WORLD TRADE
ORGANIZATIONG/SPS/GEN/337
G/TBT/W/179
26 July 2002
(02-4153 )
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/6 AND G/SPS/N/EEC/149
(PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL ON GENETICALLY MODIFIED
FOOD AND FEED – COM(2001) 425 FINAL)
Submission by the European CommunitiesG/SPS/GEN/337
G/TBT/W/179
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Response from the European Commission to comments submitted by WTO Members under
either or both G/TBT/N/EEC/6 and G/SPS/N/EEC/149
(Proposal for a Regulation of the European Pa rliament and of the Council on genetically
modified food and feed – COM(2001) 425 final)
I. INTRO DUCTION ................................................................................................................. ...4
II. GENERAL CO MMENTS........................................................................................................4
A. N OTIFICATION UNDER SPS .........................................................................................................4
B. O BJECTIVE OF THE PROPOSAL ....................................................................................................5
C. GM FOODS ARE TREATED AS IF THEY WERE INHERENTLY UNSAFE ............................................5
D. P ROPOSAL MORE TRADE RESTRICTIVE THAN NECESSARY ..........................................................6
E. S EPARATION OF GM FOODS AND NOVEL FOODS ........................................................................7
F. D IFFERENCE WITH NOVEL FOOD REGULATION ..........................................................................7
III. AUTHORIZATION PROCE DURE .......................................................................................8
A. S UBSTANTIAL EQUIVALENCE ......................................................................................................8
B. C HEMICAL MODIFICATION OF A GM DERIVATIVE ......................................................................9
C. P ROCESSING AIDS - ENZYMES .....................................................................................................9
D. S COPE OF APPLICATION / AUTHORIZATION ...............................................................................10
E. R ISK ASSESSMENT AND RISK MANAGEMENT ............................................................................10
F. E NVIRONMENTAL RISK ASSESSMENT ........................................................................................11
G. R OLE OF COMPETENT AUTHORITIES ..........................................................................................11
H. "N O RISK " REQUIREMENT .........................................................................................................11
I. "S HOULD NOT MISLEAD THE CONSUMER " REQUIREMENT ........................................................12
J. P OST-MARKET MONITORING AND MONITORING PLANS ............................................................13
K. D ETECTION METHODS ...............................................................................................................14
L. R OLE OF COMMUNITY REFERENCE LABORATORY ...................................................................14
M. O THER LEGITIMATE FACTORS ...................................................................................................15
N. P UBLIC INFORMATION ...............................................................................................................16
O. D ECISIONS - TIME FRAME , APPEALS ..........................................................................................17
P. A UTONOMOUS ACTION OF MEMBER STATES ............................................................................17
Q. 1 % THRESHOLD FOR NON -AUTHORISED GM- MATERIAL .........................................................18
IV. LAB ELING .................................................................................................................... .........19
A. W HAT IS THE RISK BASIS FOR LABELING ?.................................................................................19
B. L ABELING THE METHOD OF PRODUCTION AND "LIKE PRODUCTS "............................................20
C. L ABELING TERM :  GENETICALLY MODIFIED OR BIO -ENGINEERED ............................................21G/SPS/GEN/337
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D. P RODUCED FROM A GMO, BUT NOT CONTAINING A GMO ......................................................21
E. L ABELING FOR PROCESSING AIDS - ENZYMES ...........................................................................22
F. L ABELING : RISK OF FRAUD .......................................................................................................22
G. GM- FREE LABELING ..................................................................................................................24
H. L ABELING THRESHOLD .............................................................................................................25
I. T HRESHOLD FOR AUTHORISED AND UNAUTHORISED MATERIAL ..............................................26
J. E THICAL OR RELIGIOUS CONCERNS ..........................................................................................27
K. R ISK OF UNEVEN APPLICATION OF LABELING REQUIREMENTS .................................................28
L. L INKAGE TO BIOSAFETY PROTOCOL .........................................................................................28
M. GM FEED - AUTHORISATION AND LABELING ............................................................................29
N. GM FEED LABELING – UNIQUE CODES ......................................................................................30
V. MISCELLANE OUS ...............................................................................................................3 0
A. L ACK OF ADDITIONAL GUIDANCE .............................................................................................30
B. E UROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES ....................................31
C. R EGISTER OF AUTHORISED GM FOODS AND FEEDS ..................................................................32
D. E MERGENCY MEASURES : CRITERIA – ROLE OF EFSA ..............................................................32
E. E MERGENCY MEASURES : INTERNATIONAL CO -OPERATION ......................................................33
F. M ONITORING AND CONTROL : INTERNATIONAL COLLABORATION ............................................33
G. S TANDARDIZED TESTING METHODOLOGIES ..............................................................................33G/SPS/GEN/337
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I. INTRODUCTION
The European Commission thanks all those who have submitted comments on Proposal
COM(2001) 425 final as notified under either  or both G/TBT/N/EEC/6 and G/SPS/N/EEC/149.
This document provides the comprehensive response of the European Commission to
comments submitted by WTO Members under either or both G/TBT/N/EEC/6 and
G/SPS/N/EEC/149.
For the sake of clarity and precision, comments have been regrouped by subject matter.
Extracts from comments by WTO Members are shown in italics for ease of reference, and the answerfrom the European Commission is shown in regular font.  The European Commission apologises for
any - obviously unintended - inaccuracy or om ission resulting from this way of proceeding.
II. GENERAL COMMENTS
A. N
OTIFICATION 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:
"Given the stated objective of the proposed regulation, it would be our 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 or
animal 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 theUnited States welcomes the notification to WTO Members under the TBT Agreement, we question why
a parallel notification was not also made to WTO Members under the SPS Agreement.  The
United States would encourage the Commission to also evaluate the proposed regulation in light of
the disciplines of the SPS Agreement.  Could the Commission please explain its rationale or otherwise
provide a notification to the SPS Committee? "G/SPS/GEN/337
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Response of the European Commission:
The proposed Regulation will lay down a gene ral, horizontal framework for regulating
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 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.
B. O
BJECTIVE OF THE PROPOSAL
Comment by the United States:
"The proposed regulation fails to distinguish between considerations of health, safety and the
environment on the one hand, and those of perceived consumer desires, on the other hand. "
Response of the European Commission:
The European Commission considers that any given piece of legislation can serve a number
of purposes and objectives.  The objectives of the proposal in question are not contradictory; they are
almost always intertwined and there is therefore no need to distinguish between clauses whichprimarily serve one purpose and others which primarily serve another purpose.  Nor is there, in the
view of the European Commission, any obligation un der international treaties to operate on the basis
of such distinctions.
C. GM 
FOODS ARE TREATED AS IF THEY WERE INHERENTLY UNSAFE
Comment by Argentina:
"The Proposals start from the premises which, without scientific support, aim to uphold the
unjustified presumption of the harmfulness of f oods containing Genetically Modified Organisms
(GMOs)."
"Products containing or produced from GMOs are granted different treatment from other
products, in particular taking into account that it is never possible to achieve absolute scientific
certainty. "
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 and
approved 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). "
Response of the European Commission:
The own research of the European Community has not concluded that GM foods are safe
per se ;  it has confirmed that those GM plants and derived products so far developed and marketed in
the European Community, following usual risk asse ssment procedures, have not shown any new risks
to human health or the environment, beyond the usual uncertainties of conventional plant breeding, orG/SPS/GEN/337
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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 be
developed in the future should not be assessed and evaluated to ensure that the European Community
level of protection is also achieved.
Any country is free under the WTO law to establish pre-marketing approval and labeling
requirements, if the other provisions of the relevant WTO Agreements are respected.  Moreover, there
is growing international consensus "that a pre-market safety assessment should be undertaken
following a structured and integrated approach and be performed on a case-by-case basis"
(paragraph 12 of the "Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern
Biotechnology", at step 8 of the Elaboration Proced ure of the Codex Alimentarius Commission).  It is
precisely this pre-market safety assessment and the ensuing risk management decision-process which
the proposed Regulation purposes to establish, through a targeted reform of the current pre-market
risk analysis provided for in Regulation (EC) No 258/97 (novel foods) currently in force.
D. PROPOSAL MORE TRADE RESTRICTIVE THAN NECESSARY
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 proposed
measures 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 essence, the Proposed Regulation is very similar to Australia's own provisions on 'Food
Produced using Gene Technology' that came into effect on 7 December 2001, with the notable
exception of:  mandatory labeling of GM food in the absence of detectable DNA or protein;
authorisation and mandatory labeling of GM feed;  and, mandatory traceability of GM food and feed.The European Commission therefore understands the above comment from Australia to refer to those
three specific aspects.  Mandatory labeling of GM food in the absence of DNA or protein, on the one
hand, and authorisation and labeling of GM feed, on the other hand, will be discussed below.
Traceability of GM food and feed is discussed in response to comments received on Proposal
COM(2001) 182 final under G/TBT/N/EEC/7 and G/SPS/N/EEC/150.
