WORLD TRADE
ORGANIZATIONG/SPS/GEN/338
G/TBT/W/180
26 July 2002
(02-4173)
Committee on Sanitary and Phytosanitary Measures
Committee on Technical Barriers to TradeOriginal:  English
RESPONSE FROM THE EUROPEAN COMMISSION TO COMMENTS SUBMITTED BY
WTO MEMBERS UNDER EITHER OR BOTH G/TBT/N/EEC/7 AND G/SPS/N/EEC/150
(PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL ON TRACEABILITY AND LABELING OF GENETICALLY MODIFIED
ORGANISMS AND TRACEABILITY OF GENETICALLY MODIFIED
FOOD AND FEED – COM(2001) 182 FINAL)
Submission by the European CommunitiesG/SPS/GEN/338
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Response from the European Commission to comments submitted by WTO
Members under either or both G/TBT/N/EEC/7 and G/SPS/N/EEC/150
(Proposal for a Regulation of th e European Parliament and of the Council on traceability and
labeling of genetically modified organisms and traceability of genetically
modified food and feed – (COM(2001) 182 final)
I. INTRO DUCTION ................................................................................................................. ...3
II. NOTIFICATION UNDER SP S ...............................................................................................3
III. OBJECTIVE OF THE PROPOSAL.......................................................................................4
IV. SCIENTIFIC BASIS FOR TRACEAB ILITY .......................................................................7
V. TRACEABILITY GUARANTEE S FOOD SAFETY............................................................9
VI. TRACEABILITY AND MONITORI NG................................................................................9
VII. TRACEABILIT Y OF FEED .................................................................................................11
VIII. PRESENTATION OF THE PROPOSAL ............................................................................12
IX. IMPLEMENTATION OF  TRACEABIL ITY......................................................................13
1. Implementation is difficult.................................................................................................. ...13
2. The proposal is not workable, enforceable and would be very costly to
implement ...................................................................................................................... ..........13
3. The use of batch numbering systems ....................................................................................14
4. Costs of tr aceability ........................................................................................................ ........15
5. Discrimination of processing aids..........................................................................................16
6. Unique codes................................................................................................................. ...........17
7. Technical guidance on sampling............................................................................................17
X. OTHER CO NCERNS .............................................................................................................18
1. Labeling req uirements ........................................................................................................ ...18
2. EU food producers have shifted away from GM sources....................................................19
3. Legal uncertainty and non-complian ce costs........................................................................19
4. Fraudulent claims in documentation ....................................................................................20
5. Specific concerns of the United States...................................................................................21
6. Link to the bio-safety protocol.............................................................................................. .21
7. Separation of GM foods and Novel Foods ............................................................................22
8. Linkages between the two proposals.....................................................................................229. Alternativ e measures ......................................................................................................... .....23G/SPS/GEN/338
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I. INTRODUCTION
The European Commission wishes to thank all WTO Members who submitted comments on
the Proposal for a Regulation concerning traceability and labeling of genetically modified organisms
(GMOs) and traceability of genetically modi fied (GM) food and feed COM(2001) 182 final as
notified under either or both G/ TBT/N/EEC/7 and G/SPS/N/EEC/150.
This document provides the response of the European Commission to comments submitted by
WTO Members under either or both G/TBT/N/EEC/7  and G/SPS/N/EEC /150.  For the sake of clarity
and precision, comments have been grouped by subject matter.  Extracts from comments by WTOMembers are shown in italics for ease of reference, and the response from the European Commission
is shown in regular font.  The European Commission apologises for any - obviously unintended –
inaccuracy or omission resulting from this way of proceeding.
II. NOTIFICATION UNDER SPS
Comment by Australia:
"Like a number of other countries, Australia is concerned to ensure that GM foods do not
have adverse human health effects, including in  the longer term; and that consumers can make an
informed choice about whether to purchase GM f oods.  Accordingly, Australia adopted a revised
Australia and New Zealand Food Standard A18 – 'Food Produced using Gene Technology' that came
into effect on 7 December 2001.  However, Australia regards preventing adverse human health effects
and the provision of consumer information as two separate issues and treats them separately under
the revised food standard.  Accordingly, Australia made separate notifications to address each of
these issues – one to the Sanitary and Phytosanitary (SPS) Committee regarding food safety matters(on requirements for pre-market safety assessments); and one to the TBT Committee regarding the
new Australian labeling requirements for GM foods.  Australia is concerned that the EC has not made
a similar distinction in its notifications. "
Comment by Canada:
"These regulations, at least in part, appear to have a health and safety related objective. Is
the EC intending to also notify these under the Agreement on the Application of Sanitary and
Phytosanitary Measures?  If not, why?"
Comment by the United States:
"According to the EU's proposal, "Traceability  is used to facilitate the withdrawal of
products due to unforeseen adverse effects to hu man health, animal health or the environment…"
Given the stated objective of the proposed regu lation, it would be U.S. understanding that the
proposed regulation is therefore, in whole or in part, a measure defined as a sanitary or
phytosanitary measure under the WTO, i.e., one applied, among other things, "to protect human oranimal life or health within the territory of  the Member from risks arising from additives,
contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs."  While the
United States welcomes the notification to WTO Members under the TBT Agreement, we question why
a parallel notification was not also made to WT O Members under the SPS Agreement. The United
States would encourage the Commission to also evaluate the proposed regulation in light of thedisciplines of the SPS Agreement. Could the Commi ssion please explain its rationale or otherwise
provide a notification to the SPS Committee? "G/SPS/GEN/338
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Response of the European Commission:
The notified Proposal will lay down a general, horizontal framework for traceability and
labeling  of genetically modified organisms and traceabi lity of genetically modified food and feed.  As
such, it pursues multiple objectives relating to consumer, health, and environmental protection and,
thus, may fall potentially under either the TBT or the SPS Agreement.  However, only when this
framework legislation is applied to concrete cases and to specific products will it be possible to state
with precision which of the two WTO Agreements will be applicable.  For these reasons, the
European Commission did notify the Proposal under both the TBT and the SPS Agreements.
III. OBJECTIVE OF THE PROPOSAL
Comment by Australia:
"Australia seeks an explanation of the substantive reasoning behind each of the stated objectives
given for the for the two proposals. It is unclea r to Australia how the EC's proposals would achieve
the EC's stated objectives. "
Comment by the United States:
"Would the Commission please provide an explanation of how the objectives, as outlined in the
proposal, are met through the specific requirements proposed?   Are there any elements of theproposal that were not specifically intended to address one of the stated objectives? Without further
description of the type of unforeseen effects anticipated, it is unclear how the proposed traceability
and labeling measures would meet the stated objectives. "
Response of the European Commission:
Background
The concept of traceability specifically for GMOs was introduced into European Community
law for the first time in Directive 2001/18/EC (O.J. No L 106/1 of 17 April 2002) on the deliberaterelease of GMOs into the environment in so far as Article 4(6) requires that member States shall
ensure traceability at all stages of the placing on the market of GMOs.
