Persistent organic pollutants - annex I amendment | Consultation Period 01 September 2020 - 29 September 2020

Article 1 of Regulation (EU) 2019/1021 establishes as the objective of that Regulation to protect human health and the environment from Persistent Organic Pollutants (‘POPs’) by prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the market and use of substances subject to the Stockholm Convention on POPs.

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds have been listed in Annex I to Regulation (EU) 2019/1021 with Commission Delegated Regulation (EU) 2020/784. At the time of the adoption of this act, the medical devices industry informed the Commission that some of the articles they manufacture (including some critical to treat patients) contain PFOA and its salts above the limit of 25 ppb (0,025 mg/kg, 0,0000025 % by weight) set in the Commission delegated act

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