Explanatory Memorandum to COM(2010)781 - Control of major-accident hazards involving dangerous substances - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2010)781 - Control of major-accident hazards involving dangerous substances. |
|---|---|
| source | COM(2010)781  |
| date | 21-12-2010 |
Directive 96/82/EC on the control of major-accident hazards involving dangerous substances (hereinafter the Seveso II directive) is aimed at preventing major accidents involving large quantities of dangerous substances (or mixtures thereof) as listed in its Annex I and to limit the consequences of such accidents for man and the environment. There is a tiered approach to the level of controls, with the larger the quantities of substances, the stricter the rules.
The Directive has to be amended due to changes in the EU system of classification of dangerous substances to which the Directive refers. In the light of this, it was decided in 2008 to launch a wider review since the basic structure of the Directive and its main requirements have remained essentially unchanged since its adoption. Although the review has shown that that overall the existing provisions are fit for purpose and that no major changes are required, a number of areas were identified where limited amendments would be appropriate in order to clarify and update certain provisions and to improve implementation and enforceability while maintaining or slightly increasing the level of protection for health and environment.
The proposal is intended to address these issues.
Industrial accidents involving dangerous substances often have very serious consequences. Some well-known major accidents like Seveso, Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield have taken many lives and/or damaged the environment and cost up to billions of euro. In the wake of these accidents, political awareness has sharpened towards recognising the risks and taking appropriate precautionary action to protect citizens and communities.
The Seveso II Directive, which covers around 10,000 establishments within the European Union, has been instrumental in reducing the likelihood and consequences of chemical accidents. However there is continuing need to ensure that existing high levels of protection are maintained and if possible further improved.
The current provisions are those established by the Seveso II Directive. The aim is to revise those provisions.
The main reason for the revision of the Seveso II Directive is to align its Annex I to Regulation (EC) No. 1272/2008 on classification, labelling and packaging of dangerous substances and mixtures (hereinafter the CLP Regulation), which amends and repeals Directives 67/548/EEC and 1999/45/EC to which the Seveso II Directive currently refers. The CLP rules become definitive with effect from 1 June 2015.
Consultation of interested parties
During the review process over the last two years, stakeholders (individual companies, industry associations, NGOs, Member State competent authorities) were consulted in a number of ways, including web-base questionnaires available for all stakeholders; consultation of competent authorities in the Member States through the regular meetings of the committee of competent authorities (CCA) and related seminars; on the Annex I alignment, via a multi-stakeholder technical working group, comprising experts from Member States, industry and environmental NGOs (the technical report from which is available on DG ENV's website); and a stakeholder consultation meeting held on 9 November 2009 in Brussels, attended by around 60 representatives from national and European industry and environmental NGOs as well as individual companies, following which around fifty written submissions were received.
There was general agreement that no major changes to the Directive are necessary. There was broad support in principle for further clarifying and updating the provisions, although views varied on specifics.
Further details can be found in the impact assessment and on DG ENV's website at ec.europa.eu/environment/seveso/review).
As part of the review process, several studies were carried out by external contractors. These included two studies assessing the effectiveness of the Directive and two studies supporting the impact assessment of the economic, social and environmental impacts of the various policy options.
The findings from the three-yearly implementation reports from Member States were also taken into account.
Further details can be found in the impact assessment and on DG ENV's website at ec.europa.eu/environment/seveso/review).
The main problems covered in the impact assessment related to the alignment of Annex I to the CLP Regulation and the impact on the scope of the Directive, which was the key issue. Related to that issue were possible other technical amendments to Annex I and the procedures for adapting Annex I in the future. Other issues related to information to the public and information management systems and land-use planning, where experience of implementation to date indicates that some opportunities for improvements or new requirements may exist; and other detailed provisions which could usefully be clarified or updated, in some cases to more closely reflect existing practices.
The impact assessment assessed a number of policy options with the aim of identifying a cost-effective package of measures to address these issues. The assessment has led the Commission to propose a number of amendments, of which the main ones are as follows.
As regards the alignment of Annex I, a simple change of reference or one-to-one translation from the old classification system to the CLP Regulation is not possible, mainly because for health hazards the old hazard classification categories toxic and very toxic do not correspond to the new CLP Acute Toxicity 1 to 3, which are moreover divided into different exposure routes (oral, dermal and inhalation). A further complication is that as substances are classified or re-classified under the CLP Regulation over time, this will automatically impact on the scope of the Seveso legislation. The Commission is proposing the option that, in addition to a very limited impact on scope shared with other options, maintains a high level of protection taking into account the most likely and relevant exposure routes in the event of a major accident. To deal with situations arising over time from the alignment where substances are included/excluded under the Directive that do/do not present a major-accident hazard, a package of corrective mechanisms to adapt Annex I via delegated acts is proposed.
As regards information to the public, etc, it is proposed to improve the level and quality of information and how this is collected, managed, made available, updated and shared in an efficient and streamlined way. This will bring the Directive more into line with the Aarhus Convention on access to information, public participation in decision-making and access to justice in environmental matters, update its procedures to take account of advances in information management systems such as the internet and the ongoing efforts to improve the efficiency of such systems like the Shared Environmental Information System (SEIS) initiative and the INSPIRE Directive (2007/2/EC).
The remaining amendments proposed are relatively minor technical adaptations to existing provisions.
Taken as a whole, the potential changes considered represent a moderate adaptation of the Directive and would not significantly affect the level of protection or the costs of the Directive. Overall, the costs of these are low compared with the total costs of the Directive.
The impact assessment is submitted with this proposal.
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- Grounds for and objectives of the proposal
- General context
- Existing provisions in the area of the proposal
- Consistency with other policies and objectives of the Union
- 2. CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- Collection and use of expertise
- Impact assessment
- Summary of the proposed action
- Legal basis
- Subsidiarity principle
- Proportionality principle
- Choice of instrument
- 5. ADDITIONAL INFORMATION
- Repeal of existing legislation
- Correlation table
- Article 1
- Article 2
- Article 3
- Article 4
- Article 5
- Article 6
- Article 7
- Article 8
- Article 9
- Article 10
- Article 11
- Article 12
- Article 13
- Article 14
- Articles 15 and 16
- Articles 17,18,19 and 27
- Article 20
- Article 21
- Article 22
- Articles 23 to 26
- Articles 28 to 31
- Other Annexes
The aim of the proposal is to revise the Directive to align it to the CLP Regulation and also to clarify, improve or add certain provisions to ensure better, more consistent implementation and enforcement of the legislation with the aim of achieving a high level of protection, while where possible simplifying legislation and reducing administrative burdens.
The primary objective of the Directive is the protection of the environment. This proposal is therefore based on Article 192 i TFEU.320
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Union.
The objectives of the proposal cannot be sufficiently achieved by the Member States since the Seveso II Directive sets goals and objectives for the prevention and control of major accidents throughout the European Union. This principle is maintained in the current proposal. In addition, many major accidents can have transboundary effects. All Member States could be affected by such accidents and therefore need to take measures in order that the risks to the population and the environment in each Member State can be reduced. XXXX
Community action will better achieve the objectives of the proposal because of the need to avoid significantly different levels of protection in the Member States, particularly in view of possible distortions of competition that could result. The proposal leaves the detailed means of implementation, compliance and enforcement to be decided by the appropriate authorities.3
The proposal therefore complies with the subsidiarity principle.
The proposal complies with the proportionality principle for the following reasons.331It follows the goal-setting approach of the Seveso II Directive, leaving sufficient flexibility to the Member States to determine how to achieve the objectives laid down. The new provisions do not go beyond what is necessary and the current proportionate approach, with the level of controls based on the quantities of dangerous substances present in establishments, is maintained.
332
The proposed instrument is a directive.34Given the fact that the existing legislation sets Community objectives while leaving the choice of measures for compliance to the Member States, the best instrument is a directive. Given the nature and extent of the changes compared with the current Directive, a revision of that in the form of an amending Directive or recast would not be appropriate. A new directive is therefore proposed.
The proposal has no implication for the Community budget.
Simplification
Some elements of the proposal should help to reduce unnecessary administrative burden, in particular by encouraging, at Member State level, coordinated inspections, more integration in information and procedural requirements, and by simplifying and streamlining implementation reporting requirements through moving towards an extended shared information system. Clarifications to existing provisions will also improve readability and give greater legal certainty.
The adoption of the proposal will lead to repeal of the existing Directive.
The Member States are required to communicate to the Commission the text of national provisions transposing the Directive as well as a correlation table between those provisions and this Directive.560
European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.570
Detailed explanation of the proposal
The following provides information about the specific Articles. Except where indicated otherwise, the provisions are unchanged in substance from those set out in Directive 96/82/EC.
This Article outlines the aim and objectives of the Directive.
Article 2 defines the scope of the Directive, which applies to establishments where dangerous substances listed in Annex I are present above prescribed thresholds. The provisions of Article 2 are essentially unchanged from Directive 96/82/EC. However the order of Parts 1 and 2 of Annex I has been reversed so that Part 1 of Annex I lists categories of dangerous substances according to their generic hazard classification (in accordance with the CLP Regulation) and part 2 lists named dangerous substances or groups of substances that, notwithstanding their generic hazard classification, warrant specific listing.
The main differences in terms of content of the Annex are as follows.
The main change concerns health hazards. The former category 'Very Toxic' has been aligned to the CLP category 'Acute Toxic 1' and 'Toxic' to 'Acute Toxic 2' (all exposure routes) and 'Acute Toxic 3' (dermal and inhalation routes).
Several more specific CLP categories for physical hazards that did not exist before replace the more general old categories for oxidizing, explosive, and flammable hazards. These, together with the environmental hazard categories, represent a straightforward translation and maintain the current scope in relation to such hazards as closely as possible. For the new category of flammable aerosols, the thresholds have been adapted proportionately to those that apply currently based on their flammable properties and components; and for reasons of consistency, the group of pyrophoric substances has been completed by the inclusion of pyrophoric solids.
The new Annex I Part 2 retains the old Part 1 largely unchanged. The only changes are an updated reference to the CLP Regulation for liquefied flammable gases; the inclusion of anhydrous ammonia, boron triflouride, and hydrogen sulphide as named substances, previously covered by their hazard categories, to keep their thresholds unchanged; the inclusion of heavy fuel oil in the entry for petroleum products; clarifications to the notes in relation to ammonium nitrate; and an update of the toxic equivalency factors for dioxins.
Furthermore the exclusions to the Directive previously listed in Article 4 of Directive 96/82/EC are listed here. These are maintained, subject to the following changes:
– to remove any possible doubts, the exception to the exclusion for the exploitation of minerals in mines and quarries or boreholes is amended to include underground gas storage.
– the possibility to exclude substances from being regarded as dangerous substances for the purposes of the Directive because they do not present a major-accident hazard (see Article 4).
Among the excluded areas are the offshore exploration and exploitation of minerals, including hydrocarbons. As announced in its recent communication 'Facing the challenge of the safety of offshore oil and gas operations' in the light of the oil rig accident in the Gulf of Mexico, the Commission will assess the appropriate way to strengthen environmental legislation with provisions that may be necessary to complement existing environmental legislation in relation to pollution control, inspection and accident prevention and management as regards individual offshore installations, ensuring a high level of protection of the environment in such activities. Corresponding legislative proposals will include either extending the scope of existing legislation to offshore oil and gas installations or a stand-alone initiative for such operations.
This Article defines the basic terms used in the Directive. Compared with Directive 96/82/EC, the following changes should be highlighted:
– the definitions of 'establishment' and 'operator' have been clarified, with the latter brought more into line with the definition in the Industrial Emissions Directive.
– the reference to ‘presence of dangerous substances’ in Article 2 of Directive 96/82/EC is moved to this Article
– definitions are added for the different kinds of establishments falling within the Directive's scope and 'inspections'. Definitions are also included for 'the public' and 'the public concerned', in line with the EU legislation implementing the Aarhus Convention.
– the definition of 'installation' is clarified to make it clear that underground installations are included.
This new Article provides for correction mechanisms to adapt Annex I as necessary via delegated acts. This is needed in particular to address unwanted effects from the alignment of Annex I to the CLP Regulation and subsequent adaptations to that Regulation, which could lead to substances and possibly mixtures being automatically included in or excluded from the Directive irrespective of whether or not they present a major accident hazard. The mechanisms would take the form of EU-wide substance derogations and establishment-specific derogations at Member State level on the basis of harmonised criteria for substances/mixtures that are caught but should be excluded, and, as a counterpart, a safeguard provision enabling the inclusion of non-captured hazards. The criteria for the derogations would be based on those laid down in Commission Decision 98/433/EC and would be established by delegated acts by 30 June 2013.
This Article repeats the existing requirements of Article 5 of Directive 96/82/EC, which set out the general obligations on operators.
This Article extends the information obligations in relation to notifications set out in Article 6 of Directive 96/82/EC to include information about neighbouring establishments, etc, whether or not they are covered by the Directive, needed for the purposes of Article 8 relating to domino effects. In addition operators will be required to update their notifications at least every five years. All this will help competent authorities to manage implementation of the Directive more effectively.
Article 7 of Directive 96/82/EC is amended to make it clear that all establishments must have a major-accident prevention policy (MAPP) proportionate to the hazards. The scope of the MAPP and its relationship with safety management systems (SMS) pursuant to Article 9 and Annex III is also clarified, by deleting the reference to the latter.
