Royal Decree 1254/1999 of 16 July 1999 approving measures to control the risks inherent in major accidents involving dangerous substances, and their amendments, incorporated into our national law. Council Directive 96 /82/EC of 9 December 1996 on the control of the risks inherent in serious accidents involving dangerous substances and Directive 2003 /105/EC of the European Parliament and of the Council, of 16 December 2003 amending Directive 96 /82/EC of 9 December 1996 on the approximation of the laws of the Member States relating to the

Royal Decree 1196/2003 of 19 September approving the Basic Civil Protection Guideline for the control and planning of serious accidents involving dangerous substances, development the main new features introduced by Royal Decree 1254/1999 of 16 July 1999, in line with the provisions of Royal Decree 407/1992 of 24 April 1992, which adopted the Basic Standard for Civil Protection, which constitutes the framework for the fundamental for the elaboration and integration of the various civil protection plans and that considers chemical risk as a special planning object.

According to all this, the State Plan for Civil Protection was developed in the face of chemical risk, approved by Royal Decree 1070/2012 of July 13, which aims to establish the organization and procedures of action of those resources and services of the State and, where appropriate, other public and private entities, which are necessary to ensure an effective response of the whole of the Public Administrations, to the different situations of emergency by accident with dangerous substances, in which the national interest is present, as the mechanisms to support the plans of autonomous communities in the cases that require it.

At European level and by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, the European Union adopted the United Nations Global Harmonised Classification and Labelling of Substances and Mixtures, with which new classes and categories of danger were introduced which do not correspond entirely to those used in Council Directive 96 /82/EC, of 9 December 1996.

In order to adapt to the new classification system, the European Commission considered a fundamental revision of this Directive to be necessary, which would also take account of harmonisation with other Directives, improve their understanding and contribute to a more consistent application of the same.

Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of the risks inherent in serious accidents involving dangerous substances and on which it was adopted was approved. amend and subsequently repeals Directive 96 /82/EC.

By Order PRE/1206/2014 of 9 July, amending Annex I to Royal Decree 1254/1999 of 16 July 1999, compliance with the provisions of this Directive has been complied with only in respect of the introduction of the '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 4 July 2012 are transposed into our internal order.

This provision is made in the development of Law 2/1985, of 21 January, of 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 on which they are carried out, as well as the obligation of their holders to have an organisation for self-protection and an internal emergency plan for the prevention of risks and immediate control of the claims that may occur.

It also provides for the power of competent bodies and authorities to require information on certain issues and the ability of public administrations to develop an external emergency plan that, together with with the aforementioned internal emergency plan, they constitute a single integrated action plan.

On the other hand, Law 21/1992 of 16 July, of Industry, provides in Chapter I, "Industrial Security", of Title III, the provisions of Law 2/1985, of 21 January, and typifies in its title V, "Infractions and sanctions", the failure to comply with the safety measures provided for in this law and in the regulatory standards for development.

With regard 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. A correction mechanism for this Annex is also included in order to provide for subsequent adaptations to the classification system which could have an impact on substances for which it is demonstrated that they do not present a serious accident risk.

The provisions related to the public's access to information on the application of the royal decree are reinforced, with the effective participation of the public interested in decision-making and with the public's rights to bringing an action before the courts. This is in accordance with Law 27/2006 of 18 July on the rights of access to information, public participation and access to justice in the field of the environment.

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 making available to the public are strengthened.

In accordance with the provisions of Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on procedures for consultation of industrialists and public participation in the framework of the This royal decree provides for the coordination of these procedures with those existing in other regulations. Since its scope does not coincide, and because of the confluence of these at the state and sectoral level, the aforementioned coordination is generally contemplated, entrusting the General Administration of the State to promote the actions necessary to coordinate the procedures and controls in question.

It should be borne in mind that industrial operators will be able to make use in any case of the economic operators ' protection mechanisms in Chapter VII of Law 20/2013 of 9 December 2013 on the guarantee of the market unit, when understand that some principle or provision of that law has been infringed, including the principle of the simplification of charges, as a result of duplicate formalities or lack of coordination in the administrative proceedings under this law royal decree and other regulations.

With regard to inspections of establishments affected by this royal decree, stricter criteria are introduced to ensure compliance with safety standards, as well as effective implementation of the control measures considered.

Likewise, this royal decree contemplates the general structure of the civil protection planning for special risks, integrated by the state plan, the plans of autonomous communities and, within the latter, the plans of Municipal action, which constitutes the integrated national model to enable the coordination and joint action of the various services of the administrations in the event of serious accidents involving dangerous substances.

Taking into account the special competence distribution between public administrations in terms of explosives, pyrotechnic material and cardboard, this royal decree is limited to regulating, for the establishments in which These products are handled or stored, aspects related to the external planning of emergencies and information to the affected public, the planning of the territory, the prompt notification of accidents and the consultation and public participation in works projects in the immediate vicinity of the establishments; regulated by legislation specifies the other aspects referred to in Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012.

This royal decree was reported favourably by the plenary of the National Civil Protection Commission at its meeting on October 20, 2014, as well as by the Permanent Inter-Ministerial Commission on Arms and Explosives at its meeting. of 15 April 2015.

Has been submitted to the public information procedure provided for in Article 24.1 (c) of Law 50/1997 of 27 November of the Government.

In its virtue, on the proposal of the Ministers of the Interior, of Development, of Employment and Social Security, of Industry, Energy and Tourism, of Agriculture, Food and Environment, and of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 18 September 2015,

DISPONGO:

Article 1. Object.

This royal decree aims to prevent serious accidents involving dangerous substances, as well as the limitation of their consequences on human health, property and the environment.

Article 2. Scope.

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 Corps;

(b) The hazards created by ionising radiation 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 to the loading and unloading activities and the transfer to and from another type of transport for docks, jetties or railway or railway logistics facilities outside the establishments referred to in this royal decree;

(d) The transport of dangerous substances by pipeline, including pumping stations, which are outside the establishments referred to in this royal decree;

e) The exploitation of minerals in mines, quarries, and drilling; in particular, exploration, extraction and treatment activities;

(f) Exploration and offshore (off-shore) exploitation of minerals, including hydrocarbons;

g) The storage of gas in underground offshore sites, both in those specifically dedicated to storage, and in which mineral exploration and extraction activities are also carried out, including hydrocarbons;

h) Waste dumps, including the underground storage of waste.

3. By way of derogation from points (e) and (h) of the preceding paragraph, they shall fall within the scope of this royal decree:

(a) Operational facilities for the disposal of mining waste, including dikes and sterile rafts, containing dangerous substances;

b) Land-based underground 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 in which Dangerous substances are involved;

(c) The temporary storage of metallic mercury considered as waste referred to in Article 3 of Regulation (EC) No 1102/2008 of the European Parliament and of the Council of 22 October 2008 on the prohibition of 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 cardboard material are processed, handled or stored, regulated respectively by the Explosives Regulation, approved by Royal Decree 230/1998 of 16 February, and by the Regulation of pyrotechnic articles and cardboard, approved by Royal Decree 563/2010 of 7 May, shall be governed by their specific rules, except as regards:

(a) The external emergency planning, which shall be governed by the provisions of Article 13.

(b) Land use planning, which shall apply to it as provided for in Article 14.

(c) Information to the public concerned, which shall be governed by the provisions of Article 15.2.a).

(d) Public consultation and participation in projects for the execution of works in the vicinity of establishments referred to in Article 16.1.c) which shall apply to it as set out in Article 16.

e) Early notification of accidents, which shall apply to it as provided for in Article 17.1.

To these effects the Government Delegations in the Autonomous Communities where they radiate such establishments and the corresponding competent bodies of the Autonomous Communities, will be provided with all the necessary information to ensure the proper performance of the functions and powers conferred on them.

Article 3. Definitions.

For the purposes of this royal decree, it is understood by:

1. Serious accident: any event, such as an emission in the form of leakage or discharge, a major fire or explosion, resulting from an uncontrolled process during the operation of any establishment to which the actual application is applicable a decree, which poses a serious, immediate or deferred risk to human health, property, or the environment, within or outside the establishment and in which one or more dangerous substances are involved.

2. Storage: the presence of a certain amount of hazardous substances for storage purposes, storage in custody or reserve.

3. Domino effect: the concatenation of effects that multiplies the consequences of an accident, because dangerous phenomena may affect, in addition to the external vulnerable elements, other containers, pipes or equipment thereof the establishment or other nearby establishments, in such a way as to produce a new leak, fire, explosion or explosion in them, which will in turn generate new dangerous phenomena.

4. Establishment: the entire site under the control of an industrial site in which dangerous substances are found in one or more facilities, including common or related infrastructure or activities; lower or higher level.

5. Establishment of a lower level: an establishment in which dangerous 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 shall, where applicable, be used as the rule for the sum of note 4 to Annex I.

6. Establishment of a higher level: an establishment in which dangerous substances are present in quantities equal to or greater than those specified in column 3 of Part 1 or Part 2 of Annex I. All this shall, where appropriate, 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 that date of entry into force is included in the scope of this royal decree without changing its classification as a lower level establishment or higher level establishment.

8. New establishment:

a) An establishment that works or builds from the effective date of this royal decree, or

(b) an operational site that becomes included in the scope of this royal decree, or a lower level establishment that becomes a higher level establishment or vice versa, from the date of the entry into force of this royal decree, due to modifications in its facilities or activities that result in a change of its inventory of dangerous substances.

9. Neighbouring establishment: an establishment whose proximity to another establishment increases the risk or consequences of a major accident.

10. Other establishment: an operational site which falls within the scope of this royal decree, or a lower level establishment which becomes a higher level establishment or vice versa, from the date of entry in force of this royal decree, due to reasons other than those mentioned in paragraph 8.b).

11. Industrial: any natural or legal person who exploits or controls an establishment or installation or where, where the rules so provide, the economic or decisive power has been delegated to the technical exploitation of the setting or the installation.