1
In the following pages the Commission will explai n the need for specific requirements of the
proposed Regulation and what alternative, possibly less trade-restrictive measures were considered
(see, in particular, the section on "GM-free labeling").  The European Commission contends that by
clarifying the rules under which GM-food and feed can be placed on the European Communitymarket, the proposed measure facilitates rather than restricts trade in GM-foods and feeds.
                                                     
1 Contained in document G/SPS/GEN/338 and G/TBT/W/180.G/SPS/GEN/337
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E. 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 a ppears to be inconsistent in its application, e.g., by
including 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 newregulatory 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 Proposed Regulation is identical to the
scope of Regulation (EC) No 258/97 (novel foods),  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 in progress within the Codex Alimentarius  Task Force on Foods derived from
Biotechnology.
F. DIFFERENCE WITH NOVEL FOOD REGULATION
Comment by Canada:
"Canada requests that the EC explain how the proposed regulations differ from relevant
existing regulations, in particular the novel food regulations.  If there are differences, could the EC
explain what the distinctions are based on? "
Response of the European Commission:
The proposed Regulation differs from the current regulatory framework applicable to
genetically modified food and feed mainly in the following respects.
− A centralised Community procedure would be established for the authorisation of
GM food (under the current system the authorisation procedure is only partlycentralised).  A single scientific evaluation would be undertaken by the European
Food Safety Authority (under the current system the scientific evaluation is originallycarried out by one member State competent body and may have to be complemented
by the relevant Scientific Committee(s) established at Community level) followed by
a single authorisation decision by the Community.
− The same centralised authorisation procedure would be applied to GM feed.G/SPS/GEN/337
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− A ten year data exclusivity would be granted for some of the information submitted in
support of applications.
− Detailed requirements would be introduced in respect of the particulars and
documents to be supplied in support of applications (in particular lodging of reference
material and methods for detection and identification).
− New transparency provisions, modeled on those laid down in Directive 2001/18/EC,
would allow for public consultation after publication of the opinion of the EuropeanFood Authority.
− A threshold (maximum 1%) would be introd uced for the adventitious or technically
unavoidable presence of unapproved GM material in food and feed which have at
least received a positive evaluation by the relevant scientific committee of the
European Community (this was not foreseen in Regulation (EC) No 258/97 on novel
foods).
− New labeling requirements would enable consumers to make informed choices and
avoid also deceptive practices.
III. AUTHORIZATION PROCEDURE
A. SUBSTANTIAL EQUIVALENCE
Comment by the United States:
"The United States notes that the EU is eliminating the simplified notification procedure as
laid down in Regulation EC No 258/97 on novel foods and novel food ingredients for bio-engineered
products which are substantially equivalent to existing foods.  To date, no bio-engineered foods have
completed the long novel foods and novel food ingredients approval procedures.  If this is indicative
of the future operation of the food and feed approval process, the United States has great concerns
about its potential impact on trade. "
Response of the European Commission:
The Proposed Regulation does not, indeed, include a notification procedure as laid down in
Regulation (EC) No 258/97 on novel foods and novel  food ingredients for genetically modified food
which are "substantially equivalent" to existing foods.  The use of this regulatory short-cut for
"substantially equivalent" GM foods has been very controversial in the Community in recent years.
Recent discussions at international level have shown that demonstration of  substantial
equivalence is a key step in the safety assessment process of foods derived from modernbiotechnology, but it is not a safety assessment in itself (see "Proposed Draft Principles for the Risk
Analysis of Foods Derived from Modern Biotechnology" at Step 8 of the Elaboration Procedure of the
Codex Alimentarius Commission).
In proposing the Regulation on genetically modi fied food and feed, the Commission took this
new development into account together with the n eed to apply the same set of transparent and
vigorous assessment rules to all GM-food (and feed).G/SPS/GEN/337
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B. CHEMICAL MODIFICATION OF A GM DERIVATIVE
Comment by Switzerland:
"Switzerland does not require authorisation of materials which have been obtained by
chemical modification of a chemically defined s ubstance derived from a GMO, e.g. modified starch
products. The Swiss authorities would like to obt ain information on whether such foodstuffs will
require authorisation in the EU after abandonment of the notification procedure.  Switzerland
estimates that the control of products containing su ch materials is difficult as enforcement supported
by analytical methods is virtually impossible.  In this context the Swiss authorities are also concerned
about potential trade distortions resulting from diverging regulations. "
Response of the European Commission:
Under the proposed Regulation, the authorization of a GMO for food or feed use would,
unless otherwise stated in the authorisation, encompass the authorization of all materials (food or
feed) which have been obtained by chemical modification of a chemically defined substance derivedfrom that GMO, for example: modified starch product.  This is not different from the current situation
under Regulation (EC) No 258/97 on novel foods a nd novel food ingredients.  The Commission is not
aware that the application of Regulation (EC) No  258/97 (novel foods) to chemically defined
substances derived from GMOs has led to trade distortions.
C. P
ROCESSING AIDS - ENZYMES
Comment by Canada:
"Canada would ask the EC why GM enzymes and other processing aids are not subject to the
safety assessment and authorization procedure contained in these draft regulations?  Is it that thesafety assessment for these products is covered elsewhere in Community regulation? "
Response of the European Commission:
Enzymes, as such, are not excluded from the scope of the authorization provisions of the
proposed Regulation.
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 Community
legislation and therefore subject to the authorization provisions of the proposed Regulation.
Processing aids (i.e. materials used during processi ng but not present in the finished food), including
enzymes used as processing aids, are not food ingredients, i.e. they are not  food under European
Community legislation; they are therefore not subject to the authorization provisions of the proposed
Regulation.
The European Commission would like to stress that the proposed Regulation is not, in this
respect, in any way different from the current legal situation as it results from the application ofRegulation (EC) No 258/97, which has never ledto any concern in this respect.
However, the European Commission has already announced to the European Parliament that
it is considering bringing forward new legislation on enzymes.G/SPS/GEN/337
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D. SCOPE OF APPLICATION / AUTHORIZATION
Comment by the United States:
"Could the text of regulation, rather than the Explanatory Memorandum, please clarify
whether the requirement for authorization applies only  to biotech events or to individual feed or food
products made or derived from these events?  And further, can an applicant seek approval for a
biotech event for food or feed, and assume all products and derivatives have received authorization? "
Response of the European Commission:
The text of the proposed Regulation makes it abundantly clear that the requirement for
authorization applies both to genetically modified organisms for food use and to food or feed
containing, consisting of or produced from a genetically organism (see Article 4(2) and 17(2) ).
However, authorization cannot be requested under a single application for different GMOs which
contain the same manipulation event.
An applicant can seek approval for a genetically modified organism for food and/or feed use
and request that all food and/or feed products and derivatives be covered by the authorization (see
Article 4(4) first indent and 17(4) first indent).
However, authorization can also be sought and granted for a specific food or feed produced
from or containing an ingredient produced from a genetically modified organism as well as food or
feed produced from or containing that food or feed (see Article 4(4) second indent and 17(4) second
indent).
E. RISK ASSESSMENT AND RISK MANAGEMENT
Comment by the United States:
"The proposed regulation foresees that a new European Food Authority (EFA) will be
required to undertake scientific risk assessments for both bio-engineered foods and feed, yet final
approval decisions will be taken by member Sates in committee, rather than by the EFA itself, whose
opinion appears designed to be limited to scientific and technical considerations ."
"The United States applauds the creation of the European Food Authority and its involvement
in the approval process.  However, we note its limited role.  Decisions will still be made through a
political process.  How will the EU ensure that the authorization is based on science and not politics,
given that the member States will vote on the approvals by qualified majority and neither they, nor the
Commission, who is responsible for drafting the proposed decision on authorization, are bound by theopinion of the EFA? "
Response of the European Commission:
European Community food law in general (see Regulation (EC) 178/2002) and the proposed
Regulation in particular, are based on the principles of risk analysis established at the international
level.  The European Commission draws the attention of the United States to the general decisions of
the Codex Alimentarius  Commission, in particular the Statements of Principle Relating to the Role of
Food Safety Risk Assessment, which provide that:  "There should be a functional separation of risk
assessment and risk management, while recognising that some interactions are essential for apragmatic approach".G/SPS/GEN/337
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The proposed Regulation is entirely consistent with this principle; the functional separation of
risk assessment and risk management is ensured through assigning the former to the European Food
Safety Authority and the latter to the European Commission assisted by a regulatory committee of
member States' representatives.
In the constitutional structure of the European Community, as in many other legal systems,
risk management measures are not the province of risk assessors but of the regulatory authorities
which are subject to  political and judicial control.
F. ENVIRONMENTAL RISK ASSESSMENT
Comment by the United States:
"Could the EU please clarify how the risk  assessments in Article 6.5 in 2001/425 and in
Annex II in 2001/18 differ? "
Response of the European Commission:
There would be no difference between the environmental risk assessment carried out under
the proposed Regulation (under Article 7(3)(e) of the proposed Regulation actually, rather than
Article 6(5) which concerns the application) and the environmental risk assessment foreseen in Part C
Directive 2001/18/EC.
