Persistent Organic Pollutants Regulation

02019R1021-20241017 → 02019R1021-20250804

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naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms.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). 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 … 1,243 unchanged words … 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. Perfluorooctane sulfonic acid (PFOS), its salts and its derivatives (PFOS) PFOS-related compounds C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives 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 equal to or below 10 mg/kg (0,001 % by weight) where it is present … 1,166 unchanged words … 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) perfluorooctane sulfonic acid (PFOS), its salts and its derivatives (PFOS), 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. 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. This exemption shall be reviewed and assessed by the Commission no later than 25 August 2023. 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). 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. (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 4 July 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. 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 ; (b) latex printing inks; (c) plasma nano-coatings. 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. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023. 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. Dicofol 115-32-2 204-082-0 None 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. 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. 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 ; (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. Part B Substances listed only in the Protocol Substance CAS No EC No Specific exemption on intermediate use or other specification