title: Council Directive 2014/87/Euratom of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations

text:
               25.7.2014

               EN

               Official Journal of the European Union

               L 219/42

         COUNCIL DIRECTIVE 2014/87/EURATOM
   of 8 July 2014
   amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof,
   Having regard to the proposal from the European Commission, drawn up after having obtained the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States,
   Having regard to the opinion of the European Parliament (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Whereas:

               (1)

               Council Directive 2013/59/Euratom (3) establishes uniform basic safety standards for the protection of the health of individuals subject to occupational, medical and public exposures against the dangers arising from ionising radiation.

               (2)

               Council Directive 2009/71/Euratom (4) imposes obligations on the Member States to establish and maintain a national framework for nuclear safety. That Directive reflects the provisions of the main international instruments in the field of nuclear safety, namely the Convention on Nuclear Safety (5), as well as the Safety Fundamentals (6) established by the International Atomic Energy Agency (‘IAEA’).

               (3)

               Council Directive 2011/70/Euratom (7) imposes obligations on the Member States to establish and maintain a national framework for spent fuel and radioactive waste management.

               (4)

               Council Conclusions of 8 May 2007 on nuclear safety and safe management of spent nuclear fuel and radioactive waste highlighted that ‘nuclear safety is a national responsibility exercised where appropriate in an EU-framework. Decisions concerning safety actions and the supervision of nuclear installations remain solely with the operators and national authorities’.

               (5)

               The Fukushima nuclear accident in Japan in 2011 renewed attention worldwide on the measures needed to minimise risk and ensure the most robust levels of nuclear safety. Based on the European Council conclusions of 24-25 March 2011, the national competent regulatory authorities, together with the Commission in the framework of the European Nuclear Safety Regulators Group (ENSREG), established by Commission Decision 2007/530/Euratom (8), carried out Community-wide comprehensive risk and safety assessments of nuclear power plants (‘stress tests’). The results identified a number of improvements which could be implemented in nuclear safety approaches and industry practices in the participating countries.
               Moreover, the European Council also called on the Commission to review, as appropriate, the existing legal and regulatory framework for the safety of nuclear installations and propose any improvements that may be necessary. The European Council also stressed that the highest standards for nuclear safety should be implemented and continuously improved in the Union.

               (6)

               A strong competent regulatory authority with effective independence in regulatory decision-making is a fundamental requirement of the Community nuclear safety regulatory framework. It is of utmost importance that the competent regulatory authority has the ability to exercise its powers impartially, transparently and free from undue influence in its regulatory decision-making to ensure a high level of nuclear safety. Regulatory decisions and enforcement actions in the field of nuclear safety should be based on objective safety-related technical considerations and should be established without any undue external influence that might compromise safety, such as undue influence associated with changing political, economic or societal conditions.
               The provisions of Directive 2009/71/Euratom on functional separation of competent regulatory authorities should be strengthened to ensure the regulatory authorities' effective independence from undue influence in their regulatory decision-making and to guarantee that they are provided with the appropriate means and competencies to properly carry out the responsibilities assigned to them. In particular, the regulatory authority should have sufficient legal powers, sufficient staffing and sufficient financial resources for the proper discharge of its assigned responsibilities.
               The strengthened requirements should be however without prejudice to close cooperation, as appropriate, with other relevant national authorities or to general policy guidelines issued by Member States.

               (7)

               The regulatory decision-making process should take into account competences and expertise, which may be provided by technical support organisations. This expertise should be based on state-of-the-art scientific and technical knowledge, including from operational experience and safety-related research, knowledge management, and adequate technical resources.

               (8)

               In accordance with Part 1 of the IAEA General Safety Requirements, the role of the Member States in establishing the framework for nuclear safety, and the role of the regulator in implementing that framework, should both be respected.

               (9)

               Given the specialised nature of the nuclear industry and the limited availability of staff with the required expertise and competence, resulting in the possible rotation of staff with executive responsibility between the nuclear industry and the regulators, special attention should be given to avoiding conflicts of interest. Moreover, arrangements should be made to ensure that there is no conflict of interest for those organisations that provide the competent regulatory authority with advice or services.

               (10)

               The consequences of a nuclear accident can go beyond national borders, therefore close cooperation, coordination and information exchange between competent regulatory authorities of Member States in the vicinity of a nuclear installation, irrespective of whether those Member States operate nuclear installations or not, should be encouraged. In this respect, Member States should ensure that appropriate arrangements are in place to facilitate such cooperation on nuclear safety matters with cross-border impacts.

               (11)

               In order to ensure that the proper skills are acquired and that adequate levels of competence are achieved and maintained, all parties should ensure that all staff having responsibilities relating to the nuclear safety of nuclear installations and to on-site emergency preparedness and response arrangements, undergo a continuous learning process. That can be achieved through the establishment of training programmes and training plans, procedures for periodic review and updating of the training programmes as well as appropriate budgetary provisions for training.

               (12)

               Another key lesson learned from the Fukushima nuclear accident is the importance of enhancing transparency on nuclear safety matters. Transparency is also an important means of promoting independence in regulatory decision-making. Therefore, the current provisions of Directive 2009/71/Euratom on the information to be provided to the general public should be made more specific as to the type of information be provided. In addition, the general public should be given opportunities to participate in the relevant phases of the decision-making process related to nuclear installations in accordance with the national framework for nuclear safety, taking into account the different national systems. Decisions on licensing remain the responsibility of national competent authorities.

               (13)

               The requirements of this Directive on transparency are complementary to those of the existing Euratom legislation. Council Decision 87/600/Euratom (9) imposes obligations on Member States to notify and provide information to the Commission and to other Member States in case of a radiological emergency on their territory, whilst Directive 2013/59/Euratom includes requirements on Member States to inform the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency, and to provide at regular intervals updated information to the population likely to be affected in the event of such an emergency.

               (14)

               During their 6th Review Meeting, the Contracting Parties to the Convention on Nuclear Safety reiterated their commitment to the findings of the 2nd Extraordinary Meeting which took place after the Fukushima accident. In particular, they stressed that ‘nuclear power plants should be designed, constructed and operated with the objectives of preventing accidents and, should an accident occur, mitigating its effects and avoiding off-site contamination’, and that ‘regulatory authorities should ensure that these objectives are applied in order to identify and implement appropriate safety improvements at existing plants’.

               (15)

               In view of the technical progress achieved through the provisions of the IAEA and by the Western European Nuclear Regulators Association (‘WENRA’) and responding to the lessons learnt from the stress tests and the Fukushima nuclear accident investigations, Directive 2009/71/Euratom should be amended to include a high level Community nuclear safety objective covering all stages of the lifecycle of nuclear installations (siting, design, construction, commissioning, operation, decommissioning). In particular, this objective calls for significant safety enhancements in the design of new reactors for which the state of the art knowledge and technology should be used, taking into account the latest international safety requirements.

               (16)

               That objective should notably be reached through nuclear safety assessments, which fall under the scope of this Directive. They should be carried out by the licence holders under the control of the national competent regulatory authority and may be used for the assessment of the risk of a major accident, as covered by Directive 2011/92/EU of the European Parliament and of the Council (10), provided that the requirements of this Directive are met.

               (17)

               The concept of defence-in-depth is fundamental to the safety of nuclear installations and is the basis for implementing high level nuclear safety objectives. Application of the defence-in-depth principles, as recognised in international standards and guidance and by WENRA, ensures that safety activities are subject to, as far as reasonably practicable, independent layers of provisions, so that in the event that a failure were to occur, it would be detected, compensated or corrected by appropriate measures. The effectiveness of each of the different layers is an essential element of defence-in-depth to prevent accidents and mitigate the consequences should they occur. Defence-in-depth is generally structured in five levels. Should one level fail, the subsequent level comes into play. The objective of the first level of protection is the prevention of abnormal operation and system failures. If the first level fails, abnormal operation is controlled or failures are detected by the second level of protection. Should the second level fail, the third level ensures that safety functions are further performed by activating specific safety systems and other safety features. Should the third level fail, the fourth level limits accident progression through accident management, so as to prevent or mitigate severe accident conditions with external releases of radioactive materials. The last objective (the fifth level of protection) is the mitigation of the radiological consequences of significant external releases through the off-site emergency response.