12. Inspection: any action, including on-site visits, controls of internal measures, systems, reports and follow-up documents and any subsequent checks necessary, carried out by the competent bodies in each case, or in its name, in order to review and promote compliance with the establishments with the requirements of this royal decree.

13. Installation: a technical unit within an establishment, irrespective of whether it is at ground or ground level, where dangerous substances are produced, used, handled or stored, including all equipment, structures, pipes, machinery, tools, special railway branches, docks, loading or unloading springs for use, sears, tanks or similar structures, whether or not they are afloat, necessary for the operation of that installation.

14. Mixture: a mixture or solution composed of two or more substances.

15. Hazard: the intrinsic capacity of a hazardous substance or the potential of a physical situation to cause harm to human health, property or the environment.

16. Presence of dangerous substances: the current or anticipated presence of dangerous substances in the establishment, or of dangerous substances which may be reasonable to provide for the loss of control of the processes; including storage activities in any facility within an establishment, in quantities equal to or greater than the threshold quantities set out in Parts 1 or 2 of Annex I.

17. Public: one or more natural or legal persons and, in accordance with legal provisions or with common practices, associations, organisations or groups constituted by such persons.

18. Public concerned: for the purposes of Article 15 (2), the staff of an establishment and the population of its environment which, according to the studies of risk analysis and consequences, could suffer from the effects of a possible accident on their health severe.

19. Interested public: the public which is or may be affected by the decisions taken on one of the cases referred to in Article 16.1, or which has an interest to invoke in the taking of those decisions; for the purposes of the present definition, non-governmental organisations working in favour of the protection of the health of persons or the environment and meeting the relevant requirements laid down by the legislation shall be deemed to be of interest to non-governmental organisations. national.

20. Risk: the likelihood of a specific effect occurring over a particular period of time or in particular circumstances.

21. Dangerous substance: any substance or mixture listed in Part 1 or listed in Part 2 of Annex I, including those in the form of raw material, product, by-product, waste or intermediate product.

Article 4. Assessment of serious accident hazards for a given hazardous substance.

1. Where appropriate or, in any case, on the basis of a notification by a Member State in accordance with paragraph 2, the European Commission shall assess whether it is impossible in practice for a particular hazardous substance listed in Part 1 or listed in Part 2 of Annex I, a release of matter or energy which could cause a serious accident in normal or abnormal circumstances which could reasonably be foreseen. That assessment shall take into account the information referred to in paragraph 3 and shall be based on one or more of the following characteristics:

(a) The physical form of the hazardous substance under normal conditions of process, handling or loss of unanticipated isolation.

(b) The inherent properties of the hazardous substance, in particular those relating to the behaviour of dispersion in a serious accident scenario, such as molecular mass and saturated vapour pressure.

c) The maximum concentration of the 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 where appropriate, in particular where they are covered by legislative provisions. The European Union.

2. Where the competent authority 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 paragraph 1, it shall notify the Full of that Commission together with the relevant justification, including the information referred to in paragraph 3.

3. For the purposes of paragraphs 1 and 2, the information necessary to assess the health, physical or environmental hazard properties of the hazardous substance concerned shall include:

(a) A comprehensive list of the properties necessary to assess the potential of the hazardous substance for physical injury, 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 attack mode in the body, the ratio of injuries to deaths, and long-term effects, as well as other relevant properties) that may generate health hazards or physical hazards.

d) Properties (such as, ecotoxicity, persistence, bioaccumulation, long-distance environmental transport potential, and other relevant properties) that may generate environmental hazards.

e) When available, the classification by the European Union of the substance or mixture.

(f) Information on the specific process conditions of the substance (e.g. temperature, pressure and other relevant conditions) under which the substance or mixture is stored, used and/or may be present in the case of foreseeable abnormal operations or an accident such as a fire.

4. Following the favourable report of the National Civil Protection Commission, the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior will provide the European Commission with the appropriate documentation, who, following the evaluation of the referred to in paragraph 1, shall, if appropriate, submit a legislative proposal to the European Parliament and the Council to exclude the dangerous substance in question from the scope of Directive 2012/18/EU of the European Parliament and of the Council Council of 4 July 2012.

Article 5. General industrial obligations.

The industrialists whose establishments are applicable this royal decree are obliged to:

(a) Adopt the measures provided for in this royal decree and how many 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, in particular, on the basis of the controls and inspections referred to in Article 21, that they have taken all necessary measures foreseen in this royal decree.

Article 6. Competent authorities.

1. They are considered competent authorities for the purposes of this royal decree:

a) The Ministry of the Interior, through the Directorate General of Civil Protection and Emergencies, to:

1. To maintain a permanent relationship with the European Commission for the purposes set out in Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012, and in particular:

Inform, as soon as possible and in accordance with the procedure specified in Article 22, of serious accidents that have occurred in the Spanish territory and which meet the criteria of Annex IV.

Exchange information on the experience gained in the prevention of major accidents and the limitation of their consequences and, in particular, on the measures envisaged in this royal decree.

To 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 4 July 2012 in the Spanish State.

To provide the Commission with the information referred to in Article 4.

2. To maintain a permanent relationship with the relevant government delegations, and with the competent bodies of the autonomous communities for the purposes set out 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 Risk Civil Protection Plan chemical, approved by Royal Decree 1070/2012, dated July 13.

Collect reports or questionnaires related to technical aspects and the implementation of this provision.

Draw up regular reports on the lessons learned from serious accidents in Spain, according to the information set out in Article 17.

3. 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 its results and the dissemination of them.

4. To make available to other Member States of the European Union, which could be affected by the potential cross-border effects of a serious accident in an establishment based on Spanish territory, the information sufficient to enable the Member State concerned to take appropriate preventive and protective measures. Furthermore, the information received from other Member States in relation to serious accidents occurring in establishments of the type referred to, located outside the territory, is transferred to the competent authorities of the autonomous communities. Spanish, 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).

5. To make available to the Member States concerned, the decision that an establishment close to its territory may not present any danger of a serious accident outside its perimeter and does not require an emergency plan in accordance with Article 13 (4), as well as to 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.

6. Inform and transfer to the National Civil Protection Commission, the proposal for approval of the foreign emergency plans that have been drawn up and approved by the competent bodies of the autonomous communities, as well. as its successive revisions.

7. To participate in the implementation of the State Plan for Civil Protection in the Face of Chemical Risk, approved by Royal Decree 1070/2012 of July 13, in response to emergency situations in which the national interest is present, as well as in support of the external emergency plans of autonomous communities in the cases that require it.

8. 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, for:

1. To receive, evaluate and employ the information referred to in Articles 7 to 13 and, where appropriate, the information referred to in Article 17, as well as to collect as much data as is deemed appropriate in the exercise of its competencies.

2. Develop, approve and refer to the National Civil Protection Commission, for approval, the external emergency plans of the establishments of the higher level, as provided for in Article 13.

3. Order the implementation of the external emergency plans and direct them, in accordance with the Basic Civil Protection Guideline for the control and planning of the risk of serious accidents involving hazardous substances, approved by Royal Decree 1196/2003 of 19 September.

4. Inform the Delegation or Subdelegation of the Government concerned and the Directorate General for Civil Protection and Emergencies of the Ministry of the Interior through the information of a serious accident at the time of the news of a serious accident. National Emergency Room.

5. To elaborate and refer to the Directorate General for Civil Protection and Emergencies of the Ministry of the Interior the reports that the European Commission requests on the application of this royal decree.

6. Apply the soil use control requirements referred to in Article 14, through the territorial management instruments developed in this respect.

7. To ensure compliance with the obligations established in this royal decree, by exercising the corresponding powers of inspection and sanction, in accordance with the legal order.

8. º Submit a 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.

9. Keep up to date, in collaboration with the Ministry of Interior's Directorate General for Civil Protection, the National Chemical Risk Database.

(c) Government Delegates in the Autonomous Communities or, where appropriate, the Government Subdelegates, in accordance with the provisions of Law 6/1997 of 14 April of the Organization and the Functioning of the General Administration of Status and other applicable rules, for:

1. To collaborate with the competent bodies of the autonomous communities in the elaboration of the external emergency plans.

2. To provide the necessary information to the competent authority in the field of civil protection of the autonomous community for the elaboration of the corresponding emergency plans of the establishments affected by the Explosives Regulation or by the Regulation on pyrotechnic articles and cardboard.

3. Receive the information provided for in Article 22 and Annex III through the National Chemical Risk Database.

4. To collect as much data, studies, reports as necessary in order to exercise the competencies, functions and powers that are recognized by its regulatory provisions.

5. To assume the functions that are attributed to them in the State Plan of Civil Protection in the case of the chemical risk.

d) Municipalities or other local entities, if any, for:

1. To collaborate with the competent bodies of the autonomous community, in the elaboration of the plans of external emergency that affect their municipal term, providing the necessary information, in which they will be included data relating to population censuses, municipal mapping, identification of escape routes, organisation of municipal civil protection and other equivalents.

2. To develop and maintain updated the municipal or local action plan, following the guidelines of the external emergency plans; to participate in the execution of the latter directing and coordinating the measures and actions referred to in those, such as notices to the population, activation of the precise protection measures and conduct of exercises and drills of civil protection.

3. Approve the municipal or local action plan and refer it to the Autonomous Civil Protection Commission for approval.

4. Inform immediately the competent authority of the autonomous community on serious accidents originating in its municipal term, as well as any incidents that may result in its triggering, with independence of the warning systems to be determined in the external emergency plan.

5. Apply in their urban planning instruments, the requirements for the control of the use of the soil referred to in Article 14.

2. The competent authorities and the other public administrations, in compliance with the provisions of this royal decree, shall act in accordance with the principles of coordination and collaboration and shall ensure that the information of interest obtained under this royal decree are available to 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, spatial planning and urban planning and ports.

In this respect, the National Civil Protection Commission, in accordance with Royal Decree 967/2002 of 20 September 2002, which regulates its composition and operating system, constitutes the coordinating body and cooperation between the organs of the General Administration of the State and the Administrations of the Autonomous Communities for the implementation of this royal decree.

Likewise, in the territorial area of the autonomous communities, the autonomous commissions of civil protection, represented by the State's peripheral administration, the organs of the autonomous community and the corporations will be represented. local, the coordination core for the implementation of this royal decree.

3. The competent authorities referred to in paragraph 1 of this Article shall accept the equivalent information which, in compliance with Articles 7 to 13, are submitted by manufacturers in accordance with other relevant national legislation. In such cases, the competent authorities shall ensure that all the requirements of this royal decree are met.

Article 7. Notification.

1. Manufacturers, whose establishments are implementing this royal decree, are obliged to send a notification to the competent authority of the autonomous community where they radiate, containing at least the following information:

a) Industrial name or business name, or both, and full address of the corresponding establishment;

b) Industrial address of the industry and full address.

(c) Name and position of the person responsible for the establishment, if he is a person other than the operator referred to in point (a).

(d) Information sufficient to identify the dangerous substances and the category of substances concerned or which may be present. In any case:

1. Denomination of the substance, CAS number and UN number.

2. Identification of hazards and classification according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the labelling and packaging of substances and mixtures.

3. Composition and component information if it were a mixture.

4. º Category to which it belongs in Annex 1 part 1, of this royal decree.

e) The amount and physical form of the hazardous substance or substances concerned.

f) The activity or activity intended for the installation or storage area.

g) Immediate setting of the establishment and factors capable of causing a serious accident or of aggravating its consequences, including, where available, details of neighbouring establishments, of sites remaining outside the scope of this royal decree, areas and works that may cause or increase the risk or consequences of a serious and domino effect accident.

When the establishments are located in the port public domain, this information will also be provided to the competent maritime authorities and port authorities.

2. The notification referred to in paragraph 1, or its update, shall be submitted by the operator:

(a) In the case of new establishments, within a reasonable period of time before the construction or operation begins, or before the changes resulting in a change in the inventory of dangerous substances. All within the time limit determined by the competent authority of the Autonomous Community, which shall in no case exceed one year from the application for a work licence.

(b) In all other cases, within one year from the date on which this royal decree applies to the establishment in question.

3. Paragraphs 1 and 2 shall not apply if the operator has already sent a notification to the competent authority in compliance with the requirements of Royal Decree 1254/1999 of 16 July 1999 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 operator shall inform the competent authority of the autonomous community in advance in the following circumstances and shall, where appropriate, update the notification:

(a) A significant increase or decrease in the significant quantity or modification of the characteristics or physical form of the present hazardous substance, as indicated in the notification sent by the industrialist under the paragraph 1, or significant modification of processes where it is employed, or

b) Modification of an establishment or facility that may have significant consequences for the hazards of a major accident, or

c) Final closure or decommissioning of the establishment, or

(d) Changes in the information referred to in points (a), (b) or (c) of paragraph 1.

Article 8. Severe accident prevention policy.

1. The industrialists of all the establishments to which this royal decree applies, must define and implement correctly their policy of prevention of serious accidents as well as to translate it into a written document.

The implementation of this policy will aim to ensure a high level of protection of human health, the environment and property and will be proportionate to the dangers of serious accident at the establishment. It shall include the general objectives and principles of industrial action, the allocation of tasks and management responsibilities and the commitment to permanently improve the control of the risks of serious accidents and to ensure a high level of protection.

2. The document defining the policy for the prevention of serious accidents shall 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 prior to the start of construction or operation, or prior to the modifications resulting in a change in the inventory of dangerous substances. All this, within the specific time limit determined by the competent authority of the Autonomous Community.

(b) In all other cases, from one year from the date on which this royal decree applies to the establishment in question.

This document will be kept at the disposal of the competent port authorities and maritime capitanies when the establishments are located in the port public domain.

3. For higher level establishments, the document defining its serious accident prevention policy shall be part of the safety report referred to in Article 10.

4. Paragraph 1 shall not apply if the operator has established and implemented, before the date of entry into force of this royal decree, his policy of preventing serious accidents in accordance with Royal Decree 1254/1999 of 16 July 1999. which complies with the provisions of paragraph 1 and has not changed.

5. Without prejudice to Article 11, the operator shall periodically review its policy for the prevention of serious accidents, at least every five years, and update it where necessary. The document defining the updated prevention policy shall be kept at the disposal of the competent bodies of the autonomous community.

6. The policy for the prevention of serious accidents shall be implemented by means of a safety management system through appropriate means, structures and procedures in accordance with Annex II and, in any case, in a proportionate manner to the hazards of serious accidents and the complexity of the organisation or activities of the establishment.

Article 9. Domino effect.

1. The competent bodies of the autonomous communities, using the information provided by the industry pursuant to Articles 7 and 10 or through a request for additional information or through the inspections in accordance with Article 21, determine the upper and lower-level establishments or groups of establishments in which the probability and consequences of a major accident may be increased due to the geographical position and proximity of such establishments; establishments, as well as the presence in these of dangerous substances.

2. Where the competent bodies of the autonomous communities have additional information to that provided by the industry in accordance with Article 7.1 (g), they shall make such information available to them if it is necessary for the application of this Article.

3. The competent bodies of the Autonomous Communities shall establish communication protocols to ensure that the establishments so determined:

(a) The data necessary to enable industrialists to take into account the nature and magnitude of the general risk of serious accidents in their accident prevention policies should be properly exchanged. serious, security management systems, security reports, and internal emergency or self-protection plans;

b) Cooperate in the information to the population and neighbouring sites not included in the scope of this royal decree, as well as in the provision of information to the competent authority for the preparation of the external emergency plans.

4. Accidents which may occur through a domino effect between installations of the same establishment shall be covered by the safety reports referred to in Article 10.

Article 10. Security report.

1. Manufacturers of higher-level establishments are required to produce a safety report, which is intended to:

(a) Demonstrate that a serious accident prevention policy has been established through a safety management system in accordance with the elements set out in Annex II.

b) Demonstrate that the risks of accidents have been identified and assessed, with particular rigour in cases where these can lead to serious consequences, and that the necessary measures have been taken to prevent them and to limit its consequences on human health, the environment and property.

(c) Prove that the design, construction, operation and maintenance of any installation, storage area, equipment and infrastructure linked to its operation, which are related to the risk of a serious accident in the establishment, they have sufficient security and reliability.

d) Prove that internal emergency or self-protection plans have been developed and provide the necessary data to enable the development of the external emergency plan in order to take the necessary measures in the event of an accident severe.

e) Provide sufficient information to the competent authorities to enable them to make decisions on the implementation of new establishments, or to authorise other types of projects in the vicinity of the existing establishments.

2. The safety report shall contain at least the information contained in the Basic Civil Protection Guideline for the control and planning of the risk of serious accidents involving dangerous substances, approved by the Royal Decree 1196/2003 of 19 September.

The safety report shall expressly indicate the names of the relevant organisations involved in their preparation.

In accordance with the provisions of Article 6.3, the safety report and any other studies or reports of a similar nature to be carried out by the industrialists under the applicable sectoral legislation may merge into a single document for the purposes of this Article, where such a merger allows the avoidance of unnecessary duplication of the information and the repetition of the work carried out by the operator or the competent authority, provided that comply with all the requirements of this Article and those required by the sectoral legislation which is applicable. In this respect, in the event of possible consequences for the environment, the analysis of environmental risks prepared in compliance with Law 26/2007 of 23 October of Environmental Responsibility may be used.

3. The operator shall present the safety report to the competent authority of the autonomous community, with due regard to the following deadlines:

(a) In the case of new establishments, prior to the start of their construction or operation or prior to the modifications resulting in a change in the inventory of dangerous substances, all within the specific time limit to be determined by the the competent body of the Autonomous Community.

(b) In the case of existing higher-level establishments, before the one-year period from the date of entry into force of this royal decree.

(c) In the case of other establishments, within two years from the date on which this royal decree applies to the establishment in question.

4. Paragraphs 1, 2 and 3 shall not apply to the operator when he has already sent the security report to the competent authority of the autonomous community before the date of entry into force of this royal decree, in compliance with the requirements of the Royal Decree. Decree 1254/1999 of 16 July 1999 and the information contained in it complies with paragraphs 1 and 2 and has not changed. In order to comply with paragraphs 1 and 2, the operator shall submit all the modified parts of the safety report in the manner prescribed by the competent authority within the time limits referred to in paragraph 3.

5. Any safety report shall be evaluated. For the assessment of safety reports, the competent authority of the autonomous community may, if it considers it appropriate, require the cooperation of the control bodies empowered in accordance with the provisions of the Regulation of the infrastructure for industrial quality and safety, approved by Royal Decree 2200/1995 of 28 December.

6. Once the safety report has been evaluated, the competent authority of the autonomous community shall decide within the maximum period of six months from the date of delivery of the safety report on the safety conditions of the establishment in respect of serious accidents. the following senses:

(a) Communicate to the industry its conclusions on the examination of the safety report, if any, upon request for additional information and/or amendments.

(b) It shall prohibit the entry into service or continuation of the activity of the establishment concerned, in accordance with the powers and procedures provided for in Article 20.

7. Without prejudice to Article 11, the operator should periodically review the safety report and update it, if appropriate, as follows:

a) At least every five years.

b) In the wake of a major accident at its establishment, where necessary.

(c) At any time, on the initiative of the operator or at the request of the competent authority, where it is justified by new data or in order to take account of new technical knowledge on safety.

The updated security report, or its updated parts, will be sent without delay to the competent authority of the autonomous community.

For the purposes of Article 22, the competent authority of the autonomous community shall inform the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior through the Base of such updates. national data on chemical risk.

8. In the case of establishments located in the harbour public domain, the industrial will also transmit copy of the safety report and its subsequent updates to the harbour authority and competent marine capitanies. The competent authority of the autonomous community shall also inform the port authority and the maritime authority of the conclusions of the safety report referred to in paragraph 6.

