Proposal for a Directive of the European Parliament and of the Council Amending Directive 2001/18/CE concerning the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred to the Commission
Date: 2006-12-22
Institutions: European Commission
Subjects: EU law, approximation of laws, environmental protection, genetically modified organism, health policy, marketing, operation of the Institutions

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2006 
COM(2006) 920 final 

2006/0296 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

Amending 

Directive 2001/18/CE 
concerning the deliberate release into the environment of genetically modified 
organisms, as regards the implementing powers conferred to the Commission  

(presented by the Commission) 

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   EN 

 
 
 
  
 
2006/0296 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

Amending 

Directive 2001/18/CE 
concerning the deliberate release into the environment of genetically modified 
organisms, as regards the implementing powers conferred to the Commission  

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions 3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4 

Whereas: 

(1) 

(2) 

1 
2 
3 
4 
5 
6 

Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council5  provides  that 
certain measures are to be adopted in accordance with Council Decision 1999/468/EC 
of 28 June 1999 laying down the procedures for the exercise of implementing powers 
conferred on the Commission6. 

Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced 
a  regulatory  procedure  with  scrutiny  to  be  used  for  the  adoption  of  implementing 
measures  of  general  scope  which  seek  to  amend  non-essential  elements  of  a  basic 
instrument adopted in accordance with the procedure referred to in Article 251 of the 
Treaty,  including  by  deleting  some  of  those  elements  or  by  supplementing  the 
instrument by the addition of new non-essential elements. 

… 
… 
… 
… 
OJ L 106, 17.4.2001, p. 1–39 
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 
11). 

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(3) 

(4) 

In accordance with the joint statement of the European Parliament, the Council and the 
Commission7 on Decision 2006/512/EC, instruments which are already in force must 
be  adjusted  in  accordance  with  the  applicable  procedures,  so  as  to  replace  the 
regulatory  procedure  laid  down  in  Article  5  of  the  Decision  1999/468/EC  by  the 
regulatory procedure with scrutiny, wherever there are measures which fall within its 
scope. That statement indicates a list of instruments that should be adjusted as a matter 
of urgency, including Directive 2001/18/EC. 

In particular power should be conferred on the Commission to adapt certain Annexes, 
establish  criteria  for  the  notification  and  fix  minimum  thresholds.  Since  those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Directive and supplement it by the addition of new non essential elements, they should 
be adopted in accordance with the regulatory procedure with scrutiny provided for in 
Article 5a of Decision 1999/468/EC. 

(5) 

Directive 2001/18/EC should therefore be amended accordingly. 

(6) 

Since  the  amendments  to  be  made  to  Directive  2001/18/EC  are  adjustments  of  a 
technical nature which only concern the committee procedures, they do not need to be 
transposed by the Member States. It is therefore not necessary to lay down provisions 
to that effect, 

HAVE ADOPTED THIS DIRECTIVE: 

Directive 2001/18/EC is amended as follows:  

Article 1 

(1) In Article 16, paragraphs 2 and 3 are replaced by the following: 

"2. The Commission shall establish the criteria and information requirements referred 
to  in  paragraph  1  as  well  as  any  appropriate  requirements  for  a  summary.  Those 
measures,  designed 
this  Directive  by 
to  amend  non-essential  elements  of 
supplementing  it,  shall  be  adopted,  after  consultation  of  the  relevant  Scientific 
Committee, in accordance with the regulatory procedure with scrutiny referred to in 
Article  30  (3).  The  criteria  and  the  information  requirements  shall  be  such  as  to 
ensure a high level of safety to human health and the environment and be based on 
the  scientific  evidence  available  on  such  safety  and  on  the  experience  gained  from 
the release of comparable GMOs. 

The requirements set out in Article 13(2) shall be replaced by those adopted above, 
and  the  procedure  set  out  in  Article  13(3),  (4),  (5)  and  (6)  and  Articles  14  and  15 
shall apply. 

3.  Before  the  procedure  referred  to  in  Article  30(3)  for  a  decision  on  criteria  and 
information  requirements  referred  to  in  paragraph  1  is  initiated,  the  Commission 
shall make the proposal available to the public. The public may make comments to 

7 

OJ C 255, 21.10.2006, p.1  

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the Commission within 60 days. The Commission shall forward any such comments, 
together with an analysis, to the Committee set up pursuant to Article 30." 

(2) In Article 21, paragraph 2 is replaced by the following: 

"For  products  where  adventitious  or  technically  unavoidable  traces  of  authorised 
GMOs  cannot  be  excluded,  a  minimum  threshold  may  be  established  below  which 
these products shall not have to be labelled according to the provision in paragraph 1.  

The  Commission  shall  establish  the  threshold  levels  according  to  the  product 
concerned.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 30(3)." 

(3) Article 27 is replaced by the following: 

"Article 27 

Adaptation of Annexes to technical progress 

The adaptation to technical progress of Sections C and D of Annex II, Annexes III to 
VI,  and  section  C  of  Annex  VII,  designed  to  amend  non-essential  elements  of  this 
Directive, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 30(3)." 

(4) In Article 30, paragraph 3 is replaced by the following: 

"Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4),  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof." 

This  Directive  shall  enter  into  force  on  the  [..]  day  following  that  of  its  publication  in  the 
Official Journal of the European Union. 

Article 2 

Article 3 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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