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CAS number

CAS 335-67-1 perfluorooctanoic acid

CAS 335-67-1 · EC 206-397-9 · Index No 607-704-00-2

Where CAS 335-67-1 appears: every table entry that prints it among its identifiers, in the newest version of each act this record holds, and every recorded change to those entries. Many entries name a group of substances and print no number, so absence here is not absence from the law. Not legal advice.

Where it appears now

CLP Annex VI section 3, Index No 607-704-00-2

Last changed in the version detected · Annex VI on this site

Annex VI section 3, table 1
Index NoChemical nameEC NoCAS NoClassificationLabellingSpecific Conc. Limits, M-factors and ATEs Notes
Hazard Class and Category Code(s)Hazard statement Code(s)Pictogram, Signal Word Code(s)Hazard statement Code(s)Suppl. Hazard statement Code(s)
607-704-00-2perfluorooctanoic acid206-397-9335-67-1Carc. 2 Repr. 1B Lact. Acute Tox. 4 Acute Tox. 4 STOT RE 1 Eye Dam. 1H351 H360D H362 H332 H302 H372 (liver) H318GHS08 GHS07 GHS05 DgrH351 H360D H362 H332 H302 H372 (liver) H318

CLP Annex VI section 3, table 2, Index No 607-704-00-2

Last changed in the version detected · Annex VI on this site

Annex VI section 3, table 2
Index NoInternational Chemical IdentificationEC NoCAS NoClassificationLabellingConcentration LimitsNotes
607-704-00-2perfluorooctanoic acid206-397-9335-67-1Carc. Cat. 3; R40 Repr. Cat. 2; R61 R64 T; R48/23 Xn; R20/22-48/21/22 Xi; R41T R: 61-20/22-40-41-48/23-48/21/22-64 S: 45-53

Cosmetics Regulation Annex II, Reference number 1561

Last changed in the version in force , by Regulation (EU) 2019/831 and 5 others, the acts that change names · Annex II on this site

Annex II, table 1
Reference numberSubstance identification
Chemical name/INNCAS numberEC number
abcd
1561Perfluorooctanoic acid335-67-1206-397-9

PIC Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Last changed in the version in force , by Regulation (EU) 2023/1656, the act that change names · Annex I on this site

Annex I, table 1
ChemicalCAS NoEC NoCN code Subcategory Use limitation Countries for which no notification is required
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds 335-67-1 and others206-397-9 and othersex29159070i(1)-i(2)sr-b

PIC Regulation Annex I, table 2, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Last changed in the version in force , by Regulation (EU) 2022/643, the act that change names · Annex I on this site

Annex I, table 2
ChemicalCAS NoEC NoCN code Category Use limitation
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1 and others206-397-9 and others29159070 and othersisr

PIC Regulation Annex I, table 3, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Last changed in the version in force , by Regulation (EU) 2023/1656, the act that change names · Annex I on this site

Annex I, table 3
ChemicalRelevant CAS number(s)HS code Pure substance HS code Mixtures containing substance Category
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1 and others2915.90 and othersIndustrial

PIC Regulation Annex V, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Last changed in the version in force , by Regulation (EU) 2022/643, the act that change names · Annex V on this site

Annex V, table 1
Description of chemicals/article(s) subject to export banAdditional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)
The export ban only applies to fire-fighting foam that contains or may contain PFOA, its salts and PFOA-related compounds.Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsEC No 206-397-9 and others CAS No 335-67-1 and others CN codes ex29159070 and others

POPs Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Last changed in the version in force , by Regulation (EU) 2025/843 and 2 others, the acts that change names · Annex I on this site

Annex I, table 1
SubstanceCAS NoEC NoSpecific exemption on intermediate use or other specification
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 (PFOS), its salts and PFOS-related compounds as listed in this Annex.335-67-1 and others206-397-9 and others1. 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 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.

POPs Regulation Annex IV, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Last changed in the version in force , by Regulation (EU) 2025/2457, the act that change names · Annex IV on this site

Annex IV, table 1
SubstanceCAS NoEC NoConcentration limit referred to in Article 7(4)(a)
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I335-67-1 and others206-397-9 and others1 mg/kg (PFOA and its salts), 40 mg/kg (sum of PFOA-related compounds) By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.

