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ZeroPM Regulatory Watch April 2026

RAC and SEAC support EU wide PFAS restriction with targeted derogations

ECHA published on 25 March the final opinion of the Risk Assessment Committee (RAC) and the draft opinion of the Socio-Economic Committee (SEAC) on the PFAS restriction. Both committees support an EU wide PFAS restriction, subject to derogations, on the manufacture, placing on the market and use of PFAS. The RAC opinion stated that all PFAS should be covered by the restriction and that there is no sufficient evidence to support the exclusion of certain sub-group of PFAS (e.g. fluoropolymers, fluorinated gases). The RAC also confirmed that there is no safe level of emissions. The committee considered that ‘a full ban of PFAS is an effective measure to minimise PFAS emissions […] and would result in a 96% reduction of emissions. In addition, the RAC recommended that additional risk managements measures are taken to minimise emissions in case derogation are adopted. The committee noted that the only derogation it could support is a derogation for personal protective equipment and associated impregnating agents to protect the health and safety of workers.

The draft SEAC opinion noted that ‘use-specific derogations where costs to society outweigh the benefits’ are necessary to ensure the proportionality of the restriction. For the eight new sectors listed in the revised background document but not included in the assessment, the committee recommended time-limited derogations for all uses until an evaluation of these sectors is performed. The SEAC also agreed that measures to minimise emissions in case of derogation should be adopted, although noting that the costs and benefits of these measures could be assessed because of information gaps.

The consultation on the draft SEAC opinion, opened until 25 May, invites stakeholders to provide information on the economic and social impacts of the PFAS restrictions on various sectors and on the availability and economic feasibility of alternatives. The consultation consists of a general survey and sector specific surveys for each of the sectors covered by the restriction. ECHA published in December a guidance document providing instructions to reply to the consultation.

Commission guidance on PPWR recommends stepwise approach methodology to comply with PFAS concentration limits in food contact materials

The Commission published on 30 March 2026 a guidance document on the Packaging and Packaging Waste Regulation (PPWR), accompanied by a Frequently Asked Questions document. Both documents aim to help businesses implement the Regulation and to support a harmonised approach of the national market surveillance authorities for the enforcement of the Regulation. The Regulation banned as of 12 August 2026 the placing on the market of food contact materials containing PFAS above maximum concentration limits. The Regulation introduced three concentration limits – 25 μg/kg for individual non-polymeric PFAS, 250 μg/kg for the sum of non-polymeric PFAS and 50 mg/kg for total (polymeric and non-polymeric) PFAS. The guidance document recognises that ‘there is no harmonised methodology for [testing the presence of] PFAS in food contact packaging at EU level’. To enforce the PFAS limits as of August 2026, the guidance recommends a stepwise approach, starting with total fluorine quantification, following which all samples where total fluorine is below 50 mg/kg would be considered compliant with the PPWR. The guidance recommends checking the two other concentration limits only as an additional step as, based on ‘evidence currently available’, samples compliant with the 50 mg/kg total fluorine concentration limit would also be compliant with the two other concentration limits set by the Regulation. Direct TOP (total oxidizable precursors) analysis is recommended to check compliance with the 25 μg/kg and 250 μg/kg concentration limits. In the meeting of the Technical Adaptation Committee on Waste, some Member States expressed concerns that the methodology proposed by the Commission is ‘not sufficient for regulatory compliance’ as the Regulation ‘includes three limit values that should be all checked’.

EFSA to update its opinion on the risk to human health of the presence of PFAS in food

In an answer to MEPs’ written question published on 26 March, Health Commissioner Várhelyi indicated that ‘EFSA will be asked to assess […] whether it would be necessary to update its opinion’ from 2020 on the risk to human health of the presence of PFOS, PFOA, PFNA and PFHxS in food. Data available to EFSA in 2020 were insufficient to conclude the risk assessment for other PFAS than these four. To close this data gap, the Commission Recommendation on the monitoring of PFAS in food from 2022 asked Member States to monitor a range of PFAS in various food products in 2022-2025 and to submit their monitoring data to EFSA by 30 June 2026. Based on these new data, the Commission will also discuss with Member States whether maximum levels of PFAS in food should be revised to cover more PFAS and/or more food products. Current EU legislation sets maximum levels of PFOS, PFOA, PFNA and PFHxS (and their sum) in meat, fish and eggs.

Updates on ongoing legislative procedures:

  • Revision of the EU water legislation formally adopted: The European Parliament formally adopted the act amending the Water Framework Directive, the Groundwater Directive and the Environmental Quality Standards Directive on 26 March 2026. The Council had adopted the act in February. It notably introduces surface and groundwater quality standards for PFAS. The Act was signed by the presidents of both institutions on 30 March and will soon be published in the Official Journal. Member States will then have until 21 December 2027 to transpose the Directive in their national law.
  • Agreement on pharmaceutical package published: The provisional agreement on the revision of the Directive on medicinal products for human use reached between the Parliament and the Council on 10 December 2025 was published on 6 March 2026. The agreement maintains the main provisions from the Commission proposal on environmental risk assessments of medicinal products, including the requirement that the ERA indicates whether a medicinal product contains an active substance that is a PBT, vPvB, PMT, vPvM, or endocrine disruptor. The ERA must also include risk mitigation measures to avoid o limit emissions to air, water and soil of pollutants listed in the Groundwater Directive, EQSD and IED. The incompleteness or low quality of the ERA remains a ground for refusing the marketing authorisation. The provision subjecting to medical prescription medicinal products containing active substances that are PBT, vPvB, PMT or vPvM is kept in the provisional agreement, with however the vague condition that no ‘other circumstances of use justify otherwise’. The provisional agreement was endorsed by the SANT Committee of the Parliament on 18 March; it still needs to be formally adopted by both institutions.

Upcoming consultation deadlines:

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/