EN    EN EN 
SANCO/06326/2009 Rev. 1 (POOL/E3/2009/06326/06326R1-EN.doc)   
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) final SANCO/06326/2009 – rev. 1   
Draft 
COMMISSION REGULATION 
of 
amending Commission Regulation (EC)  No 1881/2006 of 19 December 2006 setting 
maximum levels for certain contaminants in foodstuffs as regards aflatoxins  
(Text with EEA relevance) 
(Memorandum from Ms A. VASSILIOU) 
 
WORKING DOCUMENT – DOES NOT NECESSARILY REPRESENT 
THE COMMISSION’S VIEWS  
EN 3   EN Draft 
COMMISSION REGULATION 
of 
amending Commission Regulation (EC)  No 1881/2006 of 19 December 2006 setting 
maximum levels for certain contaminants in foodstuffs as regards aflatoxins  
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 (E C) No 1881/2006 of 19 December 2006 setting maximum 
levels for certain contaminants in foodstuffs
2 sets maximum levels for aflatoxin B1 
and aflatoxin total (aflatoxin B1 + G1 + B2 + G2) in a range of foodstuffs.  
(2) It is necessary to amend certain maximum leve ls for aflatoxins in certain foodstuffs to 
take into account developments in C odex Alimentarius and new information 
(3) Codex Alimentarius established a level of  15 µg/kg aflatoxin total in almonds, 
hazelnuts and pistachios intended for furt her processing and a level of 10 µg/kg 
aflatoxin total in almonds, hazel nuts and pistachios "ready-to-eat"3.  
(4) The Scientific Panel on Contaminants in  the Food Chain (CONTAM Panel) of the 
European Food Safety Authority (EFSA) expressed on 25 January 2009 an opinion on 
the potential increase of consumer health risk by a possible increase of the existing 
maximum levels for aflatoxins in almonds, hazelnuts and pistachios and derived products
4.  The CONTAM Panel concluded that  changing the maximum levels for 
                                                 
1 OJ L 37, 13.2.1993, p. 1.  
2 OJ L 364, 20.12.2006, p. 5.  
3  Codex General Standard for Contaminants and toxins in foods  (CODEX STAN 193-1995) 
http://www.codexalimentarius.net/ download/standards/17/CXS_193e.pdf  
4  Opinion of the Scientific Panel on Contaminants in the food chain on a request from the commission 
related to the potential increase of consumer health  risk by a possible increase of the existing maximum 
levels for aflatoxins in almonds hazel nuts and pistachios a nd derived products. The EFSA Journal 
(2007) 446, 1-127.  http://www.efsa.europa.eu/cs/Bl obServer/Scientific_Opinion/CON TAM%20_op_ej446_aflatoxins_en,3
.pdf?ssbinary=true  
   
EN 4   EN total aflatoxins from 4 to 8 or 10 µg/kg in almonds, hazelnuts and pistachios would 
have minor effects on the estimates of diet ary exposure, cancer ri sk and the calculated 
Margins of Exposure (MOEs). The Panel fu rthermore concluded that exposure to 
aflatoxins from all sources should be as  low as reasonably achievable, because 
aflatoxins are genotoxic and carcinogenic. The data indica te that reduction of total 
dietary exposure to aflatoxins could be  achieved by reducing the number of highly 
contaminated foods reaching the market and reducing exposure from food sources 
other than almonds, hazelnuts and pistachios. 
(5) Codex Alimentarius established only a maximum level for aflatoxin total.  The 
corresponding aflatoxin B1 level was dete rmined by making use of the database on 
occurrence of aflatoxins in food used by EFSA for the exposure assessment.  
(6) In the EFSA opinion on aflatoxins it can be observed that oilseeds and derived 
products are an important contributor to the human aflatoxin exposure. EFSA 
concluded that exposure to aflatoxins from all sources should be as low as reasonably 
achievable. Furthermore, notifications in the Rapid Alert System for Food and Feed 
(RASFF) indicate high levels of aflatoxins in  oilseeds such as sunflower seeds, melon 
seeds, … It is therefore pr oposed to set also a maximum level for oilseeds other than 
groundnuts, similar to the existing ma ximum levels for groundnuts.   
