At the beginning of July last year, a number of amendments came into force under the REACH legislation and the POPs Regulation (read more).
It is now announced that a very important exception is foreseen for medical devices, which will allow certain companies to continue to use these components up to a certain level. But for medical devices only!
Article 4(1)(b) of Annex I to the Regulation (EU) 2019/1021 applies to concentrations of PFOA and its salts and/or related compounds not exceeding 2 mg/kg (0.0002 % by mass) when present in medical devices other than invasive devices and implantable devices.
Perfluorooctanoic acid (PFOA), its salts and related compounds were included in Annex I to Regulation (EU) 2019/1021 by Commission Delegated Regulation (EU) 2020/784. At the time of adoption of this act, the medical devices industry had informed the Commission that some of the articles they manufacture (including some critical items for the treatment of patients) contained PFOA and its salts above the 25 ppb (0.025 mg/kg, 0.0000025 % by mass) limit set in the Commission delegated act. This is not the result of an intentional use of PFOA in the production of the articles, but is most likely related to the presence of PFOA impurities in the short-chain PFAS alternatives used to manufacture the medical devices.
These medical devices are non-implantable and non-invasive and since they do not qualify for an exemption, they should not be manufactured after 3 December 2020. In order to ensure that these medical devices can continue to be manufactured, the Commission proposes to amend the entry for PFOA, its salts and related compounds in Annex I to Regulation (EU) 2019/1021 by introducing an unintentional trace contaminant (UTC) limit of 2 ppm (2 mg/kg, 0.0002 % by mass) for medical devices other than implantable devices and invasive devices, to be reviewed after two years.