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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