Opinion of the Committee of the Regions onthe Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed,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, andthe Proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms
Date: 2002-11-14
Institutions: European Committee of the Regions
Subjects: animal nutrition, foodstuff, genetically modified organism, human nutrition

14.11.2002

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Official Journal of the European Communities

C 278/31

Opinion of the Committee of the Regions on

— the ‘Proposal for a Regulation of the European Parliament and of the Council on genetically

modified food and feed’,

— 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’, and

— the ‘Proposal for a Regulation of the European Parliament and of the Council on the

transboundary movement of genetically modified organisms’

(2002/C 278/10)

THE COMMITTEE OF THE REGIONS,

having regard to 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);

having regard to 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);

having regard to the Proposal for a Regulation of the European Parliament and of the Council on the
transboundary movement of genetically modified organisms [COM(2002) 85 final — 2002/0046 (COD)];

having regard to the Proposal for a Directive on the deliberate release into the environment of genetically
modified organisms and repealing Council Directive 90/220/EEC — COM(2000) 293 final;

having regard to the decisions taken by the Council on 15 September and 2 October 2001 and 1 March
2002 to consult it, under the first paragraph of Article 265 and Articles 152 and 175 of the Treaty
establishing the European Community;

having regard to its Bureau’s decision of 6 February 2002 to instruct the Commission for Sustainable
Development to draw up the opinion;

having regard to its Opinion of 12 April 2001 on the Communication from the Commission to the
Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions
on the White Paper on Food Safety — COM(1999) 719 final (CdR 77/2000 fin) (1);

having regard to its Opinion of 14 June 2001 on the establishment of a European Food Safety Authority
(CdR 64/2001 fin) (2);

having regard to the draft opinion adopted by the Commission for Sustainable Development on 25 March
2002 (CdR 33/2002 rev. — rapporteur: Mr Bertrand, Mayor of Saint-Silvain-Bellegarde, F/EPP),

adopted the following opinion at its 44th plenary session, held on 15 and 16 May 2002 (meeting of
16 May).

POSITION AND RECOMMENDATIONS
OF THE COMMITTEE OF THE REGIONS

Preamble

1.
In the light of the technical, scientific and legal aspects
of the current situation — both within and outside the EU —
there is a need to flesh out EU rules on genetically modified

( 1) OJ C 226, 8.8.2000, p. 7.
( 2) OJ C 357, 14.12.2001, p. 22.

food and feed products. The forthcoming establishment of the
European Food Safety Authority also increases the need to
take action in this respect. The Committee of the Regions
supports the European Commission’s proposal aimed at
ensuring coherent application of a body of EU rules enhancing
food safety throughout the EU.

2.
The Committee of the Regions is in favour of establishing
a body of rules which would ensure transparency as regards
the use of GMOs in the agri-food chain. There is a need for
transparency, in respect of both the authorisation procedure
and also the traceability of genetically modified products
throughout the agri-food chain. With this aim in view, the

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Committee of the Regions points out that the concept of ‘from
farm-gate to plate’ seems to be too limiting as the agri-food
chain extends from the suppliers of industrial products to
farmers, right up to the final consumer. The Committee of the
Regions therefore prefers to use the expression ‘from plough
to plate’.

3.
The rules must also enable purchasers — be they
intermediate users, such as stock-breeders, or final consumers
Information must be
— to exercise freedom of choice.
comprehensive and clear and afford health and legal protection
to the users of both food and feed products.

4.
The Committee of the Regions stresses that ‘traceability’
and ‘labelling’ are different and complementary concepts.
‘Traceability’ implies the establishment of a monitoring system
which makes it possible to trace the history and origin of
a product.
‘Labelling’ provides transparency in commercial
transactions. Labelling also involves a commitment and a legal
liability on the part of the body which affixes the label to the
product concerned.

5.
The Committee of the Regions takes the view that the
goal of affording a high level of protection for life, health and
the environment can be achieved only through a coherent
body of Community rules, defining the responsibility of all the
players in the agri-food chain. This should also boost consumer
confidence with regard to public health and food safety.

