will also be provided to the port authorities. The information to be transmitted will be the following: a) The circumstances that have concurred for the accident to occur; b) The dangerous substances and quantities initially involved in the accident, or that they may be due to its unfavorable evolution; c) The data available to evaluate the direct and indirect effects in the short, medium and long term, on human health, property and the environment; d) The internal emergency measures adopted; Page 18 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION e) The planned internal emergency measures; f) The external support measures necessary to control the accident and care for those affected; g) Other information regarding the same that may be requested by the competent authority. For this, the direct communication procedures with the center must be adapted. of emergencies that the competent authority has for these purposes. 2. After the event, the industrialist must, within a reasonable period of time established by the competent body of the autonomous community: a) Send to the competent bodies of the autonomous community, detailed, the causes and effects produced as a result of the accident. b) Inform the competent bodies of the autonomous community of the measures planned to: 1st Mitigate the effects of the accident in the medium and long term. 2.º Prevent similar accidents from occurring, based on the experiences acquired. c) Update the information provided, in the event that more rigorous investigations reveal new facts that modify said information or the conclusions derived from it. Article 18. Measures to be adopted by the competent authority, after a serious accident. After the emergency situation due to a serious accident, the competent bodies of the autonomous community must: a) Make sure that measures are adopted in the medium and long term, which are necessary. b) Collect, through inspection, investigation or other appropriate means, the information necessary for a complete analysis of the accident in the technical, organizational and management aspects. c) Provide what is necessary for the industrialist to take the necessary palliative measures. d) Formulate recommendations on future prevention measures. Article 19. Information that the competent body of the autonomous community will provide in the event of a serious accident. 1. In order to ensure coordination in cases of serious accidents between the authorities called upon to intervene, as well as to comply with the information requirements of the European Commission, the competent bodies of the autonomous communities will inform at the moment in which news of a serious accident, to the corresponding Government Delegation and, where appropriate, to the Government Sub-delegation of the province where the establishment is located, as well as to the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior through of the National Emergency Room. 2. The competent bodies of the autonomous communities will send the information on serious accidents to the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior as soon as possible, and no later than two months after the date of the accident. that occur in its territory. For those who meet the criteria of annex IV of this royal decree, this information will contain, at a minimum, the following data: a) Name and address of the authority responsible for preparing the report. b) Date, time and place of the accident, full name of the industrialist and address of the establishment in question. c) A brief description of the circumstances of the accident, indicating the hazardous substances involved and the immediate effects on human health and the environment. d) A brief description of the emergency measures adopted and the immediate precautions necessary to avoid a repetition of the accident. Page 19 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION e) The results of their investigations into the accident and recommendations. This information may be delayed in order to enable the conclusion of legal proceedings, in the event that such communication may affect such proceedings. In order to comply with what is indicated in this section, the corresponding standardized formats will be agreed within the National Civil Protection Commission, following the criteria recommended by the European Commission. 3. For the purposes of the provisions of article 22, the competent body of the autonomous community will incorporate the information referred to in section 2 to the National Chemical Risk Database. 4. Likewise, the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior will provide standardized information to the European Commission, in accordance with the provisions of article 6. Article 20. Prohibition of exploitation. 1. The competent bodies of the autonomous communities must prohibit the operation or entry into service of any establishment, facility, storage area, or any part of them when the measures adopted by the owner for the prevention and reduction of serious accidents are justifiably considered manifestly insufficient. In particular, they will take into account serious cases in which the necessary measures mentioned in the inspection report. 2. The competent bodies of the autonomous communities may prohibit the operation or entry into service of any establishment, installation or storage area, or any part thereof, if the industrialist has not submitted the notification, reports or other information. required by this royal decree within the established term. 3. The competent body of the autonomous community will inform the National Civil Protection Commission of the decisions taken in its territory in accordance with the provisions of sections 1 and 2. 4. Faced with the prohibitions of sections 1 and 2, the affected industrialist may file an appeal, in accordance with the provisions of Law 30/1992, of November 26, on the Legal Regime of Public Administrations and Common Administrative Procedure. Article 21. Inspections. 1. The competent bodies of the autonomous communities shall establish a system of inspections and appropriate control measures for each type of establishment included in the scope of application of this royal decree. 