ANNEX I

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.

▼B

Substance

CAS No

EC No

Specific exemption on intermediate use or other specification