(7) A maximum level of 2 µg/kg for aflatoxin B1 and 4 µg/kg aflatoxin total has been 
established in all cereals and all products  derived from cereals with the exception of 
maize to be subjected to sorting or other physical treatment before human 
consumption for which a maximum level of 5 µg/kg for aflatoxin B1 and 10 µg/kg for 
aflatoxin total has been estab lished. Rice in husk regularly cont ains levels of aflatoxins 
slightly above the maximum levels. After milling, a process which removes the husk, the levels of aflatoxins in the white mille d rice are below the maximum levels. It is 
therefore appropriate to appl y the same approach for rice as the existing approach for 
maize i.e. a higher level of af latoxin B1 and aflatoxin total for rice to be subjected to 
sorting or other physical treatment before hum an consumption or use as an ingredient 
in foodstuffs.   
(8) Following recent scientific evidence, a part of the aflatoxin contamination can be 
found on the shell of Br azil nuts. The maximum levels refe r to the edible part of the 
nuts and therefore it is appropr iate to modify the footnote indicating that in case nuts 
"in shell" are analysed, it is assumed when  calculating the afla toxin content all the 
aflatoxin is on the edible part.   
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council has opposed them. 
HAS ADOPTED THIS REGULATION:  
EN 5   EN Article 1 
Regulation (EC) No 1881/2006 is amended as follows:  
1. Article 4 is replaced by the following: 
"Article 4 
Specific provisions for groundnut, other oilseed s, nuts, dried fruit, rice and maize  
Groundnuts, other oilseeds, nuts, dried fruit,  rice and maize not complying with the 
appropriate maximum levels of aflatoxi ns laid down in points 2.1.5, 2.1.6, 2.1.7, 2.1.8, 2.1.10 
and 2.1.11 of the Annex can be placed on the market provided that these foodstuffs: 
(a) are not intended for direct human consump tion or use as an ingredient in foodstuffs, 
(b) comply with the appropriate maximum levels laid down in points 2.1.1, 2.1.2, 2.1.3, 
2.1.4, 2.1.9 and 2.1.12 of the Annex, 
(c) are subjected to a treatment involving sor ting or other physical  treatment and that 
after this treatment the maximum levels laid down in points 2.1.5, 2.1.6, 2.1.7, 2.1.8, 2.1.10 and 2.1.11 of the Annex are not exceeded, and this treatment does not result in 
other harmful residues, 
(d) are labelled clearly showing their use, a nd bearing the indication “product shall be 
subjected to sorting or other physical tr eatment to reduce aflatoxin contamination 
before human consumption or use as an ingredient in foodstuffs”. The indication 
shall be included on the label of each individual bag, box etc. or on the original accompanying document. The consignment/batch identification code shall be indelibly marked on each individual bag, box etc. of the consignment and on the 
original accompanying document." 
2. Article 5 is replaced by the following: 
 "Article 5 
Specific provisions for groundnuts, other oils eeds, derived products thereof and cereals  
A clear indication of the intended use must ap pear on the label of each individual bag, box, 
etc. or on the original accompanying document.  This accompanying document must have a 
clear link with the consignment by means of me ntioning the consignmen t identification code, 
which is on each individual bag, box, etc. of the consignment. In addition the business activity 
of the consignee of the consignment give n on the accompanying document must be 
compatible with the intended use. 
In the absence of a clear indication that thei r intended use is not for human consumption, the 
maximum levels laid down in points 2.1.5 and 2.1.11 of the Annex shall apply to all 
groundnuts, derived products thereof and cereals placed on the market.  
As regards the exception of groundnuts and other oilseeds for crushing of the application of 
the maximum levels laid down in point 2.1.1. of the Annex, the excep tion only applies to 
consignments which are clearly labelled showin g their use and bearing the indication "product  
EN 6   EN to be subject to crushing for the production of refined vegetable oil". The indication shall be 
included on the label of each individual bag, box etc. or on the accompanying document(s). 
The final destination must be a crushing plant." 
3. The Annex, Section 2 is amended as follows: 
(a) The entries for Aflatoxins (2.1) are replaced by the en tries in the Annex to this 
Regulation. 
