Opinion of the 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" (COM(2001) 182 final — 2001/0180 (COD))
Date: 2001-03-21
Institutions: European Economic and Social Committee
Subjects: animal nutrition, consumer protection, foodstuff, genetically modified organism, human nutrition, labelling

27.5.2002

EN

Official Journal of the European Communities

C 125/69

Opinion of the 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’

(COM(2001) 182 final — 2001/0180 (COD))

(2002/C 125/14)

On 15 September 2001 the Council decided to consult the European 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 4 March 2002. The rapporteur
was Mr Espuny Moyano.

At its 389th Plenary Session on 20 and 21 March 2002 (meeting of 21 March), the European Economic
and Social Committee adopted the following opinion by 81 votes to 10, with 21 abstentions.

1.

Introduction

The Commission proposal sets out

1.1.
to establish a
framework for regulating the traceability and labelling of
genetically modified organisms (GMOs) and of food and feed
products produced from GMOs. Its purpose is to facilitate
(i) withdrawal of products if unforeseen adverse effects on
public or animal health should occur (ii) targeted monitoring
of possible environmental effects, and (iii) accurate and
complete labelling to enable operators and consumers to
exercise real freedom of choice, and the authorities to control
and verify labelling claims.

1.2.
The draft regulation applies to every stage in the
placing on the market of products consisting of, or containing,
GMOs and of foods and feed materials produced from GMOs,
including additives and flavourings.

1.3.
The draft regulation does not apply to medicinal
products for human and veterinary use (Council Regulation
(EEC) No 2309/93).

1.4. Unique codes

The Commission is to establish a system for the development
and assignment of unique codes to GMOs by setting up a
regulatory committee (under Article 10 of the draft regulation).
The system may be adapted by the same procedure (Article 8).

Information that a product consists of, or contains, a
1.5.2.
GMO must be provided in the first stage of market placement,
together with the relevant unique code.

1.5.3.
sequent stage.

This information must be transmitted to each sub-

1.5.4.

The information is to be retained for five years.

1.6. Traceability requirements for products produced from GMOs

1.6.1.
Operators placing products produced from GMOs
on the market must provide operators receiving the products
with an indication of each of the food ingredients, additives or
flavourings, or feed materials or additives, which is produced
from GMOs.

1.6.2.

Operators must retain this information for five years.

1.5. Traceability and labelling requirements for GMOs

1.7.

Exemptions

The labels of pre-packaged products consisting of, or
1.5.1.
containing GMOs must be marked with the words ‘This
product contains genetically modified organisms’.

1.7.1.
Article 6 provides for certain exemptions: for exam-
ple, operators supplying food to the ultimate consumer are
not obliged to retain documentation detailing to whom
products were sold.

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The proposal obliges the Member States to adopt
1.8.
inspection and control measures and stipulates that
the
Commission must have developed prior technical guidance on
sampling and testing.

The Member States are to lay down penalties applicable

1.9.
to infringements of the draft regulation.

with the obligations and procedures which it lays down.
Directive 2001/18/EC also introduces an obligation to
implement a monitoring plan in order to trace and identify
any direct or indirect, immediate, delayed or unforeseen effects
on human or animal health or the environment of GMOs or
products manufactured from or containing GMOs, after they
have been placed on the market.

The regulation is to enter into force on the twentieth
1.10.
day following its publication, although the bulk of its content
is to apply from the ninetieth day following publication in the
Official Journal of the European Communities of the system
for development and assignment of the unique codes.

2.5.
As health and the environment are already supposed
to be protected by the above legislation, the proposal for a
regulation under consideration must focus on regulating the
traceability of GMOs and food and feed containing GMOs as a
way of further enhancing the level of security and health
protection provided by the directive referred to above and
improving the labelling of GM food and feed.

