EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11185/2018 CIS 
(POOL/E2/2018/11185/11185 -EN CIS)  
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No  1881/2006 as regards maximum levels of lead 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 lead 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 A rticle  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 sets maximum levels  for lead (Pb) in a 
range of foodstuffs.   
(2) On 18  March 2010, the European Food Safety Authority (‘the Authority’)  adopted an 
opinion on lead in food3. The Authority  identified that lead can cause developmental 
neurotoxicity in young children and cardiovascular issues  and nephrotoxicity in adults . 
The risk assessment for lead was based on  these  potential ly critical adverse effects. 
The Authority  concluded that there w as no evidence for a threshold for a number of 
critical endpoints , including developmental neurotoxicity and adult nephrotoxicity. 
Therefore , it was not appropriate to derive a tolerable weekly intake . The Authority  
expressed a concern that there was potential that the current levels of dietary exposure 
to lead might  affect neurodevelopment in  foetuses, infants and children.  
(3) The Authority ’s conclusions  were confirmed by the conclusions of the report of the 
Joint FAO/WHO Expert Committee on Food  Additives and Contaminants 
(FAO /WHO) in 2010.4 
(4) Taking into account the most recent occurrence data, the Codex Alimentarius 
Commission at its 41th Session (‘CAC41’) lowered the Codex maximum level  for lead 
in salt (excluding  salt from marshes) from 2 mg/kg to 1 mg/kg.  
(5) Taking into account the most recent occurrence data , the Codex Alimentarius 
Commission at its 42nd Session (‘CAC42 ’) lowered the Codex maximum levels  of 0,5 
mg/kg for edible offal to 0 ,2 mg/kg for edible offal from  cattle, 0 ,15 mg/kg for edible 
offal from  pigs and 0 ,1 mg /kg for edible offal from  poultry. It also lowered the 
maximum levels  for “wine made from grapes ” from 0 ,2 mg/kg to 0 ,1 mg/kg and set a 
                                                 
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 CONTAM Panel (EFSA Panel on Conta minants in the Food Chain), 2010 . Scientific Opinion on 
lead in food . EFSA Journal 2010;8(4):1570, 
https://efsa.onlinelibrary.wiley.com/do i/epdf/10.2903/j .efsa.2010.1570  
4 Evaluation of Certain Food Additives and Contaminants. Seventy -third report of the joint FAO/WHO 
Expert Committee on Food Additives. WHO Technical Report Series 960.   EN 2  EN maximum level  for fortified /liqueur “wines made from grapes ” at 0,15 mg/kg. Both 
maximum levels  apply to wine made from grapes harvested after the date the CAC42  
adopt ed the maximum levels .  
(6) In light of these developments and of the most recent occurrence data, the dietary 
exposure to lead in food should be reduce d within the Union by lowering the existing 
maximum levels  or setting additional maximum levels  for foodstuffs for which lower 
levels of lead are reasonably achievable, namely offal, certain foods for i nfants and 
young children, salt  and wild fungi. For th e same reasons, the maximum level s for 
lead in wine s should be reduced and a maximum level for liqueur wine should be 
established as regards those products produced from future harvests. Finally, for those 
same reasons, but also to help fight fraudulent practices , such as the addition of lead 
chromate to turmeric , maximum levels for spices should be established.  
(7) Regulation (EC) No 1881/2006 should therefore be amended accordingly . 
(8) Given that lead is a weak indirect genotoxic carcinogen, and consequently i ts presence 
is a higher risk for public health, products not complying with the new maximum 
levels  for lead and placed on the market before the entry into force  of this Regulation 
should  only be allowed to remain on the market for a short period of time . 
(9) 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 A nnex to 
this Regulation.  
Article  2 
Foodstuffs listed in the Annex that were lawfully placed on the market before the entry into 
force of this Regulation  may remain on the market  until [ publication office please introduce 
the date 6 months after the entry into force ].   
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.  
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