Major accidents often have serious consequences, as evidenced by accidents like Seveso, Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield. Moreover the impact can extend beyond national borders. This underlines the need to ensure that appropriate precautionary action is taken to ensure a high level of protection throughout the Union for citizens, communities and the environment. There is therefore a need to ensure that the existing high level of protection remains at least the same or increases.

Directive 96/82/EC has been instrumental in reducing the likelihood and consequences of such accidents thereby leading to a better level of protection throughout the Union. A review of that Directive has confirmed that the rate of major accidents has remained stable. While overall the existing provisions are fit for purpose, some changes are required in order to further strengthen the level of protection, in particular with regard to the prevention of major accidents. At the same time the system established by Directive 96/82/EC should be adapted to changes to the Union system of classification of substances and mixtures to which that Directive refers. In addition, a number of other provisions should be clarified and updated.

It is therefore appropriate to replace Directive 96/82/EC in order to ensure that the existing level of protection is maintained and further improved, by making the provisions more effective and efficient, and where possible by reducing unnecessary administrative burdens by streamlining or simplification, provided that safety and environmental and human health protection are not compromised. At the same time, the new provisions should be clear, coherent and easy to understand to help improve implementation and enforceability, while the level of protection of human health and the environment remains at least the same or increases. The Commission should cooperate with the Member States on the practical implementation of this Directive. That cooperation should, inter alia, address the issue of self-classification of substances and mixtures. As appropriate, stakeholders such as representatives of industry, workers and non-governmental organisations promoting the protection of human health or the environment should be involved in the implementation of this Directive.

Major accidents can have consequences beyond frontiers, and the ecological and economic costs of an accident are borne not only by the establishment affected, but also by the Member States concerned. It is therefore necessary to establish and apply safety and risk-reduction measures to prevent possible accidents, to reduce the risk of accidents occurring and to minimise the effects if they do occur, thereby making it possible to ensure a high level of protection throughout the Union.

Certain industrial activities should be excluded from the scope of this Directive provided they are subject to other legislation at Union or national level providing for an equivalent level of safety. The Commission should continue to examine whether there are significant gaps in the existing regulatory framework, in particular as regards new and emerging risks from other activities as well as from specific dangerous substances and, if appropriate, present a legislative proposal to address those gaps.

For the purpose of classifying upgraded biogas, any developments on standards under the European Committee for Standardisation (CEN) should be taken into account.

Unwanted effects from the alignment to Regulation (EC) No 1272/2008 and subsequent adaptations to that Regulation having an impact on the classification of substances and mixtures may occur. On the basis of criteria included in this Directive, the Commission should assess whether, notwithstanding their hazard classification, there are dangerous substances which do not present a major-accident hazard and, where appropriate, submit a legislative proposal to exclude the dangerous substance concerned from the scope of this Directive. The assessment should start swiftly, in particular after the change of classification of a substance or mixture, in order to avoid unnecessary burdens for operators and competent authorities in the Member States. Exclusions from the scope of this Directive should not prevent any Member State from maintaining or introducing more stringent protective measures.

Operators should have a general obligation to take all necessary measures to prevent major accidents, to mitigate their consequences and to take recovery measures. Where dangerous substances are present in establishments above certain quantities the operator should provide the competent authority with sufficient information to enable it to identify the establishment, the dangerous substances present and the potential dangers. The operator should also draw up and, where required by national law, send to the competent authority a major-accident prevention policy (MAPP) setting out the operator’s overall approach and measures, including appropriate safety management systems, for controlling major-accident hazards. When the operators identify and evaluate the major-accident hazards, consideration should also be given to the dangerous substances which may be generated during a severe accident within the establishment.

In order to reduce the risk of domino effects, where establishments are sited in such a way or so close together as to increase the likelihood of major accidents, or aggravate their consequences, operators should cooperate in the exchange of appropriate information and in informing the public, including neighbouring establishments that could be affected.

In order to demonstrate that all that is necessary has been done to prevent major accidents, and to prepare emergency plans and response measures, the operator should, in the case of establishments where dangerous substances are present in significant quantities, provide the competent authority with information in the form of a safety report. That safety report should contain details of the establishment, the dangerous substances present, the installation or storage facilities, possible major-accident scenarios and risk analysis, prevention and intervention measures and the management systems available, in order to prevent and reduce the risk of major accidents and to enable the necessary steps to be taken to limit the consequences thereof. The risk of a major accident could be increased by the probability of natural disasters associated with the location of the establishment. This should be considered during the preparation of major-accident scenarios.

To prepare for emergencies, in the case of establishments where dangerous substances are present in significant quantities, it is necessary to establish internal and external emergency plans and to establish procedures to ensure that those plans are tested and revised as necessary and implemented in the event of a major accident or the likelihood thereof. The staff of an establishment should be consulted on the internal emergency plan and the public concerned should have the opportunity to give its opinion on the external emergency plan. Sub-contracting may have an impact on the safety of an establishment. Member States should require operators to take this into account when drafting a MAPP, a safety report or an internal emergency plan.

When considering the choice of appropriate operating methods, including those for monitoring and control, operators should take into account available information on best practices.

In order to provide greater protection for residential areas, areas of substantial public use and the environment, including areas of particular natural interest or sensitivity, it is necessary for land-use or other relevant policies applied in the Member States to ensure appropriate distances between such areas and establishments presenting such hazards and, where existing establishments are concerned, to implement, if necessary, additional technical measures so that the risk to persons or the environment is maintained at an acceptable level. Sufficient information about the risks and technical advice on these risks should be taken into account when decisions are taken. Where possible, to reduce administrative burdens, especially for small and medium-sized enterprises, procedures and measures should be integrated with those under other relevant Union legislation.

In line with the Aarhus Convention, effective public participation in decision-making is necessary to enable the public concerned to express, and the decision-maker to take account of, opinions and concerns that may be relevant to those decisions, thereby increasing the accountability and transparency of the decision-making process and contributing to public awareness of environmental issues and support for the decisions taken.

In order to ensure that adequate response measures are taken if a major accident occurs, the operator should immediately inform the competent authority and communicate the information necessary to enable it to assess the effects of that accident on human health and on the environment.

Local authorities have an interest in the prevention of major accidents and mitigation of their consequences and can have an important role to play. This should be taken into account by the Member States in the implementation of this Directive.

In order to facilitate the exchange of information and to prevent future accidents of a similar nature, Member States should forward information to the Commission regarding major accidents occurring on their territory, so that the Commission can analyse the hazards involved, and operate a system for the distribution of information concerning, in particular, major accidents and lessons learned from them. That exchange of information should also cover ‘near misses’ which Member States regard as being of particular technical interest for preventing major accidents and limiting their consequences. Member States and the Commission should strive to ensure the completeness of the information held on information systems established to facilitate the exchange of information on major accidents.

Member States should determine the competent authorities responsible for ensuring that operators fulfil their obligations. The competent authorities and the Commission should cooperate in activities in support of implementation such as the development of appropriate guidance and exchanges of best practice. To avoid unnecessary administrative burden, information obligations should be integrated, where appropriate, with those under other relevant Union legislation.

In order to take into account technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes II to VI to adapt them to technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

Member States should lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

Since the objective of this Directive, namely to ensure a high level of protection of human health and the environment, cannot be sufficiently achieved by Member States and can, therefore, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

Directive 96/82/EC should therefore be amended and subsequently repealed,