RAC and SEAC are considering other restriction options than a ban for certain industrial applications of PFAS
ECHA and authorities from Denmark, Germany, the Netherlands, Norway and Sweden have published a progress update on the ongoing process to restrict PFAS under the REACH Regulation. As of now, the Risk Assessment Committee (RAC) has reached a provisional conclusion on the hazard assessment of PFAS. Given the wide scope of the restriction, the RAC and the Socio-Economic Analysis (SEAC) have taken a sector-based approach to assess the risks and socio-economic impacts of the restriction. The two Committees have so far reached provisional conclusions on five sectors: consumer mixtures and miscellaneous consumer articles, cosmetics, ski wax, metal plating and manufacture of metal products and petroleum and mining. Discussions on at least six more sectors are planned in 2024 and 2025 and new uses have been identified based on consultation inputs (sealing applications, technical textiles, printing applications and other medical applications, such as packaging and excipients for pharmaceuticals).
According to the progress note, following the consultation, Committees are considering whether restriction options other than a ban could achieve the aim to significantly reduce the PFAS emissions throughout their life cycle, in particular for sectors where the socio-economic impacts may be disproportionate. Such options could be setting conditions for the continued manufacture, placing on the market and uses of PFAS until suitable alternatives are available. Sectors where such options are considered are batteries, fuel cells, and electrolysers, and they could be considered for other sectors, such as medical devices, semiconductors and fluoropolymers.
Commission proposes ban on pesticide active substances degrading into TFA
The Commission has issued a draft implementing regulation for the non-renewal of the active substance flufenacet under the Plant Protection Products Regulation. Flufenacet is widely used in Europe as active substance in herbicides for cereal crops. In its scientific opinion published in September 2024, EFSA concluded that the active substance meets the criteria to be identified as an endocrine disruptor and identified very high potential for groundwater contamination by trifluoroacetic acid (TFA). The active substance had been identified as forming TFA in large quantities by the UBA since 2017 and was considered the most important plant protection product for TFA inputs into the environment in Germany. The implementing regulation will be discussed at the Member States Committee early December and could be adopted at its next meeting, in the first half of 2025.
The Commission has also issued an implementing regulation for the non-renewal of the active substance flutolanil. The active substance is used as fungicide for potato or flower growing. In its scientific opinion published in June 2023, EFSA identified significant data gaps preventing the finalisation of the risk assessment for consumers, specifically regarding metabolites, including TFA occurrence. Based on its structure (C-CF3 group) the substance is however suspected to degrade into TFA. In addition, EFSA identified other risks for workers, aquatic invertebrates, mammals and bees, justifying the non-renewal of the active substance.
ECHA updated guidance on applying the CLP Regulation with new hazard classes
ECHA has updated the guidance on the application of the CLP Regulation criteria with information related to the new hazard classes. The guidance gathers available reliable information to conclude on each property (e.g. P, vP, M, vM), information on the application of a weight of evidence to conclude on classification and labelling, provisions on dealing with multiple studies for the same property, and information on mixture classification. The guidance also contains specific considerations on pesticides and biocides (such as additional test methods or approaches), and other issues like outliers, treatment of values very close to regulatory thresholds, use of (Q)SARs, monitoring data or modelling, and updated information on rulings of the European Court of Justice. During the webinar presenting the guidance, ECHA recalled that the guidance is an iterative process, and that it could be updated in future years, once additional experience has been built with classification of substances under new hazard classes.
Denmark publishes national PFAS ban in textiles
Denmark has notified the EU about its national ban on PFAS in textile products and footwear on 27 November. The Danish government had announced in April its intention to propose such a ban, ahead of the EU PFAS restriction. From 1 July 2026 and until the EU PFAS restriction comes into effect, Danish companies will not be allowed to import or sell clothing, footwear and waterproofing agents for clothing and footwear containing PFAS in concentrations greater than 50 mg F/kg. The ban does not apply to other textiles, such as home textiles, and accessories. The ban also specifically exempts personal protective equipment where PFAS content constitutes a safety function, medical devices and reused or recycled items. The Danish government estimates that the temporary national ban will ‘limit emissions of PFAS to the environment in Denmark in the range of 200-300 tonnes per year, which corresponds to approximately 35-50% of the estimated total emissions from the production and marketing of products’.
European Parliament’s rapporteur proposes the inclusion of data on substances in articles and alternatives in common data platform
The ENVI Committee’s rapporteur presented the draft report on the Commission proposal for a Regulation establishing a common data platform on chemicals on 25 November. The draft report proposes to integrate, as part of the common data platform, a new database containing information on substances in articles and their alternatives, generated or submitted as part of the implementation of EU legislation. The rapporteur also proposes to include data generated under the Ecodesign for Sustainable Products Regulation (ESPR) and made available through the ESPR web portal (containing data included in digital product passports) in the scope of the common data platform to improve data availability on substances in products and alternatives.
Ban on PFOA in firefighting foams delayed until end of 2025
The POP Regulation provides an exemption for the use of PFOA, its salts and PFOA-related compounds in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, which is set to expire on 4 July 2025. Following communications with authorities and stakeholders that many operators have difficulties to respect this deadline, based difficulties in measuring PFOA-related compounds in the foams and underestimation of the volumes of foams containing PFOA, the Commission proposes to amend the POPs Regulation to extend the deadline until 3 December 2025, the latest possible date according to the Stockholm Convention.
European Parliament adopted decision to enter trilogues on water legislation
On 4 December, the ENVI Committee voted in favour of entering interinstitutional discussions with the Commission and the Council on the revision of the Water Framework Directive, Groundwater Directive and Environment Quality Standards Directive, final step of the legislative procedure before the adoption of the text. The Parliament had adopted its position in September 2023 and the Council in June 2024.
More information of upcoming actions related to persistent and mobile substances
For more information of regulations under the regulatory watch, as well as a Gantt Chart of the roll out, continuously updated spreadsheet and more information, please visit https://zeropm.eu/regulatory-watch/