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 oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium
Date: 2006-07-11
Institutions: European Commission
Subjects: genetically modified organism, labelling, marketing, marketing standard, oil seed rape, plant health legislation, plant health treatment

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.7.2006 
COM(2006) 78 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 oilseed rape products (Brassica napus L., 
lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide 
glufosinate-ammonium 

(presented by the Commission) 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  Belgian  authorities 
received a notification (Reference C/BE/96/01) concerning the placing on the market 
of  oilseed  rape  products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and  Ms8xRf3), 
genetically modified for tolerance to the herbicide glufosinate-ammonium. 

The  notification  covered  cultivation  and  import  of  the  genetically  modified  oilseed 
rape products  (Brassica napus L., lines Ms8,  Rf3 and  Ms8xRf3) for  all uses as for 
any other oilseed rape including use as or in feed, but with the exception of uses as or 
in food, in the Community. 

In  accordance  with  Article  14  of  the  Directive,  the  Belgian  competent  authority 
forwarded  to  the  Commission  its  assessment  report  of  the  notification,  which 
concluded  that  the  genetically  modified  oilseed  rape  products  (Brassica  napus  L., 
lines  Ms8,  Rf3  and  Ms8xRf3)  should  be  placed  on  the  market  for  import  and 
processing  and  for  use  as  any  other  oilseed  rape  but  not  for  the  requested  use  of 
cultivation. 

The Commission forwarded the assessment report to all other Member States, some 
of  which  raised  and  maintained  objections  to  the  placing  on  the  market  of  the 
products  in  terms  of  allergenicity,  toxicity,  monitoring  plan,  pollen  dispersal, 
accidental  spillage  and  detection  of  the  products;  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, shall, without delay, submit 
to  the  Council  a  proposal  relating  to  the  measures  to  be  taken  and  inform  the 
European  Parliament  (informed  on  6  December  2005).  The  European  Parliament 
may consider appropriate to take a position in accordance with Article 8 of the above 
Decision. 

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  on  the  proposal 
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 shall 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 shall be adopted 
by the Commission. 

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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 oilseed rape products (Brassica napus L., 
lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide 
glufosinate-ammonium 

(Only the Dutch and French texts are authentic) 

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  genetically  modified  oilseed 
rape  products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and  Ms8xRf3)  was  submitted  by 
Bayer BioScience N.V. to the competent authority of Belgium. 

The  notification  covered  cultivation  and  import  of  the  genetically  modified  oilseed 
rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) for all uses as for any 
other oilseed rape including use as or in feed, but with the exception of uses as or in 
food, in the Community. 

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, 
the  competent  authority  of  Belgium  prepared  an  assessment  report,  which  was 
submitted to the  Commission and the competent authorities of other Member States; 
whereby  the  assessment  report  concluded  that  the  genetically  modified  oilseed  rape 
products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and  Ms8xRf3)  should  be  placed  on  the 

1 

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

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(5) 

(6) 

(7) 

(8) 

(9) 

market for import and processing and for use as any other oilseed rape but not for the 
requested use of cultivation.  

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

In  view  of  the  objections  raised  by  the  competent  authority  of  Belgium  and  other 
Member  States  concerning  cultivation  of  the  genetically  modified  oilseed  rape 
products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and  Ms8xRf3),  the  opinion  of  EFSA  is 
restricted to import and processing, including use in feed. 

The  opinion  adopted  in  September  2005  by  the  European  Food  Safety  Authority, 
concluded that the genetically modified oilseed rape products (Brassica napus L., lines 
Ms8,  Rf3  and  Ms8xRf3)  are  as  safe  as  conventional  oilseed  rape  for  humans  and 
animals,  and in  the  context of  the  intended uses, for the environment. The European 
Food  Safety  Authority  also  concluded  that  the  monitoring  plan  provided  in  the 
notification was acceptable in view of the intended uses. 

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 the 
genetically  modified  oilseed  rape  products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and 
Ms8xRf3) will adversely affect human or animal health or the environment. 

Processed oil from genetically modified oilseed rape derived from (a) the Ms8 oilseed 
rape  line  and  all  conventional  crosses,  (b)  the  Rf3  oilseed  rape  line  and  all 
conventional crosses and (c) the hybrid combination Ms8 x Rf3 has been placed on the 
market  in  accordance  with  Art.  5  of  Regulation  (EC)  No  258/97  of  the  European 
Parliament and the Council of 27 January 1997 concerning novel foods and novel food 
ingredients2. As a consequence, it is subject to the requirements provided for in Article 
8 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 
22 September 2003 on genetically modified food and feed3 and may be placed on the 
market  and  used  in  accordance  with  the  conditions  mentioned  in  the  Community 
register of genetically modified food and feed. 

