EU regulation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) is evolving rapidly. Companies need to be aware of the restrictions already adopted and the initiatives that may expand the substances, products and uses affected. Anticipating these changes is key to reviewing formulations, raw materials, packaging and control systems before new obligations arise.
EU regulatory framework on PFAS
PFAS are not regulated through a single provision. The European framework combines rules on chemical substances, persistent organic pollutants, food, drinking water, packaging and environmental protection. Each may establish prohibitions, concentration limits, monitoring requirements or conditions for placing products on the market.
Regulation (EU) 2019/1021 on persistent organic pollutants restricts specific PFAS, such as PFOS, PFOA and PFHxS, together with their salts and related substances. The REACH Regulation includes restrictions for other groups, including certain perfluorocarboxylic acids and PFHxA.
The same substance may be affected by the legislation applicable in different cases, contaminants in food, water for human consumption, persistent organic pollutants and REACH. To interpret the obligations correctly, it is advisable to start with what PFAS are, how they behave and why they may enter the food chain, and then identify the product, use and applicable regulations.
Current restrictions on food, water and packaging
In food, Regulation (EU) 2023/915 establishes maximum levels for PFOS, PFOA, PFNA and PFHxS in certain categories, both individually and for the sum of the four. European recommendations complement this framework through monitoring programmes aimed at expanding the available data and investigating sources of contamination. The applicable limits, the foods affected and the criteria for interpreting analytical results form part of this specific PFAS control framework for food.
In water intended for human consumption, Directive (EU) 2020/2184 introduces parameters for the sum of certain PFAS and for total PFAS. Since 12 January 2026, Member States must monitor these substances in a harmonised manner and take measures when the established values are exceeded.
With regard to packaging, Regulation (EU) 2025/40 on packaging and packaging waste introduces limits for PFAS present in packaging intended for food contact. Its general application begins on 12 August 2026 and affects the placing on the market of packaging that reaches or exceeds the specified values.
These rules have different purposes. Maximum levels in food affect its placing on the market; water parameters are intended to ensure its quality; and packaging limits apply to the material before it is placed on the market. Therefore, the established values should not be transferred directly or extrapolated from one area to another.
Upcoming changes in EU regulation
The most far-reaching change is the general PFAS restriction proposal submitted under REACH by Germany, Denmark, the Netherlands, Norway and Sweden. Its aim is to limit the manufacture, placing on the market and use of a very broad group of substances, with transitional periods and possible exemptions where suitable alternatives do not yet exist, these measures will be implemented through an amendment to the REACH Regulation.
The procedure is still ongoing. The European Chemicals Agency (ECHA) is assessing the risks, available alternatives and socioeconomic impacts. The European Commission plans to use this scientific assessment to prepare a proposal, meaning that the final scope, timelines and exemptions may still change.
In addition, the European Union is strengthening the monitoring of PFAS in water, soils, emissions and other sources of contamination. This development points towards greater coordination between chemicals regulation and sector-specific rules, as well as broader information and monitoring requirements.
What are the implications for companies
Companies must identify where PFAS may be present: raw materials, formulations, coatings, processing aids, products, packaging or components supplied by third parties. It is also advisable to review supplier declarations, as a generic statement such as ‘PFAS-free’ may not define which substances it covers or how it has been verified.
The analysis should prioritise uses with the highest regulatory risk, check the rules applicable in each market and assess alternatives before the transitional periods end. Legal consultancy in food quality and safety makes it possible to translate the legal framework into specific requirements for each product, documentation and activity.
How AINIA can help you
At AINIA, we identify the applicable regulations, analyse their impact and help companies prepare adaptation plans. With our LEXAINIA regulatory monitoring service, we help you anticipate regulatory changes concerning PFAS, with access to up-to-date regulations, relevant legal information and individualised analyses of their potential impact on business activities.