(b) The text of footnote 5 is replaced by "The maximum levels refer to the edible 
part of groundnuts and nuts. If groundnuts and nuts “in sh ell” are analysed, it is 
assumed when calculating the aflatoxin c ontent all the contamination is on the 
edible part, except possibly in  the case of Brazil nuts." 
Article 2 
This Regulation shall enter into fo rce on the twentieth day following that of its publication in the 
Official Journal of the European Union.  
It shall apply from 1 February 2010.  
This Regulation shall be binding in its entirety and directly appl icable in all Member States. 
Done at Brussels,  
 For the Commission 
 Androulla VASSILIOU  Member of the Commission  
EN 7   EN ANNEX  
Foodstuffs1 Maximum levels (µg/kg) 
"2.1 Aflatoxins 
 B1 Sum of B 1, B2, 
G1 and G 2 M1 
2.1.1 Groundnuts and other oilseeds (*), with the exception 
of groundnuts and other oilseeds for crushing for refined vegetable oil produc tion, to be subjected to 
sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs 8.0
5 15.05 - 
2.1.2. Almonds and pistachios to be subjected to sorting, or 
other physical treatment, before human consumption or use as an ingredient in foodstuffs  12.0
5 15.05 - 
2.1.3.  Hazelnuts to be subjected to sorting, or other physical 
treatment, before human consumption or use as an ingredient in foodstuffs 8.0
5 15.05  
2.1.4 Nuts, other than the nuts listed in 2.1.2. and 2.1.3,  to be 
subjected to sorting, or othe r physical treatment, before 
human consumption or use as an ingredient in foodstuffs 5.0
5 10.05 - 
2.1.5 Groundnuts and other oils eeds(*) and processed 
products thereof, with the exception of refined vegetable oils, intended for direct human consumption or use as an ingred ient in foodstuffs  2.0
5 4.05 - 
2.1.6. Almonds and pistachios, intended for direct human 
consumption or use as an i ngredient in foodstuffs (**) 8.05 10.05 - 
2.1.7. Hazelnuts, intended for dire ct human consumption or 
use as an ingredient in foodstuffs (**) 5.05 10.05  
2.1.8. Nuts, other than the nuts listed in 2.1.6. and 2.1.7, and 
processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs  2.0
5 4.05 - 
2.1.9 Dried fruit to be subjected to  sorting, or other physical 
treatment, before human consumption or use as an ingredient in foodstuffs 5.0 10.0 - 
2.1.10 Dried fruit and processed pr oducts thereof, intended for 
direct human consumption or use as an ingredient in 
foodstuffs 2.0 4.0 - 
2.1.11 All cereals and all product s derived from cereals, 
including processed cereal products, with the exception 
of foodstuffs listed in 2.1.12, 2.1.15 and 2.1.17  2.0 4.0 -  
EN 8   EN 2.1.12 Maize and rice to be subj ected to sorting or other 
physical treatment before human consumption or use as an ingredient in foodstuffs 5.0 10.0 - 
2.1.13 Raw milk6, heat-treated milk and milk for the 
manufacture of milk-based products  - - 0.050
2.1.14 Following species of spices:  
Capsicum spp  (dried fruits ther eof, whole or ground, 
including chillies, chilli pow der, cayenne and paprika) 
Piper spp  (fruits thereof, including white and black 
pepper)  
Myristica fragrans (nutmeg) 
Zingiber officinale  (ginger) 
Curcuma longa  (turmeric) 
Mixtures of spices containing one of the 
abovementioned spices  5.0 10.0 - 
2.1.15 Processed cereal-based foods and baby foods for 
infants and young children3,7 0.10 - - 
2.1.16 Infant formulae and follow-on formulae, including 
infant milk and follow-on milk4,8 - - 0.025
2.1.17 Dietary foods for special medical purposes9,10 intended 
specifically for infants  0.10 - 0.025
 
(*) Oilseeds falling under CN 1201, 1203, 1204, 1205, 1206, 1207 and derived products CN 
1208 - melon seeds fall under code ex 1207 99 
(**) In case derived/ processed products thereof are derived/processed solely or almost solely 
from the nuts concerned, the maximum levels as established for the corresponding nuts apply 
also to the derived/processed products.  In other cases, Article 2 (1) and 2(2) a pply for the derived/processed products."