New provisions are introduced requiring that the MAPP should be available in writing and sent to the competent authority and that it should be updated at least every five years, in line with the proposed frequency for updating notifications under Article 6.
This Article covers so-called domino effects. It maintains the obligation on competent authorities to identify those establishments that are so close together that the consequences of a major accident are increased. However the text is clarified to make it clear that the provisions apply to both upper- and lower-tier establishments and that the key aim is to ensure that operators exchange information with neighbouring establishments, including those that fall outside the scope of the Directive.
This Article maintains the core requirement for upper-tier establishments to prepare a safety report, previously contained in Article 9 of Directive 96/82/EC. The main change is to clarify the relationship with the MAPP and SMS, particularly in respect of the obligations for lower-tier establishments in the latter regard. The need for a proportionate approach is also highlighted.
The content of the safety report is detailed in Annex II and remains largely unchanged (see below). The need for the report to demonstrate that possible major-accident scenarios have been taken into account is also underlined.
As regards the safety management system (SMS), changes are introduced in Annex III (see below) to remove the references to the MAPP, which lower-tier establishments are required to have. At the same time it is underlined that the SMS, in particular for a lower-tier establishment, should a Member State so require, should be proportionate to the hazards and risks.
The provisions for periodic updating of the safety report are maintained, but with an express requirement for such updated reports to be communicated without delay to the competent authorities.
This Article requires operators to update their managements systems and procedures and, in particular, their MAPP and safety report in the event of significant modifications within their establishment. Minor changes are introduced in line with changes made to related provisions.
Article 11 maintains the requirements relating to emergency planning for upper-tier establishments previously set out in Article 11 of Directive 96/82/EC, subject to two minor modifications: to require that public consultation on external emergency plans is in line with the principles of the relevant provisions of Directive 2003/35/EC implementing the Aarhus Convention; and to make clearer the separation of responsibilities between operators and competent authorities in relation to the review, testing and updating of internal and external emergency plans. In addition, to avoid significant delays in the completion of plans, which are an essential in terms of adequate preparedness and response in the event of accidents, a new obligation is for the competent authority to draw up the external emergency plan within 12 months after receipt of the necessary information from the operator.
Annex IV details the information to be contained in the plans and carries over the requirements laid down in the corresponding Annex in Directive 96/82/EC, with certain amendments (see below).
This Article contains the provisions relating to land-use planning. It is essentially unchanged from Directive 96/82/EC apart from minor changes such as to clarify that the aim is to protect the environment as well as human health and that it applies to all establishments; to provide for measures other than safety distances (which may not be appropriate) to protect areas of particular natural sensitivity or interest; and to provide where possible for integration of land-use planning procedures with those under the Environmental Impact Assessment Directive and similar legislation; and to provide the possibility for competent authorities to require lower-tier establishments to provide sufficient risk-related information for the purposes of land-use planning. These changes will bring the text more into line with its aims and more closely reflect existing practice.
This Article retains the current requirements that information should actively be made available to persons liable to be affected by a major accident and also kept permanently available. It leaves open who is responsible for the provision of such information. The main changes are to extend the information to include basic information for all establishments (name, address and activities), which is provided to the Commission under Article 19 of the current Directive, but is not made publicly available; and for upper-tier establishments, a summary of the major-accident scenarios and key information from the external emergency plan; and, without precluding other forms of communication, to have this information kept permanently available to the public online and provided to a central database at Union level as provided for in Article 20.
Confidentiality of information is ensured, where necessary and appropriate, by Article 21.
These changes will make it easier for the public to access relevant information and be better informed in the vent of an accident. It will also make it easier for competent authorities to monitor that information is available and kept up to date.
This is a new Article that builds on and extends the requirements laid down in Article 13 i of the current Directive requiring that the public should be able to give its opinion in certain cases relating to land-use planning, modifications to existing establishments, external emergency plans, etc. The provisions are largely based on Directive 2003/35/EC, with the aim to bring the Seveso II Directive more into line with the corresponding provisions of the Aarhus Convention.
These two Articles relate to the reporting of major accidents by operators and competent authorities respectively. The main change is setting a 12 months deadline for the submission of reports to avoid lengthy delays in the reporting of accidents by Member States. This, and a change to the quantity threshold set out in Annex VI, which establishes the criteria for reportable accidents (see below), will aid prevention of future accidents by allowing early reporting and analysis of accidents and near-misses involving significant high quantities of dangerous substances so that information and lessons learned can be shared.
These Articles maintain and build upon the existing provisions relating to the role and responsibilities of competent authorities with the aim of ensuring more effective implementation and enforcement.
