Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed" (COM(2001) 425 final — 2001/0173 (COD))
Date: 2002-05-30
Institutions: European Economic and Social Committee
Subjects: animal nutrition, consumer information, genetically modified organism, health policy, human nutrition, labelling, new product

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Opinion of the Economic and Social Committee on the ‘Proposal for a Regulation of the European
Parliament and of the Council on genetically modified food and feed’

(COM(2001) 425 final — 2001/0173 (COD))

(2002/C 221/22)

On 2 October 2001, the Council decided to consult the Economic and Social Committee, under Article
95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 6 May 2002. The rapporteur was
Ms Thomas.

At its 391st plenary session on 29 and 30 May 2002 (meeting of 30 May), the Economic and Social
Committee adopted the following opinion by 53 votes to 40, with four abstentions.

1.

Introduction

1.1.
The Commission proposal aims to establish a frame-
work to provide improved, harmonised, uniform and trans-
parent procedures for the safety assessment of genetically
modified (GM) food and GM animal feed. Its main objectives
are (i) to protect human and animal health (ii) to lay down
Community procedures for the regulation of GM food and
feed and (iii) to provide for the labelling of GM food and feed
to allow the consumer to have a genuine choice.

The Commission proposal covers GMOs used as food
1.2.
or feed or food or feed containing, consisting of or produced
from GMOs, or containing ingredients produced from GMOs
(Articles 3 and 16). Products ‘produced from a GMO’ involves
those products in which a proportion of the end product has
been derived from the original GM material. These would be
covered by the proposed regulation. Those products which
have been produced with the assistance of a GM organism but
where no material derived from the organism is present in the
end product termed products ‘produced with a GMO’ would
not be covered. This is in line with the current provisions of
the Novel Foods Regulation.

The current authorisation procedure for GM foods is
1.4.
set out in Regulation (EC) No. 258/97 on novel foods and
novel food ingredients (1). Feed containing GMOs have so far
been authorised in accordance with Directive 90/220/EEC (2).
There is no authorisation procedure for GM feed.

1.5.
The authorisation granted in accordance with the
established procedure is to be valid throughout the Community
for a period of ten years and will be renewable.

2. Labelling

2.1.
The proposal extends the current labelling provisions
to all GM food regardless of whether DNA or protein can be
detected. All food and feed products which are subject to
authorisation under the proposed regulation would be subject
to mandatory labelling. Thus a number of foodstuffs which
are not currently required to be labelled such as highly refined
oils derived from GM crops, will be required to be labelled.
Similarly, several animal feeds, currently unlabelled, would
have to be labelled.

1.3.
The proposal enables a single application to be filed to
obtain both the authorisation for the deliberate release of a
GMO into the environment and for authorisation for the use
of this GMO in food or feed.

(1) See Opinion of the Economic and Social Committee on the
Proposal for a Council Regulation (EEC) on novel foods and novel
food ingredients, OJ C 108, 19.4.1993 p. 8.

(2) See Opinion of the Economic and Social Committee on the
Proposal
for a European Parliament and Council Directive
amending Directive 90/220/EEC on the deliberate release into the
environment of genetically modified organisms, OJ C 407,
28.12.1998, p. 1.

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3.

Implementation

3.1.
GM material may be present in minute amounts in
non-GM food and feed as a result of adventitious or technically
unavoidable contamination. In these cases, food or feed would
not be subject to the labelling requirements of the proposed
regulation. It is proposed to establish a threshold of 1 % for
minute traces of GM materials. Food or feed containing less
than this amount would not need to be labelled.

3.2.
Applicants are required to provide a method for
detection, including sampling and identification of the trans-
formation event for the purpose of ensuring enforceability.

3.3.
It is proposed to establish a Community Reference
Laboratory to test and validate the proposed methods for
sampling and detection to provide the means for a harmonious
approach for control across the Community.

The Member States are required to introduce effective
3.4.
penalties for infringements of the provisions of this Regulation
(Article 44).

4. General comments

4.1.
The proposal for a Regulation of the European Parlia-
ment and of the Council on genetically modified food and feed
examined in this opinion should be seen in a wider social
context. The continuing moratorium on authorisation for the
placing on the market of new GMOs in Europe seems set to
end. Agriculture in Europe is on the threshold of a new era in
which widespread use will be made of genetically modified
products.

animal. The second concerns the use of genetically modified
enzymes, vitamins, additives, etc. produced in closed con-
ditions in the processing of agricultural raw materials. The
EESC feels it is important that the Commission also adopts
this distinction.

4.5.
It is also clear in the light of the recently published
European Environment Agency report on gene transfer from
GM plants (1) that consumers want to be given clear infor-
mation not only about products, but also about the product
chain.

