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 the transboundary movement of genetically modified organisms amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2003-06-12
Institutions: European Commission
Subjects: environmental protection, environmental risk prevention, export, genetically modified organism, public health, third country

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 12.6.2003
COM(2003) 360 final

2002/0046 (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 THE TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED
ORGANISMS

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

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 THE TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED
ORGANISMS

1. 

BACKGROUND

The  Commission  forwarded  the  above  proposal  for  a  regulation  based  on
Article 175(1) to the Parliament and to the Council on 18 February 2002.

The Committee of the Regions delivered its opinion on 16 May 2002

The  European  Economic  and  Social  Committee  delivered  its  opinion  on  17  July
2002.

The European Parliament adopted an opinion at first reading on 24 September 2002.

The  Commission  accepted  some  of  the  Parliament’s  amendments.  It  submitted  an
amended proposal to the Council on 16 October 2002 including these amendments.

The Council adopted its common position unanimously on 4 March 2003.

On  4 June  2003,  the  European  Parliament  adopted  eight  amendments  to  the
Council’s common position at second reading.

This  opinion  presents  the  Commission’s  position  on  the  European  Parliament’s
amendments pursuant to Article 251(2)(c) of the EC Treaty.

2. 

PURPOSE OF THE COMMISSION PROPOSAL

The  objective  of  this  Proposal  is  to  implement  the  relevant  provisions  of  the
Cartagena  Protocol  on  Biosafety  by  establishing  a  common  system  of  notification
and  information  for  exports  to  third  countries  of  genetically  modified  organisms
(GMOs). This system will contribute to ensuring an adequate  level  of  protection in
the  field  of  the  safe  transfer,  handling  and  use  of  GMOs  that  may  have  adverse
effects on the conservation and the sustainable use of biological diversity, taking also
into  account  risks  to  human  health  and  specifically  focussing  on  transboundary
movements.

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3. 

COMMISSION OPINION ON THE PARLIAMENT’S AMENDMENTS

3.1. 

Summary of the Commission’s position

The Commission can accept the European Parliament’s eight amendments in full. It
considers  that  the  compromise  package  that  these  amendments  constitutes  will
enable  the  Community  to  implement  in  due  time  its  obligations  pursuant  to  the
ratification of the Cartagena Protocol on Biosafety.

3.2. 

Parliament amendments at second reading

3.2.1.  Amendments accepted

3.2.1.1.  Amendment  19  (Respect  of  the  national  regulatory  framework  of  the  Party  of

Import)

Amendment 19 does recognise the need to respect the Party or non-Party of Import's
regulatory biosafety framework consistent with the Protocol. This is in line with the
position  taken  on  numerous  occasions  by  the  Commission  in  international  fora,
which  is  to  respect  the  right  of  counties  to  a  free  informed  choice  with  regards  to
GMOs. So the Commission can accept amendment 19.

3.2.1.2.  Amendments  21  and  22  (Obligation  to  wait  for  prior  written  consent  before

proceeding with the export of a GMO)

Amendments 21 and 22 impose an obligation to wait for prior written consent before
proceeding  with  the  export  of  a  GMO.  The  Commission  believes  that  this  goes
beyond  the  Biosafety  Protocol.  This  is  actually  the  only  amendment  from  the
package  on  which  the  Commission  has  some  reluctance.  However,  as  part  of  the
overall compromise, the Commission can agree on both amendments.

3.2.1.3.  Amendments  24 

to  26  (Improved  public  access 

to 

information  regarding

transboundary movements of GMOs)

Amendments 24 to 26 improve public access to information regarding transboundary
movements of GMOs, which is in line with the general framework on public access
to  environmental  information  and  with  Directive  2001/18/EC  on  the  deliberate
release of GMOs into the environment. So the Commission can accept amendments
24 to 26

3.2.1.4.  Amendment 20 (Exemption for pharmaceuticals)

Amendment  20  aims  at  clarifying  the  scope  of  exemptions  for  pharmaceuticals  for
humans that are addressed by international agreements or organisations, limiting it to
those agreements or organisation to which the EU and its Member States are parties.
The compromise amendment can be accepted.

3.2.1.5.  Amendment 23 (Articulation of paragraphs one and three of Art. 5 of the Common

Position)

Amendment  23  aims  at  clarifying  the  articulation  of  the  different  paragraphs  of
Article 5 of  the Common Position.  The  Commission  expressed  reservation  on  both
paragraphs one and three of Art. 5 for political and technical reasons. However, on a

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perspective of drafting quality, the EP amendment improves  the  legal  clarity  of the
text and can be accepted.

4. 

CONCLUSION

Pursuant  to  Article  250(2)  of  the  EC  Treaty,  the  Commission  is  amending  its
proposal as indicated above.

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