In September 2020, the European Commission has proposed Commission Delegated Regulation (EU) to amend Annex I to Persistent Organic Pollutants Regulation (EU) 2019/1021 as regards the entry of

perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. The specific exemption of PFOA shall be amended as following:

1. In point 3, “perfluoro” shall be added before carbon chain.
2. In point 4, the limit of ionizing irradiation 400 kilograys shall be removed.
3. Point 10 shall be newly added as following:
   For the purposes of this entry, exemption from the control measures shall apply to concentrations of PFOA and its salts and/or PFOA-related compounds equal to or below 2 mg/kg (0.0002 % by weight) where they are present in medical devices other than invasive devices and implantable devices. This exemption shall be reviewed and assessed by the Commission no later than two years after these amendments enter into force.

Note:

Annex I: Substances prohibited to be used for manufacturing, placing on the market and use.

Details of requirements on PFOA, its salts and PFOA-related compounds in EU POPs Regulation please refer to previous Insight (link).