Article 1Objective 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 2Definitions
For the purposes of this Regulation:
‘placing on the market’ means placing on the market as defined in point 12 of Article 3 of Regulation (EC) No 1907/2006;
‘article’ means article as defined in point 3 of Article 3 of Regulation (EC) No 1907/2006;
‘substance’ means substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;
‘mixture’ means mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;
‘manufacturing’ means manufacturing as defined in point 8 of Article 3 of Regulation (EC) No 1907/2006;
‘use’ means use as defined in point 24 of Article 3 of Regulation (EC) No 1907/2006;
‘import’ means import as defined in point 10 of Article 3 of Regulation (EC) No 1907/2006;
‘waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC;
‘disposal’ means disposal as defined in point 19 of Article 3 of Directive 2008/98/EC;
‘recovery’ means recovery as defined in point 15 of Article 3 of Directive 2008/98/EC;
‘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;
‘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;
‘stockpile’ means substances, mixtures or articles accumulated by the holder that consist of or contain any substance listed in Annex I or II.
Article 3Control 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 4Exemptions 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 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:
(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.
4.Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7.
Article 5Stockpiles
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 6Release reduction, minimisation and elimination
1.Within two years of the date of entry into force of this Regulation or Regulation (EC) No 850/2004, whichever date came first, Member States shall draw up inventories for the substances listed in Annex III released into air, water and land in accordance with their obligations under the Convention and the Protocol and shall subsequently maintain such inventories.
2.Member States shall communicate their action plans on measures to identify, characterise and minimise, with a view to eliminating where feasible as soon as possible, the total releases of substances listed in Annex III as recorded in their inventories drawn up in accordance with their obligations under the Convention, to the Commission, the Agency and to the other Member States as part of their national implementation plans, pursuant to Article 9.
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.
3.Member States shall, when considering proposals to construct new facilities or to significantly modify existing facilities using processes that release chemicals listed in Annex III, 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, without prejudice to Directive 2010/75/EU of the European Parliament and of the Council(2).
Article 7Waste 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 Council Directive 96/59/EC(3), waste consisting of, containing or contaminated by any substance listed in Annex IV to this Regulation shall be disposed of or recovered, without undue delay and in accordance with Part 1 of Annex V to this Regulation, in such a way as to ensure that the POP content is destroyed or irreversibly transformed so that the remaining waste and releases do not exhibit the characteristics of POPs.
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 on their own 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 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:
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;
the holder concerned has provided information on the POP content of the waste to the competent authority;
the operation is in accordance with relevant Union legislation and with the conditions laid down in relevant additional measures referred to in paragraph 5;
the Member State concerned has informed the other Member States, the Agency and the Commission of its authorisation and the justification for it.
5.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 by the competent authority designated by that Member State in accordance with paragraph 4 and Annex V, adopt implementing acts concerning the implementation of this Article. In particular, the Commission may specify the format of the information to be submitted by Member States in accordance with point (b)(iv) of paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3).
6.Member States shall take the necessary measures to ensure the control and traceability, in accordance with Article 17 of Directive 2008/98/EC, of waste containing or contaminated by a substance listed in Annex IV to this Regulation.
Article 8Tasks of the Agency and the Forum
1.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.
2.The Forum shall be used to coordinate a network of the Member States' authorities responsible for enforcement of this Regulation.
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.
3.The Secretariat of the Agency shall carry out the tasks allocated to the Agency under this Regulation.
Article 9Implementation plans
1.When preparing and updating 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 make it publicly available and communicate its publication to the Commission, the Agency and to the other Member States.
3.When Member States are preparing and updating their implementation plans, the Commission, supported by the Agency, and the Member States shall exchange information on the content, including information on measures taken at national level to identify and assess sites contaminated by POPs, as appropriate.
4.The Commission, supported by the Agency, shall maintain a plan for the implementation of Union obligations under the Convention and shall publish, review and update that plan, as appropriate.
Article 10Monitoring
1.The Commission, supported by the Agency, and the Member States shall establish or maintain, as appropriate, 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 substances as listed in Part A of Annex III in the environment. When establishing or maintaining such programmes and mechanisms, due account shall be taken of developments under the Protocol and the Convention.