4.6.
The European Economic and Social Committee
acknowledges the initiative made by the Commission in
combining the Proposal for a regulation of the European
Parliament and of the Council on traceability and labelling of
genetically modified organisms and traceability of food and
feed products produced from genetically modified organisms
and amending Directive 2001/18/EC (2) and the Proposal for a
Regulation of the European Parliament and of the Council on
genetically modified food and feed. The Committee especially
welcomes the ‘one door — one key’ procedure which should
reinforce both safety and consumer confidence. The EESC
accepts that the current Community legislation on GMOs
needs to be extended to animal feed and that there needs to be
a specific evaluation of genetic modification relating to
substances such as food additives, flavourings or feed additives,
where they have been produced from GMOs. The EESC is
concerned that the two proposals in question only apply to
products produced from GMOs, but not to products produced
with a GMO, thus excluding certain important links in the
food chain from the scope of the proposed regulations. It also
urges the Commission to support consumer information
campaigns to highlight the possible advantages and risks of
GMOs, so as to enable people to make more informed choices.

4.2.
The Committee sees it as a major failing that this
period of moratorium has not been used as an opportunity for
a structured debate encompassing the whole of society on the
pros and cons of employing genetic engineering in agriculture.

4.6.1.
The Committee notes that some parts of the proposal
are complex and could give rise to misinterpretations, e.g. in
It thus
the cases of Recital 15 and Articles 3 and 16.
recommends that the Commission further clarifies and simpli-
fies concepts such as those referred to in Article 2(3) and (6).

4.3.
There are widely differing views on genetic engineering
within society. However, it is fair to say that arguments vary
considerably according to the context. A clear distinction is
made between ‘red genetic engineering’ (the use of genetically
engineered products in medicine) and ‘green genetic engineer-
ing’ (the use of genetically engineered products in agriculture
and the food industry).

4.4.
There are also two distinctive aspects to the debate on
green genetic engineering. The first concerns the deployment
of genetically modified organisms in the open countryside (i.e.
not within closed conditions) and the use of these by man and

(1) Genetically modified organisms (GMO): The significance of gene
flow through pollen transfer, Environmental issue report No 28
of the European Environment Agency.

(2) See Opinion of the European Economic and Social Committee on
the Proposal for a Regulation of the European Parliament and of
the Council concerning traceability and labelling of genetically
modified organisms and traceability of food and feed products
produced from genetically modified organisms and amending
Directive 2001/18/EC, adopted on 21 March 2002.

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4.7.
The Commission’s proposal on GMOs comes at a time
when consumer confidence in safety has been undermined by
a series of food scares. Inevitable feelings of uncertainty about
new and unfamiliar products are played upon by the mass
media and doubts have arisen about the rigour of safety tests
meant to assess risks to human health. Moreover, there is an
increasing distrust of government departments, politicians,
journalists — and even of scientists, which was to some extent
compounded by the slowness to react in the BSE crisis. The
Committee therefore stresses the importance of effective
deployment of the European Food Authority so as to ensure
an adequate level of food safety. Also, clear, understandable,
accurate and informative classification and labelling has the
potential to make an important contribution to dispelling such
doubts. The Eurobarometer data provides strong evidence that
consumers want
to be able easily to identify food that
contains GM materials or which has been produced using GM
substances. Only on the basis of labelling can a consumer’s
right to choose be ensured.

4.8.
The rationale in the proposal for labelling food and
feed products which do not contain any GM materials but
which have been produced from GMOs needs to be explained
more clearly. The Committee notes that such products will
have already been subject to rigorous safety tests with regard
to human health (including allergenicity). If the purpose of
labelling these products is to inform the consumer that such
products, while containing no GM materials, nevertheless
originate from GM crops, and thereby provide him or her with
more choice, this should be explicitly set out. The EESC regards
this in principle as an important advance. However, it will be
difficult to explain to consumers why products such as highly
refined oils derived from GM crops have to be labelled (even if
the modified DNA sequence is not detectable), while animal
products derived from animals fed on GM feeds do not. The
Committee considers that, in order to ensure complete freedom
of choice for the consumer, it is vital to define in the clearest
and most transparent way possible the rules for labelling GM
products, including food and feed derived from GM crops or
products produced with a GMO whether or not containing
protein or genetic material detectable from analysis.

Nevertheless, the Commission proposes to provide consumers
with information which will enable them to make their own
decisions. The Committee welcomes this wholeheartedly.
However, if for example animal products involving GM feed
are not covered by the labelling regulations, consumers will be
deprived of the freedom to choose all the way along the
‘animal product’ production chain; they will be unable to
determine whether or not genetic engineering has been
involved in the manufacture of the products they buy.