9. The competent authority of the autonomous community may require manufacturers of lower-level establishments to draw up and submit to that body certain aspects of the safety report which may be necessary for compliance with this Directive. of the specified in Articles 8 and 9.

Article 11. Modifying an installation, setting, or storage zone.

1. In case of modification of an establishment, installation, storage area, process, or characteristics, physical form or quantities of dangerous substances, which may have significant consequences for the risks of serious accident, or which may result in a lower level establishment becoming a higher level establishment or vice versa, the industrial one:

(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 safety management plan. internal emergency or self-protection referred to in Articles 8, 10 and 12, within the time limits laid down in these provisions.

(b) Report to the competent authority of the Autonomous Community on such updates before proceeding with such amendment. 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 authority of the autonomous community shall inform the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior of such updates through the National Base of chemical risk data.

3. For the purposes of paragraph 1, amendments may be considered which may have a significant impact on the risks of a major accident, the following:

a) The change in the affectation level of the establishment, passing from a lower to higher level, or vice versa.

(b) The change in the physical state of any dangerous substance, or of the processes in which it intervenes, so that the release of matter or energy resulting from an accident risk may be foreseen under certain conditions severe.

(c) The incorporation of new dangerous substances in quantities equal to or greater than the thresholds in column 2 of Part 1 or Part 2 of Annex I. All this, where applicable, the rule of the sum of the Note 4 to Annex I.

(d) The increase of the quantities of dangerous substances present in quantities below the thresholds of column 3 of Part 1 or Part 2 of Annex I, where such increase is equal to or greater than the thresholds of the Column 2 of Part 1 or Part 2 of Annex I. All this shall apply, where applicable, to the rule of the sum of Note 4 to Annex I;

(e) The increase of 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, where that increase is 30% or more of the quantity present and, at the same time, increase by 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, as a whole, they meet any of the above conditions.

The ratio of the quantitative and qualitative criteria mentioned in this paragraph is non-limiting. In any event, the competent authority of the Autonomous Community may lay down more restrictive criteria.

Article 12. Internal emergency plans or self-protection plans.

1. In all the establishments subject to the provisions of this royal decree, the industry must draw up an internal emergency plan or self-protection, defining the organization and set of means and procedures for action, with the to prevent accidents of any kind and, where appropriate, to limit the effects within the establishment.

Your content will be in accordance with the basic Civil Protection Guideline for control and planning for the risk of serious accidents involving dangerous substances, approved by Royal Decree 1196/2003 of 19 September and the regulations in force on self-protection. They shall be drawn up after consultation with the staff of the establishment and the workers of subcontracted undertakings or long-term subcontractors; in any event, in compliance with Article 18, with regard to information, consultation and participation. of the workers, of the Law 31/1995, of 8 November, of Prevention of Occupational Risks.

2. The competent bodies of the autonomous communities shall lay down appropriate rules for the purpose of the industrial keeping up to date of the internal emergency or self-protection plans, by means of their amendment in accordance with the which would have been produced in the establishments and, in any event, in periods not exceeding three years. The review shall take into account changes in the establishments concerned, as well as new technical knowledge and knowledge of the measures to be taken in the event of a major accident.

3. In the context of the obligations arising from the coordination of business activities referred to in Article 24 of Law 31/1995 of 8 November 1995, developed by Royal Decree 171/2004 of 30 January 2004 on the coordination of business activities, the owner of the establishment must report the contents of the emergency plan or self-protection to those subcontracted and self-employed enterprises which carry out their business in that 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 emergency plan or self-protection plan shall be referred to the competent authority of the autonomous community, as well as to the competent port authorities and maritime capitanies where the establishments are located in the domain. port public:

(a) For new establishments, before the start of their operation or before any changes in the inventory of dangerous substances, all within the time limit set by the Community autonomic.

b) For existing establishments, no later than one year from the date of entry into force of this royal decree, unless the plan drawn up in compliance with the requirements of Royal Decree 1254/1999, of 16 July, prior to that date and the information contained therein, 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 manufacturers of the higher level establishments shall provide, in the terms and time limits referred to in paragraph 4, the information necessary for the competent authority in the field of civil protection of the autonomous community. Develop the external emergency plans.

Article 13. External emergency plans.

1. For higher-level establishments, including those regulated by the Explosives Regulation, and by the Regulation on pyrotechnic articles and cardboard, the bodies responsible for civil protection of the autonomous communities develop, with the collaboration of the industrialists, an external emergency plan to prevent and, if necessary mitigate, the consequences of the possible serious accidents previously analyzed, classified and evaluated, in which the more suitable protection measures, the human and material resources required and the scheme coordination of the authorities, bodies and departments called to intervene.

Your approval content and procedure shall comply with the requirements of the Basic Civil Protection Guideline for the control and planning of serious accidents involving dangerous substances, approved by Royal Decree 1196/2003 of 19 September.

The time limit for its preparation and approval shall be two years from the receipt of the safety report and the information referred to in Article 12

5).

2. In order to prepare or modify substantially the external emergency plans, the competent bodies of the autonomous communities shall establish consultation mechanisms so that the public concerned may give their opinion from a stage early.

3. The competent bodies of the autonomous communities shall organise a system to ensure the periodic review, updating, testing and, where appropriate, the modification of all external emergency plans at appropriate intervals which shall not be required. to exceed three years. Account shall be taken of both the changes in the establishments concerned and the organisation of the emergency services called to intervene, as well as the new technical knowledge and knowledge about the measures to be taken in the event of a major accident.

This system will ensure that all administrations, agencies and services involved have timely updates, tests and reviews carried out in the external emergency plans. The competent authority of the autonomous community shall also ask the National Civil Protection Commission for a new type-approval, if it considers it appropriate, on the basis of periodic reviews, extensions, replacements or other changes that vary the conditions under which the initial approval was made.

4. The competent authority of the autonomous community may decide, in the light of the information contained in the safety report, that the provisions of paragraph 1 concerning the obligation to establish an external emergency plan shall not apply; provided that the impact of the accidents provided for in the safety report is shown to have no impact on the outside. This justified decision shall be communicated to the National Civil Protection Commission for the purposes referred to in Article 6.

5. In relation to those establishments that are located in the harbour public domain, the harbour authorities and the competent marine capitanies will collaborate with the competent organs of the autonomous communities in the elaboration of the external emergency plan.

Article 14. Land use planning.

1. The competent bodies of the autonomous communities shall ensure that the objectives of the prevention of serious accidents and the limitation of their consequences for human health, property and the environment are taken into account in their instruments of territorial and urban planning and other relevant ones. Seek to achieve such objectives by controlling:

a) The placement of new establishments.

(b) Changes to the establishments referred to in Article 11.

(c) New works, such as communication routes, public places and residential areas, carried out in the vicinity of establishments, where the site or the works executed may cause or increase the risk or the consequences of a major accident.

2. Instruments for the allocation or use of land and other relevant instruments, as well as the procedures for implementing them, shall take into account the need for the long term:

(a) To maintain the appropriate distances between, on the one hand, the establishments covered by this royal decree, and, on the other, the housing areas, the areas frequented by the public, the recreational areas and, to the extent of the possible, the great routes of transport. For establishments also affected by the explosives Regulation or by the Regulation on pyrotechnic articles and cardboard, these distances may in no case be less than the minimum distances to be observed for the site of factories, workshops and warehouses established in the Technical Instruction Supplementary No 10 of the Explosives Regulation, approved by Order PRE252/2006 of 6 February, and in the Technical Instruction Complementary n. 10 of the Regulation of pyrotechnic articles and cardboard.

(b) to protect areas which have a particular natural interest or are particularly sensitive in the vicinity of establishments, maintaining, where appropriate, appropriate safety distances or other relevant measures.

(c) For existing establishments, to take additional technical measures, in accordance with Article 5, in order not to increase the risks to human health and the environment.

3. The bodies empowered to take decisions in this field shall establish appropriate consultation procedures to facilitate the implementation of policies adopted pursuant to paragraph 1. The procedures will be such that, when decisions of an urban nature are taken, sufficient information is provided by the industrialists on the risks linked to the establishment and a technical opinion to the in respect of, based on the study of specific cases or on general criteria.

In order to avoid duplication, the phase of public information and consultation will be joint for all those procedures established in the regulations that apply to the approval or authorization of the plan, program or project demand this phase.

4. Manufacturers of lower-level establishments, at the request of the competent bodies of the autonomous community, shall provide information on the risks linked to the establishment which is necessary for the purposes of planning the occupation of the soil.

Article 15. Information to the public.

1. The competent authority shall, in each case, make the information referred to in Annex III available to the public on a permanent basis and also in electronic form. The information shall be updated as necessary, also in the light of the amendments referred to in Article 11.

2. In the case of higher-level establishments, the competent authority in collaboration with the manufacturers of the establishments shall also ensure that:

(a) The public concerned, including those in all buildings and public areas, such as schools and hospitals, and in all the surrounding areas, for the purposes referred to in Article 9, regularly, by the most appropriate means and without having to request it, clear and comprehensible information on the safety measures and the behaviour to be taken in the event of a major accident.

This information shall include at least the data referred to in Annex III, being provided at least every five years and being updated where necessary, also on the basis of the amendments referred to in Annex III. Article 11.

(b) The security report shall be made available to the public upon request, without prejudice to the provisions of Article 23.3. For this purpose, a modified report shall be made available to the public, for example in the form of a non-technical summary, which shall include general information on the hazards of a major accident and its potential effects on human health, property and the environment in the event of a major accident;

(c) The inventory of dangerous substances is available to the public upon request, without prejudice to the provisions of Article 23.3.

3. For the purposes of Article 22, the competent authority of the autonomous community shall incorporate the information referred to in paragraph 2 into the National Chemical Risk Database.

Article 16. Public consultation and participation in decision making.