2. These inspections will be appropriate for the type of establishment in question, will not depend on the receipt of the safety report or any other report submitted, and will enable a planned and systematic examination of the technical, organizational and management teams. applied in the establishment, so that the industrialist can demonstrate, in particular: a) That it has taken the appropriate measures to prevent serious accidents, given account of the activities of the establishment. b) That it has taken the appropriate measures to limit the consequences of accidents serious inside and outside the establishment. c) That the data and information provided in the security report, or other reports presented, faithfully reflect the security status of the establishment. d) That it has established programs and informed the staff of the establishment about the protective measures and action in the event of an accident. 3. The competent body of the autonomous community will ensure that all establishments are covered by a regional or local inspection plan and will ensure that this plan is reviewed and, where appropriate, updated periodically. Inspection plans will include the following: a) A general assessment of the relevant security aspects. Page 20 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION b) The geographical area covered by the inspection plan. c) The list of establishments covered by the plan. d) The list of groups of establishments with a possible domino effect according to article 9. e) A list of the establishments in which sources of danger or external risks particular conditions may increase the probability or the consequences of a serious accident. f) The procedures for routine inspections, including the programs for those inspections in accordance with section 4. g) The non-routine inspection procedures indicated in section 5. h) Provisions on cooperation between the different authorities responsible for inspections. To carry out the inspections, the competent body of the autonomous community may require, if it deems it appropriate, the collaboration of control bodies authorized by the competent Administration, in accordance with the provisions of the Regulation of the infrastructure for quality and safety. industrial Security. 4. Based on the inspection plans mentioned in section 3, the competent authority in each case will periodically prepare routine inspection programs for all establishments, including the frequency of on-site visits for the different types of establishments. The period between two consecutive on-site visits shall not exceed one year for higher-tier establishments and three for lower-tier establishments, unless the competent authority has developed an inspection program based on a systematic assessment of the hazards of serious accident of the establishments in question. This systematic hazard assessment will be based on at least the following criteria: a) The possible repercussion of the establishments on human health, goods and the environment. b) The history of compliance with the requirements of this royal decree. Where appropriate, the relevant findings of inspections carried out in accordance with other regulations will also be taken into account. 5. Non-routine inspections will be carried out to investigate, as soon as possible, serious complaints, serious accidents and near misses, incidents and cases of non-compliance. 6. Within a period of four months following each inspection, the competent authority of the autonomous community shall notify the industrialist of the conclusions of the inspection and all the actions deemed necessary. The competent authority will ensure that the industrialist carries out all these necessary actions within a reasonable period of time after receiving the communication. This period will be determined by the competent body of the autonomous community. If an important case of non-compliance with this real has been detected during an inspection decree, another inspection will be carried out within six months. When the inspection reports reveal data of relevant interest for other areas of administrative action, in terms of risks to human health, occupational health and safety, industrial safety and quality, land use planning and urban planning, the environment or port security, the competent bodies of the autonomous communities will send a copy of such reports to the respective competent authorities in such matters, so that they can adopt the pertinent measures. The competent bodies in matters of inspection shall inform the corresponding regional civil protection commissions, by means of an annual report prepared for this purpose, the results and circumstances that have occurred in the inspections carried out. Where possible and appropriate, inspections will be coordinated with those carried out under other regulations. Page 21 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 7. For the purposes of the provisions of article 22, the competent body of the autonomous community will incorporate the information referred to in sections 3 and 6 to the National Chemical Risk Database. 8. The General Directorate of Civil Protection and Emergencies of the Ministry of the Interior will establish mechanisms and instruments to exchange experiences and consolidate knowledge, among the competent authorities of the autonomous communities and for them to participate in these mechanisms within the scope of the European Union, when appropriate. 9. The competent bodies of the autonomous communities will ensure that the industrialists provide the competent authorities with all the assistance that is necessary so that they can carry out the inspections and gather the necessary information for the performance of their obligations for the purposes of this Act. decree, in particular so that the authorities can fully assess the possibility of a major accident and determine the possibilities of increasing the probability or severity of major accidents, prepare an external emergency plan and take into account substances that, due to their form physical condition, its particular conditions or its location, may require additional consideration. Article 22. Exchanges and information system. 1. The General Directorate of Civil Protection and Emergencies of the Ministry of the Interior and the competent bodies of the autonomous communities will exchange information on the experience gained in the matter of preventing serious accidents and limiting their consequences. Said information will fundamentally deal with the operation of the measures foreseen by this Royal Decree and will be shared through the National Chemical Risk Database. 