Proposal for a Council Decision authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2008-10-30
Institutions: European Commission
Subjects: animal nutrition, consumer information, genetically modified organism, health policy, market approval, oil seed rape

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.10.2008 
COM(2008) 678 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing or produced from 
genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the 
commercialisation of this oilseed rape in third countries until 2005 pursuant to 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The attached proposal for a Council Decision concerns food and feed containing or produced 
from genetically modified oilseed rape T45, for which a request for placing on the market was 
submitted  by  Bayer  CropScience  AG  to  the  competent  authority  of  the  United  Kingdom  on 
28 October  2005,  under  Regulation  (EC)  No  1829/2003  on  genetically  modified  food  and 
feed.  

The  attached  proposal  also  concerns  the  placing  on  the  market  of  other  products  containing 
T45 oilseed rape for the same uses as any other oilseed rape with the exception of cultivation. 

The applicant indicated in its application and in communications to the Commission that the 
commercialisation of T45 oilseed rape seeds was stopped after the 2005 planting season. 

Therefore,  the  only  purpose  of  the  application  is  to  cover  the  presence  of  T45  oilseed  rape 
resulting from its past cultivation in third countries. 

On  5  March  2008,  the  European  Food  Safety  Authority  gave  a  favourable  opinion  in 
accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is 
unlikely  that  the  placing  on  the  market  of  the  products  containing  or  produced  from  T45 
oilseed  rape  as  described  in  the  application  will  have  adverse  effects  on  human  or  animal 
health or the environment. 

Against  this  background,  a  draft  Commission  Decision  authorising  the  placing  on  the 
Community  market  of  products  containing  or  produced  from  genetically  modified  oilseed 
rape T45 was submitted to the Standing Committee on the Food Chain and Animal Health, on 
14 July 2008, for vote. The Committee delivered no opinion: ten Member States (146 votes) 
voted  in  favour,  twelve  Member  States  (167  votes)  voted  against  and  five  Member  States 
(32 votes) abstained. 

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in 
accordance  with  Article  5  of  Council  Decision  1999/468/EC  modified  by  Council  Decision 
2006/512/EC, the Commission is required to submit to the Council a proposal relating to the 
measures to be taken, the Council having three months in which to act by a qualified majority, 
and inform the Parliament. 

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Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing or produced from 
genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the 
commercialisation of this oilseed rape in third countries until 2005 pursuant to 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council 

(Only the German text is authentic) 
(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the 
Council  of  22  September  2003  on  genetically  modified  food  and  feed1,  and  in  particular 
Articles 7(3) and 19(3) thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

On 28 October 2005, Bayer CropScience AG submitted to the competent authority of 
the  United  Kingdom  an  application,  in  accordance  with  Articles  5  and  17  of 
Regulation  (EC)  No  1829/2003,  for  the  placing  on  the  market  of  foods,  food 
ingredients, and feed containing or produced from T45 oilseed rape. 

The application also covers the placing on the market of other products containing T45 
oilseed  rape  for  the  same  uses  as  any  other  oilseed  rape  with  the  exception  of 
cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) 
No 1829/2003, it includes the data and information required by Annexes III and IV 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/EEC2 and information and conclusions about 
the risk assessment carried out in accordance with the principles set out in Annex II to 
Directive 2001/18/EC. 

(3) 

On  17  April  2007,  Bayer  CropScience  AG  submitted  to  the  Commission  an 
application,  in  accordance  with  Articles  8(4)  and  20(4)  of  Regulation  (EC) 
No 1829/2003,  for  the  authorisation  of  existing  products  produced  from  T45  oilseed 
rape (food additives and feed materials produced from T45 oilseed rape). 

1 
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OJ L 268, 18.10.2003, p 1. 
OJ L 106, 17.4.2001, p. 1. 

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(4) 

(5) 

(6) 

(7) 

(8) 

The applicant indicated in its applications and in communications to the Commission 
that  the  commercialisation  of  T45  oilseed  rape  seeds  was  stopped  after  the  2005 
planting season. 

Therefore,  the  only  purpose  of  these  applications  is  to  cover  the  presence  of  T45 
oilseed rape resulting from its past cultivation in third countries. 

On  5  March  2008,  the  European  Food  Safety  Authority  ('EFSA’)  gave  a  single 
comprehensive favourable opinion for both applications in accordance with Articles 6 
and  18  of  Regulation  (EC)  No  1829/2003  and  concluded  that  it  is  unlikely  that  the 
placing on the market of the products containing or produced from T45 oilseed rape as 
described in the applications ('the products') will have any adverse effects on human or 
animal health or the environment in the context of their intended uses3. In its opinion, 
EFSA considered all the specific questions and concerns raised by the Member States 
in the context of the consultation of the national competent authorities as provided for 
by Articles 6(4) and 18(4) of that Regulation. 