1. Specific projects relating to:

shall be subject to consultation and participation of the public concerned at an early stage:

a) The planning of new establishments, in accordance with Article 14.

(b) Significant changes to the establishments referred to in Article 11, where they are subject to the requirements of Article 14.

(c) The execution of works in the vicinity of establishments, where the site or works executed may increase the risk or consequences of a major accident, in accordance with Article 14.

2. In relation to the specific projects referred to in paragraph 1, the competent authority shall, in each case, inform the public, by means of a notice published in the relevant official gazette for at least 15 working days, without prejudice to its possible publication on an official website during the same period of the following cases:

a) The object of the particular project.

(b) Where appropriate, the fact that a project is subject to an environmental impact assessment, or to consultations between Member States.

(c) Data on the competent bodies responsible for taking the decision, from which relevant information can be obtained and to which comments may be submitted or questions asked, as well as the time limits for this.

d) The nature of the possible decisions or, where appropriate, of the draft decision.

e) An indication of the dates and locations in which the relevant information will be provided, as well as the means used to do so.

3. The competent authority in each case shall also make available to the public concerned the following elements concerning the specific projects referred to in paragraph 1:

(a) The main reports and opinions referred to the competent authority at the time the public was informed in accordance with paragraph 2.

(b) Any information other than that referred to in paragraph 2, which is relevant to the decision in question and which can only be obtained after the public has been informed in accordance with paragraph 2.

The interested public must decide within the maximum period of 30 calendar days from the receipt of the request for participation. After that period without the delivery of the statement, the procedure shall continue.

4. Where the relevant decisions are taken, the competent authority shall inform and make available to the public, through public notices or other appropriate means such as electronic means where available, and within three months from the date of the notification. from the receipt of the notification and the documents to accompany it:

a) The content of the decision and the reasons that justify it, including, where applicable, subsequent updates.

b) The results of the consultations held before making the decision and an explanation of how they were taken into account to reach it.

5. For the public concerned to have the possibility from an early stage of giving its opinion on plans or programmes relating to the matters referred to in points (a) or (c) of paragraph 1:

(a) The competent authority in each case shall consult the public concerned, making available the draft plan or programme.

(b) The interested public consulted shall decide within the maximum period of 45 working days from the receipt of the draft. After that period without the delivery of the statement, the procedure shall continue.

(c) The competent authority in each case shall take the appropriate decision within four months of the start of the consultation process.

This paragraph shall not apply to plans and programmes for which a participation procedure is carried out in accordance with Law 21/2013 of 9 December of environmental assessment.

Article 17. Information to be provided by the operator in the event of a major accident.

1. As soon as there is an incident or accident liable to cause a serious accident according to the definition given in Article 3 and making use of the most appropriate means, the industrialists of the establishments falling within the scope The application of this royal decree will be obliged to inform immediately the competent authority of the autonomous community in matters of civil protection.

The manufacturers of the establishments regulated by the explosives regulation and by the Regulation of pyrotechnic articles and cardboard, will also do so to the Delegation or Subdelegation 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 as follows:

a) The circumstances that have occurred for the accident to occur;

(b) The dangerous substances and quantities initially involved in the accident, or which may be caused by adverse developments in the accident;

(c) The data available for the assessment of direct and indirect effects in the short, medium and long term, on human health, property and the environment;

d) Internal emergency measures taken;

e) The intended internal emergency measures;

f) The external support measures necessary for the control of the accident and the attention to the affected;

g) Other information referred to by the competent authority.

For this purpose, the procedures for direct communication with the emergency centre which the competent authority has at its disposal should be adapted.

2. Subsequently, the industrial event must, within a reasonable period of time, be established by the competent authority of the autonomous community:

(a) To issue to the competent bodies of the autonomous community, in detail, the causes and effects produced as a result of the accident.

b) Inform the competent bodies of the autonomous community of the measures envisaged for:

1. º Mitigate the effects of the accident in the medium and long term.

2. Prevent similar accidents from occurring, based on acquired experiences.

c) Update the information provided, in the event that more rigorous investigations reveal new facts that modify such information or the conclusions that may result from it.

Article 18. Measures to be taken by the competent authority after a major accident.

The emergency situation after a serious accident has been completed, the competent bodies of the autonomous community must:

a) Ensure that medium-and long-term measures are taken, that they are necessary.

(b) Collect, through inspection, investigation or other appropriate means, the information necessary for a complete analysis of the accident in the technical, organisational and management aspects.

c) Dispose what is necessary for the industrialist to take the necessary palliative measures.

d) Formulate recommendations on future prevention measures.

Article 19. Information to be provided by the competent authority of the Autonomous Community in the event of a major accident.

1. In order to ensure coordination in cases of serious accidents between the authorities called to intervene, as well as to meet the requirements of information to the European Commission, the competent bodies of the autonomous communities inform the delegation of the Government concerned and, where appropriate, the Subdelegation of the Government of the province where the establishment is situated, as well as the Directorate-General, at the time of the report of a serious accident, Civil Protection and Emergencies of the Ministry of the Interior through the National Emergency Room.

2. The competent bodies of the autonomous communities shall forward to the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior as soon as possible and, at the latest, two months after the date of the accident, the information of serious accidents occurring on its territory. For those who meet the criteria in Annex IV to this royal decree, this information shall contain at least the following information:

a) Name and address of the authority responsible for producing the report.

b) Date, time and place of the accident, full name of the operator and address of the establishment concerned.

c) A brief description of the circumstances of the accident, with indication of the hazardous substances involved and the immediate effects on human health and the environment.

d) A brief description of the emergency measures taken and the immediate precautions necessary to avoid the repetition of the accident.

e) The results of their investigations into the accident and recommendations. This information may be delayed in order to allow for the conclusion of court proceedings, where such communication may affect such procedures.

For compliance with this paragraph, the National Civil Protection Commission shall agree on the corresponding standard formats, in accordance with the criteria recommended by the European Commission.

3. For the purposes of Article 22, the competent body of the autonomous community shall incorporate the information referred to in paragraph 2 into the national chemical risk database.

4. The Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior shall also provide the standard information to the European Commission, as provided for in Article 6.

Article 20. Prohibition of exploitation.

1. The competent bodies of the autonomous communities shall prohibit the holding or entry into service of any establishment, installation, storage area or any part thereof where the measures taken by the holder for the purpose of the prevention and reduction of serious accidents are considered to be manifestly insufficient.

In particular, they shall take into account serious cases where the necessary measures referred to in the inspection report have not been adopted.

2. The competent bodies of the autonomous communities may prohibit the operation or entry into service of any establishment, installation or storage area or of any part thereof if the operator has not presented the notification, reports or other information required by this royal decree within the time limit set.

3. The competent authority of the autonomous community shall inform the National Civil Protection Commission of the decisions taken in its territory in accordance with paragraphs 1 and 2.

4. In the light of the prohibitions laid down in paragraphs 1 and 2, the industrial concerned may bring an action, in accordance with the provisions of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Administrative Procedure. Common.

Article 21. Inspections.

1. The competent bodies of the autonomous communities shall establish a system of inspections and control measures appropriate to each type of establishment within the scope of this royal decree.

2. Such inspections shall be appropriate for the type of establishment concerned, shall not depend on the receipt of the safety report or any other report submitted and shall enable a planned and systematic examination of the technical equipment, of the organisation and management modes applied in the establishment, in order to enable the operator to demonstrate, in particular:

a) That it has taken appropriate measures to prevent serious accidents, taking into account the activities of the establishment.

b) That you have taken appropriate measures to limit the consequences of serious accidents inside and outside the establishment.

c) That the data and information provided in the security report, or other reports presented, faithfully reflect the security of the establishment.

d) That it has established programmes and informed staff of the establishment on protective and action measures in the event of an accident.

3. The competent authority of the autonomous community shall ensure that all establishments are covered by a regional or local inspection plan and ensure that this plan is reviewed and, where appropriate, regularly updated.

The inspection plans will include the following:

a) An overall assessment of the relevant security aspects.

b) The geographical area covered by the inspection plan.

c) The relationship of the establishments covered by the plan.

d) The relationship of the groups of establishments with possible domino effect according to Article 9.

e) A list of establishments in which sources of danger or specific external risks may increase the likelihood or consequences of a major accident.

(f) Procedures for routine inspections, including programmes for such inspections in accordance with paragraph 4.

g) The procedures for non-routine inspections referred to in paragraph 5.

(h) Provisions on cooperation between the different authorities responsible for inspections.

In order to carry out the inspections, the competent authority of the autonomous community may, if it deems appropriate, require the collaboration of control bodies authorized by the competent authority, in accordance with the the provisions of the Regulation on infrastructure for industrial quality and safety.

4. On the basis of the inspection plans referred to in paragraph 3, the competent authority shall, in each case, regularly draw up routine inspection programmes for all establishments, including the frequency of on-site visits to the different types of establishments.

The period between two consecutive on-site visits shall not exceed one year for the higher level establishments and three for the lower level, unless the competent authority has drawn up an inspection programme. based on a systematic assessment of the serious accident hazards of the establishments concerned.

This systematic assessment of hazards will be based on at least the following criteria:

(a) The possible impact of establishments on human health, property and the environment.

b) The compliance history of the requirements of this royal decree.

Where appropriate, the relevant findings of inspections carried out in accordance with other regulations shall also be taken into account.

5. Non-routine inspections shall be carried out to investigate, as soon as possible, serious complaints, serious accidents and accident incidents, incidents and cases of non-compliance.

6. Within four months of each inspection, the competent authority of the autonomous community shall communicate to the operator the conclusions of the inspection and any action deemed necessary. The competent authority shall ensure that the operator carries out all such necessary action within a reasonable period after receiving the communication. This period shall be determined by the competent authority of the Autonomous Community.

If an important case of non-compliance with this royal decree has been detected, another inspection will be carried out within six months.

