Commission Delegated Regulation (EU) 2021/115 of 27 November 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (Text with EEA relevance)

What Commission Delegated Regulation (EU) 2021/115 of 27 November 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (Text with EEA relevance) requires

Commission Delegated Regulation (EU) 2021/115, adopted on 27 November 2020 and published in the Official Journal of the European Union on 2 February 2021 (L 36/7), amends Annex I to Regulation (EU) 2019/1021 on persistent organic pollutants. The amendment specifically modifies the fourth column ('Specific exemption on intermediate use or other specification') of the entry for perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Part A of Annex I. The regulation addresses three key changes: first, it introduces an Unintentional Trace Contaminant (UTC) limit of 2 mg/kg (0,0002 % by weight) for PFOA, its salts and/or PFOA-related compounds present in medical devices other than invasive devices and implantable devices, subject to a Commission review no later than 22 February 2023; second, it removes the reference to the 400 kilograys threshold for ionising irradiation in the production of PTFE micropowders, setting a UTC limit of 1 mg/kg (0,0001 % by weight) for PFOA and its salts in PTFE micropowders produced by ionising irradiation or by thermal degradation; and third, it clarifies that the UTC limit for PFOA-related compounds used as transported isolated intermediates applies to fluorochemicals with a 'perfluoro carbon chain equal to or shorter than 6 atoms'. This Regulation is binding in its entirety and directly applicable in all Member States, entering into force on the twentieth day following its publication.

Pillar: Legal & IP Sovereignty · Authority: European Commission · Version: 1.0.0 · Last updated: 2021-02-02

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R0115

SHA-256 integrity: 804b8948e6b75703134dfcadeff403c63882a78f559ed27338d8c30f60207737

Primary Citations — 8 traced to source

• Recital (5): 'After the adoption of Delegated Regulation (EU) 2020/784, the Commission was informed of the presence of unintentional impurities of PFOA and its salts above the limit of 0,025 mg/kg (0,0000025 % by weight) laid down in that Regulation in some medical devices other than implantable devices and invasive devices.'
• Recital (6): 'In order to avoid the prohibition of manufacturing of such medical devices after 3 December 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) should be set for PFOA, its salts and PFOA-related compounds, subject to a review.'

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