2. The General Directorate of Civil Protection and Emergencies of the Ministry of the Interior will manage and keep said Database operational and available to the competent bodies, with detailed information on the establishments contemplated in this royal decree, as well as with the information on accidents defined in article 19, paragraph 2. The General Directorate of Civil Protection and Emergencies of the Ministry of the Interior, in collaboration with the competent bodies of the autonomous communities, will keep said Base updated. 3. To facilitate compliance with the provisions of section 1 of article 15, the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior will allow, through its website and if the competent authority of the autonomous community so considers it, to put available to the public the data in annex III not considered confidential according to article 23. Article 23. Access to information and confidentiality. 1. For the sake of greater transparency, the competent authorities in each case must make the information received in application of this royal decree available to any natural or legal person who requests it, in the terms provided in Law 27/2006, of July 18, which regulates the rights of access to information, public participation and access to justice in environmental matters (incorporates Directives 2003/4/CE and 2003/35/CE). 2. The disclosure of information required by virtue of this royal decree, including that by virtue of article 15, may be rejected or restricted by the competent authority when the conditions established in article 13 of Law 27/2006 of 18 are met. of July. 3. The disclosure of the complete information referred to in article 15, paragraph 2, letters b) and c), which is held by the competent authority in each case, may be denied by it, without prejudice to what provided in section 2, if the industrialist has requested that certain parts of the safety report or the inventory of dangerous substances not be disclosed for the reasons provided for in article 13 of Law 27/2006, of July 18. The competent authority in each case may also decide, for the same reasons, that certain parts of the report or inventory are not disclosed. In these cases, and prior page 22 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION agreement of said competent authority, the industrialist will provide him with a modified report or inventory from which those parts are excluded. Article 24. Access to justice. 1. Any applicant who requests information in accordance with article 15.2, letters b) or c), or article 23.1, may file the administrative appeals regulated in Title VII of Law 30/1992, of November 26, and other applicable regulations. and, where appropriate, the contentious-administrative appeal provided for in Law 29/1998, of July 13, regulating the Contentious-Administrative Jurisdiction, for the acts or omissions of the competent body in relation to your request, in the terms provided in Law 27/2006, of July 18. 2. The interested public, in the cases to which article 16.1 applies, may present the administrative appeals regulated in title VII of Law 30/1992, of November 26, and other applicable regulations and, where appropriate, the contentious-administrative appeal regulated in Law 29/1998, of July 13, in the terms provided in Law 27/2006, of July 18. Article 25. Penalty system. Without prejudice to the infractions that the autonomous communities may establish, the breach of the provisions of this royal decree will be qualified and sanctioned in accordance with the following regulations: a) Law 2/1985, of January 21, on Civil Protection. b) Title V «Infringements and penalties» of Law 21/1992, of July 16, on Industry. c) Chapter V “Infringements and penalties” of Law 26/2007, of October 23, on Environmental Responsibility. First additional provision. Application to Ceuta and Melilla. The provisions contained in article 6.1, on the competent bodies of the autonomous communities of this royal decree, are applied by the competent bodies of the cities of Ceuta and Melilla. Second additional provision. Information to the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior. No later than March 30, 2016, and subsequently each year, the competent authority of the autonomous communities will provide the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior, a report on the application of this royal decree. Third additional provision. Duty of information to the European Commission. No later than September 30, 2019, and subsequently every four years, the General Directorate of Civil Protection and Emergencies of the Ministry of the Interior will provide the European Commission with a report on the application of this royal decree. Fourth additional provision. No increase in public spending. The measures included in this Royal Decree may not lead to an increase in staffing, remuneration or other personnel expenses. Unique derogatory provision. Regulatory repeal. Royal Decree 1254/1999, of July 16, which approves control measures for the risks inherent in serious accidents involving dangerous substances, is hereby repealed, as well as any provisions of equal or lower rank that oppose the provisions of this Royal Decree. First final provision. Competence title. This royal decree is issued under the exclusive jurisdiction of the State in matters of public security foreseen in article 149.1.29.