EN    EN EN 
SANCO/00875/2007 – rev 4 
  
EN 1   EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
SANCO/00875/2007 –rev 4 
 
Draft 
COMMISSION REGULATION 
of 
amending Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels 
for certain contaminants in foodstuffs as regards ochratoxin A.  
 (Text with EEA relevance) 
(Memorandum from Ms A VASSILIOU) 
  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
amending Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels 
for certain contaminants in foodstuffs as regards ochratoxin A.  
 (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 (EC) No 1881/2006
2 sets maximum levels for certain 
contaminants in foodstuffs. 
(2) The European Food Safety Authority (EFSA) has, on a request from the Commission, 
adopted an updated scientific opinion relati ng to ochratoxin A (OTA) in food on 4 
April 20063, 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 th an dried vine fruit, 
cocoa and cocoa products, spices, meat produc ts, green coffee, beer and liquorice, as 
well as a review of the existing maximum leve ls, in particular for OTA in dried vine 
fruit and grape juice, has to be considered in the light of the recent EFSA scientific 
opinion.  
                                                 
1 OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
2  OJ L  
3 Opinion of the Scientific Panel on contaminants in the Food Chain of the EFSA on a request from the 
Commission related to ochratoxin A in food.  
http://www.efsa.europa.eu/etc/medialib/efsa/scie nce/contam/contam_opinions/ 1521.Par.0001 .File.dat/c
ontam_op_ej365_ochratoxin_a_food_en1.pdf   
EN 3   EN  
(4) Based upon the opinion, it was considered that the exis ting maximum levels are 
appropriate to protect public health and have to be retained. As regards the foodstuffs 
not yet covered by Regulation (EC) 1881/ 2006, it was consider ed necessary and 
appropriate for the protection of public he alth 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 th e population, 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 very high 
levels of OTA in these commodities can be  found. A maximum level is appropriate to 
be set in these cases to avoid that thes e very highly contaminated commodities could 
enter the food chain.  
(5) It was considered, based upon the available information, not 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 wine s as they are not a signifi cant contributor to OTA 
exposure or no very high levels of OTA has been found in these commodities to a 
significant extent. In the case of green coffee and beer, the presence of OTA is already 
controlled at another more appropriate st age of the production chain (respectively 
roasted coffee and malt).  
(6) Very high levels of OTA has been observe d at several occasions in spices and 
liquorice. It is therefore appr opriate to set a maximum leve l for spices and liquorice.  
(7) A recent FVO inspection in a main exporting country of paprika to the EU, has 
demonstrated that no legislation, prevention m easures and official controls are in place 
to control the presence of ochratoxin A in spi ces. In order to protec t public heal th, it is 
appropriate to establish wit hout delay a maximum level fo r ochratoxin A in spices. 
This level should enable the producing countri es to put prevention measures in place 
and not disrupt trade to an un acceptable extent. The level ha s then to be reviewed to 
reflect the level achievabl e by applying good practices in two years time when 
exporting countries have been able to  put these good pract ices in place.   
(8) It is appropriate to continue the mon itoring of OTA in foodstuffs for which no 
maximum level has been set and in case of regular findings of unus ually high levels of 
OTA, the setting of a maximum level for OTA in these foodstuffs might be considered 
as yet appropriate taking into account these new findings.  
(9) Regulation (EC) 1881/2001 should ther efore be amended accordingly.  
(10) 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.  
EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 1881/2006 is amended as follows:  
(1) In the Annex, section 2: Mycotoxins , the following entry 2.2.11 is deleted  
"2.2.11 Green coffee, dried fruit ot her than dried vine fruit, 
beer, cocoa and cocoa produc ts, liqueur wines, meat 
products, spices and liquorice -" 
 (2)  In the Annex, section 2: Mycot oxins, the following entries 2.2.11 and 2.2.12 are 
inserted after the entry 2.2.10. 
"2.2.11 Spices  
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 containi ng one of the abovementioned 
spices  
 30 µg/kg (*)  
 
 
2.2.12. Liquorice (Glycyrrhiza gl abra, Glycyrrhiza inflate and 
other species )  
2.2.12.01 Liquorice root, ingredient for herbal infusion 
2.2.12.02 Liquorice extract  (**), for use in fo od in particular 
beverages and confectionary  
 
20 µg/kg  80 µg/kg   
(*)  The level will be reviewed before 1 July 2012 in view of setting a level of 15 µg/kg, to 
reflect the application of good pr actices to prevent ochratoxin  A formation, unless the food 
business operators can demonstrate that this lower level is not achievable by applying good 
practices.   
(**) The maximum level applies to the pure a nd undiluted extract, obtained whereby 1 kg of 
extract is obtained from 3 to 4 kg liquorice root). 
 
 Article 2 
This Regulation shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union . 
It shall apply from 1 July 2010. This Regulation shall not apply to products which were  placed on the mark et before 1 July 
2010 in conformity with the provisions applicab le. The burden of proving when the products 
were placed on the market shall be  borne by the food business operator.  
EN 5   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 Androulla  VASSILIOU 
 Member of the Commission