WORLD TRADE
ORGANIZATIONG/SPS/GEN/98
14 October 1998
(98-3950)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION G/SPS/N/EEC/51
General reply of the European Communities
The following communication was received from the European Communities on
12 October 1998.
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Toxicology of aflatoxins
1. The Scientific Committee for Food of the European Community (SCF) expressed on
23 September 1994 an opinion on aflatoxins, ochratoxin A and patulin (Reports of the Scientific
Committee for Food, 35th series).
2. At that time the Committee concluded for aflatoxins , inter alia :
"Aflatoxins are genotoxic carcinogens.   For this type of carcinogen, it is generally felt that
there is no threshold dose below which no tumour formation would occur.  In other words,
only a zero level of exposure will result in no risk.
It agreed with the recent evaluations of IARC1 (1993) with respect to the carcinogenicity and
genotoxicity of the aflatoxins.  From the many reports on risk assessment, it can be concluded
that even very low levels of exposure to aflatoxins, i.e. 1 ng/kg b.w./day or less contribute
to the risk of liver cancer.
For aflatoxin M1, the Committee concluded that there is sufficient evidence that aflatoxin M1
is a genotoxic carcinogen ; its carcinogenic potency is estimated to be approximately
10 times lower than aflatoxin B1."
3. This evaluation is also in agreement with the JECFA2 evaluation (1987) that for these potent
carcinogens (aflatoxins) their presence in food should be limited to "irreducible levels" which it
defined as "that concentration of a substance which can not be eliminated from a food without
involving the discarding of the food altogether, severely compromising the ultimate availability ofmajor food supplies".
3
4. At the 49th meeting, held in Rome, Italy from 17 to 26 June 1997, the JECFA reviewed a wide
range of studies in both animals and humans that provided qualitative and quantitative information on
the hepato-carcinogenicity of aflatoxins.  The report  of the discussions concerning aflatoxins has been
                                                     
1 International Agency for Research on Cancer.
2 Joint FAO/WHO Expert Committee on Food Additives.
3 Evaluation of certain food additives and contaminants; Thirty-first report of the Joint FAO/WHO
Expert Committee on Food Additives; WHO Technical Report Series 759, WHO, Geneva, 1987.G/SPS/GEN/98
Page 2
disseminated as a draft with the summary report of the meeting.  Many notifications of third countries
referred to this JECFA report.4
5.  The Scientific Committee for Food of the European Community (SCF) discussed this recent
JECFA evaluation at its 108th plenary session in September 19975 merely on the basis of the draft
summary report.
6. The Committee (SCF) recognized the great effort made by JECFA to perform a quantitative
risk assessment by combining carcinogenic potencies and human exposure data, but noted also the
several limitations and assumptions, inherent in this approach, which were clearly set out in the
report.  The Committee concluded that it was not possible to assess the degree of uncertainty, arising
from these limitations and assumptions, in the quantitative risk assessment and felt therefore that it
was premature for SCF to draw definitive conclusions on this issue.
7. The Committee noted that the toxicology of the aflatoxins is not questioned by JECFA
"Aflatoxins are amongst the most potent muta genic and carcinogenic substances known" and
that several statements of the JECFA are not in compatible with the SCF opinion on aflatoxins
expressed in 1994 and concluded that this opinion remains valid.
8. On the basis of this assessment it is considered that fixing maximum levels, besides
preventive measures to avoid contamination, contri bute to the protection of the consumer.  These
limits must be set at a level as low as reasonably achievable (= ALARA principle) .
Maximum limits
9. For groundnuts, nuts, dried fruit, cereals and processed products thereof intended for direct
human consumption or as an ingredient in foodstuffs, maximum limits remain at the level of 4 µg/kgaflatoxin total (B
1 +B 2 + G 1 + G 2) and 2 µg/kg, aflatoxin Bl.  It is generally accepted that the
establishment of an international standard for raw commodities applying to incoming raw materials
does not preclude individual countries from establishing more stringent standards for finished
products that ultimately reach the consumer.6
10. Sorting techniques and other possible physical treatments which reduce the aflatoxin content
can be carried out on unprocessed groundnuts, nuts, dried fruit and possibly cereals to obtain the final
consumer product.  Taking these techniques into account, higher maximum limits for groundnuts, nuts
and dried fruit to be subjected to a sorting or other physical treatment, before their human
consumption or their use as an ingredient in foodstuffs are proposed.
11. Following modifications have been adopted to the draft measures as notified, taking into
account the comments:
12. Maximum limits for unprocessed groundnuts has been increased from 10 ppb  (aflatoxin
total) to 15 ppb , in line with the limit currently under discussion in Codex Alimentarius.7  T h i s
increase will also be considered for unprocessed nuts, dried fruit if data are provided before
1 July 1999 proving the effectiveness of the sorting techniques or other physical treatments to reduce
                                                     
4 Joint FAO/WHO Expert Committee on Food Additives, Forty-ninth meeting, Rome, 17-
26 June 1997, Summary and Conclusions, enclosed section.
5 Minutes of the 108th meeting of the Scientific Committee for Food held on 18-19 September 1997 in
Brussels.
6 CRD 5 of the 28th CCFAC meeting.
7ALINORM 99/12, Report of the Thirtieth Session of the Codex Committee on Food Additives and
Contaminants, The Hague, The Netherlands, 9-13 March 1998, paras. 64-72 and Appendix X.G/SPS/GEN/98
Page 3
an aflatoxin level of 15 ppb in unprocessed nuts and dried fruit to the maximum level set for products
intended for direct human consumption or use as an food ingredient.
13. For cereals it cannot be excluded that sorting techniques or other physical treatments can
reduce the level of contamination of aflatoxins.  In order to be able to check the real effectiveness of
the sorting techniques or other physical treatments and, if necessary to fix specific maximum limitsfor the unprocessed cereal, the maximum limits laid down in the Regulation apply only to the cereals
and processed products thereof intended for direct human consumption or as an ingredient in
foodstuffs.  In the absence of data justifying the fixing of a specific maximum limit for unprocessed
cereals, the maximum limit laid down for cereals and processed products thereof intended for direct
human consumption or as an ingredient of food, will also apply to the unprocessed cereals from
1 July 1999 on.
14. Aflatoxin M1 is believed to be significantly less carcinogenic than aflatoxin Bl.  However,
because the intakes of milk and milk products by humans can be considerable, particularly among
infants and young children, a maximum limit of aflatoxin M1 for milk has been set at the level of 0.05
µg/kg aflatoxin M1.  The maximum limit of 0.05 ppb of aflatoxin M1 for milk and milk products is in
line with the standard currently under discussion in the Codex Alimentarius.
8
Sampling provisions
15. Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the
methods of analysis for the official control of the levels for certain contaminants in foodstuffs9 apply
to the competent authorities of the Member States  which have to ensure that the sampling, sample
preparation and methods of analyses used for the official control of the level of aflatoxins infoodstuffs is carried out in accordance with the pr ovisions laid down in Annexes of this Directive.
Therefore the draft directive has not been formally notified to the WTO.  As this Directive does not
involve direct obligations towards third countries, the draft measure has not been formally notified.
However, given the importance of the sampling provisions to determine the aflatoxin content of a lot,
the draft measures have been transmitted to the WTO for information.
16. In the comments submitted by Members of WTO, many comments referred to the sampling
provisions.
17. Adequate sampling is crucial for estimating lot average levels and is an essential component
in the development of any standard for mycotoxins, particularly due to the non-homogeneous
distribution of aflatoxin contamination in foods such as grains, nut kernels, pulses and dried fruits
(e.g. figs).  In such material the distribution is seldom homogeneous.  Whereas only a small number of
particles may be contaminated, these individual particles may be highly contaminated.  In order todescribe the expected distribution and to ensure that such isolated "hot spots" are detected adequate
sampling is needed ( ... ) (paragraph 5 of CX/FAC 97/16).
18. As the result of the comments made by several Members of WTO, the sampling provisions
for the products intended to be subjected to sortin g or other physical treatment to reduce the aflatoxin
contamination have been modified taking into account the comments from the Members of WTO,while the sampling provisions for final consumer products remained unchanged.
19. As mentioned above, the sampling provisions to control the aflatoxin level in products
intended for direct human consumption or use as an ingredient in food remained unchanged.  It is
                                                     
8ALINORM 99/12, Report of the Thirtieth Session of the Codex Committee on Food Additives and
Contaminants, The Hague, The Netherlands, 9-13 March 1998, paras. 73-75 and Appendix X.
9 OJ L201, 17.7.98, p.93.G/SPS/GEN/98
Page 4
generally accepted that the establishment of an international standard for raw commodities applying to
incoming raw materials does not preclude individual countries from establishing more stringent
maximum limits for finished products that ultimately reach the consumer.10  It is consistent with this
reasoning that sampling provisions at international level for raw commodities does not preclude more
stringent sampling rules at country level for products intended for direct human consumption or use asan ingredient in food.  Indeed, the European Communities is of the opinion that the sampling
provisions must minimize the consumer's risk , without rendering trade impossible or causing
enormous costs for the operators.
20. As already mentioned above, the sampling provisions for the products intended to be
subjected to sorting or other physical treatment to reduce the aflatoxin contamination (raw products)
have been modified as a result of comments made by Members of WTO.  The draft directive,
transmitted for information to WTO, stipulated that each subsample of the aggregate sample has tocomply with the maximum limit.  The modification consists of that the above-mentioned Commission
Directive 98/53/EC provides for that in the case of groundnuts, nuts and dried fruit subjected to a
sorting or other physical treatment the lot is accepted if the aggregate sample (in case the available
equipment is able to homogenize the aggregate sample as a whole) or the average of the
subsamples conforms to the maximum limit.
21. It can be stated that the sampling provisions fixed for the products intended to be subjected to
sorting or other physical treatment are to a great exte nt in line with the sampling provisions which are
currently under discussion in the Codex Alimentarius .
11
22. However some differences remain.  The European Communities refers therefore to the
relevant comments submitted at the 30th session of CCFAC.12  These points are reiterated hereafter.
23. The sampling plan currently under discussion in Codex (100 incremental samples, 20 kg
sample) provides an approximately equal balance between the producer risk and the consumer risk.
Because of the toxicity of the aflatoxins, the European Communities is of the opinion that a sampling
plan must minimize the consumer's risk, withou t rendering trade impossible or causing enormous
costs for the operators.
24. The European Commission services notes that in the assumption of a guideline level of
15 µg/kg and using the sampling plan, currently under discussion in Codex13 for raw shelled peanuts,
a lot with aflatoxin concentration of 30 µg/kg (2x guideline level) will be accepted in 32.5 per cent of
the cases and a lot with aflatoxin concentration of 60 µg/kg (4x guideline level) in 9.5 per cent
(acceptance probabilities on the basis of data contained in the FAO Food and Nutrition Paper 55
(Rome, 1993), "Sampling Plans for Aflatoxin Analysis in Peanuts and Corn".
25. The European Communities consider the acceptance probabilities of lots with such a high
aflatoxin content too high and is of the opinion that because of the toxicity of the aflatoxins, the
sampling plan must minimize the consumer's ri sk, without rendering trade impossible or causing
enormous costs for the operators.
26. Furthermore in appendix X of ALINORM 99/12 it is stated that the "[Maximum of [15 µg/kg]
for total aflatoxins for peanuts intended for further processing, based on a sample size of 20 kg as
                                                     
10 CRD 5 of the 28th CCFAC meeting.
11 ALINORM 99/12, Report of the Thirtieth Session of the Codex Committee on Food Additives and
Contaminants, The Hague, The Netherlands, 9-13 March 1998, paras. 64-72 and Appendix X.
12  CRD 5 - Comments from EC submitted in response to CL 1997/6-FAC.
13 ALINORM 99/12, Report of the Thirtieth Session of the Codex Committee on Food Additives and
Contaminants, The Hague, The Netherlands, 9-13 March 1998, Appendix X.G/SPS/GEN/98
Page 5
referenced in the following material obtained from FAO Food and Nutrition Paper 55 (Rome, 1993),
"Sampling Plans for Aflatoxins Analysis in Peanuts and Corn"]".  However the operating
characteristic curves and proposed sample size enclosed refer only to raw shelled peanuts, while the
proposed draft maximum level and sampling plan refer peanuts intended for further processing.
However from the data provided in the FAO Food an d Nutrition Paper 55 it can be concluded that for
in-shell peanut a sample size of 27 kg is needed to obtain similar acceptance probabilities as for the
20 kg samples in the case of raw shelled peanuts.
27. Another important remark of the European Communities is that the number of incremental
samples to be taken must be defined as a function of the lot size.
28. Linking the number of incremental samples to lot sizes for sampling for aflatoxin
contamination is scientifically justified because of the very heterogeneous distribution of aflatoxins
within a lot.  It is generally recognized that in the case of heterogeneous distribution of thecontaminant to be controlled within a lot, the samp le size (number of incremental samples) has to be
increased as the lot size increases to guarantee an equivalent level of performance.
29. General guidelines on sampling have been considered at the Codex Committee on Methods of
Analysis and Sampling since its 19
th Session for three consecutive sessions.  Paragraph 2.2.9 Lot size
and sample size of the document CX/MAS 98/3 which will be discussed at the next session of theCodex Committee on Methods of Analysis and Sampling
14 states that "it is usual to increase the
sample size as the lot size increases, especially when the lot is not homogeneous".