ª of the Constitution. Page 23 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION Second final provision. Incorporation of European Union Law. By means of this royal decree, Directive 2012/18/EU of the European Parliament and of the Council, of July 4, 2012, is incorporated into the Spanish legal system, on the control of the risks inherent in serious accidents involving dangerous substances and which modifies and subsequently repeals Directive 96/82/EC. Third final provision. Coordination of procedures. The competent bodies of the General State Administration will promote the necessary actions to coordinate, as far as possible and with full respect for the distribution of powers between the different Administrations, the procedures and controls provided for in this Royal Decree with those regulated in the corresponding sectoral regulations when the scopes of application partially coincide. Fourth final provision. Regulatory development. By the Ministers of the Interior, Development, Employment and Social Security, Industry, Energy and Tourism, Agriculture, Food and Environment, and Health, Social Services and Equality, within the scope of their respective powers, The provisions necessary for the execution and development of the provisions of this Royal Decree shall be issued. Fifth final provision. Regulatory authorization. The Ministers of the Interior, of Public Works, of Employment and Social Security, of Industry, Energy and Tourism, of Agriculture, Food and Environment, and of Health, Social Services and Equality, or the Minister of the Presidency, upon proposal of those, following a report from the National Civil Protection Commission, according to the assumptions in each case, to modify the annexes of this royal decree by means of a ministerial order. Sixth final provision. Entry into force. This royal decree will enter into force the day after its publication in the «Official State Gazette». Given in Madrid, on September 21, 2015. FELIPE R. The Vice President of the Government and Minister of the Presidency, SORAYA SÁENZ DE SANTAMARIA ANTÓN ANNEX I Hazardous substances Hazardous substances included in the hazard categories listed in column 1 of part 1 of this annex shall be subject to the threshold quantities indicated in columns 2 and 3 of part 1. In case a dangerous substance is included in both part 1 and part 2 of this annex, the threshold quantities indicated in columns 2 and 3 of part 2 will apply. Part 1 Categories of dangerous substances This part covers all dangerous substances included in the categories hazards listed in column 1: Page 24 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION column 1 column 2 Column 3 threshold amounts (in tons) of dangerous substances what is referred to Hazard categories in accordance with Regulation (EC) No. 1272/2008, of the European Parliament and of the Council, of December 16, 2008. in article 3, paragraph 10, for the purposes of applying the level requirements lower level requirements superior Section “H” – HEALTH HAZARDS H1 ACUTE TOXICITY - Category 1, all routes of exposure. 5 20 H2 ACUTE TOXICITY – Category 2, all routes of exposure 50 200 – Category 3, route of exposure inhalation (see note 7). H3 SPECIFIC TARGET ORGAN TOXICITY (STOT) - SINGLE EXPOSURE 50 200 STOT SE Category 1. Section “P” – PHYSICAL HAZARDS P1a EXPLOSIVES (see note 8) – Unstable explosives or – Explosives of divisions 1.1, 1.2, 1.3, 1.5 or 1.6, or 10 50 – Substances or mixtures that have explosive properties in accordance with method A.14 of Regulation (EC) No. 440/2008, of the European Parliament and of the Council, of December 16, 2008, (see note 9) and not belong to the hazard classes 'organic peroxides' or 'self-reactive substances or mixtures'. P1b EXPLOSIVES (see note 8) 50 200 Explosives of Division 1.4 (see note 10). P2 FLAMMABLE GASES 10 50 Flammable gases of categories 1 or 2. P3a FLAMMABLE AEROSOLS 150 (grandson) 500 (grandson) "Flammable" aerosols of categories 1 or 2, containing flammable gases of categories 1 or 2 or flammable liquids of category 1. P3b FLAMMABLE AEROSOLS "Flammable" aerosols of categories 1 or 2, which do not contain flammable gases of categories 1 or 2 or flammable liquids of category 1. 5,000 (grandson) 50,000 (grandson) P4 COMBUSTION GASES 50 200 Category 1 oxidizing gases. P5a FLAMMABLE LIQUIDS – Category 1 flammable liquids, or 10 50 – Category 2 or 3 flammable liquids held above their boiling point, or – Other liquids with a flash point ÿ 60 °C, held above their boiling point (see note 11). P5b FLAMMABLE LIQUIDS – Category 2 or 3 flammable liquids where particular process conditions, for example high pressure or temperature, may create serious accident hazards, or 50 200 – Other liquids with a flash point ÿ 60 °C when particular process conditions, for example high pressure or temperature, may create serious accident hazards (see note 11). P5c FLAMMABLE LIQUIDS 5.000 50.000 Flammable liquids of categories 2 or 3 not included in P5a and P5b. P6a SELF-REACTING SUBSTANCES AND MIXTURES and ORGANIC PEROXIDES 10 50 Self-reactive substances and mixtures of types A or B or organic peroxides of types A or B. P6b SELF-REACTING SUBSTANCES AND MIXTURES and ORGANIC PEROXIDES 50 200 Self-reactive substances and mixtures of types C, D, E, or F or organic peroxides of types C, D, E, or F. P7 PYROPHORIC LIQUIDS AND SOLIDS Pyrophoric liquids of category 1 50 200 Pyrophoric solids of category 1. P8 OXIDIZING LIQUIDS AND SOLIDS Oxidizing liquids of categories 1, 2 or 3, or 50 200 Oxidizing solids of categories 1, 2 or 3. Section “E” – ENVIRONMENTAL HAZARDS E1 Hazardous to the aquatic environment in category Acute 1 or Chronic 1. 100 200 E2 Hazardous to the aquatic environment in chronic category 2. 200 500 Section “O” – OTHER HAZARDS O1 Substances or mixtures with indication of danger EUH014. 100 500 O2 Substances and mixtures which, in contact with water, emit category 1 flammable gases. 100 500 O3 Substances or mixtures with indication of danger EUH029. 50 200 Part 2 Nominated Hazardous Substances Column 1 column 2 Column 3 Threshold quantities (tonnes) for the purposes of CAS number (1 ) applying the Hazardous substances Level requirements Lower level requirements superior 1. Ammonium nitrate (see note 12) – 5.000 10.000 2. Ammonium nitrate (see note 13) – 1.250 5.000 3. Ammonium nitrate (see note 14) – 350 2.500 4. Ammonium nitrate (see note 15) – 10 50 5. Potassium nitrate (see note 16) – 5.000 10.000 6. Potassium nitrate (see note 17) – 1.250 5.000 Page 25 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION Column 1 column 2 column 3 Threshold quantities (tonnes) for the purposes of applying the CAS number (1 ) Hazardous substances level requirements lower level requirements superior 7. Diarsenic pentaoxide, arsenic (V) acid and/or salts 8. Arsenic trioxide, 1303-28-2 1 2 arsenious (III) acid and/or salts 9. Bromine 10. Chlorine 11. Nickel compounds in 1327-53-3 0,1 inhalable powder form: nickel monoxide, nickel dioxide, nickel sulfide, trinickel 7726-95-6 20 100 disulfide, dinickel trioxide 12. Ethyleneimine 13. Fluorine 14. Formaldehyde 7782-50-5 10 25 (concentration ÿ 90%) – 1 151-56-4 10 20 7782-41-4 10 20 50-00-0 5 50 15. Hydrogen 16. 