EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10872/2014 […](2015) XXX  
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC)  No 1881/2006 as regards maximum levels of inorganic 
arsenic in foodstuffs 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of inorganic 
arsenic in 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 food
1, and in particular Article 2(3) thereof, 
Whereas: (1) Commission Regulation (EC)  No 1881/2006 sets maximu m levels for certain 
contaminants in foodstuffs. 
(2) The Scientific Panel on Contaminants in  the Food Chain (CONTAM Panel) of the 
European Food Safety Authority (EFSA) adopted an opinion on arsenic in food
2 on 
12 October 2009. In this opini on, CONTAM Panel conclude d that the provisional 
tolerable weekly intake (PTWI) of 15 μg/kg body weight established by the Joint 
FAO/WHO Expert Committee on Food Additives  (JECFA) is no longer appropriate as 
data had shown that inorganic arsenic cause s cancer of the lung and urinary bladder in 
addition to skin, and that a range of adve rse effects had been reported at exposures 
lower than those reviewed by the JECFA.  
(3) CONTAM Panel identified a range of benchmark dose lower confidence limit 
(BMDL 01) 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. The scientific opinion concluded that the 
estimated dietary exposures to inorganic ar senic for average and high level consumers 
in Europe are within the range of the BMDL 01 values identified, and that therefore 
there is little or no margin of  exposure and the possibility of  a risk to some consumers 
cannot be excluded. 
(4) The scientific opinion identified high consum ers of rice in Europe, such as certain 
ethnic groups, and children under three years of  age as the most exposed to inorganic 
arsenic dietary exposure. Dietary exposur e to inorganic arsenic for children under 
three years old, including from rice-based foods , is in general estim ated to be about 2 
to 3-fold that of adults. 
(5) Since the analysis of inorga nic arsenic is reliable for rice and rice based products, 
maximum levels for inorganic arsenic should be set for ri ce and rice based products. 
Differentiated maximum levels should be pr oposed in view of the arsenic content. 
(6) The scientific information on the need for a specific maximum level for parboiled 
milled rice is very recent. Therefore, Member States should collect additional data 
                                                 
1 OJ L 37, 13.2.1993, p. 1.  
2 Scientific Opinion on Arsenic in Food. EFSA Journal 2009; 7(10):1351.   
EN 3   EN before 1 January 2018 on the inorganic arseni c content of this commodity in order to 
confirm the need for a specific maximum leve l for this commodity and to reassess the 
maximum limit. 
(7) The occurrence data demonstrate that rice  cakes and rice wafers can contain high 
levels of inorganic arsenic and as th ese commodities can make an important 
contribution to the dietary exposure of infants and young chil dren. Therefore, a 
specific maximum level for these commodities should be envisaged. 
(8) Rice is an important ingred ient in a broad variety of  food for infants and young 
children. Therefore, a specific maximum level should be established for this 
commodity when used as an ingred ient for the production of such food. 
(9) Member States and food business operators s hould be allowed time to adapt to the new 
maximum levels established by this Regul ation. The date of application of the 
maximum levels of arsenic should therefore be deferred.  
(10) The measures provided for in this Regulati on 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 
The maximum levels of arsenic in subsection 3.5. (Arsenic) of the Annex to Regulation (EC) 
No 1881/2006, as amended by this Regula tion, shall apply from 1 January 2016.  
Foodstuffs not complying with these maximum levels which are lawf ully placed on the 
market prior to the date of application may con tinue to be marketed after that date 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  Jean-Claude JUNCKER  
EN 4   EN ANNEX 
The Annex to Regulation (EC) No 1881/2006 is amended as follows: (1) The following subsection is introduced  after Subsection 3.4 Tin (inorganic): 
'3.5 Arsenic (inorganic)(50) (51)  
3.5.1 Non-parboiled milled rice (polished or white rice) 0,20 
3.5.2 Parboiled rice and husked rice  0,25 
3.5.3 Rice waffles, rice wafers, rice crackers and rice cakes 0,30 
3.5.4 Rice destined for the production of food for infants and 
young children (3)  0,10' 
 
(2) The following endnotes are added: 
'(50) Sum of As(III) and As(V) 
(51) Rice, husked rice, milled rice and parboiled rice as defined in Codex Standard 
198-1995'