30. This principle is also applied in existing. sampling plans currently used in the United States,
United Kingdom and the Netherlands where the number of incremental samples to be taken is defined
as a function of the lot size.15
31. The European Commission services are therefore of the opinion that the sampling plan should
specify the lot size to which the sampling provisions apply and has taken up this provision in the
sampling plan as described in Commission Directive 98/53/EC.  In accordance with the paragraph 71
of the report of the Thirtieth Session of the Codex Committee on Food Additives and Contaminants
(ALINORM 99/12), the European Communities has th e intention to submit an alternative sampling
plan to the Codex Alimentarius Commission for cons ideration by the twenty-third Session of the
Codex Alimentarius Commission in Rome from 28 June to 3 July 1999.
Methods of analysis
32. The European Commission services are of the opinion that a criteria-based approach, whereby
a set of performance criteria are established with which the method used should comply, is
appropriate.  The criteria-based approach has the advantage that, by avoiding setting down specificdetails of the method used, developments in methodology can be exploited without having to
reconsider or modify the specified method.  The performance criteria established for methods should
include all the parameters that need to be addres sed by each laboratory such as the detection limit,
repeatability, coefficient of variation, reproducibility coefficient of variation, and the percent recovery
necessary for various statutory limits.  Utilizing this approach, laboratories would be free to use theanalytical method most appropriate for their facilities.
                                                     
14 Agenda item 4(a) of the Twenty-second Session of the Codex Committee on Methods of Analysis
and Sampling, Budapest, Hungary, 23-27 November 1998.
15 Whitaker et al (1995) Evaluation of Sampling Plans Used in the United States, United Kingdom and
the Netherlands to test raw shelled peanuts for aflatoxin, Journal of AOAC International Vol. 78, No 4, pp.1010-
1018.G/SPS/GEN/98
Page 6
33. The criteria-based approach is also discussed at the Codex Committee on Methods of
Analysis and Sampling.  Point 2 of the document CX/MAS 98/5 "Criteria for evaluating Acceptable
Methods of Analysis for Codex Purposes - Method s of Analysis or Method Criteria" which will be
discussed at the next session of the Codex Committee on Methods of Analysis and Sampling16 states
that "The Committee has accepted in principle an alternative approach whereby a defined set ofcriteria to which methods should comply without specifically endorsing specific methods should be
adopted".
34. Furthermore, besides analytical methods based on TLC for aflatoxin quantification as
proposed in Codex, HPLC methods are now  also commonly used on a routine basis.
35. The European Commission services question also the need to mention "a hammer mill with a
# 14 screen (3.1 mm diameter hole in the screen) similar to the type used by the US Department of
Agriculture to prepare samples for aflatoxin analysis  is specified for peanuts" in an international
standard and has adopted a more general requirement such as, that the laboratory sample should be
finely ground and mixed thoroughly using a process that has been demonstrated to achieve complete
homogenisation.
36. For the above-mentioned reasons the provisions concerning the method of analysis in
Commission Directive 98/53/EC are not identical to the provisions outlined in Appendix X of
ALINORM 99/12.  In accordance with the paragraph 71 of the report of the Thirtieth Session of the
Codex Committee on Food Additives and Cont aminants (ALINORM 99/12), the European
Communities has the intention to submit comments  to the provisions concerning the sample
preparation and proposed method of analysis to the Codex Alimentarius Commission for
consideration by the twenty-third Session of th e Codex Alimentarius Commission in Rome from 28
June to 3 July 1999.
                                                     
16 Agenda item 5 of the Twenty-second Session of the Codex Committee on Methods of Analysis and
Sampling, Budapest, Hungary, 23-27 November 1998.G/SPS/GEN/98
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ANNEX
NOTIFICATION G/SPS/N/EEC/51
COMMENTS RECEIVED FROM MEMBER OF WTO
COUNTRY DATE
INDIA (1) 23.01.1998
IRAN 24.01.1998
GAMBIA 04.02.1998
PHILIPPINES 11.02.1998
MALAYSIA 12.02.1998
AUSTRALIA 12.02.1998
UNITED STATES OF AMERICA 13.02.1998
TURKEY 13.02.1998
ARGENTINA 13.02.1998
SOUTH AF RICA 13.02.1998
SENEGAL 13.02.1998
INDIA (2) 13.02.1998
INDIA (3) 16.02.1998
THAILAND 16.02.1998
BRAZIL 16.02.1998
PERU 25.02.1998
NEW ZEALAND 23.03.1998
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