WORLD TRADE  
ORGANIZATION  G/SPS/GEN/533 
16 November 2004 
 (04-4868) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
REPLY TO COMMENTS SUBMITTED BY COLOMBIA 
 
Submission by the European Communities
 
  
 The following communication, dated 5 November 2004, is being circulated at the request of 
the Delegation of the European Communities.  
_______________ 
  
 The European Communities thanks Colombia  for providing comments to the "Draft 
Commission Regulation amending Commission Regula tion (EC) No. 466/2001 (Official Journal L77, 
16/03/2001;  pages 1-13) as regards ochratoxin A" (OTA) notified to the WTO in document 
G/SPS/N/EEC/247.  The European Communities h as examined the comments carefully and is 
providing hereby a response to the issues raised by Colombia. 
 
Comment by Colombia: 
 Cereals and cereal products are stated to be the main contributor of OTA to the European diet 
(50 per cent) and the studies cited show that the contribution of coffee to OTA intake is 8 per 
cent.  We would therefore like to know the argume nt used to maintain, without any scientific 
justification whatsoever, that the OTA intake fr om coffee is considered significant enough to 
justify the levels established in the notified draft measure. 
 
Toxicology and the need for measures to re duce the presence of OTA in the food chain
 
 
1. The EU Scientific Committee on Food (SCF) c oncluded in its opinion on OTA, expressed on 
17 September 1998, that OTA is a mycotoxin which possesses carcinogenic, nephrotoxin, teratogenic, immunotoxic and possibly neurotoxic properties.  Therefore the Scientific Committee for Food 
considers "it would be prudent to reduce exposure to  ochratoxin A as much as possible".  
2. Furthermore, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated 
ochratoxin A at its 56
th meeting in 2001.  JECFA concluded that "efforts are needed to ensure that 
intakes of ochratoxin A do not exceed the PTWI [provisional tolerable weekly intake] , and this could 
best be achieved by lowering overall contami nation by appropriate agricultural, storage and 
processing practices".  
3. The effective implementation of prevention measu res is of major importance to reduce overall 
contamination.  The adoption of achievable maximum levels does provide a strong incentive for the 
application of these preventive measures.  They furt her provide a tool for the authorities to control the 
correct application by each actor in th e chain of these prevention measures.  G/SPS/GEN/533 
Page 2  
 
 Exposure assessment 
 
 
4. An assessment of the dietary intake of OTA by the population of the European Communities 
has been performed in the framework of Council Directive 1993/5/EEC of 25 February 1993 on assistance to the Commission and co-operation by the member States in the scientific examination of 
questions relating to food (SCOOP).
 1  The main contributor to the OTA exposure is cereal and cereal 
products.  Wine, coffee and beer were identified as significant contributors to human OTA exposure.  Dried vine fruit and grape juice contributed to a si gnificant extent to the OTA-exposure for specific 
vulnerable groups of consumers such as children. 
The measures 
 
 
5. A maximum level for OTA has been already est ablished for cereal and cereal products and 
dried vine fruit by Regulation (EC) 466/2001 and h as been applied since 5 April 2002.  The level of 
OTA in beer is indirectly controlled as the OTA in  beer originates from the presence of OTA in malt, 
for which a maximum level of 3 µg/kg has been es tablished.  The setting of a maximum level for 
OTA in beer is therefore not immediately necessary to protect public health as the level of OTA in 
beer is indirectly controlled by the maximum level of OTA in malt.  
6. Given the significant contribution of wine and roasted coffee together with soluble coffee to 
the OTA human exposure and the significant contribu tion of grape juice to the OTA exposure of 
children, it is appropriate to set maximum levels  for these foodstuffs, in addition to the existing 
maximum levels of OTA, to protect public hea lth by preventing the distribution of unacceptably 
highly contaminated foodstuffs: 
- roasted coffee beans and ground roasted coffee  5.0 µg /kg 
- s o l u b l e  c o f f e e       1 0 . 0  µg /kg 
- wine and other wine and/or grape must based beverages 2.0 µg/kg 
- grape juice and grape juice ingredients in other beverages 2.0 µg /kg 
Comment by Colombia: 
 
