Article 1 Objective and scope
1. Taking into account, in particular, the precautionary principle, the objective of this Regulation is to protect human health and the environment from persistent organic pollutants by prohibiting, phasing out as soon as possible, or restricting the production, placing on the market and use of substances subject to the Stockholm Convention on Persistent Organic Pollutants, hereinafter ‘the Convention’, or the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants, hereinafter ‘the Protocol’, and by minimising, with a view to eliminating where feasible as soon as possible, releases of such substances, and by establishing provisions regarding waste consisting of, containing or contaminated by any of these substances. 2. Articles 3 and 4 shall not apply to waste consisting of, containing or contaminated by any substance listed in Annexes I or II.
Article 2 Definitions
For the purposes of this Regulation: (a) ‘placing on the market’ means supplying or making available to third persons against payment or free of charge. Imports into the customs territory of the Community shall also be deemed to be placed on the market; (b) ‘article’ means an object composed of one or more substances and/or preparations which during production is given a specific shape, surface or design determining its end use function to a greater extent than its chemical composition does; (c) ‘substance’ is as defined in Article 2 of Council Directive 67/548/EEC ( 11 ); (d) ‘preparation’ is as defined in Article 2 of Directive 67/548/EEC; (e) ‘waste’ is as defined in Article 1(a) of Council Directive 75/442/EEC ( 12 ); (f) ‘disposal’ is as defined in Article 1(e) of Directive 75/442/EEC; (g) ‘recovery’ is as defined in Article 1(f) of Directive 75/442/EEC.
Article 3 Control of production, placing on the market and use
1. The production, placing on the market and use of substances listed in Annex I, whether on their own, in preparations or as constituents of articles, shall be prohibited. 2. The production, placing on the market and use of substances listed in Annex II, whether on their own, in preparations or as constituents of articles, shall be restricted in accordance with the conditions set out in that Annex. 3. Member States and the Commission shall, within the assessment and authorisation schemes for existing and new chemicals and pesticides under the relevant Community legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate measures to control existing chemicals and pesticides and prevent the production, placing on the market and use of new chemicals and pesticides, which exhibit characteristics of persistent organic pollutants.
Article 4 Exemptions from control measures
1. Article 3 shall not apply in the case of: (a) a substance used for laboratory-scale research or as a reference standard; (b) a substance occurring as an unintentional trace contaminant in substances, preparations or articles. 2. Article 3 shall not apply in respect of substances occurring as a constituent of articles produced before or on the date of entry into force of this Regulation until six months after the date of its entry into force. Article 3 shall not apply in the case of a substance occurring as a constituent of articles already in use before or on the date of entry into force of this Regulation. However, immediately upon becoming aware of articles referred to in the first and second subparagraph, a Member State shall inform the Commission accordingly. Whenever the Commission is so informed or otherwise learns of such articles, it shall, where appropriate, notify the Secretariat of the Convention accordingly without further delay. 3. Where a substance is listed in Part A of Annex I or in Part A of Annex II, a Member State wishing to permit, until the deadline specified in the relevant Annex, the production and use of that substance as a closed-system site-limited intermediate shall notify accordingly the Secretariat of the Convention. However, such notification may be made only if the following conditions are satisfied: (a) an annotation has been entered in the relevant Annex expressly to the effect that such production and use of that substance may be permitted; (b) the manufacturing process will transform the substance into one or more other substances that do not exhibit the characteristics of a persistent organic pollutant; (c) it is not expected that either humans or the environment will be exposed to any significant quantities of the substance during its production and use, as shown through assessment of that closed system in accordance with Commission Directive 2001/59/EC ( 13 ). The notification shall be communicated also to the other Member States and to the Commission and shall give details of actual or estimated total production and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any persistent organic pollutant starting material in the final product. The deadlines referred to in the first subparagraph may be amended in cases where, following a repeat notification from the Member State concerned to the Secretariat of the Convention, express or tacit consent is issued under the Convention for the continued production and use of the substance for another period.
Article 5 Stockpiles
1. The holder of a stockpile, which consists of or contains any substance listed in Annex I or Annex II, for which no use is permitted, shall manage that stockpile as waste and in accordance with Article 7. 2. The holder of a stockpile greater than 50 kg, consisting of or containing any substance listed in Annex I or Annex II, and the use of which is permitted shall provide the competent authority of the Member State in which the stockpile is established with information concerning the nature and size of that stockpile. Such information shall be provided within 12 months of the entry into force of this Regulation and of amendments to Annexes I or II and annually thereafter until the deadline specified in Annex I or II for restricted use. The holder shall manage the stockpile in a safe, efficient and environmentally sound manner. 3. Member States shall monitor the use and management of notified stockpiles.