G. ROLE OF COMPETENT AUTHORITIES
Comment by the United States:
"The EFA may ask a "food assessment body" [Article 7.3 (d)] or "feed assessment body"
[Article 20.3 (d)] in a member State to do a safety assessment, or a "competent authority" to carry out
an environmental risk assessment.  What criteria would be used by the EFA to determine if safety
and/or environmental risk assessments were required beyond the initial information provided by the
applicant?  Could the EU provide more guidance as to  the role that these bodies will play in individual
regulatory decisions?"
Response of the European Commission:
The role of a food (or feed) assessment body of a member State which would be asked to
perform a safety assessment under either Article 7(3)(d) or Article 20(3)(d) in the case of a feed, and
of a competent authority which would be asked to perform an environmental risk assessment under
Article 7(3)(e) or Article 20(3)(e) would be to accomplish the preparatory work for the scientificopinion of the European Food Safety Authority.  This work, which can best be compared to the role of
a "rapporteur", would always be required, irrespective of the quality of the initial information
provided by the applicant, but it could be entrusted to a body or an authority of a member State, or
performed internally by the European Food Safety Authority.
H. "N
O RISK " REQUIREMENT
Comment by Argentina:
"Products containing or produced from GMOs are granted different treatment from other
products, in particular taking into account that it is never possible to achieve absolute scientificcertainty. "G/SPS/GEN/337
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Comment by Canada:
"Canada requests that the EC clarify the obje ctive of the Authorization portion of the
regulations. Canada finds the authorization process outlined in the proposed regulations to beunclear and is concerned that the EC appears to be trying to fundamentally alter the regulatory
process by requiring products to meet a "no risk" standard, as outlined in article 4 of the
Authorization and Labeling Regulation.  As it is impossible to prove something has "no risk," Canada
asks that the EC clarify what it considers a "risk" to be, and elaborate on how these regulations assist
the risk management process? "
Comment by the United States:
"In addition, the legislation sets a standard of "no risk" as the basis for regulatory decision-
making, which could ultimately block the authorization process since it is impossible to guarantee "no
risk" for any product, biotech or conventional. "
"Article 4.1 establishes, among other things, a requirement that biotech foods "must not
present a risk for human health or the environment. "  As stated previously, Article 17.1 requires that
biotech feed "must not present a risk for animal he alth, human health or the environment."  This level
of assurance is wholly unobtainable for any food or feed product, regardless of the production
method, as the absence of risk can never be proven.  Virtually every food or feed carries some level of
risk if not properly handled.  What kind or degree of evidence does the EU envision would be
necessary to demonstrate that this standard has been met?  How does this relate to 2000/286's
proposed food and feed safety standard, and/or existing standards established for food additives, or
pesticide residues in food, and what is the basis for any difference? "
Response of the European Commission:
The European Commission notes the concern expressed by Argentina, Canada and the
United States.  The proposed Regulation did not intend to impose an absolute "no risk" standard for
genetically modified food and feed, but only a standard that can meet the high level of protection
required by the EC Treaty (e.g. Article 95, paragraph 3).  The applicants should not be required,
therefore, to demonstrate the absence of any unknow n risk for human health, animal health or the
environment.
The Commission accepts that a clarification of Article 4(1) first indent may be desirable in
that respect and will bring this issue to the attent ion of the European Parliament and of the Council as
they consider the proposed Regulation.
I. "SHOULD NOT MISLEAD THE CONSUMER " REQUIREMENT
Comment by Switzerland:
"According to Article 4 of the Commission's proposal (COM (2001) 425 final) it is required,
in order to obtain an authorisation, that "food falling within the scope must not mislead the
consumer".  What is meant by this requirement?  Are there any examples of food that is misleading by
itself? Should this requirement not rather be treated as an aspect of labeling? "
Comment by the United States:
"Article 6.3 (e) requires applicants for authorization of biotech food to provide studies or
otherwise demonstrate that the food satisfies the requirements of Article 4.1, i.e., that it does not,G/SPS/GEN/337
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among other things, "mislead the co nsumer."  Article 19.3 (e) requires applicants for authorization of
biotech feed to provide studies or otherwise demonstrate that the feed satisfies the requirements of
Article 17.1, i.e., that it does not, among other things, "mislead the user."   Please clarify the types of
information that would show that a food or feed (versus a food or feed label) does not mislead
consumers or users. "
Response of the European Commission:
Whilst "misleading the consumer" is indeed normally an aspect of labeling, advertising or
presentation, there are instances in which the intrinsic characteristics of a food could be misleading
for the consumer.  For instance, the food could have been modified to suggest that it is fresh whilst itis 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 coming decades, including productsderived from genetically modified animals as the case may be.
Article 6(3)(e) should not be understood to mean that studies would be needed for the purpose
of demonstrating that each and every criterion laid down in Article 4(1) has been satisfied.  This, and
other similar matters, will be clarified in the detailed guidance which will be published and refinedover time by the European Food Safety Authority under Article 6(8) and 19(8).
Finally, the European Commission would observe that the "not mislead the consumer"
criterion has been carried from Regulation (EC) No 258/97, where its application never led to any
difficulty.
J. P
OST-MARKET MONITORING AND MONITORING PLANS
Comment by the United States:
"Articles 6.3 (k) , 6.5 (b), 19.3 (k) and 19.5 (b) require applicants to develop proposals for
post-market monitoring and monitoring plans for environmental effects.  What are the criteria to be
used by applicants in ascertaining whether post-market monitoring is appropriate?  Without specificrisks to humans, animals, and the environment identified, it will be difficult for firms to develop such
plans and carry them out.  Articles 10 and 23 indicate that once an authorization is granted, post-
market monitoring or other restrictions may be "imposed."  What criteria will guide the Commission
in ascertaining whether specific restrictions and/or monitoring plans are needed?  Will such
monitoring requirements also apply to any conventional products? "
Response of the European Commission:
The provisions in Articles 6(3)(k) and 19(3)(k) on the one hand, and those in Articles 6(5)(b)
and 19(5)(b) on the other hand must be clearly distinguished.
Post-market monitoring for the use of the food for human consumption as foreseen in
Article 6(3)(k) or for the use of the feed for animal consumption as foreseen in Article 19(3)(k) would
only be required where appropriate, based on the outcome of the risk assessment.  This is in line, for
example, with the "Proposed Draft Principles for the Risk Analysis of Foods Derived from ModernBiotechnology" at Step 8 of the Elaboration Proc edure of the Codex Alimentarius Commission, which
state (at paragraph 20) that "Post-market monitoring may be an appropriate risk management measure
in specific circumstances.  Its need and utility should be considered, on a case-by-case basis, duringG/SPS/GEN/337
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risk assessment and its practicability should be considered during risk management."  Therefore, it
can be expected that within the context of the proposed Regulation, post-market monitoring will be
undertaken for the purpose of:  (a) verifying conclusi ons about the absence or the possible occurrence,
impact and significance of potential consumer health  effects;  and (b) monitoring changes in nutrient
intake levels, associated with the introduction of foods likely to significantly alter nutritional status, to
determine their human health impact.
Post-market monitoring requirements can and have been imposed to non-GM products.  In
fact, under Regulation (EC) No 258/97, post-market monitoring commitments have so far only been
imposed in respect of non-GM products.
The monitoring plan for environmental effects as foreseen in Articles 6(5)(b) and 19(5)(b)
would always be required when the application concerns a GMO, as this is indeed a requirement of
Directive 2001/18/EC.
K. DETECTION METHODS
Comment by the United States:
"Articles 6.3 (i) and 19.3 (i) require the applicant to supply a method for sampling and
detection of each event in foods and feeds.  The United States is concerned that reliable methods for
quantifying biotech material within the low levels established as tolerances by the EU are not yetavailable.  Furthermore, detection methods and limi ts of detection vary depending on the method and
degree of processing.  In many cases, no trace of the event will be present in the final processed
product.  When the margin of error is so low, inconsistent test results will increase the level of
uncertainty for shippers thereby discouraging trade for some and increasing liability for others
despite best efforts. "
Response of the European Commission:
Articles 6(3)(i) and 19(3)(i) are very clear that supplying a detection method for the
identification of the transformation event is always required, whilst supplying a detection method for
the detection and identification of the transformation event in the foods or feeds produced from it is
only required where applicable.  Thus, a method for detection and identification of the transformation
will not be required where transgenic material cannot be detected in the foods or feeds produced from
the GMO.
This, and other similar matters, will be clarified in the detailed guidance which will be
published and refined over time by the European Food Safety Authority under Article 6(8) and 19(8).
As the United States know, the European Community has been soliciting co-operation with
trading partners on the development of reliable methods for detection and quantification of biotech
material.
L. ROLE OF COMMUNITY REFERENCE LABORATORY
Comment by Canada:
"The current lack of validated testing and sampling methods for the detection of GMOs leads
to the possible use, by importers in the EC and elsewhere, of inconsistent testing and sampling
methods and therefore of unreliable test results.  Canada understands that the newly established
Community Reference Laboratory (CRL) will be responsible for validating methods for the detection
of GMOs.  Canada would like to ask the EC what cr iteria the CRL will adhere to for validation ofG/SPS/GEN/337
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methods, and if validation will be done at the member State, EC or international levels and will third
countries be involved? "
Comment by the United States:
"Please clarify the responsibilities of the Community Reference Laboratory (CRL) (Article 7.3
(f); Article 33 and Annex) and the national reference laboratories with regards to the testing for
biotech events, data evaluation, and dispute settlement.  How frequently will these laboratories test?
