PFAS Legislation

PFAS Legislation

PFAS in Food, New EU legislation from 1 Jan 2023

The necessity to lower the acceptable intake values for PFAS had been discussed for years in the light of new research demonstrating adverse and toxic effects also at very low levels. Moreover, the number of epidemiological studies had increased allowing more direct assessment. In Sep 2020 EFSA (EU food safety authority) published a final scientific opinion. Previous TDI (tolerable daily intake) limit values had included PFOS and PFOA only with separate limits. The new TWI (tolerable weekly intake) value of 4.4 ng/kg BW/week was instead based on the sum of four PFAS. The decision to substitute daily values with weekly was to reflect the accumulative nature of the substances, and the four PFAS were selected considering their, at large, comparable exposure, blood levels and expected toxicity. This also motivated treating them as a group. The drastically lowered acceptable intake value was derived from observed immune system effects in animals and humans such as lowered antibody and T-cell responses at vaccination of children. The intake covers both food and water, and the TWI has already in some cases formed the basis for or motivated new regulation.
The four PFAS (PFAS4) comprises:

- PFOS - Perfluorooctane sulphonic acid
- PFOA - Perfluorooctanoic acid
- PFNA - Perfluorononanoic acid
- PFHxS - Perfluorohexane sulphonic acid

Limit values for PFAS levels in food have been decided by the EU Commission and apply to animal foods such as meat, fish, crustaceans and eggs (Regulation (EU) 2022/2388 amending Regulation (EC) No 1881/2006). Limit values came into force on 1 Jan 2023 implying that food containing more PFAS than the limit value may not be sold. There is already a limit value for drinking water (see below) and the European Food Safety Authority (EFSA) assesses that many people in Europe are ingesting too much PFAS from water and various foods.

The companies are responsible for ensuring that the limit values are not exceeded in their food. Authorities that control food companies can decide that food must be removed from the market if it contains more PFAS than the limit value allows. In total, the regulation contains limits for four individual PFAS and the sum of these. The substances are the same as the ones EFSA established an intake value for (TWI).

Table max values

EFSA and other bodies have also identified the need of new and more comprehensive data on PFAS concentrations and composition of food within the union. An EU recommendation, (EU) 2022/1431, was published in Aug 2022 calling for monitoring of a wide range of foodstuffs between 2022-25. The recommendation does not only cover animal foods, but for example fruit and vegetables, cereals, beverages and baby food. The screening is to be performed in collaboration between authorities and food business operators. The analytical scope is not only limited to PFAS4, in total 27 individual PFAS substances and two classes are listed to be determined if possible.

For some kinds of food there are also indicative PFAS4 levels given. If these values are exceeded further investigations should be initiated.

An Implementing Regulation (EU) 2022/1428 that sets out requirements for sampling and analysis has also been published. It concerns primarily samples that have been taken as part of an official control. However, applicable parts such as sample preparation and analysis are considered and followed in our work. Eurofins SE has a wide experience of e.g. the requirements for the official pesticide control.

PFAS in Drinking Water

Guideline values for PFAS in drinking water have existed in some countries for a number of years (e.g. SE and DK). EU's revised drinking water directive (EU 2020/2184; DWD) will lead to a broader implementation across the member states. In the directive 20 PFAS are given and the sum of these has a limit of 100 ng/l. There is also an alternative parameter “PFAS total” of 500 ng/l, but the method to apply for measurement has not been decided upon yet. The limits have no direct connection to EFSA’s TWI value for PFAS4. In some countries such as DK and SE, and possibly in NL and BE in coming years, additional limit values for PFAS4 have been introduced of 2 and 4 ng/l in DK and SE, respectively. In comparison, these much lower levels have been derived from the EFSA TWI. In the case of SE and DK also PFAS20 have been extended with the addition of 6:2 FTS and PFOSA in DK and the former in SE.

PFAS Legislation

PFAS Legislation

PFAS in Drinking Water

Read more and download regulations on the links below: