WORLD TRADE
ORGANIZATIONG/SPS/GEN/405
19 June 2003
(03-3267)
Committee on Sanitary and Phytosanitary Measures Original:  English
RESPONSE TO THE COMMENTS FROM ARGENTINA (G/SPS/GEN/354)
to the replies by the European Commission to the comments provided by several WTO Members to
the legislative proposals notified under ei ther or both G/TBT/N/EEC/6 - G/SPS/N/EEC/1491 and
either or both G/TBT/N/EEC/7 - G/SPS/N/EEC/1502
Submission by the European Commission
                                                     
1 Proposal for a Regulation of the European Parliament and of the Council on Genetically Modified
Food and Feed – COM(2001) 425 FINAL.
2 Proposal for a Regulation of the European Parliament and of the Council on Traceability and
Labelling of Genetically Modified Organisms and Tr aceability of Genetically modified Food and Feed –
COM(2001) 182 FINAL.G/SPS/GEN/405
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Table of contents
Background 4
Preamble 4
1. COMMENTS BY ARGENTINA ON THE OBSERVANCE OF THE
NOTIFICATION PROCEDURE ............................................................................................5
1.1. Response by the European Commission:................................................................................5
2. COMMENTS BY ARGENTINA ON RISK ASSESSMENT AND RELATED
ISSUES: ........................................................................................................................ .............5
2.1. Response of the European Commission:.................................................................................5
3. COMMENT BY ARGENTINA ABOUT LABE LLING.......................................................6
3.1. Response of the European Commission:.................................................................................6
4. COMMENT BY ARGENTINA ABOUT PARAMETERS CONSIDERED TO
AUTHORIZE A FOOD............................................................................................................6
4.1. Response of the European Commission:.................................................................................6
5. COMMENT BY ARGENTINA ABOU T PROCESSING  AIDS:.........................................7
5.1. Response of the European Commission:.................................................................................7
6. COMMENT BY ARGENTINA ABOUT INTEGRATION OF SCIENTIFIC
ADVICE INTO M ANAGEMEN T ..........................................................................................7
6.1. Response of the European Commission:.................................................................................7
7. COMMENT BY ARGENTINA AB OUT NATIONAL MEASURES:.................................7
7.1. Response of the European Commission:.................................................................................8
8. COMMENT BY ARGENTINA ABOUT LA BELLING GMO MEDICINES :..................8
8.1. Response of the European Commission:.................................................................................8
9. COMMENT BY ARGENTINA ABOUT A MODIFICATION TO THE
ORIGINAL PROPOSAL :.......................................................................................................8
9.1. Response of the European Commission:.................................................................................8
10. COMMENT BY ARGENTINA ABOUT FACTORS CONSIDERED IN RISK
ANALYSIS:...................................................................................................................... .........8
10.1. Response of the European Commission:.................................................................................9
11. COMMENT BY ARGENTINA ABOUT CONSUMERS CONCERNS TO
LABEL GMO FOOD: ..............................................................................................................9
11.1. Response of the European Commission:.................................................................................912. COMMENT BY ARGENTINA ON LABELLING REQUIREMENTS AND
TRADE RESTRI CTION: ......................................................................................................10
12.1. Response of the European Commission:...............................................................................10
13. COMMENT BY ARGENTINA AB OUT CROP SEGR EGATION: .................................10
13.1. Response of the European Commission:...............................................................................1014. COMMENT BY ARGENTINA ON T RACEABILITY ALTE RNATIVES: ....................10G/SPS/GEN/405
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14.1. Response of the European Commission:...............................................................................10
15. COMMENT BY ARGENTINA ON POST  MARKETING MONITORING: ..................11
15.1. Response of the European Commission:...............................................................................11
16. COMMENT BY ARGENTINA ON POST  MAKING MONITORING (2):.....................11
16.1. Response of the European Commission:...............................................................................1117. COMMENT BY ARGENTINA ABOUT ENVIRONMENTAL
MONITORING:.................................................................................................................... ..11
17.1. Response of the European Commission:...............................................................................12
18. COMMENT BY ARGENTINA ABOUT ETHICAL- RELIGIOUS
CONSIDERAT IONS:.............................................................................................................12
18.1. Response of the European Commission:...............................................................................12
19. COMMENT BY ARGENTINA ABOU T CARTAGENA PR OTOCOL:..........................12
19.1. Response of the European Commission:...............................................................................12
20. COMMENT BY ARGENTINA ABOUT THE UNIQUE CODE SYSTEM:....................13
20.1. Response of the European Commission:...............................................................................13
MEMO/02/160 - Questions and Answers on th e Registration of GMOs in the EU 14G/SPS/GEN/405
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Background
In Document G/SPS/GEN/337 (G/TBT/W/179) of 26 July 2002, the European Commission
replied to comments made on the legal draft ("proposals") notified in either or both G/TBT/N/EEC/6
and G/SPS/N/EEC/1493.  In document G/SPS/GEN/338 (G/TBT/W/180) of 26 July 2002, the
European Commission replied to comments received on the legal draft notified in either or both
G/TBT/N/EEC/7 and G/SPS/N/EEC/1504.  Further to this, in document G/SPS/GEN/354 of
4 November 2002, Argentina provided further comments concerning the aforementioned EC
responses.  Moreover, in accordance with the co-d ecision procedure foreseen in Article 251 of the
EC Treaty, both proposals were submitted to the European Parliament (EP) for a first reading.  The
EP changed both proposals and returned them to the Council.  Now the Council, after examining the
amendments contained in the EP's opinions, has adopted;
1. a " Common position with a view to the adoption of Regulation of the European
Parliament and of the Council on genetically modified food and feed " which has
been forwarded to the European Parliame nt (EP) for a second reading and notified
to the WTO (G/SPS/N/EEC/149/Add.2, 11 April 2003);  and
2. a " Common position with a view to the adoption of a regulation of the European
Parliament and of the Council concerning the labelling and traceability of
genetically modified organisms and traceability of food and feed products produced
from genetically modified organisms and amending Directive 2001/18/EC " which
has been forwarded to the EP for a se cond reading and notified to the WTO
(G/SPS/N/EEC/150/Add.2, 11 April 2003).
Preamble
In notices G/SPS/N/ EEC/149/Add.2 and G/SPS/N/EEC/150/A dd.2, the EC made it clear to
all its trade partners that the progress of both proposals can be followed through an Internet site fullydedicated to the decision-making process between institutions (i.e. the Commission, the Council and
the EP).  This site is called "Inter-Lex"
5 and provides access to the original proposal as well as to
further modifications and numerous informative notes.  In order to achieve full transparency on this
procedure, the Commission will also reply to further questions or requests for information that
cannot be answered either by examining the information texts available through "Inter-Lex", or by
this or previous replies .
In the following pages, the questions raised by Argentina in Document G/SPS/GEN/354
(4 November 2002) are responded to.  The questions have been grouped into 20 clusters with a
corresponding 20 replies.  Some of these replies elaborate further or refer the reader to previous
responses in documents G/SPS/GEN/337 and G/SPS/GEN/338.
Further to this, and in supplement to the responses to the questions by Argentina, an annex is
attached to this reply that transcribes Commission document MEMO/03/160 (of 4 March 2003)
"Questions and answers on the regulation on GMOs in the EU ".
                                                     
