II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 165/2010  
of 26 February 2010  
amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in 
foodstuffs as regards aflatoxins  
(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 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 levels for 
aflatoxins in certain foodstuffs to take into account devel ­
opments in Codex Alimentarius and new information 
contained in recent scientific advice.  
(3) Codex Alimentarius established a level of 15 μg/kg 
aflatoxin total in almonds, hazelnuts and pistachios 
intended for further processing and a level of 10 μg/kg 
aflatoxin total in almonds, hazelnuts 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) adopted on 25 January 2007 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 total aflatoxins from 
4 to 8 or 10 μg/kg in almonds, hazelnuts and pistachios 
would have minor effects on the estimates of dietary 
exposure, cancer risk and the calculated margins of 
exposure (MOEs). The Panel furthermore concluded that 
exposure to aflatoxins from all sources should be as low 
as reasonably achievable, because aflatoxins are genotoxic 
and carcinogenic. The data indicate that reduction of 
total dietary exposure to aflatoxins could be achieved 
by reducing the number of highly contaminated foods 
reaching the market through more effective enforcement 
and reducing exposure from food sources other than 
almonds, hazelnuts and pistachios.  
(5) The Contam Panel adopted on 16 June 2009 a statement 
on the effects on public health of an increase of the 
levels for aflatoxin total from 4 μg/kg to 10 μg/kg for 
tree nuts other than almonds, hazelnuts and 
pistachios (  5 ). The Panel concluded that based on the 
information which was available in 2007 public health 
would not be adversely affected by increasing the levels 
for total aflatoxins from 4 μg/kg to 10 μg/kg for other 
tree nuts, including Brazil nuts. Given the current 
discussions in Codex Alimentarius on the maximum 
levels for aflatoxins in Brazil nuts, it is appropriate to 
align the level for aflatoxins in Brazil nuts with the 
Codex level for almonds, hazelnuts and pistachios.EN L 50/8 Official Journal of the European Union 27.2.2010  
( 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 ) The EFSA Journal  (2007) 446, 1-127. http://www.efsa.europa.eu/cs/ 
BlobServer/Scientific_Opinion/CONTAM%20_op_ej446_aflatoxins_ 
en.pdf?ssbinary = true  
( 5 ) Statement of the Scientific Panel on Contaminants in the Food Chain 
on a request from the European Commission on the effects on 
public health of an increase of the levels for aflatoxin total from 
4 μg/kg to 10 μg/kg for tree nuts other than almonds, hazelnuts and 
pistachios.  The EFSA Journal  (2009) 1168, 1-11. http://www.efsa. 
europa.eu/cs/BlobServer/Statement/contam_statement_ej1168_ 
aflatoxin_other_treenuts_en,0.pdf?ssbinary = true(6) Codex Alimentarius established only a maximum level 
for aflatoxin total. The corresponding aflatoxin B1 level 
was determined by making use of the database on 
occurrence of aflatoxins in food used by EFSA for the 
exposure assessment.  
(7) In the EFSA opinion on aflatoxins it is 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 etc. It is therefore 
proposed to also set a maximum level for oilseeds 
other than groundnuts (peanuts), in line with the 
existing maximum levels for groundnuts (peanuts). 
However, as aflatoxins are nearly completely removed 
by the process for producing refined vegetable oils, it is 
appropriate to exclude oilseeds, including groundnuts 
(peanuts), intended for crushing for refined vegetable 
oil and refined vegetable oil.  
(8) 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 established. Rice 
in husk regularly contains levels of aflatoxins slightly 
above the maximum levels. After milling, a process 
which removes the husk, the levels of aflatoxins in the 
white milled rice are below the maximum levels. It is 
therefore appropriate to apply the same approach for 
rice as the existing approach for maize, and to set a 
higher maximum level of aflatoxin B1 and aflatoxin 
total for rice to be subjected to sorting or other 
physical treatment before human consumption or use 
as an ingredient in foodstuffs.  
(9) The maximum levels refer to the edible part of the tree 
nuts. However, recent scientific evidence has demon ­
strated that a part of the aflatoxin contamination can 
be found on the shell of Brazil nuts. Therefore, it is 
appropriate to modify the footnote in the Annex, indi ­
cating the procedure to be followed in case tree nuts ‘in 
shell’ are analysed, to take into account this recent 
scientific information.  
(10) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
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 oilseeds, tree 
nuts, dried fruit, rice and maize  
Groundnuts (peanuts), other oilseeds, tree nuts, dried fruit, 
rice and maize not complying with the appropriate 
maximum levels of aflatoxins 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 consumption 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 sorting 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, and bearing the 
indication “product shall be subjected to sorting or other 
physical treatment 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. and on the original 
accompanying document. The consignment/batch identi ­
fication code shall be indelibly marked on each indi ­
vidual 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 (peanuts), other 
oilseeds, derived products thereof and cereals  
A clear indication of the intended use must appear on the 
label of each individual bag, box, etc. and on the original 
accompanying document. This accompanying document 
must have a clear link with the consignment by means of 
mentioning the consignment identification code, which is on 
each individual bag, box, etc. of the consignment. In addition 
the business activity of the consignee of the consignment 
given on the accompanying document must be compatible 
with the intended use.  
