+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
---+Article 2 Definitions
---+Article 3 Control of manufacturing, placing on the market and use, and the listing of substances
------+Article 3 1.
------+Article 3 2.
------+Article 3 3.
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---+Article 4 Exemptions from control measures
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---+Article 5 Stockpiles
------+Article 5 1.
------+Article 5 2.
------+Article 5 3.
---+Article 6 Release reduction, minimisation and elimination
------+Article 6 1.
------+Article 6 2.
------+Article 6 3.
---+Article 7 Waste management
------+Article 7 1.
------+Article 7 2.
------+Article 7 3.
------+Article 7 4.
------+Article 7 5.
------+Article 7 6.
---+Article 8 Tasks of the Agency and the Forum
------+Article 8 1.
------+Article 8 1a.
------+Article 8 2.
------+Article 8 3.
---+Article 9 Implementation plans
------+Article 9 1.
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---+Article 10 Monitoring
------+Article 10 1.
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---+Article 11 Information exchange
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------+Article 11 2.
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---+Article 12 Technical assistance
---+Article 13 Monitoring of implementation
------+Article 13 1.
------+Article 13 2.
------+Article 13 3.
------+Article 13 4.
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---+Article 14 Penalties
---+Article 15 Amendment of Annexes
------+Article 15 1.
------+Article 15 2.
---+Article 16 The budget of the Agency
------+Article 16 1.
------+Article 16 2.
---+Article 17 Formats and software for publication or notification of information
---+Article 18 Exercise of the delegation
------+Article 18 1.
------+Article 18 2.
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------+Article 18 5.
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---+Article 19 Competent authorities
---+Article 20 Committee procedure
------+Article 20 1.
------+Article 20 2.
------+Article 20 3.
---+Article 21 Repeal
---+Article 21a Transitional provision
------+Article 21a 1.
------+Article 21a 2.
---+Article 21b Review
---+Article 22 Entry into force
---+ANNEX I
---+ANNEX II
---+ANNEX III
---+ANNEX IV
---+ANNEX V
---+ANNEX VI
---+ANNEX VII
English - European Union - Environment -

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)

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)

This Regulation shall be binding in its entirety and directly applicable in all Member States.

1. Panoramica

,
Titolo Regolamentazione
Article 1 Objective and subject matter

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

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 5 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 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
Article 14 Penalties

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
Article 16 The budget of the Agency
Article 17 Formats and software for publication or notification of information

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

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.

Article 20 Committee procedure
Article 21 Repeal

Article 21

Repeal

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 21a Transitional provision
Article 21b Review

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.

Article 22 Entry into force

Article 22

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.

ANNEX I




ANNEX I

Part A

Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention



Substance

CAS No

EC No

Specific exemption on intermediate use or other specification

Tetrabromodiphenyl ether

C12H6Br4O

40088-47-9 and others

254-787-2 and others

►C1  
1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of tetrabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. ►M16  
2.  For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:
(a)  10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council (10);
(b)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council (11), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.  ◄
3.  By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed:
electrical and electronic equipment within the scope of Directive 2011/65/EU of the European Parliament and of the Council (1).
4.  Use of articles already in use in the Union before 25 August 2010 containing tetrabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.  ◄

Pentabromodiphenyl ether

C12H5Br5O

32534-81-9 and others

251-084-2 and others

1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of pentabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. ►M16  
2.  For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:
(a)  10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.  ◄ ►C1  
3.  By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed:
electrical and electronic equipment within the scope of Directive 2011/65/EU.
4.  Use of articles already in use in the Union before 25 August 2010 containing pentabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.  ◄

Hexabromodiphenyl ether

C12H4Br6O

36483-60-0 and others

253-058-6 and others

1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of hexabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. ►M16  
2.  For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:
(a)  10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.  ◄ ►C1  
3.  By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed:
electrical and electronic equipment within the scope of Directive 2011/65/EU.
4.  Use of articles already in use in the Union before 25 August 2010 containing hexabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.  ◄

Heptabromodiphenyl ether

C12H3Br7O

68928-80-3 and others

273-031-2 and others

1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of heptabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. ►M16  
2.  For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:
(a)  10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.  ◄ ►C1  
3.  By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed:
electrical and electronic equipment within the scope of Directive 2011/65/EU.
4.  Use of articles already in use in the Union before 25 August 2010 containing heptabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.  ◄

Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE)

