The manufacturing, placing on the market and use of substances whether on their own, in mixtures or in articles of substances listed on the Annex I of the EU POP regulation is prohibited. Exemptions can be included in Annex I.
On the 2nd of February a delegated act was published in the Official Journal amending the PFOA entry in Annex I of the EU POP regulation in relation to those exemptions. Three changes have been made: two changes concern some clarifications, one adds an exemption for the unintended presence of PFOA in some medical devices up to 2mg/kg. That exemption has to be reviewed within two years.
The amendments concern the following three elements:
- A clarification concerning the exemption for presence of PFOA when producing fluoropolymers: instead of stating that the exemption is for ‘for the production of fluorochemicals with a carbon chain equal to or shorter than 6 atoms’ it is now stated ‘for the production of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms’.
- An element is deleted as compliance was not feasible. It concerns the explicit reference to up to 400 kilograys when producing polytetrafluoroethylene (PTFE) micropowders by ionising irradiation.
- A new exemption has been added related to the presence of PFOA, its salts and/or PFOA-related compounds equal to or below 2 mg/kg (0,0002 % by weight) where they are present as Unintentional Trace Contaminant (UTC) in medical devices other than invasive devices and implantable devices. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.
The legal text (delegted text) can be consulted here.
The consolidated version of the EU POP regulation can be consulted here.
