On 16 December 2020, the European Commission has published Commission Regulation (EU) 2020/2096 to amend Annex XVII to REACH Regulation (EC) No 1907/2006. Following entries of Annex XVII to REACH Regulation shall be deleted, as more severe restrictions are laid down for those substances in the POPs Regulation (Regulation (EU) 2019/1021):
The amendments shall enter in force on 5 January 2021.
The following tables are the comparison of the entries in REACH Regulation and in POPs Regulation:
1.Pentachlorophenol (PCP) and its salts and esters
| Regulation | REACH Regulation (Regulation (EC) No 1907/2006) Annex XVII, Entry 22 | POPs Regulation (Regulation (EU) 2019/1021) Annex I, Part A |
| Limit | (1) ND (Not detected) for substance; (2) < 0.1% as constituent in substances, in mixtures | ND (Not detected) (for substances, mixtures, articles) |
| Product | Substances, mixtures | Substances, mixtures, articles |
| Effective date | Deleted by Regulation (EU) 2020/2096 which enters in force on 5 January 2021. | Apply from 15 July 2019 |
| Exemption | None | None |
2.Bis(pentabromophenyl)ether (decabromodiphenyl ether; DecaBDE)
| Regulation |
REACH Regulation (Regulation (EC) No 1907/2006) Annex XVII, Entry 67 |
POPs Regulation (Regulation (EU) 2019/1021) Annex I, Part A |
| Limit |
(1) ND (Not detected) for substance; (2) < 0.1% as constituent in substances, in mixtures, in articles |
(1) ≤ 10 mg/kg (0.001%) of DecaBDE for substance; (2) ≤ 500 mg/kg (0.05%) of sum of TetraBDE, PentaBDE, HexaBDE, HeptaBDE and DecaBDE in mixtures, articles. |
| Product | Substances, mixtures, articles | Substances, mixtures, articles |
| Effective date | Deleted by Regulation (EU) 2020/2096 which enters in force on 5 January 2021. | Apply from 15 July 2019 |
| Exemption |
1. Substance, constituent of substances, mixtures that is to be used, or is used: (a) in the production of an aircraft before 2 March 2027; (b) in the production of spare parts for either of the following: (i) An aircraft produced before 2 March 2027; (ii) Motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry vehicles within the scope of Regulation (EU) No 167/2013 or machinery within the scope of Directive 2006/42/EC, produced before 2 March 2019 . 2. Articles: (a) Articles placed on the market before 2 March 2019; (b) Aircraft produced in accordance with subparagraph 1(a); (c) Spare parts of aircraft, vehicles or machines produced in accordance with subparagraph 1(b); (d) electrical and electronic equipment within the scope of Directive 2011/65/EU. |
1. Substances (Provided that Member States report to the Commission by December 2019) used in: (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 and specified by this Entry, produced before 15 July 2019, either until 2036 or the end of service life of those motor vehicles, whichever date comes earlier; (c) electric and electronic equipment within the scope of Directive 2011/65/EU. 2. Article: Articles already in use before 15 July 2019 in the Union. |
3.Perfluorooctanoic acid (PFOA) and its salts, and PFOA-related substances
| Regulation | REACH Regulation (Regulation (EC) No 1907/2006) Annex XVII, Entry 68 | POPs Regulation (Regulation (EU) 2019/1021) Annex I, Part A |
| Limit |
(1) ND (Not detected) for substance; (2) < 25 ppb (0.0000025%) of PFOA and its salts as constituent in substances, in mixtures, in articles; (3) < 1000 ppb (0.0001%) of PFOA-related substances as constituent in substances, in mixtures, in articles |
(1) ≤ 0.025 mg/kg (0.0000025%) of PFOA and its salts, for substances, mixtures, articles; (2) ≤ 1 mg/kg (0.0001%) of PFOA-related compounds, for substances, mixtures, articles; Other limits: (3) ≤ 20 mg/kg (0.002%) of PFOA-related compounds for substance to be used as a transported isolated intermediate for the production of fluorochemicals with a carbon chain equal to or shorter than 6 atoms; (4) ≤ 1 mg/kg (0.0001%) of PFOA and its salts in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation of up to 400 kilograys or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders |
| Product | Substances, mixtures, articles | Substances, mixtures, articles |
| Effective date | Deleted by Regulation (EU) 2020/2096 which enters in force on 5 January 2021. | Apply from 4 July 2020 |
| Exemption |
1. Substance, constituent of substances, mixtures, articles: (a) before 4 July 2022 to: (i) equipment used to manufacture semi-conductors; (ii) latex printing inks. (b) before 4 July 2023 to: (i) textiles for the protection of workers from risks to their health and safety; (ii) membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment; (iii) plasma nano-coatings. (c) before 4 July 2032 to medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. 2. Substance, constituent of substances, mixtures, articles: (a) perfluorooctane sulfonic acid and its derivatives, which are listed in Part A of Annex I to Regulation (EC) No 850/2004; (b) the manufacture of a substance where this occurs as an unavoidable by-product of the manufacture of fluorochemicals with a carbon chain equal to or shorter than 6 atoms; (c) a substance that is to be used, or is used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met; (d) a substance, constituent of another substance or mixture that is to be used, or is used: (i) in the production of implantable medical devices within the scope of Directive 93/42/EEC; (ii) in photographic coatings applied to films, papers or printing plates; (iii) in photo-lithography processes for semiconductors or in etching processes for compound semiconductors; (e) concentrated fire-fighting foam mixtures that were placed on the market before 4 July 2020 and are to be used, or are used in the production of other fire-fighting foam mixtures. 3. Mixtures: Fire-fighting foam mixtures which were:(a) placed on the market before 4 July 2020; or (b) produced in accordance with point 2(e), provided that, where they are used for training purposes, emissions to the environment are minimised and effluents collected are safely disposed of. 4. Articles: (a) articles placed on the market before 4 July 2020; (b) implantable medical devices produced in accordance with point 2(d)(i); (c) articles coated with the photographic coatings referred to in point 2(d)(ii); (d) semiconductors or compound semiconductors referred to in point 2(d)(iii). |
1. Substances used in: (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. 2. Substances: Fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) in installed systems, including both mobile and fixed systems, subject to specific conditions, until 4 July 2025; 3. Substance used in: Use of perfluooroctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products; 4. Articles: Articles already in use in the Union before 4 July 2020; 5. Substances used in: (a) Medical devices other than implantable ones within the scope of Regulation (EU) 2017/745, until 3 December 2020; (b) Latex printing inks, until 3 December 2020; (c) Plasma nano-coatings, until 3 December 2020. |
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