On March 26, 2026, the European Chemicals Agency (“ECHA”) published a draft opinion of its Socio-Economic Assessment Committee (“SEAC”) on the proposed universal ban of per- and polyfluoroalkyl substances (“PFAS”) under the EU REACH Regulation (“PFAS Proposal”). The SEAC’s draft opinion and the opinion of ECHA’s Risk Assessment Committee (“RAC”) recommend removing or significantly reducing many of the time-unlimited and time-limited derogations for specific uses of PFAS included in the initial PFAS Proposal. If the European Commission follows the recommendations of the RAC and SEAC, the marketing and manufacture of life sciences products (e.g., human medicines, veterinary products, medical devices, cosmetics, other consumer care products) and other consumer products containing PFAS in the European Union could be severely restricted as from 2029.
ECHA’s publication of the SEAC’s draft opinion has triggered a 60-day public consultation period (until May 25, 2026) during which industry will have the opportunity to submit comments on the draft opinion to try to influence the regulatory process that will follow within the next year. This is likely to be the last chance companies will have to comment on the PFAS Proposal before ECHA sends its opinions to the European Commission.
Below we briefly outline the PFAS Proposal and the SEAC’s draft opinion, particularly their impact on life sciences and similar consumer products and provide recommendations on issues to consider when submitting comments to ECHA.
1. The PFAS Proposal
The PFAS Proposal, submitted by five Member States in January 2023, is a broad group restriction. It does not identify all the substances that would be subject to its universal restriction; instead, the Proposal follows a grouping approach and proposes to ban substances that meet a very broad definition of PFAS. As a result, the Proposal would ban over ten thousand substances and most uses, while for many companies it would be difficult to identify each and every substance that may be within the scope of the ban.
In effect, the PFAS Proposal would prohibit: (i) the manufacture, use and placing on the market of PFAS on their own, and (ii) the placing on the market of substances, mixtures and articles containing PFAS above very low thresholds, subject to limited derogations. We provide some examples of possible derogations for healthcare and other consumer care uses.
- The PFAS Proposal provides a time-unlimited derogation for active substances in human and veterinary medicinal products (as well as biocidal and plant protection products). This time-unlimited derogation does not extend to excipients of human medicines and veterinary products, or to substances used in medical devices, cosmetic products and other consumer products.
- The PFAS Proposal also provides for time-limited derogations for specific uses. For example, excipients in ophthalmic and dermatological treatments would benefit from a 13.5-year derogation. The blisters for medicines would benefit from a derogation of 6.5 years, while stoppers, syringes, inhalers, injection devices, and transdermal patch components would be exempted for 13.5 years. Implantable and invasive medical devices would be subject to derogations of 13.5 years. Similarly, the packaging of medical devices using fluoropolymers and perfluoropolyethers would be exempted for 13.5 years.
- Other types of packaging would not benefit from derogations. The Proposal provides a time-unlimited derogation for paper and board articles containing recovered material, but excludes food-contact material and packaging. It also provides a derogation of 23.5 years for plastic articles containing recovered material, with the exception of food-contact material and food-contact packaging.
2. The RAC’s Opinion
The opinion of the RAC, adopted on March 2, 2026, assesses whether the PFAS Proposal is appropriate to reduce risks to human health and the environment under the REACH framework. The RAC opinion supports the PFAS Proposal’s universal ban and only supports one of the Proposal’s derogations (i.e., personal protective equipment and associated impregnating agents to prevent negative effects on the health and safety of workers). The RAC also recommends that, in any case, any other derogations be accompanied by additional risk management measures, including reporting, labelling, and site-specific PFAS management plans.
3. The SEAC’s Draft Opinion
The SEAC’s draft opinion focuses on the availability of alternative substances and techniques, as well as the socio-economic impact of the PFAS Proposal’s restrictions. It considers a broad REACH restriction appropriate and supports a universal ban with only some time-limited use-specific derogations. While the SEAC’s draft opinion is more supportive of derogations than the RAC, if the European Commission follows its recommendations, the restrictions on PFAS are likely to be significantly stricter than those included in the PFAS Proposal.
The following are the SEAC draft opinion’s key aspects for companies marketing healthcare and similar consumer products:
- The SEAC considers that the time-unlimited derogation for active substances in human medicines and veterinary products (and biocides and pesticides) is not justified and is inconsistent with the rest of the proposal. It recommends that such active substances should instead benefit only from time-limited derogations.
- For other uses, including excipients for ophthalmological and dermatological treatments, medicinal product packaging and broader medical applications, the SEAC considers that it cannot conclude whether the proposed derogations are justified, and recommends short time-limited derogations pending further assessment. The SEAC does not recommend derogations for excipients in other types of human medicines. The opinion also does not recommend derogations for cosmetic products.
- For medical devices, the SEAC takes a more defined position and considers the derogations for implantable and invasive devices justified, while it finds the derogation for medical device packaging only partly justified, supporting it only for PCTFE-based packaging and for the use of PPAs in flexible packaging, with a 13.5-year derogation.
- Beyond healthcare and consumer care applications, the SEAC also takes a restrictive approach to other uses, including consumer-facing applications such as textiles. For example, while the PFAS Proposal provides a 13.5-year derogation for textile articles containing recovered material, the SEAC only considers such a derogation justified in principle but cannot conclude on its appropriate duration, indicating that the proposed timeframe may be excessive.
