RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/W/78
27 August 1998
(98-3326)
Committee on Technical Barriers to Trade Original:  French
REPLY BY THE EUROPEAN COMMISSION TO THE COMMENTS BY THE
UNITED STATES AND CANADA ON NOTIFICATION 97.766
Communication from the European Community
The European Commission has transmitted the following communication, dated
13 August 1998, to the Secretariat, with the request that it be circulated to members of the Committee.
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I. BACKGROUND
1. Placing genetically modified soya beans (Glycine max L.) and genetically modified maize
(Zea mays L.) on the market had been authorized without any special labelling requirements prior to
the entry into force of Regulation (EC) No. 258/97 of the European Parliament on 15 May 1997 and
of the Council on 27 January 1997, concerning novel foods and novel food ingredients.1
2. Regulation (EC) No. 1813/97, adopted by the Commission on 19 September 19722,
prescribed specific labelling requirements for foods and food ingredients produced from genetically
modified soya beans or genetically modified maize that are not equivalent to their conventional
counterparts.  Council Regulation (EC) No. 1139/98, adopted by the Council on 26 May 19983,
replaces Council Regulation (EC) No. 1813/97 and gives details concerning the labelling
requirements for these foodstuffs.
3. In order to ensure that foods produced from GMO soya/maize are not treated differently from
foods produced from other GMO varieties subject to Regulation (EC) No. 258/97, the same criterionhas been used to determine whether a food or food ingredient is equivalent.
II. REPLY TO THE COMMENTS BY THE UNITED STATES
1. Choice of criterion
4. The European Union points out that its approach to labelling is based on application of a
concept of "equivalence" applied under Article 8 of the Regulations on novel foods and repeated inArticle 2 of Regulation (EC) No. 1813/97.  It differs from the concept of " substantial equivalence"
that applies to procedures for obtaining an au thorization to place novel foods or novel food
ingredients on the market.
5. Based on a scientific assessment, the European Union is convinced that the presence of DNA
or proteins resulting from genetic modification in foods and food ingredients is the best criterion for
                                                     
1OJ No. L 43 of 14 February 1997, p.1.
2OJ No. L 257 of 20 September 1997, pp.7-8.
3OJ No. L 159 of 3 June 1998, pp.4-7.G/TBT/W/78
Page 2
distinguishing between a product derived from GM Os and a so-called "conventional" product.  Foods
and food ingredients containing DNA or proteins resulting from genetic modification are therefore not
equivalent to their conventional counterparts a nd consequently should be subject to labelling
requirements.
2. Utilization of tests and setting of a threshold
6. As already emphasized, the European Union's approach to labelling is based on the principle
according to which the GMO origin of a food or food ingredient must be scientifically verifiable
(presence of traces of DNA or protein) and/or proved by other means.
7. Ascertaining whether or not a food or food ingredient is of GMO origin does not always mean
carrying out tests.  Scientific and technical knowledge of the food characteristics of the foodstuff, on
the one hand, or documentary information, on the other, may be enough.
8. In addition, the European Union has decided to draw up a "negative" list of foods or food
ingredients for which the absence of traces is not in any doubt.  These are considered equivalent
within the meaning of the Regulation and are not subject to the labelling requirement (preambular
paragraph 17).  The list will be drawn up on the basis of an indisputable scientific assessment.
9. Moreover, taking into account residual cases where there may be uncertainty regarding the
GMO origin and where tests would be needed, the Community authorities have undertaken toencourage the development of recognized methods of detecting DNA or protein resulting from genetic
modification, on the one hand, and to consider the possibility of setting a threshold for the detection of
traces of DNA or protein below which labellin g will not be required, where adventitious
contamination of a foodstuff by DNA or protein cannot be excluded, on the other (preambular
paragraphs 14 and 15 and Declaration by the Council).
3. Labelling format
10. The European Union wished to establish a standard labelling format, not allowing for any
alternative, on the one hand in order to make the choice and the information easier for the consumer,
and, on the other, to make sure that there were no divergent interpretations or legal uncertainties for
producers.
11. The indication must be worded as follows:  "produced from genetically modified soya" or
"produced from genetically modified maize" or "contains ingredients produced from genetically
modified soya/maize", whichever is appropriate.  Th is wording must appear in the list of ingredients,
in parentheses, immediately after the name of the ingredient concerned.
12. The words may also appear in a prominently displa yed footnote to the list of ingredients, in a
typeface, of at least the same size as the list of ingredients itself.  A simpler form of wording may be
used on the labels if the ingredients are already listed as being produced from soya or maize.  Forexample, "flour produced from genetically modified soya" may be shortened to "genetically modified
soya flour" and/or may appear in a footnote at the bottom of the label, denoted by an asterisk.
13. In the case of products for which no list of ingredients exists, the necessary information must
appear clearly on the labelling of the product.
14. This Regulation applies without prejudice to the right of producers to include claims
voluntarily on the labelling of their products prov ided that these conform to Directive 79/112/EEC,
which states that such indications must not be liable to mislead consumers.G/TBT/W/78
Page 3
15. If the modified characteristics or food properties may affect the health of certain sections of
the population or give rise to ethical concerns, the labelling should take this into account and mention
it.
The words "may contain"
16. The formula "may contain" cannot be used on the labelling of foods or food ingredients
produced from genetically modified soya/maize if they are to be delivered to the final consumer.
17. Nevertheless, in order to take into account the practical needs of producers, especially in the
case of bulk consignments4 which may contain both genetically modified and conventional products,
an indication of the possible presence of GMOs was deemed to be sufficient, under Regulation (EC)
No. 258/97.
III. REPLY TO THE COMMENTS BY CANADA
1. Scope
18. Regulation (EC) No. 1139/98 only deals with the labelling of foods or food ingredients
produced from genetically modified soyabeans (Glycine max L.) or genetically modified maize (Zea
mays L.) authorized by Decision 96/281/EC5 and Decision 97/98/EC 6 respectively.
19. Although it is outside the legal framework of  Regulation (EC) No. 258/97, it seems clear that
the adoption of Regulation (EC) No. 1139/98, which is the first practical instance of implementationand interpretation of the new concept of "non-equivalence", will constitute a model when
implementing the Regulation on novel foods.  Producers should therefore take it into account in their
labelling proposals, both when notifying or requesting an authorization for a novel food or novel food
ingredient under Regulation (EC) No. 258/97.
20. Furthermore, this Regulation's provisions only lay down additional specific requirements on
labelling for foods and food ingredients to be supplied to the final consumer.
2. Labelling format
21. The European Union wished to establish a standard labelling format, not allowing for any
alternative, on the one hand in order to make the choice and the information easier for the consumer,
and, on the other, to make sure that there were no divergent interpretations or legal uncertainties forproducers.
22. The indication must be worded as follows:  "produced from genetically modified soya" or
"produced from genetically modified maize" or "contains ingredients produced from genetically
modified soya/maize", whichever is appropriate.  Th is wording must appear in the list of ingredients,
in parentheses, immediately after the name of the ingredient concerned.
                                                     
