Perfluoroalkylated substances (PFASs) are a vast group of fluorinated compounds that have been widely used in industrial and consumer applications including stain- and water-resistant coatings for fabrics and carpets, oil-resistant coatings for paper and cardboard food contact materials, floor polishes, insecticide formulations, fire-fighting foams, and mining and oil well surfactants. Their widespread use, together with their persistency in the environment has resulted in a widespread environmental contamination. Contamination of food with these substances is mainly the result of bioaccumulation in aquatic and terrestrial food chains and also the use of PFASs-containing food contact materials is likely to contribute to human exposure to PFASs.
Perfluoroctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) and their salts are the PFASs which are found in food and in humans in the highest concentrations. The European Food Safety Authority (EFSA) therefore asked its Scientific Panel on Contaminants in the Food chain to prepare an opinion on the importance of food and the relative contribution of the different foodstuffs and food contact materials to the human exposure to PFOS, PFOA and their salts and to advise on further steps in relation to the risk assessment of PFASs. EFSA adopted a Scientific Opinion on PFOS, PFOA and their salts on 21 February 2008, stating that further data on PFASs levels in food and in humans would be recommended, particularly with respect to monitoring trends in human exposure.
In order to collect further occurrence data on PFASs in food, on 17 March 2010 the Commission adopted Commission Recommendation (EU) 2010/161 on the monitoring of PFASs in food.
At the request of the Commission, on 9 July 2020 EFSA updated its risk assessment of PFOS and PFOA and extended it to perfluorononanoic acid (PFNA) and perfluorohexane sulfonic acid (PFHxS), taking into account the most recent scientific information and the occurrence data gathered under Recommendation 2010/161/EU (EFSA 2020 opinion on the risk to human health related to the presence of PFASs in food). EFSA concluded that PFOS, PFOA, PFNA and PFHxS can cause developmental effects and may have adverse effects on serum cholesterol, the liver and the immune system and birth weight. It considered the effects on the immune system as the most critical effect and it established a group tolerable weekly intake (TWI) of 4.4 ng/kg body weight per week for the sum of PFOS, PFOA, PFNA and PFHxS, which is also protective against the other effects of those substances. It concluded that the exposure of parts of the European population to those substances exceeds the TWI, which is of concern. Therefore maximum levels for PFOS, PFOA, PFNA and PFHxS and the sum of PFOS, PFOA, PFNA and PFHxS in eggs, fish meat, crustaceans, bivalve molluscs, meat and offal of farmed and wild animals were established by means of Regulation (EU) 2022/2388 of 7 December 2022.
Furthermore, in its 2020 opinion on the risk to human health related to PFASs, EFSA noted that a representative set of occurrence data are still lacking for many foods and, therefore, it recommended to gather such data for a wide range PFASs in a broad range of widely consumed foods. Furthermore, since the measured concentrations of PFASs in certain foods (e.g. fruits, vegetables, milk) were only obtained with very sensitive analytical methods, which are currently not achievable for the majority of the laboratories, it recommended to implement sensitive analytical methods for the analyses of PFASs. Following this opinion the Commission adopted Recommendation (EU) 2022/1431 on the monitoring of PFASs in food, with the aim of gathering occurrence data for a wide range of PFASs in foods, which are relevant for the human exposure to PFASs, in order to support a dietary exposure assessment and assess the need to regulate PFASs in other specific commodities. Furthermore the Commission recommends to carry out follow-up investigations towards the sources of contamination, to allow the implementation of follow-up measures to avoid the occurrence of PFASs in food. For this purpose by mean of Recommendation (EU) 2022/1431 indicative levels of concentrations of PFASs in fruits, vegetables, milk and baby food were established. Those levels should not affect the possibility to place on the market any food, but investigations should be carried out when the concentration of PFASs in a foodstuff exceeds those levels. In order to quantify concentrations of PFASs in the quantities in which they occur, the Commission recommends to use sufficiently sensitive methods. For this purpose in Recommendation (EU) 2022/1431 target limits of quantification for different commodity groups are recommended.
Food of animal origin is an important contributor to the human exposure to PFASs. EFSA concluded that PFASs transfer from feed to animal derived food, with clear differences between species and the type of PFASs. Such PFASs transfer may also occur from soil ingested by foraging farm animals and from drinking water for animals. Therefore, for the follow-up investigations aiming at determining the causes of contamination, where the maximum levels of PFASs in food of animal origin set out in Regulation (EU) 2022/XXXX (the Regulation number will be added after publication, which is foreseen on 8 December 2022) are exceeded, it is important that laboratories are able to also control feed, animal drinking water and the soil on which animals live. As only a limited number of laboratories is able to analyse PFASs in feed, further work is being undertaken by the European Reference Laboratory for halogenated persistent organic pollutants in feed and food, to help the laboratories to develop such capability. While that work should allow for the adoption in the future of further recommendations concerning PFASs in feed, once there is a sufficient analytical capability among the laboratories, in the meanwhile, those Member States, whose laboratories are already able to analyse PFASs in feed, following Recommendation (EU) 2022/1431 are recommended to already do so and, in those Member States which do not have the required analytical capability yet, the laboratories should already validate analytical methods for PFASs in feed.
Methods of sampling and analysis for the control of PFASs in food are established by Commission Implementing Regulation (EU) 2022/1428.
Babyfood, as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).