- The SEAC considers that no derogation is needed for food contact materials and packaging, in line with the Proposal’s approach of not providing derogations for general packaging uses.
The SEAC does not question the PFAS Proposal’s grouping approach.
The publication of the SEAC’s draft opinion has started a 60-day public consultation period during which stakeholders may submit comments before SEAC adopts its final opinion. The consultation is strictly limited to the content of the SEAC draft opinion and its assessment of the PFAS Proposal. It is not an opportunity to re-argue hazard or risk issues (which are the competence of the RAC).
Companies that are likely to be affected by the PFAS Proposal should consider submitting comments during the consultation. Such comments may help to improve the opinion of the SEAC and prepare the ground for the Commission’s deliberations next year. However, any comments submitted to ECHA should be prepared with care and reviewed by legal counsel.
Below, we outline a few considerations that companies should keep in mind when preparing their submissions.
1. Understand how the consultation is structured and what the SEAC is looking for
The consultation is designed to support the work of the SEAC in assessing whether the proposed restriction is proportionate on the basis of evidence. The SEAC is very unlikely to consider political arguments or general positions for or against PFAS restrictions. In practice, this means that submissions are only likely to carry weight if they focus on the availability of alternatives, substitution timelines, economic and operational impacts, and any interdependencies across uses. Comments should substantiate any claims made on these aspects.
The process is organized through two types of surveys: (i) sector-specific surveys, which cover uses explicitly evaluated by the SEAC, and (ii) a general survey, which allows comments on broader sections of the draft opinion or on uses not specifically assessed. Companies should therefore identify relevant sector(s) and map their activities to the corresponding use, sub-use or application. Where activities cover multiple uses or sectors, separate submissions will be required for each.
ECHA has published a consultation guidance and a mapping of PFAS uses to help companies prepare and submit their comments.
2. Work within the structure of the questionnaire and provide targeted input
The consultation is conducted through a structured questionnaire in EUSurvey, and all information must be entered directly into predefined fields. Attachments cannot be submitted, and external links will not be reviewed. The questionnaire combines multiple-choice questions, numerical inputs, and short free-text responses, with strict character limits (typically between 2,000 and 5,000 characters per answer).
For each relevant use, companies are expected to provide concise but substantiated information, including: how PFAS (or alternatives) are used and their function; whether suitable alternatives exist (and if not, why); how alternatives perform in practice; the estimated timeline for substitution; and quantitative data on PFAS use. Companies must also assess the impact of a phase-out, including effects on operations (e.g., closure, relocation, costs, and product quality), and provide, where possible, quantified economic and broader societal impacts (e.g., profits, jobs, and access to products). Estimates are acceptable, but assumptions should be clearly explained, as the SEAC may request further substantiation.
3. Any preparation of common comments by consortia or groups with competitors must respect EU competition law
Discussions among companies in preparation of a submission are subject to EU competition rules. In particular, where competitors are involved, care must be taken to avoid the exchange of any competitively sensitive information. Generally, consortia members should not share individualized information on socio‑economic impacts, costs, substitution timelines, or alternatives. Where information is provided in a joint context, it is prudent for such information to be anonymized and aggregated, for example through an independent third party. The preparation of any common comments should therefore be handled with caution and closely reviewed by legal counsel.
4. Handle confidentiality carefully
The consultation allows confidential submissions, but confidentiality must be claimed per response and supported by a justification. Justifications must be specific: companies need to explain why the information is commercially sensitive and how disclosure would concretely harm them. Generic statements are not sufficient. Even where confidentiality is accepted by ECHA, submitted information may still be subject to disclosure following requests for access to documents under EU transparency rules.
Overall, it is best to avoid the submission of detailed confidential information as the risk of disclosure cannot be excluded. For example, companies may want to refer to ranges rather than to specific concentrations.
5. Beware of product liability risks
ECHA is expected to proactively make publicly available the (non-confidential) comments received, and NGOs and journalists are likely to scrutinize them in search of acknowledgements of PFAS uses, alternatives available, and similar information. Such information may attract media attention and could be used in product liability litigation, in particular in the U.S. and other third countries. This emphasizes the need to protect confidential information when submitting comments, but also to assess whether particular information (or comments) should be submitted at all.
6. Use the consultation as part of a broader strategy
Participation in the consultation will serve not only to influence the SEAC’s final opinion, but also to shape the European Commission’s future proposal, support engagement with Member States during the subsequent phase of the process, and strengthen any future legal challenge of the restriction before the EU General Court, It is best to submit any concerns on the SEAC’s draft opinion during the current public consultation rather than leave them for future discussions with the European Commission or for a possible legal challenge before the Court.
Following the consultation:
- Once the consultation closes (May 25, 2026) the SEAC will review the submissions and adopt its final opinion (expected by the end of 2026);
- ECHA will transmit the PFAS Proposal, RAC and SEAC opinions, and comments received to the Commission by the end of 2026;
- The Commission will decide whether to propose an amendment to Annex XVII of the REACH Regulation, taking into account the RAC and SEAC opinions;
- Any such amendment must be adopted through the regulatory procedure with scrutiny. This essentially means that the Commission will be able to adopt the restrictions it proposes unless a substantial number of Member States oppose them;
- The Commission is unlikely to adopt any restrictions on PFAS until the third quarter of 2027. The restrictions would not start applying before 2029.
If you have any questions regarding the contents of this alert, please contact the following.
Back