               (18)

               Together with defence-in-depth, an effective nuclear safety culture is regarded as a fundamental factor in achieving a high level of nuclear safety and its continuous improvement. Indicators for an effective nuclear safety culture include, in particular: the commitment at all levels of staff and management within an organisation to nuclear safety and its continuous improvement; the promotion of the ability of staff at all levels to question the delivery of relevant safety principles and practices to continuously improve nuclear safety; the ability of staff to report safety issues in a timely manner; the identification of the lessons learnt from operational experience; and the systematic reporting of any deviation from normal operating conditions or arrangements relevant to accident management that have the potential to have an impact on nuclear safety. Important elements which help to achieve a strong nuclear safety culture include, in particular, effective management systems, appropriate education and training and arrangements by the licence holder to register, evaluate and document internal and external safety significant operating experience and effective resolution of issues that have been raised.

               (19)

               Where ‘reasonably practicable’ is used in this Directive it should be applied in accordance with established definitions, in particular the WENRA and IAEA definitions.

               (20)

               Following the nuclear accidents at Three Mile Island and Chernobyl, the Fukushima nuclear accident highlighted once again the critical importance of the containment function, which is the last barrier to protect people and the environment against radioactive releases resulting from an accident. Therefore the applicant for a licence for the construction of a new power or research reactor should demonstrate that the design limits the effects of a reactor core damage to within the containment, i.e. the applicant should prove that a large or unauthorised radioactive release outside the containment is extremely unlikely, and that applicant should be able to demonstrate with a high degree of confidence that such a release will not occur.

               (21)

               More specific arrangements for accident management and on-site emergency response should be required to address the prevention and mitigation of accidents. Those should be in accordance and without prejudice to the relevant provisions of the Directive 2013/59/Euratom. The licence holder should provide for procedures, guidelines and arrangements that address accidents including severe accidents, that could occur in all operational modes, including full power, shutdown and transitional states, ensuring consistency and continuity between all such procedures and arrangements, and ensuring that they are exercised, reviewed and updated. Those arrangements should also provide for sufficient staff, equipment and other necessary resources. An organisational structure with clear allocation of responsibilities, and coordination amongst response bodies should be provided.

               (22)

               The stress tests demonstrated the key role of enhanced cooperation and coordination mechanisms between all parties that have responsibilities for nuclear safety. The peer-reviews have proved to be a good means of building confidence, with the aim of developing and exchanging experience and ensuring the common application of high nuclear safety standards.

               (23)

               Cooperation on nuclear safety between Members States is well established and can give added value in terms of nuclear safety, transparency and openness towards stakeholders at the European and international level.
               Member States, through their competent regulatory authorities making relevant use of ENSREG, and building on the expertise of the WENRA, should every six years define a methodology, Terms of Reference and a time frame for Peer Reviews on a common specific technical topic related to the nuclear safety of their nuclear installations. The common specific technical topic to be considered should be identified among the WENRA safety reference levels or on the basis of operating experience feed-back, incidents and accidents and technological and scientific developments. Member States should perform a national self-assessment and make arrangements for common peer reviews by other Member States' competent regulatory authorities of their national self-assessment.
               Reports on the findings of those peer reviews should be produced. Member States should establish national action plans for addressing any relevant findings and their own national assessment, taking into account the results of those peer review reports. The peer review reports should also form the basis of any summary report of the outcome of the Union-wide topical peer review exercise prepared collectively by the competent regulatory authorities of the Member States. The summary report should not aim to rank the safety of nuclear installations but rather focus on the process and technical findings of the topical peer review so that the knowledge gained from the exercise can be shared.
               Reciprocal trust should prevail in peer reviews, and it would therefore be appropriate for the Commission, whenever practicable, to inform Member States when it intends to use the results of peer review reports in its policy documents.

               (24)

               The obligations of the Member States to report on the implementation of this Directive and the obligation of the Commission to draw up a report on the basis of the national reports should provide an opportunity to take stock of, and evaluate, the various aspects of the implementation of this Directive as well as its effectiveness. A number of relevant reporting obligations, such as the Convention on Nuclear Safety reports, exist at international level, the results of which might be used for the evaluation of the implementation of this Directive. Moreover, additional reporting requirements should be established under this Directive in relation to the findings of the topical peer reviews of nuclear installations. Consequently, with a view to simplifying the legislation and reducing the administrative burden, the reporting obligation for the Member States should be made less onerous both as regards the frequency of reporting and the content of the reports.

               (25)

               In line with a graded approach, the implementation of the provisions of this Directive depends on the types of nuclear installations on the territory of a Member State. Therefore, when implementing these provisions in national law, Member States should take into account the potential magnitude and nature of risks posed by the nuclear installations that they plan or operate. In particular, the graded approach should concern those Member States that keep only a small inventory of nuclear and radioactive materials, e.g. those linked to the operation of smaller research reactor facilities, which in case of a severe accident would not engender consequences comparable to those generated by nuclear power plants.

               (26)

               The provisions of this Directive which are intrinsically linked to the existence of nuclear installations, namely those concerning the licence holder's obligations, the new specific requirements for nuclear installations and the provisions concerning on-site emergency preparedness and response should not be applicable to Member States without nuclear installations. The provisions of this Directive should be transposed and implemented in a proportionate manner in accordance with national circumstances and taking into account the fact that those Member States do not have nuclear installations, whilst ensuring that nuclear safety receives appropriate attention by the government or by the competent authorities.

               (27)

               According to Directive 2009/71/Euratom, the Member States have to establish and maintain a national legislative, regulatory and organisational framework for the nuclear safety of nuclear installations. The decision as to how the provisions of the national framework are adopted and through which instrument they are applied rests with the competence of the Member States.

               (28)

               In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the provisions of a directive and the corresponding parts of national transposition instruments. With regard to this Directive the legislator considers the transmission of such documents to be justified.

               (29)

               Directive 2009/71/Euratom should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2009/71/Euratom is amended as follows:

               (1)

               the heading of Chapter 1 is replaced by the following:
               ‘OBJECTIVES, SCOPE AND DEFINITIONS’.

               (2)

               Article 2 is amended as follows:

                           (a)

                           paragraph 1 is replaced by the following:
                           ‘1.   This Directive shall apply to any civilian nuclear installation subject to a licence.’;

                           (b)

                           paragraph 3 is replaced by the following:
                           ‘3.   This Directive supplements the basic standards referred to in Article 30 of the Treaty as regards the nuclear safety of nuclear installations and is without prejudice to the existing Community legislation for the protection of the health of the workers and the general public against the dangers arising from ionising radiation, and in particular Council Directive 2013/59/Euratom (11).

                              (11)  Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).’."

               (3)

               Article 3 is amended as follows:

                           (a)

                           paragraph 1(a) is replaced by the following:

                                       ‘(a)

                                       a nuclear power plant, enrichment plant, nuclear fuel fabrication plant, reprocessing plant, research reactor facility, spent fuel storage facility; and’;

                           (b)

                           the following paragraphs are added:

                                       ‘6.

                                       “accident” means any unintended event, the consequences or potential consequences of which are significant from the point of view of radiation protection or nuclear safety;

                                       7.

                                       “incident” means any unintended event, the consequences or potential consequences of which are not negligible from the point of view of radiation protection or nuclear safety;

                                       8.

                                       “abnormal operations” means an operational process deviating from normal operation which is expected to occur at least once during the operating lifetime of a facility but which, in view of appropriate design provisions, does not cause any significant damage to items important to safety or lead to accident conditions;

                                       9.

                                       “design basis” means the range of conditions and events taken explicitly into account in the design, including upgrades, of a nuclear installation, according to established criteria, so that the installation can withstand them without exceeding authorised limits by the planned operation of safety systems;

                                       10.

                                       “design basis accident” means accident conditions against which a nuclear installation is designed according to established design criteria, and for which the damage to the fuel, where applicable, and the release of radioactive material are kept within authorised limits;

                                       11.

                                       “severe conditions” means conditions that are more severe than conditions related to design basis accidents; such conditions may be caused by multiple failures, such as the complete loss of all trains of a safety system, or by an extremely unlikely event.’.

