EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10384/2021 CIS 
(POOL/E2/2021/10384/10484 -EN 
CIS.docx)  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 1881/2006 as regards maximum levels of arsenic in certain 
foods  
(Text with EEA relevance)    
EN 1  EN  COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 1881/2006 as regards maximum levels of arsenic in certain 
foods  
(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 , including inorganic arsenic  in a range of foodstuffs.  
(2) Arsenic is a ubiquitous metalloid present at low concentrations in rocks, soil and 
natural ground water. In addition, anthropogenic activity has also contributed to 
increase the levels of arsenic in the environment through industrial emissions (mining, 
smelting of non -ferrous metals and burning of fossil fuels) as well as  with the use of 
arsenic as part of fertilisers, wood preservatives, insecticides or herbicides . Although 
dermal and inhalation exposure is possible, food and drinking water are the principal 
routes of exposure to arsenic .  
(3) On 12 October 2009 , the Scientif ic Panel on Contaminants in the Food Chain ( ‘the 
CONTAM Panel ’) of the European Food Safety Authority (‘the Authority’) adopted 
an opinion on arsenic in food3. In that opinion, the CONTAM Panel concluded that the 
provisional tolerable weekly intake (PTWI) of 15 μg/kg body weight (b.w.) , 
established by the Joint FAO/WHO Expert Committee on Food Additives ( ‘JECFA ’) 
was no longer appropriate , as data had shown that inorganic arsenic causes cancer of 
the lung , of the urinary bladder and the skin, and that a ran ge of adverse effects had 
been reported at exposures lower than those reviewed by the JECFA.  
(4) The CONTAM Panel identified a range of ‘benchmark dose lower confidence limit ’ 
(BMDL01) values between 0,3 and 8 μg/kg b.w. per day for cancers of the lung, skin 
and bladder, as well as skin lesions. In its  scientific opinion , the CONTAM Panel  
concluded that the estimated dietary exposures to inorganic arsenic for average and 
high l evel consumers in Europe are within the range of the BMDL01 values identified, 
and that therefore the possibility of a risk to some consumers cannot be excluded.  
(5) The scientific opinion identified high consumers of rice in Europe, such as certain 
ethnic gr oups and children under three years of age , as most subject ed to inorganic 
                                                 
1 OJ L 37, 13.2.1993, p.  1.  
2 Commission Regulation (EC) No  1881/2006 of 19  December 2006 setting maximum levels for certain 
contaminants in foodstuffs (OJ L 364, 20.12.2006, p.  5). 
3 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food. 
EFSA Journal 2009; 7(10):1351, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.135.   
EN 2  EN  arsenic dietary exposure. Dietary exposure to inorganic arsenic for children under 
three years old, including from rice -based foods, was estimated to be a bout 2 to 3 -fold 
that of adults.  
(6) In its scientific  report  of 20144 on the dietary exposure to inorganic arsenic in the 
European population, the Authority  identified grain -based products as the main 
contributor to the exposure , and rice, milk and dairy products as important 
contribu tors. However, t he heterogeneity of the food consumption data, the conversion 
of total arsenic to inorganic arsenic and the treatment of left censored data represented 
significant  uncertainties in the exposure assessment.  
(7) In light of that information , Commission  Regulation (EU) 2015/10065 set maximum 
levels for  the presence of  inorganic arsenic only in rice and rice -based products and in 
accordance with  Commission Recommendation (EU) 2015/13816, Member States 
were called upon to monitor , during 2016, 20 17 and 2018 , the presence of arsenic  in 
foods , preferably  by determining the content of inorganic and total arsenic and, if 
possible,  other relevant arsenic species, in a wide variety of food s.  
(8) In its scientific report  of 20217, the Authority  assessed the chronic dietary exposure to 
inorganic arsenic, taking into account the most recent occurrence data for inorganic 
arsenic in food. It concluded that across the different age classes, the main contributors 
to the dietary exposure to inorganic a rsenic  were rice, rice-based products, grains and 
grain -based products not containing rice  and drinking water. The Authority has further 
concluded that p articular foodstuffs indicated for the young population (e.g. cereal -
based food for infants and young c hildren and biscuits, rusks and cookies for children , 
infant formulae, follow -on formulae , foods for special medical purposes intended  for 
infants and young children and y oung child formulae, baby foods and fruit juices ) 
made a relevant contribution in the  dietary exposure to inorganic arsenic  in this 
population  group . In the adult population, food groups such as ‘ fish and other seafood’ 
were also apparent sources of inorganic arsenic in certain countries.  
(9) The existing mean and 95th percentile exposure s to arsenic in food still lie within the 
range of the BMDL01 values identified in the CONTAM Panel scientific  opinion  of 
2009 . It is therefore appropriate to establish new maximum levels for commodities 
contributing to exposure to arsenic and lower existing maximum levels, where feasible  
on the basis of the occurrence data . 
(10) The Codex Alimenta rius sets a maximum level of 0.5 mg/kg for total arsenic in salt8. 
It is appropriate to set the same maximum level in Union legislation.  
(11) Regulation (EC) No  1881/2006 shou ld therefore be amended accordingly.  
                                                 
4 Scientific report of EFSA on the  dietary exposure to inorganic arsenic in the European population, 
EFSA Journal 2014; 12(3): 3597, 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3597.  
5 Commission Regulation (EU) 2015/1006 of 25 June 2015 amending Regulation (EC) No 18 81/2006 as 
regards maximum levels of inorganic arsenic in foodstuffs (OJ L 161, 26.6.2015, p . 14).  
6 Commission Recommendation (EU) 2015 /1381 of 10 August 2015 on the monitoring of arsenic in food 
(OJ L213, 12.8.2015, p. 213 ). 
7 Scientific report of EFSA on the chronic dietary exposure to inorganic arsenic,  EFSA Journal 2021; 
19(1): 6380, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3597 . 
8 Codex General Standard for Contaminants and Toxin in Foods and Feeds – GSCTFF (CODEX STAN 
193-1995).   
EN 3  EN  (12) 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 re main on the market.  
(13) 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 that were lawfully placed on the market before the entry into force of this 
Regulation 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.  
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