EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10124/2019 ANNEX CIS 
(POOL/E2/2019/10124/10124 -EN 
ANNEX CIS.docx)  
[…](2019) XXX  draft  
ANNEX 1  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
amending Regulation (EC) 1881/2006 as regards maximum levels of 3 -
monochloropropane diol (3 -MCPD), 3 -MCPD fatty acid esters and glycidyl fatty acid 
esters in certain foods    
EN 1  EN ANNEX  
In the Annex to Regulation (EC) No 1881/2006, Section 4 "3-monochloropropanediol (3 -
MCPD) and glycidyl fatty acid esters " is replaced by the following:  
ʽSection 4: 3 -monochloropropane  diol (3 -MCPD) , 3-MCPD fatty acid esters and glycidyl 
fatty acid esters  
Foodstuffs (1) Maximum level  
(µg/kg)  
4.1 3-monochloropropane  diol (3 -MCPD)   
4.1.1  Hydrolysed vegetable protein (30) 20 
4.1.2  Soy sauce (30) 20 
4.2 Glycidyl fatty acid esters , expressed as glycidol   
4.2.1.  Vegetable oils and fats , fish oil s and oils from other marine organisms 
placed on the market for the final consumer or for use as an ingredient 
in food , with the exception of the foods referred to in 4.2.2 and of 
virgin olive oils (*) 1000  (***)  
4.2.2.  Vegetable oils and fats, fish oils and oil s from other marine organisms 
destined for the production of baby food and processed cereal -based 
food for infants and young children (3)  500 (***) , (******)   
4.2.3  Infant formula, follow -on formula and foods for special medical 
purposes intended for infants and young children (3) (29) and young -
child formula  (29) (**)(powder)  50 (***)  
4.2.4  Infant formula, follow -on formula and foods for special medical 
purposes intended for infants and young children (3) (29) and young -
child formula(29) (**)(liquid)  6.0 (***)  
4.3 Sum of  3-monochloropropane  diol (3 -MCPD) and 3 -MCPD fatty 
acid esters, expressed as 3 -MCPD  (****)  
4.3.1.  Vegetable oils and fats, fish oils and oils from other marine organisms 
placed on the market for the final consumer or for use as an ingredient 
in food falling within the following categories, with the exception of 
the foods  referred to in 4.3.2  and of virgin olive oil s (*):  
- oils and fats from coconut, maize, rapeseed, sunflower, soybean , 
palm kernel and olive oils  (composed of refined olive oil and virgin 
olive oil ) (*) and mixtures of oils and fats with oils and fat s only from 
this category ; 
- other vegetable oils  (including pomace olive oils  (*)), fish oils and 
oils from other marine  organisms and mixtures of oils and fats with 
oils and fats only from this category ; 
- mixtures of oils and fats from the two above mentioned categories .   
 
 
 
 
 
1250  
 
 
2500  
--- (*****)  
4.3.2.  Vegetable oils and fats , fish oil s and oils from other marine organisms  
destined for the production of baby food and processed cereal -based 
food for infants and young children (3)  750(******)   
4.3.3  Infant formula, follow -on formula and foods for special medical 
purposes intended for infants and young children (3) (29) and young -
child formula(29) (**) (powder)  125  
4.3.4  Infant formula, follow -on formula and foods for special medical 15   
EN 2  EN purposes intended for infants and young children  (3) (29) and young -
child formula  (29) (**) (liquid)  
 
(*) As defined in Part VIII of Annex VII to Regulation (EU) No  1308/2013 of the 
Europ ean Parliament and of the Council of 17  December 2013 establishing a 
common organisation of the markets in agricultural products and repealing Council 
Regulations (EEC) No  922/72, (EEC) No  234/79, (EC) No  1037/2001 and (EC) 
No 1234/2007 ( OJ L 347, 20.12.20 13, p. 671) . 
(**) ʽyoung  child formula ʼ refers to milk -based drinks and similar protein -based products 
intended for young children . These products are outside the scope of Regulation 
(EU) 609/2013 (Report from the Commission to the European Parliament and the 
Council on young -child formulae  (COM/2016/0169 final ) ( https://eur -
lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:52016DC0169&qid =1559628885154&from=E
N) 
(***) For fish oil and oils from other marine organisms  and young -child formula , the 
maximum levels shall apply from 1 January 2021.  
(****) The maximum level s shall apply from 1 Janu ary 2021.  
(*****) The oils and fats used as ingredient for the mixture shall comply with the maximum 
level established for the oil and fat. Therefore, the level of the sum of 3 -
monochloropropane  diol (3 -MCPD) and 3 -MCPD fatty acid esters, expressed as 3 -
MCPD in the mixture , shall not exceed the leve l calculated in accord ance with  
Article 2 (1)(c) of Regulation  (EC) 1881/2006 . In case the quantitative composition is 
not known for the competent authority and the food business operator, not producing 
the mixture, the level of the sum of 3 -MCPD  and 3 -MCPD  fatty acid esters, 
expressed as 3 -MCPD in the mixture shall in any case not exceed 2500 µg/kg.   
(***** *)When the  product is a mixture of different oils or fats of the same or of different 
botanical origins, the maximum level applies for the mixture . The oils and fats used 
as ingredient for the mixture shall comply with the maximum level established for 
the oil and fat in point 4.3.1.