1163-19-5

214-604-9

1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of decaBDE equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. ►M16  
2.  For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:
(a)  10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c)  by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.  ◄
3.  By way of derogation, the manufacturing, placing on the market and use of decaBDE shall be allowed for the following purposes, provided that Member States report to the Commission by December 2019 in accordance with the Convention:
(a)  in the manufacturing of an aircraft, for which type approval has been applied for before 2 March 2019 and has been received before December 2022, until 18 December 2023, or, in cases where the continuing need is justified, until 2 March 2027;
(b)  in the manufacturing of spare parts for either of the following:
(i)  an aircraft, for which type approval has been applied for before 2 March 2019 and has been received before December 2022, produced before 18 December 2023, or, in cases where the continuing need is justified, produced before 2 March 2027, until the end of service life of that aircraft;
(ii)  motor vehicles within the scope of Directive 2007/46/EC of the European Parliament and of the Council (2), produced before 15 July 2019, either until 2036 or the end of service life of those motor vehicles, whichever date comes earlier; ►C1  
(c)  electric and electronic equipment within the scope of Directive 2011/65/EU.  ◄ ►C1  
4.  The specific exemptions for spare parts for use in motor vehicles referred to in point 3(b)(ii) shall apply for the manufacturing and use of commercial decaBDE falling into one or more of the following categories:
(a)  powertrain and under-hood applications such as battery mass wires, battery interconnection wires, mobile air condition (MAC) pipes, powertrains, exhaust manifold bushings, under- hood insulation, wiring and harness under-hood (engine wiring, etc.), speed sensors, hoses, fan modules and knock sensors;
(b)  fuel system applications such as fuel hoses, fuel tanks and fuel tanks under body;
(c)  pyrotechnical devices and applications affected by pyrotechnical devices such as airbag ignition cables, seat covers/fabrics (only if airbag relevant) and airbags (front and side).  ◄
5.  Use of articles already in use before 15 July 2019 in the Union containing decaBDE shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.
6.  Without prejudice to the application of other Union provisions on the classification, packaging and labelling of substances and mixtures, articles in which decaBDE is used shall be identifiable by labelling or other means throughout its life cycle. ►C1  
7.  The placing on the market and use of articles containing decaBDE imported for the purposes of the specific exemptions in point 3 shall be allowed until the expiry of those exemptions. Point 6 shall apply as if such articles were produced pursuant to the exemption in point 3. Such articles already in use by the date of expiry of the relevant exemption may continue to be used.  ◄
8.  For the purposes of this entry ‘aircraft’ means the following:
(a)  a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 of the European Parliament and of the Council (3) or with a design approval issued under the national regulations of a contracting state of ICAO, or for which a certificate of airworthiness has been issued by an ICAO Contracting State under Annex 8 to the Convention on International Civil Aviation;
(b)  a military aircraft.

►M12  
Perfluorooctane sulfonic acid (PFOS), its salts and PFOS-related compounds
C8F17SO2X
(X = OH, Metal salt (O-M+), halide, amide, and other related compounds 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

►M12  
1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOS or any of its salts equal to or below 0,025 mg/kg (0,0000025 % by weight) where they are present in substances, mixtures or in articles.  ◄ ►M12  
2.  For the purposes of this entry, Article 4(1), point (b), shall apply to the sum of concentrations of all PFOS-related compounds equal to or below 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles.  ◄
3.  Use of articles already in use in the Union before 25 August 2010 containing PFOS shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. ►M12  
4.  If the quantity released into the environment is minimised, manufacturing and placing on the market shall be allowed until 7 September 2025 for use as mist suppressant for non-decorative hard chromium (VI) plating in closed loop systems. Provided that those Member States where PFOS is used report to the Commission by 7 September 2024 on progress made to eliminate PFOS and justify the continuing need for this use, the Commission shall review the need for a prolongation of the derogation for this use of PFOS for a maximum of five years by 7 September 2025.
Where such a derogation concerns production or use in an installation within the scope of Directive 2008/1/EC of the European Parliament and of the Council (4), the relevant best available techniques for the prevention and minimisation of emissions of PFOS described in the information published by the Commission pursuant to Article 17(2), second subparagraph, of Directive 2008/1/EC shall apply.
►M2  As soon as new information on details of uses and safer alternative substances or technologies becomes available, the Commission shall review the derogation in the second subparagraph so that:
(a)  the uses of PFOS will be phased out as soon as the use of safer alternatives is technically and economically feasible;
(b)  a derogation can only be continued for essential uses for which safer alternatives do not exist and where the efforts undertaken to find safer alternatives have been reported on;
(c)  releases of PFOS into the environment have been minimised by applying best available techniques.  ◄  ◄ ►M12  
5.  Once standards are adopted by the European Committee for Standardisation (CEN) they shall be used as the analytical test methods for demonstrating the conformity of substances, mixtures and articles to points 1 and 2. Any other analytical method for which the user can prove equivalent performance could be used as an alternative to the CEN standards.  ◄

DDT (1,1,1-trichloro-2,2-bis(4-chlorophenyl)ethane)

50-29-3

200-024-3

—

Chlordane

57-74-9

200-349-0

—

Hexachlorocyclohexanes, including lindane

58-89-9

200-401-2

—

319-84-6

206-270-8

319-85-7

206-271-3

608-73-1

210-168-9

Dieldrin

60-57-1

200-484-5

—

Endrin

72-20-8

200-775-7

—

Heptachlor

76-44-8

200-962-3

—

Endosulfan

115-29-7

959-98-8

33213-65-9

204-079-4

1.  Placing on the market and use of articles already in use before or on 10 July 2012 containing endosulfan shall be allowed.

2.  Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1.

Hexachlorobenzene

118-74-1

204-273-9

►M6  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of hexachlorobenzene equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances, mixtures or articles. ◄

Chlordecone

143-50-0

205-601-3

—

Aldrin

309-00-2

206-215-8

—

Pentachlorobenzene

608-93-5

210-172-0

—

Polychlorinated Biphenyls (PCB)

1336-36-3 and others

215-648-1 and others

Without prejudice to Directive 96/59/EC, articles already in use at the time of the entry into force of this Regulation are allowed to be used.

