Version · POPs Regulation
Version in force
Made by Regulation (EU) 2023/866 32023R0866 on EUR-Lex (external, EUR-Lex)
Version 8 of 15 recorded for POPs Regulation.
First seen by emendrix on , when it first read this version; that is not a legal date.
1 change in this version
Consolidated versions 02019R1021-20230610 → 02019R1021-20230818. v1 is the previous version, v2 this one.
What changed
Annex I, Modified§
dates added to the text: 2023-08-18, 2023-08-25 · dates removed: 2022-07-05
Explanation, written by a model and checked against the cited text
In the PFOA entry, point 3's review-and-assessment deadline for the transported isolated intermediate exemption was changed from 5 July 2022 to 25 August 2023.
Point 4 was rewritten: the reference to Article 4(1), point (b) is now expressed differently, an end date of 18 August 2023 was added for the PTFE micropowder use, the previous 5 July 2022 review deadline sentence was removed, and a new final sentence was added limiting the 1 mg/kg threshold to manufacture, placing on the market and use of PFOA and its salts present in PTFE micropowders transported or treated to reduce PFOA concentration below 0,025 mg/kg.
In point 5, the punctuation after subpoint (d) was changed from a semicolon to a full stop.
Cited: Annex I, v1 (external, EUR-Lex) · Annex I, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Each CAS and EC number in these tables links to its own page, which lists every entry that prints it across the acts this record holds.
0 entries added, 1 amended, 0 removed.
1 entry amended
| Identifiers | Version | Substance | CAS No | EC No | Specific exemption on intermediate use or other specification |
|---|---|---|---|---|---|
| Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9 | Before | 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) perfluorooctane sulfonic acid and its derivatives (PFOS), 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 |
| After | 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) perfluorooctane sulfonic acid and its derivatives (PFOS), 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). 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 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. 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. |
Text from EUR-Lex, before and after
Previous version, in force 10 June 2023 02019R1021-20230610 → this version, in force 18 August 2023 02019R1021-20230818
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 … 2,925 unchanged words … 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 5.7.2022. 25 August 2023.
4. For the purposes of this entry, Article 4(1), point (b) of Article 4(1) (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. 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. This exemption The limit of 1 mg/kg (0,0001 % by weight) shall be reviewed apply only to manufacture, placing on the market and assessed 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 the Commission no later than 5.7.2022. weight).
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; 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 … 325 unchanged words … and implantable devices. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.
Dicofol 115-32-2 204-082-0 None
Part B
Substances listed only in the Protocol
Substance CAS No EC No Specific exemption on intermediate use or other specification
The full entry is committed at eu/32019R1021/CHANGELOG.md.