3 Proposal for a Regulation of the European Parliament and of the Council on Genetically Modified
Food and Feed – COM(2001) 425 final.
4 Proposal for a Regulation of the European Parliament and of the Council on Traceability and
Labelling of Genetically Modified Organisms and Tr aceability of Genetically Modified Food and Feed –
COM(2001) 182 final.
5 http://europa.eu.int/prelex/rech_simple.cfm?CL=en.G/SPS/GEN/405
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1. COMMENTS BY ARGENTINA ON THE OBSERVANCE OF THE NOTIFICATION
PROCEDURE
Argentina points out that the text notified  was 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 in detail.
1.1. Response by the European Commission:
The European Commission has forwarded the latest text, which is the Common Position of
the Council on the Proposal for a Regulation on GM food and feed and the Common Position of the
Council on the Proposal for a Regulation on traceability and labelling of GMOs and traceability of
GM food and feed to the SPS and TBT Committees for information.
2. COMMENTS BY ARGENTINA ON RISK ASSESSMENT AND RELATED ISSUES:
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 itsconventional counterparts?
Do the European Communities consider that the different treatment of GMO products and
their conventional counterparts is consistent wi th 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 the environment caused by pesticides, reduction
in the type and quantities of certain pesticides in the final product, naturally fortified food, same risk
as the conventional product, etc.)?
2.1. Response of the European Commission:
The European Commission would like to refer to the justifications already provided in
documents G/SPS/GEN/337 and G/SPS/GEN/338 concerning its response to similar comments
submitted by other WTO Members.  The European Commission considers its proposals both SPSand TBT compatible.G/SPS/GEN/405
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The European Commission does not consider that labelling the fact that a food contains,
consists or is produced from a GMO as partial information, but rather that it increases transparency
in the market place.  It facilitates consumer choice and ultimately, the market forces will determine
whether products are purchased or not. Current European Community food law does not exclude the
possibility of labelling "positive" aspects as proposed by Argentina provided that claims are truthfuland not misleading.  The European Commission is  not, however, aware of business operators who
have or are making use of this possibility.
3. COMMENT BY ARGENTINA ABOUT LABELLING
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 characteristicsof the final product?
3.1. Response of the European Commission:
The European Community approach to labelling is not new.  The general European
Community law on labelling of foodstuffs (Directive 2000/13/EC), which was adopted for the first
time in 1979, provides that "the labelling and methods used must not be such as could mislead the
purchaser to a material degree, particularly as to the characteristics of the foodstuff and, in particular
as to its nature, identity, properties, composition, quantity, durability, origin or provenance, method
of manufacture or production".
Since 1997, Regulation (EC) 258/97 on novel foods and novel food ingredients has provided
for mandatory labelling of food containing or consisting of GMOs.  In 1998, this requirement was
extended also to cover food produced from a GMO based on detectability of DNA and protein
resulting from the genetic modification.  Therefore, the fact that a food is genetically modified orproduced from GMOs is already considered a characteristic of the final product with relevance for
consumers.  Enabling the consumer to make an individual choice would ensure that they are not
liable to be misled, and thereby foster increased public confidence and acceptance of GM food.
4. COMMENT BY ARGENTINA ABOUT PARAMETERS CONSIDERED TO
AUTHORIZE A FOOD
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.
4.1. Response of the European Commission:
The European Commission would reiterate its comments in documents G/SPS/GEN/337 and
G/SPS/GEN/338, which were made in response to comments from other WTO Members that also
raised the issue:  "Whilst 'misleading the consumer' is indeed normally an aspect of labelling,
advertising or presentation, there are instances in which the intrinsic characteristics of a food could
be misleading for the consumer.  For instance, the f ood could have been modified to suggest that it is
fresh whilst it is not, or a food could have been modified to present the appearance of another food,
more attractive to the consumer.  Whilst such situations have not yet arisen in respect of genetically
modified foods, this does not mean that the case may not arise in the future.  The proposed
Regulation is not meant to deal only with the type of products that went to the market over the last
decade, it is also meant to deal with products that may be placed on the market in the comingdecades, including products derived from genetically modified animals as the case may be."G/SPS/GEN/405
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The European Commission would like to point out that the "not mislead the consumer"
criterion has been carried from Regulation (EC) No 258/97, where its application has never led to
any difficulty.
5. COMMENT BY ARGENTINA ABOUT PROCESSING AIDS:
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
gene introduced 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?
5.1. Response of the European Commission:
If an ingredient produced from a GMO is present in the final product, it is a basic fact that
the ingredient is produced from a GMO irrespective of whether DNA or protein resulting from thegenetic modification can be detected or not.
6. COMMENT BY ARGENTINA ABOUT INTEGRATION OF SCIENTIFIC ADVICE
INTO MANAGEMENT
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 discretionarypractices and ensure that the final measure is based on science.
How do the European Communities interpret this obligation, in other words, how do the
decision-making bodies (agencies) take into account the scientific assessment of risk?
6.1. Response of the European Commission:
The European Commission agrees that risk assessment is a separate "procedure" to that of
risk management.  The European Community has a long history of basing its decisions, relating to
the safety of the environment and health, on risk assessment. Regulation (EC) 178/2002, laying
down the general principles and requirements of food law, establishing the European Food Safety
Authority and laying down matters of food safety, provides for the separation of risk assessment and
risk management.
7. COMMENT BY ARGENTINA ABOUT NATIONAL MEASURES:
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 European
Communities and member States did not have authority to take national measures restricting themarketing 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 .G/SPS/GEN/405
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7.1. Response of the European Commission:
The Common Position on the Regulation on GM Food and Feed adopted on 17 March 2003
provides that member States may adopt emergency measures in very specific circumstances that
relate to the protection of human health, animal health or the environment.
8. COMMENT BY ARGENTINA ABOUT LABELLING GMO MEDICINES :
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?
8.1. Response of the European Commission:
The European Commission does not agree with the suggestion that medicines are consumed
as food.  The European Commission does not consider medicines to be foods, but to be prescribed to
cure diseases.
9. COMMENT BY ARGENTINA ABOUT A MODIFICATION TO THE ORIGINAL
PROPOSAL :
In several parts of the draft text as 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
doubts expressed 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 foods in comparison with
conventional foods?
9.1. Response of the European Commission:
The European Commission has suggested modifying the text accordingly and the member
States have agreed to change the original proposal to "should not present an unacceptable risk to
human health or the environment".  This is reflected in the Common Position on the proposed
Regulation on GM Food and Feed.
10. COMMENT BY ARGENTINA ABOUT FACTORS CONSIDERED IN RISK
ANALYSIS:
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 relati onship 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?
Could the European Communities identify what other factors are to be taken into account in
risk analysis?G/SPS/GEN/405
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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?
10.1. Response of the European Commission:
In terms of "other legitimate factors", the European Commission would reiterate its response
in document G/SPS/GEN/337 made to similar comments submitted by other WTO Members:  "TheEuropean Commission contends that the proposed Regulation is entirely consistent with the General
Principles for Risk Analysis recognized at the inte rnational level, which allows risk managers to take
into account not only the results of a science-based risk assessment but also other legitimate factors
relevant for the matter under consideration."
In Regulation (EC) 178/2002, it is indicated that other legitimate factors, relevant to the
matter under consideration, include societal, economic, traditional, ethical and environmental factors
and the feasibility of controls.  Such factors relate to risk management decisions.
11. COMMENT BY ARGENTINA ABOUT CONSUMERS CONCERNS TO LABEL
GMO FOOD:
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?
11.1. Response of the European Commission:
In the European Community, concerns and demands of citizens and interest groups are part
of the political, democratic process.
The consumer demands are reflected in the positions of European consumer organisations,
and the governments of the member States.  The demands are also having effects on the situation in
the market place.  The fact that the European Parliament and the vast majority of member States
have endorsed the proposed labelling requirements with the objective of ensuring transparency in the
market place and facilitating consumer choice demonstrates that there is wide-spread democratic
support of meeting the consumer demands in the European Community.
The most recent Eurobarometer survey (No 58) of March 2003 indicates that a majority of
Europeans do not support GM food and consider that these are not useful for society.  This further
confirms the need to provide consumers with the choice to buy or not to buy GM foods.G/SPS/GEN/405
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12. COMMENT BY ARGENTINA ON LABELLING REQUIREMENTS AND TRADE
RESTRICTION:
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)?
12.1. Response of the European Commission:
Labelling requirements to inform consumers about the presence of material that are known
to cause a health problem to subsections of a population are fully justified by the SPS Agreement.
Labelling requirements with the purpose of facilitating consumer choice is not regulated by the
SPS Agreement.
13. COMMENT BY ARGENTINA ABOUT CROP SEGREGATION:
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
and traceability, what are the differences between the mechanisms proposed in the draft regulations
and segregation and separate identity systems?
13.1. Response of the European Commission:
The proposals do not require GMOs or GM food to be separated from other crops.
14. COMMENT BY ARGENTINA ON TRACEABILITY ALTERNATIVES:
What alternatives to traceability were considered and why were they rejected?
14.1. Response of the European Commission:
The Commission would reiterate its comments made in document G/SPS/GEN/338 to
similar questions submitted by other WTO Members:  "In preparation of its Proposal, the EuropeanCommission examined the merits and disadvantages of a number of different labelling approaches,
including the one that would complement the current mandatory labelling provisions (based on the
presence of DNA or protein resulting from the genetic modification) with a Community-wide
voluntary "GMO-free" (or similarly phrased) scheme.
The European Commission's preparatory work, including experiences in some member
States, revealed that voluntary "GMO-free" (or similarly phrased) schemes were beset by a number
of technical, commercial and other difficulties.  It also became evident that consumers in the
European Community were primarily interested in knowing whether their food was produced from
GMOs or contained ingredients produced from GM Os.  Consumers clearly prefer to be informed
what is in products and not what is not in products.  For instance irradiated food has to be labelled as
such. European Community law allows for "free of" labelling claims provided the claim is truthful
and not misleading. It would be considered misl eading to label a food "GMO-free" or "non-GM" if
there is no corresponding GM food on the market.  "GMO-free" products are already supplied by the
Organic Production scheme, which excludes the us e of GMOs in the whole production chain on a
very strict basis.  A second "GMO-free" production scheme is therefore also considered to be
confusing for consumers and potentially misleading."
In this context, traceability of GMOs and food and feed produced from GMOs would ensure
that information concerning whether a food or a feed is consisting of, containing or produced from aG/SPS/GEN/405
Page 11
GMO is available at all stages of the placing on the market and should thereby facilitate accurate
labelling of the final product, reduce the reliance on analytical methods as well as provide the means
for inspection and control of labelling claims.
The European Commission would also like to reiterate that the two proposals facilitate
consumer choice and a demand driven approach.
15. COMMENT BY ARGENTINA ON POST MARKETING MONITORING:
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 effect on human health is it expected to find when a food has 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?
15.1. Response of the European Commission:
The proposal provides that the need for post market monitoring requirements be assessed on
a case by case basis during risk assessment. This is in line, for example, with the "Proposed DraftPrinciples for the Risk Analysis of Foods Deri ved from Modern Biotechnology" at Step 8 of the
Elaboration Procedure of the Codex Alimentarius Commission, which state (at paragraph 20) that
"Post-market monitoring may be an appropriate risk management measure in specific
circumstances".
16. COMMENT BY ARGENTINA ON POST MAKING MONITORING (2):
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?
16.1. Response of the European Commission:
The need for post market monitoring requirements is already evaluated during the risk
assessments carried out under the Regulation (EC) 258/97 on novel foods and novel food
ingredients.  An example of such requirements can be found in Commission Decision of 24 July
2000 (2000/500/EC) on the authorization for the placing on the market of "yellow fat spreads with
added phytosterol esters".  It is the authorization holder who is responsible for carrying out the
monitoring in accordance with above-menti oned Decision.  Another example of monitoring
requirements in European Community Food Law is Directive 94/35/EC, 94/36/EC and 95/2/EC on
food additives, which provide that member States shall establish a monitoring system for the
consumption of food additives.
17. COMMENT BY ARGENTINA ABOUT ENVIRONMENTAL MONITORING:
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 thanrecombinant DNA?G/SPS/GEN/405
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17.1. Response of the European Commission:
The European Community requirements for post market monitoring of GMOs is in fact not
new and are laid down in Directive 2001/18/EC, which following adoption by the Council and the
European Parliament entered into force in March 2001.  The scope of that Directive covers GMOs
exclusively.
18. COMMENT BY ARGENTINA ABOUT ETHICAL- RELIGIOUS
CONSIDERATIONS:
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?
18.1. Response of the European Commission:
Bovine albumin is not authorized for oenological practices in the EU.  Article 43 and
Annex IV and V of Council Regulation 1493/1999 forbids the use of this product.  The generalEuropean Community labelling requirements provide for labelling of ingredients
(Directive 2000/13/EEC), but not labelling of processing aids.
19. COMMENT BY ARGENTINA ABOUT CARTAGENA PROTOCOL:
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
the requirements 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)?
19.1. Response of the European Commission:
The European Commission  disagrees with Argentina that the proposal greatly exceeds the
requirements of the protocol.  The European Commission has noted the overwhelming support for
the Biosafety protocol from developing countries and for specific information requirementsconcerning transboundary movements of living modified organisms.  To date, 103 countries have
signed the Protocol, many of them developing  countries.  Moreover, the European Commission
believes that the proposals will foster social acceptability of the application of biotechnology in the
agri-food sector and thereby promote trade in such products.
The European Commission would like to reiterate that it is ready to consider requests from
developing countries for technical co-operation and assistance to address identified priorities and
needs.G/SPS/GEN/405
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20. COMMENT BY ARGENTINA ABOUT THE UNIQUE CODE SYSTEM:
When do the European Communities think that the Unique Code system will be
implemented?
20.1. Response of the European Commission:
The system for developing and assigning unique codes is to be adopted and implemented
after final agreement on the Proposal on traceability and labelling of GMOs and traceability of food
and feed produced from GMOs by the Council and the European Parliament.G/SPS/GEN/405
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MEMO/02/1606
Brussels, 4 March 2003
QUESTION AND ANSWERS ON THE REGULATION OF GMOS IN THE EU
This questions and answers fact sheet is divided into two sections;  Part A covers legislation in
force;  Part B covers the legislative proposals  on traceability and labelling put forward in
July 2001
What are GMOs and GMMs?
Genetically modified organisms (GMOs) a nd genetically modified micro-organisms
(GMMs) can be defined as organisms (and micro- organisms) in which the genetic material (DNA)
has been altered in a way that does not occur naturally by mating or natural recombination.  The
technology is often called "modern biotechnology" or "gene technology", sometimes also
"recombinant DNA technology" or "genetic engineering".  It allows selected individual genes to betransferred from one organism into another, also between non-related species.
PART A:  LEGISLATION IN FORCE
What is the current legislation in the EU on GMOs?
Community legislation on GMOs has been in place since the early 1990s and throughout the
decade, this regulatory framework has been further extended and refined.  The EU
introduced specific legislation designed to protect its citizens' health and the environment
while simultaneously creating a unified market for biotechnology.
The main legislation under which experimental releases and placing on the market of
genetically modified organisms (GMOs) have been authorized in the Community was, up
until 17 October 2002, Directive 90/220/EEC  On this date, the Directive was repealed by
the new, updated Directive 2001/18/EC of the European Parliament and Council on the
deliberate release of genetically modified organisms.
Directive 2001/18/EC, as for Directive 90/220 /EEC, puts in place a step-by-step approval
process on a case by case assessment of the risks to human health and the environment
before any GMO or product consisting of or containing GMOs, such as maize, tomatoes, or
microorganisms can be released into the environment or placed on the market.
Products derived from GMOs, such as paste or ketchup from a GMO tomato are not covered
by this horizontal Directive but by vertical, sectoral legislation, for example the Regulation
on Novel Foods and Novel Food Ingredients of 27 January 1997 (Regulation (EC) 258/97).
Directive 90/219/EEC, as amended by Council  Directive 98/81/EC on the contained use of
GMMs, regulates the contained use of GMMs for research and industrial purposes.
What has changed under the new Directive for the deliberate release of GMOs?
The revised Directive 2001/18/EC strengthens the existing rules on the release of GMOs into
the environment. In particular, it introduces:
                                                     