Member States shall identify and remove from use equipment (e.g. transformers, capacitors or other receptacles containing liquid stocks) containing more than 0,005 % PCBs and volumes greater than 0,05 dm3, as soon as possible but no later than 31 December 2025.

Mirex

2385-85-5

219-196-6

—

Toxaphene

8001-35-2

232-283-3

—

Hexabromobiphenyl

36355-01-8

252-994-2

—

►C1  Hexabromocyclododecane ◄

‘Hexabromocyclododecane’ means: hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane; beta-hexabromocyclododecane; and gamma-hexabromocyclododecane

25637-99-4,

3194-55-6,

134237-50-6,

134237-51-7,

134237-52-8

247-148-4,

221-695-9

►M10  
1.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of hexabromocyclododecane equal to or below 75 mg/kg (0,0075 % by weight) where it is present in substances, mixtures, articles or as constituents of the flame-retarded articles. For the use of recycled polystyrene in the production of EPS and XPS insulation material for use in buildings or civil engineering works, point (b) shall apply to concentrations of hexabromocyclododecane equal to or below 100 mg/kg (0,01 % by weight). The exemptions laid down in this point 1 shall be reviewed and assessed by the Commission by 1 January 2026.  ◄
2.  Expanded polystyrene articles containing hexabromocyclododecane already in use in buildings before 21 February 2018 in accordance with Commission Regulation (EU) 2016/293 (5) and Commission Implementing Decision No 2016/C 12/06 (6), and extruded polystyrene articles containing hexabromocyclododecane already in use in buildings before 23 June 2016 may continue to be used. Article 4(2), third and fourth subparagraphs shall apply to such articles.
3.  Without prejudice to the application of other Union provisions on the classification, packaging and labelling of substances and mixtures, expanded polystyrene placed on the market after 23 March 2016 in which hexabromocyclododecane was used shall be identifiable by labelling or other means throughout its life cycle.

Hexachlorobutadiene

87-68-3

201-765-5

1.  Placing on the market and use of articles already in use before or on 10 July 2012 containing hexachlorobutadiene shall be allowed.

2.  Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1.

Pentachlorophenol and its salts and esters

87-86-5 and others

201-778-6 and others

►M5  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of pentachlorophenol and its salts and esters equal to or below 5 mg/kg (0,0005 % by weight) where they are present in substances, mixtures or articles. ◄

Polychlorinated naphthalenes (7)

70776-03-3 and others

274-864-4 and others

1.  Placing on the market and use of articles already in use before or on 10 July 2012 containing polychlorinated naphthalenes shall be allowed.

2.  Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1.

Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)

85535-84-8 and others

287-476-5

1.  By way of derogation, the manufacturing, placing on the market and use of substances or mixtures containing SCCPs in concentrations lower than 1 % by weight or articles containing SCCPs in concentrations lower than 0,15 % by weight shall be allowed.

2.  Use shall be allowed in respect of:

(a)  conveyor belts in the mining industry and dam sealants containing SCCPs already in use before or on 4 December 2015; and

(b)  articles containing SCCPs other than those referred to in point (a) already in use before or on 10 July 2012.

3.  The third and fourth subparagraphs of Article 4(2) shall apply to the articles referred to in point 2.

▼M1

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds

‘Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds’ means the following:

(i)  perfluorooctanoic acid, including any of its branched isomers;

(ii)  its salts;

(iii)  PFOA-related compounds which, for the purposes of the Convention, are any substances that degrade to PFOA, including any substances (including salts and polymers) having a linear or branched perfluoroheptyl group with the moiety (C7F15)C as one of the structural elements.

The following compounds are not included as PFOA-related compounds:

(i)  C8F17-X, where X = F, Cl, Br;

(ii)  fluoropolymers that are covered by CF3[CF2]n-R’, where R’=any group, n> 16;

(iii)  perfluoroalkyl carboxylic acids (including their salts, esters, halides and anhydrides) with ≥ 8 perfluorinated carbons;

(iv)  perfluoroalkane sulfonic acids and perfluoro phosphonic acids (including their salts, esters, halides and anhydrides) with ≥ 9 perfluorinated carbons;

(v)   ►M13  perfluorooctane sulfonic acid (PFOS), its salts and PFOS-related compounds as listed in this Annex. ◄

335-67-1 and others

206-397-9 and others

1.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA or any of its salts equal to or below 0,025 mg/kg (0,0000025 % by weight) where they are present in substances, mixtures or articles.
2.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of any individual PFOA-related compound or a combination of PFOA-related compounds equal to or below 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles.
►M4  3.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA-related compounds equal to or below 20 mg/kg (0,002 % by weight) where they are present in a substance to be used as a transported isolated intermediate within the meaning of Article 3 point 15(c) of Regulation (EC) No 1907/2006 and fulfilling the strictly controlled conditions set out in Article 18(4)(a) to (f) of that Regulation for the production of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms. ◄ ►M13   ►M8  This exemption shall be reviewed and assessed by the Commission no later than 25 August 2023. ◄  ◄ ►M8  
4.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFOA and its salts equal to or below 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders until 18 August 2023. All emissions of PFOA during the manufacture and use of PTFE micropowders shall be avoided and, if not possible, reduced as far as possible. The limit of 1 mg/kg (0,0001 % by weight) shall apply only to manufacture, placing on the market and use of PFOA and its salts where they are present in PTFE micropowders that are transported or treated for the purpose to reduce the concentration of PFOA and its salts below the limit of 0,025 mg/kg (0,0000025 % by weight).  ◄ ►M13  
4a.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFOA or any of its salts equal to or below 1 mg/kg (0,0001 % by weight) and to concentrations of any individual PFOA-related compound or combination of PFOA-related compounds equal to or below 10 mg/kg (0,001 % by weight) where they are present in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems. This limit value shall apply until 3 August 2028.
4b.  For the purposes of this entry, Article 4(1), point (b), shall apply to the sum of the concentration of PFOA, its salts and PFOA-related compounds equal to or below 10 mg/kg (0,001 % by weight) where they are present in fluorine-free fire-fighting foam and originate from fire-fighting equipment which has undergone cleaning in accordance with the best available techniques.  ◄
5.  By way of derogation, the manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds shall be allowed for the following purposes:
(a)  photolithography or etch processes in semiconductor manufacturing, until 4 July 2025;
(b)  photographic coatings applied to films, until 4 July 2025;
(c)  textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety, until 4 July 2023;
(d)  invasive and implantable medical devices, until 4 July 2025. ►M8  
(e)  manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:
(i)  high-performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles;
(ii)  industrial waste heat exchanger equipment,
(iii)  industrial sealants capable of preventing leakage of volatile organic compounds and PM2.5 particulates;
until 4 July 2023.  ◄
6.  By way of derogation, the use of PFOA, its salts and PFOA-related compounds shall be allowed in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, until ►M13  3 December 2025 ◄ , subject to the following conditions:
(a)  fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for training;
(b)  fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for testing unless all releases are contained;
(c)  as from 1 January 2023, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall only be allowed in sites where all releases can be contained;
(d)  fire-fighting foam stockpiles that contain or may contain PFOA, its salts and/or PFOA-related compounds shall be managed in accordance with Article 5.
‘firefighting foam’ means any mixture to fight fires with foam and includes but is not limited to firefighting foam concentrates and firefighting foam solutions to produce the foam.
7.  By way of derogation, the use of perfluooroctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products shall be allowed, subject to review and assessment by the Commission by 31 December 2026, every four years thereafter and by 31 December 2036.
8.  Use of articles already in use in the Union before 4 July 2020 containing PFOA, its salts and/or PFOA-related compounds shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.
9.   ►C2  By way of derogation, the manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds shall be allowed until 3 December 2020 for the following purposes: ◄
(a)  medical devices other than implantable ones, within the scope of Regulation (EU) 2017/745 (8);
(b)  latex printing inks;
(c)  plasma nano-coatings. ►M4  
10.  For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA and its salts and/or PFOA-related compounds equal to or below 2 mg/kg (0,0002 % by weight) where they are present in medical devices other than invasive devices and implantable devices. ►M13  —22 February 2023— ◄  ◄ ►M13  
11.  Articles containing PFOA, its salts or PFOA-related compounds already in use in the Union before or on the date of expiry of the relevant exemption laid down in points 5(a) to (d) may continue to be used.  ◄

▼M3

Dicofol

115-32-2

204-082-0

None

▼M9

Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds

‘Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds’ means the following:

(i)  perfluorohexane sulfonic acid, including any of its branched isomers;

(ii)  its salts;

(iii)  PFHxS-related compounds which, for the purposes of the Convention, are any substance that contains the chemical moiety C6F13S- as one of its structural elements and that degrades to PFHxS.

355-46-4 and others

206-587-1 and others

1.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFHxS or any of its salts equal to or below 0,025 mg/kg (0,0000025 % by weight) where they are present in substances, mixtures or articles.

2.  For the purposes of this entry, Article 4(1), point (b), shall apply to the sum of concentrations of all PFHxS-related compounds equal to or below 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles.

3.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFHxS, its salts and PFHxS-related compounds equal to or below 0,1 mg/kg (0,00001 % by weight) where it is present in concentrated firefighting foam mixtures that are to be used or are used in the production of other firefighting foam mixtures. This exemption shall be reviewed and assessed by the Commission no later than 28 August 2026.

▼M11

Methoxychlor

‘Methoxychlor’ refers to any possible isomer of dimethoxydiphenyltrichloroethane or any combination thereof.

72-43-5

30667-99-3

76733-77-2

255065-25-9

255065-26-0

59424-81-6

1348358-72-4

and others

200-779-9

For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of methoxychlor equal to or below 0,01 mg/kg (0,000001 % by weight) where they are present in substances, mixtures or articles.

▼M14

2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol

(UV-328)

25973-55-1

247-384-8

1.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of UV-328 equal to or below:

(a)  100 mg/kg (0,01 % by weight) from 4 August 2025;

(b)  10 mg/kg (0,001 % by weight) from 4 August 2027;

(c)  1 mg/kg (0,0001 % by weight) from 4 August 2029;

where they are present in substances, mixtures or articles.

2.  By way of derogation, the placing on the market of UV-328 present in articles and the use of such articles shall be allowed for the following purposes:

(a)  in land-based motor vehicles, until 4 August 2030;

(b)  in industrial coating for land-based motor vehicles, engineering machines, rail transportation vehicles, and in heavy-duty coatings for large steel structures, until 4 August 2030;

(c)  in mechanical separators in blood collection tubes, until 4 August 2030;

(d)  in triacetyl cellulose film in polarisers, until 4 August 2030;

(e)  in photographic paper, until 4 August 2030;

(f)  in civilian and military aircrafts, until 4 August 2030;

(g)  in spare parts for any of the following:

(i)  land-based motor vehicles;

(ii)  stationary industrial machines for use in agriculture, forestry and construction;

(iii)  liquid crystal displays in instruments for analysis, measurements, control, monitoring, testing, production and inspection, other than for medical applications;

where UV-328 was initially used in their production, until the end of their service life or 31 December 2043, whichever comes earlier;

(h)  in spare parts for any of the following:

(i)  liquid crystal displays in devices within the scope of Regulation (EU) 2017/745, and within the scope of Regulation (EU) 2017/746 of the European Parliament and of the Council (9);

(ii)  liquid crystal displays in instruments for analysis, measurements, control, testing, production and inspection;

where UV-328 was initially used in their production, until the end of their service life;

(i)  in spare parts for civilian and military aircrafts where UV-328 was initially used in their production, until 31 December 2030.

3.  Articles containing UV-328 already in use in the Union before or on the date of expiry of the relevant exemption laid down in point 2(a) to (i) may continue to be used.

▼M15

Dechlorane Plus

‘Dechlorane Plus’ includes its syn-isomer and anti-isomer

13560-89-9

135821-03-3

135821-74-8

236-948-9

1.  For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of Dechlorane Plus:

(a)  equal to or below 1 000  mg/kg (0,1 % by weight) where they are present in substances, mixtures or articles until 15 April 2028;

(b)  equal to or below 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles after 15 April 2028.

2.  By way of derogation, the placing on the market and use of Dechlorane Plus shall be allowed for the following purposes:

(a)  aerospace, space and defence applications, until 26 February 2030;

(b)  medical imaging applications, until 26 February 2030;

(c)  radiotherapy devices and installations, until 26 February 2030;

(d)  spare parts for, and the repair of, any of the following:

(i)  land-based motor vehicles;

(ii)  stationary industrial machines for use in agriculture, forestry and construction;

(iii)  marine, garden, forestry and outdoor power equipment other than that covered under (ii);

(iv)  aerospace, space and defence applications;

(v)  instruments for analysis, measurements, control, monitoring, testing, production and inspection;

where Dechlorane Plus was initially used in their production, until the end of their service life or until 31 December 2043, whichever comes earlier:

(e)  spare parts for, and the repair of, any of the following:

(i)  medical devices and accessories for medical devices within the scope of Regulation (EU) 2017/745;

(ii)  in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices within the scope of Regulation (EU) 2017/746;

where Dechlorane Plus was initially used in their production, until the end of their service life.

3.  The Commission shall assess the need for a prolongation of the specific exemptions in points (a), (b) and (c) of paragraph 2 at the latest by 1 April 2028.

4.  Articles containing Dechlorane Plus already in use in the Union before or on the date of expiry of the relevant exemption laid down in paragraph 2(a) to (d) may continue to be used.

5.  Placing on the market and use of spare parts containing Dechlorane Plus referred to in paragraph 2, point (d)(iv) that are present in the territory of the Union before or on 31 December 2043 shall be allowed.

▼M18

Chlorpyrifos

2921-88-2

220-864-4

For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of chlorpyrifos equal to or below 0,01 mg/kg (0,000001 % by weight) where they are present in substances, mixtures or articles.

▼B

(1)   

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).

(2)   

Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p.1).

(3)   

Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).

(4)   

Directive 2008/1/EC of the European Parliament and of the Council of 15 January 2008 concerning integrated pollution prevention and control (OJ L 24, 29.1.2008, p. 8).

(5)   

Commission Regulation (EU) 2016/293 of 1 March 2016 amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annex I (OJ L 55, 2.3.2016, p. 4).

(6)   

OJ C 10, 13.1.2016, p. 3.

(7)   

Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms.

►M1  (8)   

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

 ◄
(9)   

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/2017/746/oj).

(10)   

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI: http://data.europa.eu/eli/reg/2004/1935/oj).

(11)   

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, ELI: http://data.europa.eu/eli/dir/2009/48/oj).

Part B

Substances listed only in the Protocol



Substance

CAS No

EC No

Specific exemption on intermediate use or other specification

 

 

 

 

ANNEX II




ANNEX II

LIST OF SUBSTANCES SUBJECT TO RESTRICTIONS

Part A

Substances listed in the Convention and in the Protocol



Substance

CAS No

EC No

Conditions of restriction

 

 

 

 

Part B

Substances listed only in the Protocol



Substance

CAS No

EC No

Conditions of restriction

 

 

 

 

ANNEX III




ANNEX III

LIST OF SUBSTANCES SUBJECT TO RELEASE REDUCTION PROVISIONS

PART A

Substance (CAS No)

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF)

Polychlorinated biphenyls (PCB)

▼C1

PART B

Substance (CAS No)

▼B

Hexachlorobenzene (HCB) (CAS No 118-74-1)

Polycyclic aromatic hydrocarbons (PAHs) ( 4 )

Pentachlorobenzene (CAS No 608-93-5)