What method was established to determine the maximum OTA levels in roasted and soluble coffee?  
7. Commission Directive 2002/26/EC of 13 March 2002 laying down the sampling methods and 
the methods of analysis for the official control of the levels of ochratoxin A in foodstuffs fixes general 
criteria, with which the method of analysis has to co mply in order to ensure that the laboratories in 
charge of the control use methods of analysis with comparable levels of performance.  These 
performance criteria consist, inter alia , of the repeatability, the  reproducibility and the recovery rate. 
                                                     
 
1 OJ L 52, 4.3.1993, p. 18.  G/SPS/GEN/533 
 Page 3 
 
 
 Performance characteristics for ochratoxin A  
 
Ochratoxin A 
 Level µg/kg 
RSD
r % RSD R % Recovery % 
< 1 ≤ 40 ≤ 60 50 to 120 
1 - 10 ≤ 20 ≤ 30 70 to 110 
  
• The detection limits of the methods used are not  stated as the precision values are given at the 
concentrations of interest 
• The precision values are calculated from the Horwitz equation:  RSD
R = 2(1-0.5logC)
 
 WHERE: 
 
• RSD R is the relative standard deviation calculated from results generated under 
reproducibility conditions [(s R / x) x 100] 
• C is the concentration ratio (i.e. 1 = 100g/100g, 0.001 = 1,000 mg/kg 
 This is a generalized precision equation, which has been found to be independent of analyte and 
matrix but solely dependent on concentrati on for most routine methods of analysis. 
 
8. The CEN method EN 14132 "Determination of ochratoxin A in barley and roasted coffee – 
HPLC method with immunoaffinity column clean- up" complies with the criteria set out in the 
legislation.  
Comment by Colombia: 
 
If cereals and cereal products are the main source s of OTA exposure in the European diet, why 
are the maximum levels established for them  the same as those for roasted coffee? 
 
9. The level established for cereal products for hu man consumption is not the same as the level 
proposed for roasted coffee.  All products derived from cereals (including processed cereal products 
and cereal grains intended for direct human consump tion) have to comply with the maximum level of 
3 µg/kg, including also the cereals and cereal products used as an ingredient in foodstuffs.  The maximum level proposed for roasted coffee beans a nd ground roasted coffee, with the exception of 
soluble coffee, is 5 µg/kg.  
10. The raw cereal grains for which a maximum leve l of 5 µg/kg is estab lished are not intended 
for direct consumption or direct use as an ingredient in foodstuffs but have to undergo a cleaning, 
sorting or other physical treatment to reduce the OTA content before their use as foodstuff or as an 
ingredient in foodstuffs (to be compared with "g reen coffee" which has fi rst to undergo a treatment 
before use as foodstuff).  
Comment by Colombia: 
 
If beer is indirectly controlled by means of th e maximum OTA limits established for its main 
input, namely malt, why is soluble coffee co ntrolled by maximum OTA limits when its main 
input, roasted coffee, is also controlled? 
 
11. The concentration factor of OTA in soluble coffee is about 2 in comparison with ground 
roasted coffee.  In the absence of a specific maximu m level of OTA in soluble coffee, there is the real G/SPS/GEN/533 
Page 4  
 
 risk that control authorities would apply the same  maximum level for OTA in soluble coffee as the 
level established for roasted coffee, which would cr eate trade problems for soluble coffee.  As the 
concentration factor is about two, the establishment of a maximum level of 10 µg/kg for soluble coffee, and the compliance with it, does not requi re additional efforts from the operator in case the 
soluble coffee is obtained from ground roasted coffee complying with the maximum level of 5 µg/kg 
OTA.  On the other hand, it does provide a guarantee on the uniform enforcement of a harmonized 
maximum level across the European Communities.  
Comment by Colombia: 
 Why is there a need to protect public health in relation to soluble coffee and not in relation to 
beer? 
 
12. The answer to this question can be found in  the answer on question 1 (exposure assessment) 
combined with the answer given on question 4. 
 
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