(10)  Unique identifiers should be assigned to the genetically modified oilseed rape products 
(Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) 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. 

2 

3 
4 
5 

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.1. 
OJ L 268, 18.10.2003, p.24. 
OJ L 10, 16.01.2004, p. 5-10. 

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(11)  Adventitious  or  technically  unavoidable  traces  of  genetically  modified  organisms  in 
products are exempted from labelling and traceability requirements in accordance with 
thresholds  established  under  Directive  2001/18/EC  and  Regulation  (EC)  No 
1829/2003. 

(12) 

(13) 

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 products and the protection of particular ecosystems, environments or 
geographical areas.  

In  the  light  of  the  opinion  of  the  European  Food  Safety  Authority,  an  appropriate 
management system should be in place to prevent grains of the genetically modified 
oilseed  rape  products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and  Ms8xRf3)  entering 
cultivation. 

(14)  Prior to the placing on the market of the products, 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. 

(15)  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 5 December 2005, 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  Belgium  to  the  placing  on  the  market,  in  accordance  with  this  Decision,  of  the 
products  identified  in  Article  2,  as  notified  by  Bayer  BioScience  N.V.  (Reference 
C/BE/96/01). 

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 
Products 

1. 

The  genetically  modified  organisms  to  be  placed  on  the  market  as  or  in  products, 
hereinafter  ‘the  products’,  are  grains  of  oilseed  rape  (Brassica  napus  L.)  from  the 
individual female and male lines containing events Ms8 and Rf3 respectively as well 
grains  obtained  from  traditional  crossings  (Ms8xRf3  hybrid)  between  these  female 
and male parental lines, which contain the following inserted DNA; 

Female line (Ms8) 

(1) 

PTA29-barnase-3’nos: 

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•  The tapetum cell-specific promoter PTA29 from Nicotiana tabacum 

•  The barnase gene from Bacillus amyloliquefaciens to engineer male sterility 

•  Part  of  the  3’  non-coding  region  (3’  nos)  of  the  nopaline  synthase  gene  of 

Agrobacterium tumefaciens 

(2) 

PssuAra-bar-3’g7: 

•  The PssuAra promoter from Arabidopsis thaliana 

•  The bar gene isolated from Streptomyces hygroscopicus conferring tolerance to the 

herbicide glufosinate-ammonium 

•  The  3’  untranslated  sequence  of  the  TL-DNA  gene  7  of  Agrobacterium 

tumefaciens 

Male line (Rf3) 

(1) 

PTA29-barstar-3’nos: 

•  The tapetum cell-specific promoter PTA29 from Nicotiana tabacum 

•  The barstar gene from Bacillus amyloliquefaciens to engineer fertility restoration 

•  Part  of  the  3’  non-coding  region  (3’  nos)  of  the  nopaline  synthase  gene  of 

Agrobacterium tumefaciens 

(3) 

PssuAra-bar-3’g7: 

•  The PssuAra promoter from Arabidopsis thaliana 

•  The bar gene isolated from Streptomyces hygroscopicus conferring tolerance to the 

herbicide glufosinate-ammonium 

•  The  3’  untranslated  sequence  of  the  TL-DNA  gene  7  of  Agrobacterium 

tumefaciens 

2. 

The  consent  shall  cover  grains  from  progeny  derived  from  crosses  of  oilseed  rape 
line  Ms8,  Rf3  and  Ms8xRf3  with  any  traditionally  bred  oilseed  rape  as  or  in 
products. 

Article 3 
Conditions for placing on the market 

The  products  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) 

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; 

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(b) 

the unique identifiers of the products shall be; 

ACS-BNØØ5-8 for lines containing the Ms8 event alone;  

ACS-BNØØ3-6 for lines containing the Rf3 event alone, and; 

(c) 

(d) 

ACS-BNØØ5-8 x ACS-BNØØ3-6 for hybrid lines containing both the Ms8 and Rf3 
events. 

