Proposal for a Council Decision authorising the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the French, Dutch and German texts are authentic)
Date: 2007-06-25
Institutions: European Commission
Subjects: agro-industry, animal nutrition, consumer information, genetically modified organism, health policy, human nutrition, market approval, sugar beet

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.6.2007 
COM(2007) 346 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of food and feed produced from genetically 
modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 
of the European Parliament and of the Council 

(Only the French, Dutch and German texts are authentic) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The  attached  proposal  for  a  Council  Decision  concerns  food  an  feed  produced  from 
genetically  modified  sugar  beet  H7-1,  for  which  a  request  for  placing  on  the  market  was 
submitted by KWS SAAT AG and Monsanto Europe S.A. to the competent authorities of The 
United Kingdom on 12 November 2004, under Regulation (EC) No 1829/2003 on genetically 
modified food and feed.  

On  20  December  2006,  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  produced  from  sugar  beet  H7-1  as 
described in the application will have any adverse effects on human or animal health or the 
environment  in  the  context  of  their  intended  uses.  In  giving  its  opinion,  the  Authority 
considered all specific questions and concerns raised by the Member States. 

Against  this  background,  a  draft  Commission  Decision  authorising  the  placing  on  the 
Community market of food and feed produced from genetically modified sugar beet H7-1 was 
submitted  to  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health,  on  19  April 
2007, for vote. The Committee delivered no opinion: sixteen Member States (195 votes) voted 
in  favour,  nine  Member  States  (92  votes)  voted  against  and  two  Member  States  (58  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 food and feed produced from genetically 
modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 
of the European Parliament and of the Council 

(Only the French, Dutch and German texts are 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, 

Whereas: 

(1) 

(2) 

(3) 

On 12 November 2004, KWS SAAT AG and Monsanto Europe S.A. submitted to the 
competent  authorities  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 produced from sugar beet H7-1 ('the application'). 

The initial scope of the application also included beet leaves and small pieces of roots 
resulting from the root processing that may be fermented to produce silage for animal 
feed.  These  products,  which  are  not  considered  as  produced  from  GMOs  but  as 
containing or consisting of GMOs, were removed from the scope of the application by 
the applicants on 14 February 2006.  

On  20  December  2006,  the  European  Food  Safety  Authority  (‘EFSA’)  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  produced  from  sugar  beet  H7-1,  as  described  in  the  application  ('the 
products') will have any adverse effects on human or animal health or the environment 
in  the  context  of  their  intended  uses2.  In  its  opinion,  EFSA  considered  all  specific 
questions and concerns raised by the Member States. 

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2 

OJ L 268, 18.10.2003, p 1. Regulation as amended by Commission Regulation (OJ L 368, 23.12.2006, 
p. 99). 
http://www.efsa.europa.eu/en/science/gmo/gm_ff_applications/more_info/741.html 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Taking  into  account  those  considerations,  authorisation  should  be  granted  for  the 
products. 

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 organisms3. 

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. 

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, as provided for 
in point (e) of Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003. 

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. 

In  accordance  with  Articles  4(2)  and  16(2)  of  Regulation  (EC)  No  1829/2003,  the 
conditions for authorisation of the products are binding all persons placing them on the 
market.  

(10)  No opinion was delivered by the Standing Committee on the Food Chain and Animal 

Health, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically modified sugar beet (Beta vulgaris subsp. vulgaris) H7-1, as specified in point (b) 
of the Annex to this Decision, is assigned the unique identifier KM-ØØØH71-4, as provided 
for in Regulation (EC) No 65/2004. 

Article 2 
Authorisation 

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) 

(b) 

foods and food ingredients produced from KM-ØØØH71-4 sugar beet; 

feed produced from KM-ØØØH71-4 sugar beet. 

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OJ L 10, 16.1.2004, p. 5. 

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Article 3 
Labelling 

For the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) 
of Regulation (EC) No 1829/2003, the 'name of the organism’ shall be 'sugar beet’. 

Article 4 
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 5 
Authorisation holders 

1. 

The authorisation holders shall be: 

(a)  KWS SAAT AG, Germany; 

and 

(b)  Monsanto  Europe  S.A.,  Belgium,  representing  Monsanto  Company,  United 

States of America. 

2. 

Both  authorisation  holders  shall  be  responsible  for  fulfilling  the  duties  imposed  on 
authorisation holders by this Decision and Regulation (EC) No 1829/2003. 

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

Article 6 
Validity 

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Article 7 
Addressees 

This Decision is addressed to: 

(a) 

KWS SAAT AG, Grimsehlstrasse 31– D 37574 Einbeck – Germany; 

and 

(b) 

Monsanto Europe S.A., Scheldelaan 460, Haven 627 – B 2040 Antwerp Belgium. 

Done at Brussels,  

For the Council 
The President 

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ANNEX 

(a) 

Applicants and Authorisation holders: 

Name: 

KWS SAAT AG.  

Address: 

Grimsehlstrasse 31– D 37574 Einbeck – Germany 

and 

Name: 

Monsanto Europe S.A.  

Address: 

Scheldelaan 460, Haven 627 – B 2040 Antwerp – Belgium 

On  behalf  of  Monsanto  Company  -  800  N.  Lindbergh  Boulevard  –  St.  Louis, 
Missouri 63167 - United States of America. 

(b) 

Designation and specification of the products:  

(1)  Foods and food ingredients produced from KM-ØØØH71-4 sugar beet; 

(2)  Feed produced from KM-ØØØH71-4 sugar beet. 

The genetically modified KM-ØØØH71-4 sugar beet, as described in the application, 
expresses  the  CP4  EPSPS  protein  after  insertion  of  the  cp4  epsps  gene  from 
Agrobacterium sp. strain CP4 into sugar beet (Beta vulgaris subsp. vulgaris).  

The CP4 EPSPS protein confers tolerance to glyphosate containing herbicides.  

(c) 

Labelling: 

For  the  purposes  of  the  specific  labelling  requirements  laid  down  in  Articles  13(1) 
and  25(2)  of  Regulation  (EC)  No  1829/2003,  the  'name  of  the  organism’  shall  be 
’sugar beet’. 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  PCR  based  method  for  the  quantification  of  KM-
ØØØH71-4 sugar beet. 

Validated  on  seeds  by  the  Community  reference  laboratory  established  under 
Regulation 
http://gmo-
crl.jrc.it/statusofdoss.htm 

1829/2003, 

published 

(EC) 

No 

at 

Reference  Material:  ERM®-BF419  accessible  via  the  Joint  Research  Centre 
(JRC)  of  the  European  Commission,  the  Institute  of  Reference  Materials  and 
Measurements (IRMM) at 
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm. 

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(e) 

Unique identifier: 

KM-ØØØH71-4 

(f) 

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

Not applicable. 

(g) 

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

Not required. 

(h) 

Monitoring plan 

Not applicable. 

(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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