               (4)

               In Chapter 2, the following title is inserted after the heading ‘OBLIGATIONS’:

                  ‘SECTION 1

                     General obligations’.

               (5)

               Article 4(1) is replaced by the following:
               ‘1.   Member States shall establish and maintain a national legislative, regulatory and organisational framework (“national framework”) for the nuclear safety of nuclear installations. The national framework shall provide in particular for:

                           (a)

                           the allocation of responsibilities and coordination between relevant state bodies;

                           (b)

                           national nuclear safety requirements, covering all stages of the lifecycle of nuclear installations;

                           (c)

                           a system of licensing and prohibition of operation of nuclear installations without a licence;

                           (d)

                           a system of regulatory control of nuclear safety performed by the competent regulatory authority;

                           (e)

                           effective and proportionate enforcement actions, including, where appropriate, corrective action or suspension of operation and modification or revocation of a licence.

                     The determination on how national nuclear safety requirements referred to in point (b) are adopted and through which instrument they are applied remains within the competences of the Member States;’.

               (6)

               In Article 5, paragraphs 2 and 3 are replaced by the following:
               ‘2.   Member States shall ensure the effective independence from undue influence of the competent regulatory authority in its regulatory decision-making. For this purpose, Member States shall ensure that the national framework requires that the competent regulatory authority:

                           (a)

                           is functionally separate from any other body or organisation concerned with the promotion or utilisation of nuclear energy, and does not seek or take instructions from any such body or organisation when carrying out its regulatory tasks;

                           (b)

                           takes regulatory decisions founded on robust and transparent nuclear safety-related requirements;

                           (c)

                           is given dedicated and appropriate budget allocations to allow for the delivery of its regulatory tasks as defined in the national framework and is responsible for the implementation of the allocated budget;

                           (d)

                           employs an appropriate number of staff with qualifications, experience and expertise necessary to fulfil its obligations. It may use external scientific and technical resources and expertise in support of its regulatory functions;

                           (e)

                           establishes procedures for the prevention and resolution of any conflicts of interest;

                           (f)

                           provides nuclear safety-related information without clearance from any other body or organisation, provided that this does not jeopardise other overriding interests, such as security, recognised in relevant legislation or international instruments.

                     3.   Member States shall ensure that the competent regulatory authority is given the legal powers necessary to fulfil its obligations in connection with the national framework described in Article 4(1). For this purpose, Member States shall ensure that the national framework entrusts the competent regulatory authorities with the following main regulatory tasks, to:

                           (a)

                           propose, define or participate in the definition of national nuclear safety requirements;

                           (b)

                           require that the licence holder complies and demonstrates compliance with national nuclear safety requirements and the terms of the relevant licence;

                           (c)

                           verify such compliance through regulatory assessments and inspections;

                           (d)

                           propose or carry out effective and proportionate enforcement actions.’.

               (7)

               Articles 6, 7 and 8 are replaced by the following:
               ‘Article 6
               Licence holders
               Member States shall ensure that the national framework requires that:

                           (a)

                           the prime responsibility for the nuclear safety of a nuclear installation rests with the licence holder. That responsibility cannot be delegated and includes responsibility for the activities of contractors and sub-contractors whose activities might affect the nuclear safety of a nuclear installation;

                           (b)

                           when applying for a licence, the applicant is required to submit a demonstration of nuclear safety. Its scope and level of detail shall be commensurate with the potential magnitude and nature of the hazard relevant for the nuclear installation and its site;

                           (c)

                           licence holders are to regularly assess, verify, and continuously improve, as far as reasonably practicable, the nuclear safety of their nuclear installations in a systematic and verifiable manner. That shall include verification that measures are in place for the prevention of accidents and mitigation of the consequences of accidents, including the verification of the application of defence-in-depth provisions;

                           (d)

                           licence holders establish and implement management systems which give due priority to nuclear safety;

                           (e)

                           licence holders provide for appropriate on-site emergency procedures and arrangements, including severe accident management guidelines or equivalent arrangements, for responding effectively to accidents in order to prevent or mitigate their consequences. Those shall in particular:

                                       (i)

                                       be consistent with other operational procedures and periodically exercised to verify their practicability;

                                       (ii)

                                       address accidents and severe accidents that could occur in all operational modes and those that simultaneously involve or affect several units;

                                       (iii)

                                       provide arrangements to receive external assistance;

                                       (iv)

                                       be periodically reviewed and regularly updated, taking account of experience from exercises and lessons learned from accidents;

                           (f)

                           licence holders provide for and maintain financial and human resources with appropriate qualifications and competences, necessary to fulfil their obligations with respect to the nuclear safety of a nuclear installation. Licence holders shall also ensure that contractors and subcontractors under their responsibility and whose activities might affect the nuclear safety of a nuclear installation have the necessary human resources with appropriate qualifications and competences to fulfil their obligations.

                     Article 7
               Expertise and skills in nuclear safety
               Member States shall ensure that the national framework requires all parties to make arrangements for the education and training for their staff having responsibilities related to the nuclear safety of nuclear installations so as to obtain, maintain and to further develop expertise and skills in nuclear safety and on-site emergency preparedness.
               Article 8
               Transparency
               1.   Member States shall ensure that necessary information in relation to the nuclear safety of nuclear installations and its regulation is made available to workers and the general public, with specific consideration to local authorities, population and stakeholders in the vicinity of a nuclear installation. That obligation includes ensuring that the competent regulatory authority and the licence holders, within their fields of responsibility, provide in the framework of their communication policy:

                           (a)

                           information on normal operating conditions of nuclear installations to workers and the general public; and

                           (b)

                           prompt information in case of incidents and accidents to workers and the general public and to the competent regulatory authorities of other Member States in the vicinity of a nuclear installation.

                     2.   Information shall be made available to the public in accordance with relevant legislation and international instruments, provided that this does not jeopardise other overriding interests, such as security, which are recognised in relevant legislation or international instruments.
               3.   Member States shall, without prejudice to Article 5(2), ensure that the competent regulatory authority engages, as appropriate, in cooperation activities on the nuclear safety of nuclear installations with competent regulatory authorities of other Member States in the vicinity of a nuclear installation, inter alia, via the exchange and/or sharing of information.
               4.   Member States shall ensure that the general public is given the appropriate opportunities to participate effectively in the decision-making process relating to the licensing of nuclear installations, in accordance with relevant legislation and international instruments.’.

               (8)

               The following Section is inserted after Article 8:

                  ‘SECTION 2

                     Specific obligations

               Article 8a
               Nuclear safety objective for nuclear installations
               1.   Member States shall ensure that the national nuclear safety framework requires that nuclear installations are designed, sited, constructed, commissioned, operated and decommissioned with the objective of preventing accidents and, should an accident occur, mitigating its consequences and avoiding:

                           (a)

                           early radioactive releases that would require off-site emergency measures but with insufficient time to implement them;

                           (b)

                           large radioactive releases that would require protective measures that could not be limited in area or time.

                     2.   Member States shall ensure that the national framework requires that the objective set out in paragraph 1:

                           (a)

                           applies to nuclear installations for which a construction licence is granted for the first time after 14 August 2014;

                           (b)

                           is used as a reference for the timely implementation of reasonably practicable safety improvements to existing nuclear installations, including in the framework of the periodic safety reviews as defined in Article 8c(b).

                     Article 8b
               Implementation of the nuclear safety objective for nuclear installations
               1.   In order to achieve the nuclear safety objective set out in Article 8a, Member States shall ensure that the national framework requires that where defence-in-depth applies, it shall be applied to ensure that:

                           (a)

                           the impact of extreme external natural and unintended man-made hazards is minimised;

                           (b)

                           abnormal operation and failures are prevented;

                           (c)

                           abnormal operation is controlled and failures are detected;

                           (d)

                           accidents within the design basis are controlled;

                           (e)

                           severe conditions are controlled, including prevention of accidents progression and mitigation of the consequences of severe accidents;

                           (f)

                           organisational structures according to Article 8d(1) are in place.