1333-74-0 5 50 Hydrochloric acid (liquefied gas) 7647-01-0 25 250 17. Alkyl lead derivatives 18. Flammable – 5 50 liquefied gases of categories 1 or 2 (including LPG) and natural gas (see note 18) – 50 200 19. Acetylene 20. 74-86-2 5 50 Ethylene oxide 21. Propylene 75-21-8 5 50 oxide 75-56-9 5 50 22. Methanol 67-56-1 500 5.000 23. 4,4ÿ-methylene-bis (2-chloroaniline) and/or its salts in powder form 24. Methyl isocyanate 25. 101-14-4 0,01 Oxygen 26. Toluene 2,4-diisocyanate 624-83-9 0,15 7782-44-7 200 2.000 584-84-9 10 100 2,6-toluene diisocyanate 91-08-7 27. Carbonyl dichloride (phosgene) 75-44-5 0,3 0,75 28. Arsine (arsenic trihydride) 7784-42-1 0,2 1 29. Phosphine (phosphorus trihydride) 7803-51-2 0,2 1 30. Sulfur dichloride 31. Sulfur 10545-99-0 1 trioxide 32. Polychlorodibenzofurans 7446-11-9 15 75 and polychlorodibenzodioxins (including TCDD) calculated in TCDD equivalent (see note 20) – 0,001 33. The following CARCINOGENS or mixtures containing the following carcinogens in concentrations greater than 5% by weight: 4-aminodiphenyl and/or its salts, trichlorobenzene, benzidine and/or its salts, bis(chloromethyl) ether, methyl and chloromethyl ether, 1,2-dibromoethane, diethyl – 0,5 2 sulfate, dimethyl sulfate, dimethyl carbamoyl chloride, 1 ,2-dibromo-3- chloropropane, 1,2-dimethylhydrazine, dimethylnitrosamine, hexamethylphosphoric triamide, hydrazine, 2-naphthylamine and/or its salts, 4- nitrodiphenyl by 1,3 propanesulfone 34. Petroleum Products and Alternative Fuels a) gasoline and naphtha b) kerosene (including jet fuel) c) gas oils (including automotive gas oils, heating oils and the components used in commercial gas oil blends) – 2.500 25.000 d) heavy fuel oils e) alternative fuels to the products mentioned in letters a) to d) intended for the same purposes and with similar properties in terms of flammability and environmental hazards 35. Anhydrous ammonia 36. 7664-41-7 50 200 Boron trifluoride 37. Hydrogen 7637-07-2 5 20 sulfide 38. Piperidine 39. Bis(2- 7783-06-4 5 20 dimethylaminoethyl)(methyl)amine 110-89-4 50 200 40. 3-(2-ethylhexyloxy)propylamine 41. Sodium 3030-47-5 50 200 hypochlorite mixtures(*) classified as hazardous to the 5397-31-9 50 200 aquatic environment in acute hazard category 1 [H400] containing less than 5% active chlorine and not classified in any other hazard category in part 1 of annex I. 200 500 (*) Provided that the mixture, in the absence of sodium hypochlorite, is not classified as dangerous for the aquatic environment in category 1 of acute danger [H400]. 42. Propylamine (see note 20) 107-10-8 500 2.000 43. tert-Butyl acrylate (see note 21) 44. 2-methyl-3-butenenitrile 1663-39-4 200 500 (see note 21) 16529-56-9 500 2.000 45. Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (dazomet) (see note 21) 533-74-4 100 200 46. Methyl acrylate (see note 20) 47. 3-methylpyridine 96-33-3 500 2.000 (see note 21) 48. 1-bromo-3-chloropropane (see note 20) 108-99-6 500 2.000 109-70-6 500 2.000 1 ( ) The CAS number is shown for information only. Annex I Notes: 1. Substances and mixtures are classified according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council, of December 16, 2008. 2. Mixtures will be treated in the same way as pure substances as long as they comply with the concentration limits established according to their properties according to Regulation (EC) No. 1272/2008, of the European Parliament and of the Council, of 16 from December Page 26 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION of 2008, or its latest adaptation to technical progress, unless a percentage composition or other description is specifically indicated. 3. The amounts indicated above as thresholds refer to each establishment. The quantities that must be taken into account for the application of the relevant articles are the maximum that are present, or may be present, at a given time. For the calculation of the total amount present, hazardous substances existing in an establishment will not be taken into account only in an amount equal to or less than 2% of the amount indicated as threshold, if their situation within the establishment is such that it cannot reach cause a serious accident anywhere else in the establishment. 4. The following rules, on the sum of dangerous substances, or categories of dangerous substances, will be applied when appropriate. In the event that no dangerous substance is present in an establishment in an amount equal to or greater than the corresponding threshold amount, the following rule shall be applied to determine if the pertinent requirements of this royal decree are applicable to said establishment. This royal decree will be applied to higher level establishments if the sum: q1/QU1 + q2/QU2 + q3/QU3 + q4/QU4 + q5/QU5 + is equal to or greater than 1, where: qx = the quantity of the dangerous substance or category of dangerous substances x referred to in Part 1 or Part 2 of this Annex, and QUX = the relevant threshold quantity for the hazardous substance or category x from Part 1 Column 3 or Part 2 Column 3 of this Annex. This royal decree will apply to lower level establishments if the sum: q1/Q L1 + q2/Q L2 + q3/QL3 + q4/QL4 + q5/QL5 + is equal to or greater than 1, being: qx = the quantity of the dangerous substance or category of dangerous substances x referred to in Part 1 or Part 2 of this Annex, and QLX = the relevant threshold quantity for the hazardous substance or category x from Part 1 Column 2 or Part 2 Column 2 of this annex. This rule will be used to assess health hazards, physical hazards and hazards environmental. Therefore, it must be applied three times: a) For the sum of the dangerous substances listed in part 2 that fall into acute toxicity categories 1, 2 or 3 (inhalation) or STOT SE category 1, together with the dangerous substances listed in section H, subsections H1 to H3, of part 1. b) For the sum of the hazardous substances listed in part 2 consisting of explosives, flammable gases, flammable aerosols, oxidizing gases, flammable liquids, self-reactive hazardous substances and mixtures, organic peroxides, pyrophoric liquids and solids, oxidizing liquids and solids , together with the substances listed in section P, subsections P1 to P8, of part 1. c) For the sum of the hazardous substances listed in part 2 that fall, as substances hazardous to the aquatic environment, in categories 1 acute toxicity, 1 chronic toxicity or 2 chronic toxicity, together with the hazardous substances included in section E, subsections E1 and E2, of part 1. The relevant provisions of this Royal Decree shall apply if any of the sums obtained in a), b) or c) is equal to or greater than 1. 