in force 2025-11-17 MODIFIED+6,041 −1,231§
Amended by Regulation (EU) 2025/718 32025R0718 · Regulation (EU) 2025/1482 32025R1482
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: 2004-10-27, 2009-06-18, 2025-12-30, 2027-05-17, 2027-12-30 · dates removed: 2021-07-16
The list of referenced legal instruments now also includes Regulation (EC) No 1935/2004 on food contact materials and Directive 2009/48/EC on the safety of toys, and the earlier reference to a review by 16 July 2021 of the combined tetra-, penta-, hexa-, hepta- and decaBDE limit has been removed.
For each of the tetra-, penta-, hexa-, hepta- and decaBDE entries, the single combined concentration limit of up to 500 mg/kg for mixtures or articles has been replaced by a tiered structure of limits that distinguishes ordinary mixtures or articles, mixtures or articles containing recovered material, and toys or child-care products containing recovered material, with different mg/kg thresholds applying upon entry into force of the Regulation and then as of 30 December 2025, 17 May 2027 and 30 December 2027, and with food contact materials under Regulation (EC) No 1935/2004 excluded from these limits.
The PFOS entry's points 1 and 2 have been rewritten so that the limit for PFOS and its salts is now set at 0,025 mg/kg in substances, mixtures or articles, and a separate limit of 1 mg/kg is set for the sum of concentrations of all PFOS-related compounds, replacing the earlier separate thresholds for substances or mixtures and for semi-finished products, articles, textiles or coated materials.
Cited: Annex I, v2 · Annex I, v1
text before / after
02019R1021-20251015 → 02019R1021-20251203
ANNEX I
Part A
Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention
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).
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).
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).
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).
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).
OJ C 10, 13.1.2016, p. 3.
Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms.
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.
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).
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).
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).
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 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.
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 concentration concentrations of those substances up to 500 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 review Regulation (EC) No 1935/2004 of the European Parliament and assessment of the Council
;
(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 Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard European Parliament and of the Council
, 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 health and the environment. 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
.
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.
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 concentration concentrations of those substances up to 500 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 review 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 assessment 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 the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard 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 health Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and the environment. 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.
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.
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 concentration concentrations of those substances up to 500 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 review 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 assessment 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 the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard 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 health Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and the environment. 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.
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.
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 concentration concentrations of those substances up to 500 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 review 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 assessment 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 the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard 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 health Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and the environment. 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.
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.
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 up to 500 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 review 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 assessment 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 the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard 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 health Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and the environment. 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 … 477 unchanged words … 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 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 10 0,025 mg/kg (0,001 (0,0000025 % by weight) where it is they are present in substances substances, mixtures or in mixtures. articles.
2. For the purposes of this entry, Article 4(1), point (b) of Article 4(1) (b), shall apply to the sum of concentrations of PFOS in semi-finished products all PFOS-related compounds equal to or articles, or parts thereof, if the concentration of PFOS is lower than 0,1 below 1 mg/kg (0,0001 % by weight calculated with reference to the mass of structurally weight) where they are present in substances, mixtures or micro-structurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is lower than 1 μg/m2 of the coated material. 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.
4. If the quantity released into the environment is … 3,050 unchanged words … paragraph 2, point (d)(iv) that are present in the territory of the Union before or on 31 December 2043 shall be allowed.
Part B
Substances listed only in the Protocol
Substance CAS No EC No Specific exemption on intermediate use or other specification