Hexachlorobutadiene (CAS No 87-68-3)

Polychlorinated naphthalenes (CAS No 70776-03-3 and others)

ANNEX IV




ANNEX IV

List of substances subject to waste management provisions set out in Article 7



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 (1)

 

 

10 mg/kg

▼M7

Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)

85535-84-8

287-476-5

►M17  
1 500  mg/kg
By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that 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: ►C3  
(a)  until 29 December 2025, 500 mg/kg;  ◄ ►C3  
(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

▼B

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

▼M7

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and dioxin-like polychlorinated biphenyls (dl-PCBs)

 

 

►M17  
5 μg/kg (2)
By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.  ◄

▼B

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 (3)

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

▼M7

Hexabromocyclododecane (4)

25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8

►C4  
247-148-4
221-695-9  ◄

►M17  
500 mg/kg
By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value to not higher than 200 mg/kg.  ◄

▼M7

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

►M17  
1 mg/kg (PFOA and its salts),
40 mg/kg (sum of PFOA-related compounds)
By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.  ◄

▼C4

Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds

355-46-4 and others

206-587-1 and others

►M17  
1 mg/kg (PFHxS and its salts),
40 mg/kg (sum of PFHxS-related compounds)
By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.  ◄

▼B

(1)   

Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms.

(2)   

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.

(3)   

The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply.

(4)   

‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane, beta-hexabromocyclododecane and gamma-hexabromocyclododecane.

ANNEX V




ANNEX V

WASTE MANAGEMENT

Part 1

Disposal and recovery under Article 7(2)

The following disposal and recovery operations, as provided for in Annexes I and II of Directive 2008/98/EC, are permitted for the purposes of Article 7(2), when applied in such a way as to ensure that the persistent organic pollutant content is destroyed or irreversibly transformed



D9

Physico-chemical treatment.

D10

Incineration on land.

R1

Use principally as a fuel or other means to generate energy, excluding waste containing PCBs.

R4

Recycling/reclamation of metals and metal compounds, under the following conditions: The operations are restricted to residues from iron- and steel-making processes such as dusts or sludges from gas treatment or mill scale or zinc-containing filter dusts from steelworks, dusts from gas cleaning systems of copper smelters and similar wastes and lead-containing leaching residues of the non-ferrous metal production. Waste containing PCBs is excluded. The operations are restricted to processes for the recovery of iron and iron alloys (blast furnace, shaft furnace and hearth furnace) and non-ferrous metals (Waelz rotary kiln process, bath melting processes using vertical or horizontal furnaces), provided the facilities meet as minimum requirements the emission limit values for PCDDs and PCDFs laid down in accordance with Directive 2010/75/EU of the European Parliament and of the Council (1), whether or not the processes are subject to that Directive and without prejudice to the other provisions of the Directive.

(1)   

Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).

Pre-treatment operation prior to destruction or irreversible transformation pursuant to this Part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with this Part of this Annex. Where only part of a product or waste, such as waste equipment, contains or is contaminated with persistent organic pollutants, it shall be separated and then disposed of in accordance with the requirements of this Regulation. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to destruction or irreversible transformation pursuant to this part of this Annex.

Part 2

Wastes and operations to which Article 7(4)(b) applies

The following operations are permitted for the purposes of Article 7(4)(b) in respect of the wastes specified, defined by the six-digit code as classified in Commission Decision 2000/532/EC ( 5 ).

Pre-treatment operations prior to permanent storage pursuant to this part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with Part 1 of this Annex. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to permanent storage pursuant to this part of this Annex.



Wastes as classified in Decision 2000/532/EC

Maximum concentration limits of substances listed in Annex IV (1)

Operation

10

WASTES FROM THERMAL PROCESSES

Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs): 10 000 mg/kg;

Aldrin: 5 000 mg/kg;

Chlordane: 5 000 mg/kg;

Chlordecone: 5 000 mg/kg;

DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl) ethane): 5 000 mg/kg;

Dieldrin: 5 000 mg/kg;

Endosulfan: 5 000 mg/kg;

Endrin: 5 000 mg/kg;

Heptachlor: 5 000 mg/kg;

Hexabromobiphenyl: 5 000 mg/kg;

Hexabromocyclododecane (3): 1 000 mg/kg;

Hexachlorobenzene: 5 000 mg/kg;

Hexachlorobutadiene: 1 000 mg/kg;

Hexachlorocyclohexanes, including lindane: 5 000 mg/kg;

Mirex: 5 000 mg/kg;

Pentachlorobenzene: 5 000 mg/kg;

Perfluorooctane sulfonic acid and its derivatives (PFOS) (C8F17SO2X) (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers): 50 mg/kg;

Polychlorinated Biphenyls (PCB) (6): 50 mg/kg;

►M7

 

Polychlorinated dibenzo-p-dioxins and dibenzofurans and dioxin-like polychlorinated biphenyls (dl-PCBs): 5 mg/kg;

 ◄

Polychlorinated naphthalenes (*): 1 000 mg/kg;

►M7

 

Sum of the concentrations of tetrabromodiphenyl ether (C12H6Br4O), pentabromodiphenyl ether (C12H5Br5O), hexabromodiphenyl ether (C12H4Br6O), heptabromodiphenyl ether (C12H3Br7O) and decabromodiphenyl ether (C12Br10O): 10 000 mg/kg;

 ◄

Toxaphene: 5 000 mg/kg;

►M7

 

Pentachlorophenol, its salts and esters: 1 000 mg/kg;

Dicofol: 5 000 mg/kg;

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds: 50 mg/kg (PFOA and its salts), 2 000 mg/kg (PFOA-related compounds);

Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds:

50 mg/kg (PFHxS and its salts), 2 000 mg/kg (PFHxS-related compounds).

 ◄

Permanent storage shall be allowed only when all the following conditions are met:

(1)  The storage takes place in one of the following locations:

— safe, deep, underground, hard rock formations,

— salt mines,

— a landfill site for hazardous waste, provided that the waste is solidified or partly stabilised where technically feasible as required for classification of the waste in subchapter 19 03 of Decision 2000/532/EC.

(2)  The provisions of Council Directive 1999/31/EC (4) and Council Decision 2003/33/EC (5) were respected.

(3)  It has been demonstrated that the selected operation is environmentally preferable.

10 01

Wastes from power stations and other combustion plants (except 19)

►M7  10 01 03 ◄

►M7  Fly ash from peat and untreated wood ◄

10 01 14 * (2)

Bottom ash, slag and boiler dust from co-incineration containing hazardous substances

10 01 16 *

Fly ash from co-incineration containing hazardous substances

10 02

Wastes from the iron and steel industry

10 02 07 *

Solid wastes from gas treatment containing hazardous substances

10 03

Wastes from aluminium thermal metallurgy

10 03 04 *

Primary production slags

10 03 08 *

Salt slags from secondary production

10 03 09 *

Black drosses from secondary production

10 03 19 *

Flue-gas dust containing hazardous substances

10 03 21 *

Other particulates and dust (including ball-mill dust) containing hazardous substances

10 03 29 *

Wastes from treatment of salt slags and black drosses containing hazardous substances

10 04

Wastes from lead thermal metallurgy

10 04 01 *

Slags from primary and secondary production

10 04 02 *

Dross and skimmings from primary and secondary production

10 04 04 *

Flue-gas dust

10 04 05 *

Other particulates and dust

10 04 06 *

Solid wastes from gas treatment

10 05

Wastes from zinc thermal metallurgy

10 05 03 *

Flue-gas dust

10 05 05 *

Solid waste from gas treatment

10 06

Wastes from copper thermal metallurgy

10 06 03 *

Flue-gas dust

10 06 06 *

Solid wastes from gas treatment

10 08

Wastes from other non-ferrous thermal metallurgy

10 08 08 *

Salt slag from primary and secondary production

10 08 15 *

Flue-gas dust containing hazardous substances

10 09

Wastes from casting of ferrous pieces

10 09 09 *

Flue-gas dust containing hazardous substances

16

WASTES NOT OTHERWISE SPECIFIED IN THE LIST

16 11

Waste linings and refractories

16 11 01 *

Carbon-based linings and refractories from metallurgical processes containing hazardous substances

16 11 03 *

Other linings and refractories from metallurgical processes containing hazardous substances

17

CONSTRUCTION AND DEMOLITION WASTES (INCLUDING EXCAVATED SOIL FROM CONTAMINATED SITES)

17 01

Concrete, bricks, tiles and ceramics

17 01 06 *

Mixtures of, or separate fractions of concrete, bricks, tiles and ceramics containing hazardous substances

17 05

Soil (including excavated soil from contaminated sites), stones and dredging spoil

17 05 03 *

Soil and stones containing hazardous substances

►M7  17 05 04 ◄

►M7  Soil and stones other than those mentioned in 17 05 03 ◄

17 09

Other construction and demolition wastes

17 09 02 *

Construction and demolition wastes containing PCB, excluding PCB containing equipment

17 09 03 *

Other construction and demolition wastes (including mixed wastes) containing hazardous substances

19

WASTES FROM WASTE MANAGEMENT FACILITIES, OFF-SITE WASTE WATER TREATMENT PLANTS AND THE PREPARATION OF WATER INTENDED FOR HUMAN CONSUMPTION AND WATER FROM INDUSTRIAL USE

19 01

Wastes from incineration or pyrolysis of waste

19 01 07 *

Solid wastes from gas treatment

19 01 11 *

Bottom ash and slag containing hazardous substances

19 01 13 *

Fly ash containing hazardous substances

19 01 15 *

Boiler dust containing hazardous substances

19 04

Vitrified waste and waste from vitrification

19 04 02 *

Fly ash and other flue-gas treatment wastes

19 04 03 *

Non-vitrified solid phase

►M7  20 ◄

►M7  MUNICIPAL WASTES (HOUSEHOLD WASTE AND SIMILAR COMMERCIAL, INDUSTRIAL AND INSTITUTIONAL WASTES) INCLUDING SEPARATELY COLLECTED FRACTIONS ◄

►M7  20 01 ◄

►M7  Separately collected fractions (except 15 01) ◄

►M7  20 01 41 ◄

►M7  Wastes from chimney sweeping ◄

(1)   

These limits apply exclusively to a landfill site for hazardous waste and do not apply to permanent underground storage facilities for hazardous waste, including salt mines.

(2)   

Any waste marked with an asterisk ‘*’ is considered as hazardous waste pursuant to Directive 2008/98/EC and is subject to the provisions of that Directive.

