WORLD TRADE
ORGANIZATIONG/TBT/W/94
16 October 1998
(98-3740)
Committee on Technical Barriers to Trade Original:  English
EUROPEAN COUNCIL REGULATION NO. 1139/98
COMPULSORY INDICATION OF THE LABELING
OF CERTAIN FOODSTUFFS PRODUCED FROM
GENETICALLY MODIFIED ORGANISMS
Submission by the United States
I. INTRODUCTION
1. The United States brought this issue to the attention of the Committee on Technical Barriers
to Trade during the July 1998 meeting.  Prior to  adoption of the final regulation ((EC) No. 1139/98)
the United States provided comments to the European Union (EU).  The United States appreciates theEU’s 30 July 1998 response to our concerns with the proposed regulation and the reply to the
July 1998 intervention in the WTO TBT Committee (G/TBT/W/78).  The EU response, however,
does not address our fundamental concerns regarding its implementation.  Because of the significant
trade between the EU and the United States affected by this regulation, we have taken the opportunity
at this TBT Committee meeting to submit the comments made at the July 1998 TBT Committeemeeting as a formal paper.
2. The United States continues to be concerned about the practical consequences of
implementation of the regulation, i.e., that it will adversely affect trade and set an unfortunate
example for future regulation of food and agricultural products. In the last WTO TBT Committee
meeting Brazil, Canada and New Zealand shared similar concerns.  The practical considerations of the
EU’s regulation have intensified, now that the regulation has come into effect.  The United States
urgently requests that the EC address our concer ns and comply with its obligations under the
Agreement, with respect to these and future regulations.
II. BACKGROUND
3. The EC first notified regulation (EC) No. 1 139/98 concerning Compulsory Indication of the
Labeling of Certain Foodstuffs Produced from Genetically Modified Organisms on
12 December 1997 (G/TBT/Notif.97.766).  The United States submitted comments on the proposal on
20 January 1998.  The regulation was adopted by the EC as a proposal on 31 December 1997. On
26 February 1998, the EC submitted the proposed regulation to the EU Council of Ministers
(Council). An amended version of the proposed regulation was subsequently submitted to the Council
(sn2534/98).  The Council adopted a final regulation based on this amended proposed regulation on
3 June 1998 ((EC) No. 1138/98).  In the July 1998 TBT Committee meeting, the United Statesdelegate raised concerns regarding implementation of the final regulation.  On 30 July 1998, the EU
provided a response to the U.S. comments.  Regulation (EC) No. 1139/98 entered into force on
3 September 1998.
III. REGULATION (EC) NO. 1139/98'S LABELING REQUIREMENTS
4. The regulation requires that a food or food ingredient produced from genetically modified
soybeans or genetically modified corn that contains DNA or protein resulting from such geneticG/TBT/W/94
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modification bear the words “produced from genetically modified soya” or “produced from
genetically modified maize” on the ingredient list or on the food label.  In the final regulation, the
European Union states that, among other objectives, the labeling requirements are:
... necessary to ensure that the final consumer is informed of any characteristic or food property,
such as composition, nutritional value or nutritional effects or the intended use of the food, whichrenders a food or food ingredient no longer equivalent to an existing food or food ingredient ...
The United States applauds the objective of providing useful information to consumers.  Our
fundamental concern, however, is that the regulation will not achieve this objective, nor others which
are set forth in the preamble.  In addition, problems with implementation make compliance difficult,
at best.
IV. REGULATION DOES NOT ACCOMPLISH ITS ALLEGED LEGITIMATE
OBJECTIVE
5. The regulation is based on the assumption that foods and food ingredients produced from
genetically modified soy beans or corn that contain protein or DNA resulting from genetic
modification are not “equivalent” to their conventional counterparts.
1  Nowhere in the preamble, in
the regulation, nor in the EU’s July response is an empirical basis or other indication provided as to
why the presence of protein or DNA resulting from genetic modification would render the food
different in any material respect (i.e., “composition, nutritional value or nutritional effects”) from like
products that did not result from genetic modification.  In its response to the U.S. comments, the EU
states that it remains convinced that the presence of DNA or protein resulting from geneticmodification differentiates a biotechnology product fr om other “traditional” products.  However, the
EU does not in any way claim that this regulation is promulgated to address any particular risk to
human or animal health.  Indeed, the United States is unaware of any evidence that would
demonstrate that genetically modified varieties as a class differ from conventional varieties in
composition, nutritional value or nutritional effects.  We therefore have questions about what the
EU’s legitimate objectives are with respect to providing “proper information to the final consumer”
and are concerned that, in fact, the labeling requirements imposed by the regulation could contribute
to consumer deception.
6. The mere presence of  protein or DNA resulting from genetic modification is not sufficient to
establish that a food is no longer equivalent to its conventional counterpart in terms of its
“composition, nutritional value or nutritional effects or the intended use of the food.”  In our
comments provided to the Commission, the United States explained that current U.S. policy does notrequire that genetically modified foods and food ingredients or additives be labelled to declare their
means of production (i.e., that they are genetically  modified).  Likewise, the United States has not
required labeling for foods produced from plant varieties developed using other methods of plant
breeding, such as chemical- or radiation-induced mutagenesis, somaclonal variation, or cell culture.
The basis for U.S. policy is that we are not aware of any information that foods or food ingredients
developed through genetic engineering or modification differ as a class in composition, quality or
safety from products produced by other methods of breeding.
7. Generally, products are labelled based on their attributes or characteristics.  Products whose
attributes or characteristics do not differ in their essential characteristics from their conventional
counterparts are not required to bear special labeling.  For example, the “Flavr Savr” tomato that isproduced through genetic engineering is not required to bear special labeling because it does not differ
significantly from other commercial tomatoes.  We do not believe that the mere presence of DNA or
                                                     
1If the DNA has been destroyed during processing, the food would be considered “equivalent” as long
as there is no protein present as a result of genetic modification.G/TBT/W/94
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protein resulting from genetic modification is sufficient to establish that a food is no longer equivalent
to an existing food in terms of its composition, nutritional value or intended use.  The EU approach
does not make sense in view of the alterations in DNA and protein content that occur through many
methods of breeding.
8. In its July response, the EU points out that the Novel Foods regulation distinguishes between
the concepts of “substantial equivalence” and “equivalence”.  The United States understands that the
EU is making this distinction. However, the logical extension to the EU approach would be that any
changes in protein or DNA due to genetic manipulation of the plant using any technique traditionally
utilised in plant breeding (e.g., chemical mutagene sis, somaclonal variation, wide crosses) would
result in food that would no longer be considered “equivalent”. Yet the EU regulation does not require
labeling for products that contain new DNA and/or protein as a result of these practices used around
the world.  Products that have the same traits and attributes but are produced by other processes arenot subject to such monitoring.
9. As is the case for foods produced by other technologies, the United States requires labeling of
foods produced through modern biotechnology if necessary to denote significant changes in a food
with respect to composition (e.g., nutritional content) , storage, preparation or usage, or safety.  For
example, modifications that incorporate a new allergen  into a product, in general, must be identified.
The United States also encourages the industry to disseminate information concerning genetically
modified foods, but does not believe that labeling is the most practical way to provide access to such
information, particularly for commingled commodities and processed foods containing material from
different sources.  The costs of applying such labeling will ultimately be borne by the consumer and
will not provide any greater assurance of safety.  Excessive labeling also tends to confuse, rather thaninform, the consumer.
V. IMPLEMENTATION PROBLEMS AND PRACTICAL LIMITATIONS ON
COMPLIANCE
10. As adopted, the regulation does not clearly establish the need for labeling nor does it establish
procedures to ensure compliance on a non-discriminatory basis.  The lack of clarity in the use oflabeling could lead to an unrealistic requirement that GMO and non-GMO products be segregated.
The failure to identify the type of tests or resi due limits required for determining the presence of a
GMO could unnecessarily and negatively impact trade.  In the EU’s response to the U.S. comments,
the EU only says that it is encouraging validated detection methods.  This is not adequate to clarify
what exporters need to know in order to comply with this regulation.  The EU did not address the
following points in its response.
11. The final regulation does not state how to determine when to use the label designating that a
product does contain protein or DNA from genetic modification.  This could lead to a de facto
requirement to segregate GMO and non-GMO products .  Segregation would require nothing less then
establishing two or more parallel storage, transport and processing systems.  This would be extremely
burdensome for suppliers and difficult to justify, given the questions raised before with respect to the
objectives of the regulations.  If consumers needed to be assured (for some reason yet to be identifiedby the EU) that the food they were eating did not contain products of genetic modification, the EU
could have adopted the “may contain” option wh ich appeared in the original Commission proposal.
This option would have notified consumers of any possibility that the products might have been the
result of genetic modification, without requiring that all products be tested.
12. The regulation does not establish procedures to ensure enforcement of the regulation on a
non-discriminatory basis.  For example, it does not address if, when or how often tests would be
required to determine if protein or DNA from genetic modification is present. It does not tell us how
the regulation will be enforced.G/TBT/W/94
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13. Although the regulation recognizes the need for a standard test, it does not stipulate what that
test would be nor does the EU response give any in dication of what tests would be used.  There is no
single test to determine whether protein and DNA from genetic modification appears in a product.
There are a growing number of extremely sensitive tests for protein and DNA.  However, these tests
are used primarily for research purposes and are both time-consuming and expensive.
14. Moreover, the regulation provides no guidance for choosing the specific proteins or segments
of nucleic acids to be monitored.  In order for a supplier or regulator to test for the presence of DNA
or protein from genetic modification, it would be necessary to know which protein, or specific piece
of DNA, is being monitored.  The variety and number of traits that are introduced into crops via
modern biotechnology are increasing rapidly.  As these agriculture biotechnology products enter the
market, the complexity and difficulty of such testing will become increasingly burdensome if, as we
have been led to believe, this regulation is to serve as the model for future labeling and testing
requirements.
15. The regulation recognizes the need for determinin g limits of detection levels for these tests
but again does not set those limits. For example, under the regulation, a food would not have to be
labelled if protein or DNA from genetic modification has been destroyed by processing.  However,
the regulation does not stipulate detection level limit for determining whether the protein or DNAwould be considered to be present in that food. The lack of set detection level limits could inevitably
lead to a shifting and unpredictable standard for testing and the potential need for retesting of
previously tested materials as methodologies change.  It also raises questions as to how the
Community will be able to ensure the application of the regulation is non-discriminatory.
16. In its response the EU “retains the principle of the establishment of a negative list.” They do
not, however, give any indication as to what that lis t would contain, the specific criteria that will be
used to establish the list, or the time-frame in which the list will be established.
VI. CONCLUSION
17. The United States continues to believe the regulation will create problems for our exports and
raises serious questions under the Agreement.  We continue to have concerns about the fundamentalbasis for the information the EU purports is “prope r” and needed on an “urgent” basis to provide to
consumers absent further information and about the precedent it may set for future regulation.
Furthermore, the EC has still not explained how it will address a number of practical implementation
difficulties we believe need to be addressed to ensure non-discrimination and that the regulation
otherwise does not pose an unnecessary obstacle to international trade.
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