6 In order to adapt the text of  MEMO/02/160 to this document, its original formatting has been
modified.  The original page setting can be found in http://europa.eu.int/rapid/start/cgi/guesten.ksh (in English
and French).G/SPS/GEN/405
Page 15
- principles for the environmental risk assessment (see below);
- mandatory post-market monitoring requirements, including on long-term effects
associated with the interaction with other GMOs and the environment;
- mandatory information to the public;- a requirement for member States to ensure labelling and traceability at all stages of
the placing on the market;
- first approvals for the release of GMOs to be limited to a maximum of ten years;- the consultation of the Scientific Committee(s) to be obligatory;- an obligation to consult the European Parliament on decisions to authorize the
release of GMOs;  and
- the possibility for Council of Ministers to adopt or reject a Commission proposal for
authorization of a GMO by qualified majority.
How does  the environmental risk assessment procedure work from 17 October
onwards?
The safety of GMOs depends on the characteristics of the inserted genetic material, the final
organism that is produced, the receiving environment and the interaction between the GMO
and the environment.  The objective of the environmental risk assessment is to identify andevaluate potential adverse effects of the GMO(s).  These include direct or indirect,
immediate or delayed, effects taking into account any cumulative and long term effects on
human health and the environment which may arise from the deliberate release or placing on
the market of that GMO(s).  The environmental risk assessment also requires evaluation in
terms of how the GMO was developed and examines the potential risks associated with the
new gene products produced by the GMO (for example toxic or allergenic proteins), and the
possibility of gene-transfer (for example of antibiotic resistance genes).
The methodology of the risk assessment is as follows:- Identification of any characteristics of the GMO(s) which may cause adverse
effects;
- Evaluation of the potential consequences of each adverse effect;- Evaluation of the likelihood of the occurrence of each identified potential adverse
effect;
- Estimation of the risk posed by each identified characteristic of the GMO(s);- Application of management strategies for risks from the deliberate release or placing
on the market of GMO(s);  and
- Determination of the overall risk of the GMO(s).G/SPS/GEN/405
Page 16
The Scientific Committee on Plants (SCP) issued opinions on applications for the placing on
the market of 17 GM plant varieties under Directive 90/220/EEC.  In one application, an
unfavourable opinion was given due to an insufficient risk assessment in terms of the
presence of a number of uncharacterised genes within the GM plant variety, in particular the
gene which confers resistance to amikacin, a clinically important antibiotic.  This applicationwas withdrawn.
The Scientific Committee on Food is responsible for opinions relating to Novel Foods.  This
Committee has issued 3 favourable opinions on food of plant origin (tomato and maize) and
4 on products of microbial origin.
What is the  procedure for approval of the release of GMOs into the environment?
Under Directive 2001/18/EC, a company intending to market a GMO must first submit an
application to the competent national authority of the member State where the product is to
be first placed on the market.
The application must include a full environmental risk assessment. If the national authority
gives a favourable opinion on the placing on the market of the GMO concerned, this member
State informs the other member States via the Commission.  If there are no objections, the
competent authority that carried out the original  evaluation grants the consent for the placing
on the market of the product.  The product may then be placed on the market throughout theEuropean Union in conformity with any conditions required in that consent.
If objections are raised and maintained, a decision has to be taken at Community level.  The
Commission first asks for the opinion of its Scientific Committees composed of independent
scientists, highly qualified in the fields associated with medicine, nutrition, toxicology,biology, chemistry, or other similar disciplines.
If the scientific opinion is favourable, the Commission then proposes a draft Decision to the
Regulatory Committee composed of representatives of member States for opinion.  If the
Regulatory Committee gives a favourable opinion, the Commission adopts the Decision.
If not, the draft Decision is submitted to the Council of Ministers for adoption by qualified
majority or rejection.  If the Council does not act within 3 months, the Commission can
adopt the decision.
During the notification process, the public is also informed and has access to the publicly
available data on the internet http://gmoinfo.j rc.it/, for example, the summary notification
format, the assessment reports of the competent authorities or the opinion of the Scientific
Committees.
For experimental releases, notifications are examined and consent is granted as appropriate
by the authorities of the member State in which the release is to be conducted.
How many GMOs have been approved  for release into the environment?
Since Directive 90/220/EEC entered into force in October 1991, the commercial release of
18 GMOs has been authorized in the EU, mostly by a Commission Decision following aqualified majority vote in the Regulatory Committee.  In two cases the Commission
Decision has not yet been implemented by the member State (see Annex 1).G/SPS/GEN/405
Page 17
Since October 1998, no further authorisations were granted under Directive 90/220/EEC
although there were 13 applications pending at the time of its repeal (see Annex 2).   Some
member States also invoked Article 16, the so-called safeguard clause, of Directive
90/220/EEC to temporarily ban the placing on the market of genetically modified maize and
oilseed rape products in their territories.  There are currently nine outstanding Article 16cases involving Austria, Luxembourg, France, Greece, Germany and United Kingdom.
These cases have been examined by the Scientific Committee on Plants, which in all cases
deemed that the information submitted by member States did not justify their bans.
Currently the Commission has received eighteen (18) notifications under Directive
2001/18/EC.  These are listed in Annex 3.  Seven (7) of these are products which were
pending under Directive 90/220/EC at the time of its repeal (c.f. Annex 2).
What are the current rules on  the marketing of GM foods?
Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients sets out rules for
authorization and labelling of novel foods including food products containing, consisting orproduced from GMOs.
The first step of an authorization procedure is an assessment of an application to market a
GM food product by the member State where the food is to be first placed on the market.  In
case of a favourable opinion, this member State informs the other member States via theCommission.  If there are no objections agai nst the application, this member State can
authorize the product for marketing in the entire EU.
If there are objections by other member States, a decision at Community level is required.
The Commission consults the Scientific Committees on matters relating to public health andadopts a decision after receiving a favourable opinion from the Regulatory Committee
composed of member State representatives.
As a derogation from the full authorization procedure, the Novel Foods Regulation provides
for a simplified procedure for foods derived from GMOs but no longer containing GMOs
which are "substantially equivalent" to existing foods with respect to composition,
nutritional value, metabolism, intended use and the level of undesirable substances.  In suchcases, the companies only have to notify the Commission when placing a product on the
market together with either scientific justific ation that the product is substantially equivalent
or an opinion to the same effect, delivered by the competent authorities of a member State.
How many GMOs have been approved for use in food products?
Two genetically modified plants, a variety of soybean and a variety of maize have been
authorized under Directive 90/220/EEC prior to  the entry into force of the Novel Foods
Regulation, to be on the European market for the use in food. Under the Novel Foods
Regulation no products consisting of or containing live GMOs have so far been authorizedunder the full procedure.  Ten applications concerning such products are pending at different
stages in the procedure (Annex 4).  Several products produced from GMOs have been
notified to the Commission as being substantially equivalent (see Annex 5).  Recently, two
cotton seed oils for food use have been placed on the market in the EU in accordance with
this procedure.  The list of notifications is published in the Official Journal of the EU once ayear.G/SPS/GEN/405
Page 18
What are the current rules on genetically modified feed and which ones have been
authorized?
There is currently no Community legislation governing the use of material derived from
GMOs in feed.  This is provided for in the Proposal on GM food and feed, which wasadopted by the Commission on 25 July 2001.  However, eight GMOs are authorized in
accordance with Directive 90/220/EEC for the purpose of use in feed; these are four maize
varieties, three rape varieties and one soya variety (see Annex 1).
What are the current rules on  genetically modified seeds?
Community legislation on seeds, notably Directive 98/95/EC, specifies that national
authorities that have agreed to the use of a se ed on their territory must notify this acceptance
to the Commission.  The Commission examines the information supplied by the member
State concerned and its compliance with the provisions of Community seeds legislation.  If
such is the case, the Commission includes the variety concerned in the "Common Catalogue
of varieties of Agricultural Plant Species" which means the seed can be marketed throughoutthe EU.  The seed legislation furthermore requires that GMO seed varieties have to be
authorized in accordance with Directive 90 /220/EEC before they are included in the
Common Catalogue and marketed in the EU.  If the seed is intended for use in food, it also
has to be authorized in accordance with the Novel Foods Regulation.
Legislation on the marketing of forestry reproductive material also requires prior
authorization of GM material in line with the requirements of Directive 90/220.  Community
rules governing the marketing of vine material  in line with Directive 90/220/EEC have also
been adopted.
Further rules on growing conditions and other requirements for purity concerning the
presence of GM seeds in seed lots of traditiona l varieties, as well as detailed labelling rules
are to be proposed.
What are the rules for Medicines, Pr otection of workers and Transport
Authorization of medicinal products for human and veterinary use (including such derived
from genetically modified organisms) is regulated under Regulation (EEC) 2309/93 laying
down Community procedures for the authorization and supervision of medicinal products for
human and veterinary use.
Council Directive 90/679/EEC on the protection of workers from the risks related to
exposure to biological agents at work also  regulates GMOs alongside other biological
agents.
What are the current rules on labelling?
The EU recognizesthe consumers’ right for info rmation and labelling as a tool to make an
informed choice.
Since 1997 labelling to indicate the presence of GMOs as such or in a product is mandatory.
From 17 October 2002 onwards Directive 2001/18 /EC foresees that member States shall
take all necessary measures to ensure a labelling of GMOs as or in products at all stages of
the placing on the market.G/SPS/GEN/405
Page 19
The Novel Foods Regulation provides for the mandatory labelling of foods and food
ingredients which contain or consist of a GMO without prejudice to the other labelling
requirements of Community law.  The labelling requirements for foods produced from
GMOs, but no longer containing GMO are based on the concept of equivalence7.
Council Regulation (EC) 1139/98 lays down provisions for the labelling of foods and food
ingredients derived from one maize and one soya8 variety based on the presence of DNA or
protein resulting from genetic modification.  This criterion serves as a model providing the
rules applicable to labelling of all foods and food ingredients derived from GMO.
In January 2000, the Commission adopted Re gulation (EC) 50/2000 ensuring that also
additives and flavourings have to be labelled if DNA or protein of GMO origin is present in
the final product.
Regulation (EC) 49/2000 addresses the problem of adventitious presence of GM material in
conventional food.  It introduces a 1% de minimis  threshold for the adventitious presence of
DNA or protein resulting from genetic modification below which labelling is not required.Operators have to be in a position to demonstrate that they have used appropriate steps to
avoid the presence of GM material.
Genetically modified seed varieties must be labelled, in accordance with Council Directive
98/95/EEC.  The label has to show clearly that it is a GM variety.
Currently, there is no specific Community legislation on the labelling of feed produced from
GMOs.
PART B:  NEW LEGISLATIVE PROPOSALS
What are the contents of the latest proposals from European Commission concerning
traceability and labelling of GMOs?
The European Commission adopted on 25 July 2001 two legislative proposals on GMOs.
They set up a harmonised community system to trace GMOs, introduce the labelling of GM
feed, reinforce the current labelling rules on GM food and establish a streamlinedauthorization procedure for GMOs in food and feed and their deliberate release into the
environment.
The proposals aim to put into place a stringent regulatory framework and to close existing
legal gaps.  They address the legitimate concerns of citizens, consumer organisations andeconomic operators.
A strict safety assessment of GMOs will continue to assure a high level of health and
environmental protection. The labelling of all GM food and feed products will allow
consumers and farmers to decide if they want to buy food or feed produced from a GMO, ornot.
                                                     