                     2.   In order to achieve the nuclear safety objective set out in Article 8a, Member States shall ensure that the national framework requires that the competent regulatory authority and the licence holder take measures to promote and enhance an effective nuclear safety culture. Those measures include in particular:

                           (a)

                           management systems which give due priority to nuclear safety and promote, at all levels of staff and management, the ability to question the effective delivery of relevant safety principles and practices, and to report in a timely manner on safety issues, in accordance with Article 6(d);

                           (b)

                           arrangements by the licence holder to register, evaluate and document internal and external safety significant operating experience;

                           (c)

                           the obligation of the licence holder to report events with a potential impact on nuclear safety to the competent regulatory authority; and,

                           (d)

                           arrangements for education and training, in accordance with Article 7.

                     Article 8c
               Initial assessment and periodic safety reviews
               Member States shall ensure that the national framework requires that:

                           (a)

                           any grant of a licence to construct a nuclear installation or operate a nuclear installation, is based upon an appropriate site and installation-specific assessment, comprising a nuclear safety demonstration with respect to the national nuclear safety requirements based on the objective set in Article 8a;

                           (b)

                           the licence holder under the regulatory control of the competent regulatory authority, re-assesses systematically and regularly, at least every 10 years, the safety of the nuclear installation as laid down in Article 6(c). That safety reassessment aims at ensuring compliance with the current design basis and identifies further safety improvements by taking into account ageing issues, operational experience, most recent research results and developments in international standards, using as a reference the objective set in Article 8a.

                     Article 8d
               On-site emergency preparedness and response
               1.   Without prejudice to the provisions of the Directive 2013/59/Euratom, Member States shall ensure that the national framework requires that an organisational structure for on-site emergency preparedness and response is established with a clear allocation of responsibilities and coordination between the licence holder, and competent authorities and organisations, taking into account all phases of an emergency.
               2.   Member States shall ensure that there is consistency and continuity between the on-site emergency preparedness and response arrangements required by the national framework and other emergency preparedness and response arrangements required under Directive 2013/59/Euratom.’.

               (9)

               The following Chapter is inserted after Article 8d:
               ‘CHAPTER 2a

                  PEER REVIEWS AND REPORTING

               Article 8e
               Peer reviews
               1.   Member States shall, at least once every 10 years, arrange for periodic self-assessments of their national framework and competent regulatory authorities and invite an international peer review of relevant segments of their national framework and competent regulatory authorities with the aim of continuously improving nuclear safety. Outcomes of such peer reviews shall be reported to the Member States and the Commission, when available.
               2.   Member States shall ensure that, on a coordinated basis:

                           (a)

                           a national assessment is performed, based on a specific topic related to nuclear safety of the relevant nuclear installations on their territory;

                           (b)

                           all other Member States, and the Commission as observer, are invited to peer review the national assessment referred to in point (a);

                           (c)

                           appropriate follow-up measures are taken of relevant findings resulting from the peer review process;

                           (d)

                           relevant reports are published on the above mentioned process and its main outcome when results are available.

                     3.   Member States shall ensure that arrangements are in place to allow for the first topical peer review to start in 2017, and for subsequent topical peer reviews to take place at least every six years thereafter.
               4.   In case of an accident leading to situations that would require off-site emergency measures or protective measures for the general public, the Member State concerned shall ensure that an international peer review is invited without undue delay.’.

               (10)

               Article 9 is amended as follows:

                           (a)

                           paragraph 1 is replaced by the following:
                           ‘1.   Member States shall submit a report to the Commission on the implementation of this Directive for the first time by 22 July 2014, and then by 22 July 2020.’;

                           (b)

                           paragraph 3 is deleted.

               (11)

               In Article 10, the following paragraph is inserted after paragraph 1:
               ‘1a.   The obligations of transposition and implementation of Articles 6, 8a, 8b, 8c and 8d shall not apply to Member States without nuclear installations, unless they decide to develop any activity related to nuclear installations subject to a licence under their jurisdiction.’.

         Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 August 2017. They shall immediately inform the Commission thereof.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive and of any subsequent amendments to those provisions.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 8 July 2014.

            For the Council

            The President

         P. C. PADOAN

      (1)  Opinion of 2 April 2014 (not yet published in the Official Journal).

      (2)  OJ C 341, 21.11.2013, p. 92.

      (3)  Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).

      (4)  Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009. p. 18).

      (5)  Commission Decision 1999/819/Euratom of 16 November 1999 concerning the accession to the 1994 Convention on Nuclear Safety by the European Atomic Energy Community (Euratom) (OJ L 318, 11.12.1999, p. 20).

      (6)  IAEA Safety Fundamentals: Fundamental safety principles, IAEA Safety Standard Series No SF-1 (2006).

      (7)  Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (OJ L 199, 2.8.2011. p. 48).

      (8)  Commission Decision 2007/530/Euratom of 17 July 2007 on establishing the European High Level Group on Nuclear Safety and Waste Management (OJ L 195, 27.7.2007, p. 44).

      (9)  Council Decision of 14 December 1987 on Community arrangements for the early exchange of information in the event of a radiological emergency (OJ L 371, 30.12.1987, p. 76).

      (10)  Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1).


Avis juridique important

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31981L0126

Commission Directive 81/126/EEC of 16 February 1981 amending the Annexes to Council Directives 66/401/EEC, 66/402/EEC and 69/208/EEC on the marketing of fodder plant seed, cereal seed and seed of oil and fibre plants respectively and Directives 78/386/EEC and 78/388/EEC

Official Journal L 067 , 12/03/1981 P. 0036 - 0037 Spanish special edition: Chapter 03 Volume 21 P. 0051  Portuguese special edition Chapter 03 Volume 21 P. 0051  Finnish special edition: Chapter 3 Volume 13 P. 0023  Swedish special edition: Chapter 3 Volume 13 P. 0023

COMMISSION DIRECTIVE of 16 February 1981 amending the Annexes to Council Directives 66/401/EEC, 66/402/EEC and 69/208/EEC on the marketing of fodder plant seed, cereal seed and seed of oil and fibre plants respectively and Directives 78/386/EEC and 78/388/EEC (81/126/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 80/754/EEC (2), and in particular Article 21a thereof,  Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (3), as last amended by Directive 79/692/EEC (4), and in particular Article 21a thereof,  Having regard to Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (5), as last amended by Directive 80/304/EEC (6), and in particular Article 20a thereof,  Whereas, in the light of the development of scientific and technical knowledge, Annexes I and II to Directive 66/401/EEC, Annex III to Directive 66/402/EEC and Annex II to Directive 69/208/EEC should be amended for the reasons set out below;  Whereas the conditions to be satisfied by the crop and by the seed, including the varietal purity standards, should be amended so as to conform with the schemes for the varietal certification of seed moving in international trade laid down by the Organization for Economic Cooperation and Development (OECD) ; whereas, as a result the time limits for implementation laid down in the first indent of Article 2 (1) of Commission Directive 78/386/EEC of 18 April 1978 amending the Annexes to Directive 66/401/EEC on the marketing of fodder plant seed (7) and in the first indent of Article 2 (1) of Commission Directive 78/388/EEC of 18 April 1978 amending the Annexes to Directive 69/208/EEC on the marketing of seed of oil and fibre plants (8) should be amended;  Whereas the standards as regards the determination of seeds of Rumex by number should be relaxed for certified seed of some further fodder plant species, unless there is doubt whether the standards laid down in Directive 66/401/EEC are satisfied;  Whereas, in order to satisfy the conditions for official examination of seed carried out in accordance with current international methods, it is necessary to revise the provisions laid down in Directive 66/402/EEC in respect of the maximum weight per lot of Zea mays seed;  Whereas standards in respect of the maximum content by number of seeds of other plant species in hemp seeds should be adapted to the seed quality standards normally achieved;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Annex I to Directive 66/401/EEC is hereby amended as follows:    1. In item 4 the words "of the species or varieties other than Pisum sativum uni-clonal varieties of Poa spp." are replaced by the words "other than those of the species Pisum sativum, Brassica napus var. napobrassica, Brassica oleracea convar. acephala, Raphanus sativus ssp. oleifera, or of apomictic uni-clonal varieties of Poa spp.".  (1) OJ No 125, 11.7.1966, p. 2298/66. (2) OJ No L 207, 9.8.1980, p. 36. (3) OJ No L 125, 11.7.1966, p. 2309/66. (4) OJ No L 205, 13.8.1979, p. 1. (5) OJ No L 169, 10.7.1969, p. 3. (6) OJ No L 68, 14.3.1980, p. 33. (7) OJ No L 113, 25.4.1978, p. 1. (8) OJ No L 113, 25.4.1978, p. 20.        2. The following sentence shall be added to item 4 : "In the case of the species Pisum sativum, Brassica napus var. napobrassica, Brassica oleracea convar. acephala, Raphanus sativus spp. oleifera and of apomictic uni-clonal varieties of Poa spp. only the first sentence is applicable".          Article 2 Annex II to Directive 66/401/EEC is hereby amended as follows:  In item 2A of section I, column 14, part "GRAMINEAE", the letter (n) is inserted in the case of species other than Phleum bertolonii and Phleum pratense.   Article 3 Annex III to Directive 66/402/EEC is hereby amended as follows:  In column 2 of the table the figure 20 is replaced by the figure 40 in the case of Zea mays.   Article 4 Annex II to Directive 69/208/EEC is hereby amended as follows:  In item 2A of section I, column 5, the figure 10 is replaced by the figure 30 in the case of Cannabis sativa.   Article 5 The first indent of Article 2 (1) of Directive 78/386/EEC is replaced by the following:  "    - the provisions of Article 1 (1) in respect of Annex I (3) and (4) on 1 January 1981;       - the provisions of Article 1 (2) in respect of Annex II (I) (1) and Annex II (II) (1) on 1 January 1982.        "  Article 6 The first indent of Article 2 (1) of Directive 78/388/EEC is replaced by the following:  "- the provisions of Article 1 (1) in respect of Annex I (3) and of Article 1 (2) in respect of Annex II (I) (1) on 1 January 1982."  Article 7 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with:    - Articles 1, 5 and 6 with effect from 1 January 1981,       - the other provisions of this Directive not later than 1 July 1982.         2. Member States shall ensure that seed is subject to no marketing restrictions due to different dates of implementation of this Directive in accordance with the second indent of paragraph 1.   Article 8 This Directive is addressed to the Member States.     Done at Brussels, 16 February 1981.  For the Commission  Poul DALSAGER  Member of the Commission


