EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
The objective of Regulation (EU) 2019/1021 is 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.
Perfluorooctane sulfonic acid and its derivatives (PFOS) is listed in Annex I to Regulation (EU) 2019/1021 (‘PFOS entry’). Following Article 4(1)(b) of Regulation (EU) 2019/1021, the PFOS entry in Annex I includes Unintentional Trace Contaminant (UTC) limits in substances, mixtures and articles in points 1 and 2 of the fourth column and a specific exemption for the use as mist suppressant for non-decorative hard-chromium plating in point 4. Following Article 15(1) of Regulation (EU) 2019/1021, the Commission can modify existing entries in order to adapt them to scientific and technical progress.
PFOS was the first per- and polyfluoroalkyl compound (PFAS) to be regulated in the EU, and the UTCs were set a long time ago. Therefore, it is very unlikely that it is still present in substances and mixtures at the level of the current UTC (10 mg/kg). ECHA did a screening of the REACH registrations dossier and did not find any indication of PFOS being present as impurity in substances and mixtures.
Concerning the UTC for articles, PFOS uses were very similar to those of PFOA, another PFAS listed in Annex I to Regulation 2019/1021 (for example, coating of textiles and leather, use in semiconductors, etc). There is no indication that a limit different from that for PFOA is needed.
Moreover, the way the PFOS entry is described in column 1 is different from the one of PFOA, as it says ‘PFOS and its derivatives’, while for PFOA it says ‘PFOA, its salts and PFOA-related compounds’. The intention is in both cases to cover the whole group of substances including PFOS/PFOA, their salts and the substances that degrade to PFOS and PFOA.
Finally, the PFOS entry, in its point 5, refers to the availability of analytical methods, while no other entry in the POPs Regulation specifies such details.
For these reasons, the following modifications should be made:
·aligning the wording of the substance identification for the entry of PFOS with the one for PFOA;
·introducing a UTC level for PFOS and its salts of 0,025 mg/kg (in line with the one for PFOA);
·reducing the UTC for PFOS-related substances in substances, mixtures and articles to 1 mg/kg (in line with the one for PFOA);
·deleting point 5.
Concerning the specific exemption for the use as mist suppressant for non-decorative hard-chromium plating, the Commission consulted an expert group (the 'POPs CA meeting') on 2 June 2022 and there was no objection to the proposal to delete this specific exemption, which indicates that it is no longer needed in the EU.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
The 'POPs CA meeting' was consulted on the draft delegated act on 24 November 2022, 14 June 2023 and 29 November 2023 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