emendrix

Persistent Organic Pollutants Regulation

POPs Regulation · 32019R1021 · every event for this act · on EUR-Lex

Everything Regulation (EU) 2025/2457 amended · also amended Medical Devices Regulation

in force 2026-01-01

02019R1021-20251203 → 02019R1021-20260101

Amended by Regulation (EU) 2025/2457 32025R2457

Regulation (EU) 2025/2457 of the European Parliament and of the Council of 26 November 2025 amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 as regards the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals (Text with EEA relevance)

detected 2026-09-04

6 provisions touched — 6 substantive, 0 date-only, 0 disputed · every change carries an explanation that passed its citation check

MODIFIED +1,898 −11 Art. 8 Tasks of the Agency and the Forum

applies from: unchanged

The text adds a new task in point (i) of Article 8(1), under which the Agency, upon request by the Commission, draws up and submits within 12 months a report on the impacts on human health, the environment and socioeconomic impacts of introducing or amending concentration limit values in Annex IV or V.

A new paragraph 1a is inserted, setting out the required content of that report, describing a public notice and comment process the Agency must run, requiring an opinion from the Committee for Socioeconomic Analysis within 9 months of the report's submission, and requiring the Agency to forward the report and that opinion to the Commission.

The prior version of Article 8(1) ended at point (h) and contained no paragraph 1a.

Cited: Art. 8, v2 · Art. 8, v1

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02019R1021-2025120302019R1021-20260101

Article 8 Tasks 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. 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. 1a. 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. 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.

MODIFIED +147 −188 Art. 13 Monitoring of implementation

applies from: unchanged

Paragraph 2 now refers to a Member State sharing information with the European Environmental Agency (the EEA) rather than with the Information Platform for Chemical Monitoring, and the cross-reference to point (e) of paragraph 1 is rephrased as "paragraph 1, point (e)".

The second subparagraph of paragraph 2 changes the Agency's role from using the Information Platform for Chemical Monitoring to compile, store and share the information, to transmitting that information to the EEA for compiling, storing and sharing.

Cited: Art. 13, v2 · Art. 13, v1

text before / after

02019R1021-2025120302019R1021-20260101

Article 13 Monitoring 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 paragraph 1, point (e) of paragraph 1 (e), with the Information Platform for Chemical Monitoring, this shall be indicated by European Environmental Agency (the EEA), that Member State shall indicate that in its the report and the Member State and, in doing so, shall be considered deemed to have fulfilled its reporting obligations under that point. Where the information referred to in paragraph 1, point (e) of paragraph 1 (e), is contained in the report of a Member State provided to the Agency, the Agency shall use transmit the Information Platform for Chemical Monitoring information to the EEA 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).

MODIFIED +318 −213 Art. 15 Amendment of Annexes

applies from: unchanged

Paragraph 2 now empowers the Commission to adopt delegated acts under Article 18 to amend Annexes IV and V, rather than requiring the Commission merely to keep those Annexes under review and make legislative proposals to amend them.

The basis for adapting Annexes IV and V is changed to changes to the list of substances set out in Annexes I, II or III, whereas before it referred to changes to the list of substances in the Annexes to the Convention or the Protocol.

The scientific and technical progress ground for modifying existing entries in Annexes IV and V is expanded to expressly include developments in waste treatment and decontamination technologies or new scientific information on health and environmental impacts associated with a substance's presence in waste.

Cited: Art. 15, v1 · Art. 15, v2

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Article 15 Amendment 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 is empowered to adopt delegated acts in accordance with Article 18, in order to amend 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 I, II or the Protocol III or to modify existing entries or provisions in the Annexes to this Regulation in order Annex IV and V to adapt them to scientific and technical progress. progress, including developments in waste treatment and decontamination technologies or new scientific information regarding health and environmental impacts associated with the presence of a substance in waste.

MODIFIED +90 −56 Art. 18 Exercise of the delegation

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2026-01-01 · dates removed: 2019-07-15

The five-year delegation start date was changed from 15 July 2019 to 1 January 2026, and the cross-references in paragraphs 2, 3 and 6 were updated from citing Article 15(1) to citing Article 15 generally.

In paragraph 6, the connector between the listed articles was changed from 'and' to 'or'.

Cited: Art. 18, v2 · Art. 18, v1

text before / after

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Article 18 Exercise 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 Article 4(3), Article 10(2) and 15(1) Article 15 shall be conferred on the Commission for a period of five years from 15 July 2019. 1 January 2026. 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 Article 4(3), Article 10(2) and 15(1) Article 15 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 Article 4(3), Article 10(2) and 15(1) or Article 15 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.

INSERTED +398 −0 Art. 21b Review

applies from: unknown (an inserted provision states its own application date only in prose)

A new Article 21b, titled Review, has been added, directing the Commission to monitor the tasks, workload and remit of the scientific committees of the European Chemicals Agency, taking into account regulatory developments concerning the status of resources and the governance of those committees, and to present a legislative proposal to amend the Regulation accordingly where appropriate.

Cited: Art. 21b, v2

text before / after

inserted text (02019R1021-20260101)

Article 21b
Review
Taking due account of any regulatory developments concerning the status of the resources and of the governance of the scientific committees of the European Chemicals Agency, the Commission shall monitor the situation regarding the tasks, workload and remit of the scientific committees, and, where appropriate, present a legislative proposal to amend this Regulation accordingly.

MODIFIED +380 −561 Annex IV ANNEX IV

applies from: unchanged

In each of the five review clauses concerning concentration limits (for short-chain chlorinated paraffins, PCDD/PCDF and dl-PCBs, hexabromocyclododecane, PFOA, and PFHxS), the wording changed from stating that the Commission shall adopt a legislative proposal to lower the value, to stating that the Commission shall adopt a delegated act in accordance with Article 15(2) to lower the value.

The deadline reference in each clause was also rephrased from ending with the words no later than 30 December 2027 to beginning with the words by 30 December 2027, without changing the date itself.

Cited: Annex IV, v1 · Annex IV, v2

text before / after

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ANNEX IV List of substances subject to waste management provisions set out in Article 7 Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms. The limit is calculated as the sum of PCDD, PCDF and dl-PCBs according to the toxic equivalency factors (TEFs) set out in Part 2, in the third paragraph, in the table, of Annex V. The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply. Hexabromocyclododecane means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane, beta-hexabromocyclododecane and gamma-hexabromocyclododecane. Substance CAS No EC No Concentration limit referred to in Article 7(4)(a) Endosulfan 115-29-7 959-98-8 33213-65-9 204-079-4 50 mg/kg Hexachlorobutadiene 87-68-3 201-765-5 100 mg/kg Polychlorinated naphthalenes 10 mg/kg Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs) 85535-84-8 287-476-5 1500 mg/kg The By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal delegated act in accordance with Article 15(2) to lower that value no later than 30 December 2027. value. Tetrabromodiphenyl ether C12H6Br4O 40088-47-9 and others 254-787-2 and others Sum of the concentrations of tetrabromodiphenyl ether C12H6Br4O, pentabromodiphenyl ether C12H5Br5O, hexabromodiphenyl ether C12H4Br6O, heptabromodiphenyl ether C12H3Br7O and decabromodiphenyl ether C12Br10O: (a) until 29 December 2025, 500 mg/kg; (b) from 30 December 2025 until 29 December 2027, 350 mg/kg, or, if higher, the sum of the concentration of those substances where they are present in mixtures or articles, as set out in the fourth column, point 2, of Annex I for the substances tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether; (c) from 30 December 2027, 200 mg/kg or, if higher, the sum of the concentration of those substances where they are present in mixtures or articles, as set out in the fourth column, point 2, of Annex I for the substances tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether. Pentabromodiphenyl ether C12H5Br5O 32534-81-9 and others 251-084-2 and others Hexabromodiphenyl ether C12H4Br6O 36483-60-0 and others 253-058-6 and others Heptabromodiphenyl ether C12H3Br7O 68928-80-3 and others 273-031-2 and others Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE) C12Br10O 1163-19-5 and others 214-604-9 and others Perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) 1763-23-1 2795-39-3 29457-72-5 29081-56-9 70225-14-8 56773-42-3 251099-16-8 4151-50-2 31506-32-8 1691-99-2 24448-09-7 307-35-7 and others 217-179-8 220-527-1 249-644-6 249-415-0 274-460-8 260-375-3 223-980-3 250-665-8 216-887-4 246-262-1 206-200-6 and others 50 mg/kg Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and dioxin-like polychlorinated biphenyls (dl-PCBs) 5 μg/kg The By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal delegated act in accordance with Article 15(2) to lower that value, where such lowering is feasible in accordance with scientific and technical progress, no later than 30 December 2027. value. DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl)ethane) 50-29-3 200-024-3 50 mg/kg Chlordane 57-74-9 200-349-0 50 mg/kg Hexachlorocyclohexanes, including lindane 58-89-9 319-84-6 319-85-7 608-73-1 210-168-9 200-401-2 206-270-8 206-271-3 50 mg/kg Dieldrin 60-57-1 200-484-5 50 mg/kg Endrin 72-20-8 200-775-7 50 mg/kg Heptachlor 76-44-8 200-962-3 50 mg/kg Hexachlorobenzene 118-74-1 204-273-9 50 mg/kg Chlordecone 143-50-0 205-601-3 50 mg/kg Aldrin 309-00-2 206-215-8 50 mg/kg Pentachlorobenzene 608-93-5 210-172-0 50 mg/kg Polychlorinated Biphenyls (PCB) 1336-36-3 and others 215-648-1 50 mg/kg Mirex 2385-85-5 219-196-6 50 mg/kg Toxaphene 8001-35-2 232-283-3 50 mg/kg Hexabromobiphenyl 36355-01-8 252-994-2 50 mg/kg Hexabromocyclododecane 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 247-148-4 221-695-9 500 mg/kg The By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal delegated act in accordance with Article 15(2) to lower that value to not higher than 200 mg/kg no later than 30 December 2027. mg/kg. Pentachlorophenol, its salts and esters 87-86-5 and others 201-778-6 and others 100 mg/kg Dicofol 115-32-2 204-082-0 50 mg/kg Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I 335-67-1 and others 206-397-9 and others 1 mg/kg (PFOA and its salts), 40 mg/kg (sum of PFOA-related compounds) The By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal delegated act in accordance with Article 15(2) to lower that value, where such lowering is feasible in accordance with scientific and technical progress, no later than 30 December 2027. value. Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds 355-46-4 and others 206-587-1 and others 1 mg/kg (PFHxS and its salts), 40 mg/kg (sum of PFHxS-related compounds) The By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal delegated act in accordance with Article 15(2) to lower that value, where such lowering is feasible in accordance with scientific and technical progress, no later than 30 December 2027. value.

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The full entry, with the citation mapping v1 = 02019R1021-20251203, v2 = 02019R1021-20260101, is committed at eu/32019R1021/CHANGELOG.md.