title: Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air

text:
               26.1.2005

               EN

               Official Journal of the European Union

               L 23/3

      DIRECTIVE 2004/107/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 15 December 2004
   relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               On the basis of principles enshrined in Article 175(3) of the Treaty, the Sixth Community Environment Action Programme, adopted by Decision No 1600/2002/EC of the European Parliament and of the Council (3), establishes the need to reduce pollution to levels which minimise harmful effects on human health, paying particular attention to sensitive populations, and the environment as a whole, to improve the monitoring and assessment of air quality including the deposition of pollutants and to provide information to the public.

               (2)

               Article 4(1) of Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management (4) requires the Commission to submit proposals for regulating the pollutants listed in Annex I to that Directive taking into account the provisions laid down in paragraphs 3 and 4 of that Article.

               (3)

               Scientific evidence shows that arsenic, cadmium, nickel and some polycyclic aromatic hydrocarbons are human genotoxic carcinogens and that there is no identifiable threshold below which these substances do not pose a risk to human health. Impact on human health and the environment occurs via concentrations in ambient air and via deposition. With a view to cost-effectiveness, ambient air concentrations of arsenic, cadmium, nickel and polycyclic aromatic hydrocarbons, which would not pose a significant risk to human health, cannot be achieved in specific areas.

               (4)

               With the aim of minimising harmful effects on human health, paying particular attention to sensitive populations, and the environment as a whole, of airborne arsenic, cadmium and nickel and polycyclic aromatic hydrocarbons, target values should be set, to be attained as far as possible. Benzo(a)pyrene should be used as a marker for the carcinogenic risk of polycyclic aromatic hydrocarbons in ambient air.

               (5)

               The target values would not require any measures entailing disproportionate costs. Regarding industrial installations, they would not involve measures beyond the application of best available techniques (BAT) as required by Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (5) and in particular would not lead to the closure of installations. However, they would require Member States to take all cost-effective abatement measures in the relevant sectors.

               (6)

               In particular, the target values of this Directive are not to be considered as environmental quality standards as defined in Article 2(7) of Directive 96/61/EC and which, according to Article 10 of that Directive, require stricter conditions than those achievable by the use of BAT.

               (7)

               In accordance with Article 176 of the Treaty, Member States may maintain or introduce more stringent protective measures relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons provided that they are compatible with the Treaty and that they are notified to the Commission.

               (8)

               Where concentrations exceed certain assessment thresholds, monitoring of arsenic, cadmium, nickel and benzo(a)pyrene should be mandatory. Supplementary means of assessment may reduce the required number of sampling points for fixed measurements. Further monitoring of background ambient air concentrations and deposition is foreseen.

               (9)

               Mercury is a very hazardous substance for human health and the environment. It is present throughout the environment and, in the form of methylmercury, has the capacity to accumulate in organisms, and in particular to concentrate in organisms higher up the food chain. Mercury released into the atmosphere is capable of being transported over long distances.

               (10)

               The Commission intends to come forward in 2005 with a coherent strategy containing measures to protect human health and the environment from the release of mercury, based on a life-cycle approach, and taking into account production, use, waste treatment and emissions. In this context, the Commission should consider all appropriate measures with a view to reducing the quantity of mercury in terrestrial and aquatic ecosystems, and thereby the ingestion of mercury via food, and avoiding mercury in certain products.

               (11)

               The effects of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons on human health, including via the food chain, and the environment as a whole, occur through concentrations in ambient air and via deposition; the accumulation of these substances in soils and the protection of ground water should be taken into account. In order to facilitate review of this Directive in 2010, the Commission and the Member States should consider promoting research into the effects of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons on human health and the environment, particularly via deposition.

               (12)

               Standardised accurate measurement techniques and common criteria for the location of measuring stations are important elements in assessing ambient air quality so that the information obtained is comparable throughout the Community. Providing reference measurement methods is acknowledged to be an important issue. The Commission has already mandated work on the preparation of CEN standards for the measurement of those constituents in ambient air where target values are defined (arsenic, cadmium, nickel and benzo(a)pyrene) as well as for the deposition of heavy metals with a view to their early development and adoption. In the absence of CEN standard methods, the use of international or national standard reference measurement methods should be permitted.

               (13)

               Information on the concentrations and the deposition of the regulated pollutants should be forwarded to the Commission as a basis for regular reports.

               (14)

               Up-to-date information on ambient air concentrations and deposition of regulated pollutants should be readily available to the public.

               (15)

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

               (16)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6).

               (17)

               The amendments necessary for adaptation of this Directive to scientific and technical progress should relate solely to criteria and techniques for the assessment of concentrations and deposition of regulated pollutants or detailed arrangements for forwarding information to the Commission. They should not have the effect of modifying the target values either directly or indirectly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Objectives
   The objectives of this Directive shall be to:

               (a)

               establish a target value for the concentration of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air so as to avoid, prevent or reduce harmful effects of arsenic, cadmium, nickel and polycyclic aromatic hydrocarbons on human health and the environment as a whole;

               (b)

               ensure, with respect to arsenic, cadmium, nickel and polycyclic aromatic hydrocarbons, that ambient air quality is maintained where it is good and that it is improved in other cases;

               (c)

               determine common methods and criteria for the assessment of concentrations of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air as well as of the deposition of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons;

               (d)

               ensure that adequate information on concentrations of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air as well as on the deposition of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons is obtained and ensure that it is made available to the public.