In  particular,  EFSA  concluded  that  as  no  indication  of  biologically  relevant 
compositional  and  agronomical  changes  was  identified  for  seeds  from  T45  oilseed 
rape except the presence of the PAT protein, no further animal safety studies with the 
whole food/feed (e.g. a 90-day toxicity study in rats) are needed. 

In  its  opinion,  EFSA  also  concluded  that  the  environmental  monitoring  plan, 
consisting of a general surveillance plan, submitted by the applicant is in line with the 
intended  use  of  the  products.  However,  due to  the  physical  characteristics  of  oilseed 
rape  seeds  and  methods  of  transportation,  EFSA  recommended  that  appropriate 
management  systems  should  be  in  place  to  minimise  accidental  loss  and  spillage  of 
transgenic  oilseed  rape  during  transportation,  storage,  handling  and  processing.  The 
monitoring plan submitted by the applicant has been modified to take into account this 
EFSA recommendation. 

(9) 

In  order  to  monitor  the  phasing  out  of  T45  oilseed  rape,  its  presence  in  imported 
products should be regularly reported. 

(10)  Taking into account those considerations, it is appropriate to grant an authorisation to 
the 

in  products  of  T45  oilseed  rape  resulting  from 

cover 
commercialisation of T45 oilseed rape seeds in third countries until 2005. 

the  presence 

(11)  A unique identifier should be assigned to each GMO as provided for in Commission 
Regulation  (EC)  No  65/2004  of  14  January  2004  establishing  a  system  for  the 
development and assignment of unique identifiers for genetically modified organisms4. 

(12)  On the basis of the EFSA opinion, no specific labelling requirements other than those 
provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to 
be  necessary  for  foods,  food  ingredients  and  feed  containing,  or  produced  from  T45 
oilseed rape. However, in order to ensure the use of the products within the limits of 
the  authorisation  provided  for  by  this  Decision,  the  labelling  of  feed  containing  the 
GMO  and  other  products  than  food  and  feed  containing  the  GMO  for  which 

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http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620786239.htm 
OJ L 10, 16.1.2004, p. 5. 

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authorisation  is  requested  should  be  complemented  by  a  clear  indication  that  the 
products in question must not be used for cultivation. 

(13)  Similarly, the EFSA opinion does not justify the imposition of specific conditions or 
restrictions for the placing on the market and/or specific conditions or restrictions for 
the  use  and  handling,  including  post-market  monitoring  requirements,  or  of  specific 
conditions 
the  protection  of  particular  ecosystems/environment  and/or 
geographical  areas,  as  provided  for  in  point  (e)  of  Articles  6(5)  and  18(5)  of 
Regulation (EC) No 1829/2003. 

for 

(14)  All relevant information on the authorisation of the products should be entered in the 
Community  register  of  genetically  modified  food  and  feed,  as  provided  for  in 
Regulation (EC) No 1829/2003. 

(15)  Article 4(6) 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/EC5,  lays  down 
labelling requirements for products consisting or containing GMOs. 

(16)  This Decision is to be notified through the Biosafety Clearing-House to the Parties to 
the  Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological  Diversity 
pursuant  to  Articles  9(1)  and  15(2)(c)  of  Regulation  (EC)  No  1946/2003  of  the 
European Parliament and of the Council of 15 July 2003 on transboundary movements 
of genetically modified organisms6. 

(17)  The applicant has been consulted on the measures provided for in this Decision. 

(18)  The Standing Committee on the Food Chain and Animal Health has not delivered an 

opinion within the time-limit laid down by its Chairman, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically  modified  oilseed  rape  (Brassica  napus  L.)  T45,  as  specified  in  point  (b)  of  the 
Annex to this Decision, is assigned the unique identifier ACS-BNØØ8-2, as provided for in 
Regulation (EC) No 65/2004. 

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OJ L 268, 18.10.2003, p. 24. 
OJ L 287, 5.11.2003, p. 1. 

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1. 

2. 

1. 

2. 

1. 

2. 

1. 

Article 2 
Authorisation 

The purpose of this Decision is to grant an authorisation covering, for the products 
referred  to  in  paragraph  2,  the  presence  of  ACS-BNØØ8-2  oilseed  rape  resulting 
directly  or  indirectly  from  the  commercialisation,  until  2005,  of  ACS-BNØØ8-2 
oilseed rape seeds in third countries. 

The following products are authorised for the purposes of Articles 4(2) and 16(2) of 
Regulation  (EC)  No  1829/2003  in  accordance  with  the  conditions  set  out  in  this 
Decision: 

(a) 

foods  and  food  ingredients  containing  or  produced  from  ACS-BNØØ8-2 
oilseed rape; 

(b) 

feed containing or produced from ACS-BNØØ8-2 oilseed rape; 

(c) 

products other than food and feed containing ACS-BNØØ8-2 oilseed rape for 
the same uses as any other oilseed rape with the exception of cultivation. 

