Maximum levels of perfluoroalkyl substances in foods

Commission Regulation (EU) 2022/2388 of 7 December 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of perfluoroalkyl substances in certain foodstuffs

Update

The EU has introduced a new contaminant category, “perfluoroalkyl substances”, and has set maximum levels for eggs, fish, meat, crustaceans, bivalve molluscs, meat, and animal products.

Impacted Products

Eggs, fish, meat, crustaceans, bivalve molluscs, meat and edible offal of bovine animals, pigs, poultry, sheep, and game animals

What is changing?

This legislation amends Regulation (EC) No. 1881/2006 on contaminants in foods (now replaced by Regulation (EU) 2023/915 – see Regulation on maximum levels for certain contaminants in food). It introduces perfluoroalkyl substances (PFAS) as a new category of contaminants. It sets maximum levels for PFAS in eggs, fish, crustaceans, bivalve molluscs, meat, and animal products (details in Table 1).

Why?

Limiting production and use of PFAS in food processing and packaging will help limit future dietary exposure.

EFSA has concluded that for parts of the European population, exposure to these substances exceeds the tolerable weekly intake (TWI). This is of concern because PFAS may have adverse effects on serum cholesterol, the liver and the immune system, and birth weight. EFSA considers the effects on the immune system to be the most critical. Maximum levels in food for the sum of perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorohexane sulfonic acid (PFHxS) should therefore be set to ensure a high level of human health protection.

Timeline

The new PFAS maximum limits apply from 1 January 2023.

What are the major implications for exporting countries?

Bioaccumulation reflects long-term use of PFAS. Comprehensive overviews of historical and current production of PFOA, PFOS and compounds suggest that production volumes are decreasing in Western Europe, Japan and the USA, where their manufacture is becoming regulated (Wang et al. 2014). In contrast, volumes of PFAS and its production appear to be increasing in China, India, Poland and Russia (Wang et al. 2014). Third countries where manufacturing of these substances is absent or less concentrated are less likely to be directly concerned by this regulation.

Recommended Actions

Exporters of dairy and animal products, fish and seafood, meat, and livestock should review existing levels of PFAS in these products.

Where levels exceed the EU’s limits, further initiatives must be undertaken to identify and reduce exposure.

For information on recommended methods of sampling and analysis of PFAS in foodstuffs, see EURL-POPs (2022).

Background

Perfluoroalkyl substances (PFAS) are used in numerous commercial and industrial applications. Together with their persistence in the environment, this has resulted in widespread contamination of food with these substances, mainly due to bioaccumulation in aquatic and terrestrial food chains. Diet is the major source of PFAS exposure, but the use of food contact materials containing PFAS, including non-stick coatings on cookware, is also likely to contribute to human exposure. Contamination from packaging and processing reflects the current production and use of PFAS.

EFSA (2020) evaluated the risk to human health related to the presence of PFAS in food. This followed the EFSA (2018) opinion on two PFAS: perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA), which derived separate tolerable weekly intakes (TWI) for these compounds based on effects observed in humans.

Resources

Sources

Tables & Figures

Source: based on Annex to Regulation (EU) 2022/2388