EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10000/2022 CIS 
(POOL/E2/2022/10000/10000 -EN 
CIS.docx)  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of ochratoxin A in 
certain foodstuffs  
(Text with EEA relevance)   EN 0  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of ochratoxin A in 
certain foodstuffs  
(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 food1, and in particu lar Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 sets maximum levels for certain 
contaminants , including ochratoxin A , in foodstuffs.  
(2) Ochratoxin A is a mycotoxin naturally produced by fungi of the genus Aspergillus and 
Penicillium and is found as a contaminant in a wide variety of foods, such as  cereals 
and ce real products, coffee beans, dried fruits, wine and grape juice, spices and 
liquorice . Ochratoxin A is formed during sun drying and storage of crops . The 
formation  can be prevented by applying good drying and storage practices.    
(3) In 20 20, the European Food Safety Authority (‘the Authority’) adopted an update of 
the scientific opinion on ochratoxin A in food3. The Authority considered that it was  
not appropriate to establish a health based guidance value for ochratoxin A and that 
the Tolerable Weekly Intake of 120 ng/kg body weight ( bw) as established by the 
Authority in 2006 is consequently no longer valid.  It further concluded that t he 
calculated  margins of exposure for carcinogenic effects  of ochratoxin A  indicate a 
possible health concern for certain consumer groups.  
(4) Maximum levels for ochratoxin A have already been established for certain foods by 
Regulation (EC) No 1881/2006. Taking into accou nt that ochratoxin A has been found 
in foods for which no maximum level has been established yet and which contribute to 
the human exposure to ochratoxin A, it is appropriate to set a maximum level also for 
these foods such as dried fruit other than dried vine fruit, certain liquorice products, 
dried herbs, certain ingredients for herbal infusions, certain oilseeds, pistachio nuts 
and cocoa powder. Even if the relationship between the level of ochratoxin A in malt 
and in non -alcoholic malt beverages, and in  dried dates and date syrup needs to be 
further clarified, it is also appropriate to set already a maximum level in non -alcoholic 
malt beverages and date syrup. Also taking into account the available occurrence data, 
                                                 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (EC) No 1881/2006 of 19 December  2006 setting maximum levels for certain 
contaminants in foodstuffs  (OJ L 364, 20.12.2006, p. 5 ).  
3 Scientific Opinion on the   risk assessment of ochratoxin A in food. EFSA Journal 2020;  18(5):6113, 
150 pp. https://doi.org/10.2903/j.efsa.2020.6113 . 
 EN 1  EN it is appropriate to lower the existing  maximum levels  of ochratoxin A  in certa in 
foods , such as bakery products, dried vine fruit, roasted coffee and soluble coffee . In 
addition, the existing provisions for ochratoxin A in certain spices has been broadened 
to all spices. For cheese and ham, ad ditional monitoring on the presence of ochratoxin 
A is appropriate before establishing maximum levels.  
(5) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(6) To enable economic operators to prepare for the new rules introduced by this 
Regulation, it is appropriate to provide for a reasonable time until the new maximum 
levels apply . It is also appropriate  to provide for a transitional period for foodstuffs 
lawful ly placed on the market before the date of application of this Regulation .  
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EC) No  1881/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2   
Foodstuffs listed in the Annex , lawfully placed on the market before 1 January 2023 , may 
remain on the market  until their date of minimum durab ility or use -by-date.   
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
It shall apply from 1 January 2023.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  