Regulation (EC) No 178/2002 (O.J. No. L 31/1 of  1 February 2002) laying down the general
principles and requirements of food law (General Food Law), establishing the European Food SafetyAuthority and laying down procedures in matters of food safety provides in terms of traceability that
all food and feed business operators must have systems in place to identify from whom they have
received a food or feed and to whom they have sold a food or feed (one step back and one step
forward).
This is due to the fact that experience has shown that the functioning of the market in food
and feed can be jeopardised where it is impossible to trace food and feed.  The European Community
therefore deems it necessary to establish a comprehensive system of traceability of all food and feed
within food and feed businesses so that targeted and accurate withdrawals can be undertaken or
information given to consumers or control officials, thereby avoiding the potential for unnecessary
wider disruption in the event of food safety problems.
However, traceability provisions in current European Community law governing food and
feed and in the General Food Law do not specifically address traceability of products produced from
GMOs.G/SPS/GEN/338
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Therefore, 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, creating  conditions of unequal and unfair competition.
A Community Regulation, taking as a base the requirements of Directive 2001/18/EC, laying
down a harmonised framework for traceability of such products would, therefore, provide for legal
certainty as well as a coherent and consistent approach that should contribute to the effective
functioning of the internal market.
Objectives
The retroactive tracking of the movement of GMOs and food and feed  produced from GMOs
through the production and distribution chains will be facilitated by traceability requirements based on
transmission and retention of relevant information for such products, at all stages of their placing on
the market. Such a traceability "system" facilitates:
• withdrawal of products should an unforeseen risk to human health, animal health or the
environment be established;
• monitoring of potential environmental effects;
• accurate labeling, including control and verification of labeling claims.
It should be clarified that the facilitation of accurate labeling is generally not linked to safety,
but provides an improvement in the fairness and transparency of transactions.  It will thereby facilitate
the task of operators who must comply with regulatory or commercial requirements on the part oftheir customers, such as labeling of the final product.
The European Commission believes that the proposed requirements will enhance
transparency and facilitate the implementation of measures, where appropriate, to ensure safety
throughout the food and feed chain, contributing also to restore users and consumers confidence in theapplication of gene technology in the agro-food sector.
The Proposal does not prejudice more specific requirements concerning traceability and
labeling under other European Community law on such as batch or lot numbering for pre-packaged
products.  Existing traceability systems are base d on paper or computerised documentation and
analytical detection methods where appropriate.  These systems should be easily capable of being
adapted to deal with the additional traceability requirements concerning GMOs and GM food and
feed.
Meeting the objectives
The Proposal lays down the following requirem ents to ensure a harmonised framework for
traceability of GMOs at all stages of their placing on the market:
• Operators shall have in place systems and procedures to identify to whom and from
whom products are made available (one step back and one step forward).
• Operators shall transmit specified information (see below) concerning the identity of a
product in terms of the individual GMOs it  contains or whether it is produced from
GMOs.G/SPS/GEN/338
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• Operators shall retain specified information for a period of 5 years and make it available
to competent authorities on demand.
The Proposal does not specify the means to transmit and retain this information given that
existing systems to do so are already in place in many organisations.
Requirements for GMOs
The objectives for traceability of GMOs and products produced from GMOs are not identical
and therefore the specified information to be transmitted and retained differs for each.  This Proposal
provides for the traceability of individual GMOs within a product on the basis of authorised
transformation events.
Traceability to facilitate withdrawals and environmental monitoring of GMOs will, therefore,
require that the specific identity of a GMO and its associated traits and characteristics can be
established.  This can be facilitated via a traceability system that utilises a means of unique
identification for GMOs.  The Proposal requires that operators shall transmit to the operator receiving
products the following specified information:
• That the product contains or consists of GMOs
• A unique code(s) relating to the GMO(s) contained in the product
It is essential that the specific identity of GMOs  that are to be intentionally introduced into the
environment for cultivation can be established.  This is because these products contain 'viable' GMOs
that are capable of reproduction and dissemination.  In this context, the Proposal requires that
operators have to specify exactly the identity of the GMOs contained in the products and transmit this
information to the operator receiving the product.  Specific identity is provided for by use of uniquecodes assigned to individual GMOs.
The potential risk to the environment for products containing GMOs for direct use in food,
feed or processing, on the other hand, is negligible or even absent as they will not be cultivated.  The
European Commission considers it appropriate and ad equate that products, including bulk shipments,
containing GMOs for food, feed and processing are accompanied by documentation stating this use
with a list of unique codes for the GMOs that the product or shipment may contain.
These information requirements for the iden tification of individual GMOs closely align
with those provided for under the Biosafety Protocol  with regard to transboundary movements.  The
European Commission considers that this is of significant importance if a harmonised and consistentapproach is to be achieved for trade with third countries, particularly where bulk shipments are
concerned.
Requirements for food and feed produced from GMOs
Traceability for food and feed produced from GMOs is similarly achieved via an obligation
on operators to transmit specified information that a product is produced from GMOs to the nextoperators in the production and distribution chain.  The Proposal does not, however, require the
unique code(s) assigned to GMOs to be transmitted with a produced product based on the following:
• Unforeseen environmental effects, in partic ular, are unlikely to arise from the placing on
the market of products produced from GMOs, such as the flour produced from
genetically modified maize grains, where processing results in 'non-viable' geneticmaterial.G/SPS/GEN/338
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• The labeling requirements for GM foods do not include information concerning the
transformation event of GMOs from which the product is produced.
Transmission and retention of information that a food or feed is produced from GMOs
throughout the production and distribution chain would facilitate labeling of the final product for
operators under the current European Community food labeling scheme.  It would also provide themeans for inspection and control of compliance with current labeling provisions for GM foods and
reduce reliance on detection methodology.
