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.)

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

Article 4

Exemptions from control measures

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

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.

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

(a) 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;

(b) 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;

(c) 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;

(d) 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.

Article 5

Stockpiles

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.

Article 6

Release reduction, minimisation and elimination

Such action plans shall include measures to promote the development of, and, where it is considered appropriate, shall require the use of substitute or modified substances, mixtures, articles and processes to prevent the formation and release of substances listed in Annex III.

Article 7

Waste management

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.

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 Union legislation, provided that the content of the listed substances in the waste is below the concentration limits specified in Annex IV;

(b) a Member State or the competent authority designated by that Member State may, in exceptional cases, allow wastes listed in Part 2 of Annex V containing or contaminated by a substance listed in Annex IV up to concentration limits specified in Part 2 of Annex V to be otherwise dealt with in accordance with a method listed in Part 2 of Annex V, provided that the following conditions are fulfilled: (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 POP 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) the holder concerned has provided information on the POP content of the waste to the competent authority; (iii) the operation is in accordance with relevant Union legislation and with the conditions laid down in relevant additional measures referred to in paragraph 5; (iv) the Member State concerned has informed the other Member States, the Agency and the Commission of its authorisation and the justification for it.

Article 8

Tasks of the Agency and the Forum

The Agency shall, in addition to the tasks allocated to it under Articles 9, 10, 11, 13 and 17, carry out the following tasks:

(a) with the agreement of the Commission, provide the designated competent authorities of the Member States and the members of the Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006 (‘Forum’), as well as stakeholders as appropriate, with assistance and technical and scientific guidance in order to ensure the effective application of this Regulation;

(b) upon request, provide the Commission with technical and scientific input and assist it in order to ensure the effective implementation of this Regulation;

(c) provide technical and scientific support and input to the Commission as regards substances that may meet the criteria for listing in the Convention or the Protocol, taking into account, as appropriate, results from existing assessment schemes referred to in Article 3(3);

(d) publish on its website a notice that a proposal for the listing of a substance will be prepared by the Commission, invite all interested parties to submit comments within eight weeks, and publish those comments on its website;

(e) provide the Commission and the Member States with technical and scientific support in the preparation and review of the risk profile and the risk management evaluation of a substance considered under the Convention, invite all interested parties to submit comments or additional information, or both, within eight weeks and publish those comments on its website;

(f) upon request, provide the Commission with technical and scientific support in implementing and further developing the Convention, in particular with respect to the POPs Review Committee;

(g) compile, register, process and make available to the Commission and the competent authorities of the Member States all the information received or available pursuant to Article 4(2) and (3), point (b)(iv) of Article 7(4), Article 9(2) and Article 13(1). Where such information is non-confidential, the Agency shall make that information publicly available on its website and shall facilitate the exchange of that information with relevant information platforms such as those referred to in Article 13(2);

(h) establish and maintain sections on its website for all matters relating to the implementation of this Regulation;

(i) upon request by the Commission, draw up and submit a report within 12 months of the request on the impacts on human health and on the environment and socioeconomic impacts of introducing or amending concentration limit values specified in Annex IV or V.

The report referred to in paragraph 1, point (i), shall contain the following information:

(a) information on the impacts on human health and on the environment of waste consisting of, containing or contaminated with POPs, including impacts on waste management;

(b) information on concentrations and mass flows of POPs in relevant waste streams and on waste treatment and treatment capacities;

(c) an analysis of the impacts of the different concentration limit values considered in drawing up the report;

(d) a reasoned proposal for concentration limit values to be introduced in Annex IV and, as appropriate, in Annex V.

The Agency shall, as soon as it receives the request referred to in paragraph 1, point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared. The notice shall also invite all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.

At the latest 9 months following the submission of the report referred to in paragraph 1, point (i), of this Article, the Committee for Socioeconomic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006, shall adopt an opinion on the report and on the concentration limit values proposed therein. For that purpose Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.

The Agency shall then submit the report and the opinion of the Committee for Socioeconomic Analysis on the concentration limit values to the Commission without delay.

The members of the Forum who are appointed by a Member State shall ensure that there is appropriate coordination between the tasks of the Forum and the work of their Member State competent authority.

The Forum shall involve the enforcement authorities of Member States responsible for waste when dealing with waste-related issues.

Article 9

Implementation plans

Article 10

Monitoring

Article 11

Information exchange

The Commission, the Agency and the Member States, as appropriate, shall promote and facilitate with regard to POPs:

(a) awareness programmes, including relating to their health and environmental effects and their alternatives and on the reduction or elimination of their manufacture, 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.

Article 12

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 regional centres, as identified under the Convention, non-governmental organisations or the Agency.

Article 13

Monitoring of implementation

Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States shall draw up and publish a report containing:

(a) information on the application of this Regulation, including information on enforcement activities, infringements and penalties;

(b) information compiled from the notifications received pursuant to Article 4(2) and (3), Article 5(2) and point (b)(iv) of Article 7(4);

(c) information compiled from the release inventories drawn up pursuant to Article 6(1);

(d) information on implementation in accordance with the national implementation plans drawn up pursuant to Article 9(2);

(e) information on the presence of substances listed in Part A of Annex III in the environment, as compiled pursuant to Article 10;

(f) annual monitoring and statistical data on the actual or estimated total manufacturing and placing on the market of any substance listed in Annex I or II, including relevant indicators, overview maps, reports.

Member States shall update the report annually as far as new data or information is available and otherwise at least every three years.

Members States shall give the Commission and the Agency access to the information contained in the reports.

Where the information referred to in paragraph 1, point (e), is contained in the report of a Member State provided to the Agency, the Agency shall transmit the information to the EEA for compiling, storing and sharing that information.

Article 14

Penalties

Member States shall lay down rules on penalties applicable to infringements 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. Where Member States have not already done so before the entry into force of this Regulation, they shall notify those rules and measures to the Commission on 16 July 2020 at the latest and shall notify it, without delay, of any subsequent amendment affecting them.

Article 15

Amendment of Annexes

Whenever the Commission amends Annex I, II or III to this Regulation, it shall adopt a separate delegated act in respect of each substance.

Article 16

The budget of the Agency

For the purposes of this Regulation, the revenues of the Agency shall consist of:

(a) a subsidy from the Union, entered in the general budget of the Union (Commission Section);

(b) any voluntary contribution from the Member States.

Article 17

Formats and software for publication or notification of information

The Agency shall, in cooperation with the Member States, specify formats and software for the publication or notification of data by Member States pursuant to this Regulation and shall make them available free of charge on its website. In relation to spatial data sets and spatial data services, Member States and the Agency shall design the formats in accordance with the requirements of Directive 2007/2/EC. Member States and other parties subject to this Regulation shall use those formats and software in their data management or data exchange with the Agency.

Article 18

Exercise of the delegation

Article 19

Competent authorities

Each Member State shall designate a competent authority or authorities responsible for the administrative tasks and enforcement 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, unless it has already done so before the entry into force of this Regulation, and shall also inform the Commission of any change of designated competent authority.