4.10.
Food and feed products which have been derived
from GM materials but which do not contain any transgenic
materials (i.e. DNA and/or protein) might encourage illegal
practices and fraud. The Committee is concerned that reliance
on documentation for authenticity may not be sufficient to
avoid fraud. Some products derived from GM crops such as
highly refined oils will be identical in composition to non-GM
products. The labelling and detection procedures set out in the
proposed regulation do not make clear how enforcement will
deal with fraud. The Committee thinks that, in order to be able
to resolve these problems and safely follow all GM products
throughout the food chain, an effective system of traceability
must be better defined.

4.10.1.
The Committee welcomes the fact that the proposed
Regulation is also to apply to imports from non-EU countries.
Effective measures must, however, be taken to ensure that
imported products meet the same conditions. In order to
guarantee fair competition between the EU and non-EU
countries, there must be reliable and effective controls and
labelling systems, particularly in the case of imported products.
The Committee suggests that a set of standards should be
laid down for cases of accidental contamination below the
established threshold for GM products authorised in non EU
countries but not authorised in the EU.

4.11.
There have been concerns that the proposed regu-
lead to increased costs to the consumer. The
lation will
Committee accepts that the new labelling requirements will
impose costs on the final product and that the resulting
consumer benefits are broadly supported by the general public
as evidenced by for example, the Eurobarometer survey (1)
conducted in 2001. However, the Committee suggests that the
Commission undertake a regulatory impact assessment to
ascertain the costs of traceability, segregation and labelling.

4.9.
The EESC calls on the Commission to give further
thought to the rationale behind the draft proposal. The issue
of employing genetic engineering is decided on the basis that
only products which in no way harm the environment or
consumer health may be authorized and used. This would
mean that the consumer could have ‘blind trust’ in all products.

(1) Eurobarometer 55.2 ‘Europeans, Science and Technology’,

December 2001, European Commission, DG Research.

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4.12.
The EESC regards it as a fundamental failing that GM
plants are to be authorized in the absence of any clear liability
regulations. It is already possible to foresee that complaints
will be brought before the courts. For example, the transfer of
GM pollen to fields cultivated in accordance with the EU
Regulation on organic farming will mean that the farmer
concerned will no longer be able to market his produce as
‘organic’ because it will show up (transferred) GM components.
This will obviously cause him some financial loss which no-
one can be held liable for in the absence of any clear
regulations. The EESC considers it unacceptable that there are
no clear regulations on liability.

human and animal health and welfare in addition to con-
sumers’ interests (Article 1). However, the proposal is con-
cerned with authorisation for use and consumption and with
labelling of products which will have already been rigorously
evaluated for health and environmental risks. The new regu-
lations will enhance transparency by promoting the labelling
of GM foodstuffs in the food chain and will promote consumer
choice. The extension of regulatory controls to animal feed is
particularly welcomed.

5. Specific comments

5.1.
The Committee accepts that there is a need to set a
reasonable threshold for the level of minute traces of adven-
titious GM materials in conventionally grown foodstuffs (i.e.
non-GM). It further accepts that a level of 1 % is at present in
line both with the threshold for other substances and with
what is technically feasible (Article 5 and Article 18). Neverthe-
less, the situation should regularly be reviewed as methods of
detection improve, so that limits can be set close to the
threshold of detectability.

5.2.
As regards the definition and introduction of thresh-
olds of contamination for food and feed, the Committee thinks
there should be a standard method of analysis recognised at
level as a reference. The Committee
EU and international
therefore welcomes the Commission’s proposal to establish a
Central Reference Laboratory for the purpose of testing and
validating the proposed methods for sampling and detection.
It takes the view that effective implementation and manage-
ment of the proposed labelling and traceability of GM food-
stuffs will depend on an efficient and harmonised approach
across the community (Article 33).

6. Conclusion

6.2.
However, the EESC considers that the labelling of GM
products should be extended to all foods and animal feed that
have been produced with GMOs, that is those products which
have been manufactured with GM food processing aids such
as enzymes as well as non-GM enzymes which have been
produced from GM micro-organisms. This extension will
enable consumers to be fully aware of the application of
genetic engineering throughout the food product chain and
enable them to make a more informed choice.

6.3.
The EESC welcomes the proposal to label as GM those
food and feed products which have adventitious content of
GM materials of 1 % or more. It recommends that a set of
standards be developed for application to those imported GM
products which are approved in their country of origin but
not in the EU. The EESC takes the view that products where
the proportion of GMOs has not exceeded 1 % throughout the
production chain will in future be regarded by many con-
sumers as being ‘quality products’, on a par with certain
regional products, free-range eggs or organic produce, for
example.

6.4.
The Committee also recommends that the rationale for
the labelling of foodstuffs derived from GM products but
which do not contain any GM materials be clearly laid out. If
the main reason for labelling these foodstuffs is to increase the
social and political acceptability of foods derived from GM
crops, then this should be clearly stated. The introduction of
labelling could be enhanced by a parallel initiative to explain
the distinction of foods made ‘with’ GMOs from foods made
‘from’ GMOs to consumers.