IV. SCIENTIFIC BASIS FOR TRACEABILITY
Comment by Australia:
"Australia is concerned that the EC's traceability proposal is not founded on a scientific
basis. The traceability system proposed by the EC  includes not only mechanisms for traceability of
food, but also for the two more restrictive and stringent practices: identity preservation and
segregation.  Australia considers that traceability is a separate issue from identity preservation and
segregation and has therefore addressed traceability separately.  Australia already has effective
provisions in place to assist recalls related to food safety and to investigate cases and outbreaks offood-borne disease.  How would the EC's proposed  "traceability" system for GM food/feed improve
the EC's current food recall systems for non-GM foods/feed? "
Comment by South Africa:
"South Africa is of the opinion that a risk as sessment of genetically modified organisms and
food produced from them, is the most important aspe ct before placing the products on the market.  A
trace back system is an acceptable food safety system developed and used by the industry, should
withdrawal of the food product be required.  S hould a system to trace any unforeseen risks be
required for foods obtained from genetically modified organisms, the same argument and perhapseven stronger arguments could be developed for conventional food and foods that  are not  subject to
comprehensive risk assessments. "
Comment by the United States:
"As the leading developer and producer of agricu ltural biotech products, the United States
has significant interest in this proposal and its pot ential impact on U.S. suppliers.  The United States
also notes that the potential burdens imposed by the proposals would be substantial for suppliers in
developing countries as well.  This is particularly troublesome given it does not appear that the
proposal is attempting to respond to identified risks or hazards and is being implemented on product
that has already undergone a risk assessment and has been approved for use. "
"The U.S. continues to believe that products should be assessed for safety before release on the
market.  The United States understands that under Directive 90/220 and 01/18, products are not
allowed on the market unless they are determined to be as safe as conventional counterparts.
Unforeseen effects are not solely relegated to biotech products but are also possible for other
products.  The EU has acknowledged in a recent report (A Review of Reports: EC-Sponsored
Research of Genetically Modified Organisms) released by DG Research that these products are as
safe or even safer than conventional products.  It is accordingly unclear to the U.S. why the EU would
seek to impose additional traceability/monitoring requirements, and to do  so only with regard to
biotech products. "G/SPS/GEN/338
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Comment by Canada:
"The regulations attempt to respond to unidentified risks.  There is no scientific or medical
evidence that suggests that foods obtained through biotechnology, which have been assessed andapproved under an internationally recognized approach, such as those developed by the OECD and
FAO/WHO, are any less safe than their conventional co unterparts.  In fact, the EC's own research on
GMOs has concluded that they are as safe, or safer, than foods derived through conventional means
(A Review of Results: EC-Sponsored Research on Safety of GMOs).  Canada questions the necessity
of the proposed tracing and mandatory labeling requ irements given that the proposed requirements
will apply to biotech-derived products that hav e been approved for human and animal consumption,
and environmental release, through well established pre-market assessments. "
Response of the European Commission:
The European Commission notes the comments from Australia but would clearly point out
that the proposed requirements do not oblige operators to engage in identity preservation andsegregation systems.  The need for identity preservation and segregation depends entirely on the
marketplace and on consumer preferences and is not a consequence of the traceability requirements
under the Proposal.
The European Commission also wishes to clarify that its own research has not concluded that
GM foods are safe per se : it has confirmed that those GM foods and GM plants and derived products
so far developed and marketed, following usual risk assessment procedures, have not shown any new
risks to human health or the environment, beyond the usual uncertainties of conventional plant
breeding or risks that are likely to put in danger the chosen level of health or environmental protection
in the European Community.  This can certainly not be taken to mean that any other GM food to bedeveloped in the future should not be assessed and evaluated to ensure that the European
Community's level of protection is also achieved.
The European Commission would also like to refer to its response in section III concerning
objectives as explaining the rationale behind the Proposal.
The objectives of the Proposal, notably facilitating withdrawals and accurate labeling of food
are generally not unfamiliar to Codex Alimenta rius.  According to a paper (CX/FICS 02/2 of
January 2002) prepared by the Australian Secretariat of the Codex Committee on Food Import and
Export Inspection and Certification Systems "traceability is closely linked with product identification
and it may relate to: the origin of materials and parts, the product processing history and the
distribution and the location of the product after delivery.  Traceability is a recognized process inadopted Codex texts and texts under elaboration, even if the word "traceability" has not been used. In
most cases it is linked to product identification and recall procedures".
In document CX/FICS 02/2, the Australian Secretariat points to a number of examples,
notably the Codex General Standard for the Labeling of Pre-packaged Foods (CODEX STAN 1-1985,Rev. 1-1999) Section 4.5 Country of Origin and Section 4.6 Lot Identification.
The Lot Identification requirement was introduced more than a decade ago in the Codex
Standard on Food Labeling (Section 4.6).  The objective of the lot or batch numbering system is
understood as meeting the need for better information on the identity of products, and is therefore auseful source of information - for example when food is the subject of dispute concerning labeling
claims or constitutes a health hazard to consumers. In other words, traceability is not necessarily
confined to questions of product safety.G/SPS/GEN/338
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Article 4.5 of the Codex Standard for Food Labeling provides that the country of origin of the
food shall be declared if its omission would misl ead or deceive the consumer.  Country of origin
labeling is not safety related.  Origin labeling can in most cases not be verified through analytical
methods, but is controlled on the basis of adequate traceability based on paper documentation.
The Codex General Guidelines for use of the term " halal " concerns specific process-based
criteria for the use of the term " halal " on food.  As in the case with origin labeling, the only way to
control that 'halal' food delivered to the final consumer complies with the necessary  requirements is
through an adequate paper-based traceability system.
In summary, it is clear and recognised that traceability systems can have uses other than for
the purpose of safety and in certain cases there is no scientific basis whatsoever for such requirements.
V. TRACEABILITY GUARANTEES FOOD SAFETY
Comment by Argentina:
"It is considered that traceability "per se" guarantees food safety ".
Response by the European Commission:
The European Commission does not subscribe to the view that traceability " per se "
guarantees food safety and nowhere in the Proposal is such a statement made.  When considering the
objectives for traceability, it is important to recognise that traceability is not a 'safety measure' per se,
but when appropriately implemented can be used to 'facilitate' the application of other measures, such
as product withdrawals and monitoring, as a means to ensure safety.  Traceability is considered to be a
useful risk management tool both by companies and by control authorities.
As explained in the section concerning objectives of the Proposal, the European Commission
considers that the Proposal other than facilitating withdrawals and monitoring also facilitates accurate
labeling as well as effective law enforcement and thus helps in achieving the chosen level of
protection.
VI. TRACEABILITY AND MONITORING
Comment by South Africa:
"The objective to "target(ed) monitoring of specific effects" is acceptable in cases identified in
the risk assessment.  This is not a valid reason to trace all foods from all genetically modified
organisms. "
Comment by Switzerland:
"The Swiss authorities are concerned about the amount of administrative work needed to
meet the requirements of the proposal COM (2001) 182 final.  Switzerland is not convinced that the
goal of long term-monitoring which is, according to  the EU commission, supported by a traceability
scheme, is realistic.  It is notoriously difficult to assess effects of specific food components (e.g. table
salt) on populations.  As for GMO-derived products, difficulties would even be enhanced as the
proposed GMO-labeling rules do not contain necessary qualitative and quantitative information to
trace any potential effect back to a specific GMO.  While the labeling rules consider only the fact ofG/SPS/GEN/338
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genetic modification as such, detailed information on the organism and the specific genetic
modifications would be essential for an effective monitoring scheme.