When inspection reports give evidence of relevant interest to other areas of administrative action, in terms of risks to human health, safety and occupational health, safety and industrial quality, The competent authorities of the autonomous communities shall send copies of such reports to the respective competent authorities in such matters, in order to enable them to adopt the necessary measures, in order to enable them to adopt the relevant measures.

The competent inspection bodies shall bring to the attention of the corresponding regional civil protection committees, by means of an annual report drawn up for this purpose, the results and circumstances which have been in the inspections carried out.

Where possible and appropriate, inspections shall be coordinated with those carried out in accordance with other regulations.

7. For the purposes of Article 22, the competent authority of the autonomous community shall incorporate the information referred to in paragraphs 3 and 6 into the national chemical risk database.

8. The Directorate-General for 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 to participate in such mechanisms at the level of the European Union, where appropriate.

9. The competent bodies of the autonomous communities shall ensure that the industry provides the competent authorities with all the assistance necessary to enable them to carry out the inspections and to gather the necessary information for the performance of its obligations for the purposes of this royal decree, in particular to enable the authorities to assess exhaustively the possibility of a serious accident and to determine the likelihood of an increase in the likelihood or severity of the accident. serious accidents, preparing an external emergency plan and taking into account substances which, by their physical form, their particular conditions or their location, may require further consideration.

Article 22. Exchanges and information system.

1. The Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior and the competent bodies of the autonomous communities shall exchange information on the experience acquired in the prevention of serious and serious accidents. limitation of its consequences. This information will mainly cover the operation of the measures envisaged by this royal decree and will be shared through the National Chemical Risk Database.

2. The Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior, shall administer and maintain the operational and at the disposal of the competent bodies such Database, with detailed information on the establishments referred to in this royal decree, as well as with the information on accidents as defined in Article 19 (2

.

The Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior in collaboration with the competent bodies of the Autonomous Communities shall keep the said Base updated.

3. In order to facilitate compliance with the provisions of Article 15 (1), the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior shall allow through its website and if the competent authority of the Autonomous Community it considers it to make available to the public the data in Annex III which are not considered confidential in accordance with Article 23.

Article 23. Access to information and confidentiality.

1. In the interests of greater transparency, the competent authorities in each case shall make the information received pursuant to this royal decree available to any natural or legal person who so requests, in accordance with the terms laid down in the Law 27/2006 of 18 July on the rights of access to information, public participation and access to justice in the field of the environment (incorporates Directives 2003 /4/EC and 2003 /35/EC).

2. The disclosure of information required under this royal decree, including that pursuant to Article 15, may be refused or restricted by the competent authority when the conditions laid down in Article 13 of the Treaty are met. Law 27/2006, of July 18.

3. The disclosure of the complete information referred to in points (b) and (c) of Article 15 (2), which is held by the competent authority in each case, may be refused by the competent authority, without prejudice to paragraph 2, if the operator has requested that certain parts of the safety report or the inventory of dangerous substances be not disclosed for the reasons set out in Article 13 of Law 27/2006 of 18 July.

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 such cases, and subject to the agreement of that competent authority, the operator shall provide a modified report or inventory to which those parties are excluded.

Article 24. Access to justice.

1. Any applicant who requests information pursuant to Article 15.2 (b) or (c) or Article 23.1 may bring the administrative resources provided for in Title VII of Law No 30/1992 of 26 November 1992 and other applicable legislation and, in his Case, the legal-administrative action provided for in Law 29/1998 of July 13, regulating the Jurisdiction-Administrative Jurisdiction, for the acts or omissions of the competent body in relation to its application, in the terms provided for in the Law 27/2006, of July 18.

2. The public concerned, in the cases to which Article 16.1 applies, may submit the administrative resources referred to in Title VII of Law No 30/1992 of 26 November 1992 and other applicable rules and, where appropriate, the appeal administrative-administrative dispute under Law 29/1998 of 13 July, as provided for in Law 27/2006 of 18 July.

Article 25. Sanctioning regime.

Without prejudice to the violations that may be established by the autonomous communities, the failure to comply with this royal decree will be qualified and sanctioned in accordance with the following rules:

(a) Law 2/1985 of 21 January on Civil Protection.

b) Title V "Infractions and Sanctions" of Law 21/1992, of July 16, of Industry.

(c) Chapter V "Infractions and Sanctions" of Law 26/2007 of 23 October on Environmental Liability.

Additional disposition first. 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 applicable by the competent bodies of the cities of Ceuta and Melilla.

Additional provision second. Information to the Directorate General for Civil Protection and Emergencies of the Ministry of the Interior.

By 30 March 2016 at the latest, and thereafter each year, the competent authority of the Autonomous Communities shall provide the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior with a report on the application of this royal decree.

Additional provision third. Duty of information to the European Commission.

By 30 September 2019 at the latest, and every four years thereafter, the Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior will provide the European Commission with a report on the implementation of the royal decree.

Additional provision fourth. No increase in public spending.

The measures included in this royal decree will not be able to increase appropriations, remuneration, or other personnel costs.

Single repeal provision. Regulatory repeal.

Royal Decree 1254/1999 of 16 July 1999 laying down measures for the control of the risks inherent in serious accidents involving dangerous substances, as well as the provisions of the same provisions, is hereby repealed. or lower rank to be opposed to the provisions of this royal decree.

Final disposition first. Competence title.

This royal decree is issued under the exclusive competence of the State in matters of public security provided for in Article 149.1.29. of the Constitution.

Final disposition second. Incorporation of European Union law.

By this royal decree, Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of the risks inherent in serious accidents in the European Union is incorporated into the Spanish legal order. that dangerous substances are involved and that Directive 96 /82/EC is amended and subsequently repealed.

Final disposition third. Coordination of procedures.

The competent bodies of the General Administration of the State will promote the necessary actions to coordinate, as far as possible and with full respect for the distribution of competences among the different Administrations, procedures and controls provided for in this royal decree with those regulated in the relevant sectoral regulations where the scope of application is partially matched.

Final disposition fourth. Regulatory development.

By the Ministers of Interior, Development, Employment and Social Security, Industry, Energy and Tourism, Agriculture, Food and Environment Ministers, and Health, Social Services and Equality, in the field of respective powers, the provisions necessary for the implementation and development of the provisions of this royal decree shall be made.

Final disposition fifth. Regulatory enablement.

The Ministers of the Interior, Public Works, Employment and Social Security, Industry, Energy and Tourism, Agriculture, Food and Environment, Health, Social Services and Equality, or the Minister of State, are hereby authorised. Presidency, on a joint proposal from those, prior to the report of the National Civil Protection Commission, according to the assumptions that in each case it is dealt, to modify by ministerial order the annexes of this royal decree.

Final disposition sixth. Entry into force.

This royal decree will enter into force on the day following 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 SAENZ DE SANTAMARIA ANTON

ANNEX I

Dangerous substances

Dangerous substances included in the hazard categories listed in column 1 of Part 1 of this Annex shall be subject to the threshold quantities set out in columns 2 and 3 of Part 1.

In case a hazardous 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 shall apply.

Part 1

Dangerous substance categories

This part comprises all the hazardous substances included in the hazard categories listed in column 1:

50

Column 1	Column 2	Column 3
Danger categories in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.	threshold (in tons) of hazardous substances referenced in Article 3, paragraph 10, for application purposes of
	Requirements lower	Top level
Section "H"-HAZARDS TO HEALTH
H1 ACUTE TOXICITY- Category 1, all routes of exposure.	5	20
H2 ACUTE TOXICITY -Category 2, all exposure paths -Category 3, inhalation exposure path (see note 7).	50	200
H3 SPECIFIC TOXICITY IN CERTAIN ORGANS (STOT)-UNIQUE EXPOSURE STOT SE Category 1.	50	200
"P"-PHYSICAL HAZARDS
EXPLOSIVES P1A (SEE Note 8) -Unstable Explosives or - Explosives in divisions 1.1, 1.2, 1.3, 1.5 or 1.6, or -Substances or mixtures having explosive properties in accordance with Method A. 14 of Regulation (EC) No 440/2008 of the European Parliament and of the Council, of 16 December 2008, (see footnote 9) and do not belong to the hazard classes "organic peroxides" or "spontaneously reacting substances or mixtures".	10	50
P1b EXPLOSIVES (see the note 8) Explosives of division 1.4 (see note 10).	50	200
FLAMMABLE GASES flammable Gases in categories 1 or 2.	10	50
P3a FLAMMABLE AEROSOLS Aerosols 'flammable' of categories 1 or 2, containing flammable gases of categories 1 or 2 or flammable liquids of category 1.	150 (net)	500 (net)
P3b FLAMMABLE AEROSOLS flammable "Aerosols" of categories 1 or 2, which do not contain flammable gases from the categories 1 or 2 or flammable liquids of category 1.	5,000 (net)	50,000 (net)
P4 GASES COMBURTS Category 1 comburant Gases.	50	200
	P5a FLAMMABLE LIQUIDS -Category 1 flammable liquids, or -flammable liquids of categories 2 or 3 maintained at a temperature higher than their point of boiling, u -Other liquids with a flash point ≤ 60 ° C, maintained at a temperature above its boiling point (see note 11).	10	50
P5b FLAMMABLE LIQUIDS -flammable liquids in categories 2 or 3 when the particular conditions of process, e.g. high pressure or temperature, can create hazards of serious accidents, or Table-table_izq">-Other liquids with a flash point ≤ 60 ° C when particular process conditions, such as high pressure or temperature, can create hazards of serious accidents (see note 11).	50	200
P5c FLAMMABLE LIQUIDS Flammable Liquids of Categories 2 or 3 not included in P5a and P5b.	5,000	50,000
P6a SPONTANEOUSLY REACTING SUBSTANCES AND MIXTURES and ORGANIC PEROXIDES Substances and mixtures that react spontaneously from types A or B or organic peroxides of types A or B.	10	50
P6b SUBSTANCES AND MIXTURES THAT REACT SPONTANEOUSLY and ORGANIC PEROXIDES Substances and mixtures that spontaneously react from C, D, E, or F types or organic peroxides of types C, D, E, or F.	50	200
P7 LIQUIDS AND PIROPHORIC SOLIDS Category 1 pyrophoric liquids Pirophoric solids category 1.	50	200
P8 LIQUID AND SOLID OXIDISING liquids Category 1, 2, or 3, or	200
50 Centro_table_body"> Section "E"-HAZARDS TO THE ENVIRONMENT
	E1 Hazardous for aquatic environment in acute categories 1 or chronic 1.	100	200
E2 Dangerous for the aquatic environment in chronic category 2.	200	500
Section "O" HAZARDS
O1 Substances or mixtures with hazard indication EUH014.	100	500
O2 Substances and mixtures that, in contact with water, detach flammable gases from category 1.	100	500
O3 Substances or mixtures with hazard indication EUH029.	50	200