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 
products, or their genetic material, or reference materials available to the competent 
authorities; 

without prejudice to specific labelling requirements provided by Regulation (EC) No 
1829/2003,  the  words  ‘This  product  contains  genetically  modified  oilseed  rape’  or 
‘This  product  contains  genetically  modified  Ms8  oilseed  rape’  or  ‘This  product 
contains genetically modified Rf3 oilseed rape’ or ‘This product contains genetically 
modified Ms8xRf3 oilseed rape’, as appropriate, 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 

(e) 

as long as the products have 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 products.  

Article 4 
Monitoring 

1. 

2. 

3. 

4. 

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

The  consent  holder  shall  directly  inform  the  operators  and  users  concerning  the 
safety  and  general  characteristics  of  the  products  and  of  the  conditions  as  to 
monitoring,  including  the  appropriate  management  measures  to  be  taken  in  case  of 
accidental grain spillage. Technical guidelines for the implementation of this Article 
are provided in the Annex to this Decision. 

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, and/or by the competent authority of the Member 
State  which  received  the  original  notification,  in  the  light  of  the  results  of  the 
monitoring activities. Proposals for a revised monitoring plan shall be submitted to 
the competent authorities of the Member States. 

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5. 

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 products; 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 detection methods specific to the Ms8 and 
Rf3 events and the Ms8xRf3 hybrid oilseed rape are validated by the Community Reference 
Laboratory as referred to in the Annex of Regulation (EC) No 1829/2003, and as specified in 
Commission  Regulation  (EC)  No  641/2004  6  on  detailed  rules  for  the  implementation  of 
Regulation (EC) No 1829/2003. 

This Decision is addressed to the Kingdom of Belgium. 

Done at Brussels,  

For the Council 
The President 

6 

OJ L 102, 07.04.2004, p.14. 

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ANNEX  

Technical guidelines for the implementation of Article 4(2) 

1. 

The  consent  holder  should  inform  operators  in  the  Community  who  handle  and 
process bulk mixtures of imported oilseed rape grains which may contain Ms8, Rf3 
and Ms8xRf3 oilseed rape that: 

(a)  Ms8, Rf3 and Ms8xRf3 oilseed rape has received consent for import and use, 
in  accordance  with  the  definition  given  in  Article  3  of  the  Decision,  in  the 
Community; 

(b) 

the establishment of a general surveillance plan for any unanticipated adverse 
effects  arising  from  the  placing  on  the  market  of  Ms8,  Rf3  and  Ms8xRf3 
oilseed rape for the above uses is a condition of consent. 

The  consent  holder  should  provide  operators  with  a  national  contact  person  for  the 
reporting of any unanticipated adverse effects. 

The consent holder should inform operators that the possibility of and consequences 
arising  from  accidental  spillage  of  Ms8,  Rf3  and  Ms8xRf3  oilseed  rape  have  been 
evaluated  by  the  European  Food  Safety  Authority  (EFSA)  in  the  context  of  its 
intended uses. The consent holder should maintain regular contact with operators to 
ensure that they are informed of any changes to current practice which may change 
the conclusions of the environmental risk assessment. 

The  consent  holder  should  ensure  that  operators  are  alert  to  the  possibility  that 
accidental  spillage  of  imported  oilseed  rape  grains  in  ports  and  crushing  facilities 
may result in the germination and establishment of volunteer plants, including Ms8, 
Rf3 and Ms8xRf3 oilseed rape. 

In the event that volunteer oilseed rape plants include Ms8, Rf3 and Ms8xRf3 oilseed 
rape, the consent holder should: 

(a) 

inform  operators  that  these  plants  should  be  eradicated  to  minimise  the 
potential  for  unanticipated  adverse  effects  arising  from  the  Ms8,  Rf3  and 
Ms8xRf3 oilseed rape;  

(b)  provide operators with appropriate plans for eradicating volunteer oilseed rape 

plants that include Ms8, Rf3 and Ms8xRf3 oilseed rape.  

Under  Article  4(5)  of  Directive  2001/18/EC  and  section  C.1.6  of  Council  Decision 
2002/811/EC  of  3  October  2002  establishing  guidance  notes  supplementing  Annex 
VII to Directive 2001/18/EC7, Member States may carry out checks and/or additional 
monitoring with respect to accidental spillage of Ms8, Rf3 and Ms8xRf3 oilseed rape 
grains and identification of potential unanticipated adverse effects arising from such 
spillage. 

2. 

3. 

4. 

5. 

6. 

7 

OJ L 280, 18.10.2002, p. 27. 

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