Article 3 
Labelling 

For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) 
of  Regulation  (EC)  No  1829/2003  and  in  Article  4(6)  of  Regulation  (EC)  No 
1830/2003, the ’name of the organism’ shall be ’oilseed rape’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  ACS-BNØØ8-2  oilseed  rape  referred  to  in 
Article 2.2(b) and (c). 

Article 4 
Monitoring for environmental effects 

The  authorisation  holder  shall  ensure  that  the  monitoring  plan  for  environmental 
effects, as set out in point (h) of the Annex, is put in place and implemented. 

The  authorisation  holder  shall  submit  to  the  Commission  annual  reports  on  the 
implementation and the results of the activities set out in the monitoring activities. 

Article 5 
Monitoring of the phasing out 

The authorisation holder shall ensure that shipments of oilseed rape imported in the 
European  Union  from  a  third  country  in  which  ACS-BNØØ8-2  oilseed  rape  seeds 
were  commercialised  until  2005  are  sampled  and  tested  for  the  presence  of  ACS-
BNØØ8-2 oilseed rape. 

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2. 

3. 

The method used for the sampling of oilseed rape shall be internationally recognised. 
The testing shall be made in a duly accredited laboratory and in accordance with the 
validated method of detection as set out in the Annex to this Decision. 

The  authorisation  holder  shall  submit  to  the  Commission,  together  with  the  reports 
referred  to  in  Article  4(2),  annual  reports  on  the  monitoring  activities  for  the 
presence of ACS-BNØØ8-2 oilseed rape. 

Article 6 
Community register 

The  information  set  out  in  the  Annex  to  this  Decision  shall  be  entered  in  the  Community 
register  of  genetically  modified  food  and  feed,  as  provided  for  in  Article  28  of  Regulation 
(EC) No 1829/2003. 

Article 7 
Authorisation holder 

The authorisation holder shall be Bayer Cropscience AG. 

Article 8 
Validity 

This Decision shall apply for a period of 10 years from the date of its notification. 

Article 9 
Addressee 

This  Decision  is  addressed  to  Bayer  CropScience  AG,  Alfred-Nobel-Strasse  50,  D  -  40789 
Monheim am Rhein - Germany.  

Done at Brussels, 

For the Council 
The President 

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ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

Bayer CropScience AG 

Address: 

Alfred-Nobel-Strasse 50, D - 40789 Monheim am Rhein - Germany 

(b) 

Designation and specification of the products:  

(1)  Foods  and  food  ingredients  containing  or  produced  from  ACS-BNØØ8-2 

oilseed rape; 

(2)  Feed containing or produced from ACS-BNØØ8-2 oilseed rape; 

(3)  Products  other  than  food  and  feed  containing  of  ACS-BNØØ8-2  oilseed  rape 

for the same uses as any other oilseed rape with the exception of cultivation. 

The  genetically  modified  ACS-BNØØ8-2  oilseed  rape,  as  described  in  the 
application,  expresses  the  PAT  protein  which  confers  tolerance  to  the  glufosinate-
ammonium herbicide.  

(c) 

Labelling: 

(1)  For  the  purposes  of  the  specific  labelling  requirements  laid  down  in  Articles 
13(1)  and  25(2)  of  Regulation  (EC)  No  1829/2003,  and  in  Article  4(6)  of 
Regulation  (EC)  No  1830/2003,  the  ’name  of  the  organism’  shall  be  ’oilseed 
rape’. 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying products containing ACS-BNØØ8-2 oilseed rape referred to in 
Article 2.2(b) and (c) of this Decision. 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  PCR  based  method  for  the  quantification  of  ACS-
BNØØ8-2 oilseed rape 

Validated  on  seeds  by  the  Community  reference  laboratory  established  under 
Regulation 
http://gmo-
(EC) 
crl.jrc.ec.europa.eu/statusofdoss.htm 

1829/2003, 

published 

No 

at 

Reference Material: AOCS 0208-A accessible via the American Oil Chemists 
Society at http://www.aocs.org/tech/crm/bayer_canola.cfm 

(e) 

Unique identifier: 

ACS-BNØØ8-2 

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(f) 

Information required under Annex II to the Cartagena Protocol on Biosafety to 
the Convention on Biological Diversity: 

Biosafety Clearing-House, Record ID: see [to be completed when notified] 

(g) 

Conditions or restrictions on the placing on the market, use or handling of the 
products: 

Not required. 

(h) 

Monitoring plan 

Monitoring plan for environmental effects conforming with Annex VII to Directive 
2001/18/EC 

[Link: plan published on the internet] 

(i) 

Post  market  monitoring  requirements  for  the  use  of  the  food  for  human 
consumption 

Not required. 

Note: links to relevant documents may need to be modified over the time. Those modifications 
will be made available to the public via the updating of the Community register of genetically 
modified food and feed. 

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