EU - Amendment on Annex I to POP Regulation Recast

​Regulation (EU) 2019/1021 (POP Regulation recast) implements the commitments of the European Union under the Stockholm Convention on Persistent Organic Pollutants and under the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants.

The European Commission was informed of the presence of unintentional impurities of PFOA and its salt above the limit of 0,025 mg/kg (0,0000025% by weight) laid down in the Delegated Regulation (EU) 2020/784 in some medical devices other than implantable devices and invasive devices.

In order to avoid the prohibition of manufacturing of such medical devices after December 3, 2020, and in order to give manufacturers enough time to reduce the level of the impurities, an Unintentional Trace Contaminant (UTC) limit of 2 mg/kg (0,0002% by weight) is now set for PFOA, its salts and PFOA-related compounds, subject to review.

Therefore, a new point (point 10) is added in the fourth column of the entry as follows:

10. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA and its salt and/or PFOA-related compounds equal to or above 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 February 22, 2023.

There are two more minor amendments made in the fourth column of the PFOA entry:

1. deleted "the reference to 400 kilograys" in point 4 as the Commission was informed that it is too specific for the operators to comply with and for the authorities to check compliance
   
2. added the word "perfluoro" before "carbon chain" in point 3 for sake of clarity.