Proposal for a Council Decision concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate
Date: 2004-09-08
Institutions: European Commission
Subjects: genetically modified organism, labelling, market approval, oil seed rape, traceability, transgenic plant

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.9.2004 
COM(2004) 572 final 

Proposal for a 

COUNCIL DECISION 

concerning the placing on the market, in accordance with Directive 2001/18/EC of the 
European Parliament and of the Council, of an oilseed rape product (Brassica napus L., 
GT73 line) genetically modified for tolerance to the herbicide glyphosate 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
1. 

2. 

3. 

4. 

5. 

6. 

EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  Dutch  authorities 
received a notification (Reference C/NL/98/11) concerning the placing on the market 
of an oilseed rape product (Brassica napus L., GT73 line), genetically modified for 
tolerance to the herbicide glyphosate. 

In  accordance  with  Article  14  of  the  Directive,  the  Dutch  competent  authority 
forwarded  to  the  Commission  its  assessment  report  of  the  notification,  which 
concluded  that  no  reasons  have  emerged  on  the  basis  of  which  consent  for  the 
placing on the market of GT73 oilseed rape should be withheld.  

The Commission forwarded the assessment report to all other Member States, certain 
ones  of  which  raised  and  maintained  objections  to  the  said  report  in  terms  of 
molecular  characterisation,  allergenicity,  monitoring  and  identification/detection  of 
the  product;  whereby  the  Commission,  in  accordance  with  Article  18  of  Directive 
2001/18/EC,  is  required  to  take  a  decision  in  accordance  with  the  procedure  laid 
down  in  Article  30(2)  of  the  Directive  to  which  Articles  5  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

A draft of the measures to be taken was submitted, in accordance with Article 5(2) of 
Decision  1999/468/EC,  for  opinion,  to  the  Committee  set  up  under  Article  30  of 
Directive 2001/18/EC. 

The Committee has not delivered an opinion, which requires that, the Commission, 
in  accordance  with  Article  5(4)  of  Decision  1999/468/EC,  must,  without  delay, 
submit to the Council a proposal relating to the measures to be taken and inform the 
European Parliament. 

Article  5(6)  of  Decision  1999/468/EC  provides  that  the  Council  may,  where 
appropriate in view of any such position, act by qualified majority within a period set 
at three months in accordance with Article 30(2) of Directive 2001/18/EC. If within 
that  three-month  period,  the  Council  has  indicated  by  qualified  majority  that  it 
opposes the proposal, the Commission must re-examine it; whereas if, on expiry of 
that  period  the  Council  has  neither  adopted  the  proposed  implementing  act  nor 
indicated its opposition, then the proposed implementing act must be adopted by the 
Commission. 

EN 

2 

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Proposal for a 

COUNCIL DECISION 

concerning the placing on the market, in accordance with Directive 2001/18/EC of the 
European Parliament and of the Council, of an oilseed rape product (Brassica napus L., 
GT73 line) genetically modified for tolerance to the herbicide glyphosate 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of 
12 March  2001  on  the  deliberate  release  into  the  environment  of  genetically  modified 
organisms  and  repealing  Council  Directive  90/220/EEC1,  and  in  particular  the  first 
subparagraph of Article 18(1) thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Pursuant to Directive 2001/18/EC, the placing on the market of a product containing 
or  consisting  of  a  genetically  modified  organism  or  a  combination  of  genetically 
modified  organisms  is  subject  to  written  consent  being  granted  by  the  competent 
authority concerned, in accordance with the procedure laid down in that Directive. 

A notification concerning the placing on the market of a genetically modified oilseed 
rape product (Brassica napus L., GT73 line) was submitted by Monsanto S.A. to the 
competent authority of the Netherlands. 

The notification covers the same uses as for any other oilseed rape, with the exception 
of  the  uses  as  or  in  food  and  the  cultivation  in  the  Community  of  varieties  derived 
from  the  genetically  modified  product  (GT73  transformation  event).  The  notification 
covers  the  importation  and  storage  of  the  GT73  oilseed  rape,  and  its  use  as  feed  as 
well as in the processing for feed, and its industrial uses as or in products. 

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, 
the  competent  authority  of  the  Netherlands  prepared  an  assessment  report,  which  is 
submitted  to  the  Commission  and  the  competent  authorities  of  other  Member  States. 
That assessment report concludes that no reasons have emerged on the basis of which 
consent for the placing on the market of GT73 oilseed rape should be withheld.  

1 

OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 of the European 
Parliament and of the Council (OJ L 268, 18.10.2003, p. 24). 

EN 

3 

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(5) 

(6) 

(7) 

(8) 

(9) 

The competent authorities of certain Member States raised objections to the placing on 
the market of the product. 