Will they test only products originating within the Community as well as from third countries?   Who
will oversee the activities of these laboratories and ensure that their tests are carried out in a uniform
and timely manner?  What legal standing do test s run in one member State have in other member
States?  What will be the role of the CRL in disp ute settlement between member States?  What will be
the role of the Commission?  What will be the impact,  if any, of testing results that may be provided
from non-EC or member State sources? "
Response of the European Commission:
Under the proposed Regulation, methods of detection, including sampling and identification
of transformation events and, where applicable, for the detection and identification of the
transformation events in foods and feeds would have to be proposed by the applicant.  They would be
tested and validated by the Community reference laboratory before authorization was granted.  Theywould eventually form part of the authorization, and thus be published.
The Community reference laboratory will adhere to the validation criteria generally
recognised at the international level.  The Europ ean Community has long supported international co-
operation in this respect, which would no doubt be more advanced if other countries had shown asimilar interest.
Actual testing of products, using the validated methods laid down in the authorization, will be
a matter of controls, which is essentially left in the competence of the member States.  These controls
are implemented without consideration of the origin of products, i.e. irrespective of whether products
originate in a third country, in another member State or in the member State carrying out the controls.
Under the proposed Regulation, business operators  are not required to show the results of
tests at any stage of the production or distribution of the products concerned.  Recognition of tests
carried out in a third country or in another member State is therefore not an issue in the context of the
proposed Regulation.
However, as the United States know, the European Community is soliciting co-operation with
its trading partners on the development of validated detection and identification methods.
M. O
THER LEGITIMATE FACTORS
Comment by Argentina:
"The Community regulations leave open the possibility of introducing "other factors" in risk
assessment by departing from or belittling scientific evidence. "G/SPS/GEN/337
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Comment by Canada:
"In addition, it would be helpful to have clarification of what the EC considers, "other
legitimate factors" to be, who will decide what  factors are relevant in which cases, and how much
weight these factors would carry in the approval process? "
Comment by the United States:
"The process allows the Commission to take into account unspecified "other legitimate
factors" and to propose a decision regarding approval inconsistent with the outcome of the risk
assessment and other safety and technical information already considered under the responsibility ofthe European Food Authority.  This decision-making structure leaves substantial room for political
interference of the type that has led to the current moratorium on agricultural biotech product
approvals. "
"The articulation of what "other legitimate factors" may be taken into account by the
Commission in developing its proposed decision should be made explicit in the regulation(Article 8.1), otherwise the lack of definition could be used to arbitrarily delay or block approvals. "
Response of the European Commission:
The European Commission contends that the propos ed Regulation is entirely consistent with
the General Principles for Risk Analysis recognised at the international level, which allows riskmanagers 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.
Whilst acknowledging that the Proposal does not identify the "other legitimate factors" that
might be considered, the European Commission wo uld remind that member States have repeatedly
requested that this matter be considered by the Codex Ad Hoc Intergovernmental Task Force on Foods
derived from Biotechnology.  The European Comm ission does not remember that Canada or the
United States have ever supported that request, which has not been followed up so far.
N. P
UBLIC INFORMATION
Comment by Switzerland:
"In order to improve transparency of the decision-making process and the involvement of the
public in the authorisation process, the proposal suggests that a summary of the application and the
opinion of the European Food Authority shall be made available to the public.  The public may thus
submit comments to the Commission within 30 days after the publication of the opinion.  What exactly
is meant by "the public"?  Will public opinion be sought in form of a general opinion only or are thereinstruments of a more formal nature envisaged? "
Response of the European Commission:
The term "public" is used in the proposed Regulation to mean what is usually understood by it
in the European Community or internationally.  It refers, generally, to any natural or legal person who
may be interested in the matter at stake, although it is  not required to justify such an interest.  All sorts
of comments, whether of a general or of specific nature, can be made, the only requirements being
that they be made in writing and within the specified deadline.G/SPS/GEN/337
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O. DECISIONS - TIME FRAME , APPEALS
Comment by the United States:
"The proposed regulation indicates that the EFA will generally provide an opinion within six
months of the receipt of a valid application to  the Commission.  The Commission then has three
months to draft its proposed decision on authorization.  What is the expected time frame for a final
decision (by the member State) once the member State has received the Commission's proposal.  If the
anticipated time lines are exceeded, what recourse, if any, does the applicant have? "
"What is the time frame for the Commission to make its decision to modify, suspend, or revoke
authorizations?  What are the procedures for informing the supplier? "
"Once a new or existing product authorization is denied, can this decision be appealed, and if
so, what is the process (including anticipated time frames)? "
Response of the European Commission:
Under the proposed Regulation, all decisions on authorisations, including decisions to
modify, suspend or revoke them would be taken at Community level, i.e. will be decisions of either
the Commission or the Council as specified in Articl es 8(3), 21(3) and 36 of the proposal.  Moreover,
Articles 8(1) and 21(1) specify the time frames within which the Commission should normally reach a
decision on the application, which will initiate the subsequent steps in the authorisation procedure.
Articles 8(4) and 21(4) provide that the applicant shall be informed without delay of the decisiontaken.  As is currently the situation in nearly all areas of European Community health and
environmental protection, these time frames are specified in the authorisation procedures in order to
protect the interest of the applicant and allow judicial control.  There is plenty of case law by the
European Court of Justice on these issues.
Articles 11 and 24 of the proposal lay down the time frames on modifications, suspensions or
revocations of an authorisation.  In this case, the authorisation holder may still use the existing
authorisation until this has been modified, suspended or revoked; consequently, specifying a time
frame does not appear necessary in this respect.  Final decisions to grant, refuse, modify, suspend or
revoke an authorisation are decisions within the meaning of Article 249 of the EC Treaty, and can be
challenged before the Court of First Instance and, eventually on appeal, the Court of Justice in
conformity with and under the conditions laid down in Article 230 of the EC Treaty.  In addition, an
action for failure to take a decision within the specified time limits is also possible, under the
conditions laid down in Article 232 EC Treaty, as well as an action for possible damages under the
conditions laid down in Article 288 EC Treaty."
P. A
UTONOMOUS ACTION OF MEMBER STATES
Comments by the United States:
"In short, while the introduction of a new European Food Authority into the process could be
a helpful step toward improving the predictability of the authorization process, the new proposal fails
to address the core problem facing the European Union in biotechnology – individual member stateswill continue to be able to hold the approval process hostage to political concerns with complete
disregard for science and sound regulatory decision-making. Furthermore, the United States remains
concerned that individual member States will continue to flout EU regulations by maintaining their
own restrictions on biotech products. "
"It is clear that member States' authorities apply different principles of risk management in
regulating biotech products.  Under this regulation, how will the Commission ensure that the riskG/SPS/GEN/337
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management decisions of the individual member states are consistent and transparent? Will the
regulation strengthen the Commission's ability to enforce EU regulations currently being flouted by
several member states? "
Response of the European Commission:
The European Commission does not agree with, and cannot accept the statement that member
States have been flouting the law in this area. Regulation (EC) No 258/97 on novel foods and novel
food ingredients came into force in May 1997.  The European Commission knows of only one
instance in which one member State has suspended the authorization of genetically modified foods
placed on the market in accordance with the Regulation; the measures at stake were duly notifiedunder Article 12 of the Regulation; the matter is currently under judicial review and the European
Commission would therefore refrain from any further comment on this case.
Under the proposed Regulation, granting or refusing an authorization, or a modification,
suspension and revocation of an authorisation, and any refusal to renew an authorisation wouldbecome the preserve of the Community.  Member States would no longer have authority to take
national measures restricting the marketing of products for reasons of food or feed safety (see
Article 35).
Q. 1 % 
THRESHOLD FOR NON -AUTHORISED GM- MATERIAL
Comment by Canada:
"The Authorization and Labeling Regulation references a 1% threshold for the adventitious
or technically unavoidable presence of approved GMOs.  From a practical viewpoint, this low level is
costly and unworkable, particularly from a bul k commodity perspective.  To determine the
adventitious presence of GMOs, particularly at very low levels, such as 1%, will require time
consuming and costly tests in modern state of the art labs, and may be particularly onerous for
developing countries.  Therefore, given that most grain handling systems are designed to pool grains
and oilseeds - a threshold of 1% could be a serious impediment to trade, affecting both GMO
products and non-GMOs products. "
Comment by the United States:
"The United States appreciates the acknowledgment that reliably and consistently achieving
100 percent non-biotech content is not feasible, but experience has shown that a one percent
threshold also cannot reliably be tested and consistently be met.  To establish consumer confidence in
any system, claims must be achievable and readily verifiable. "
Response of the European Commission:
It seems that  Canada has misunderstood both the purpose and the operation of the proposed
1% threshold.  The 1% threshold foreseen in Articles 5, 18 and 42  concerns unauthorised
GM-material which have at least received a positive scientific assessment from the European
Community scientific committees.  The European Commission is not aware that Canada, or indeedmany  other countries have legislation allowing any tolerance for unauthorised GM material.
Since most countries in the world are currently operating on the basis of a 0% threshold for
unauthorised GM-material, it is difficult to understand how the introduction of a higher than 0%
threshold can be "unworkable", "particularly costly" or "particularly onerous".  The Commissionwould however welcome more precise information on feasibility problems and cost.G/SPS/GEN/337
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The introduction of a threshold, however "low", would therefore be a considerable
improvement on the current situation as, in the absence of a threshold, there is no tolerance for the
presence, at any level, of unauthorised GM material.
Under the proposed Regulation, there is no obligation, on any operator, to test for the
presence of GMOs.  The difference that the Proposed Regulation would bring is that the discovery of
unauthorised GM material in a proportion lower than 1% would no longer lead to the rejection of the
consignment (provided that the other conditions were also met) as is currently the case
IV. LABELING
A. WHAT IS THE RISK BASIS FOR LABELING ?
Comment by the United States:
"Among the stated "general objectives" of the proposed regulation is that of providing "...the
basis for ensuring a high level of protection of human life and health, animal health and welfare,
environment and consumers' interest in relation to genetically modified food and feed..."(Article 1).
The United States understands that Directive 2001/18, and the parallel food legislation, would
achieve this objective for biotech products.  Considering that any biotech foods allowed on the market
will have had to be demonstrated to be safe and th e EU has not articulated that bio-engineered foods
are unsafe, how will mandatory labeling help the Commission achieve its objective as stated in
Article 1?  Specifically, what risks are the proposed labeling requirements attempting to address? "
Response of the European Commission:
Labeling has manifold purposes, only one of which is to address risks.  Admittedly, it may
become necessary in the future to address labeling pr oblems linked to health, as the StarLink situation
in the United States has demonstrated.
One of the most important purposes of labeling is to provide full and accurate information to
consumers and to allow them to make informed choices in relation to the foods they purchase or
consume.  It is to inform consumers " as to the characteristics of the food and, in particular, as to its
nature, identity, properties, composition, quantity, durability, origin or provenance, method of
manufacture or production " (Article 2(1)(a)(i) of Directive 2000/13/EC on the labeling, presentation
and advertising of foodstuffs).
It is on this basis that food ingredients have to be labelled and not because there is a risk
associated with them.  A number of other current labeling examples, such as the mandatory obligation
to label the geographic origin of certain foods or the obligation to label specific production process or
production methods (e.g. fruit juice made from concentrated fruit juice, irradiated foods), clearly
demonstrate that labeling goes well beyond addressing risk issues to provide information that theconsumer needs in order to make informed purchasing decisions.
Since there is solid, cumulatively very strong evidence that European consumers are
interested to know whether their food is derived from genetically modified organisms, it is totally
justified for labeling to provide them with this info rmation as well.  In any case it is worth noting that
a considerable number of countries around the world have adopted labeling rules that provideprecisely this information.G/SPS/GEN/337
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B. LABELING THE METHOD OF PRODUCTION AND "LIKE PRODUCTS "
Comment by Canada:
"The regulations establish mandatory method of production labeling for all food and feed
consisting of, containing, or produced from GMOs.  Canada is concerned that the labeling
discriminates against like products on the basis of their method of production and believes this raises
serious questions as to their consistency with the EC's WTO obligations. "
Comment by Australia:
"Australia queries the inclusion of foods with very little or no novel DNA and/or protein in
the EC's labeling regime. It is Australia's view that GM products and their non-GM counterparts are
"like products" where there are no traces of novel DNA and/or protein in the final product (e.g. GM
processing aids and additives where there is no novel DNA and/or protein in the final food; very
small traces of GM flavourings; and highly refined foods eg oils and sugars). "
Comment by Switzerland:
"Switzerland does not require labeling of GMO-derived products that are separated from the
organism, purified, chemically defined and shown to be equivalent to their conventional counterpart
in the framework of safety assessment. This refl ects the principle of equal treatment of products. "
Response of the European Commission:
The question whether GM food and feed products and their non-GM counterparts are "like
products" for the purpose of the WTO Agreements, in particular the TBT Agreement, has to bedecided on a case-by-case basis.  Moreover, in the view of the European Commission, established
case law suggests that the concept of "likeness" in the WTO context should be interpreted by taking
into account all the relevant factors relating not only to the physical characteristics but also to other
properties, composition, appearance, etc. of the products which are likely to influence the competitive
relationship in the market place, not least those which have been demonstrated through empirical
evidence to determine consumers' preferences, ta stes and habits.  Thus, the specific labeling
requirements may be justified where available empirical evidence shows that consumers' choice maydepend on a specific process and production method having been used or not used which may affect
or modify the properties of a product, even if such DNA modification cannot be currently identified.
Because there is solid  evidence that for European consumers foods and food ingredients produced
from GMOs are different from those produced from conventional organisms, even where the food in
question has little difference from other conventional foods, it would be unacceptable to depriveconsumers of the information they clearly wish to have.
The European Commission further submits that even if GM food and feed products were
found to be "like" to their conventional counterpar ts, for the purposes of the TBT Agreement, WTO
Members would still have the right to draw regulatory distinctions by imposing labeling requirementsto such a category of products without, for this reason alone, being found to accord to the group of
like imported products less favourable treatment than that accorded to the group of like domestic
products, as long as the other provisions of the TBT Agreement are fulfilled, in particular the
non-discrimination and no more trade restrictive than necessary requirements of the Agreement.  In
the view of the European Commission, the proposed Regulation is designed to comply with these
requirements and care will be taken to continue complying with them when taking implementing
legislation.G/SPS/GEN/337
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C. LABELING TERM :  GENETICALLY MODIFIED OR BIO -ENGINEERED
Comment by the United States:
"The United States would note that the term "genetically modified" applies to all breeding
methods, and indeed, to all food crops.  The United St ates continues to believe that its use by the
Commission fosters the mistaken belief that only the techniques of modern biotechnology modify
genes. The United States also believes that perpetuating such mistaken beliefs impedes public
acceptance of bio-engineered foods and crops.  Th e United States, therefore, once again, recommends
that the Commission use a more accurate term to describe the products you want to capture under the
regulation. "
Response of the European Commission:
The term "genetically modified" has long been used in the European Community, and in
many other countries around the World, to designate foods and other products derived from modern
biotechnology.
The European Commission is of the opinion that terms used in labeling should be terms that
consumers recognize. It is therefore difficult to understand why a term that is so well understood by
the European consumers should be replaced by another one less well understood.
The European Commission is aware that in North America the term "bio-engineered" is
sometimes used to designate the same category of products.  The European Commission has noobjection to formulate against the use of this term in other countries, if that is a term which consumers
there recognize and understand.
D. P
RODUCED FROM A GMO, BUT NOT CONTAINING A GMO
Comment by Switzerland:
"Switzerland has reservations about the terminol ogy for labeling purposes included in the two
proposals as they differ from present regulations, are unduly long and are inconsistent with one
another.  While the wording in proposal COM (2001) 425 final reads "produced from genetically
modified [name of organism], but not containing a genetically modified organism" or "genetically
modified", the wording in proposal COM (2001) 182 final reads "this product contains genetically
modified organisms ".
"The Swiss authorities are also concerned that the current labeling terminology laid down in
Regulation (EC) No1139/98, in which the wording "p roduced from genetically modified [name of
organism]" is being used, will be replaced by these new proposals.  Switzerland has been careful to
define its own labeling rules in a way that is consistent with present EU regulations, and does not see
any benefit for the consumer in the proposed changes.  The differences may enhance confusions andtherefore Switzerland would like to keep its current legislation with regard to labeling unchanged. "
Response of the European Commission:
The European Commission has noted the comment of Switzerland.  The European
Commission attaches great value to past and on-going co-operation with Switzerland in matters of
food safety in general and in matters of food labeling in particular.  It also agrees that consistency in
the regulatory approaches is mutually beneficial.  Therefore, the Commission will bring this issue to
the attention of the European Parliament and of the Council as they are currently considering the
Proposal.G/SPS/GEN/337
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E. LABELING FOR PROCESSING AIDS - ENZYMES
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. "
Comment by Canada:
"Canada asks the EC what the scientific basis is for the inclusion of this type of product with
no detectable genetic material when other products such as cheese and wine made from GM enzymes
and other processing aids are excluded.  The exclusion of certain products from the labeling
requirements suggests that these requirements are not necessary. "
Comment by the Switzerland:
"The Swiss authorities have noted that according to the proposal processing aids derived
from GMOs do not have to be labelled even if they are passed on to the consumer as such.Switzerland believes that an informed choice of th e consumer wishing to purchase a processing aid
should be supported by adequate labeling. "
Comment by the United States:
"Please explain why processing aids, such as chymosin used in cheese and processing aids
available for wine production, are exempt from the labeling requirements.  Since the changes to EU
labeling policy laid out in this regulation are based on consumer opinion as noted the Explanatory
Memorandum, has the EU undertaken similar opi nion surveys to query consumers about this
distinction?  If yes, what were the results? "
Response of the European Commission:
As already indicated above in relation to authorization, enzymes are not excluded as such
from the scope of the proposed Regulation: where they remain in the final product, they are legally
qualified as ingredients and must be labelled accordingly..