REACH Annex XVII, Entry 68

Last changed in the version in force , by Regulation (EU) 2017/999 and Regulation (EU) 2017/1000, the acts that change names · Annex XVII on this site

Annex XVII, table 1
Column 1 Designation of the substance, of the group of substances or of the mixtureColumn 2 Conditions of restriction
68. Perfluorooctanoic acid (PFOA) CAS No 335-67-1 EC No 206-397-9 and its salts. Any related substance (including its salts and polymers) having a linear or branched perfluoroheptyl group with the formula C7F15- directly attached to another carbon atom, as one of the structural elements. Any related substance (including its salts and polymers) having a linear or branched perfluorooctyl group with the formula C8F17- as one of the structural elements. The following substances are excluded from this designation: C8F17-X, where X = F, Cl, Br. C8F17-C(=O)OH, C8F17-C(=O)O-X′ or C8F17-CF2-X′ (where X′ = any group, including salts).1. Shall not be manufactured, or placed on the market as substances on their own from 4 July 2020. 2. Shall not, from 4 July 2020, be used in the production of, or placed on the market in: (a) another substance, as a constituent; (b) a mixture; (c) an article, in a concentration equal to or above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances. 3. Points 1 and 2 shall apply from: (a) 4 July 2022 to: (i) equipment used to manufacture semi-conductors; (ii) latex printing inks. (b) 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) 4 July 2032 to medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. 4. Points 1 and 2 shall not apply to any of the following: (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. 5. Point 2(b) shall not apply to fire-fighting foam mixtures which were: (a) placed on the market before 4 July 2020; or (b) produced in accordance with point 4(e), provided that, where they are used for training purposes, emissions to the environment are minimised and effluents collected are safely disposed of. 6. Point 2(c) shall not apply to: (a) articles placed on the market before 4 July 2020; (b) implantable medical devices produced in accordance with point 4(d)(i); (c) articles coated with the photographic coatings referred to in point 4(d)(ii); (d) semiconductors or compound semiconductors referred to in point 4(d)(iii).

REACH Annex XVII appendix 6, Index No 607-704-00-2

Last changed in the version in force , by Regulation (EU) No 317/2014, the act that change names · Annex XVII on this site

Annex XVII appendix 6, table 1
SubstancesIndex NoEC NoCAS NoNotes
Perfluorooctanoic acid607-704-00-2206-397-9335-67-1

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Its history

· added · CLP Annex VI section 3, Index No 607-704-00-2

Recorded in the version detected . The change on its version page

Added entries, Annex VI section 3, table 1
IdentifiersIndex NoInternational Chemical IdentificationEC NoCAS NoClassificationLabellingSpecific Conc. Limits, M-factorsNotes
Hazard Class and Category Code(s)Hazard statement Code(s)Pictogram, Signal Word Code(s)Hazard statement Code(s)Suppl. Hazard statement Code(s)
Index No 607-704-00-2CAS 335-67-1EC 206-397-9607-704-00-2perfluorooctanoic acid206-397-9335-67-1Carc. 2H351GHS08H351
Repr. 1BH360DGHS07H360D
Lact.H362GHS05H362
Acute Tox. 4H332DgrH332
Acute Tox. 4H302H302
STOT RE 1H372 (liver)H372 (liver)
Eye Dam. 1H318H318

· added · CLP Annex VI section 3, table 2, Index No 607-704-00-2

Recorded in the version detected . The change on its version page

Added entries, Annex VI section 3, table 2
IdentifiersIndex NoInternational Chemical IdentificationEC NoCAS NoClassificationLabellingConcentration LimitsNotes
Index No 607-704-00-2CAS 335-67-1EC 206-397-9607-704-00-2perfluorooctanoic acid206-397-9335-67-1Carc. Cat. 3; R40 Repr. Cat. 2; R61 R64 T; R48/23 Xn; R20/22-48/21/22 Xi; R41T R: 61-20/22-40-41-48/23-48/21/22-64 S: 45-53

· amended · POPs Regulation Annex IV, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2025/2457, the act that change names. The change on its version page

Amended entries, Annex IV, table 1
IdentifiersVersionSubstanceCAS NoEC NoConcentration limit referred to in Article 7(4)(a)
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex ICAS 335-67-1EC 206-397-9BeforePerfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I335-67-1 and others206-397-9 and others1 mg/kg (PFOA and its salts), 40 mg/kg (sum of PFOA-related compounds) The Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal to lower that value, where such lowering is feasible in accordance with scientific and technical progress, no later than 30 December 2027.
AfterPerfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I335-67-1 and others206-397-9 and others1 mg/kg (PFOA and its salts), 40 mg/kg (sum of PFOA-related compounds) By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.