The opinion adopted on 11 February 2004 by the European Food Safety Authority, as 
established  by  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the 
Council  of  28  January  2002  laying  down  the  general  principles  and  requirements  of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures  in  matters  of  food  safety2,  concluded,  from  all  evidence  provided,  that 
Brassica napus L., GT73 line is as safe as conventional oilseed rape for humans and 
animals, and in the context of the proposed uses, for the environment. The European 
Food  Safety  Authority  also  found  that  the  monitoring  plan  provided  by  the  consent 
holder was appropriate for the intended uses of the GT73 oilseed rape. 

An examination of each of the objections in the light of Directive 2001/18/EC, of the 
information  submitted  in  the  notification  and  of  the  opinion  of  the  European  Food 
Safety  Authority,  discloses  no  reason  to  believe  that  the  placing  on  the  market  of 
Brassica  napus  L.,  GT73  line  will  adversely  affect  human  or  animal  health  or  the 
environment. 

Refined oil from GT73 oilseed rape has been commercially released for food purposes 
in  the  Community  in  accordance  with  the  procedure  referred  to  in  Article  5  of 
Regulation  (EC)  No  258/97  of  the  European  Parliament  and  the  Council  of 
27 January 1997 concerning novel foods and novel food ingredients3. 

A  unique  identifier  should  be  assigned  to  the  GT73  oilseed  rape  for  the  purposes  of 
Regulation  (EC)  No  1830/2003  of  the  European  Parliament  and  of  the  Council  of 
22 September  2003  concerning  the  traceability  and  labelling  of  genetically  modified 
organisms  and  the  traceability  of  food  and  feed  products  produced  from  genetically 
modified  organisms  and  amending  Directive  2001/18/EC4  and  Commission 
Regulation  (EC)  No  65/2004  of  14  January  2004  establishing  a  system  for  the 
development and assignment of unique identifiers for genetically modified organisms5. 

(10)  Adventitious  or  technically  unavoidable  traces  of  genetically  modified  organisms  in 
products are exempted from labelling and traceability requirements in accordance with 
(EC) 
thresholds  established  under  Directive  2001/18/EC  and  Regulation 
No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed6. 

(11) 

In the light of the opinion of the European Food Safety Authority, it is not necessary to 
establish  specific  conditions  for  the  intended  uses  with  regard  to  the  handling  or 
packaging of the product and the protection of particular ecosystems, environments or 
geographical areas.  

2 

3 

4 
5 
6 

OJ L 31, 1.2.2002, p. 1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1642/2003  (OJ L 245, 
29.9.2003, p. 4). 
OJ L 43, 14.2.1997, p. 1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1882/2003  (OJ L 284, 
31.10.2003, p. 1). 
OJ L 268, 18.10.2003, p. 24. 
OJ L 10, 16.1.2004, p. 5-10. 
OJ L 268, 18.10.2003, p. 1. 

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(12) 

In  the  light  of  the  opinion  of  the  European  Food  Safety  Authority,  an  appropriate 
management  system  should  be  in  place  to  prevent  grains  of  GT73  oilseed  rape 
entering cultivation. 

(13)  Prior to the placing on the market of the product, the necessary measures to ensure its 
labelling  and  traceability  at  all  stages  of  its  placing  on  the  market,  including 
verification by appropriate validated detection methodology, should be applicable. 

(14)  The  Committee  established  under  Article  30  of  Directive  2001/18/EC  has  not 
delivered  an  opinion  on  the  measures  laid  down  in  a  draft  Commission  Decision, 
following  its  consultation,  on  16  June  2004,  in  accordance  with  the  procedure  laid 
down in Article 30(2) of that Directive, 

HAS ADOPTED THIS DECISION: 

Article 1 
Consent 

Without prejudice to other  Community legislation, in particular Regulation (EC) No 258/97 
and  Regulation  (EC)  No  1829/2003,  written  consent  shall  be  granted  by  the  competent 
authority of the Netherlands to the placing on the market, in accordance with this Decision, of 
the  product  identified  in  Article  2,  as  notified  by  Monsanto  Europe  S.A.  (Reference 
C/NL/98/11). 

The  consent  shall,  in  accordance  with  Article  19(3)  of  Directive  2001/18/EC,  explicitly 
specify the conditions to which the consent is subject, which are set out in Articles 3 and 4. 

Article 2 
Product 

1. 

The  genetically  modified  organisms  to  be  placed  on  the  market  as  or  in  products, 
hereinafter  ‘the  product’,  are  grains  of  oilseed  rape  (Brassica  napus  L.),  with 
tolerance to the herbicide glyphosate, derived from the oilseed rape GT73 line, which 
the  vector 
tumefaciens,  using 
has  been 
PV-BNGT04. The product contains the following DNA in two cassettes: 

transformed  with  Agrobacterium 

(a)  Cassette 1 

A 5-enolpyruvylshikimate-3-phospate  synthase  (epsps)  gene  derived  from 
Agrobacterium  sp.  strain  CP4  (CP4  EPSPS),  which  confers  glyphosate 
tolerance, under the regulation of the modified figwort mosaic virus promoter 
(P-CMoVb),  terminator  sequences  from  the  pea  rbcS  E9  gene  encoding  the 
small  subunit  of  ribulose  bisphosphate  carboxylase/oxygenase  and  the 
N-terminal chloroplast transit peptide  CTP2  sequence  from  the epsps gene of 
Arabidopsis thaliana. 

