EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11183/2018 CIS 
(POOL/E2/2018/11183/11183 -EN 
CIS.docx)  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of perfluoroalkyl 
substances in certain foodstuffs  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of perfluoroalkyl 
substances in certain foodstuffs  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Council Regulation (EEC) No  315/93 of 8  February 1993 laying down 
Community procedures for contaminants in food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 sets maximum levels for certain 
contaminants in foodstuffs.  
(2) Perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), 
perfluorononanoic acid (PFNA) and perfluorohexane sulfonic aci d (PFHxS) are 
perfluoroalkyl  substances (PFAS s), which are, or were  used  in numerous commercial 
and industrial applications. 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 the diet is the major source of PFASs 
exposure. However also   the use of food contact mat erials containing PFAS s is likely 
to contribute to human exposure to them .  
(3) On 9 July 2020, the European Food Safety Authority (‘the Authority’) adopted an 
opinion on the risk to human health related to the presence of perfluoroalkyl 
substances in food.3 The Authority 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 
exceed s the TWI , which  is of concern.  
(4) Maximum levels in food for th ose substances should therefore be set to ensure a high 
level of human health protection .  
                                                 
1 OJ L 37, 13.2.1993, p.  1.  
2 Commission Regulation (EC) No  1881/2006 of 19  December 2006 setting maximum levels for cer tain 
contaminants in foodstuffs (OJ L 364, 20.12.2006, p.  5). 
3 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific opinion on the risk to human 
health related to the presence of perfluoroalkyl substances in food . EFSA Journal  2020  ; 18(9):6223 , 
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.6223 .  EN 2  EN (5) A reasonable period should be provided to allow for the food business operators to 
adapt to the maximum levels set out in this Regulation.  
(6) Taking into account that certain foodstuffs covered by this Regulation have  a long 
shelf life, foodstuffs that were law fully placed on the market before the date of 
application of this Re gulation , should be allowed to remain on the market.  
(7) Regulation (EC) No  1881/2006 should therefore be amended accordingly.  
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants , Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article  1 
The Annex to Regulation (EC) No  1881/2006 is amended in accordance with the Annex to 
this Regulation.  
Article  2 
Foodstuffs listed in the Annex , lawfully placed on the market before 1 January 2023, may 
remain on the market until their date of minimum durability or use -by date .  
Article  3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
It shall apply fr om 1 January 202 3. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN