1.CONTEXT OF THE DELEGATED ACT
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. This is not due to an intentional use of PFOA in the production of the articles, but it is most probably linked 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 benefit from an exemption, their production would be prohibited after 3 December 2020. To allow the continuation of production of these medical devices, the Commission proposes to amend the entry on PFOA, its salts and PFOA-related compounds in Annex I to Regulation (EU) 2019/1021 by introducing an Unintentional Trace Contaminant (UTC) level of 2 ppm (2 mg/kg, 0,0002 % by weight) for medical devices other than implantable devices and invasive devices, subject to review after two years.
After the adoption of the delegated act, the Commission was also informed by some stakeholders that the conditions linked to the UTC for (polytetrafluoroethylene) PTFE micropowders were too specific when mentioning that the production process by ionising irradiation needs to take place with up to 400 kilograys. In addition, it is now considered impossible for enforcement authorities to determine if PTFE micropowders have been produced with irradiation up to 400 kilograys. For this reason, it is appropriate to delete the reference to 400 kilograys, while waiting for the on-going assessment of ECHA of this UTC.
In accordance with the second subparagraph of Article 15(1) of Regulation (EU) 2019/1021, a delegated act amending Annex I to Regulation (EU) 2019/1021 should be adopted to introduce these changes in the entry on PFOA.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
The draft amendment was consulted with an expert group (the 'POP CA meeting') on 9 June 2020 and comments were taken into account. The group is composed of all the relevant stakeholders - representatives of Member States, of the European Chemicals Agency, the chemicals industry and the civil society.
A public consultation was carried out for the draft act from [insert date] to [insert date] [summarise comments received and replies]
3.LEGAL ELEMENTS OF THE DELEGATED ACT
The delegated act modifies the existing entry for PFOA, its salts and PFOA-related compounds in Annex I to Regulation (EU) 2019/1021 in order to adapt it to scientific and technical progress. The legal basis for the proposed delegated act is Article 15(1) of Regulation (EU) 2019/1021.
COMMISSION DELEGATED REGULATION (EU) …/...
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants 1 , and in particular Article 15(1) thereof,