(b)  Cassette 2 

The  variant  247  of  the  original  glyphosate  oxidoreductase  gene  (goxv247) 
derived from Ochrobactrum anthropi strain LBAA, which confers glyphosate 

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tolerance, under the regulation of the modified figwort mosaic virus promoter 
(P-CMoVb),  terminator  sequences  from  Agrobacterium  tumefaciens  and  the 
N-terminal  chloroplast  transit  peptide  sequence  CTP1  from  the  ribulose 
bisphosphate  carboxylase/oxygenase  (Arab-ssu1a)  gene  of  Arabidopsis 
thaliana. 

The product does not contain the adenyltransferase gene (aad) encoding resistance to 
streptomycin and spectinomycin, as present in the transformation vector used.  

2. 

3. 

The unique identifier of the product is MON-00073-7. 

The  consent  shall  cover  grains  from  progeny  derived  from  crosses  of  oilseed  rape 
line GT73 with any traditionally bred oilseed rape as or in products. 

Article 3 
Conditions for placing on the market 

The  product  may  be  put  to  the  same  uses  as  any  other  oilseed  rape,  with  the  exception  of 
cultivation and uses as or in food, and may be placed on the market subject to the following 
conditions: 

(a) 

(b) 

(c) 

(d) 

(e) 

1. 

the period of validity of the consent shall be for a period of 10 years starting from the 
date on which the consent is issued; 

the unique identifier of the product shall be MON-00073-7; 

without  prejudice  to  Article  25  of  Directive  2001/18/EC,  the  consent  holder  shall, 
whenever  requested  to  do  so,  make  positive  and  negative  control  samples  of  the 
product,  or  its  genetic  material,  or  reference  materials  available  to  the  competent 
authorities; 

the  words  ‘This  product  contains  genetically  modified  organisms’  or  ‘This  product 
contains genetically modified GT73 oilseed rape’ shall appear either on a label or in 
a  document  accompanying  the  product,  except  where  other  Community  legislation 
sets a threshold below which such information is not required; and 

as long as the product has not been authorised for the placing on the market for the 
purpose of cultivation, the words ‘not for cultivation’ shall appear either on a label or 
in a document accompanying the product. 

Article 4 
Monitoring 

Throughout the period of validity of the consent, the consent holder shall ensure that 
the monitoring plan, contained in the notification, to check for any adverse effects on 
human  and  animal  health  or  the  environment  arising  from  handling  or  use  of  the 
product, is put in place and implemented. 

EN 

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2. 

3. 

4. 

5. 

The  consent  holder  shall  directly  inform  the  operators  and  users  concerning  the 
safety  and  general  characteristics  of  the  product  and  of  the  conditions  as  to 
monitoring,  including  the  appropriate  management  measures  to  be  taken  in  case  of 
accidental grain spillage.  

The consent holder shall submit to the Commission and to the competent authorities 
of the Member States annual reports on the results of the monitoring activities. 

Without  prejudice  to  Article  20  of  Directive  2001/18/EC  the  monitoring  plan  as 
notified shall, where appropriate and subject to the agreement of the Commission and 
the competent authority of the Member State which received the original notification, 
be  revised  by  the  consent  holder  in  the  light  of  the  results  of  the  monitoring 
activities. 

The consent holder shall be in the position to give evidence to the Commission and 
the competent authorities of the Member States: 

(a) 

(b) 

that  the  existing  monitoring  networks,  as  specified  in  the  monitoring  plan 
contained  in  the  notification,  gathers  the  information  relevant  for  the 
monitoring of the product; and 

that  these  existing  monitoring  networks  have  agreed  to  make  available  that 
information  to  the  consent  holder  before  the  date  of  submission  of  the 
monitoring  reports  to  the  Commission  and  competent  authorities  of  the 
Member states in accordance with paragraph 3. 

Article 5 
Applicability 

This  Decision  shall  apply  from  the  date  on  which  a  detection  method  specific  to  the  GT73 
oilseed rape is validated by the Community reference laboratory as referred to in the Annex of 
Regulation  (EC)  No  1829/2003,  and  as  specified  in  Commission  Regulation7  (EC) 
No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003. 

Article 6 
Addressee 

This Decision is addressed to the Kingdom of the Netherlands. 

Done at Brussels, 

For the Council 
The President 

7 

OJ L 102, 7.4.2004, p. 14. 

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