The proposed Regulation thus maintains the current legal situation as far as the labeling of
enzymes is concerned.
However, the European Commission has already announced to the European Parliament that
it was currently considering bringing forward new and more comprehensive legislation in respect ofenzymes.  The labeling of enzymes used as processing aids will be reconsidered in this context.
F. L
ABELING : RISK OF FRAUD
Comment by Australia:
"Australia is concerned that there may be practical problems caused by the inability to detect
traces of novel DNA and/or protein in highly refined foods, opening the way for fraud and difficulties
in enforcing compliance.  How does the EC intend to address these issues? "G/SPS/GEN/337
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Comment by Canada:
"Canada is concerned that the proposed manda tory labeling requirements will apply to
highly refined products such as oils, where there is no detectable DNA or protein.  The inability to
verify labels through testing raises serious concerns about the effectiveness of the regulations and
increases the risk of fraud and misrepresentation of products.  How does the EC propose to enforce
compliance and control fraud? "
Comment by Switzerland:
"Switzerland is worried that a scheme asking for product labeling based exclusively on
information provided by documents accompanyi ng product ingredients along non-segregated food
chains, would be susceptible to fraud and error.  It has to be feared that mislabeling of products could
not be detected in many cases, which may damage th e credibility of the authorities in charge of food
safety control and subsequently the credibility of the labeling regime itself. "
Comment by the United States:
"This proposed regulation would expand mandatory labeling of biotech food and feed to
require the labeling of all food and feed products according to the biotech content of each ingredientwhether or not those ingredients are detectable in the end product and even when test methods do not
exist to confirm their presence.  In these cases it will be impossible to verify, by testing, a claim that
product ingredients are non-biotech.  The United States is greatly concerned that this regulation will,
therefore, invite fraud and a further weakening of consumer confidence in EU food safety delivery
systems. "
Response of the European Commission:
The European Commission would certainly acknowledge that enforcement of labeling
provisions is more difficult when it is not possible to verify the truthfulness of claims through
analytical methods.
This, however, is hardly a new problem and certainly not one that cannot be solved.  The
same can be said of "origin labeling", "organic labeling" and a host of other labeling situations where
the characteristic which is being labelled, irrespective of whether labeling of the said characteristic is
required or offered voluntarily, is one that cannot be controlled through analytical methods.  In all
such cases, the truthfulness of claims is normally controlled by the accompanying certification anddocumentation (i.e. traceability).
This is precisely why the European Commission has proposed that the traceability of GM
food and feed become mandatory, through the production and distribution chain (see the Proposal
notified under G/TBT/N/EEC /7 and G/SPS/N/EEC/150).
There is no objective grounds, none at all, for claiming that GM labeling, backed by
compulsory traceability of GM ingredients, would "invite fraud" any more than, say, origin labeling,
where it is mandatory and backed by compulsory traceability.
It is worth noting that the Commission has received positive comments on the feasibility of
the proposed labeling system. For example, EuroCommerce , the Retail, Wholesale and International
Trade Representation to the EU, stated that:G/SPS/GEN/337
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"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 contractualassurances or paper documentation and supplier audits, even though in theory, they
could even be held liable for an erroneous labeling of products.  Therefore, already
today, 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).
G. GM-
FREE LABELING
Comment by Canada:
"It appears that consumer inform ation is the primary objective of the labeling requirements.
Canada believes that if consumers demand non-health  and safety related information on approved
GM food or feed, market pressures will lead producers to respond.  Therefore, a better and less traderestrictive approach is a voluntary scheme which wo uld appear sufficient to provide consumers with a
"choice."  As the Commission is aware, Canada is developing a voluntary standard for the labeling of
foods derived from gene technology.  This voluntar y standard will provide a clear basis for the market
to respond, as appropriate, to consumer demands. "
"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 trade
restrictive.  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 South Africa:
"South Africa is of the opinion that the choice that consumers want, are between:  (a) 'Foods
that contain or are derived from genetically modified organisms' versus (b) 'Foods that do not containor are not obtained from genetically modified organisms'.  A situation where an increasing quantity of
foods could contain or are derived from genetically modified organisms, as a future scenario, should
be kept in mind.  This would result in a decreasing choice for those consumers that prefer (b).
Therefore, establishing a system to provide a food  chain for NON-Genetically Modified Foods, having
as little adventitious commingling with GMOs, is essential.  Paper trailing complemented withlaboratory analysis of samples taken in a statistically acceptable method seems to be a way of
verifying claims, although deficiencies of such a syst em would have to be acknowledged.  South Africa
therefore, regards labeling of all foods that contain or are derived from genetically modified
organisms as a short-sighted approach."
Comment by Switzerland:
"Switzerland regrets that the EU Commission proposa l does not include a legal basis for labeling of
foodstuffs which have been produced without the use of genetic engineering.  Many consumers wish to
purchase foodstuffs that have been produced without the use of genetically modified organisms at anystage of the production process.  This includ es for example the use of GMO derived animal
feedingstuffs in the production of meat, eggs, dairy products, etc.  Due to the absence of a respectiveG/SPS/GEN/337
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Page 25
legal basis the Swiss authorities are concerned that "GM-free" labels, which may not be true and
therefore misleading to the consumer, might be tole rated and used in EU countries.  In Switzerland,
"GM-free" labels are unlawful (if printed in French, German or Italian), as the complete absence of
GMO-derived material in foodstuffs cannot be guar anteed, a fact that is documented by the proposal
for a threshold value.  Switzerland would thus we lcome a EU-wide regulation of "negative" labeling
relating to the non-use of GE technologies in the production of the particular foodstuff.  Therefore,
Switzerland proposes that a negative label refer to the fact that the foodstuff has been produced
without the application / use of genetic engineering at any stage of the production process.  (For such
a negative label, Switzerland proposes the wording "ohne Gentechnik hergestellt", "produit sans
recours au génie génétique", and "ottenuto senza ricorso alla tecnologia genetica", respectively.).
In this context the Swiss authorities would like to obtain further information on what the EU
rules on these "negative declarations" will be.  Of particular interest is also the question whether
products carrying a "negative" declaration as outlined above can still be placed on the EU markets. "
Comment by the United States:
"The proposal indicates the objective of the "c omprehensive" labeling requirements are to
respond to an overwhelming need for consumers to make individual choices, thereby fostering
increased public confidence and acceptance of products of biotechnology.  If consumer choice is truly
the objective of the proposal, the United States would argue that a more crucial element would be togive guidance as to what would constitute a food  that has not been produced through biotechnology.
Would it not be more informative to publish guidan ce or impose requirements that would assure that
products labelled, "non-GMO" are in fact, non-biotech? "
Response of the European Commission:
In preparation of its Proposal, the 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 voluntar y "GMO-free" (or similarly phrased) scheme.
The Commission's preparatory work, including e xperiences 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 be came evident that  consumers in the European
Community 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 and
not non-irradiated.  European Community legislation allows for "Free of" labeling claims providedthe claim is truthful and not misleading. "GMO-fr ee" 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.
H. L
ABELING THRESHOLD  
Comment by Canada:
"In addition, the proposed regulations reference a 1% threshold for the adventitious or
technically unavoidable presence of approved GMOs.  Is labeling and traceability required for thosesituations where the presence of GMOs is inten tional, but less than 1%?  Can the EC clarify what
would be considered "appropriate steps" to avoi ding adventitious GMOs, as outlined in paragraph 24
of the Authorization and Labeling Regulation. "G/SPS/GEN/337
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"Given that modern, competitive grain handli ng systems are designed to pool grains and
oilseeds in farm storage, country grain elevators, railway cars, and export bulk shipments - a
tolerance level of 1% could be expected to be a serious impediment to trade. "
Response of the European Commission:
Canada appears to have misunderstood the operation of the 1% thresholds as these relate to
the adventitious or technically unavoidable presence of unauthorized GM-material (Articles 5, 18 and
42) which have been found not to present a risk for human health or the environment under ascientific assessment carried out by the relevant European Community scientific body.
The proposed labeling thresholds in Articles 13(2) and 26(2) are for the combined
adventitious presence of both authorised and unauthorised material, but no figure is specified.
Labeling and traceability would indeed be required whenever the presence of GMOs or GM-
material is intentional.
The comment that a tolerance level of 1% could be expected to be a serious impediment to
trade is difficult to understand.  If it refers to the tolerance for the adventitious presence of
unauthorised material, certainly 1% is better than 0% which is the current situation in the EuropeanUnion and, indeed, in most countries including Canada.  If it refers to the labeling threshold for the
combined presence of authorised and unauthorised material (for which no figure is specified in the
proposed Regulation), it is difficult to understand how this can be a serious impediment to trade, as
products would be allowed to the market provided that they are appropriately labelled.