The European Economic and Social Committee broadly
6.1.
welcomes the initiative introduced by the Commission to
clarify and extend the current regulatory framework. GM crops
are being widely grown in parts of the world, namely the US,
China and Argentina. In Europe, where there is a moratorium
on authorisation for the placing on the market of new GMOs,
the majority of citizens wish to avoid GM food. The Committee
notes that the primary objective of the proposal is to protect

6.5.
The Committee suggests that the proposed system is
evaluated for its vulnerability to fraud and the wider question
of enforcement addressed. This is particularly relevant to the
proposal to label those foodstuffs which are derived from GM
crops but which contain no detectable DNA or protein.

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6.5.1.
As is their right, consumers are demanding increas-
ingly strict food safety rules throughout the food chain. The
Committee takes the view that in order to rise to the challenge
of consumer demands, European industry has a vital role to
play, guaranteeing the marketing of safe, high-quality products

and promoting research and proper evaluation methods.
European industries, being subject to strict controls, have to
supply accurate, transparent and full information: in the light
of the possible risks and benefits of using GMOs, European
industries can therefore provide the best option for consumers.

Brussels, 30 May 2002.

The President

of the Economic and Social Committee

Göke FRERICHS

APPENDIX

to the Opinion of the Economic and Social Committee

The following amendments, which received at least one quarter of the votes cast, were defeated during the discussion:

Point 4.6

Delete the following sentence:

‘The EESC is concerned that the two proposals in question only apply to products produced from GMOs, but not to
products produced with a GMO, thus excluding certain important links in the food chain from the scope of the
proposed regulations.’

Reason

If products had to be labelled when they contained no detectable GMOs, this would give rise to fraud; it would also
suggest that there was a difference in the level of safety between identical products. That is not the case.

Result of the vote

For: 46, against: 55, abstentions: 1.

Point 4.8

Delete the following sentence at the end:

‘The Committee considers that, in order to ensure complete freedom of choice for the consumer, it is vital to define
in the clearest and most transparent way possible the rules for labelling GM products, including food and feed derived
from GM crops or products produced with a GMO whether or not containing protein or genetic material detectable
from analysis.’

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Reason

If products had to be labelled when they contained no detectable GMOs, this would give rise to fraud; it would also
suggest that there was a difference in the level of safety between identical products. That is not the case.

Result of the vote

For: 42, against: 54, abstentions: 1.

Point 4.9

Delete the following sentences at the end:

‘This would mean that the consumer could have ’blind trust’ in all products. Nevertheless, the Commission proposes
to provide consumers with information which will enable them to make their own decisions. The Committee
welcomes this wholeheartedly. However, if for example animal products involving GM feed are not covered by the
labelling regulations, consumers will be deprived of the freedom to choose all the way along the ’animal product’
production chain; they will be unable to determine whether or not genetic engineering has been involved in the
manufacture of the products they buy.’

Reason

Once again, reference is wrongly being made to food safety. In addition, labelling is being urged for even more
products where there is no evidence from analyses of the existence of GMOs. This leads to higher cost prices,
encourages fraud and brings about distortions of competition, since it is impossible to check imports properly.

Result of the vote

For: 43, against: 58, abstentions: 1.

Point 5.1

Replace the second and third sentences with the following:

‘The Committee proposes that the 1 % threshold be reconsidered and that any new threshold value should ensure
that GMO-free production is possible under existing farming practices and without the need for higher cost measures.’

Reason

It is incorrectly implied that GMOs are dangerous substances, although in fact they have to satisfy all safety criteria.
It must be made clear that a threshold lower than 1 % would make GMO-free production impossible without
excessive additional costs.

Result of the vote

For: 36, against: 54, abstentions: 6.

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Point 6.2

Delete.

Reason

Such an extension of labelling is completely pointless, as there is no way of detecting GMOs. This would only further
increase the likelihood of fraud. Moreover, such labelling is incompatible with WTO rules.

Result of the vote

For: 41, against: 57, abstentions: 1.

Point 6

Add a new paragraph to point 6:

‘The labelling rules and the cultivation of GMO products must not impose costly additional measures on EU
producers of GMO-free products. This means that the labelling threshold must be sufficiently high to ensure that
under normal production conditions no special measures need to be adopted in order to remain below it.’

Reason

This conclusion needs to be drawn in order to prevent GMO-free production being threatened by GMO production.
On the one hand, measures may be needed which will increase costs, and on the other hand, there is the danger of
lower yields if a product has to be labelled as a result of contamination from GMO crops. The latter case would apply
if it were no longer possible to sell an organic product as such, as a result of exceeding the labelling threshold.
Depending on the situation of the market, non-organic GMO-free product yields might also suffer.

Result of the vote

For: 38, against: 54, abstentions: 3.