POPs Regulation Amendment: Focus on PFOA
On April 28th 2023, the European Commission published an amendment regarding the limits to perfluorooctanoic acid (PFOA), its salts, and related compounds within the EU Regulation 2019/1021 - Persistent Organic Pollutants (POPs).
The amendment involves polytetrafluoroethylene (PTFE) micropowders, whereby the limit of 1 mg/kg (0.0001% by weight) can now be applied to the manufacturing and placing on the market stages when transported or processed in order to reduce the concentration of PFOA and its salts below the already present limit of 0.025 mg/kg (0.0000025% by weight).
PTFE, otherwise known as polytetrafluoroethylene or also by its trade name Teflon, is a polymer that is particularly used in numerous industries, with applications, for example, in food, medical devices, automotive and aerospace.
Among the uses closest to our everyday lives, it is applied in the kitchen as a nonstick coating for a variety of utensils-primarily frying pans and baking pans. This compound remains stable up to a temperature of 200°C, beyond which it undergoes a decomposition called pyrolysis.
Perfluorooctanoic acid (PFOA) can potentially be present as a contaminant of raw materials or as a potential degradation product if above a temperature of 250°C.
This compound is part of the larger PFAS (per- and poly-fluoroalkyl substances) family, which has been particularly targeted by the scientific community because it is linked to potential carcinogenicity, endocrine disruption and bioaccumulation characteristics.
With the April 28, 2023 amendment to the EU Regulation 2019/1021 dedicated to persistent organic pollutants (POPs) - to which PFASs are a part-of -, PTFE manufacturers will now be able to market their product for PFOA abatement purposes even with a higher limit than previously in force.
The changes affect Annex I, Part A, in the fourth column of the table in entry "Perfluorooctanoic acid (PFOA), its salts and related compounds.":
- Point 3 changes the date for review and evaluation by the Commission from July 05th 2022 to August 25th 2023 in relation to exemptions from control measures for a substance present as a non-intentional added substances (NIAS);
- In Point 4, the limit of 1 mg/kg (0.0001% by weight) of PFOA is introduced in relation to the manufacture and marketing of PTFE for the purpose of reducing the concentration of the same PFOA and its salts within the limit of 0.025 mg/kg (0.0000025% by weight);
- In Point 5, paragraph (e), which allowed until July 4th 2023 the use of PFOA, its salts and related compounds in the production of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:
- high-performance and corrosion-resistant gas filter membranes, water filter membranes, and medical tissue membranes;
- industrial waste heat exchange equipment;
- industrial sealants capable of preventing the release of volatile organic compounds and PM2 particulate matter;
In fact, the following scheme applies:
|
Limit |
Notes |
|
0.025 mg/kg |
Limit for PFOA and its salts within which they can be considered NIAS in products and articles |
|
1 mg/kg |
Limit for PFOA-related compounds or combinations of PFOA-related compounds within which they may be considered NIAS in products and articles |
|
20 mg/kg |
Limit for PFOA-related compounds within which they may be considered NIAS in intermediates isolated and transported in accordance with Article 3.15 for the purpose of production of fluorinated chemical compounds with a chain consisting of a number of perfluorocarbon atoms of 6 or less |
|
1 mg/kg |
Limit for PFOA and its salts, as an exception to the first mentioned limit, valid for PTFE when produced and marketed for the purpose of compliance with the 0.025mg/kg limit |
The new amendments will take effect on May 18th 2023, and will apply as of August 18th 2023. LabAnalysis laboratories are equipped with state-of-the-art equipment and are the best solution for PFAS monitoring required by European Regulations and international regulatory frameworks. The analysis is accredited on numerous matrices, including food contact materials and articles (FCM).
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