I. T
HRESHOLD FOR AUTHORISED AND UNAUTHORISED MATERIAL
Comment by Switzerland:
"Adventitious traces (below 1%) of GMOs in products are suggested to be exempted from the
labeling requirement.  Switzerland supports this tolerance level and believes it to be necessary.
However, this provision also includes non authorised GMO varieties.  Will there be a possibility for
third parties to obtain information on whether a risk assessment for an unauthorised GMO has beencarried out? "
"Starting from the idea that the overall goal of the labeling provisions is consumer information,
Switzerland feels that there is a certain incoheren ce between the requirement to label food that is
produced from GMOs but does not contain GMOs and the exemption of products containing GMOs in
an amount below the tolerance level of 1% from the labeling requirement. "
Response of the European Commission:
The proposed Regulation foresees that the labeling thresholds (Article 13 and 26), which
concern the adventitious or technically unavoidable presence of authorised or unauthorised genetically
modified material, would be laid down by the European Commission through the standard
(comitology) procedures.  The regime currently applicable in the European Community, where the
labeling threshold is in force under Regulation (EC) 49/2000, only concerns authorised GM material
and is indeed fixed at 1%.  However, once a level will have been set in accordance with theestablished procedures, this will be published and third parties will have access to this information.G/SPS/GEN/337
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The Commission does not see any inconsistency in its labeling approach.  Foods and feeds
intentionally produced from GMOs or containing ingredients intentionally produced from GMOs are
not exempted and will have to be labelled.  However, in order for the system to be feasible and
operational, the problem of adventitious presence had to be addressed and this is why the Commissionhas foreseen the adoption of a tolerance level for the labeling of such adventitious presence.  In other
terms, compliance with the set threshold will no t be sufficient for exemption from the labeling
requirement.  Operators will also have to supply evidence that they have taken appropriate steps to
avoid the use of GMOs or products thereof (see articles 13 and 26)
J. E
THICAL OR RELIGIOUS CONCERNS
Comment by Australia:
"Australia seeks clarification of the requirement for labeling to inform of "any characteristic
or property which gives rise to ethical or religious concern "."
"What does the EC regard as an ethical or reli gious concern?  Furthermore, in the EC's view,
what is the relevance of such concerns for TBT provisions?  Without such clarification, Australia is
concerned about the potential for free interpretation and further barriers to trade particularly if
similar requirements are not also extended to conventional foods. "
Comment by Canada:
"We would further note that the inclusion of non-science based factors, such as ethical and
religious concerns, without adequate definitions, is of particular concern to Canada. "
Comment by the United States:
"Articles 6.3(g) and 19.3 (g) call for the applicant to provide either a reasoned statement that
the food or feed, respectively, "... does not give rise to ethical or religious concerns, or a proposal for
labeling it...".  Who determines what the ethical or religious concerns are?  These vague requirements
give no guidance to food or feed manufacturers regarding what those concerns, which will vary
exceedingly from one consumer to the next in a multi-cultural society like the EU, might be.  By what
standards are potential ethical or religious concerns weighed?  Such concerns, if used for regulatorydecision making, should be detailed in the proposed regulation so that comments can be provided and
to facilitate compliance. "
"Please clarify how the additional labeling requirements for undefined ethical and religious
issues in Article 14.2 will inform a consumer that ma y prefer to avoid a biotech derived product.  Why
are these issues specific to foods produced through biotechnology and not foods produced through
other means?  Is this information also required for conventional products?  If not, why not?"  "Who
determines when a biotech food "may give rise to ethical or religious concerns" as foreseen in
Articles 14.2 (b) and 27.3 (c)?  Who determines what additional labeling requirements will be and on
what basis?  Clarification of these questions shou ld be made explicit in the proposed regulation to
afford a meaningful opportunity for comment and to provide information to U.S. exporters on the
specific requirements. "
Response of the European Commission:
The requirement that the labeling should contain appropriate information where a GM food
may give rise to ethical concerns was also used in Regulation (EC) No 258/97, where its application
does not seem to have raised any concerns.  A similar requirement is thus applicable to novel foodsG/SPS/GEN/337
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Page 28
produced through other means than biotechnology, to signal the presence of material which is not
present in an existing equivalent foodstuff and thus may give rise to ethical concerns.
The proposed Regulation adds "religious" concerns to the "ethical" concerns already
mentioned in Regulation (EC) No 258/97.  This is specifically meant to address the situation where a
gene from a bovine animal or from a pig would have been transferred into another animal species, as
this may give rise to concerns for the followers of some religions.
Under the proposed Regulation, it would be for the applicant to indicate, at the time of
application, either that the food does not give rise to ethical or religious concerns, or, on the contrary,
how it is proposed to address through labeling any ethical or religious concerns that may have beenidentified.  The European Food Safety Authority will not consider this matter in the opinion it is to
submit to the Commission, as ethical and religious concerns should not be considered in the context of
the risk assessment of the food.  It will theref ore be for the European Commission, when it shall
consider other legitimate factors, to determine whether the proposal made by the applicant is
acceptable or not in this respect.
Detailed rules for the implementation of these provisions can be adopted through the standard
procedures applicable in such cases (see Articles 15 and 28 of the proposed Regulation).
K. R
ISK OF UNEVEN APPLICATION OF LABELING REQUIREMENTS
Comment by the United States:
"The U.S. understands that operators will be required to demonstrate that they have taken
appropriate steps to avoid the adventitious presence of biotech material.  Given difficulties
encountered with the implementation of similar do cumentation requirements in other circumstances
in the EU (such as in the case of organic products), the United States is concerned about the potential
for uneven application and enforcement of this requirement across member States or even local
governments.  For example, in the case of organic products, the absence of a harmonized EU
procedure for issuing import authorizations and th e lack of EU-wide oversight of the approval and
enforcement process has resulted in varying member State procedures, policies, and approval rates
causing a great deal of uncertainty and administrative burden on organic exporters and certifers,
thereby blocking trade. "
Response of the European Commission:
The obligation for operators to demonstrate that they have taken appropriate steps to avoid the
adventitious presence of GM material is already in force in the European Community, under
Regulation (EC) No 1139/98, as amended by Regulation (EC) No 49/2000, and does appear to haveresulted in uneven application and enforcement.
Furthermore, the Proposal foresees the poss ibility to adopt detailed rules for the
implementation of the labeling provisions  (see Articles 15 and 28), and this should allow to deal with
difficulties in enforcement, should they occur.
L. L
INKAGE TO BIOSAFETY PROTOCOL
Comment by Australia:
"Noting that the Biosafety Protocol does not provide any linkage to domestic labeling
regimes, Australia would appreciate advice as to how the proposed regulations contained inG/SPS/GEN/337
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Notification G/TBT/N/EEC/6 takes account of the re quirements of the Protocol "as regards importer
obligations and notification "."
Response of the European Commission:
The proposed Regulation has taken into account Article 11.4 of the Biosafety Protocol which
determines that " a Party may take a decision on the import of living modified organisms intended for
direct use as food or feed or processing under its domestic regulatory framework that is consistent
with the objective of this Protocol".
As regards labeling, the Biosafety Protocol covers the issue of advanced information
agreement between parties to protect biological diversity, but does not address labeling of products
containing or produced from GMOs or LMOs for the purpose of informing the consumer or
facilitating consumer choice.
This matter is being given further consideration in the European Commission response to
comments submitted by WTO Members under eith er or both G/TBT/EEC /7 and G/SPS/N/EEC/150.2
M. GM FEED - AUTHORISATION AND LABELING
Comment by the 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). "
Response of the European Commission:
The European Commission would like to stress that the fact that the current proposals do not
include products derived from animals fed with GM Os, does not imply that GM feed should not be
regulated. The objective of the proposed Regulation in this field is not only a high level of protection
of human health, covering the entire food chain, but also the protection of animal health and of the
environment.
As part of the framework to improve and bring coherence to Community legislation from
"farm to table", the Commission already highlighted in the White Paper on Food Safety of
12 January 2000 the need for legislation for the eval uation, authorisation and labeling of novel feed,
in particular GM feed.
In other words, no feed shall be placed on the market or fed to animals if it is considered to
have an adverse effect on human, animal health or the environment.
Also, experience has shown that authorisation should not be granted for a single use when a
product is likely to be used both for food and feed purposes: such products should fulfil theauthorisation criteria specific to food and feed.
As regards labeling of GM feed, the EU policy is basically to provide the users (farmers,
breeders, etc.) with accurate information on the products enabling them to make a free choice.
                                                     
2 See footnote 1 above.G/SPS/GEN/337
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The European Commission believes that the proposed requirements will enhance
transparency and safety throughout the feed chain, contributing also to restore users and consumer
confidence in the application of gene technology in the agro-food sector.