"In addition, no scientific hypothesis of a negative health effect has been presented so far for
GMO-derived foodstuffs authorised after a risk a ssessment.  However, such a hypothesis would be
important as a basis for an effective monitoring programme.
"In this respect Switzerland favours a scheme of self control where the producer that
purchases raw materials or intermediate products is responsible to ensure that legal requirements are
met, especially concerning the use of authorised GM material only.  Switzerland considers
traceability of foodstuffs to be a good manufacturing practice (GMP) measure.  The responsibility forspecific measures taken in the framework of GMP s hould lie with the manufacturer of the foodstuff in
question. ."
Comment by Canada:
"The Traceability Regulation requires the establishment of an EC-wide system for the
traceability and labeling of GM food or feed products through the production and distribution chains.
The traceability requirements are aimed at facilitating "both the withdrawal of products where
unforeseen adverse effects to human health, animal he alth or the environment are established, and the
targeting of monitoring to examine potential ef fects, in particular, the [sic] environment1
"Canada agrees that traceability may facilitate a product's withdrawal in the event that a
hazard is identified.  However, risks can arise with all food products, regardless of their process and
production method (e.g., bacterial contamination, accidental presence of a toxin).
"The Traceability Regulation also indicates that traceability is intended to assist in
monitoring for long-term or unintended effects on hum an health or the environment.  The proposal is
unclear as to how the EC will accomplish this objective.
"The EC proposes to require post-market monitoring of GM foods "when appropriate."
Canada would like to ask the EC to clarify what  parameters will be used to assess the
"appropriateness" of post-market monitoring for specific GM foods?
"Canada therefore believes that it is inappropriate to suggest that comprehensive traceability
systems should be put into place to assist with measures appropriate for exceptional rather than
normal circumstances.  These issues are particularly important given the potentially enormous costs
associated with comprehensive traceability.  Particularly, the additional costs amount todiscriminatory treatment as they are not borne by other like products. "
Response of the European Commission:
The purpose of the monitoring referred to in this Proposal is to establish whether assumptions
or conclusions made in the risk assessment carried out in accordance with Directive 2001/18/EC are
correct and also to examine potential unforeseen effects resulting from the intentional release of
GMOs into the environment. Monitoring of human health effects resulting from consumption of GM
food and feed is covered by the Proposal on GM food and feed and is not addressed in the traceability
Proposal.
                                                     
1 Regulation COM (2001) 128, para. 3.G/SPS/GEN/338
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According to Article 20 of Directive 2001/18/EC, post-market monitoring of GMOs is a
mandatory requirement. It is foreseen that traceab ility will facilitate the targeting of post-market
monitoring in particular with respect to the envi ronment.  Any potential effects on the environment
are likely to differ according to the GMO in question and will largely depend on its inherent nature(species) and the specific genetic modification.  For example, potential effects arising from transfer of
genetically modified pollen to conventional crops or  related wild types will, in the first instance, be
dependent on pollen transfer itself.  Pollen transfer is likely to be highest for genetically modified
crops that are out-crossing, less for crops that are self-pollinating and absent in crops that are sterile.
Secondly, potential effects arising from the transfer of pollen will then be dependent upon the
specific modification.  The potential development of, for example, insect resistance to the Bt-toxinwill only be linked to GMOs modified to express this specific toxin.  This would not be the case for
GMOs modified specifically for tolerance to herbicides, however, as these GMOs do not contain a Bt-
toxin gene.
Consequently, targeted monitoring of potential environmental effects will require that the
specific identity of a GMO released into the environm ent, with its associated traits and characteristics,
can be established.  This can be facilitated via a traceability system that utilises a means of unique
identification for GMOs.
Post-market monitoring of GM foods is not a mandatory requirement but will be assessed on
a case-by-case basis during the risk assessment carried out by the European Food Safety Authority as
specified in the Proposal for a Regulation on GM food and feed.  There is no requirement for
mandatory post-market monitoring of genetically modified food and the traceability requirements in
the Proposal are not aimed at facilitating post ma rket monitoring of genetically modified food.
VII. TRACEABILITY OF FEED
Comment by Australia:
"Australia queries why GM feed is included in the EC's proposed regulations given the EC's
views that animals that consume GM feed are not c onsidered to be genetically modified (nor are any
products from these animals, such as meat, milk or eggs, genetically modified). "
Comment by the United States:
"The United States does not believe that expanding mandatory traceability and labeling
requirements to animal feed is justified nor will it enhance public health. "
Response of the European Commission:
As part of the framework to improve and bring coherence to European Community law from
"farm to table", the European Commission highlighted in the White Paper on Food Safety of
12 January 2000 the need for legislation concerning the evaluation, authorisation and labeling  of
novel feed, in particular GM feed.
Regulation (EC) No 178/2002 also provides for traceability requirements for feed at all stages
of production, processing and distribution.  This is due to the fact that experience has shown that the
functioning of the market in food and feed can be jeopardised where it is impossible to trace food andfeed.  The European Community therefore deems it necessary to establish a comprehensive system of
traceability of all food and feed within food and feed businesses so that targeted and accurate
withdrawals can be undertaken or information give n to consumers or control officials, therebyG/SPS/GEN/338
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avoiding the potential for unnecessary wider disruption in the event of food safety problems.  In
accordance with this Regulation, feed business operators are required to have systems in place to
identify from whom they have received a product and to whom they have sold a product.
The Proposal on traceability and labeling of GMOs and traceability of GM food and feed
extends this requirement to feed that has been genetically modified.
As regards labeling of GM feed, the policy of the European Community is basically to
provide the users (farmers, breeders, etc) with accurate information on the products enabling them to
make a free choice.  Traceability of GM feed is therefore needed to ensure labeling claims and avoid
deceptive practices.
The European Commission believes that the proposed requirements will enhance
transparency and safety throughout the feed chain, contributing also to restoring users' and consumers'
confidence in the application of gene technology in the agro-food sector.