7 This means that if a characteristic or property (composition, nutritional value or nutritional effects,
intended use) renders a food or food ingredient no longer equivalent to an existing counterpart, it has to belabelled indicating the method (ie. genetic modification) by which the characteristic or property was obtained.
8 These varieties were approved before the entering into force of the Novel Foods Regulation under
Directive 90/220/EEC on the deliberate release into the environment of genetically modified organismsG/SPS/GEN/405
Page 20
The package consists of:
- a proposal for a Regulation on traceability and labelling of GMOs and products
produced from GMOs:  COM 2001 - 1821 final, 25 July 2001, see
http://europa.eu.int/comm/food/fs/biotech/biotech09_en.pdf;  and
- a proposal for a Regulation on GM food and feed:  COM 2001 - 425 final,
25 July 2001, see http://europa.eu.int/comm/food/fs/biotech/biotech08_en.pdf.
Why is the Commission proposing specif ic rules on traceability of GMOs?
Traceability provides the means to trace products containing or produced from GMOs
through the production and distribution chains.  The general objectives are to facilitate:
- control and verification of labelling claims;- targeted monitoring of potential effects on the environment, where appropriate;  and- withdrawal of products that contain or consist of GMOs should an unforeseen risk to
human health or the environment be established.
However, whilst Directive 2001/18 includes general provisions on which a traceability
system for GMOs could be based, it neither contains a definition of traceability for GMOs,
nor does it include the objectives of traceability or a complete approach for its
implementation.
Differences and overlap between national laws, regulations and administrative provisions
concerning traceability of GMOs and food and feed products produced from GMOs may
hinder the free movement of products and create conditions of unfair competition.  A
Community Regulation based on the requirements of Directive 2001/18/EC and laying down
a harmonised framework for traceability of such products would provide legal certainty and
a coherent approach, and thus contribute to the effective functioning of the internal market.
Does traceability apply to GMOs and GM products only, or also to other food
products?
Traceability for certain products has existed for many years.  The proposed regulation sets
specific traceability requirements for GM products.  Traceability specifically for GMOs was
introduced in general terms into Community legislation with Directive 2001/18/EC
9 which
requires that member States ensure traceability at all stages of the placing on the market for
GMOs. General traceability provisions have already been laid down in Community
legislation concerning food, feed and seed.  Legislation for specific traceability scheme for
beef products has been put into place as in response to the BSE crisis (Regulation
1760/2000/EC).  Council and Parliament Regula tion (Regulation EC/178/2002) laying down
the general principles and requirements of food law, establishes also the principle of
traceability at all stages of the production and distribution chain in the food and feed sectors.
                                                     