N. GM FEED LABELING – UNIQUE CODES
Comment by the United States:
"Please clarify the requirements of Article 27 of EEC/6 on genetically modified food and feed
and Articles 4 and 5 of EEC/7 on traceability and labeling.  Article 27 appears to require the
operator to carry all relevant unique codes for feed on the accompanying document, packaging,
container, or label throughout the entire labeli ng system.  Whereas, for products that include
ingredients produced from biotech events, Article 5 requires the operator to transmit information on
which ingredients are biotech derived to the recipient of the product, although the unique codes do
not need to be transmitted. "
Response of the European Commission:
The requirement laid down in Article 27(3)(b) of the proposed Regulation applies only to feed
containing or consisting of GMOs and not to feed produced from GMOs, due to the fact that the
unique codes do not need to be transmitted for feed produced from GMOs according to the proposal
on traceability and labeling (G/TBT/N/EEC/7 and G/SPS/N/EEC/150).
Just as in the basic Community legislation in the field of feed labeling and in accordance with
the proposal on traceability and labeling, the provisions of Article 27 of the proposal on genetically
modified food and feed concerns each stage of placing on the market.  This implies that the particulars
may be mentioned on an accompanying document, as there is not always a label attached to theproduct.
This is also in line with Article 4(2) last indent of the proposal on traceability and labeling, as
the unique codes for all the GMOs potentially present in the feed have to be declared (for example on
an accompanying document) at the time of the transmi ssion of the product to the subsequent operator.
V. MISCELLANEOUS
A. L
ACK OF ADDITIONAL GUIDANCE
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 the United States:
"Finally, the United States would note that there are a number of areas which lack sufficient
detail and/or for which additional guidance is possible or explicitly foreseen in the proposal.  The
absence of such information in the proposed regulation itself limits our ability to provide meaningful
comment on a number of aspects at this juncture. "
"Articles 4.5 and 17.5 state that authorization is based on procedures set out in this proposed
regulation.  However, the proposal itself identifies a number of areas where additional guidance andG/SPS/GEN/337
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criteria will be developed.  The United States looks forward to commenting on these procedures when
they are completed. "
"The final provisions of Articles 6 and 19 indicate the Commission "may establish"
implementing rules for the application of those Articles; and, the EFA "shall publish" detailedguidance concerning the preparation and the presentation of the application.  The United States looks
forward to the opportunity to comment on these proposals as they are developed. "
"Articles 7.8 and 20.8 state that "before the entry into application of this Regulation, the
Commission shall publish a recommendation on the nature of the risk assessment to be undertaken by
the Authority for the purpose of preparing its opinion."  The United States believe this
recommendation should be published in the proposed regulation to afford a meaningful opportunity
for comment and we look forward to commenting as it is developed. "
"Article 12.5 (Renewal of food authorizations ) indicates the implem enting rules for the
application of this Article shall be established by the Commission, and 12.6 indicates the EFA will
publish detailed guidance concerning the preparation and presentation of the application (with
parallel provisions for feed).  The United States looks forward to the opportunity to comment on these
proposals as they are developed. "
"Articles 15 and 28 indicate implementing measures containing detailed rules for labeling
requirements may be adopted to address food safety concerns.  The United States looks forward to the
opportunity to provide comment on these proposals as they are developed. "
Response of the European Commission:
The EC Treaty provides, in Article 202, that in the instruments which it adopts, the Council
has to confer on the Commission powers for the impl ementation of the rules which the Council lays
down.  The implementing powers conferred on the Commission under the proposed Regulation are in
conformity with that principle.
Where appropriate, the measures adopted by the Commission under these implementing
powers are notified under the TBT and/or the SPS Agreements.
Recommendations from the European Commission and detailed guidance to be published by
the European Food Safety Authority are of a non-binding character and would normally not be
notified under the TBT and/or the SPS Agreements.
B. EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES
Comment by the United States:
"Article 34 states that the Commission or me mber States can consult the European Group on
Ethics in Science and New Technologies.  There is no time limit given for this group to deliver anopinion.  The United States is concerned that this group could delay or block the approval of a
product by not issuing timely opinions.  An anticipated time frame for the delivery of its opinion
should be published in the proposed regulation, along with procedures for addressing situations
where an opinion of this Group is not forthcoming.  How will consultations be conducted?  Will they
involve all interested parties? Under what circ umstances would such consultations take place? "
Response of the European Commission:
The United States seems to have misunderstood the role of the European Group on Ethics in
Science and New Technologies.  It is not foreseen, in the proposed Regulation, that the Group onEthics will be consulted on individual applications for authorization.G/SPS/GEN/337
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This of course, does not mean that the Commission may not, on its own initiative or at the
request of a member State, consult the Group on Ethics before reaching a specific decision.  As has
been indicated above, the Commission will not receive advise from the European Food Safety
Authority on the ethical concerns that a particular application may give rise to.  In such case, theCommission may therefore wish to obtain the advice of the Group on Ethics on the matter. In such
case, an opinion would be sought in time for the Commission to prepare its draft decision within the
three-months deadline, but in exceptionally complex cases this deadline would be extended.
C. R
EGISTER OF AUTHORISED GM FOODS AND FEEDS
Comment by the United States:
"Article 30 proposes the establishment of a register of "authorized genetically modified foods
and feeds." Could the text of the regulation, rather than the Explanatory Memorandum, please clarify
whether, if an event is approved, all food and feed derivatives will automatically be included in the
registry?  Which DG will be responsible for maintaining the registry?  Will it be available to the
public and if so, where?  The United States looks forward to commenting on this information. "
Response of the European Commission:
Entries in the Register will reflect the scope of the decision, which will itself depend on the
scope of the application.  Thus where authorization will have been requested for and granted in
respect of a GMO and foods produced from or containing ingredients produced from that GMO, thiswill be specified in the Register.
It is an internal matter for the Commission to decide which of its services is responsible for
carrying tasks assigned to it by European Community legislation.
The Register shall be made available to the public, as expressly laid down in Article 30(2),
presumably through on-line electronic access.
The European Commission has noted that the United States intends to comment on this
information, although this is not information on which the European Commission would normally
expect comments from third countries.
D. E
MERGENCY MEASURES : CRITERIA – ROLE OF EFSA
Comment by the United States:
"What criteria are required for adopting emergency measures under Article 35 (Emergency
Measures)? What is the role of the EFA in evaluating such information and the merits of takingemergency action?  Please clarify the criteria which will underpin such emergency decisions and the
role of the EFA in the proposed regulation. "
Response of the European Commission:
Emergency measures may be adopted where it is  evident that the use of a food or a feed
authorised in accordance with the proposed Regulation is likely to constitute a serious risk to human
health, animal health or the environment.  The European Food Safety Authority may be consulted
before emergency measures are taken, but this is not a prerequisite for the adoption of such measures.G/SPS/GEN/337
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E. EMERGENCY MEASURES : INTERNATIONAL CO -OPERATION
Comment by  Switzerland:
"As regards possible threats to human healt h, animal health or the environment the
Commission suggests provisions for emergency measures.  Will there be any consultation,
collaboration or information exchange with the competent authorities in foreign countries? Will other
countries have the possibility to participate in the rapid alert system? "
Response of the European Commission:
Consultation, collaboration or information exchange with the competent authorities in foreign
countries in the context of emergency measures being considered or adopted within the Community is
not foreseen under the proposed Regulation.  However, the proposed Regulation does certainly not
preclude international co-operation where the circumstances of a case makes this useful.
Under Article 50 of Regulation (EC) No 178/2002, participation in the rapid alert system may
be opened up to third countries on the basis of agreements between the Community and thosecountries and in accordance with the procedures defined in those agreements, which must be based on
reciprocity and must include confidentiality measures equivalent to those applicable in the
Community.
F. M
ONITORING AND CONTROL : INTERNATIONAL COLLABORATION
Comment by the Switzerland:
"With respect to implementation, monitoring and control does the Commission's proposal
provide for any collaboration with foreign laboratories? Will foreign test results be accepted and if so
what are the modalities for their acceptance? "
Response of the European Commission:
The proposed Regulation does not require that tests be carried out and, therefore, does not
deal with the issue of modalities for the acceptance of foreign tests.
Implementation of the Regulation, monitoring and control will be the responsibility of
member States and their control authorities.  Monitoring and control will be carried out on
Community territory and therefore there was no need for the Proposal to foresee  provisions  for
collaboration with foreign authorities/laboratories.  This does not exclude technical collaboration
between the European Community and foreign laboratories.  The European Community has been
soliciting co-operation with other countries on the development of reliable detection and identificationmethods.
G. S
TANDARDIZED TESTING METHODOLOGIES
Comment by the United States:
"Article 44 allows each member State to establish rules for penalties on infringement.  In the
absence of available, accessible and standardized testing methodology, the United States is concerned
that the member States, who will be responsible for enforcing the legislation, will not be able to do so
consistently, raising uncertainty for operators throughout the chain. "G/SPS/GEN/337
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Response of the European Commission:
The proposed Regulation does provide for available, accessible and standardized methods.
Indeed, under the proposed Regulation, no GM food or feed will be placed on the market in theEuropean Union without a valid authorization first being granted by the Community and no
authorization will be granted by the Community unless a method for detection, including sampling
and identification of the transformation event has been tested and validated by the Community
reference laboratory. As indicated, these methods will form part of the authorizations granted and will
be made available in the Register.
__________