Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2003-07-17
Institutions: European Commission
Subjects: animal nutrition, consumer information, foodstuff, genetically modified organism, health policy, labelling

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 17.07.2003
COM(2003) 459 final

2001/0173 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament's amendments
to the Council's common position regarding the
proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on genetically modified food and feed

AMENDING THE PROPOSAL OF THE COMMISSION
pursuant to Article 250 (2) of the EC Treaty

2001/0173 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament's amendments
to the Council's common position regarding the
proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on genetically modified food and feed

1.

INTRODUCTION

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is
to  deliver  an  opinion  on  the  amendments  proposed  by  the  European  Parliament  at  second
reading.  The  Commission  sets  out  its  opinion  below  on  the  9  amendments  proposed  by  the
Parliament.

2.

BACKGROUND

–  Adoption  of  the  proposal  by  the  Commission  on  25  July  2001  and  transmission  to  the
Parliament and the Council on 30 July 2001, (COM(2001) 425 final – 2001/0173(COD))

–  Opinion of the Committee of the Regions adopted on 16 May 2002

–  Opinion of the Economic and Social Committee adopted on 30 May 2002

–  Opinion of the European Parliament at first reading adopted on 3 July 2002

–  Transmission of Commission amended proposal to Council and  Parliament on 9 October

2002, (COM(2002) 559 final – 2001/0173 (COD))

–  Adoption of Common Position on 17 March 2003

–  Opinion of the European Parliament at second reading adopted on 2 July 2003

3.

PURPOSE OF THE PROPOSAL

The objectives of the proposal, which results from the White Paper on Food Safety, are:

–  to provide the basis for ensuring a high level of protection of human life and health, animal
health,  environment  and  consumers’  interest  in  relation  to  genetically  modified  food  and
feed, whilst ensuring the effective functioning of the internal market;

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–  to  lay  down  centralised  Community  procedures  for  the  assessment  (central  role  of  the
European Food Safety Authority), authorisation (comitology procedure) and supervision of
genetically modified food and feed;

–  to lay down comprehensive requirements for the labelling of genetically modified food and
feed,  with  the  aim  of  providing  the  consumers  and  users  with  a  real  choice.

The proposal covers genetically modified organisms for food and feed use as well as food
and feed containing, consisting of, or produced from genetically modified organisms.

The proposal extends the current labelling provisions to all genetically modified food and
feed  irrespective  of  the  detectability  of  DNA  and  protein.  The  applicability  of  this
requirement  will  be  ensured  through  the  provisions  laid  down  in  the  draft  Regulation
concerning the traceability and labelling of genetically modified organisms and traceability
of food and feed products produced from genetically modified organisms.

In order to ensure the feasibility and practicability of the proposed Regulation, provisions
regarding  derogation  for  adventitious  or  technically  unavoidable  presence  of  genetically
modified  organisms  in  food/feed  are  laid  down  in  the  authorisation  and  in  the  labelling
sections  of  the  proposal.  In  order  to  ensure  consistency,  it  is  proposed  that  Directive
2001/18/EC be amended accordingly.

4.

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE  EUROPEAN
PARLIAMENT

The Parliament adopted 9  amendments  (1, 7, 8,  9,  44,  45,  46,  47  and  48)  as  a  compromise
package tabled to facilitate the final adoption of the proposal.

Amendments  1  and  9  (deleting  Recital  10  and  modifying  Article  2.13)  delete  the  language
specifying  that  genetically  modified  organisms  for  release  under  part  B  of  Directive
2001/18/EC  and  genetically  modified  organisms  and  genetically  modified  micro-organisms
for contained use activities are excluded from the definition of “placing on the market”.

Amendment 8 (modifying Article 2) introduces a definition for traceability by reference to the
definition established in the Commission proposal for Regulation concerning the traceability
and  labelling  of  genetically  modified  organisms  and  traceability  of  food  and  feed  products
produced  from  genetically  modified  organisms.  This  amendment  makes  little  difference,  as
there  are  no  enacting  clauses  as  regards  traceability  in  Regulation  on  genetically  modified
food and feed.

Amendments 7, 46 and  47  delete the definition  of  risk  in  Article  2,  point  1  and  replace  the
term  “unacceptable  risk”  by  the  term  “adverse  effects”  in  Articles  4  and  16  of  the  draft
Regulation.

Amendments  44  and  45  (introducing  a  new  Article  43a  and  a  new  Recital  28a)  on  co-
existence allow Member States to take appropriate measures to avoid the unintended presence
of  genetically  modified  organisms  in  other  products  and  invite  the  Commission  to  develop
guidelines in order to provide Member States with a framework for putting this into practice.

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Amendment  48  (modifying  Article  32)  provides  that  the  contributions  from  applicants  for
authorisation  of  genetically  modified  food  and  feed  shall  not  exceed  the  costs  incurred  in
carrying out the validation of detection methods.

The Commission can accept all these amendments.

5.

CONCLUSION

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out
above.

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