In the absence of a clear indication that their 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 (peanuts), other oilseeds and derived products 
thereof and cereals placed on the market.EN 27.2.2010 Official Journal of the European Union L 50/9As regards the exception of groundnuts (peanuts) and other 
oilseeds for crushing and the application of the maximum 
levels laid down in point 2.1.1 of the Annex, the exception 
only applies to consignments which are clearly labelled 
showing their use and bearing the indication “product 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. and on the accompanying 
document(s). The final destination must be a crushing plant.’;  
3. the Annex is amended as follows:  
(a) subsection 2.1 (Aflatoxins) is replaced by the text in the 
Annex to this Regulation;  
(b) footnote 5 is replaced by the following:  
‘( 5 ) The maximum levels refer to the edible part of 
groundnuts (peanuts) and tree nuts. If groundnuts 
(peanuts) and tree nuts “in shell” are analysed, it is 
assumed when calculating the aflatoxin content all 
the contamination is on the edible part, except in 
the case of Brazil nuts.’;  
(c) the following footnotes are added:  
‘( 40 ) Oilseeds falling under codes CN 1201, 1202, 1203, 
1204, 1205, 1206, 1207 and derived products CN 
1208; melon seeds fall under code ex 1207 99.  ( 41 ) In case derived/processed products thereof are 
derived/processed solely or almost solely from the 
tree nuts concerned, the maximum levels as estab ­
lished for the corresponding tree nuts apply also to 
the derived/processed products. In other cases, 
Article 2(1) and 2(2) apply for the derived/ 
processed products.’  
Article 2  
This Regulation shall not apply to apricot kernels, oilseeds, 
other than groundnuts (peanuts) and processed products 
thereof, which were placed on the market at a date prior to 
the date of application in conformity with the provisions 
applicable at such date.  
The burden of proving when the products were placed on the 
market shall be borne by the food business operator.  
Article 3  
This Regulation shall enter into force on the 10th day following 
its publication in the  Official Journal of the European Union . 
It shall apply from the date of entry into force.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 26 February 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 50/10 Official Journal of the European Union 27.2.2010ANNEX  
Foodstuffs (  1 ) Maximum levels ( μg/kg)  
‘2.1.  Aflatoxins  B  1 Sum of B  1 , B  2 , G  1 
and G  2 M 1 
2.1.1.  Groundnuts (peanuts) and other oilseeds (  40 ), to be 
subjected to sorting, or other physical treatment, 
before human consumption or use as an ingredient 
in foodstuffs, 
with the exception of: 
— groundnuts (peanuts) and other oilseeds for 
crushing for refined vegetable oil production  8,0 (  5 ) 15,0 (  5 ) —  
2.1.2.  Almonds, pistachios and apricot kernels to be 
subjected to sorting, or other physical treatment, 
before human consumption or use as an ingredient 
in foodstuffs  12,0 (  5 ) 15,0 (  5 ) —  
2.1.3.  Hazelnuts and Brazil nuts, to be subjected to sorting, 
or other physical treatment, before human 
consumption or use as an ingredient in foodstuffs  8,0 (  5 ) 15,0 (  5 ) 
2.1.4.  Tree nuts, other than the tree nuts listed in 2.1.2 and 
2.1.3, to be subjected to sorting, or other physical 
treatment, before human consumption or use as an 
ingredient in foodstuffs  5,0 (  5 ) 10,0 (  5 ) —  
2.1.5.  Groundnuts (peanuts) and other oilseeds (  40 ) and 
processed products thereof, intended for direct 
human consumption or use as an ingredient in 
foodstuffs, 
with the exception of: 
— crude vegetable oils destined for refining 
— refined vegetable oils  2,0 (  5 ) 4,0 (  5 ) —  
2.1.6.  Almonds, pistachios and apricot kernels, intended for 
direct human consumption or use as an ingredient in 
foodstuffs (  41 ) 8,0 (  5 ) 10,0 (  5 ) —  
2.1.7.  Hazelnuts and Brazil nuts, intended for direct human 
consumption or use as an ingredient in foodstuffs (  41 ) 5,0 (  5 ) 10,0 (  5 ) 
2.1.8.  Tree nuts, other than the tree 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 ) 4,0 (  5 ) —  
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 products thereof, intended 
for direct human consumption or use as an ingredient 
in foodstuffs  2,0 4,0  —  
2.1.11.  All cereals and all products 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 27.2.2010 Official Journal of the European Union L 50/11Foodstuffs (  1 ) Maximum levels ( μg/kg)  
2.1.12.  Maize and rice to be subjected to sorting or other 
physical treatment before human consumption or 
use as an ingredient in foodstuffs  5,0 10,0  —  
2.1.13.  Raw milk (  6 ), 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 thereof, whole or ground, 
including chillies, chilli powder, 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 or more of the 
abovementioned spices  5,0 10,0  —  
2.1.15.  Processed cereal-based foods and baby foods for 
infants and young children (  3 ) ( 7 ) 0,10  —  —  
2.1.16.  Infant formulae and follow-on formulae, including 
infant milk and follow-on milk (  4 ) ( 8 ) — —  0,025  
2.1.17.  Dietary foods for special medical purposes (  9 ) ( 10 ) 
intended specifically for infants  0,10  —  0,025’EN L 50/12 Official Journal of the European Union 27.2.2010