Development of Community rules and the current situ-
ation

6.
The body of Community rules in force since the early
1990s has been supplemented and fine-tuned over the last ten
years. Directive 90/219/EEC, which has itself been amended,
deals with the contained use of genetically modified micro-
organisms for research or for industrial purposes.

7.
The first rules with regards to authorisation procedures
were set out under Directive 90/222/EEC on the deliberate
release into the environment of genetically modified organ-
isms. This Directive covers the marketing of GMOs and
products consisting of or containing GMOs, but it does not
cover products derived from GMOs. This Directive provides for
an environmental assessment and a step-by-step authorisation.
The Directive requires a case-by-case assessment of the risks to
human and animal health and the environment to be carried
out before any genetically modified organisms are released
into the environment in any of the EU Member States.

8.
Directive 2001/18 as subsequently amended will come
into force in October 2002; this Directive will carry forward
and strengthen the current laws by:

— enhancing the effectiveness and the transparency of
the decision-making process whilst, at the same time,
ensuring a high level of protection of human health and
the environment;

— clarifying a number of operational aspects, relating, inter

alia, to the scope of the measures;

— promoting the harmonisation of the risk assessment;

— improving the transparency of the decision-making pro-
cess through consultation, the establishment of reports
on ethical issues and the participation of the public in the
authorisation process;

— improving checks on the dissemination of GMOs into the
environment by making it mandatory for the Member
States to take measures to ensure traceability and the
provision of labelling at all stages in the marketing of
products and by strengthening the monitoring plans in
respect of GMOs.

9.
Regulation (EC) 258/97 on novel foods and novel food
ingredients lays down rules governing the authorisation and
labelling of food products derived from GMOs and other novel
foods. The Regulation does not, however, specify how this
information is to be presented and it does not define the
concept of ‘equivalence’. And Regulation 50/2000 fails to
stipulate a threshold in respect of adventitious presence. The
situation is identical with regard to products derived from
GMOs and intended for use in feed products since no specific
provision has been introduced in respect of the labelling of
products derived from GMOs. The proposals under review
provide the requisite information on the concept of ‘equival-
ence’ and the threshold in respect of adventitious presence.

10.
On 24 May 2000 the European Community and all its
Member States signed the Cartagena Protocol on Biosafety.
This multilateral agreement was intended to include all the
main GMO-producing countries. It was drawn up in order to
improve the level of protection in the field of the transbound-
ary movement, handling and use of living modified organisms.
In the current proposal (1), the Commission proposes ratifi-
cation of the Protocol. The Protocol can enter into force only
on the ninetieth day after the date of deposit of the fiftieth
instrument of ratification by the parties to the Convention.
The Committee of the Regions, together with the Member
States and the European Parliament, are in favour of the rapid
ratification of the Protocol.

(1) COM(2002) 85 final.

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Official Journal of the European Communities

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Proposal for a Regulation of the European Parliament and
of the Council on genetically modified food and feed (1)

The Commission’s proposal sets out the following

11.
provisions:

— an improved, harmonised, uniform and transparent pro-
cedure for the safety assessment of genetically modified
food;

— a safety assessment and an authorisation procedure for
genetically modified feed, based on the same improved
and transparent authorisation procedure as for genetically
modified food;

— that authorisation should not be granted for a single use
either as food or feed in cases where such products are
likely to be used both as food and feed;

— harmonised and comprehensive labelling requirements
for genetically modified feed in order to provide users
with accurate information about
composition and
properties.

The proposal under review covers products ‘produced

12.
from a GMO’ but not products ‘produced with a GMO’.

The Committee of the Regions welcomes the strength-
13.
ening and clarification of the assessment procedure for geneti-
cally modified food and feed by the Commission which is
aimed at establishing the necessary regulatory basis for ensur-
ing a high level of protection of human life and health.

The opinion of the European Food Safety Authority should
provide the scientific guarantee under the authorisation pro-
cedure. With this aim in view, the Committee of the Regions
reiterates the view expressed in its earlier opinion that the
European Food Safety Authority should be set up as soon as
possible; this is a prerequisite for the implementation of the
two draft Regulations under review.