         Article 2
   Definitions
   For the purposes of this Directive the definitions in Article 2 of Directive 96/62/EC, with the exception of the definition of ‘target value’, shall apply.
   The objectives of this Directive shall be to:

         (a)
         ‘target value’ means a concentration in the ambient air fixed with the aim of avoiding, preventing or reducing harmful effects on human health and the environment as a whole, to be attained where possible over a given period;

         (b)
         ‘total or bulk deposition’ means the total mass of pollutants which is transferred from the atmosphere to surfaces (e.g. soil, vegetation, water, buildings, etc.) in a given area within a given time;

         (c)
         ‘upper assessment threshold’ means a level specified in Annex II below which a combination of measurements and modelling techniques may be used to assess ambient air quality, in accordance with Article 6(3) of Directive 96/62/EC;

         (d)
         ‘lower assessment threshold’ means a level specified in Annex II below which the sole use of modelling or objective estimation techniques shall be possible to assess ambient air quality, in accordance with Article 6(4) of Directive 96/62/EC;

         (e)
         ‘fixed measurements’ means measurements taken at fixed sites either continuously or by random sampling, in accordance with Article 6(5) of Directive 96/62/EC;

         (f)
         ‘arsenic’, ‘cadmium’, ‘nickel’ and ‘benzo(a)pyrene’ mean the total content of these elements and compounds in the PM10 fraction;

         (g)
         ‘PM10’ means particulate matter, which passes through a size-selective inlet as defined in EN 12341 with a 50 % efficiency cut-off at 10 μm aerodynamic diameter;

         (h)
         ‘polycyclic aromatic hydrocarbons’ means those organic compounds, composed of at least two fused aromatic rings made entirely from carbon and hydrogen;

         (i)
         ‘total gaseous mercury’ means elemental mercury vapour (Hg0) and reactive gaseous mercury, i.e. water-soluble mercury species with sufficiently high vapour pressure to exist in the gas phase.
   Article 3
   Target values
   1.   Member States shall take all necessary measures not entailing disproportionate costs to ensure that, as from 31 December 2012, concentrations of arsenic, cadmium, nickel and benzo(a)pyrene, used as a marker for the carcinogenic risk of polycyclic aromatic hydrocarbons, in ambient air, as assessed in accordance with Article 4, do not exceed the target values laid down in Annex I.
   2.   Member States shall draw up a list of zones and agglomerations in which the levels of arsenic, cadmium, nickel, and benzo(a)pyrene are below the respective target values. Member States shall maintain the levels of these pollutants in these zones and agglomerations below the respective target values and shall endeavour to preserve the best ambient air quality, compatible with sustainable development.
   3.   Member States shall draw up a list of the zones and agglomerations where the target values laid down in Annex I are exceeded.
   For such zones and agglomerations, Member States shall specify the areas of exceedance and the sources contributing thereto. In the areas concerned, Member States shall demonstrate the application of all necessary measures not entailing disproportionate costs, directed in particular at the predominant emission sources, in order to attain the target values. In the case of industrial installations covered by Directive 96/61/EC this means the application of BAT as defined by Article 2(11) of that Directive.
   Article 4
   Assessment of ambient air concentrations and deposition rates
   1.   Ambient air quality with respect to arsenic, cadmium, nickel and benzo(a)pyrene shall be assessed throughout the territory of the Member States.
   2.   In accordance with the criteria referred to in paragraph 7, measurement is mandatory in the following zones:

               (a)

               zones and agglomerations in which levels are between the upper and the lower assessment threshold, and

               (b)

               other zones and agglomerations where levels exceed the upper assessment threshold.

         The measurements provided for may be supplemented by modelling techniques to provide an adequate level of information on ambient air quality.
   3.   A combination of measurements, including indicative measurements as referred to in Annex IV, Section I, and modelling techniques may be used to assess ambient air quality in zones and agglomerations where the levels over a representative period are between the upper and lower assessment thresholds, to be determined pursuant to Annex II, Section II.
   4.   In zones and agglomerations where the levels are below the lower assessment threshold, to be determined pursuant to Annex II, Section II, the sole use of modelling or objective estimation techniques for assessing levels shall be possible.
   5.   Where pollutants have to be measured, the measurements shall be taken at fixed sites either continuously or by random sampling. The number of measurements shall be sufficient to enable the levels to be determined.
   6.   The upper and lower assessment thresholds for arsenic, cadmium, nickel and benzo(a)pyrene in ambient air shall be those laid down in Section I of Annex II. The classification of each zone or agglomeration for the purposes of this Article shall be reviewed at least every five years in accordance with the procedure laid down in Section II of Annex II. Classification shall be reviewed earlier in the event of significant change in activities relevant to concentrations of arsenic, cadmium, nickel and benzo(a)pyrene, in ambient air.
   7.   The criteria for determining the location of sampling points for the measurement of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air in order to assess compliance with the target values shall be those listed in Sections I and II of Annex III. The minimum number of sampling points for fixed measurements of concentrations of each pollutant shall be as laid down in Section IV of Annex III, and they shall be installed in each zone or agglomeration within which measurement is required if fixed measurement is the sole source of data on concentrations within it.
   8.   To assess the contribution of benzo(a)pyrene in ambient air, each Member State shall monitor other relevant polycyclic aromatic hydrocarbons at a limited number of measurement sites. These compounds shall include at least: benzo(a)anthracene, benzo(b)fluoranthene, benzo(j)fluoranthene, benzo(k)fluoranthene, indeno(1,2,3-cd)pyrene, and dibenz(a,h)anthracene. Monitoring sites for these polycyclic aromatic hydrocarbons shall be co-located with sampling sites for benzo(a)pyrene and shall be selected in such a way that geographical variation and long-term trends can be identified. Sections I, II and III of Annex III shall apply.
   9.   Irrespective of concentration levels, one background sampling point shall be installed every 100 000 km2 for the indicative measurement, in ambient air, of arsenic, cadmium, nickel, total gaseous mercury, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8 and of the total deposition of arsenic, cadmium, mercury, nickel, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8. Each Member State shall set up at least one measuring station; however, Member States may, by agreement, and in accordance with guidelines to be drawn up under the procedure laid down in Article 6, set up one or several common measuring stations, covering neighbouring zones in adjoining Member States, to achieve the necessary spatial resolution. Measurement of particulate and gaseous divalent mercury is also recommended. Where appropriate, monitoring shall be coordinated with the European Monitoring and Evaluation of Pollutants (EMEP) monitoring strategy and measurement programme. The sampling sites for these pollutants shall be selected in such a way that geographical variation and long-term trends can be identified. Sections I, II and III of Annex III shall apply.
   10.   The use of bio indicators may be considered where regional patterns of the impact on ecosystems are to be assessed.
   11.   For zones and agglomerations within which information from fixed measurement stations is supplemented by information from other sources, such as emission inventories, indicative measurement methods and air quality modelling, the number of fixed measuring stations to be installed and the spatial resolution of other techniques shall be sufficient for the concentrations of air pollutants to be established in accordance with Section I of Annex III and Section I of Annex IV.
   12.   Data quality objectives are laid down in Section I of Annex IV. Where air quality models are used for assessment, Section II of Annex IV shall apply.
   13.   The reference methods for the sampling and analysis of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air shall be as laid down in Sections I, II and III of Annex V. Section IV of Annex V sets out reference techniques for measuring the total deposition of arsenic, cadmium, mercury, nickel and the polycyclic aromatic hydrocarbons and Section V of Annex V refers to reference air quality modelling techniques when such techniques are available.
   14.   The date by which Member States shall inform the Commission of the methods used for the preliminary assessment of air quality under Article 11(1)(d) of Directive 96/62/EC shall be the date referred to in Article 10 of this Directive.
   15.   Any amendments necessary to adapt the provisions of this Article and of Section II of Annex II and of Annexes III to V to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 6 but may not result in any direct or indirect changes to target values.
   Article 5
   Transmission of information and reporting
   1.   With regard to the zones and agglomerations where any of the target values laid down in Annex I is exceeded, Member States shall forward the following information to the Commission:

               (a)

               the lists of the zones and agglomerations concerned,

               (b)

               the areas of exceedance,

               (c)

               the concentration values assessed,

               (d)

               the reasons for exceedance, and in particular any sources contributing to it,

               (e)

               the population exposed to such exceedance.