Article 17 introduces a requirement for Member States with more than one competent authority to appoint one to take the lead in coordinating activities. It also sets out arrangements for cooperation between the competent authorities and the Commission in activities in support of implementation, using the existing committee of competent authorities ("the forum") and related technical working groups, such as development of guidance, exchanges of best practices and consideration of notifications made pursuant to Article 4.
Article 19 strengthens the existing requirements in relation to inspections. The new provisions are largely based on Recommendation 2001/331/EEC providing for minimum criteria for environmental inspections in the Member States and the Industrial Emissions Directive. The importance of making available sufficient resources for inspections, and the need to encourage exchange of information, for example at Union level through the current Mutual Joint Visits Programme for inspections, is underlined.
Articles 18 and 27 (which is new) set out the measures to be taken in the vent of non-compliance, including prohibitions of use and other penalties.
This Article relates to the availability of information on establishments and major accidents held by the Commission. The main change is that provisions of the current Directive are improved and strengthened by extending the current Seveso Plants Information Retrieval System (SPIRS ) database to include the information to the public referred to in Article 13 and Annex V and to make that database open to the public. Access could be either through links to documents directly loaded on to the system or through links to the websites of Member States and/or operators. This sharing of information would help to ensure that the public has the necessary information and allow operators and competent authorities to draw lessons from the best practices of others.
The database would also be used for the purposes of reporting on implementation by Member States, which would streamline and simplify the current arrangements.
This sets out new rules on confidentiality, which are based on Directive 2003/4/EC implementing the provisions of the Aarhus Convention relating to public access to environmental information, which place greater weight on openness and transparency while providing for non-disclosure of information in duly justified cases where confidentiality is required such as for security reasons.
This Article is a new provision, bringing the Directive more into line with the Aarhus Convention by requiring that Member States should ensure that the public concerned, including interested environmental NGOs, have access to administrative or judicial review to challenge any acts or omissions that could breach their rights in relation to access to information pursuant to Articles 13 and 21 i or consultation and participation in decision-making in relation to cases under Article 14.
Article 23 provides that Annexes I to VII will be adapted to technical progress by delegated acts (which will also be used to establish criteria for derogation pursuant to Article 4 i and the granting of derogations for substances to be listed in Part 3 of Annex I). The other Articles are standard provisions relating to the exercise of the delegation of such implementing powers, and the procedures for revocation and objections.
These Articles concern transposition by Member States, entry into force of the new Directive and repeal of Directive 96/82/EC. The date on which Member States shall apply the Directive, 1 June 2015, is the date on which the CLP Regulation becomes definitive.
Annex II contains the items to be considered in the safety report required by Article 9. The content of the different parts of the Annex are largely unchanged compared with Annex II in Directive 96/82/EC. The main changes are additional requirements in relation to information about neighbouring establishments, in particular in view of possible domino effects, and other external risks and hazards, such as environmental risks and hazards (point C of Part 1 and point A of Part 4); about lessons learned from past accidents (point C; Part 4); and about equipment to limit the consequences of major accidents (point A, part 5).
Annex III relates to the information on management systems and organisational factors to be covered in the safety report. The main changes are to remove the references to the MAPP, to clarify that the safety management system should be proportionate and that internationally recognised systems such as ISO and OSHAS should be taken into account; and to include references to safety culture. Another change is a reference to the possible use of safety performance indicators, which can be an effective tool to improve safety and assist in monitoring, assessment and enforcement, and to necessary changes to be made following audit and review of safety management systems.
Annex IV sets out the information to be included in the internal and external emergency plans required under Article 11. It is identical to Annex IV in Directive 96/82/EC save that the scope of the external emergency plan is extended to make clearer references to the need to address possible domino effects and off-site mitigatory actions to address major accident scenarios impacting on the environment.
Annex V lists the information to be provided to the public in accordance with Article 13. The main changes to the list of requirements are in Part 1, for all establishments, the inclusion of the following: details of information about major-accident hazards as set out in the MAPP or safety report (point 5), inspections carried out (point 6) and where further information can be obtained (point 7); and in Part 2, for upper-tier establishments, the inclusion of the main types of major-accident scenarios (point 1), appropriate information from the external emergency plan ( point 5) and where appropriate transboundary impacts (point 6).
Annex VI is essentially the same as that in the current Directive, listing the criteria for reporting accidents. The only change is to bring more accidents within the reporting system by reducing the quantity threshold laid down in section 1.1 to 1% of the upper-tier threshold.
Annex VII will list the criteria for granting derogations pursuant to article 4. In accordance with Article 4 i, these criteria shall be adopted by delegated act by 30 June 2013.