COMMISSION REGULATION (EU) No 594/2012  
of 5 July 2012  
amending Regulation (EC) 1881/2006 as regards the maximum levels of the contaminants 
ochratoxin A, non dioxin-like PCBs and melamine in 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 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) Commission Regulation (EU) No 1259/2011 (  3 ), 
amending Regulation (EC) No 1881/2006, established 
new maximum levels for non dioxin-like PCBs applicable 
as from 1 January 2012. It is appropriate to provide that 
those maximum levels are not applicable to foodstuffs 
which were lawfully placed on the market before that 
date.  
(3) Commission Regulation (EU) No 105/2010 (  4 ), amending 
Regulation (EC) No 1881/2006, established a final lower 
maximum level for Ochratoxin A in spices, which is 
supposed to be achievable by applying good practices. 
To enable the spices producing countries to put 
prevention measures in place and in order to avoid 
disruptions of trade to an unacceptable extent, that Regu ­
lation furthermore provided for a higher maximum level 
to be applied for a limited period of time. The Regulation 
furthermore provided that an assessment should be 
performed of the achievability of the lower levels for 
ochratoxin A by applying good practices in the 
different producing regions in the world. This assessment 
had to be done before the lower maximum level of 
Ochratoxin A would become applicable. Although a 
significant improvement in the application of good 
practices in the different producing regions in the 
world has been noticed, the projected lower maximum 
level for Ochratoxin A is not yet achieavable in  Capsicum  species on a consistent basis. It is therefore appropriate 
to postpone the application of the lower maximum level 
for Capsicum  spp.  
(4) Wheat gluten is produced as a co-product of the starch 
production. Evidence has been provided that the current 
maximum level of Ochratoxin A in wheat gluten is no 
longer achievable, in particular at the end of the storage 
season, even with the strict application of good practices 
as regards storage, possibly due to the changing climate 
conditions. It is therefore appropriate to modify the 
current maximum level to a level which is achievable 
by applying good practices and which still provides a 
high level of human health protection.  
(5) 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 in 
food (  5 ), taking into account new scientific information 
and derived a tolerable weekly intake (TWI) of 120 ng/kg 
b.w. In accordance with the conclusions of the opinion 
adopted by EFSA, the envisaged changes as regards 
Ochratoxin A in this Regulation continue to provide a 
high level of human health protection.  
(6) The EFSA has, on a request from the Commission, on 
18 March 2010, adopted a scientific opinion related to 
the melamine in feed and food (  6 ). Its findings show that 
exposure to melamine can result in the formation of 
crystals in the urinary tract. Those crystals cause 
proximal tubular damage and have been observed in 
animals and children as a result of incidents involving 
adulteration of feed and infant formula with melamine, 
leading to fatalities in some instances. The Codex 
Alimentarius Commission has established maximum 
levels for melamine in feed and food (  7 ). It is appropriate 
to include those maximum levels in Regulation (EC) No 
1881/2006 to protect public health as those levels are in 
accordance with the conclusions of the EFSA's opinion.EN 6.7.2012 Official Journal of the European Union L 176/43  
( 1 ) OJ L 37, 13.2.1993, p. 1.  
( 2 ) OJ L 364, 20.12.2006, p. 5.  
( 3 ) OJ L 320, 3.12.2011, p. 18.  
( 4 ) OJ L 35, 6.2.2010, p. 7.  ( 5 ) EFSA Panel on Contaminants in the Food Chain (CONTAM); 
Scientific Opinion on Ochratoxin A in Food EFSA Journal 2006; 
365:1-56. Available online: http://www.efsa.europa.eu/en/efsajournal/ 
doc/365.pdf  
( 6 ) EFSA Panel on Contaminants in the Food Chain (CONTAM) and 
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and 
Processing Aids (CEF); Scientific Opinion on Melamine in Food and 
Feed. EFSA Journal 2010; 8(4):1573. [145 pp.]. doi:10.2903/ 
j.efsa.2010.1573. Available online: www.efsa.europa.eu  
( 7 ) Report on the Thirty-Third Session of the Joint FAO/WHO Food 
Standards Programme, Codex Alimentarius Commission, Geneva, 
Switzerland, 5-9 July 2010 (ALINORM 10/33/REP).(7) Therefore, Regulation (EC) No 1881/2006 should be 
amended accordingly.  
(8) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council have 
opposed them,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amending provisions  
Regulation (EC) No 1881/2006 is amended as follows:  
(1) In Article 11, the first paragraph is amended as follows:  
(a) the introductory sentence is replaced by the following:  
"This Regulation shall not apply to products that were 
placed on the market before the dates referred to in 
points (a) to (f) in conformity with the provisions 
applicable at the respective date: " (b) the following points (e) and (f) are added:  
"(e) 01 January 2012 as regards the maximum levels for 
non dioxin-like PCBs laid down in section 5 of the 
Annex;  
(f) 01 January 2015 as regards the maximum level for 
Ochratoxin A in  Capsicum  spp. laid down in point 
2.2.11. of the Annex. " 
(2) The Annex is amended in accordance with the Annex to 
this Regulation.  
Article 2  
Entry into force  
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 the date of entry into force with the 
exception of the provisions laid down in point 2.2.11 of the 
Annex which shall apply from 1 July 2012.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 5 July 2012.  
For the Commission  
The President  
José Manuel BARROSOEN L 176/44 Official Journal of the European Union 6.7.2012ANNEX  
The Annex to Regulation (EC) No 1881/2006 is amended as follows:  
(1) Section 2.2 Ochratoxin A is amended as follows:  
(a) Point 2.2.2 is replaced by the following:  
"2.2.2.  All products derived from unprocessed cereals, including 
processed cereal products and cereals intended for direct 
human consumption with the exception of foodstuffs listed in 
2.2.9, 2.2.10 and 2.2.13  3,0" 
(b) Point 2.2.11 is replaced by the following:  
"2.2.11.  Spices, including dried spices  
Piper  spp (fruits thereof, including white and black pepper)  
Myristica fragrans  (nutmeg)  
Zingiber officinale  (ginger)  
Curcuma longa  (turmeric)  15 μg/kg  
Capsicum  spp. (dried fruits thereof, whole or ground, including 
chillies, chilli powder, cayenne and paprika)  30 μg/kg until 31.12.2014 
15 μg/kg as from 1.1.2015  
Mixtures of spices containing one of the abovementioned spices  15 μg/kg" 
(c) The following point 2.2.13 is inserted after point 2.2.12:  
"2.2.13.  Wheat gluten not sold directly to the consumer  8,0 " 
(2) The following section 7: Melamine and its structural analogues is added:  
"Section 7: Melamine and its structural analogues  
Foodstuffs  Maximum levels 
(mg/kg)  
7.1.  Melamine  
7.1.1.  Food with the exception of infant formulae and follow-on 
formulae (*)  2,5 
7.1.2.  Powdered infant formulae and follow-on formulae  1  
(*) The maximum level does not apply to food for which it can be proven that the level of melamine higher than 2,5 mg/kg is the  
consequence of authorized use of cyromazine as insecticide. The melamine level shall not exceed the level of cyromazine. "EN 6.7.2012 Official Journal of the European Union L 176/45