(3)   

‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha- hexabromocyclododecane, beta- hexabromocyclododecane and gamma- hexabromocyclododecane.

(4)   

Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1).

(5)   

Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC (OJ L 11, 16.1.2003, p. 27).

(6)   

The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply.

▼M7

The maximum concentration limit of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD and PCDF) and dioxin-like polychlorinated biphenyls (dl-PCBs) shall be calculated according to the following toxic equivalency factors (TEFs):

Toxicity equivalency factors (TEFs) for PCDD, PCDF and dl-PCBs



PCDD

TEF

2,3,7,8-TeCDD

1

1,2,3,7,8-PeCDD

1

1,2,3,4,7,8-HxCDD

0,1

1,2,3,6,7,8-HxCDD

0,1

1,2,3,7,8,9-HxCDD

0,1

1,2,3,4,6,7,8-HpCDD

0,01

OCDD

0,0003

PCDF

TEF

2,3,7,8-TeCDF

0,1

1,2,3,7,8-PeCDF

0,03

2,3,4,7,8-PeCDF

0,3

1,2,3,4,7,8-HxCDF

0,1

1,2,3,6,7,8-HxCDF

0,1

1,2,3,7,8,9-HxCDF

0,1

2,3,4,6,7,8-HxCDF

0,1

1,2,3,4,6,7,8-HpCDF

0,01

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

dl-PCBs

TEF

PCB 77

0,0001

PCB 81

0,0003

PCB 105

0,00003

PCB 114

0,00003

PCB 118

0,00003

PCB 123

0,00003

PCB 126

0,1

PCB 169

0,03

PCB 156

0,00003

PCB 157

0,00003

PCB 167

0,00003

PCB 189

0,00003

▼B

ANNEX VI




ANNEX VI

Repealed Regulation with list of the successive amendments thereto



Regulation (EC) No 850/2004 of the European Parliament and of the Council

(OJ L 158, 30.4.2004, p. 7)

 

Council Regulation (EC) No 1195/2006

(OJ L 217, 8.8.2006, p. 1)

 

Council Regulation (EC) No 172/2007

(OJ L 55, 23.2.2007, p. 1)

 

Commission Regulation (EC) No 323/2007

(OJ L 85, 27.3.2007, p. 3)

 

Regulation (EC) No 219/2009 of the European Parliament and of the Council

(OJ L 87, 31.3.2009, p. 109)

Only point 3.7 of the Annex

Commission Regulation (EC) No 304/2009

(OJ L 96, 15.4.2009, p. 33)

 

Commission Regulation (EU) No 756/2010

(OJ L 223, 25.8.2010, p. 20)

 

Commission Regulation (EU) No 757/2010

(OJ L 223, 25.8.2010, p. 29)

 

Commission Regulation (EU) No 519/2012

(OJ L 159, 20.6.2012, p. 1)

 

Commission Regulation (EU) No 1342/2014

(OJ L 363, 18.12.2014, p. 67)

 

Commission Regulation (EU) 2015/2030

(OJ L 298, 14.11.2015, p. 1)

 

Commission Regulation (EU) 2016/293

(OJ L 55, 2.3.2016, p. 4)

 

Commission Regulation (EU) 2016/460

(OJ L 80, 31.3.2016, p. 17)

 

ANNEX VII




ANNEX VII

CORRELATION TABLE



Regulation (EC) No 850/2004

This Regulation

Article 1(1)

Article 1

Article 2, introductory wording

Article 2, introductory wording

Article 2, points (a) to (d)

Article 2, points (1) to (4)

—

Article 2, points (5) to (7)

Article 2, point (e)

Article 2, point (8)

Article 2, point (f)

Article 2, point (9)

Article 2, point (g)

Article 2, point (10)

—

Article 2, points (11) to (13)

Article 3

Article 3(1) to (3)

—

Article 3(4) and (5)

Article 1(2)

Article 3(6)

Article 4(1) to (3)

Article 4(1) to (3)

—

Article 4(3), point (d)

Article 1(2)

Article 4(4)

Article 5

Article 5

Article 6

Article 6

Article 7(1) to (4)

Article 7(1) to (4)

Article 7(6)

Article 7(5)

—

Article 7(6)

Article 7(7)

—

—

Article 8

Article 8

Article 9

Article 9

Article 10

Article 10

Article 11

Article 11

Article 12

Article 12(1)

Article 13(1), point (a)

Article 12(3), point (a)

Article 13(1), point (b)

Article 12(3), point (b)

Article 13(1), point (c)

—

Article 13(1), point (d)

Article 12(3), point (c)

Article 13(1), point (e)

Article 12(2)

Article 13(1), point (f)

—

Article 13(2)

Article 12(4)

—

Article 12(5)

Article 13(3)

Article 12(6)

—

—

Article 13(4) and (5)

Article 13

Article 14

Article 14

Article 15(1)

Article 7(5)

Article 15(2)

—

Article 16

—

Article 17

—

Article 18

Article 15

Article 19

Articles 16 and 17

Article 20

Article 18

—

—

Article 21

Article 19

Article 22

Annexes I to V

Annexes I to V

—

Annex VI

—

Annex VII

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti
Fonte Requisito

3. Standard correlati

Standard
Fonte Requisito

Ticket collegati