Testing Requirements

Previous Restriction

Modified Content

Limit

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 perfluoro carbon chain equal to or shorter than 6 atoms (subject to conditions in REACH Regulation);
4. ≤ 1 mg/kg (0.0001%) of PFOA and its salts 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, and provided that all emissions of PFOA during the manufacture and use of PTFE micropowders shall be avoided and, if not possible, reduced as far as possible;
5. ≤ 2 mg/kg (0.0002%) of PFOA and its salts and/or PFOA-related compounds in medical devices other than invasive devices and implantable devices.

Modified Point (4) to be:
4. ≤ 1 mg/kg (0.0001%) of PFOA and its salts 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, and provided that 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%) 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%).

Exemption

1. (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. Use 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, subject to specific conditions, until 4 July 2025;

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

4. Use of articles already in use in the Union before 4 July 2020;

5. (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.