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) limit values 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) that was regulated in the EU, and the UTC limit values were set a long time ago. Therefore, it is very unlikely that PFOS is still present in substances and mixtures at the level of the current UTC limit value (10 mg/kg). ECHA did a screening of the REACH registration dossiers and did not find any indication of PFOS being present as impurity in substances or mixtures.
Concerning the UTC limit value 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 for PFOS that is different from that for PFOA is needed.
Moreover, the terminology used to identify PFOS in the entry in column 1 of Part A of Annex I is different from the terminology used in the PFOA entry, 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 terminology of the substance identification for the entry of PFOS with the terminology used for PFOA;
·introducing a UTC limit value for PFOS and its salts of 0,025 mg/kg (in line with the one for PFOA);
·reducing the UTC limit value for PFOS-related compounds 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 the POPs competent authorities expert group in a meeting (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
Experts designated by Member States were consulted in a meeting of the relevant expert group on the draft delegated act and comments were taken into account. Relevant stakeholders, including the chemicals industry and the civil society, also took part in the discussions on the amendment of the listing of PFOS in Annex I to Regulation (EU) 2019/1021 in the ‘POPs CA meeting’ and comments were taken into account.
A public consultation was carried out for the draft act from 4 December 2023 to 1 January 2024. Three comments were received from EU citizens supporting the initiative. Two comments from stakeholders underlined the possible difficulties in measuring very low levels of PFOS in specific products and waste. Two comments referred to the possible presence of PFOS in fire-fighting foams, as an impurity or deriving from contamination of fire-fighting equipment that contained PFOS-based fire-fighting foams. One of the two comments suggested introducing a transitional period for the new UTC limit value for PFOS aligned with the one foreseen for the ban of PFOA, its salts and PFOA related compounds in fire-fighting foams, that applies as from 5 July 2025. The Commission has proposed extending this deadline for the phase-out of PFOA in fire-fighting foam to 3 December 2025. As both groups of substances are probably present in the same legacy fire-fighting foams, the Commission decided to delay the application of the new UTC limit value for PFOS to 3 December 2025.
3.LEGAL ELEMENTS OF THE DELEGATED ACT