COMMISSION REGULATION (EU) No 105/2010  
of 5 February 2010  
amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in 
foodstuffs as regards ochratoxin A  
(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 (  2 ) sets 
maximum levels for certain contaminants in foodstuffs.  
(2) The Scientific Panel on Contaminants in the Food Chain 
of the European Food Safety Authority (EFSA) has, on a 
request from the Commission, adopted on 4 April 2006 
an updated scientific opinion relating to ochratoxin A 
(OTA) in food (  3 ), taking into account new scientific 
information and derived a tolerable weekly intake 
(TWI) of 120 ng/kg b.w.  
(3) It is foreseen in Regulation (EC) No 1881/2006 that the 
appropriateness of setting a maximum level for OTA in 
foodstuffs such as dried fruit other than dried vine fruit, 
cocoa and cocoa products, spices, meat products, green 
coffee, beer and liquorice, as well as a review of the 
existing maximum levels, in particular for OTA in dried 
vine fruit and grape juice, has to be considered in the 
light of the recent EFSA scientific opinion.  
(4) On the basis of the opinion adopted by EFSA, the 
existing maximum levels appear appropriate to protect 
public health and have to be retained. As regards the 
foodstuffs not yet covered by Regulation (EC) No 
1881/2006, it was considered necessary and appropriate 
for the protection of public health to establish maximum 
levels for ochratoxin A in those foodstuffs that are a 
significant contributor to the exposure of OTA (for the 
whole population, or for vulnerable group of the popu ­
lation, or for significant part of the population) or for 
those foodstuffs that are not necessarily a significant 
contributor to the exposure of OTA, but there is 
evidence that there can be found a very high level of OTA in these commodities. A maximum level is appro ­
priate to be set in these cases to avoid that those very 
highly contaminated commodities could enter the food 
chain.  
(5) On the basis of the information available, it does not 
appear necessary for the protection of public health to 
set a maximum level of OTA in dried fruit other than 
dried vine fruit, cocoa and cocoa products, meat 
products, including edible offal and blood products and 
liqueur wines as they are not a significant contributor to 
OTA exposure and high levels of OTA have been found 
only seldom in those commodities. In the case of green 
coffee and beer, the presence of OTA is already 
controlled at another more appropriate stage of the 
production chain (respectively roasted coffee and malt).  
(6) Very high levels of OTA have been observed at several 
occasions in spices and liquorice. It is therefore appro ­
priate to set a maximum level for spices and liquorice.  
(7) There is recent evidence that in some main producing 
countries of spices exporting to the Union no prevention 
measures and official controls are in place to control the 
presence of ochratoxin A in spices. In order to protect 
public health, it is appropriate to establish without delay 
a maximum level for ochratoxin A in spices. To enable 
the producing countries to put prevention measures in 
place and not to disrupt trade to an unacceptable extent, 
a higher maximum level, applicable within short notice, 
is established for a limited period of time, before the 
maximum level reflecting the level achievable by 
applying good practices enters into application. It is 
appropriate that an assessment of the achievability in 
the different producing regions in the world of the 
levels for ochratoxin A by applying good practices 
takes place before the stricter level applies.  
(8) It is appropriate to continue the monitoring of OTA in 
foodstuffs for which no maximum level has been set and 
in the case of regular findings of unusually high levels of 
OTA, setting of a maximum level for OTA in those 
foodstuffs might be considered as appropriate.  
(9) Regulation (EC) No 1881/2006 should therefore be 
amended accordingly.  
(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,EN 6.2.2010 Official Journal of the European Union L 35/7  
( 1 ) OJ L 37, 13.2.1993, p. 1.  
( 2 ) OJ L 364, 20.12.2006, p. 5.  
( 3 ) http://www.efsa.europa.eu/en/scdocs/doc/con tam_op_ej365_ 
ochratoxin_a_food_en.pdfHAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EC) No 1881/2006 is amended as 
follows:  
1. point 2.2.11 is replaced by the following points:  
‘2.2.11.  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  30 μg/kg as from 
1.7.2010 until 
30.6.2012 
15 μg/kg as from 
1.7.2012  
2.2.12.  Liquorice ( Glycyrrhiza glabra, 
Glycyrrhiza inflate  and other species)  
2.2.12.1.  Liquorice root, ingredient for herbal 
infusion  20 μg/kg  
2.2.12.2.  Liquorice extract (  42 ), for use in food 
in particular beverages and confec ­
tionary  80 μg/kg’  
2. The following footnote is added:  
‘( 42 ) The maximum level applies to the pure and undiluted 
extract, obtained whereby 1 kg of extract is obtained 
from 3 to 4 kg liquorice root).’  
Article 2  
Interested parties shall communicate to the Commission the 
results of investigations undertaken including occurrence data and the progress with regard to the application of prevention 
measures to avoid contamination by ochratoxin A in spices.  
Member States should report to the Commission findings on 
ochratoxin A in spices on a regular basis.  
The Commission will make this information available to the 
Member States in view of an assessment, before the stricter 
level applies, of the achievability in the different producing 
regions in the world of the stricter level for ochratoxin A in 
spices by applying good practices.  
Article 3  
This Regulation shall not apply to products which were placed 
on the market at a date prior to 1 July 2010 in conformity with 
the provisions applicable at such date.  
The maximum level for ochratoxin A established in point 
2.2.11 of the Annex which is applicable as from 1 July 2012 
shall not apply to products which were placed on the market at 
a date prior to 1 July 2012 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 4  
This Regulation shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
It shall apply from 1 July 2010.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 5 February 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 35/8 Official Journal of the European Union 6.2.2010