2. General comments

The Committee recognises the efforts made by the
2.1.
Commission in preparing both the present proposal for a
regulation and the Proposal for a Regulation of the European
Parliament and of the Council on genetically modified food
and feed, which are clearly related. The EESC acknowledges
that existing legislation on the placing on the market and
labelling of GMOs is inconsistent and incomplete, and there-
fore welcomes the fact that the proposal treats food and feed
products equally, which will provide greater coherence, clarity
and security for operators, users and consumers. Existing
legislation does not
to be
informed and make informed choices.

fully ensure consumers’ right

2.2.
Nevertheless, it is a serious source of concern that
certain parts of the proposal are unclear, e.g. with regard to
differentiating products using GMOs in the manufacturing
process from products manufactured from GMOs.

2.3.
The regulation is rightly based on Article 95 of the
Treaty establishing the European Community, concerning the
approximation of the laws of the Member States which have
as their object the functioning of the internal market and
taking as a base a high level of protection in the European
Union.

2.4.
Directive 2001/18/EC on the deliberate release into the
environment of genetically modified organisms, repealing
Directive 90/220/EEC, establishes a legal framework for the
deliberate release into the environment and placing on the
market of genetically modified organisms which is designed to
protect human and animal health and the environment. This
directive makes it possible to release and place on the
market products which are safe for humans, animals and the
environment following rigorous scientific testing in accordance

2.5.1.
However, as the Committee noted in its opinion on
the White Paper on Environmental Liability (1) ‘the liability
regime for damage to the environment and to biodiversity
urgently needs to be clarified’. There must also be clarification
regarding liability for adventitious contamination with GMOs
of the products of organic farming for which, at present, a 0 %
threshold applies. Neither the proposal for a Regulation under
review nor the proposal for a Directive which has been
liability clarifies the issue of
submitted on environmental
liability for GMOs. This is unacceptable in the view of the ESC.

2.6.
The draft regulation on the general principles of food
law and the European Food Authority lays down the main
obligations relating to health and food safety,
including
traceability. The traceability of GMOs or products derived
from GMOs must be identical to that stipulated in the draft
general food law regulation.

The

traceability requirements would require,

2.7.
in
addition to supporting documentation and certificates, a series
of additional checks and inspections to be carried out by both
economic operators and the supervisory authorities, which
would entail additional costs for both raw materials and
finished products. A particular problem is posed by imported
products (which either contain GMOs or were produced from
GMOs) where GMOs are not, however, present in the final
product. The Committee is fully aware that the proposals
will require commitment from international organisations,
national authorities, and trading partners, and it may take
some years to achieve full implementation in practice.

(1) Opinion of the European Economic and Social Committee on the
‘White Paper on Environmental Liability’, OJ C 268, 19.9.2000,
p. 19.

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2.8.
Verification and control will also be necessary, requir-
ing the commitment of additional economic and human
resources by the national authorities responsible for implemen-
tation. Appropriate additional resources should be allocated
at Community and national
level to ensure the effective
implementation and control of the proposed legislation, so as
to avoid diverting such resources from their fundamental
mission: to monitor the safety of food and feed products.

3. Specific comments

Point 7.3 of the Legislative financial statement (‘Other adminis-
trative expenditure deriving from the action’ appears to contain
an error of calculation concerning the total allocation for
(Title A7). Since three three-day missions at
missions
1 000 EUR each are involved, the total cannot be 1 300 EUR
as indicated in the proposal.

2.9.
For foods and feed products in which genetically
modified material is no longer present but has been used, the
traceability and labelling requirements are difficult to verify,
which could lead to unfair practices and fraud. An instance
would be highly refined oils and hydrolysed maize derived
from genetically modified raw materials, which can replace
products derived from non-genetically modified raw materials,
as their composition, characteristics and uses are identical.

There is a risk that the introduction of new require-
2.10.
ments will result in a higher final product cost, which will
probably be passed on to the consumer. However,
the
Committee underlines that the costs of the new technology
should fall on GM producers and products rather than on the
traditional products through ‘GM free’ labelling.

National governments in Europe and the EU’s political
2.11.
bodies must ensure that more stringent requirements are also
brought in at international level to protect humans and the
environment. They are called on to campaign in the various
international bodies, and especially in the OECD and the
Codex Alimentarius Commission, for the adoption of appro-
priate rules and regulations. Possible barriers to trade will be
reduced to a minimum or abolished completely as a result.