VIII.  PRESENTATION OF THE PROPOSAL
Comment by Australia:
"The proposal, as presented by the EC, suggests that food produced using biotechnology is
inherently unsafe and therefore traceability is required.  However, Australia considers that GM foodshould be safe before it enters the marketplace.  Our system of pre-market clearances ensures that
only safe food is permitted into the food supply.  Australia regards current pre-market clearance
processes as the best assurance that the effects on human health (including in the longer term) are
addressed for foods produced using biotechnology.  Moreover, based on all available scientific
evidence, GM foods that have been subjected to pre-market clearances have been found to be as safeas their conventionally produced counterparts.  Given these findings, why is the EC introducing a
mandatory "traceability" system, which includes elements of the more stringent practices of
segregation and identity preservation, for GM foods/feed, when compared with established systems
used for non-GM foods/feed? "
Comment by Argentina:
"The Proposals start from premises which, without scientific support, aim to uphold the
unjustified presumption of the harmfulness of f oods containing Genetically Modified Organisms
(GMOs). "
Response of the European Commission:
The European Commission does not agree with Australia and Argentina, and would like
Australia to clarify where the Proposal suggests th at food produced from biotechnology is inherently
unsafe?  The European Commission would like to refer to the reply concerning objectives as
explaining the rationale behind the Proposal.
The Proposal does not impose segregation and identity preservation on operators who are
trading in GMOs and GM foods/feed approved in the European Community.  However, it remains
illegal to import into the European Union GMOs or genetically modified food that have not received
authorisation in accordance with current European Co mmunity law.  Operators are, therefore, already
obliged to ensure that unauthorised GMOs or genetically modified foods are not imported into the
European Community.G/SPS/GEN/338
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IX. IMPLEMENTATION OF TRACEABILITY
1. Implementation is difficult
Comment by Argentina:
"Some of the rules contained in the Proposals for regulations are very difficult to implement
and extremely burdensome for developing countries. "
Response of the European Commission:
The obligatory information requirements foreseen by the European Commission's Proposal
are requirements that are in most cases require d either under European Community law or normal
commercial transactions.  The only additional element is that this information will have to betransmitted to all operators in the commerc ial chain within the European Community.
The European Commission would also like to refer to Article 18 of the Biosafety Protocol
concerning transboundary movements of living m odified organisms (LMOs), which provides that:
• GMOs for intentional introduction into the environment have to be accompanied by
documentation that specifies their identity and relevant traits and characteristics.  Thisclearly requires some form of unique identification for individual GMOs.
• GMOs intended for direct use as food or feed, or for processing, shall be
accompanied by documentation which clearly identifies that they "may contain"
living modified organisms and are not intended for intentional introduction into theenvironment.  A decision on the detailed requirements for this purpose, including
specification of their identity and any unique identification, shall be taken no later
than two years after the date of entry into force of this Protocol
To date, more than 120 countries, many of which are developing countries, have signed up to
the Biosafety Protocol and this, as a matter of course, includes the requirements of Article 18.
Work on detection and sampling methodology, including guidance from the European
Commission, is described in further detail below.
The European Commission is ready to consider requests from developing countries for
technical co-operation and assistance to address identified priorities and needs.
2. The proposal is not workable, enforceable and would be very costly to implement
Comment by United States:
"The United States believes that this proposal is not workable or enforceable, would be very
expensive to implement, and would not achieve the stated objectives.  The proposal is not workable or
enforceable because it would require products (for food, feed, or processing) containing or consisting
of biotech events to be accompanied by a listing of the biotech events that they may contain along
with their unique codes.  Absent expensive identity preservation systems, suppliers will be forced to
list all biotech events approved by the EU.  The diff iculty and complexities in accurately identifyingG/SPS/GEN/338
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all of the biotechnology events that could possibly be in a shipment creates enormous liability and
risk for the shipper/trader. "
Response by the European Commission:
The Proposal does not require operators to identify all individual events present in a shipment
of GMOs intended for food, feed or processing.  In fact, Article 4, paragraph 2 of the Proposal
specifies that the operator is only obliged to provide a list of the unique codes for the GMOs that the
shipment may contain together with a declaration that  the product shall only be used as food or feed,
or for processing.  A system for attributing unique codes to GMOs has already been agreed by the
OECD and it is foreseen that this will be accounted for in developing the system under the Proposal.
The European Commission would also like to point out that it remains illegal to import
GMOs or genetically modified food into the European Union that have not received authorisation in
accordance with current European Community law.  Operators are, therefore, already obliged to
ensure that unauthorised GMOs or genetically modified foods are not imported into the EuropeanCommunity.
3. The use of batch numbering systems
Comment by the United States:
"U.S. experience shows that traceback syst ems for human health or food safety, and
traceability systems for consumer  information, lead to significantly different approaches and policy
decisions.  The traceback system used in the United  States is part of a food safety system.  The U.S.
traceback system was developed largely by the private sector to recall food in response to a public
health or food safety concern.  In the United States, lot numbers, batch codes and/or processing plantindicators appear on virtually all processed food packages to satisfy the various business needs of
food producers and for traceback purposes.  Such measures are also widespread in Europe.  This less
burdensome and less costly system has worked effectively for years and enjoys a high level of public
confidence. "
Response of the European Commission:
As pointed out in the Proposal, European Community law also includes specific requirements
as regards batch or lot numbering systems.  However, and as already pointed out, due to the fact that
experience has shown that the functioning of the market in food and feed can be jeopardised where itis impossible to trace food and feed, the European Community deemed it necessary to establish a
comprehensive system of traceability within food and feed businesses so that targeted and accurate
withdrawals can be undertaken or information give n to consumers or control officials, thereby
avoiding the potential for unnecessary wider disruption in the event of food or feed safety problems.
The European Commission would like to point out that Article 6 paragraph 1 of the Proposal provides
that in cases where European Community law provides  for specific identification systems, such as lot
or batch numbering, operators shall not be obliged to retain the information concerning the genetic
modification as specified in Articles 4(2), 4(3) and 5(1), provided that this information and the lot or
batch number is clearly marked on the package.  Thus, the Proposal foresees that existing systems
concerning lot and batch numbering can continue to be used.G/SPS/GEN/338
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4. Costs of traceability
Comment by Australia:
"Australia seeks an estimate of the costs involved in developing, maintaining and enforcing
the proposed system.
"In Australia's experience, food recalls are rarely associated with failure of pre-market safety
clearances.  Given this experience and assuming that current recall systems are effective, the costs
involved in a mandatory traceability system for GM  foods/feed would not justify the extra cost and
questionable benefits to all producers and consume rs.  Australia notes that such a system would be
particularly burdensome for developing countries.
"While the EC argues that 'no credible estimate' of the cost of such a system has been
determined, studies have been undertaken of the potential impact of such systems.  An Australianstudy (Genetically Modified Grains - Market im plications for Australian grain growers by ABARE,
August 2001) assessed that "for every 1% [increase in] grain export transaction costs above that
required under normal commercial disciplines, the welfare of the world's consumers of grain
products would be lowered by an estimated US$330 million a year. "
Response of the European Commission:
In the explanatory memorandum to the Proposal the European Commission stated that it is
difficult to estimate the costs of introducing traceability specifically for GMOs and products produced
from GMOs.  This view is shared by the United States Department of Agriculture (USDA) who in a
recent article stated that "estimating the magnitude of the costs of identity preservation, tracing, and
labeling is complex and subject to varying assumptions" (see Agricultural Outlook/January-February2002).