· amended · POPs Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2025/843 and 2 others, the acts that change names. The change on its version page

Amended entries, Annex I, table 1
IdentifiersVersionSubstanceCAS NoEC NoSpecific exemption on intermediate use or other specification
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9BeforePerfluorooctanoic 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 others206-397-9 and others1. 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.
AfterPerfluorooctanoic 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 (PFOS), its salts and PFOS-related compounds as listed in this Annex.335-67-1 and others206-397-9 and others1. 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 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.

· amended · PIC Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2023/1656, the act that change names. The change on its version page

Amended entries, Annex I, table 1
IdentifiersVersionChemicalCAS NoEC NoCN code Subcategory Use limitation Countries for which no notification is required
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9BeforePerfluorooctanoic acid (PFOA), its salts and PFOA-related compounds 335-67-1 and others206-397-9 and othersex29159070 and othersi(1)-i(2)sr-b
AfterPerfluorooctanoic acid (PFOA), its salts and PFOA-related compounds 335-67-1 and others206-397-9 and othersex29159070i(1)-i(2)sr-b

· added · PIC Regulation Annex I, table 3, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2023/1656, the act that change names. The change on its version page

Added entries, Annex I, table 3
IdentifiersChemicalRelevant CAS number(s)HS code Pure substance HS code Mixtures containing substance Category
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1 and others2915.90 and othersIndustrial

· amended · POPs Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2023/866, the act that change names. The change on its version page

Amended entries, Annex I, table 1
IdentifiersVersionSubstanceCAS NoEC NoSpecific exemption on intermediate use or other specification
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9BeforePerfluorooctanoic 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 others206-397-9 and others1. 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 5.7.2022. 4. For the purposes of this entry, point (b) of Article 4(1) 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. 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 shall be reviewed and assessed by the Commission no later than 5.7.2022. 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.
AfterPerfluorooctanoic 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 others206-397-9 and others1. 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.

· added · POPs Regulation Annex IV, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2022/2400, the act that change names. The change on its version page

Added entries, Annex IV, table 1
IdentifiersSubstanceCAS NoEC NoConcentration limit referred to in Article 7(4)(a)
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex ICAS 335-67-1EC 206-397-9Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I335-67-1 and others206-397-9 and others1 mg/kg (PFOA and its salts), 40 mg/kg (sum of PFOA-related compounds) The Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal to lower that value, where such lowering is feasible in accordance with scientific and technical progress, no later than 30 December 2027.

· added · PIC Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2022/643, the act that change names. The change on its version page

Added entries, Annex I, table 1
IdentifiersChemicalCAS NoEC NoCN code Subcategory Use limitation Countries for which no notification is required
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds 335-67-1 and others206-397-9 and othersex29159070 and othersi(1)-i(2)sr-b

· added · PIC Regulation Annex I, table 2, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2022/643, the act that change names. The change on its version page

Added entries, Annex I, table 2
IdentifiersChemicalCAS NoEC NoCN code Category Use limitation
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1 and others206-397-9 and others29159070 and othersisr

· added · PIC Regulation Annex V, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2022/643, the act that change names. The change on its version page

Added entries, Annex V, table 1
IdentifiersDescription of chemicals/article(s) subject to export banAdditional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9The export ban only applies to fire-fighting foam that contains or may contain PFOA, its salts and PFOA-related compounds.Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsEC No 206-397-9 and others CAS No 335-67-1 and others CN codes ex29159070 and others

· amended · POPs Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2021/115, the act that change names. The change on its version page

Amended entries, Annex I, table 1
IdentifiersVersionSubstanceCAS NoEC NoSpecific exemption on intermediate use or other specification
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9BeforePerfluorooctanoic 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 others206-397-9 and others1. 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 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. 4. For the purposes of this entry, point (b) of Article 4(1) 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 of up to 400 kilograys or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders. 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 shall be reviewed and assessed by the Commission no later than 5.7.2022. 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.
AfterPerfluorooctanoic 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 others206-397-9 and others1. 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 5.7.2022. 4. For the purposes of this entry, point (b) of Article 4(1) 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. 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 shall be reviewed and assessed by the Commission no later than 5.7.2022. 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.

· added · POPs Regulation Annex I, the entry for Perfluorooctanoic acid (PFOA), its salts and PFOA-related…

Recorded in the version in force , by Regulation (EU) 2020/784, the act that change names. The change on its version page

Added entries, Annex I, table 1
IdentifiersSubstanceCAS NoEC NoSpecific exemption on intermediate use or other specification
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compoundsCAS 335-67-1EC 206-397-9Perfluorooctanoic 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 others206-397-9 and others1. 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 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. 4. For the purposes of this entry, point (b) of Article 4(1) 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 of up to 400 kilograys or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders. 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 shall be reviewed and assessed by the Commission no later than 5.7.2022. 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.