4Ninth preambular paragraph:  "Whereas, in respect of foods and food ingredients which are intended
to be placed on the market to be supplied to the final consumer, and which may contain both geneticallymodified and conventional produce, and without prejudice to the other labelling requirements of this Regulation,information for the consumer on the possibility that gene tically modified organisms may be present in the foods
and food ingredients concerned is deemed – by way of exception, in particular as regards bulk consignments –to fulfil the requirements of Article 8."
5OJ No. L 107 of 30 April 1996, pp. 10-11.
6OJ No. L 31 of 1 February 1997, pp. 69-70.G/TBT/W/78
Page 4
23. The words may also appear in a prominently displa yed footnote to the list of ingredients, in a
typeface, of at least the same size as the list of ingredients itself.  A simpler form of wording may be
used on the labels if the ingredients are already listed as being produced from soya or maize.  For
example, "flour produced from genetically modified soya" may be shortened to "genetically modified
soya flour" and/or may appear in a footnote at the bottom of the label, denoted by an asterisk.
24. In the case of products for which no list of ingredients exists, the necessary information must
appear clearly on the labelling of the product.
25. This Regulation applies without prejudice to the right of producers to include claims
voluntarily on the labelling of their products prov ided that these conform to Directive 79/112/EEC,
which states that such indications must not be liable to mislead consumers.
The words "may contain"
26. The words "may contain" were not accepted when the Decision was adopted.  They may not
therefore be used on the labelling of foods or food ingredients produced from genetically modified
soya/maize if these are to be delivered to the final consumer.
27. Nevertheless, in order to take into account the practical needs of producers, especially in the
case of bulk consignments7 which may contain both genetically modified and conventional products,
an indication of the possible presence of GMOs was deemed to be sufficient, under Regulation (EC)No. 258/97.
3. Utilization of tests and setting of a threshold
28. As already emphasized, the European Union's approach to labelling is based on the principle
according to which the GMO origin of a food or food ingredient must be scientifically verifiable
(presence of traces of DNA or protein) and/or proved by other means.
29. Ascertaining whether or not a food or food ingredient is of GMO origin does not always mean
carrying out tests.  Scientific and technical knowledge of the food characteristics of the foodstuff, on
the one hand, or documentary information, on the other, may be enough.
30. In addition, the European Union has decided to  draw up a "negative" list of foods or food
ingredients for which the absence of traces is not in any doubt.  These are considered equivalentwithin the meaning of the Regulation and are not subject to the labelling requirement (preambular
paragraph 17).  The list will be drawn up on the basis of an indisputable scientific assessment.
31. Moreover, taking into account residual cases where there may be uncertainty regarding the
GMO origin and where tests would be needed, the Community authorities have undertaken to
encourage the development of recognized methods of detecting DNA or protein resulting from genetic
modification, on the one hand, and to consider the possibility of setting a threshold for the detection of
traces of DNA or protein below which labellin g will not be required, where adventitious
contamination of a foodstuff by DNA or protein cannot be excluded, on the other (preambular
paragraphs 14 and 15 and Declaration by the Council).
                                                     
7Ninth preambular paragraph:  "Whereas, in respect of foods and food ingredients which are intended
to be placed on the market to be supplied to the final consumer, and which may contain both genetically
modified and conventional produce, and without prejudice to the other labelling requirements of this Regulation,
information for the consumer on the possibility that gene tically modified organisms may be present in the foods
and food ingredients concerned is deemed – by way of exception, in particular as regards bulk consignments –to fulfil the requirements of Article 8."G/TBT/W/78
Page 5
4. Monitoring application of the Regulation and sanctions
32. Regulation (EC) No. 1139/98 is a Community act that applies directly in member States.  It is
therefore the responsibility of member States to monitor observance of its application and de facto to
punish non-observance according to their domestic legislation.
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