WORLD TRADE
ORGANIZATIONG/SPS/GEN/354
4 November 2002
(02-6049)
Committee on Sanitary and
Phytosanitary MeasuresOriginal:  Spanish
RESPONSE FROM THE EUROPEAN COMMISSION TO COMMENTS
SUBMITTED BY WTO MEMBERS UNDER
G/SPS/N/EEC/149 AND 1501
Submission by Argentina
Observance of the notification procedure
Argentina points out that the text notified wa s that drawn up by the European Council, which
does not include the modifications subsequently introduced by the European Parliament.  According
to the notification procedure laid down in Decision G/SPS/7/Rev.2 " …  a notification should be
made when a draft with the complete text of a proposed regulation is available and when amendments
can still be introduced and comments taken into account ".  Accordingly, Argentina requests the
European Communities to notify the latest version of the draft regulation so that it can be examined indetail.
Without prejudice to the foregoing, Argentina po ses the questions below.  Naturally, it is be
hoped that the replies given by the European Communities will be duly substantiated and not
be confined to affirmations or denials.
1. In its presentation, the European Communities recognize that, according to its risk
assessment, genetically modified plants and produc ts obtained therefrom au thorized for marketing in
the European Communities do not represent a higher risk than their conventional counterparts, in
other words they have the same "level of safety".
In the light of this conclusion, what would be the justification for setting up a different regime
for the approval, labelling and traceability of this type of product in comparison with its conventionalcounterparts?  Do the European Communities consider that the different treatment of GMO products
and their conventional counterparts is consistent with the obligation laid down in Article 5.5 of the
SPS Agreement?
Following the results obtained from the risk analysis of authorized events and foods, is the
obligation to "communicate the risk" reflected in these results?
Could informing the customer that a food has b een modified result in partial information that
could have a negative impact on consumer decisions?  In this connection, should the information
given not include a mention of the positive aspects of the type of food (lesser impact effect on theenvironment caused pesticides, reduction in the type and quantities of certain pesticides in the final
product, naturally fortified food, same risk as the conventional product, etc.).
                                                     
1 G/SPS/GEN/337 and 338.G/SPS/GEN/354
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2. Why do the European Communities want labelling according to method of production rather
than labelling showing the characteristics of the final product?  In particular, what are the reasons for
which the objectives pursued could not be reached on the basis of a declaration of the characteristics
of the final product?
3. Argentina considers that, when authorizing the marketing of a food, whether or not
genetically modified, the only parameters to be taken into account should be technical or scientific
parameters concerning its safety.  The " should not mislead the consumer" requirement/objective is
observed if the labelling shows the specific characteristics of the final product.
4. The European Communities have replied that processing aids (i.e. materials used during
processing but not present in the finished product), including enzymes used as such, are not food
ingredients, in other words they are not foods a ccording to the European Communities' legislation.
Could the European Communities explain in practical terms what is the difference between a geneintroduced into an event, which is not present in the final product, and processing aids (including
enzymes) which are not present in the final product either?
5. Argentina considers that risk assessment is a prior and separate procedure to risk
management.  Nevertheless , the latter should be based on the former so as to prevent discretionary
practices and ensure that the final measure is based on science.  How do the European Communitiesinterpret this obligation, in other words, how do the decision-making bodies (agencies) take into
account the scientific assessment of risk?
6. In connection with the United States question on the procedures for granting or refusing an
authorization, a modification, suspension or revocation of an authorization, or refusal to renew an
authorization, the European Communities replied that these were the preserve of the EuropeanCommunities and member States did not have authority to take national measures restricting the
marketing of products for reasons of food or feed safety.
Argentina would like to know whether there are reasons other than "reasons of food or feed
safety" that authorize member States to adopt national measures restricting the marketing of products
covered by this draft text.
7. In the case of medicines prepared on the basis of modern biotechnology methods, does the
label also inform the consumer of the production method for the raw material used?  If this is not the
case, how do the European Communities achieve the objective of "informing the consumer" in this
case?