5. In the case of hazardous substances that are not covered by Regulation (EC) No. 1272/2008, of the European Parliament and of the Council, of December 16, 2008, including waste, but which are present, or may be, in an establishment and possess or may possess, under the conditions of the establishment, equivalent properties that may cause serious accidents, will be provisionally assigned to the category or most analogous nominated dangerous substance that falls within the scope of application of this royal decree. 6. In the case of dangerous substances whose properties allow them to be classified in more than one way, the lowest threshold quantities will be applied for the purposes of this real Page 27 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION decree. However, for the application of the rule of note 4, the lowest threshold quantity will be used for each group of categories of note 4, letters a) to c), applicable to the corresponding classification. 7. Dangerous substances that fall into category 3 of acute toxicity by the oral route, (H 301) will be included in subsection H2 ACUTE TOXICITY when the classification of acute dermal toxicity or the classification of acute inhalation toxicity cannot be inferred; for example, due to lack of conclusive data on dermal or inhalation toxicity. 8. The "explosives" hazard class includes explosive items [see section 2.1 of annex I to Regulation (EC) No. 1272/2008, of the European Parliament and of the Council, of December 16, 2008]. If the amount of explosive substance or mixture contained in the article is known, that amount will be considered for the purposes of this Royal Decree. If the amount of explosive substance or mixture contained in the article is not known, the entire article will be treated, for the purposes of this royal decree, as explosive. 9. It is only necessary to carry out tests of the explosive properties of substances and mixtures if in the detection procedure according to appendix 6, part 3, of the United Nations Recommendations on the transport of dangerous goods, tests and criteria («Manual Nations Tests and Criteria”)1 it is found that the substance or mixture may have explosive properties. 1 More guidance on the cases in which it is not necessary to carry out the tests can be found in the description of method A.14, see Regulation (EC) No. 440/2008 of the Commission, of May 30, 2008, by the establishing test methods in accordance with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemical Substances and Preparations (REACH) (OJ L 142 of 5.31.2008, page 1). 10. If the explosives of division 1.4 are unpackaged or repackaged, they will be assigned to subsection P1a, unless it is shown that the hazard still corresponds to division 1.4, in accordance with Regulation (EC) No. 1272/ 2008, of the European Parliament and of the Council, of December 16, 2008. 11. In accordance with point 2.6.4.5 of Annex I of Regulation (EC) No. 1272/2008, of the European Parliament and of the Council, of December 16, 2008, liquids with a flash point greater than 35 ° C may not be classified in category 3 if negative results have been obtained in the sustained flammability test L.2, Part III, section 32, of the United Nations Manual of Tests and Criteria. However, this is not applicable under conditions, such as elevated temperature or pressure, and therefore those liquids are included in this subsection. 12. Ammonium nitrate (5,000 / 10,000): fertilizers susceptible to self-decomposition. Applies to compound and complex fertilizers based on ammonium nitrate (compound and complex fertilizers contain ammonium nitrate with phosphate and/or potash) that are susceptible to self-decomposition according to the United Nations bucket test (see Manual of Tests and Criteria, Part III, subsection 38.2) whose nitrogen content due to ammonium nitrate represents: – between 15.75 %2 and 24.5 %3 by weight, and either contain a maximum of 0.4% in total of combustible or organic materials, or meet the requirements of Annex III-2 of the Regulation (CE) No. 2003/2003 of the European Parliament and of the Council, of October 13, 2003, regarding fertilizers4 . 2 The 15.75% by weight nitrogen content due to ammonium nitrate corresponds to 45% ammonium nitrate. 3 24.5 wt% nitrogen content due to ammonium nitrate corresponds to 70% ammonium nitrate. 4 DO L 304 of 21.11.2003, p. 1. – 15.75% or less by weight and with combustible materials not subject to restrictions. 13. Ammonium nitrate (1,250 / 5,000): quality for fertilizers. Page 28 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION It applies to simple fertilizers based on ammonium nitrate and compound and complex fertilizers based on ammonium nitrate that meet the requirements of Annex III-2 of Regulation (EC) No. 2003/2003, of the European Parliament and of the Council, of October 13, 2003, relative to fertilizers, and whose nitrogen content due to ammonium nitrate sea: – greater than 24.5% by weight, except for mixtures of straight fertilizers based on ammonium nitrate with dolomite, limestone and/or calcium carbonate with a purity of at least 90%, – greater than 15.75% by weight for mixtures of ammonium nitrate and ammonium sulphate, – greater than 28 %5 by weight for mixtures of straight fertilizers based on ammonium nitrate with dolomite, limestone and/or calcium carbonate with a purity of at least 90%. 5 28% by weight of nitrogen content due to ammonium nitrate corresponds to 80% ammonium nitrate. 14. Ammonium nitrate (350 / 2,500): technical quality. It applies to ammonium nitrate and ammonium nitrate mixtures whose nitrogen content due to ammonium nitrate represents: – between 24.5% and 28% by weight, and containing a maximum of 0.4% of combustible substances, – more than 28% by weight, and containing not more than 0.2% of combustible substances. It also applies to aqueous solutions of ammonium nitrate whose concentration of ammonium nitrate exceeds 80% by weight. 