Article 6 Release reduction, minimisation and elimination
1. Within two years of the date of entry into force of this Regulation, Member States shall draw up and maintain release inventories for the substances listed in Annex III into air, water and land in accordance with their obligations under the Convention and the Protocol. 2. A Member State shall communicate its action plan on measures to identify, characterise and minimise with a view to eliminating where feasible as soon as possible the total releases developed in accordance with its obligations under the Convention, to both the Commission and the other Member States as part of its national implementation plan, pursuant to Article 8. The action plan shall include measures to promote the development and, where it deems appropriate, shall require the use of substitute or modified materials, products and processes to prevent the formation and release of the substances listed in Annex III. 3. Member States shall, when considering proposals to construct new facilities or significantly to modify existing facilities using processes that release chemicals listed in Annex III, without prejudice to Council Directive 1996/61/EC ( 14 ), give priority consideration to alternative processes, techniques or practices that have similar usefulness but which avoid the formation and release of substances listed in Annex III.
Article 7 Waste management
1. Producers and holders of waste shall undertake all reasonable efforts to avoid, where feasible, contamination of this waste with substances listed in Annex IV. 2. Notwithstanding Directive 96/59/EC ( 15 ), waste consisting of, containing or contaminated by any substance listed in Annex IV shall be disposed of or recovered, without undue delay and in accordance with Annex V, part 1 in such a way as to ensure that the persistent organic pollutant content is destroyed or irreversibly transformed so that the remaining waste and releases do not exhibit the characteristics of persistent organic pollutants. In carrying out such a disposal or recovery, any substance listed in Annex IV may be isolated from the waste, provided that this substance is subsequently disposed of in accordance with the first subparagraph. 3. Disposal or recovery operations that may lead to recovery, recycling, reclamation or re-use of the substances listed in Annex IV shall be prohibited. 4. By way of derogation from paragraph 2: (a) waste containing or contaminated by any substance listed in Annex IV may be otherwise disposed of or recovered in accordance with the relevant Community legislation, provided that the content of the listed substances in the waste is below the concentration limits to be specified in Annex IV. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3). Until such time as concentration limits are established in accordance with such procedure, the competent authority of a Member State may adopt or apply concentration limits or specific technical requirements in respect of the disposal or recovery of waste under this point. (b) a Member State or the competent authority designated by that Member State may, in exceptional cases, allow wastes listed in Annex V, part 2 containing or contaminated by any substance listed in Annex IV up to concentration limits to be specified in Annex V, part 2, to be otherwise dealt with in accordance with a method listed in Annex V, part 2 provided that: (i) the holder concerned has demonstrated to the satisfaction of the competent authority of the Member State concerned that decontamination of the waste in relation to substances listed in Annex IV was not feasible, and that destruction or irreversible transformation of the persistent organic pollutant content, performed in accordance with best environmental practice or best available techniques, does not represent the environmentally preferable option and the competent authority has subsequently authorised the alternative operation; (ii) this operation is in accordance with the relevant Community legislation and the conditions laid down in relevant additional measures referred to in paragraph 6; and (iii) the Member State concerned has informed the other Member States and the Commission of its authorisation and the justification for it. (b) a Member State or the competent authority designated by that Member State may, in exceptional cases, allow wastes listed in Annex V, part 2 containing or contaminated by any substance listed in Annex IV up to concentration limits to be specified in Annex V, part 2, to be otherwise dealt with in accordance with a method listed in Annex V, part 2 provided that: (i) the holder concerned has demonstrated to the satisfaction of the competent authority of the Member State concerned that decontamination of the waste in relation to substances listed in Annex IV was not feasible, and that destruction or irreversible transformation of the persistent organic pollutant content, performed in accordance with best environmental practice or best available techniques, does not represent the environmentally preferable option and the competent authority has subsequently authorised the alternative operation; (ii) this operation is in accordance with the relevant Community legislation and the conditions laid down in relevant additional measures referred to in paragraph 6; and (iii) the Member State concerned has informed the other Member States and the Commission of its authorisation and the justification for it. Concentration limits in Annex V, part 2 shall be established by the Commission for the purposes of paragraph 4(b) of this Article. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3). Until such time as these concentration limits are established: (a) the competent authority may adopt or apply concentration limits or specific technical requirements in respect of waste being dealt with under paragraph 4(b); (b) where waste is being dealt with under paragraph 4(b), the holders concerned shall provide information on the persistent organic pollutant content of the waste to the competent authority. 6. The Commission may, where appropriate, and taking into consideration technical developments and relevant international guidelines and decisions and any authorisations granted by a Member State, or the competent authority designated by that Member State in accordance with paragraph 4 and Annex V, adopt additional measures relating to the implementation of this Article. The Commission shall define a format for the submission of the information by Member States in accordance with paragraph 4(b)(iii). Such measures shall be decided in accordance with the procedure laid down in Article 17(2). 7. The Commission shall, before 31 December 2009, review the derogations in paragraph 4 in the light of international and technical developments, in particular with regard to their environmental preferability.
Article 8 Implementation plans
1. When preparing their national implementation plans, Member States shall, in accordance with their national procedures, give the public early and effective opportunities to participate in this process. 2. As soon as a Member State has adopted its national implementation plan in accordance with its obligations under the Convention, it shall communicate it both to the Commission and to the other Member States. 3. When preparing their implementation plans, the Commission and the Member States shall exchange information on the content, as appropriate. 4. The Commission shall, within two years of the entry into force of this Regulation, draw up a plan for the implementation of Community obligations under the Convention. As soon as the Commission has adopted the Community implementation plan, it shall communicate it to the Member States. The Commission shall review and update the Community implementation plan, as appropriate.
