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Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance)Text with EEA relevance

Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance)Text with EEA relevance

Article 1 Objective and subject matter

Taking into account, in particular, the precautionary principle, the objective of this Regulation is to protect human health and the environment from POPs by prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the market and use of substances subject to the Stockholm Convention on Persistent Organic Pollutants, hereinafter ‘the Convention’, or the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants, hereinafter ‘the Protocol’, 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 those substances.

Where appropriate, Member States may apply stricter requirements than those laid down in this Regulation, in accordance with the TFEU.

Article 2 Definitions

For the purposes of this Regulation:

  1. ‘placing on the market’ means placing on the market as defined in point 12 of Article 3 of Regulation (EC) No 1907/2006;

  2. ‘article’ means article as defined in point 3 of Article 3 of Regulation (EC) No 1907/2006;

  3. ‘substance’ means substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;

  4. ‘mixture’ means mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;

  5. ‘manufacturing’ means manufacturing as defined in point 8 of Article 3 of Regulation (EC) No 1907/2006;

  6. ‘use’ means use as defined in point 24 of Article 3 of Regulation (EC) No 1907/2006;

  7. ‘import’ means import as defined in point 10 of Article 3 of Regulation (EC) No 1907/2006;

  8. ‘waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC;

  9. ‘disposal’ means disposal as defined in point 19 of Article 3 of Directive 2008/98/EC;

  10. ‘recovery’ means recovery as defined in point 15 of Article 3 of Directive 2008/98/EC;

  11. ‘closed-system site-limited intermediate’ means a substance that is manufactured for, and consumed in or used for chemical processing in order to be transformed into another substance (‘synthesis’) and where the manufacture of the intermediate and the synthesis of one or more other substances from that intermediate take place on the same site, by one or more legal entities, under strictly controlled conditions in that it is rigorously contained by technical means during its whole life cycle;

  12. ‘unintentional trace contaminant’ means a level of a substance that is incidentally present in a minimal amount, below which the substance cannot be meaningfully used, and above the detection limit of existing detection methods to enable control and enforcement;

  13. ‘stockpile’ means substances, mixtures or articles accumulated by the holder that consist of or contain any substance listed in Annex I or II.

Article 3 Control of manufacturing, placing on the market and use, and the listing of substances

1.

The manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles, shall be prohibited, subject to Article 4.

2.

The manufacturing, placing on the market and use of substances listed in Annex II, whether on their own, in mixtures or in articles, shall be restricted, subject to Article 4.

3.

Member States and the Commission shall, within the assessment and authorisation schemes for existing and new substances under the relevant Union legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate measures to control existing substances and prevent the manufacturing, placing on the market and use of new substances, which exhibit characteristics of POPs.

4.

When preparing a proposal to the Council, pursuant to Article 218(9) TFEU, for the listing of a substance in accordance with the provisions of the Convention, the Commission shall be supported by the European Chemicals Agency (‘the Agency’), established by Regulation (EC) No 1907/2006, as referred to in point (c) of Article 8(1). The competent authorities of Member States may forward proposals for listing to the Commission. In the further stages of the listing process, the Agency shall provide support to the Commission and the competent authorities of the Member States, as referred to in point (e) of Article 8(1).

5.

The Commission and the Agency shall, in all stages of the process referred to in paragraphs 3 and 4, cooperate with and inform the competent authorities of the Member States.

6.

Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7.

Article 4 Exemptions from control measures

1.

Article 3 shall not apply in the case of:

  1. a substance used for laboratory-scale research or as a reference standard;

  2. a substance present as an unintentional trace contaminant, as specified in the relevant entries of Annex I or II, in substances, mixtures or articles.

2.

For a substance added to Annex I or II after 15 July 2019, Article 3 shall not apply for a six-month period if that substance is present in articles produced before or on the date that this Regulation becomes applicable to that substance.

Article 3 shall not apply in the case of a substance present in articles already in use before or on the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first.

Immediately upon becoming aware of articles as referred to in the first and second subparagraph, a Member State shall inform the Commission and the Agency 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 manufacturing and use of that substance as a closed-system site-limited intermediate shall notify accordingly the Secretariat of the Convention.

Such notification may be made only if the following conditions are satisfied:

  1. following the request of a Member State or on the Commission's own initiative, an annotation has been entered in the relevant Annex, by means of a delegated act adopted on the basis of the fourth subparagraph;

  2. the manufacturer demonstrates to the competent authority of the Member State in which the manufacturer is established that the manufacturing process will transform the substance into one or more other substances that do not exhibit the characteristics of a POP, ensuring that it is rigorously contained by technical means during its whole life cycle;

  3. the manufacturer demonstrates to the competent authority of the Member State in which the manufacturer is established that the substance is a closed-system site-limited intermediate and that 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;

  4. the manufacturer informs the Member State on the details of actual or estimated total manufacturing 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 POP starting material in the final substance, mixture or article.

Within one month of submission of the notification to the Secretariat of the Convention, the Member State shall communicate the notification to the other Member States, to the Commission and the Agency, and shall give details of actual or estimated total manufacturing 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 POP starting material in the final substance, mixture or article.

The Commission is empowered to adopt delegated acts in accordance with Article 18 in order to amend Annexes I and II by entering annotations expressly to the effect that manufacturing and use, as a closed-system site-limited intermediate, of a substance listed in Part A of the relevant Annex may be permitted, and to amend the deadlines in such annotations 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 manufacturing and use of the substance for another period.

4.

Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7.

Article 5 Stockpiles

1.

The holder of a stockpile, which consists of or contains any substance listed in Annex I or 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 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 date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first for the holder, and of relevant amendments to Annex 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, in accordance with the thresholds and requirements laid down in Directive 2012/18/EU of the European Parliament and of the Council(1) and taking all adequate steps to ensure that the stockpile is managed in a manner that will protect human health and the environment.

3.

Member States shall monitor the use and management of notified stockpiles.

Article 6 Release reduction, minimisation and elimination

Article 7 Waste management

Article 8 Tasks of the Agency and the Forum

Article 9 Implementation plans

Article 10 Monitoring

Article 11 Information exchange

Article 12 Technical assistance

Article 13 Monitoring of implementation

Article 14 Penalties

Article 15 Amendment of Annexes

Article 16 The budget of the Agency

Article 17 Formats and software for publication or notification of information

Article 18 Exercise of the delegation

Article 19 Competent authorities

Article 20 Committee procedure

Article 21 Repeal

Article 22 Entry into force

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V

ANNEX VI

ANNEX VII