15. Ammonium nitrate (10 / 50): “out of specification” materials and fertilizers that do not pass the detonation test. Applies: – waste material from the manufacturing process and ammonium nitrate and ammonium nitrate mixtures, simple ammonium nitrate-based fertilizers and compound or complex ammonium nitrate- based fertilizers referred to in notes 14 and 15 that are or have been returned by the end user to a manufacturer, temporary storage location, or processing facility for reworking, recycling, or treatment for safe use, as no longer meeting the specifications in the notes 14 and 15, – to the subscriptions referred to in the first indent of note 13 and note 14 of this annex that do not meet the requirements of annex III-2 of Regulation (EC) No. 2003/2003, of the European Parliament and of the Council, of October 13, 2003, relative to fertilizers. 16. Potassium nitrate (5,000 / 10,000). Applies to compound fertilizers based on potassium nitrate, in pearl form/ granulated, which have the same dangerous properties as pure potassium nitrate. 17. Potassium nitrate (1,250 / 5,000). It applies to compound fertilizers based on potassium nitrate in crystalline form which have the same dangerous properties as pure potassium nitrate. 18. Enriched Biogas. For the purposes of applying this royal decree, enriched biogas may be classified under point 18 of annex I, part 2, if it has been treated in accordance with the standards applicable to purified and enriched biogas, guaranteeing a quality equivalent to that of natural gas. natural, including methane content, and contains a maximum of 1% oxygen. 19. Polychlorodibenzofurans and polychlorodibenzodioxins. The amounts of polychlorodibenzofurans and polychlorodibenzodioxins are calculated with the following weighting factors: Toxic Equivalency Factors (TEFs)-WHO 2005 Page 29 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 2,3,7,8-TCDD 1 2,3,7,8-TCDF 0,1 1,2,3,7,8-PeCDD 1 2,3,4,7,8-PeCDF 0,3 1,2,3,7,8-PeCDF 0,03 1,2,3,4,7,8-HxCDD 0.1 1,2,3,6,7,8-HxCDD 0.1 1,2,3,4,7,8-HxCDF 0,1 1,2,3,7,8,9-HxCDD 0.1 1,2,3,7,8,9-HxCDF 0,1 1,2,3,6,7,8-HxCDF 0,1 1,2,3,4,6,7,8-HpCDD 0,01 2,3,4,6,7,8-HxCDF 0,1 OCDD 0,0003 1,2,3,4,6,7,8-HpCDF 0,01 1,2,3,4,7,8,9-HpCDF 0,01 OCDF 0,0003 (T = tetra, P = penta, Hx = hexa, Hp = hepta, O = octa) Referencia – Van den Berg et al.: The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. 20. In the cases in which this dangerous substance falls within the category P5a Flammable liquids or P5b Flammable liquids, the lower threshold quantities will be applied for the purposes of this royal decree. ANNEX II Information referred to in Article 8(6) and Article 10(1)a) relating to the safety management system and organization of the establishment with a view to preventing major accidents For the application of the safety management system developed by the industrialist, The following elements will be taken into account: a) The security management system will be proportional to the hazards, the industrial activities and the complexity of the existing organization in the establishment and will be based on a risk assessment. It will include the general organizational structure, responsibilities, practices, procedures, processes and resources that allow defining and applying the major accident prevention policy. b) The security management system will include the following elements: 1. The organization and the personnel: the functions and responsibilities of the personnel associated with the management of the risks of major accidents at all levels of the organization, together with the measures adopted to raise awareness of the need for permanent improvement; determining the training needs of such personnel and organizing such training; the participation of employees and staff of subcontracted companies and self-employed workers who work in the establishment that are important from the point of view of security. 2. The identification and evaluation of the risks of serious accidents: the adoption and systematic application of procedures for the identification of the risks of serious accidents that may occur in the event of normal or abnormal operation, including, where appropriate, the outsourced activities, as well as the evaluation of their probability and severity. 3rd Operation control: the adoption and application of procedures and instructions for operation in safe conditions (including the maintenance of facilities, processes and equipment), and for the management of alarms and shutdowns temporary. Available information on best practices in terms of monitoring and control will be taken into account with a view to reducing the risk of system failure; the management and control of the risks associated with the aging of the installation's equipment and corrosion; the inventory of the installation's equipment, the strategy and methodology for monitoring and controlling the condition of the equipment; appropriate follow-up actions and necessary countermeasures. 4th The adaptation of the modifications: the adoption and application of procedures for the projects of the modifications that must be carried out in the facilities, processes or existing storage areas or for the design of new ones. Page 30 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 5th Planning for emergency situations: the adoption and application of procedures aimed at identifying foreseeable emergencies through systematic analysis, as well as drawing up, testing and reviewing emergency plans and providing specific training for affected personnel; This training will affect all staff working in the establishment, including staff from subcontracted companies and self-employed workers. 6. The monitoring of the objectives set: the adoption and application of procedures aimed at the permanent evaluation of compliance with the objectives set by the industrialist within the framework of its major accident prevention policy and its safety management system. , and the implementation of investigation and correction mechanisms in case of non-compliance; the procedures will cover the industrial system for the notification of serious accidents or near accidents, especially when there have been failures of the protection measures, and the follow- up investigation based on the lessons learned; The procedures may also include performance indicators, such as security performance indicators or other relevant indicators. 