         Member States shall also report all data assessed in accordance with Article 4, unless already reported under Council Decision 97/101/EC of 27 January 1997 establishing a reciprocal exchange of information and data from networks and individual stations measuring ambient air pollution within the Member States (7).
   The information shall be transmitted for each calendar year, by no later than 30 September of the following year, and for the first time for the calendar year following 15 February 2007.
   2.   In addition to the requirements laid down in paragraph 1, Member States shall also report any measures taken pursuant to Article 3.
   3.   The Commission shall ensure that all information submitted pursuant to paragraph 1 is promptly made available to the public by appropriate means, such as Internet, press and other easily accessible media.
   4.   The Commission shall adopt, in accordance with the procedure referred to in Article 6, any detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article.
   Article 6
   Committee
   1.   The Commission shall be assisted by the committee established by Article 12(2) of Directive 96/62/EC.
   2.   Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3.   The Committee shall adopt its Rules of Procedure.
   Article 7
   Public information
   1.   Member States shall ensure that clear and comprehensible information is accessible and is routinely made available to the public as well as to appropriate organisations, such as environmental organisations, consumer organisations, organisations representing the interests of sensitive populations and other relevant healthcare bodies, on ambient air concentrations of arsenic, cadmium, mercury, nickel and benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in Article 4(8) as well as on deposition rates of arsenic, cadmium, mercury, nickel and benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in Article 4(8).
   2.   The information shall also indicate any annual exceedance of the target values for arsenic, cadmium, nickel and benzo(a)pyrene laid down in Annex I. The information shall give the reasons for the exceedance and the area to which it applies. It shall also provide a short assessment in relation to the target value and appropriate information regarding effects on health and impact on the environment.
   Information on any measures taken pursuant to Article 3 shall be made available to the organisations referred to in paragraph 1 of this Article.
   3.   The information shall be made available by means of, for example, Internet, press and other easily accessible media.
   Article 8
   Report and review
   1.   The Commission shall, by 31 December 2010 at the latest, submit to the European Parliament and the Council a report based on:

               (a)

               the experience acquired in the application of this Directive,

               (b)

               in particular, the results of the most recent scientific research concerning the effects on human health, paying particular attention to sensitive populations, and on the environment as a whole, of exposure to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons, and

               (c)

               technological developments including the progress achieved in methods of measuring and otherwise assessing concentrations of these pollutants in ambient air as well as their deposition.

         2.   The report referred to in paragraph 1 shall take into account:

               (a)

               current air quality, trends and projections up to and beyond 2015;

               (b)

               the scope for making further reductions in polluting emissions from all relevant sources, and the possible merit in introducing limit values aimed at reducing the risk to human health, for the pollutants listed in Annex I, taking account of technical feasibility and cost-effectiveness and any significant additional health and environmental protection that this would provide;

               (c)

               the relationships between pollutants and opportunities for combined strategies for improving Community air quality and related objectives;

               (d)

               current and future requirements for informing the public and for the exchange of information between Member States and Commission;

               (e)

               the experience acquired in the application of this Directive in Member States, and in particular the conditions under which measurement has been carried out as laid down in Annex III;

               (f)

               secondary economic benefits for the environment and health in reducing the emissions of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons to the extent that these can be assessed;

               (g)

               the adequacy of the particle size fraction used for sampling in view of general particulate matter measurement requirements;

               (h)

               the suitability of benzo(a)pyrene as a marker for the total carcinogenic activity of polycyclic aromatic hydrocarbons, having regard to predominantly gaseous forms of polycyclic aromatic hydrocarbons such as fluoranthene.

         In the light of the latest scientific and technological developments the Commission shall also examine the effect of arsenic, cadmium and nickel on human health with a view to quantifying their genotoxic carcinogenicity. Taking account of measures adopted pursuant to the mercury strategy the Commission shall also consider whether there would be merit in taking further action in relation to mercury, taking account of technical feasibility and cost-effectiveness and any significant additional health and environmental protection that this would provide.
   3.   With a view to achieving levels of ambient air concentrations that would further reduce harmful effects on human health and would lead to a high level of protection of the environment as a whole, taking into account the technical feasibility and cost-effectiveness of further action, the report referred to in paragraph 1 may be accompanied, if appropriate, by proposals for amendments to this Directive, particularly taking into account the results obtained in accordance with paragraph 2. In addition the Commission shall consider regulating the deposition of arsenic, cadmium, mercury, nickel and specific polycyclic aromatic hydrocarbons.
   Article 9
   Penalties
   Member States shall determine the penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
   Article 10
   Implementation
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2007 at the latest. They shall forthwith inform the Commission thereof.
   When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive.
   Article 11
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

   Article 12
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 15 December 2004.

            For the European Parliament

            The President

         J. P. BORRELL FONTELLES

            For the Council

            The President

         A. NICOLAÏ

      (1)  OJ C 110, 30.4.2004, p. 16.

      (2)  Opinion of the European Parliament of 20 April 2004 (not yet published in the Official Journal), Council Decision of 15 November 2004.

      (3)  OJ L 242, 10.9.2002, p. 1.

      (4)  OJ L 296, 21.11.1996, p. 55. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (5)  OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 1882/2003.

      (6)  OJ L 184, 17.7.1999, p. 23.

      (7)  OJ L 35, 5.2.1997, p. 14. Decision as amended by Commission Decision 2001/752/EC (OJ L 282, 26.10.2001, p. 69).

      ANNEX I
      Target values for arsenic, cadmium, nickel and benzo(a)pyrene

                  Pollutant

                  Target value (1)

                  Arsenic

                  6 ng/m3

                  Cadmium

                  5 ng/m3

                  Nickel

                  20 ng/m3

                  Benzo(a)pyrene

                  1 ng/m3

         (1)  For the total content in the PM10 fraction averaged over a calendar year.

      ANNEX II
      Determination of requirements for assessment of concentrations of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air within a zone or agglomeration
      I.   Upper and lower assessment thresholds
      The following upper and lower assessment thresholds will apply:

                  Arsenic

                  Cadmium

                  Nickel

                  B(a)P

                  Upper assessment threshold in percent of the target value

                  60 %
                  (3,6 ng/m3)

                  60 %
                  (3 ng/m3)

                  70 %
                  (14 ng/m3)

                  60 %
                  (0,6 ng/m3)

                  Lower assessment threshold in percent of the target value

                  40 %
                  (2,4 ng/m3)

                  40 %
                  (2 ng/m3)

                  50 %
                  (10 ng/m3)

                  40 %
                  (0,4 ng/m3)

            II.   Determination of exceedances of upper and lower assessment thresholds
      Exceedances of upper and lower assessment thresholds must be determined on the basis of concentrations during the previous five years where sufficient data are available. An assessment threshold will be deemed to have been exceeded if it has been exceeded during at least three calendar years out of those previous five years.
      Where fewer than five years’ data are available, Member States may combine measurement campaigns of short duration during the period of the year and at locations likely to be typical of the highest pollution levels with results obtained from information from emission inventories and modelling to determine exceedances of the upper and lower assessment thresholds.

      ANNEX III
      Location and minimum number of sampling points for the measurement of concentrations in ambient air and deposition rates
      I.   Macroscale siting
      The sites of sampling points should be selected in such a way as to:

                  —

                  provide data on the areas within zones and agglomerations where the population is likely to be directly or indirectly exposed to the highest concentrations averaged over a calendar year;

                  —

                  provide data on levels in other areas within zones and agglomerations which are representative of the exposure of the general population;

                  —

                  provide data on deposition rates representing the indirect exposure of the population through the food chain.

            Sampling points should in general be sited so as to avoid measuring very small micro-environments in their immediate vicinity. As a guideline, a sampling point should be representative of air quality in surrounding areas of no less than 200 m2 at traffic-orientated sites, at least 250 m × 250 m at industrial sites, where feasible, and several square kilometres at urban-background sites.
      Where the objective is to assess background levels the sampling site should not be influenced by agglomerations or industrial sites in its vicinity, i.e. sites closer than a few kilometres.
      Where contributions from industrial sources are to be assessed, at least one sampling point shall be installed downwind of the source in the nearest residential area. Where the background concentration is not known, an additional sampling point shall be situated within the main wind direction. In particular where Article 3(3) applies, the sampling points should be sited such that the application of BAT can be monitored.
      Sampling points should also, where possible, be representative of similar locations not in their immediate vicinity. Where appropriate they should be co-located with sampling points for PM10.
      II.   Microscale siting
      The following guidelines should be met as far as practicable:

                  —

                  the flow around the inlet sampling probe should be unrestricted, without any obstructions affecting the airflow in the vicinity of the sampler (normally some metres away from buildings, balconies, trees and other obstacles and at least 0,5 m from the nearest building in the case of sampling points representing air quality at the building line);

                  —

                  in general, the inlet sampling point should be between 1,5 m (the breathing zone) and 4 m above the ground. Higher positions (up to 8 m) may be necessary in some circumstances. Higher siting may also be appropriate if the station is representative of a large area;

                  —

                  the inlet probe should not be positioned in the immediate vicinity of sources in order to avoid direct intake of emissions unmixed with ambient air;

                  —

                  the sampler’s exhaust outlet should be positioned so that recirculation of exhaust air to the sample inlet is avoided;

                  —

                  traffic-orientated sampling points should be at least 25 metres from the edge of major junctions and at least 4 m from the centre of the nearest traffic lane; inlets should be sited so as to be representative of air quality near the building line;

                  —

                  for the deposition measurements in rural background areas, the EMEP guidelines and criteria should be applied as far as practicable and where not provided for in the Annexes.

