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The European Union (EU) has amended Part A of Annex I in Regulation (EU) 2019/1021 on persistent organic pollutants (POP Recast) with the addition of perfluorooctanoic acid (PFOA) chemicals.

The restrictions include PFOA substances, including its branched isomers, its salts and PFOA-related compounds. This latter group are substances that degrade to PFOA and includes substances that have a linear or branched perfluoroheptyl group ((C7H15)C) as one of the structural elements.

The amending regulation – Regulation (EU) 2020/784 – includes the following requirements:

  • PFOA and any of its salts – no more than 0.025 mg/kg
  • PFOA-related compounds and a combination of PFOA-related compounds – no more than 1 mg/kg for each
  • PFOA-related compounds in substances to be used as a transported isolated intermediate for the manufacture of fluorochemicals with a carbon chain of no more than 6 atoms – no more than 20 mg/kg
  • PFOA and its salts in PTFE micropowders produced by specified techniques, as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders – no more than 1 mg/kg

Regulation (EU) 2020/784 includes ‘specific exemption on intermediate use or other specification’ and contains multiple derogations. These include allowing the use of:

1) Perfluorooctyl bromide containing perluorooctyl iodide in the manufacture of pharmaceutical products

2) Articles containing PFOA, its salts and PFOA-related compounds that are already in use before July 4, 2020

3) PFOA, its salts and/or PFOA-related compounds until:

  • December 3, 2020:

o Medical devices other than implantable ones

o Latex printing inks

o Plasma nano-coatings

  • July 4, 2023:

o Textiles for worker protection for dangerous liquids

o Manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for specific applications

  • July 4, 2025:

o Photolithography or etch processes in semiconductor manufacturing

o Photographic coatings applied to films

o Invasive and implantable medical devices

o Fire-fighting foams for Class B fires that are already installed in systems subject to certain conditions

The preamble to point 7 states that higher concentration limits should be established for applications that cannot meet the set values of 0.025 mg/kg for PFOA and its salts and 1 mg/kg for individual PFOA-related compounds or a combination of those compounds, which are subject to review by the Commission within two years with the aim of lowering the limits.

This latest POP recast amendment was published on June 15, 2020 and came into effect on July 4, 2020. This is the same date that restrictions on this group of substances would normally begin to apply under entry 68 to Annex XVII of REACH. Since PFOA, its salts and PFOA-related compounds are now regulated under POP recast, the European Commission is now planning to delete this entry.

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