4.

Final considerations

In conclusion, the Committee recognises the major effort
made by the Commission to flesh out and clarify the current
framework, and would make the following recommendations
with regard to traceability and labelling.

The use of GMOs has led to a great debate in society,
4.1.
in the course of which extreme positions lacking any serious
scientific foundation have frequently been adopted. The EESC
therefore recommends that the Commission carry out a public
information campaign publicising the advantages and risks of
the use of GMOs, in relation to food for human consumption,
animal feed and the environment. Information produced by
independent bodies to help people make informed choices
about the food they eat, including on an environmental and
ethical basis, and concerning the technologies by which they
are produced is essential.

The two proposed regulations for revamping and
4.2.
improving the labelling and traceability of products containing
or consisting of GMOs at all stages in the food chain
take account of the precautionary principle and enhance
transparency as a prerequisite for the consumer’s freedom of
choice. They make it easier for the supervisory authorities to
carry out their checks and make it easier to research the long-
term effects for humans and the environment of genetic
engineering in the food sector.

4.3.
The authorisation of GMOs is based on prior rigorous
initial scientific assessment, which guarantees that the author-
ised products pose no health risks and may circulate freely as
long as consumers are fully informed through traceability and
labelling in order to promote choice.

2.12.
The application of measures making it possible to
distinguish GMO-free products from genetically modified
products could confer a competitive advantage on firms
choosing to focus on quality, which will then be able to
offer the consumer a product which is both traceable and
transparent in terms of its ingredients.

4.4.
The use of GMOs is already a reality, given that in
2001 they were being grown on 52,6 million hectares of land,
this being a 19 % increase over the previous year, which
confirms the steady growth trend. However, surveys among
European consumers show that a clear majority are opposed
to genetically modified food.

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4.5.
Notwithstanding the above, the EESC draws the Com-
mission’s attention to the importance of carrying out compre-
hensive tests as a necessary preliminary to authorising the use

of new GMOs, proceeding on the basis of the precautionary
principle and avoiding undesired effects.

Brussels, 21 March 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 in the course of the
Committee’s debates:

Point 2.5

Replace point with the following text:

‘The draft regulation under discussion cannot focus solely on traceability rules for GMOs and food and feed obtained
from GMOs, but must also consider food and feed produced using GMOs. An enzyme or any other molecule which
accelerates the process of chemical change participates actively in all the chemical/molecular reactions through which
the food is produced, and it is therefore in principle not possible to say that two final products, one of which has
been obtained in the natural way and the other using a GMO, are substantially equivalent. Unnatural substances are
being used in respect of which no experimental evidence exists proving that they can produce products which are
identical to the natural product not only from an organoleptic point of view, but also in terms of wholesomeness,
taste, aroma etc. Rules on the labelling and traceability of GMOs should therefore also apply to products obtained
using GMOs.’

Result of the vote

For: 28, against: 51, abstentions: 14.

Point 2.7

Replace point with the following text:

‘As the aim is to ensure maximum transparency, the traceability requirements proposed should be monitored, even
if this requires a series of additional checks and inspections by both economic operators and the supervisory
authorities. Study needs to be devoted to a system which will also guarantee consumers maximum transparency with
regard to imported products (which are GMOs, contain GMOs or were produced from GMOs or using GMOs) where
GMOs are not, however, present in the final product.’

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Result of the vote

For: 30, against: 59, abstentions: 16.

Point 4.1

Amend the first sentence as follows:

‘The use of GMOs has led to a great debate in society, that is to some extent marked by fear and indeed also by
ignorance of the potential consequences.’

Result of the vote

For: 50, against: 53, abstentions: 9.

New Point 4.3.1

‘The fact that meat and other animal products from animals which have been fed genetically modified feed does not
have to be labelled accordingly does in the ESC’s view, represent a major shortcoming which decisively detracts from
the goal of giving consumers freedom of decision.’

Result of the vote

For: 43, against: 56, abstentions: 8.