2.The Commission shall regularly assess the possible need for the mandatory monitoring of a substance listed in Part B of Annex III. In the light of such an assessment and any data made available to it by Member States, the Commission is empowered to adopt delegated acts in accordance with Article 18 to amend Annex III in order to move, where appropriate, a substance from Part B of Annex III to Part A thereof.
Article 11Information exchange
1.The Commission, the Agency and the Member States shall facilitate and undertake the exchange within the Union and with third countries of information relevant to the reduction, minimisation or elimination, where feasible, of the manufacturing, use and release of POPs and to alternatives to those substances, specifying the risks and the economic and social costs related to such alternatives.
2.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:
policy- and decision-makers;
particularly vulnerable groups;
(b)the provision of public information;
(c)training, including workers, scientists, educators and technical and managerial personnel.
3.Without prejudice to Regulations (EC) No 1049/2001, and (EC) No 1367/2006 and Directive 2003/4/EC, information on the health and safety of humans and the environment shall not be regarded as confidential. The Commission, the Agency and the Member States that exchange information with a third country shall protect any confidential information in accordance with Union law.
Article 12Technical 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 13Monitoring of implementation
1.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.
2.Where a Member State shares the information referred to in point (e) of paragraph 1 with the Information Platform for Chemical Monitoring, this shall be indicated by that Member State in its report and the Member State shall be considered to have fulfilled its reporting obligations under that point.
Where the information referred to in point (e) of paragraph 1 is contained in the report of a Member State provided to the Agency, the Agency shall use the Information Platform for Chemical Monitoring for compiling, storing and sharing that information.
3.Regarding the substances listed in the Convention, the Commission, supported by the Agency, shall, at the intervals determined by the Conference of the Parties of the Convention, compile a report on the basis of the information provided by the Member States to the Agency in accordance with point (f) of paragraph 1 and communicate it to the Secretariat of the Convention.
4.The Agency shall compile and publish a Union overview report on the basis of the data referred to in paragraphs 1 and 2 that is published or notified by the Member States. The Union overview report shall include, as appropriate, indicators for outputs, results and impact of this Regulation, Union overview maps and Member State reports. The Union overview report shall be updated by the Agency at least once every six months or following receipt of a request from the Commission.
5.The Commission may adopt implementing acts concerning the minimum information to be provided in accordance with paragraph 1, including the definition of relevant indicators, overview maps and reports referred to in point (f) of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3).
Article 14Penalties
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 15Amendment of Annexes
1.The Commission is empowered to adopt delegated acts in accordance with Article 18 to amend the Annexes I, II and III to this Regulation in order to adapt them to changes to the list of substances set out in the Annexes to the Convention or the Protocol, on the basis that the Union has supported the change concerned by means of a Council decision adopted in accordance with Article 218(9) TFEU, or to modify existing entries or provisions in Annexes I and II to this Regulation in order to adapt them to scientific and technical progress.
Whenever the Commission amends Annex I, II or III to this Regulation, it shall adopt a separate delegated act in respect of each substance.
2.The Commission shall keep Annexes IV and V under constant review and shall, where appropriate, make legislative proposals to amend these Annexes in order to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress.
Article 16The budget of the Agency
1.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.
2.Revenues and expenditure for activities under this Regulation shall be combined with those relating to activities under Regulation (EU) No 649/2012 and shall be reflected in the same section in the Agency's budget. The revenues of the Agency referred to in paragraph 1 shall be used for carrying out its tasks under this Regulation.
Article 17Formats 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 18Exercise of the delegation
1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.The power to adopt delegated acts referred to in Articles 4(3), 10(2) and 15(1) shall be conferred on the Commission for a period of five years from 15 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3.The delegation of power referred to in Articles 4(3), 10(2) and 15(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4.Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6.A delegated act adopted pursuant to Articles 4(3), 10(2) and 15(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 19Competent 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.
Article 20Committee procedure
1.Except in the case referred to in paragraph 2, the Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.For matters relating to waste, the Commission shall be assisted by the Committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
3.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 21Repeal
Regulation (EC) No 850/2004 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII.
Article 22Entry 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.
Done at Brussels, 20 June 2019.
For the European Parliament
The President
A. Tajani
For the Council
The President
G. Ciamba