7th audit and review: the adoption and application of procedures for the systematic periodic evaluation of the serious accident prevention policy and the effectiveness and suitability of the safety management system; the documented review of the operation of the applied policy, the security management system and its updating, including the consideration and incorporation of the changes indicated as necessary in the audit and review exercise. APPENDIX III Information that must be provided to the population in application of article 15, paragraph 1 and paragraph 2, letter a) Part 1 For all establishments to which this Royal Decree applies: a) Name or business name of the industrialist and full address of the corresponding establishment. b) Confirmation that the establishment is subject to the regulatory or administrative provisions of application of this royal decree and that the notification referred to in article 7, section 1, or the safety report mentioned in the article 10, paragraph 1. c) Explanation in simple terms of the activity or activities carried out in the establishment. d) The common names or, in the case of dangerous substances included in Part 1 of Annex I, the generic names or the hazard classification of the relevant dangerous substances existing in the establishment that may give rise to a serious accident, indicating its main dangerous characteristics, in simple terms. e) General information on how the interested public will be notified, if necessary; adequate information on the appropriate behavior in the event of a major accident or indication of where this information can be accessed in electronic form. f) The date of the last on-site visit in accordance with article 21, paragraph 4, or indication of where this information can be accessed in electronic form; information on where you can obtain, upon request, more information about the inspection and the corresponding inspection plan, without prejudice to the requirements established in article 23. g) Detailed information on how to obtain more information in this regard, without prejudice to the requirements established in article 23. Part 2 For higher level establishments, in addition to the information mentioned in part: Page 31 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION a) General information on the nature of major accident hazards, including their potential effects on human health and the environment, and a summary of the main types of major accident scenarios and the control measures taken in anticipation of them. b) Confirmation that the industrialist is obliged to take the appropriate measures on site, including contact with the emergency services, in order to act in the event of a serious accident and minimize its effects. c) Adequate information from the external emergency plan drawn up to deal with the effects that an accident may have outside the location where it occurs. Appeals for cooperation must be included, with instructions or slogans issued by the emergency services at the time of the accident. d) Where appropriate, indication of whether the establishment is close to the territory of another Member State and there is a possibility that a major accident will have transboundary effects in accordance with the Convention on the Transboundary Effects of Industrial Accidents, of the Economic Commission for Europe of the United Nations (UNECE). ANNEX IV Criteria for the notification of a serious accident to the European Commission in accordance with the provisions of article 19, paragraph 1 1. The General Directorate of Civil Protection and Emergencies of the Ministry of the Interior, without prejudice to the powers of the Ministry of Public Works in matters of maritime pollution, must notify the European Commission of any serious accident that fits the description in point 1 or in when at least one of the consequences described in points 2, 3, 4 and 5 occurs. a) Hazardous substances involved: Any fire or explosion or accidental release of a dangerous substance involving an amount not less than 5% of the threshold amount in column 3 of part 1 or in column 3 of part 2 of Annex I. b) Damage to persons or property: 1st A death. 2nd Six people injured within the establishment that require hospitalization for 24 hours or more. 3.º A person located outside the establishment who requires hospitalization for 24 hours or more. 4th Dwelling(s) located outside the establishment damaged and unusable due to the accident. 5th Evacuation or confinement of people for more than 2 hours (people × hours): the product is equal to or greater than 500. 6th Interruption of drinking water, electricity, gas or telephone services for more than 2 hours (persons × hours): the product is equal to or greater than 1,000. c) Direct damage to the environment: 1. Permanent or long-term damage caused to terrestrial habitats: i) 0.5 ha or more of a habitat important from the point of view of the environment or conservation and protected by law, ii) 10 ha or more of more extensive habitat, including arable land. 2. Significant or long-term damage caused to freshwater or marine habitats: i) 10 km or more from a river or canal, ii) 1 ha or more of a lake or pond, iii) 2 ha or more of a delta, iv) 2 ha or more of a coastal or maritime zone. Page 32 Machine Translated by Google STATE OFFICIAL NEWSLETTER CONSOLIDATED LEGISLATION 3rd significant damage caused to an aquifer or groundwater: 1 ha or more. d) Material damage: 1. Material damage in the establishment: from 2,000,000 EUR. 2nd Material damage outside the establishment: from 500,000 EUR. e) Cross-border damages. Any serious accident directly involving a dangerous substance and giving rise to effects outside the territory of the Member State in question. 2. The General Directorate of Civil Protection and Emergencies of the Ministry of the Interior, without prejudice to the powers of the Ministry of Public Works in matters of maritime pollution, will notify the European Commission of accidents and near-misses that, even if they do not meet the criteria mentioned above, present in his opinion a special interest from the technical point of view for the prevention of serious accidents and for the limitation of their consequences. This consolidated text has legal value. More information at info@boe.es Page 33