Part 2

Hazardous substances nominated

Column 1	CAS Number (1)	Column 2	Column 3
Substances		Threshold quantities (tons) for application the
		lower level requirements	Top Level
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
7. Diarsenic pentaoxide, arsenic acid (V) and/or salts	1303-28-2	1	2
8. Arsenic trioxide, arsenious acid (III) and/or salts	1327-53-3		0.1
9. Bromine	7726-95-6	20	100
10. Chlorine	7782-50-5	10	25
11. Inhalable pulverulent nickel compounds: nickel monoxide, nickel dioxide, nickel sulphide, trinyl disulfide, dinikel trioxide	-
. Ethylene imine	151-56-4	10	20
13. Fluoride	7782-41-4	10	20
14. Formaldehyde (concentration ≥ 90%)	50-00-0	5	50
15. Hydrogen	1333-74-0	5	50
16. Hydrochloric acid (liquefied gas)	7647-01-0	25	250
17. Alkyllead derivatives	-	5	50
18. Liquefied flammable gases of categories 1 or 2 (including LPG) and natural gas (see note 18)	-	50	200
19. Acetylene	74-86-2	5	50
20. Ethylene oxide	75-21-8	5	50
21. Propylene oxide	75-56-9	5	50
22. Methanol	67-56-1	500	5,000
	23. 4,4 ' -methylene-bis (2-chloroaniline) and/or its salts in pulverulent form	101-14-4		0,01
24. Methyl isocyanate	624-83-9		0.15
25. Oxygen	7782-44-7	200	2,000
26. Toluene 2,4-diisocyanate 2,6-toluene diisocyanate	584-84-9 91-08-7	10	100
27. Carbonyl dichloride (phosgene)	75-44-5	0.3	0.75
28. Arsina (arsenic trihydride)	7784-42-1	0.2	1
29. Phosphine (phosphorus trihydride)	7803-51-2	0.2	1
30. Sulfur dichloride	10545-99-0		1
31. Sulfur trioxide	746-11-9	15	75
32. Polychlorinated dibenzofurans and polychlorinated dibenzodioxins (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, ether bis (chloromethyl), chloromethyl and methyl ether, 1,2-dibromoethane, diethyl sulphate, dimethyl sulphate, dimethyl-carbamoyl chloride, 1,2-dibromo-3-chloropropane, 1,2-dimethylhydrazine, dimethylnitrosamine, triamide hexamethylphosphoric, hydrazine, 2-naphthylamine and/or its salts, 4-nitrodiphenyl or 1,3 propanesulfona			2
. Petroleum products and alternative fuels a) gasoline and naphthas b) kerosene (including carburetorreactors) c) gas oils (including automotive gasoils, heating gas oils and components used in commercial gas mixtures) d) heavy fuel oils e) alternative fuels to products referred to in points (a) to (d) for the same purposes and with properties similar in regards to flammability and environmental hazards	-	2,500	25,000
35. Anhydrous ammonia	7664-41-7	50	200
36. Boron trifluoride	7637-07-2	5	20
37. Hydrogen sulfide	7783-06-4	5	20
38. Piperidine	110-89-4	50	200
39. Bis (2-dimethylaminoethyl) (methyl) amine	3030-47-5	50	200
40. 3-(2-ethylhexyloxy) propylamine	5397-31-9	50	200
41. Mixtures (*) of sodium hypochlorite classified as hazardous to the aquatic environment in category 1 acute hazard [H400] containing less than 5% active chlorine and not classified in any other hazard category in the Part 1 of Annex I. (*) Provided that the mixture, in the absence of sodium hypochlorite, is not classified as hazardous to the aquatic environment in category 1 acute hazard [H400].		200	500
42. Propylamine (see note 20)	107-10-8	500	2,000
43. Tert-butyl acrylate (see note 21)	1663-39-4	200	500
44. 2-methyl-3-butenonitrile (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)	96-33-3	500	2,000
47. 3-methylpyridine (see note 21)	108-99-6	500	2,000
48. 1-bromo-3-chloropropane (see note 20)	109-70-6	500	2,000

(¹) The CAS number is shown only for an indicative title.

Notes in Annex I:

1. Substances and mixtures are classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

2. Mixtures shall be treated in the same way as pure substances provided that they comply with the concentration limits established in accordance with their properties in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, or its latest adaptation to technical progress, unless a percentage composition or other description is specifically indicated.

3. The amounts that have been previously indicated as a threshold refer to each establishment.

The amounts to be taken into account for the application of the relevant items are the maximum amounts that are present, or may be, at any given time. For the calculation of the total quantity present, the dangerous substances existing in an establishment shall not be taken into account only in a quantity equal to or less than 2% of the quantity indicated as a threshold, if their situation within the establishment is such that it cannot cause a serious accident anywhere else in the establishment.

4. The following rules, on the sum of dangerous substances, or categories of hazardous substances, shall apply where appropriate.

In the event that no hazardous substance is present in an establishment equal to or greater than the corresponding threshold quantity, the following rule shall apply to determine whether they are applicable to such a establishment of the relevant requirements of this royal decree.

This royal decree will be applied to higher-level establishments if the sum:

q₁/Q_U1 + q₂/Q_U2 + q₃/Q_U3 + q₄/Q_U4 + q₅/Q_U5 + ... is equal to or greater than 1, being:

q_x = the quantity of the dangerous substance or category of dangerous substances x referred to in Part 1 or Part 2 of this Annex,

and Q_UX = the relevant threshold quantity for the hazardous substance or category x in column 3 of Part 1 or column 3 of Part 2 of this Annex.

This royal decree will apply to lower-level establishments if the sum:

q₁/Q _L1 + q₂/Q _L2 + q₃/Q_L3 + q₄/Q_L4 + q₅/Q_L5 + ... is equal to or greater than 1, being:

q_x = the quantity of the dangerous substance or category of dangerous substances x referred to in Part 1 or Part 2 of this Annex,

and Q_LX = the relevant threshold quantity for the hazardous substance or category x in column 2 of Part 1 or column 2 of Part 2 of this Annex.

This rule will be used to assess health hazards, physical hazards and environmental hazards. It should therefore be applied three times:

(a) For the sum of the dangerous substances listed in Part 2 which fall into categories 1, 2 or 3 (by inhalation) of acute toxicity or category 1 STOT SE, together with the dangerous substances included in the section H, subsections H1 to H3, part 1.

(b) For the sum of the dangerous substances listed in Part 2, consisting of explosives, flammable gases, flammable aerosols, oxidising gases, flammable liquids, hazardous substances and mixtures which react spontaneously, organic peroxides, pirophoric liquids and solids, liquid and solid oxidants, together with the substances listed in section P, subsections P1 to P8, in Part 1.

(c) For the sum of the hazardous substances listed in Part 2 that enter, as hazardous substances for 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, in Part 1.

The relevant provisions of this royal decree shall apply if any of the sums obtained in (a), (b) or (c) are equal to or greater than 1.

5. In the case of dangerous substances which are not covered by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, including waste, but which are, or may be, present in a the establishment and possession or possession of equivalent properties which may cause serious accidents on the terms of the establishment shall be provisionally assigned to the most similar category or dangerous substance nominated as scope of application of this royal decree.

6. In the case of dangerous substances whose properties allow them to be classified more in one way, the lower threshold quantities shall be applied for the purposes of this royal decree. However, for the application of the rule in note 4, the lower threshold quantity shall be used for each group of categories in note 4 (a) to (c) applicable to the corresponding classification.

7. Dangerous substances entering category 3 of acute toxicity by mouth (H 301) shall be included in subsection H2 ACUTE TOXICITY when the classification of acute dermal toxicity and the classification of toxicity cannot be inferred. acute by inhalation; for example, due to a lack of conclusive data on skin toxicity or inhalation.

8. The hazard class 'explosives' includes explosive articles (see Section 2.1 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008). If the quantity 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 quantity of explosive substance or mixture contained in the article is not known, the whole article, for the purposes of this royal decree, shall be treated as explosive.

9. It is only necessary to carry out tests on 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, testing and criteria ("United Nations Test and Criteria Manual")¹ finds that the substance or mixture may have explosive properties.

¹ More guidance on cases where testing is not necessary can be found in the description of Method A. 14, see Commission Regulation (EC) No 440/2008 of 30 May 2008 on the establishing test methods in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the registration, assessment, authorisation and restriction of chemicals (REACH) (OJ L 142, 30.6.2006, p. of 31.5.2008, p.  1).

10. If the explosives in Division 1.4 are unpacked or repackaged, they shall be assigned to Subsection P1a, unless the danger is shown to be still corresponding to Division 1.4 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008.

11. In accordance with point 2.6.4.5 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, liquids with a flash point of more than 35 ° C may not be classified in category 3 if they are obtained negative results in the sustained solubility test L. 2, Part III, Section 32 of the United Nations Manual of Testing and Criteria. However, this is not applicable under conditions, such as a high temperature or pressure, and therefore those liquids are included in this subsection.

