EU Approved Restrictions on PFOA and Related Compounds under Persistent Organic Pollutants (POPs) Regulation

On 15 June 2020, the European Commission has published Delegated Regulation (EU) 2020/784 to amend Annex I to Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs), adding an entry to restrict perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. The regulation shall apply from 4 July 2020.

According to the introduction of Regulation (EU) 2020/784, the new restrictions will replace the ones in Annex XVII of REACH Regulation (EC) No 1907/2006.

The PFOA restrictions under Regulation (EU) 2020/784 are:

a. Concentrations of PFOA or any of its salts present in substances, mixtures or articles shall not be greater than 0.025 mg/kg (0.0000025%);

b. Concentrations of any individual or a combination of PFOA-related compounds present in substances, mixtures or articles shall not be greater than 1 mg/kg (0.0001%);

c. Concentrations of PFOA-related compounds in 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, shall not be greater than 20 mg/kg (0.002%);

d. Concentrations 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, shall not be greater than 1 mg/kg (0.0001%).

The derogations and exemptions to the restrictions are modified from the ones in REACH Regulation. Exemptions include:

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 polyinylidene 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);

f. 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);

g. Use of perfluooroctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products;

h. Articles already in use in the Union before 4 July 2020 containing PFOA, its salts and/or PFOA-related compounds;

i. Medical devices other than implantable ones within the scope of Regulation (EU) 2017/745 (until 3 December 2020);

j. Latex printing inks (until 3 December 2020);

k. Plasma nano-coatings (until 3 December 2020).

Note:

1. “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.

2. 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 perfluorophosphonic acids (including their salts, esters, halides and anhydrides) with ≥ 9 perfluorinated carbons;

v) Perfluorooctane sulfonic acid and its derivatives (PFOS), as listed in Annex I of the POPs Regulation.