            The following factors may also be taken into account:

                  —

                  interfering sources

                  —

                  security

                  —

                  access

                  —

                  availability of electrical power and telephone communications

                  —

                  visibility of the site in relation to its surroundings

                  —

                  safety of the public and operators

                  —

                  the desirability of co-locating sampling points for different pollutants

                  —

                  planning requirements.

            III.   Documentation and review of site selection
      The site selection procedures should be fully documented at the classification stage by such means as compass-point photographs of the surrounding area and a detailed map. Sites should be reviewed at regular intervals with repeated documentation to ensure that selection criteria remain valid over time.
      IV.   Criteria for determining numbers of sampling points for fixed measurement of concentrations of arsenic, cadmium, nickel and benzo(a)pyrene in ambient air
      Minimum number of sampling points for fixed measurement to assess compliance with target values for the protection of human health in zones and agglomerations where fixed measurement is the sole source of information.
      (a)   Diffuse sources

                  Population of agglomeration or zone
                  (thousands)

                  If maximum concentrations exceed the upper assessment threshold (1)

                  If maximum concentrations are between the upper and lower assessment thresholds

                  As, Cd, Ni

                  B(a)P

                  As, Cd, Ni

                  B(a)P

                  0–749

                  1

                  1

                  1

                  1

                  750–1 999

                  2

                  2

                  1

                  1

                  2 000–3 749

                  2

                  3

                  1

                  1

                  3 750–4 749

                  3

                  4

                  2

                  2

                  4 750–5 999

                  4

                  5

                  2

                  2

                  ≥ 6 000

                  5

                  5

                  2

                  2

            (b)   Point sources
      For the assessment of pollution in the vicinity of point sources, the number of sampling points for fixed measurement should be determined taking into account emission densities, the likely distribution patterns of ambient air pollution and potential exposure of the population.
      The sampling points should be sited such that the application of BAT as defined by Article 2(11) of Directive 96/61/EC can be monitored.

         (1)  To include at least one urban-background station and for benzo(a)pyrene also one traffic-oriented station provided this does not increase the number of sampling points.

      ANNEX IV
      Data quality objectives and requirements for air quality models
      I.   Data quality objectives
      The following data quality objectives are provided as a guide to quality assurance.

                  Benzo(a)pyrene

                  Arsenic, cadmium and nickel

                  Polycyclic aromatic hydrocarbons other than benzo(a)pyrene, total gaseous mercury

                  Total deposition

                  — Uncertainty

                  Fixed and indicative measurements

                  50 %

                  40 %

                  50 %

                  70 %

                  Modelling

                  60 %

                  60 %

                  60 %

                  60 %

                  — Minimum data capture

                  90 %

                  90 %

                  90 %

                  90 %

                  — Minimum time coverage:

                  Fixed measurements

                  33 %

                  50 %

                  Indicative measurements (1)

                  14 %

                  14 %

                  14 %

                  33 %

            The uncertainty (expressed at a 95 % confidence level) of the methods used for the assessment of ambient air concentrations will be evaluated in accordance with the principles of the CEN Guide to the expression of uncertainty in measurement (ENV 13005-1999), the methodology of ISO 5725:1994, and the guidance provided in the CEN Report, ‘Air quality — Approach to uncertainty estimation for ambient air reference measurement methods’ (CR 14377:2002E). The percentages for uncertainty are given for individual measurements, which are averaged over typical sampling times, for a 95 % confidence interval. The uncertainty of the measurements should be interpreted as being applicable in the region of the appropriate target value. Fixed and indicative measurements must be evenly distributed over the year in order to avoid skewing of results.
      The requirements for minimum data capture and time coverage do not include losses of data due to regular calibration or normal maintenance of the instrumentation. Twenty-four-hour sampling is required for the measurement of benzo(a)pyrene and other polycyclic aromatic hydrocarbons. With care, individual samples taken over a period of up to one month can be combined and analysed as a composite sample, provided the method ensures that the samples are stable for that period. The three congeners benzo(b)fluoranthene, benzo(j)fluoranthene, benzo(k)fluoranthene can be difficult to resolve analytically. In such cases they can be reported as sum. Twenty-four hour sampling is also advisable for the measurement of arsenic, cadmium and nickel concentrations. Sampling must be spread evenly over the weekdays and the year. For the measurement of deposition rates monthly, or weekly, samples throughout the year are recommended.
      Member States may use wet only instead of bulk sampling if they can demonstrate that the difference between them is within 10 %. Deposition rates should generally be given as μg/m2 per day.
      Member States may apply a minimum time coverage lower than indicated in the table, but not lower than 14 % for fixed measurements and 6 % for indicative measurements provided that they can demonstrate that the 95 % expanded uncertainty for the annual mean, calculated from the data quality objectives in the table according to ISO 11222:2002 — ‘Determination of the uncertainty of the time average of air quality measurements’ will be met.
      II.   Requirements for air quality models
      Where an air quality model is used for assessment, references to descriptions of the model and information on the uncertainty shall be compiled. The uncertainty for modelling is defined as the maximum deviation of the measured and calculated concentration levels, over a full year, without taking into account the timing of the events.
      III.   Requirements for objective estimation techniques
      Where objective estimation techniques are used, the uncertainty shall not exceed 100 %.
      IV.   Standardisation
      For substances to be analysed in the PM10 fraction, the sampling volume refers to ambient conditions.

         (1)  Indicative measurement being measurements which are performed at reduced regularity but fulfil the other data quality objectives.

      ANNEX V
      Reference methods for assessment of concentrations in ambient air and deposition rates
      I.   Reference method for the sampling and analysis of arsenic, cadmium and nickel in ambient air
      The reference method for the measurement of arsenic, cadmium and nickel concentrations in ambient air is currently being standardised by CEN and shall be based on manual PM10 sampling equivalent to EN 12341, followed by digestion of the samples and analysis by Atomic Absorption Spectrometry or ICP Mass Spectrometry. In the absence of a CEN standard method, Member States are allowed to use national standard methods or ISO standard methods.
      A Member State may also use any other methods which it can demonstrate give results equivalent to the above method.
      II.   Reference method for the sampling and analysis of polycyclic aromatic hydrocarbons in ambient air
      The reference method for the measurement of benzo(a)pyrene concentrations in ambient air is currently being standardised by CEN and shall be based on manual PM10 sampling equivalent to EN 12341. In the absence of a CEN standard method, for benzo(a)pyrene or the other polycyclic aromatic hydrocarbons referred to in Article 4(8), Member States are allowed to use national standard methods or ISO methods such as ISO standard 12884.
      A Member State may also use any other methods which it can demonstrate give results equivalent to the above method.
      III.   Reference method for the sampling and analysis of mercury in ambient air
      The reference method for the measurement of total gaseous mercury concentrations in ambient air shall be an automated method based on Atomic Absorption Spectrometry or Atomic Fluorescence Spectrometry. In the absence of a CEN standardised method, Member States are allowed to use national standard methods or ISO standard methods.
      A Member State may also use any other methods which it can demonstrate give results equivalent to the above method.
      IV.   Reference method for the sampling and analysis of the deposition of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons
      The reference method for the sampling of deposited arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons shall be based on the exposition of cylindrical deposit gauges with standardised dimensions. In the absence of a CEN standardised method, Member States are allowed to use national standard methods.
      V.   Reference air quality modelling techniques
      Reference air quality modelling techniques cannot be specified at present. Any amendments to adapt this point to scientific and technical progress must be adopted in accordance with the procedure laid down in Article 6.