Article 9 Monitoring
The Commission and the Member States shall establish, in close cooperation, appropriate programmes and mechanisms, consistent with the state of the art, for the regular provision of comparable monitoring data on the presence of dioxins, furans and PCBs as identified in Annex III in the environment. When establishing such programmes and mechanisms, due account shall be taken of developments under the Protocol and the Convention.
Article 10 Information exchange
1. The Commission and the Member States shall facilitate and undertake the exchange within the Community and with third countries of information relevant to the reduction, minimisation or elimination, where feasible, of the production, use and release of persistent organic pollutants and to alternatives to those substances, specifying the risks and the economic and social costs related to such alternatives. 2. The Commission and Member States, as appropriate, shall promote and facilitate with regard to persistent organic pollutants: (a) awareness programmes, including relating to their health and environmental effects and their alternatives and on the reduction or elimination of their production, use and release, especially for: (i) policy and decision makers, (ii) particularly vulnerable groups; (a) awareness programmes, including relating to their health and environmental effects and their alternatives and on the reduction or elimination of their production, use and release, especially for: (i) policy and decision makers, (ii) particularly vulnerable groups; (b) the provision of public information; (c) training, including workers, scientists, educators and technical and managerial personnel. 3. Without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information ( 16 ), information on health and safety of humans and the environment shall not be regarded as confidential. The Commission and the Member States that exchange other information with a third country shall protect any confidential information as mutually agreed.
Article 11 Technical assistance
In accordance with Articles 12 and 13 of the Convention, the Commission and the Member States shall cooperate in providing appropriate and timely technical and financial assistance to developing countries and countries with economies in transition to assist them, upon request and within available resources and taking into account their particular needs, to develop and strengthen their capacity to fully implement their obligations under the Convention. Such support may also be channelled through non-governmental organisations.
Article 12 Reporting
1. Member States shall every three years forward to the Commission information on the application of this Regulation, including information on infringements and penalties. 2. Member States shall provide the Commission every year with statistical data on the actual or estimated total production and placing on the market of any substance listed in Annex I or II. 3. Within three years of the date of entry into force of this Regulation and every three years thereafter, Member States shall provide the Commission with: (a) summary information compiled from the notifications, concerning stockpiles, received pursuant to Article 5(2); (b) summary information compiled from the release inventories drawn up pursuant to Article 6(1); (c) summary information on the presence of dioxins, furans and PCBs as identified in Annex III in the environment, as compiled pursuant to Article 9. 4. As regards the data and information to be provided by Member States pursuant to paragraphs 1, 2 and 3, the Commission shall develop in advance a common format in accordance with the procedure referred to in Article 16(2). 5. Regarding the substances listed in the Convention, the Commission shall, at intervals to be determined by the Conference of the Parties of the Convention, compile a report on the basis of the information provided by the Member States in accordance with paragraph 2 and communicate it to the Secretariat of the Convention. 6. The Commission shall every three years compile a report on the application of this Regulation and shall integrate it with the information already available in the context of the EPER, as established by Commission Decision 2000/479/EC ( 17 ), and CORINAIR Emission Inventory of EMEP (Cooperative Programme for Monitoring and Evaluation of the Long-Range Transmission of Air Pollutants in Europe), and with the information provided by the Member States under paragraphs 1, 2 and 3 to form a synthesis report. This report shall include information on the use of derogations as referred to in Article 7(4). It shall forward a summary of the synthesis report to the European Parliament and to the Council and make it available to the public without delay.
Article 13 Penalties
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission one year after entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them.
Article 14 Amendment of Annexes
1. Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where appropriate, amend Annexes I, II and III accordingly. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 16(3). 2. Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where appropriate, amend Annex IV accordingly. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3). 3. The Commission shall adopt modifications to the existing entries in Annexes I, II and III, including their adaptation to scientific and technical progress. 4. The Commission shall adopt modifications to the existing entries in Annex IV and modifications to Annex V, including their adaptation to scientific and technical progress.
Article 15 Competent authorities
Each Member State shall designate the competent authority or authorities responsible for the administrative tasks required by this Regulation. It shall inform the Commission of such designation at the latest three months after the entry into force of this Regulation.
Article 16 Committee for general matters
1. The Commission shall be assisted by the Committee established by Article 29 of Directive 67/548/EEC for all matters under this Regulation except for those relating to waste. 2. Where reference is made to this paragraph, 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. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 17 Committee for waste matters
1. The Commission shall be assisted by the Committee established by Article 18 of Directive 75/442/EEC, for matters relating to waste under this Regulation. 2. Where reference is made to this paragraph, 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. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 18 Amendments to Directive 79/117/EEC
In Part B of the Annex to Directive 79/117/EEC, ‘Persistent organochlorine compounds’, items 1 to 8 shall be deleted.
Article 19 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . This Regulation shall be binding in its entirety and directly applicable in all Member States.