The European Commission considers that the transmission and retention of information can
largely be incorporated into existing (documentary ) systems for transactions and as such should not
imply significant extra costs for operators and consumers.  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.
For operators supplying food derived from GMOs to the market, traceability only implies that
operators must inform the next operator in the chai n that the food, feed or food/feed ingredient is
derived from GMOs and retain that document. This is neither particularly burdensome nor costly and
it does not entail segregation.
Aggregated costs, if any, will be passed on to the consumer and the labeling of GM foods
ensures that consumer demands will ultimately drive the market in the direction of their preferencesalso taking into account the price of the food.
Traceability and systematic labeling will promote transparency in the market place and the
freedom of choice for consumers, as well as, leaving it to the market forces to decide the fate of the
different products.
A non-harmonised approach resulting in the establishment of different traceability
requirements in member States may hinder the free movement of products, creating conditions of
unequal and unfair competition.  The costs of such an approach are also difficult to estimate but
would most likely result in much higher costs for all operators.G/SPS/GEN/338
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The Proposal foresees that transmission and retention of information as a means to facilitate
traceability will even limit the need for sampling and testing of products to confirm their identity at
every stage of the placing on the market.  This would result in a reduction in the costs for companiesto meet the current labeling  criteria in European Community law particularly for retailers.
Sampling and testing would, however, still be required for verification whenever reliable
documentation is not available from exporting countries and for control and inspection purposes.  A
degree of cost must, therefore, be considered in this respect.  The Proposal foresees that the European
Commission shall develop guidance on sampling and detection.  This will minimise legal uncertainty
and alleviate the burden in terms of testing and sampling for operators.  Current experience withdetection methods demonstrates that testing raw ingredients is much more simple and cost-effective
than testing the final products on the supermarket shelves.
It should be emphasised that the potential costs of traceability should also be weighed against
the potential costs of no traceability system.  The establishment of effective traceability requirementscould prevent excessive economic losses or brand damage in case an unforeseen risk to human health
or the environment arises.  The recent case in the United States, where a genetically modified maize
variety approved only for use in animal feed entered the food chain and the subsequent need for
urgent recall of products from the market, has clearly demonstrated the usefulness of a traceability
system.  Although voluntary traceability systems can  also be useful, mandatory ones are more likely
to be followed in a consistent way by all operators in the production and distribution chain, which can
also be instrumental in helping prevent such pr oblems arising in the first place, thereby avoiding
potential huge costs for the companies involved and for public authorities.
5. Discrimination of processing aids
Comment by Australia:
"Australia seeks a scientific or other explanation behind the EC proposal to discriminate
between foods produced from GMOs (including highly refined oils and sugars that have no traces of
modified DNA or protein) and foods produced with GM enzymes (eg enzyme processing aids used in
the production of many cheeses and wines).  Such a distinction suggests that the EC's proposal is
based on non-product related processing and production methods rather than product
characteristics "
Response of the European Commission:
Enzymes, as such, are not excluded from the scope of the provisions of the Proposal.Enzymes are used in food production either as additives, or as processing aids.  Additives,
including enzymes used as food additives, are food ingredients, i.e. food under European Communitylaw and therefore subject to the provisions of the Proposal.  Processing aids (i.e. materials used during
processing but not present in the finished product), including enzymes used as processing aids, are not
food ingredients, i.e. they are not food under European Community law; they are therefore not  subject
to the provisions of the Proposal.
The European Commission would like to stress that  the Proposal is not, in this respect, in any
way different from the current legal situation as it results from the application of Regulation (EC)No 258/97, which has never led to any concern in this respect.G/SPS/GEN/338
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However, the European Commission has already announced to the European Parliament that
it is considering bringing forward new legislation on enzymes.
6. Unique codes
Comment by the United States:
"What is the system for the development and assignment of unique codes to "genetically
modified organisms? "
Comment by Switzerland:
"Switzerland welcomes the proposal of the introdu ction of a unique identifier code system in
the EU.  However, the Swiss authorities would like to emphasize the importance of an internationally
agreed / harmonised system, such as the one unde r development in the frame of OECD work. "
Response of the European Commission:
The Proposal takes, as its point of departure, the authorised transformation events from which
genetically modified organisms are developed.  It is foreseen that the system will determine the
alphanumeric make-up of codes to provide unique identification for these events.  This will take
account of ongoing work in international organisatio ns and it is notable that the OECD has recently
adopted a document detailing a format for this purpose (ENV/JM/MONO(2002)7).  It is also foreseen
under the system that the appropriate unique code would be provided as part of the notification or
automatically prescribed as part of the consent on the basis of information provided in the
notification.
7. Technical guidance on sampling
Comment by Canada:
"Canada notes that in some aspects of the regulations there is a lack of sufficient detail or
additional guidance is foreseen.  The absence of such information limits our ability to providecomments.  When does the EC anticipate that these proposals will be developed?  Canada looks
forward to the opportunity to comment on these proposals. "
Comment by South Africa:
"South Africa is of the opinion that there w ould be many shortcomings in a traceability
system as a way to verify labeling claims as described by the EU documents COM(2001)182 and
COM(2001)425. This could be even more so in the circumstances of developing countries. "
Comment by the United States:
"The traceability requirements may be problematic for developing countries, particularly for
those importing from many sources for further proce ssing and re-export to third countries.  When will
the EU provide importers with guidance on sampling and testing for bulk commodities so that they
can determine the identity of the biotech events in  products where this information is not available?
"According to Article 9.1, member States shall ensure compliance.  Article 9.2 indicates the
Commission will, in the future, develop technical guidance on sampling and testing to facilitate a
coordinated approach for implementation.  The United States is concerned with potentialG/SPS/GEN/338
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discrepancies in testing and enforcement across the Community and would welcome the opportunity
to review and comment on the proposed technical guidance as it is developed. "
Response of the European Commission:
According to Article 9 of the Proposal, the European Commission will provide guidance on
sampling and testing prior to the application of the traceability provisions to facilitate implementation.
The Joint Research Centre of the European Commission is currently working on the
development of sampling and testing methodology a nd has established a network of member States
laboratories for this purpose.  Third country laboratories, governmental organisations and competentauthorities are welcome to participate in the work.
The Codex Alimentarius Task Force on Foods Derived from Modern Biotechnology has
identified a number of methods for the identification or detection of genetic modification in foods and
agreed to transmit these methods for the consideration of the Codex Committee on Methods ofAnalysis and Sampling.  The European Commission would encourage all countries to engage in the
work on sampling and detection.