9 OJ L 106, 17.4.2001, p.1.G/SPS/GEN/405
Page 21
What are the new rules on traceability of GMOs?
Under the rules of the proposed Regulation on traceability business operators must transmit
and retain information about products that contain or are produced from GMOs at each stage
of the placing on the market.
In particular, the requirements are that:- operators shall have systems and procedures in place to identify to whom and from
whom products are made available;
- for GMOs intended for deliberate release into the environment, operators must
transmit specified information on the identity of the individual GMO(s) a product
contains;
- for GMOs intended for food, feed or for processing, business operators may either
transmit the specified information mentioned above or transmit a declaration that theproduct shall only be used as food or feed or for processing, together with the
identity of the GMO(s) that the product may contain;
- for food and feed produced from GMO(s) operators shall inform the next operator in
the chain that the product is produced from GMO(s);  and
- operators shall retain the information for a period of 5 years and make it available to
competent authorities on demand.
Transmission and keeping records of this information will reduce the need for sampling and
testing of products.  To facilitate a co-ordinated approach for inspection and control by the
member States, the Commission will develop technical guidance on sampling and testing
methods prior to the application of this proposed regulation.
How does traceability work in practice?
Traceability can be defined as the ability to trace products through the production and
distribution line.  For example, where production starts with a genetically modified seed , the
company selling the seed would have to inform any purchaser that it is genetically modified,
together with more specified information allowing the specific GMO to be precisely
identified.  The company is also obliged to keep a register of business operators who have
bought the seed.
Equally the farmer would have to inform any purchaser of the harvest that it is genetically
modified and keep a register of operators to whom he has made the harvest available.
The proposal covers all GMOs that have received Community authorization for the placing
on the market, that is all products, including food and feed, containing or consisting of
GMOs.
Examples are seeds, which have been genetically modified and bulk quantities or shipments
of whole GM grain eg. soybean and maize.
The proposal also covers food and feed which are derived from a GMO.  This includes
tomato paste and ketchup produced from a GM tomato or starch, oil or flour produced from
a GM maize.G/SPS/GEN/405
Page 22
What are the cost implications for operators of the traceability proposal?
It is difficult to estimate the exact costs of introducing traceability specifically for GMOs
and products derived from GMOs.
Information with respect to the supplier, customer, price and transaction date as well as the
nature, source, contents and amount of the product already accompanies the majority of
transactions.  This information has also to be retained by operators under national
administrative systems, for example for filling in VAT returns.  Transmission and retention
of the information specified in the proposal could largely be incorporated into existing
systems for transactions and as such, should not imply significant extra costs for operators.
What are the new proposed labelling rules a nd what is the difference with the existing
rules?
The proposal extends the current labelling provisions to all genetically modified food or
feed, irrespective of the detectability of genetically modified DNA or protein.  All food and
feed which consist of, contain or are produced from GMOs would have to be labelled as
such.  The purpose is to inform consumers and farmers about the exact nature and
characteristics of the food or feed, so that they can make informed choices.
The current GM labelling system is based on the detectability of genetically modified DNA
or protein in the final food product. In practi ce this means that highly processed foodstuffs
produced from GM material, such as highly refined oils, do not need to be labelled.  The
proposed labelling rules extend the labelling requirements to all food and ingredients
produced from GMOs to allow consumers to exercise their freedom of choice.
Genetically modified feed will need to be labelled along the same principles to give
livestock farmers accurate information on the composition and properties of feed.  This will
mean that a large number of feedstuffs currently not subject to GM labelling requirements,
such as GM soy meal in feed or compound feedstuffs and the four genetically modified feed
plants authorized under Directive 90/220/EEC will in future need to be labelled.  See also
Annex 6.
Will the meat or milk of an animal fed with GM feed also be labelled as GM?
In line with the general EU rules on labelling, the proposal does not require labelling of
products that are not food ingredients such as processing aids.  It does not require labellingof products such as meat, milk or eggs obtai ned from animals fed with genetically modified
feed or treated with genetically modified medicinal products.
How will GM food and feed in future be authorized?
Clear rules are already set out in the EU for the assessment and authorization of GMOs and
GM-food, but the responsibilities are currently divided between the member States and the
Community.  The Commission has proposed to replace this with a "one door – one key"
procedure for the scientific assessment and authorization of GMOs and GM food and feed  It
puts in place a streamlined, uniform and transparent Community procedure for all marketingapplications, whether they concern the GMO itself or the food and feed products derived
thereof.  This means that business operators need not request separate authorisations for use
of the GMO, and for its use in feed or in food, but that a single risk assessment and a single
authorization are given for a GMO and its possible uses.  This will ensure that experiencesG/SPS/GEN/405
Page 23
such as with Starlink maize in the US are avoided because GMOs likely to be used as food
and feed can only be authorized for both uses, or not at all.
The scientific risk assessment will be carried out by the European Food Safety Authority
covering both the environmental risk and human and animal health safety assessment.  Itsopinion will be made available to the public and the public will have the possibility to make
comments.  On the basis of the opinion of the European Food Authority, the Commission
will draft a proposal for granting or refusing authorization.  The proposal will, as it is
currently the case, be approved through qualified majority of the member States within a
Regulatory Committee.
Products authorized shall be entered into a public register of GM-food and feed.
Authorisations will be granted for a period of 10 years, subject where appropriate to a
post-market monitoring plan.  Authorisations are renewable for 10-year periods.
The simplified procedure for putting on the market GM-foods which are considered to be
substantially equivalent to existing foods will be abandoned.
Will there be new rules on GM seed?
Two further proposals relating to GM seeds in seeds of conventional varieties are to be
adopted in the near future.  The first one is a Commission Directive amending the annexes ofthe different seed Directives, setting additional conditions and requirements concerning the
adventitious or technically unavoidable presence of GM seeds in seed lots of non-GM
varieties and specifying the labelling requirements of seeds of genetically modified varieties.
At the same time a Commission Regulation on a protocol for sampling and testing of seed
lots of non-GM varieties for the presence of GM seed will define how seed testing has to be
carried out when applying the requirements set out in the previously mentioned Commission
Directive will be put forward.
Why is the Commission proposing to allow the presence of traces of GMOs which have
received a favourable scientific assessment, but which are not yet formally approved?
The adventitious or unintended presence of GMOs in products placed on the market in the
European Union is largely unavoidable and can occur during cultivation, handling, storage
and transport.  This situation already exists and affects products originating both in the
Community and third countries.
This is not a problem which is not unique to GMOs.  In the production of food, feed and
seed, it is practically impossible to achieve products that are 100% pure.
The proposal acknowledges this fact and defines the specific conditions under which a
technically unavoidable presence of GMOs not yet formally authorized could be permitted.
A number of GMOs have already been assessed by the Scientific Committees advising the
European Commission as not posing a danger to environment and health, but their final
approval is still pending.  The proposal allows the presence of these GMOs in a food or feed
up to a maximum of 1% below which labelling and traceability will not be enforced.  This ison the basis that the presence of such material is adventitious or technically unavoidable and
has been subject to a scientific risk assessment by the relevant Scientific Committees or
European Food Authority, which has concluded that the material does not present a risk for
human health and the environment.G/SPS/GEN/405
Page 24
This exemption aims to solve the problem faced by operators who have tried to avoid
GMOs, but find that their products contain a low percentage of GM material due to
accidental or technically unavoidable contamination.  Current legislation on GM foods
(Regulation 1139/98, see above) already sets a threshold of 1% for the labelling of approvedGM material.
Are the new labelling rules in line with the international trade rules?
The proposals take account of the Community's  international trade commitments and of the
requirements of the Cartagena Protocol on Biosafety with respect to obligations of
importers.  A further legislative proposal setting rules concerning the obligations ofexporters and other elements of the Cartagena Protocol is being prepared.
The political agreement in Council on the Proposals
In its political agreements in 2002, the Council endorses the main features of the original
Commission Proposals.  However, the political agreement includes two significant changes:
- a 0.9 % threshold for the labelling of GM food and feed.  The Commission
originally proposed that the threshold be fixed in comitology procedure;  and
- a 0.5 % threshold instead of 1 % as suggested by the Commission for presence of
GM material in food or feed, or for processing, which has received a favourable
scientific risk assessment by the Scientific Committees or the European Food Safety
Authority, but which has not yet been finally approved to be placed on the market.
The political agreement also limits the application of this threshold to three yearsand provides that a detection method must be publicly available.
Concerns and questions raised by third countries
A detailed response to the concerns and questions raised by third countries in the WTO
context can be found on web-site:
http://europa.eu.int/comm/food/fs/gmo/resp_ec_com182_en.pdf
concerning the traceability Proposal, and on web-site:
http://europa.eu.int/comm/food/fs/gmo/resp_ec_com425_en.pdf
concerning the GM food and feed Proposal.
Will the Commission resume the authorization process of GMOs?
The revised rules on the deliberate release of genetically modified organisms in Directive
2001/18/EC set out effective, efficient and transparent measures to ensure a high level of
protection for human health and the environment.   The two legislative proposals put forward
in July 2001 build on the principles of this Directive and provide a regulatory framework for
labelling and traceability.  Together, this package of measures aims to address the concerns
of member States and to build consumer confidence in the authorization of GM products.The revised Directive and the two proposals for Regulations are expected to pave the way
for a resumption of GM authorisations in the European Union.G/SPS/GEN/405
Page 25
How is the issue of exchange of GMOs reg ulated with Countries outside of the EU?
The UNEP Cartagena Protocol on Biosafety to  the Convention on Biological Diversity was
adopted on 29 January 2000.  The overall purpose of this United Nations agreement is to
establish common rules to be followed in transboundary movements of GMOs in order toensure, on a global scale, the protection of biodiversity and of human health.  The
Commission Proposal on the transboundary mo vements of GMOs, dated from 18 February
2002, is linked to the recent ratification by the European Community of the Cartagena
Protocol on Biosafety.
The European Union has to fulfil its international obligations and therefore we transpose into
our own legal order the provisions of the Biosafety Protocol.  The Commission's Proposal
complements the existing Community regulatory  framework, in particular for exports of
GMOs, in order to align it with the provisions of the Biosafety Protocol.
The main elements of the proposal are the following:
- Firstly, the obligation to notify exports of GMOs intended for deliberate release into
the environment;
- Secondly, the obligation to provide information to our international partners on
Community practices, legislation and decisions on GMOs, as well as on accidentalreleases of GMOs;  and
- Thirdly, a set of rules for identifying  GMOs for exports.  These rules are in line
with latest developments in Community legislation on GMOs, and in particular with
the provisions of the Draft Regulation on Traceability and Labelling.
The current Proposal does not foresee new specific Community provisions for imports or for
movements of GMOs between member States.  These operations will continue to be covered
by existing Community legislation.G/SPS/GEN/405
Page 26Annex 1
GMO PRODUCTS – APPROVED UNDER DIRECTIVE 90/220/EEC
as of March 2001
Product Notifier Date of Commission
Decision10 / Member State
Consent11
1. Vaccine against Aujeszky's disease Vemie Veterinär Chemie
GmbH18.12.92
2. Vaccine against rabies Rhône-Mêrieux
C/B/92/B28 & C/F/93/03-0219.10.93
3. Tobacco tolerant to bromoxynil SEITA
C/F/93/08-0208.06.94
4. Vaccine against Aujeszky's disease (further uses)12Vemie Veterinär Chemie
GmbH
C/D/92/I-118.07.94
5. Male sterile swede rape resistant to glufosinate ammonium (MS1, RF1)
Uses : breeding activitiesPlant Genetic Systems
C/UK/94/M1/106.02.96
6. Soybeans tolerant to glyphosate
Uses : import and processingMonsanto
C/UK/94/M3/103.04.96
7. Male sterile chicory  tolerant to glufosinate ammonium
Uses : breeding activitiesBejo-Zaden BV
C/NL/94/2520.05.96
8. Bt-maize tolerant to glufosinate ammonium
(Bt-176)Ciba-Geigy
C/F/94/11-0323.01.97
9. Male sterile swede rape tolerant to glufosinate ammonium (MS1, RF1)13
Uses : import and processingPlant Genetic Systems
C/F/95/05/01/A06.06.97
(not finally approved by
FR)
10. Male sterile swede rape tolerant to glufosinate ammonium (MS1, RF2)14Plant Genetic Systems
C/F/95/05/01/B06.06.97
(not finally approved by F)
11. Test kit to detect antibiotic residues in milk Valio Oy
C/F1/96-1NA14.07.97
                                                     