8. In several parts of the draft text notified it is mentioned, inter alia , that genetically modified
food "should not present any risk to human health or the environment".  As a result of the doubtsexpressed by several countries to the effect that such a level of security is absolutely unattainable for
every type of food, the European Communities undertook to modify the text.  Could the European
Communities explain how the text was adjusted to these requirements so that it does not constitute
discrimination against genetically modified f oods in comparison with conventional foods?
9. Article 2.2 of the SPS Agreement clearly establishes the obligation to base sanitary and
phytosanitary measures on sufficient scientific evidence.  In this connection, various reports of the
Appellate Body have recognized the close relations hip between this Article and the obligation to base
measures on a risk assessment.
What are the reasons for which the adoption of decisions based on so-called "other factors"
are not incompatible with the aforementioned Articles of the SPS Agreement?G/SPS/GEN/354
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Could the European Communities identify what other factors are to be taken into account in
risk analysis?
Do these factors differ in number and weight from those considered in the risk analysis for a
conventional food?
Are the other legitimate factors taken into account by the European Communities at the risk
analysis stage different from those considered for the authorization?
Could the European Communities state whether the "other legitimate factors" it is intended to
take into account in the risk analysis are in conformity with Article 5.2 of the SPS Agreement?
10. On several occasions, the European Communities mention that there is "solid evidence" that
the labelling requirements have been drawn up in response to the concern/needs of consumers.  What
do the European Communities mean by solid evidence and on what studies is this based, how is the
European Commission's action in response to  such concerns regulated or implemented?
11. What are the reasons for which it is considered that the various labelling requirements for
genetically modified foods and their conventional counterparts would not violate the principle of not
being more trade-restrictive than required (Article 5.6 of the SPS Agreement)?
12. If it is the European Communities' view that it would not be necessary to implement a system
of segregation and separate identity in order to comply with the draft regulations on labelling andtraceability, what are the differences between the mechanisms proposed in the draft regulations and
segregation and separate identity systems?
13. What alternatives to traceability were considered and why were they rejected?
14. Bearing in mind that the European Communities have recognized that the genetically
modified foods authorized have shown that they ha ve the same level of safety as their conventional
counterparts, on what basis has post-market monitoring been established?  What effects on human
health is it expected to find when a food ha s been approved for consumption by the Community
authorities?  If the objective pursued through post-market monitoring is to verify that the conclusions
reached in the risk analysis are still valid, should the monitoring not then come within the mandatory
scope of competence of community health authorities?
15. Could the European Communities give examples of cases in which it has been established
that post-market monitoring of conventional foods that had been fortified had to be carried out?  Who
is responsible for such monitoring and what results that differed from those in the risk analysis of the
product were reached?
16. Has the environmental monitoring envisaged by the European Communities also been
adopted in the case of events that have occurred using techniques for obtaining seeds other than
recombinant DNA?
17. The European Communities have indicated that the ethical and religious considerations to be
taken into account in labelling are specially intended  to cover, for example, a situation in which the
gene of a bovine animal or a pig has been transferred to another animal species, because this could
raise concerns on the part of those belonging to certain religions.
In the case of methods which use animal albumin to clarify wines, is this information given to
consumers on the labels?G/SPS/GEN/354
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18. In response to Argentina's question regarding the cost of the system which the European
Communities intend to implement, it was stated th at the requirements are the same as those in
Article 18(2)(a) of the Cartagena Protocol.
Firstly, Argentina wishes to point out that this Protocol has not yet entered into force, and the
labelling and traceability requirements in the European Communities' draft text greatly exceed therequirements laid down in the aforementioned Article of the Protocol.
How did the European Communities take into account the special needs of developing
countries when drawing up this draft regulation (Article 10.1 of the SPS Agreement)?
19. When do the European Communities think that the Unique Code system will be
implemented?
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