The EC Treaty provides, in Article 202, that in the instruments which it adopts, the Council
has to confer on the European Commission powers for the implementation of the rules which theCouncil lays down.  The implementing powers co nferred on the European Commission under the
notified Proposal are in conformity with that principle.
Where appropriate, the measures adopted by the European Commission under these
implementing powers are notified under the TBT and/or the SPS Agreements.
The European Commission is ready to consider requests from developing countries for
technical co-operation and assistance to address identified priorities and needs.
X. OTHER CONCERNS
1. Labeling requirements
Comment by United States:
"The proposed regulation would impose labeling requirements on products that have already
been approved for use and for which no specific handling, usage, safety, or compositional distinctionshave been identified.  The result of the foregoing could be a further erosion of consumer confidence in
the EU's regulatory system, becaus e the consumer is left without truly accurate information about the
product. "
Response of the European Commission:
Under current European Community law genetically  modified foods have to be labelled even
in cases where there are no specific handling, usage, safety, or compositional distinctions.  The
objective is to inform the consumer about the fact that the food or food ingredient is genetically
modified.
The European Commission is not aware of any studies indicating that the current rules for
providing information to the consumer about genetically modified foods has or will erode consumer
confidence in the European Community's regulatory system.  On the contrary, theG/SPS/GEN/338
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Eurobarometer 2000 and various other surveys throughout Europe show that European consumers are
demanding clear labeling whether food contain or ar e produced from a GMO(s) in order to make an
individual choice.
The European Commission believes that providing accurate information by labeling all food
or food ingredients containing or produced from GMOs will foster confidence in the regulatory
system and social acceptance of the applicat ion of biotechnology in agri-food production, and
ultimately facilitates trade in such products.
2. EU food producers have shifted away from GM sources
Comment by the United States:
"As more biotech events and products are approved and used worldwide, tracking these
products through the distribution system and/or testi ng will become more complex, if not impossible.
The result is added expense and liability risk for shipping products without any corresponding
increase in consumer and environmental protection.  Already, EU food processors have shifted away
from foreign sources of food ingredients to meet the extremely low one percent threshold for labeling.
This is only possible because the approval process in the EU is blocked and planted acreage of
biotech crops is minimal. "
Response of the European Commission:
The European Community is not the only region in the world that operates with a 1% labeling
threshold for the adventitious presence of GM-material in food products.  The comments by the
United States indicate that other reasons than those mentioned by the United States determine
business decisions of European Community food processors and other economic operators, notablymarket signals such as perceived consumer preferences in the European Community.  If the consumer
preferred GM food, business operators would not have to avoid GM sources in their products.  Such
business decisions and their motivation do not concern TBT issues.
3. Legal uncertainty and non-compliance costs
Comment by the United States:
"The legal uncertainty and non-compliance risks compounded at each step of the food chain
by the documentation requirements will discourage trade and increase delays and liability costs for
exporters, EU importers, and processors. "
Response of the European Commission:
According to Regulation (EC) No 178/2002 each food and feed business operator is
responsible for ensuring that products comply with  European Community law.  In the majority of
cases, operators further down the production and distribution chain may rely on documentation
received from suppliers as, in the absence of reason to believe that the supplied data is false or
misleading, there would be no benefit in re-testing products for compliance with European
Community law concerning contaminants, additives, flavourings, pesticides etc. at each stage of the
placing on the market.
The European Commission also notes that according to a recent article by USDA, "both
USDA and FDA rely ultimately on documentation maintained by private firms to trace the flow of
inputs into the final food products" (see Agri cultural Outlook, January-February 2002, page 24).G/SPS/GEN/338
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Concerning genetically modified foods, the European Commission would like to refer to a
statement by EuroCommerce, the Retail, Wholesale and International Trade Representation to the EU,
that:
"In spite of the sensitivity of the available methods of analysis, it is no longer possible
for retailers, as the last placers of products on the market, to provide analytical proof
of transgenic ingredients in final products due to the multiple processing stages
involved in many foodstuffs. Thus, frequently, retailers can only rely on contractual
assurances or paper documentation and supplier audits, even though in theory, they
could even be held liable for an erroneous labeling of products. Therefore, alreadytoday, they are dependent on correct and complete information from their suppliers
as well as on appropriate documentation. "  EuroCommerce, Position Paper on
COM(2001) 425 final and COM (2001) 182 final, March 2002).
European retailers continue to place products on the market and to rely on correct information
from their suppliers.  The traceability requirements will reduce liability risk  and enhance the legalcertainty for operators, notably operators at the end of the chain who are responsible for the accurate
labeling of a food.  The requirements also alleviate the burden of testing for operators.
4. Fraudulent claims in documentation
Comment by the United States:
"Imposing such traceability requirements without the means for testing the veracity of
documentation can lead to fraudulent practices and fuel consumer distrust in the regulatory regime.
How does the EU intend to detect fraudulent claims in documentation? "
Response of the European Commission:
All legislation can potentially lead to fraudulen t practices, however fraudulent practices do
not necessarily lead to distrust in regulatory re gimes, but rather in the operators who commit fraud.
The European Commission would certainly acknowledge that enforcement of traceability
provisions is more difficult when it is not possible to verify the truthfulness of claims through
analytical methods.
Control based on paper documentation is not new, but has existed for many years.  For
instance Article 4.5 of the Codex Standard for Food Labeling provides that the country of origin of
the food shall be declared if its omission would mislead or deceive the consumer.  Country of origin
labeling claims can in most cases not be verified through analytical methods, but is verified through
paper-based traceability.
According to a paper (CX/FICS 02/2 of January 2002) prepared by the Australian Secretariat
of the Codex Committee on Food Import and Export Inspection and Certification Systems "the
application of traceability "to ensure fair practices in the food trade" is probably most directly linked
to the first of the General Principles set down in the General Standard for Labeling of Pre-packaged
Foods which reads:  "Pre-packaged food shall not be described or presented on any label or in any
labeling in a manner that is false, misleading or is likely to create an erroneous impression regarding
its character in any respect".  This application is also expressed in the Guidelines for the Production,
Processing, Labeling and Marketing of Organically Produced Foods , the aims of which include "toG/SPS/GEN/338
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protect consumers against deception and fraud in the market place and unsubstantiated product
claims"".
In other words paper-based traceability can be and is applied to ensure fair practices in the
food trade , to provide relevant information and to protect consumers against deception and fraud.
For instance, origin labeling and dolphin safe tuna labeling are implemented and controlled
on the basis of paper-based traceability.