10 Where objections were raised by member State authorities.
11 In the absence of objections by member State authorities.
12 Linked to item 1 (same product, further uses).
13 Linked to item 5 (same product, further uses).
14 This product is the result of a different transformation event to that of No. 9.G/SPS/GEN/405
Page 27Product Notifier Date of Commission
Decision10 / Member State
Consent11
12. Carnation lines with modified flower colour Florigene
C/NL/96/1401.12.97
(MS consent)
13. Swede rape tolerant to glufosinate ammonium (Topas 19/2)
Uses : import and processingAgrEvo
C/UK/95/M5/122.04.98
14. Maize tolerant to glufosinate ammonium (T25) AgrEvo
C/F/95/12/0722.04.98
15. Maize expressing the Bt cryIA(b) gene (MON 810) Monsanto
C/F/95/12-0222.04.98
16. Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b) gene (Bt-11)
Uses : import and processingNovartis
(formerly Northrup King)
C/UK/96/M4/122.04.98
17. Carnation lines with improved vase life Florigene
C/NL/97/1220.10.98
(MS consent)
18. Carnation lines with modified flower colour Florigene
C/NL/97/1320.10.98
(MS consent)G/SPS/GEN/405
Page 28Annex 2
GMO PRODUCTS - PENDING APPROVAL UNDER DIRECTIVE 90/220/EEC
As of October 2002
Product notification details Company
1. Maize expressing the Bt cryIA(b) gene (MON 809)
from France (C/F/95/12-01/B)
Received by the Commission: 06.08.96
Favourable opinion of EU Scientific Committee 19.05.98
Uses:  as any other maize Pioneer
 
2. Male sterile chicory15
from the Netherlands (C/NL/94/25/A)
Received by the Commission: 20.09.96
Favourable opinion of EU Scientific Committee 18.12.98
Uses:  food and feed Bejo-Zaden BV
 
3. Swede rape tolerant to glufosinate ammonium
(FALCON GS40/90)
from Germany (C/DE/96/5)
Received by the Commission: 25.11.96
Uses: as any other swede rape AgrEvo GmbH
 
4. Male sterile swede rape tolerant to glufosinate ammonium (MS8, RF3)
from Belgium (C/BE/96/01)
Received by the Commission: 16.01.97
Favourable opinion of EU Scientific Committee 19.05.98
Uses: as any other swede rapePlant Genetic Systems
5. Fodder beet tolerant to glyphosate
from Denmark (C/DK/97/01)
Received by the Commission: 09.10.97
Favourable opinion of EU Scientific Committee 23.06.98
Uses:  production of seeds and roots, animal feedDLF-Trifolium, Monsanto and
Danisco Seed
                                                     
 15 This is the same product as No. 7 on the list of a pproved GMOs, which was restricted to breeding activities.
 G/SPS/GEN/405
Page 29Product notification details Company
6. Tomato with reduced activity of the expression of th e endogenous tomato fruit PG genefrom Spain (C/ES/96/01)
received by the Commission: 24.11.97
Favourable opinion of EU Scientific Committee 23.06.98
Uses: as any other processing tomato  Zeneca
7. Cotton expressing the Bt cryIA(c) gene (line 531)
from Spain (C/ES/96/02)
Received by the Commission: 24.11.97
Favourable opinion of EU Scientific Committee 14.07.98
Uses: as any other cotton Monsanto
8. Cotton tolerant to herbicide (line 1445)
from Spain (C/ES/97/01)
Received by the Commission: 24.11.97
Favourable opinion of EU Scientific Committee 14.07.98
Uses: as any other cotton Monsanto
9. Potato with altered starch composition
from Sweden (C/SE/96/3501)
Received by the Commission: 20.05.98
Favourable opinion of EU Scientific Committee 18.07.02
Uses: as any other starch potato AMYLOGENE
10. Swede rape tolerant to glufosinate ammonium (Liberator)
from Germany (C/DE/98/6)
Received by the Commission: 29.10.98
Favourable opinion of EU Scientific Committee 30.11.00
Uses: as any other swede rape AgrEvo GmbH
 
11. Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b) gene (Bt-11)16
from France (C/F/96/05-10) and Spain (C/ES/98/02)
Received by the Commission: 12.04.99 and 03.05.99 respectively
Favourable opinion of EU Scientific Committee 30.11.00
Uses : cultivation Novartis
                                                     
 16 This is the same product as No. 16 on the list of approved GMOs, which was restricted to import and processing.G/SPS/GEN/405
Page 30Product notification details Company
12. Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b) gene (T25 + MON810)17
from the Netherlands (C/NL/98/08)
Received by the Commission: 29.04.99
Favourable opinion of EU Scientific Committee 06.06.00
Uses: as any other maizePioneer
13. Maize tolerant to glyphosate (GA21)
from Spain (C/ES/98/01)
Received by the Commission: 20.05.99
Favourable opinion of EU Scientific Committee 22.09.00
Uses:  as any other maizeMonsanto
                                                     
17 This product is obtained from conventionally derived crosses between Nos. 14 and 15 on the list of approved GMOs.G/SPS/GEN/405
Page 31Annex 3
GMO PRODUCTS – NOTIFICATIONS RECEIVED BY THE COMMISSION UNDER DIRECTIVE 2001/18/EC
As of 20 February 2003
Product notification details Company
 1. Oil seed rape – herbicide resistant GT 73
 Received by the Netherlands (C/NL/98/11) under Dir 90/220/EC.
 Received by the Commission under Dir 2001/18 : 16/1/03
 Uses:  import and uses in feed and industrial processing, not for cultivation. Monsanto
 
2. Maize Roundup Ready NK603, tolerant to glyphosate herbicide
Received by Spain (C/ES/00/01) under Dir 90/220 : 21/12/2000
Received by the Commission under Dir 2001/18 : 17/01/03
Uses:  import and use in feed and industrial processing, not for cultivation.Monsanto
 3.  Maize hybrid MON810 x NK603 (glyphosate-tolerant and containing Bt toxin)
 Received by UK under Dir 90/220/EC. (C/GB/02/M3/03)
 Received by the Commission under Dir 2001/18 : 15/01/03
 Uses:  import and use in feed and industrial processing, not for cultivation. Monsanto
4. Potato with altered starch composition
from Sweden (C/SE/96/3501)
Received by the Commission under Dir 90/220: 20.05.98
Favourable opinion of EU Scientific Committee 18.07.02
Received by the Commission under Dir 2001/18/EC: 24/01/03
 Uses: for cultivation and production of starch, not for use as human food. AMYLOGENE
 HB
5. Oilseed rape (Ms8, Rf3)
from Belgium (C/BE/96/01)
Received by the Commission: under Dir 90/220 16.01.97
Favourable opinion of EU Scientific Committee 19.05.98
Received by the Commission under Dir 2001/18: 5/02/03
 Uses: import and cultivation in the EU, uses in feed and industrial processing. Bayer CropScience
6. Soybeans Glufosinate tolerant (Events A 2704-12 and A 5547-127)
from Belgium (C/BE/98/01)
Received by the Commission under Dir 2001/18: 5/02/03
 Uses: import only Bayer CropScienceG/SPS/GEN/405
Page 32Product notification details Company
 7. Roundup Ready sugar beet (event T9100152), glyphosate tolerant
 from Belgium C/BE/99/01
 Received by the Commission under Dir 2001/18: 5/02/03
 Uses: for cultivation and use in animal feed, processing of sugar and other products. Monsanto/
Syngenta
8. Oilseed rape tolerant for glufosinate-ammonium herbicides.
(FALCON GS40/90pHoe6/Ac)
from Germany (C/DE/96/5)
Received by the Commission under Dir 90/220: 25.11.96
Opinion of EU Scientific Committee 27.07.98
 Received by the Commission under Dir 2001/18: 7/02/03
 Uses: for import and cultivation Bayer CropScience
 
 
9. Oilseed rape tolerant for glufosinate-ammonium (Liberator pHoe6/Ac)
from Germany (C/DE/98/6)
Received by the Commission under Dir 90/220: 29.10.98
 Favourable opinion of EU Scientific Committee 30.11.00
 Received by the Commission under Dir 2001/18: 7/02/03
 Uses: for import and cultivation Bayer CropScience
 10. Roundup Ready Sugar Beet event H7-1 (tolerant to glyphosate)
 from Germany C/DE/00/8
 Received by the Commission under Dir 2001/18: 7/02/03
 Uses: for cultivation and use in processing of sugar and other processed products. KWS SAAT
AG/Monsanto
 11. Maize MON 863 X MON 810 (protection  against certain insect pests)
 from Germany C/DE /02/9 (6788-01-09)
 Received by the Commission under Dir 2001/18: 7/02/03
 Uses:, for import and use of grain and grain products. Monsanto
 12. Oilseed rape (event T45) tolerant for glufosinate-ammonium herbicide
 from UK C/GB/99/M5/2
 Received by the Commission under Dir 2001/18: 10/02/03
 Uses: import and use in feed and industrial processing. Bayer CropScience
13. Maize herbicide and insect resistant (line 1507 -- CRY1F)
received by the Netherlands (C/NL/00/10) under Dir 90/220/EC.
Received by the Commission under Dir 2001/18 : 12/02/03
Uses: import and processing, not for cultivation Pioneer/
Mycogen SeedsG/SPS/GEN/405
Page 33Product notification details Company
14. Insect-protected Cotton expressing the Bt cryIA(c) gene (line 531)
from Spain (C/ES/96/02)
(Received by the Commission under Dir 90/220: 24.11.97
 Favourable opinion of EU Scientific Committee 14.07.98)
 Received by the Commission under Dir 2001/18: 12/2/03
Uses: for import, processing and cultivation Monsanto
15. Roundup Ready Cotton tolerant to herbicide (line 1445)
from Spain (C/ES/97/01)
(Received by the Commission under Dir 90/220: 24.11.97
 Favourable opinion of EU Scientific Committee 14.07.98)
 Received by the Commission under Dir 2001/18: 12/2/03
 Uses: for import, processing and cultivation Monsanto
16. Roundup Ready Maize tolerant to glyphosate (GA21)
from Spain (C/ES/98/01)
Received by the Commission under Dir 90/220: 20.05.99
Favourable opinion of EU Scientific Committee 22.09.00
 Received by the Commission under Dir 2001/18: 13/2/03
Uses: use in feed and industrial processingMonsanto
17. Maize MaisGard/Roundup Ready (derived from MON 810 and GA21).  Tolerance to glyphosate and Cry1Ab protein derived from
Bt.
Received by Spain (C/ES/99/02) 3/9/1999 under Dir 90/220/EC.
Received by the Commission under Dir 2001/18: 13/2/03
Uses: import and use in feed and industrial processing, not for cultivation. Monsanto
18. Maize 1507 (or Bt Cry1F 1507)
Received by Spain (C/ES/01/01) 11/7/2001 under Dir 90/220/EC.
Received by the Commission under Dir 2001/18: 13/2/03
Uses: import, feed and industrial processing, and cultivation Pioneer Hi-Bred
/Mycogen SeedsG/SPS/GEN/405
Page 34Annex 4
Pending applications under Regulation (EC) N° 258/97 of the European Parliament and of the Council
Applicant Description of Food or Food
IngredientInitial Assessment Carried
out byApplication Date Status By June 2002
1Bejo-Zaden
P.O.Box 50
NL - 1749 WarmenhuizenTransgenic Radicchio rosso
with male sterilityThe Provisional Committee
for the safety evaluation of
novel foods (VcVnv) (NL)8 April 1998 Under assessment by the
Scientific Committee on Food
(SCF).
2Bejo-Zaden
P.O.Box 50
NL - 1749 WarmenhuizenTransgenic Green hearted
Chicoree with male sterilityThe Provisional Committee
for the safety evaluation of
novel foods (VcVnv) (NL)8 April 1998 Under assessment by the SCF
3Monsanto Services
International S.A.
Avenue de Tervueren 270-272
B - 1150 BruxellesRoundup Ready Maize line
GA21The Provisional Committee
for the safety evaluation of
novel foods (VcVnv)24 July 1998 SCF opinion of 27 February
2002
4 Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B - 9000 GentLiberty Link Soybean by
AgrEvoBioveiligheidsraad (B) 2 February 1999 Initial assessment report
pending.
5 Novartis Seeds AG
CH - 4002 BaselBt11 sweet maize Gezondheidsraad (NL) 11 February 1999 SCF opinion of 13 March 2002
6 Monsanto Services
International S.A.
Avenue de Tervueren 270-272
B - 1150 BelgiumMaisGard /g226/RoundupReady /g226 Gezondheidsraad (NL) 16 March 2000 Initial assessment report pending
7 Monsanto Europe S.A.
Avenue de Tervueren 270-272
B - 1150 Brussels and;
Novartis Seeds AB, Box 302
S - 261 23 LandskronaFoods and food ingredients
derived from Roundup Ready /g226
Sugar BeetGezondheidsraad (NL) Initial assessment report pending
8 Pioneer Overseas Corporation
Avenue Tedesco 7
B - 1160 BrusselsFood products of genetically
modified B.t. CRY1F Maize
line 1507Gezondheidsraad (NL) 26 February 2001 Initial assessment report pendingG/SPS/GEN/405
Page 35Applicant Description of Food or Food
IngredientInitial Assessment Carried
out byApplication Date Status By June 2002
9 Monsanto Services
International S.A.
Avenue Tervueren 270–272
B - 1150 BruxellesRoundup Ready maize line
NK603Gezondheidsraad (NL) June 2001 Initial assessment report
10 Monsanto Services
International S.A.
Avenue de Tervueren 270-272
B - 1150 BruxellesInsect protected maize line
MON 863 and maize hybrid
MON 863 X MON 810Robert Koch Institut (D) 28 August 2002 Initial assessment report pendingG/SPS/GEN/405
Page 36Annex 5
Notifications Pursuant to Article 5 of Regulation (EC) N° 258/97 of the European Parliament and of the Council
Applicant Description of
Food or Food IngredientScientific Evidence Notification Transmission to
Member States
1 AgrEvo UK Limited
Chesterford Park
Saffron Walden
UK - Essex CB10 1XLProcessed oil from genetically modified
canola seed, transformation event TOPAS
19/2 and all conventional crossed“Report on oil from a genetically
modified (GM) glufosinate
ammonium tolerant oilseed rape”
(ACNFP)*9 June 1997 24 June 1997
2a Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B - 9000 GentProcessed oil from genetically modified
oilseed rape seed derived from: i) male
sterile MS1Bn (B91-4) oilseed rape line
and all conventional crosses; ii) fertility
restorer RF2Bn (B94-2) oilseed rape line
and all conventional crosses; iii) hybrid
combination MS1XRF2“Report on oil from a fertility
restorer line for use in a hybrid
breeding programme for genetically
modified (GM) oilseed rape”
(ACNFP)*10 June 1997 24 June 1997
again
28 July 1998
2b Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B - 9000 GentProcessed oil from genetically modified
oilseed rape seed derived from: i) male
sterile MS1Bn (B91-4) oilseed rape line
and all conventional crosses; ii) fertility
restorer RF1Bn (B93-101) oilseed rape
line and all conventional crosses; iii)
hybrid combination MS1XRF1“Report on oil from a fertility
restorer line for use in a hybrid
breeding programme for genetically
modified (GM) oilseed rape”
(ACNFP)*; and
“Report on oil from genetically
modified oilseed rape” (ACNFP)*10 June 1997 24 June 1997
again
28 July 1998
3 Monsanto Services
International S.A
Avenue de Tervueren 270-272
B - 1150 BrusselsRefined oil from glyphosate tolerant
oilseed rape line GT73“Report on oil from genetically
modified (GM) glyphosate tolerant
oilseed rape” (ACNFP)*10 November
199721 November
1997
4 Monsanto Services
International S.A
Avenue de Tervueren 270-272
B - 1150 BrusselsFood and food ingredients produced from
maize flour, maize gluten, maize
semolina, maize starch, maize glucose
and maize oil derived from the progeny of
maize line MON 810“Report on processed products
from genetically modified (GM)
insect protected maize” (ACNFP)*10 December
19976 February 1998
                                                     