· amended · CLP Annex VI section 3, Index No 607-704-00-2

Recorded in the version in force , by Regulation (EU) 2018/669 and 2 others, the acts that change names. The change on its version page

Amended entries, Annex VI section 3, table 1
IdentifiersVersionIndex NoChemical nameEC NoCAS NoClassificationLabellingSpecific Conc. Limits, M-factorsNotes
Hazard Class and Category Code(s)Hazard statement Code(s)Pictogram, Signal Word Code(s)Hazard statement Code(s)Suppl. Hazard statement Code(s)
Index No 607-704-00-2CAS 335-67-1EC 206-397-9Before607-704-00-2perfluorooctanoic acid206-397-9335-67-1Carc. 2H351GHS08H351
Repr. 1BH360DGHS07H360D
Lact.H362GHS05H362
Acute Tox. 4H332DgrH332
Acute Tox. 4H302H302
STOT RE 1H372 (liver)H372 (liver)
Eye Dam. 1H318H318
After607-704-00-2perfluorooctanoic acid206-397-9335-67-1Carc. 2Repr. 1B Lact. Acute Tox. 4 Acute Tox. 4 STOT RE 1 Eye Dam. 1H351H360D H362 H332 H302 H372 (liver) H318GHS08GHS07 GHS05 DgrH351H360D H362 H332 H302 H372 (liver) H318

· added · Cosmetics Regulation Annex II, Reference number 1561

Recorded in the version in force , by Regulation (EU) 2019/831 and 5 others, the acts that change names. The change on its version page

Added entries, Annex II, table 1
IdentifiersReference numberSubstance identification
Chemical name/INNCAS numberEC number
abcd
Reference number 1561CAS 335-67-1EC 206-397-91561Perfluorooctanoic acid335-67-1206-397-9

· added · REACH Annex XVII, Entry 68

Recorded in the version in force , by Regulation (EU) 2017/999 and Regulation (EU) 2017/1000, the acts that change names. The change on its version page

Added entries, Annex XVII, table 1
IdentifiersColumn 1 Designation of the substance, of the group of substances or of the mixtureColumn 2 Conditions of restriction
Entry 68CAS 335-67-1EC 206-397-968. Perfluorooctanoic acid (PFOA) CAS No 335-67-1 EC No 206-397-9 and its salts. Any related substance (including its salts and polymers) having a linear or branched perfluoroheptyl group with the formula C7F15- directly attached to another carbon atom, as one of the structural elements. Any related substance (including its salts and polymers) having a linear or branched perfluorooctyl group with the formula C8F17- as one of the structural elements. The following substances are excluded from this designation: C8F17-X, where X = F, Cl, Br. C8F17-C(=O)OH, C8F17-C(=O)O-X′ or C8F17-CF2-X′ (where X′ = any group, including salts).1. Shall not be manufactured, or placed on the market as substances on their own from 4 July 2020. 2. Shall not, from 4 July 2020, be used in the production of, or placed on the market in: (a) another substance, as a constituent; (b) a mixture; (c) an article, in a concentration equal to or above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances. 3. Points 1 and 2 shall apply from: (a) 4 July 2022 to: (i) equipment used to manufacture semi-conductors; (ii) latex printing inks. (b) 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) 4 July 2032 to medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. 4. Points 1 and 2 shall not apply to any of the following: (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. 5. Point 2(b) shall not apply to fire-fighting foam mixtures which were: (a) placed on the market before 4 July 2020; or (b) produced in accordance with point 4(e), provided that, where they are used for training purposes, emissions to the environment are minimised and effluents collected are safely disposed of. 6. Point 2(c) shall not apply to: (a) articles placed on the market before 4 July 2020; (b) implantable medical devices produced in accordance with point 4(d)(i); (c) articles coated with the photographic coatings referred to in point 4(d)(ii); (d) semiconductors or compound semiconductors referred to in point 4(d)(iii).

· added · REACH Annex XVII appendix 6, Index No 607-704-00-2

Recorded in the version in force , by Regulation (EU) No 317/2014, the act that change names. The change on its version page

Added entries, Annex XVII appendix 6, table 1
IdentifiersSubstancesIndex NoEC NoCAS NoNotes
Index No 607-704-00-2CAS 335-67-1EC 206-397-9Perfluorooctanoic acid607-704-00-2206-397-9335-67-1

Sources