5. Specific concerns of the United States
Comment by the United States:
"The U.S. is concerned that the proposal will continue to undermine the EU's efforts to
establish a credible food safety regulatory regime.  The proposal will weaken European consumerconfidence in the safety of its food supply.  The proposal does nothing to ensure food safety and it
encourages fraudulent labeling claims.  This outcome is not in any country's interest. "
Response of the European Commission:
The European Commission does not agree with the United States and as previously
mentioned considers that the proposed requirements will enhance transparency and safety throughoutthe food and feed chain, contributing also to restore users and consumers confidence in the application
of gene technology in the agro-food sector.  The statement by the United States does nothing to ensure
or enhance the confidence of the European consumer in the safety of food and cannot be considered
relevant in the context of the TBT Agreement.
6. Link to the bio-safety protocol
Comment by Australia:
"Australia seeks clarification of Notification G/TBT/N/EEC/7, which states that the proposed
regulation on traceability and labeling of GMOs would take account of the requirements of theBiosafety Protocol "as regards specification of the identity of GMOs".  The detail contained in Box 6
of the Notification states that for GMOs intended for food, feed or processing (FFP), operators may
transmit a declaration that the product shall be only used for FFP, "together with the identity
(unique) codes of all GMOs the product may contain".  Australia considers that the EC's explanation
is not justified as requirements under Article 18.2 (a) have yet to be fully negotiated. "
Response by the European Commission:
It is correct that requirements under Article 18.2 (a) concerning the specification of the
identity of GMOs are under negotiation.  However, this does not prevent the European Commissionfrom proposing what information it considers s hould accompany transboundary movements of GMOs
intended for food, feed or for processing.  The European Commission maintains that its Proposal, in
terms of the traceability requirements for GMOs intended for food, feed or, for processing, is
consistent with Article 18.2 (a) of the Protocol.
Moreover, the European Commission continues to closely monitor developments in
international fora, for example, concerning the system for unique codes as developed by the OECD,
with the objective of establishing a system for unique codes in the European Community which is
consistent with international agreements.G/SPS/GEN/338
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7. Separation of GM foods and Novel Foods
Comment by Canada:
"In particular, Canada would ask the EC why these mandatory regulations are only applied
to foods and feeds produced with certain biotechnologies and not to other novel foods and feeds
which could be subject to genetic alteration via other production methods?  Canada is concerned that
the EC is fundamentally altering the way products are regulated by proposing a regulatory system
based on non product related processing and production methods rather than product characteristics.
Even within this processed-based system, the EC appears to be inconsistent in its application, e.g., byincluding foods produced "from" GMOs while excluding foods produced "with" GMOs ."
Response of the European Commission:
Novel foods other than GM foods will remain subject to the provisions of Regulation (EC)
No 258/97, which also provide for a pre-market risk assessment and risk management process.  These
provisions are themselves being reviewed and will also be adapted, in due course, to the new
regulatory framework for food safety laid down in Regulation (EC) No 178/2002.
The establishment of a specific risk analysis process for genetically modified foods is entirely
consistent with developments at the international le vel, where specific standards, guidelines or other
principles are being developed for foods derived from biotechnology, notably within the Ad Hoc
Intergovernmental Task Force on Foods derived from Biotechnology established by the CodexAlimentarius Commission.
The European Commission is not proposing to change the scope of the regulatory framework
applicable to genetically modified foods: the scope of the Proposal is identical to the scope of the
Novel Food Regulation, i.e. food produced "from" GMOs are covered, and those produced "with"
GMOs are not.  Again, this is consistent with the approach at international level, notably the work inprogress within the Codex Alimentarius Task Force on Foods derived from Biotechnology.
8. Linkages between the two proposals
Comment by Canada:
"The linkages between the two proposed regulations are not clear.  For example, it is unclear
if the threshold for adventitious presence of appr oved GMOs is the same in the Traceability
Regulation, as the threshold outlined in the Authorization and Labeling Regulation.  In addition,
although it is clear that products made "with" GM enzymes and processing aids are excluded from the
scope of the Authorization and Labeling Regulation, it is not clear that these products are excludedfrom the scope of the Traceability Regulations. "
Response of the Commission:
Article 6 paragraph 3 and 4 of the Proposal explicitly exempts products intended for food and
feed and for processing from traceability provided the conditions and thresholds established in
accordance with Articles 5, 18 and 42 of the Proposal for a Regulation on GM food and feed are met.
Nowhere is it stated that processing aids are included in the scope of the traceability Proposal,
however it is clear from the scope of the Proposal that products containing GMOs are covered, whichincludes of course the deliberate release of processing aids containing a GMO(s).G/SPS/GEN/338
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There is a clear link between the two Proposals in so far as the traceability requirements for
food and feed produced from GMOs will facilitate that such products are accurately labelled in
accordance with Article 13 and 26 of the Proposal for a GM food and feed Regulation.
9. Alternative measures
Comment by Canada:
"In addition, Canada is very concerned by the EC's apparent failure to consider alternative
measures to those outlined in the regulations, which meet the stated objectives, and are less traderestrictive.  Canada asks the EC if any other measures were explored?  If so, what led the EC to
recommend mandatory labeling and traceability measur es over a less restrictive, market driven
approach, such as voluntary labels?  For example, Canada is developing a voluntary standard for the
labeling of foods derived from gene technology.  This voluntary standard will provide a clear basis
for the market to respond, as appropriate, to consumer demands. "
Comment by the United States:
"What other less trade distorting options were considered?  Why were these rejected? "
Comment by Australia:
"Australia regards the proposals to be more trade restrictive than necessary to fulfil a
legitimate objective and therefore raises concerns about the EC's WTO obligations under Article 2.2
of the TBT Agreement.  Extensive international studies (including those conducted by the EC) show
that there is no scientific evidence of GM f ood and feed posing any greater risk than their
conventional counterparts.  Given this, Australia questions how the EC assessed its proposedmeasures against the risk of non-fulfilment of the claimed legitimate objectives?  What alternative,
less trade-restrictive measures were considered by the EC and why were these alternatives
discarded?"
Response of the European Commission:
In preparation of its Proposal, the Eur opean Commission examined the merits and
disadvantages of a number of different labeling  approaches, including the one that would complement
the current mandatory labeling  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, incl uding experiences in some member States,
revealed that voluntary "GMO-free" (or simila rly phrased) schemes were beset by a number of
technical, commercial and other difficulties.  It also became evident that consumers in the EuropeanCommunity were primarily interested in knowing whether their food was produced from GMOs or
contained ingredients produced from GMOs.  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" labeling  claims provided the claim is truthful and not
misleading. It would be considered misleading 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 use 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.G/SPS/GEN/338
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The European Commission would like to point out that the Proposal together with the
Proposal for a Regulation on GM food and feed facilitates consumer choice and a demand driven
approach.
__________