RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/W/104
12 February 1999
(99-0558)
Committee on Technical Barriers to Trade Original:  French
RESPONSE FROM THE EUROPEAN COMMISSION TO COMMENTS BY THE
UNITED STATES AND CANADA CONCERNING NOTIFICATION 97.766
Communication from the European Community
The following communication, dated 4 February 1999, has been received from the
European Commission with the request that it be circulated to members of the Committee.
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SUBJECT: Council Regulation (EC) No. 1139/98 of 26 May 1998 concerning the compulsory
indication on the labelling of certain foodstuffs produced from genetically modified
organisms of particulars other than thos e provided for in Directive 79/112/EEC.
I. BACKGROUND
1. The approach adopted in the context of Regu lation (EC) No. 1139/98 regarding the labelling
of foods and food ingredients produced from genetically modified soya beans or maize, which was
adopted on 26 May 1998 and entered into force on 1 September 1998, constitutes the first concrete
application of Community provisions on the labelling of foods and food ingredients derived from
modern biotechnologies, and will be used as a basis inter alia  for the implementation of
Regulation (EC) 258/97 concerning novel foods and novel food ingredients.
II. REPLIES TO THE COMMENTS BY THE UNITED STATES
A. CHOICE OF CRITERION DEFINING THE CONCEPT OF EQUIVALENCE FOR LABELLING AND
CONSUMER INFORMATION PURPOSES
2. The European Union points out that its approach to labelling is based on application of the
concept of "equivalence" established in Article 8 of the Regulation concerning novel foods and
repeated in Article 2 of Regulation (EC) 1813/97.  Regulation (EC) No. 1139/98 sets out to define this
concept.
3. Based on a scientific assessment, the European Union is convinced that the presence in foods
and food ingredients of DNA or protein resulting from genetic modification is the best criterion for
distinguishing a GMO-derived product from a "conventional" product.  Consequently, such foods or
food ingredients are no longer considered equivalent, for labelling purposes, to conventional foods or
food ingredients.
B. ESTABLISHEMENT OF A NEGATIVE LIST
4. 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 and which are considered equivalent within themeaning of the Regulation and are therefore not subject to the labelling requirement.G/TBT/W/104
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5. The list is to be drawn up on the basis of an indisputable scientific assessment.
6. For that purpose, the Community authorities have instituted a consultation procedure with the
Scientific Committee on Food, in accordance with Article 2(2) of Regulation (EC) No. 1139/98.  As
soon as the Committee has given its opinion, the Community authorities will take the necessary stepsto draw up the list.
C. 
ANALYTICAL METHODS :  THE PRESENT SITUATION
7. The setting of a detection threshold calls for the prior validation of analytical methods of
detection.  The Community authorities and the member States of the European Union have therefore
taken several initiatives to this end.  We know th at methods or means already exist for detecting the
presence of DNA or protein and we can therefore expect rapid results as regards the harmonization of
such methods.  However, their validation will obviously take time.
D. SETTING OF A DE MINIMIS   THRESHOLD
8. As stated by the European Union in its initial reply, the Community authorities are looking
into the possibility of setting a de minimis  threshold for DNA or protein traces, below which labelling
would not be required, where adventitious contamination of foodstuffs by DNA or proteins cannot be
excluded.  However, it would appear difficult to establish a maximum value at this stage.  The
Community authorities are continuing to study the subject but are not currently in a position toprovide more detailed information.
9. The Regulation has been in force since 1 September 1998 and imposes the requirement of
compulsory labelling whenever a food or food ingredient exhibits traces of DNA or protein and is
intended to be offered as such to the final consumer.  This requirement is imposed on anon-discriminatory basis.
10. Lastly, the European Union would point out that the Regulation applies without prejudice to
the right of operators to include voluntary claims on their product labels, provided that they are in
conformity with the provisions of Directive 79/112/EEC, which stipulates that such indications must
not be liable to mislead consumers.
III. REPLY TO THE COMMENTS BY CANADA
A. 
LABELLING FORMAT
11. The European Union wished to establish a standard labelling format allowing for no
alternative, in order to facilitate consumer choice and information, on the one hand, and to avoid
divergent interpretations and legal uncertainties for operators, on the other.
12. The indication must be worded as follows:  "produced from genetically modified soya" or
"produced from genetically modified maize" or "contains ingredients produced from geneticallymodified 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.
13. This provision of Regulation (EC) No. 1139/98, adopted on the basis of Article 2 of
Regulation (EC) No. 1813/97, and more particularly the second subparagraph of paragraph (a)thereof, stipulates that the labelling must in dicate the characteristics or properties modified
(composition, nutritional value or nutritional effects or intended use of the food), together with the
method by which that characteristic or property was obtained.  By virtue of these provisions, the
indication that a food or food ingredient is produced  from, say, "genetically modified soya or maize",G/TBT/W/104
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reflects the modified characteristics (composition) of the food and the method by which it was
obtained "genetically", which are to be mentioned on the labelling.
B. SETTING OF A DE MINIMIS THRESHOLD
14. As stated by the European Union in its initial reply, the Community authorities are looking
into the possibility of setting a de minimis  threshold for DNA or protein traces, below which labelling
would not be required, where adventitious contamination of foodstuffs by DNA or proteins cannot be
excluded.  However, it appears difficult at this stage to establish a maximum value.  The Community
authorities are continuing to study the subject but are not currently in a position to provide more
detailed information.
15. The regulation has been in force since 1 September 1998 and lays down the requirement of
compulsory labelling whenever a food or food ingredient exhibits traces of DNA or protein.
16. Lastly, the European Union would point out that this Regulation applies without prejudice to
the right of operators to include voluntary claims on their product labels, provided that they are inconformity with Directive 79/112/EEC, which stipulates that such indications must not be liable to
mislead consumers.
C.
ANALYTICAL METHODS :  THE PRESENT SITUATION
17. The setting of a detection threshold calls for the prior validation of analytical methods of
detection.  The Community authorities and the member States of the European Union have therefore
taken several initiatives to this end.  While rapi d results can be expected with regard to the
establishment of methods, their validation will obviously take time.  Moreover, the European Union is
taking an active part in international work in this field and the results obtained at that level willnaturally be taken into account by the Union.
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