Regarding EC Regulation Number 1881/2006, the European Commission (EC) has amended the Maximum Residue Limits (MRLs) for Perfluoroalkyl substances in certain foodstuffs. This amendment is covered under Regulation Number 2022/2388 which took effect on January 1, 2023.
Perfluoroalkyl substances (PFASs) are synthetic organofluorine chemicals encompassing thousands of individual compounds, such as Perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA) and perfluorohexane sulfonic acid (PFHxS). First developed in the 1940s they have been used in numerous commercial and industrial applications such as textile, carpet, paper and leather treatments.
PFAS’s properties chemical stability, water resistance and persistency in the environment have resulted in widespread environmental contamination. In food, contamination with these substances is mainly the result of bioaccumulation in aquatic and terrestrial food chains. Additionally, the use of food contact materials containing PFAS contributes to human exposure. Exposure to PFAS can cause developmental effects and may have adverse effects on serum cholesterol, the liver and the immune system.
The European Union is concerned about the effect of PFASs in food and has established maximum residue limits (MRLs) for Perfluoroalkyl substances in foodstuffs in European Commission Regulation (EC) Number 1881/2006. This has been done to ensure a high level of human health protection.
On July 9, 2020, the European Food Safety Authority (EFSA) adopted an opinion on the risk to human health related to the presence of perfluoroalkyl substances in food. It considered the effects on the immune system as the most critical 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 protective against the other effects of those substances. EFSA concluded that the exposure of parts of the European population to those substances exceeds the TWI, which is of concern.
Therefore, the Annex to Regulation (EC) Number 1881/2006 has amended MRLs to cover commodities under Regulation Number 2022/2388 (see at table 1). This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union and took effect on January 1, 2023. [1]
Table 1: Maximum Residue Limits of PFASs in certain foodstuffs
|
Food Commodities |
Maximum Levels μg/kg wet weight | |||||
| PFOS* | PFOA* | PFNA* | PFHxS* | Sum of PFOS, PFOA, PFNA and PFHxS*,** | ||
| Eggs | 1.00 | 0.30 | 0.70 | 0.30 | 1.70 | |
| (1) | Muscle meat of fish, except those listed under (2) and (3) Muscle meat of fish listed in (2) and (3), in case they are intended for the production of food for infants and young children. | 2.00 | 0.20 | 0.50 | 0.20 | 2.00 |
| (2) | Muscle meat of the following fish, in case they are not intended for the production of food for infants and young children: - Baltic herring (Clupea harengus membras) - Bonito (Sarda and Orcynopsis species) - Burbot (Lota lota) - European sprat (Sprattus sprattus) - Flounder (Platichthys flesus and Glyptocephalus cynoglossus) - Grey mullet (Mugil cephalus) - Horse mackerel (Trachurus trachurus) - Pike (Esox species) - Plaice (Pleuronectes and Lepidopsetta species) - Sardine and pilchard (Sardina species) - Seabass (Dicentrarchus species) - Sea catfish (Silurus and Pangasius species) - Sea lamprey (Petromyzon marinus) - Tench (Tinca tinca) - Vendace (Coregonus albula and Coregonus vandesius) - Silverly lightfish (Phosichthys argenteus) - Wild salmon and wild trout (wild Salmo and Oncorhynchus species) - Wolf fish (Anarhichas species) |
7.00 | 1.00 | 2.50 | 0.20 | 8.00 |
| (3) | Muscle meat of the following fish, in case they are not intended for the production of food for infants and young children: - Anchovy (Engraulis species) - Babel (Barbus barbus) - Bream (Abramis species) - Char (Salvelinus species) - Eel (Anguilla species) - Pike-perch (Sander species) - Perch (Perca fluviatilis) - Roach (Rutilus rutilus) - Smelt (Osmerus species) - Whitefish (Coregonus species) |
35.00 | 8.00 | 8.00 | 1.50 | 45.00 |
| Crustaceans and bivalve mollusks. For crustaceans the maximum level shall apply to muscle meat from appendages and abdomen. In crabs and crab-like crustaceans (Brachyura and Anomura) muscle meat from appendages. | 3.00 | 0.70 | 1.00 | 1.50 | 5.00 | |
| Meat of bovine animals, pigs and poultry | 0.30 | 0.80 | 0.20 | 0.20 | 1.30 | |
| Meat of sheep | 1.00 | 0.20 | 0.20 | 0.20 | 1.60 | |
| Offal of bovine animals, sheep, pigs and poultry | 6.00 | 0.70 | 0.40 | 0.50 | 8.00 | |
| Meat of game animals, with the exception of bear meat | 5.00 | 3.50 | 1.50 | 0.60 | 9.00 | |
| Offal of game animals, with the exception of bear offal | 50.00 | 25.00 | 45.00 | 3.00 | 50.00 | |
* The maximum level applies to the sum of linear and branched stereoisomers, whether they are chromatographically separated or not.
** For the sum of PFOS, PFOA, PFNA and PFHxS, lower bound concentrations are calculated on the assumption that all the values below the limit of quantification are zero.
What do the changes mean?
This update has the potential to affect agricultural producers and food manufacturers. Food products destined for Europe, if listed in Table 1, must not have PFAS residues exceeding the MRLs. Complying with food safety regulations can be a complex, time-consuming and expensive process. Food producers should seek professional advice.
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