* ACNFP:  Advisory Committee on Novel Foods and Processes (UK).G/SPS/GEN/405
Page 37Applicant Description of
Food or Food IngredientScientific Evidence Notification Transmission to
Member States
5 AgrEvo France S.A.
Les Algorithmes
Bâtiment Thalès
Saint Aubin
F - 91197 Gif-sur-Yvette Cedexi) Starch and all its derivatives; ii) crude
and refined oil; iii) all heat-processed or
fermented products obtained from
hominys, grits and flour (dry milled
fragments) obtained from the genetically
modified maize, tolerant to glufosinate
ammonium, transformation event T25 and
all the varieties derived from“Report on processed products
from genetically modified (GM)
glufosinate ammonium tolerant
maize” (ACNFP)*12 January 1998 6 February 1998
6 Novartis Seeds AG
Schwarzwaldallee 215
CH - 4058 BaselFood and food ingredient products
derived from the original transformant
Bt11 crossed with the Northrup King
Company inbred line #2044 (maize), as
well as from any inbred and hybrid lines
derived from it and containing the
introduced genesACNFP* Report on grain from
maize genetically modified for
insect resistance30 January 1998 6 February 1998
7 Pioneer Overseas Corporation
Avenue Tedesco, 7
B - 1160 BrusselsNovel foods and novel food ingredients
produced from gentically modified maize
line MON 809ACNFP* Report on genetically
modified (GM) insect protected
maize Pioneer Hi-bred International
– line MON 80914 October 1998 23 October 1998
8 Hoechst Schering,
AgrEvo GmbH
Industriepark Hoechst
AgrEvo-Haus K 607
D - 65926 Frankfurt am MainProcessed oil from genetically modified
oilseed rape derived from Falcon GS
40/90BgVV** Stellungnahme zur
wesentlichen Gleichwertigkeit des
aus der transgenen, Glufosinat-
toleranten Rapssorte Falcon
GS/40/90 gewonnenen raffinierten
Speiseöls21 October 1999 8/9 November
1999
9 Hoechst Schering,
AgrEvo GmbH
Industriepark Hoechst
AgrEvo-Haus K 607
D - 65926 Frankfurt am MainProcessed oil from genetically modified
oilseed rape derived from Liberator L62BgVV** Stellungnahme zur
wesentlichen Gleichwertigkeit des
aus der transgenen, Glufosinat-
toleranten Rapssorte Liberator
pHoe6/Ac gewonnenen raffinierten
Speiseöls21 October 1999 8/9 November
1999
                                                     
** BgVV:  Bundesamt für gesundheitlichen Verbraucherschutz und Veterinärmedizin (D).G/SPS/GEN/405
Page 38Applicant Description of
Food or Food IngredientScientific Evidence Notification Transmission to
Member States
10 Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B - 9000 GentProcessed oil from genetically modified
oilseed rape derived from: the male sterile
MS8 (DBN 230-0028) oilseed rape line
and all conventional crosses; the fertility
restorer RF (DBN212-0005) oilseed rape
line and all conventional crosses; the
hybrid combination MS8 x RF3BgVV** Stellungnahme zur
wesentlichen Gleichwertigkeit des
aus der transgenen, Glufosinat-
toleranten Rapssorte MS8/RF3
gewonnenen, raffinierten Speiseöls21 October 1999 8/9 November
1999
11 F. Hoffman – La Roche Ltd.
Vitamins & Fine Chemicals
Regulatory Affairs
Bldg 241/283
CH - 4070 BaselRiboflavin from Bacillus subtilis as
nutrientACNFP* Report on Riboflavin from
fermentation using genetically
modified (GM) Bacillus subtilis20 March 2000 26 April 2000
12 Monsanto Services
International
Avenue de Tervueren 270-272
B - 1150 BrusselsCottonseed oil from genetically modified
cotton line 1445 (herbicide resistant)ACNFP* Request for an Article 5
opinion on the substantial
equivalence of cotton seed oil and
food ingredients derived from
Roundup ® Ready cotton24 July 2002 19 December
2002
13 Monsanto Services
International
Avenue de Tervueren 270-272
B -1150 BrusselsCottonseed oil from genetically modified
cotton line 531 (insect protected)ACNFP* Request for an Article 5
opinion on the substantial
equivalence of cottonseed oil and
food ingredients derived from
insect protected cottonseed24 July 2002 19 December
2002G/SPS/GEN/405
Page 39
Annex 6
Labelling of GM-Food and GM-Feed – Examples 18
GMO-type EXAMPLELabelling
Required
at presentLabelling
required
in future
GM plant Chicory19Yes Yes
GM seed Maize seeds Yes Yes
GM food Maize, Soybean sprouts, Tomato Yes Yes
Maize flour20Yes Yes
Highly refined maize oil, soybean oil, rape
seed oil21No YesFood produced
from GMOs
Glucose syrup produced from maize starch21No Yes
Food from animals fed on
GM feedEggs, meat, milk No No
Food produced with the help
of a GM enzymebakery products produced with the help of
amylaseNo No
Food additive/flavouring
produced from GMOsHighly filtered lecithin extracted from GM
soybeans used in chocolate21No Yes
GM Feed Maize22Yes Yes
Feed produced from a
GMOCorn gluten feed, Soybean meal No Yes
Feed additive produced
from a GMOVitamin B2 (riboflavin) No Yes
__________
                                                     
18 The examples include foods which have not been authorized for marketing in the EU.  See Annex II
for a list of products which can legally be marketed in the EU.
19 One chicory has been approved for breeding purposes under Directive 90/220/EC, but not for food
use.
20 DNA or protein of GM origin detectable in the final product.
21 DNA or protein of GM origin not detectable in the final product.
22 The current labelling rules entered into force in 1997, and do not include four GMOs approved prior
to that date.