12. Ammonium nitrate (5,000/10,000): fertilizers susceptible to self-decomposition.

It 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 test with the the United Nations (see the Manual of Tests and Criteria, Part III, Subsection 38.2) for which the 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 for combustible or organic materials, or meet the requirements of Annex III-2 to the Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 on fertilisers⁴.

² The 15.75% by weight of nitrogen content due to ammonium nitrate corresponds to 45% ammonium nitrate.

³ 24.5% by weight of nitrogen content due to ammonium nitrate corresponds to 70% ammonium nitrate.

⁴ OJ L 304, 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.

It applies to simple ammonium nitrate fertilisers and to compound and complex fertilisers based on ammonium nitrate which comply with the requirements of Annex III-2 to Regulation (EC) No 2003/2003 of the European Parliament and of the European Parliament. Council of 13 October 2003 on fertilisers, the nitrogen content of which is due to ammonium nitrate:

-exceeding 24,5% by weight, except for mixtures of simple ammonium nitrate fertilisers with dolomite, limestone and/or calcium carbonate of 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 simple ammonium nitrate fertilisers with dolomite, limestone and/or calcium carbonate of a purity of at least 90%.

⁵ The 28% by weight of nitrogen content due to ammonium nitrate corresponds to 80% ammonium nitrate.

14. Ammonium nitrate (350/2,500): technical quality.

Applies to ammonium nitrate and mixtures of ammonium nitrate whose nitrogen content due to ammonium nitrate represents:

-between 24,5% and 28% by weight and containing not more than 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 ammonium nitrate concentration exceeds 80% by weight.

15. Ammonium nitrate (10/50): "out of specification" materials and fertilizers that do not exceed the detonability test.

Applies:

-to the waste material of the manufacturing process and to ammonium nitrate and mixtures of ammonium nitrate, simple fertilisers based on ammonium nitrate and compound or complex fertilisers based on ammonium nitrate to which they relate Notes 14 and 15 which are or have been returned by the end user to a manufacturer, to a temporary storage site or to a processing facility for reworking, recycling or processing in order to use them under conditions secure, for having failed to meet the specifications of Notes 14 and 15,

-to the fertilisers referred to in the first indent of Note 13 and note 14 to this Annex which do not comply with the requirements of Annex III-2 to Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003, concerning fertilisers.

16. Potassium nitrate (5,000/10,000).

Applies to potassium nitrate based compound fertilizers, in perlada/granulated form, which have the same hazardous properties as pure potassium nitrate.

17. Potassium nitrate (1,250/5,000).

It applies to potassium nitrate based compound fertilizers in crystalline form that have the same hazardous properties as pure potassium nitrate.

18. Enriched biogas.

For the purposes of implementing this royal decree, enriched biogas may be classified under point 18 of Part 2 of Annex I if it has been treated in accordance with the rules applicable to purified and enriched biogas, ensuring a quality equivalent to that of natural gas, including methane content, and contains a maximum of 1% oxygen.

19. Polychlorinated dibenzofurans and polychlorinated dibenzodioxins.

The quantities of polychlorinated dibenzofurans and polychlorinated dibenzodioxins are calculated with the following weighting factors:

Toxic Equivalence Factors (FET) -WHO 2005

1,2,3,7,8-PeCDD

1,2,3,7,8,9-HxCDD

2,3,7,8-TCDD	1	2,3,7,8-TCDF	0.1
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
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)

Reference-Van den Berg et al.: The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalence Factors for Dioxins and Dioxin-like Compounds.

20. In cases where this hazardous substance falls within the flammable Flammable Liquid or Flammable P5b category, the lower threshold amounts shall be applied for the purposes of this royal decree.

ANNEX II

Information referred to in Article 8 (6) and Article 10 (1) (a) concerning the safety management system and the organisation of the establishment with a view to the prevention of major accidents

For the implementation of the safety management system developed by the industry, account shall be taken of the following elements:

(a) The safety management system shall be proportionate to the hazards, industrial activities and complexity of the organisation existing in the establishment and shall be based on a risk assessment. It shall include the general organisational structure, responsibilities, practices, procedures, processes and resources that enable the definition and implementation of the policy of prevention of serious accidents.

b) The security management system will consider the following items:

1. The organisation and staff: the roles and responsibilities of staff associated with the management of major accident risks at all levels of organisation, together with the measures taken to raise awareness of the risks the need for permanent improvement; the identification of the training needs of such staff and the organisation of such training; the participation of employees and the staff of subcontracted firms and self-employed workers working in the in the establishment that are important from the security point of view.

2. The identification and assessment 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, subcontracted activities, as well as the assessment of their likelihood and severity.

3. Operation control: the adoption and implementation of procedures and instructions for safe operation (including maintenance of facilities, processes and equipment), and for the operation of management of alarms and temporary stops. Account shall be taken of the information available on best practices for monitoring and control with a view to reducing the risk of system failure; the management and control of the risks associated with the ageing of the equipment of the installation and corrosion; the inventory of the installation equipment, the strategy and methodology for monitoring and control of the state of the equipment; the appropriate follow-up actions and the necessary countermeasures.

4. The adaptation of the modifications: the adoption and application of procedures for the projects of the modifications to be carried out in the existing installations, processes or storage areas or for the design of new ones.

5. Planning for emergency situations: the adoption and implementation of procedures to identify foreseeable emergencies through systematic analysis, as well as to develop, test and review plans This training will affect all staff working in the establishment, including the staff of the subcontracted companies and self-employed workers.

6. Monitoring of the objectives set: the adoption and implementation of procedures for the permanent assessment of the achievement of the objectives set by the industry in the framework of its policy of prevention serious accidents and their safety management system, and the introduction of investigation and correction mechanisms in the event of non-compliance; the procedures shall cover the industrial system for the notification of major accidents or (a) accident conditions, in particular where there have been failures of the protective measures, and the monitoring based on lessons learned; procedures may also include performance indicators, such as safety performance indicators or other relevant indicators.

7. The audit and review: the adoption and implementation of procedures for the systematic systematic evaluation of the policy of prevention of serious accidents and the effectiveness and suitability of the safety management system; documented review of the functioning of the policy implemented, the security management system and its update, including the consideration and incorporation of the changes identified as necessary in the audit and review exercise.

ANNEX III

Information to be provided to the population pursuant to Article 15 (1) and (2) (a)

Part 1

For all establishments to which this royal decree applies:

a) Name or social reason for the industrial and full address of the corresponding establishment.

(b) Confirmation that the establishment is subject to the regulatory or administrative provisions implementing this royal decree and that the notification provided for in the Directive has been submitted to the competent authority Article 7, paragraph 1, or the security report referred to in Article 10 (1

.

c) Explanation in simple terms of the activity or activities carried out in the establishment.

(d) Common names or, in the case of dangerous substances listed in Part 1 of Annex I, the generic names or hazard classification of the relevant dangerous substances in the establishment which may result in a serious accident, indicating its main dangerous characteristics, in simple terms.

(e) General information on how the interested public will be notified, if necessary; appropriate information on the appropriate behaviour in the event of a serious accident or indication of where it can be accessed information in electronic form.

f) The date of the last on-site visit in accordance with Article 21 (4), or indication of where this information can be accessed electronically; information on where it can be obtained, upon request, details of the inspection and the relevant inspection plan, without prejudice to the requirements laid down in Article 23.

g) Detailed information on how to obtain more information in this respect, without prejudice to the requirements set out in Article 23.

Part 2

For top-level establishments, in addition to the information mentioned in part:

(a) General information on the nature of the hazards of serious accidents, including their potential effects on human health and the environment and summary of the main types of serious accident scenarios and the control measures taken in anticipation of them.

(b) Confirmation that the operator is obliged to take appropriate measures at the site, including contact with the emergency services, in order to act in the event of a major accident and to minimise its effects.

(c) Appropriate information on the external emergency plan developed to deal with the effects an accident may have outside the site where it occurs. Calls for cooperation should 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 of a serious accident having cross-border effects in accordance with the Convention on Effects cross-border 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 (1)

1. The Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior, without prejudice to the powers of the Ministry of Public Works in the field of maritime pollution, shall notify the European Commission of any serious accident which has occurred. adjustment to the description in point 1 or in which at least one of the consequences described in points 2, 3, 4 and 5 is given.

a) Dangerous substances involved:

Any fire or explosion or accidental release of a hazardous substance in which an amount of not less than 5% of the quantity referred to as a threshold in column 3 of Part 1 or column 3 of Part 2 is involved of Annex I.

b) Perjudgments of persons or property:

1. º One death.

2. º Six people injured within the facility requiring hospitalization for 24 hours or more.

3. º A person outside the establishment who requires hospitalization for 24 hours or more.

4. Housing (s) located outside the damaged establishment (s) and unusable because of the accident.

5. º Evacuation or confinement of persons for more than 2 hours (persons × hours): the product is equal to or greater than 500.

6. Inruption 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 an important habitat from the point of view of the environment or conservation and protected by law,

ii) 10 ha or more of a more widespread habitat, including labor lands.

2. Significant or long-term damage caused to freshwater or marine habitats:

i) 10 km or more of a river or channel,

ii) 1 ha or more than one lake or pond,

iii) 2 ha or more than one delta,

iv) 2 ha or more than one coastal or maritime zone.

3. Significant damage caused to an aquifer or groundwater: 1 ha or more.

d) Material damage:

1. Material Damage in the Establishment: starting from 2,000,000 EUR.

2. Material Damage outside the establishment: from EUR 500,000.

e) Cross-border damage.

Any major accident involving a direct intervention of a hazardous substance and originating for purposes outside the territory of the Member State concerned.

2. The Directorate-General for Civil Protection and Emergencies of the Ministry of the Interior, without prejudice to the powers of the Ministry of Development in the field of maritime pollution, shall notify the European Commission of the accidents and accident which, although not complying with the quantitative criteria mentioned above, is of particular interest from the technical point of view for the prevention of serious accidents and for the limitation of their consequences.