14.
The Committee of the Regions particularly welcomes
the application of the ‘one door — one key’ procedure which
will make it possible to follow up applications for authorisation
more effectively and accelerate authorisation. This should
enhance consumer safety and bolster confidence. Experience
has shown that products able to be used either as food or as
animal-feed need to meet both the criteria applicable to food
and those for animal-feed.

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

15.
In order to ensure safety and secure the confidence of
consumers and all the players in the agri-food chain, food
authorisation should hinge upon observance of the following
criteria:

— absence of risk to human or animal health or to animal

feed;

— the need to inform users and consumers.

16.
The Committee of the Regions takes the view that the
establishment of the threshold in respect of the procedure for
is a
authorising the placing of products on the market
contributory factor to ensuring the necessary public-health
and legal safety. In this context, the threshold level set should
be applicable throughout the agri-food chain and be based on
the ‘trace concept’ used to define the purity of food products.
Furthermore, the Committee of the Regions stresses that this
threshold must be consistent with the establishment of other
thresholds,
for example the threshold for the mandatory
labelling of genetically modified seeds (Directive 98/95/EC).

17.
The authorisation procedure applies to food and feed
containing a GMO or produced from a GMO. The Committee
of the Regions highlights the need for Community law to be
made more coherent in the case of food products requiring
specific applications for marketing authorisation, namely food
additives, baby-food, infant formulae and food supplements.
In the case of these products authorisation is valid for a
maximum period of
ten years, which can be extended,
depending on the results of a monitoring plan.

18.
The Committee of the Regions supports the establish-
ment of a Community Register of Genetically Modified Food
and Feed which lists product information, studies demonstrat-
ing that the product is safe and methods of detection. The
Committee of the Regions recommends that the Commission
facilitate public access to this Community Register and specify
the terms of access in order to ensure that people are fully
informed as to these food products.

19.
The Committee of the Regions feels that the transitional
period during which existing authorisations for placing prod-
ucts on the market are maintained should end as soon as
possible.

20.
The Committee of the Regions supports the proposal
made by the Commission in the draft Regulation that the
products in question should be labelled since the current
provisions are difficult
to enforce
against third parties and do not ensure total transparency,
either for the final consumer or the various operators, such as
stock-breeders.

to implement, difficult

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21.
The Commission proposes to extend these labelling
provisions to food and animal feed irrespective of the detecta-
bility of DNA or protein. The Committee of the Regions
expresses reservations over this extension for the following
reasons:

25.
The Committee of the Regions calls for the Commission
to be authorised to seek to harmonise assessment procedures
for genetically modified food and feed and to seek to align the
traceability measures applicable at international
level with
those which will apply in the EU.

— the recent health scares have demonstrated that documen-
tary traceability is not sufficient in itself to enable animal
feed to be strictly monitored;

— the only way to ensure that commercial transactions are
not fraudulent is by means of checks based on the
detection of DNA or protein in a product placed on the
market.

22.
Purchasers (users or final consumers) must be able to
select the quality of the food which they buy in a fully
informed way and on the basis of the legal, public health and
commercial criteria which they set. The Committee of the
Regions urges the Council and the European Parliament to
draw a distinction, in the product description, between prod-
ucts containing GMOs and products containing no further
trace of GMOs.

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 (1)

23.
The Committee of the Regions supports the draft
regulation which specifies the implementing provisions in
respect of the traceability and labelling of genetically modified
food and feed.

24.
The Commission proposes that these implementing
provisions be applicable both to food produced in the EU and
imported food. Responsibility for checking imported food
rests with each of the Member States, which will also determine
the penalties for fraudulent practices.

The Committee of the Regions supports the formulation of
this principle and the clarification of responsibilities in the
Community.

The Committee of the Regions wishes, however, to underline
the fact that the implementing provisions set out in the draft
regulation do not make for coherence between measures
relating to the traceability of products imported into the EU
and the additional measures we would like to see, over and
above, for example, those set out in the Cartagena Protocol.

Proposal for a Regulation of the European Parliament and
of
the Council on the transboundary movement of
genetically modified organisms (2)

The Committee of the Regions supports the procedure

26.
set out in the Cartagena Protocol for the following reasons:

a)

b)

c)

the need for the exchange of
information between
the exporter and the importer by means of complete
notification before the first transboundary movement,

the establishment of a system for the exchange of
information before products are placed on the market,

the establishment of a link between bilateral agreements
and Community law, leaving the Member States scope,
for example, to apply Community law rather than the
provisions of the Protocol in relation to movements of
GMOs within the European Union and the European
Economic Area,

d)

recognition of the Community procedure for authorising
the placing on the market of GMOs, with the opinion of
the European Food Safety Authority.

The Committee of the Regions supports the proposed

27.
implementing strategy, i.e.:

e)

f)

imposing obligations on exporters which do not exist in
European law,

applying current Community law to importers in the
European Union.

for exports of GMOs

28.
The Committee reiterates its support for ratification of
the Cartagena Protocol. The proposal concerns the specific
requirements
to non-Community
countries, but
the protocol deals exclusively with living
modified organisms. This means that it is not always possible
to lay down the detailed arrangements for the traceability and
labelling of products containing a ‘non-living’ GMO or derived
from a GMO imported from a non-Community country.

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

(2) COM(2002) 85 final — 2002/0046 (COD).

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29.
The Committee of the Regions stresses the importance
of the exchange of information between Member States in the
case of unintentional transboundary movements. To the extent
that food safety is concerned here, the Committee of the
Regions proposes that the early warning system be integrated
into the procedure. The Committee of the Regions calls on the
Commission to ensure that suitable procedures are established
by each of the Member States.
30.
The Committee of the Regions notes that the proposal
for a Regulation does not tackle the issue of legal liability in
the event of withdrawal arising from an unintentional move-
ment of GMOs, so as to provide the food chain players with
legal certainty.
31.
The Committee of the Regions endorses the conclusions
of the Lisbon European Summit which aim to turn the EU into
an area of knowledge and competitivity based in particular

on biotechnologies. The CoR would like to see greater
consideration given to food safety in world trade while
maintaining the overall competitiveness of the EU’s regions in
the trading of agri-food products.

Conclusion

32.
The Committee of the Regions feels that the introduc-
tion and implementation, at Community level, of the two draft
Regulations will enhance both the quality and the safety of EU
products and provide purchasers (users and consumers) with
more information in order to enable them to exercise freedom
of choice. The Committee of the Regions calls for the extension
of this requirement beyond the borders of the Community.

Brussels, 16 May 2002.

The President

of the Committee of the Regions

Albert BORE

Opinion of the Committee of the Regions on the ‘Proposal for a Decision of the European
Parliament and of the Council amending Decision No 1254/96/EC laying down a series of
guidelines for trans-European energy networks’

(2002/C 278/11)

THE COMMITTEE OF THE REGIONS,

having regard to the report from the Commission to the European Parliament, the Council, the Economic
and Social Committee and the Committee of the Regions on the implementation of the guidelines for
Trans-European Energy Networks in the period 1996-2001;

having regard to the Communication from the Commission to the European Parliament and the Council
on European Energy Infrastructure;

having regard to the proposal for a Decision of the European Parliament and of the Council amending
Decision No 1254/96/EC laying down a series of guidelines for trans-European energy networks
(COM(2001) 775 final);

having regard to the decision of its President of 8 April to appoint Mauro Pili, President of the
Autonomous Region of Sardinia (I/EPP), as Rapporteur-General responsible for drafting an opinion on
this matter, in accordance with Rule 40(2) of the Rules of Procedure;

having regard to Articles 154, 155, 156, 158 and 265 of the Treaty of Amsterdam, in particular
Article 154(2) which stipulates that Community action must ‘... take account in particular of the need to
link island, landlocked and peripheral regions with the central regions’;