Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the French text is authentic)
Date: 2008-01-31
Institutions: European Commission
Subjects: animal nutrition, cereal product, food safety, foodstuff, genetically modified organism, health policy, labelling, maize, market approval

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 31.1.2008 
COM(2008) 47 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council 

(Only the French text is authentic) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The attached proposal for a Council Decision concerns food and feed containing, consisting 
of, or produced from genetically modified maize GA21, for which a request for placing on the 
market  was  submitted  by  Syngenta  Seeds  S.A.S.  to  the  competent  authorities  of  the  United 
Kingdom  on  29  July  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 or 
consisting  of  maize  GA21  for  the  same  uses  as  any  other  maize  with  the  exception  of 
cultivation. 

On  31  Mars  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 containing, consisting of, or produced 
from  maize  GA21  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,  consisting  of,  or  produced  from  genetically 
modified  maize  GA21  was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and 
Animal Health, on 20 December 2007, for vote. The Committee delivered no opinion: thirteen 
Member States (155 votes) voted in favour, five Member States (65 votes) voted against, six 
Member  States  (114  votes)  abstained  and  three  Member  States  (11  votes)  were  not 
represented. 

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, consisting of, or produced 
from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council 

(Only the French 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 
Article 7(3) and Article 19(3) thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

On 29 July 2005, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, 
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  containing,  consisting  of,  or 
produced from GA21 maize.  

That application also covers the placing on the market of other products containing or 
consisting of GA21 maize for the same uses as any other maize with the exception of 
cultivation. Therefore, in accordance with the provision of 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. 

1 

2 

OJ  L  268,  18.10.2003,  p  1.  Regulation  as  amended  by  Commission  Regulation  (EC)  No  1981/2006 
(OJ L 368, 23.12.2006, p. 99). 
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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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

On 17 April 2007, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection 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  GA21  maize  (food  additives,  feed  materials  and  feed  additives 
produced from GA21 maize). 

On  2  October  2007,  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,  consisting  of,  or  produced  from 
GA21 maize as described in the applications ('the products') will have adverse effects 
on human or  animal health or  the environment3. In its  opinion, EFSA considered  all 
specific  questions  and  concerns  raised  by  the  Member  States  in  the  context  of  the 
consultation of the national competent authorities provided for by Articles 6 (4) and 18 
(4) of that Regulation. 

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. 

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 organisms4. 

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  the  foods,  food  ingredients,  and  feed  containing,  consisting  of,  or 
produced  from  GA21  maize.  However,  in  order  to  ensure  the  use  of  the  products 
within  the  limits  of  authorisation  provided  by  this  Decision,  the  labelling  of  feed 
containing or consisting of the GMO and other products than food and feed containing 
or  consisting  of  the  GMO  for  which  authorisation  is  requested  should  be 
complemented by a clear indication that the products in question must not be used for 
cultivation.  

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 

(10)  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. 

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4 

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785956.htm 
OJ L 10, 16.1.2004, p. 5. 

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(11)  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 of or containing GMOs. 

(12)  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 Article 9(1) and Article 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. 

(13)  The Standing Committee on the Food Chain and Animal Health has not delivered an 
opinion within the time-limit laid down by its Chairman and the measures provided for 
in this Decision must therefore be adopted by the Council, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically modified maize (Zea mays L.) GA21, as specified in point (b) of the Annex to this 
Decision,  is  assigned  the  unique  identifier  MON-ØØØ21-9,  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) 

(c) 

foods  and  food  ingredients  containing,  consisting  of,  or  produced  from  MON-
ØØØ21-9 maize; 

feed containing, consisting of, or produced from MON-ØØØ21-9 maize; 

products,  other  than  food  and  feed,  containing  or  consisting  of  MON-ØØØ21-9 
maize for the same uses as any other maize with the exception of cultivation. 

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6 

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

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Article 3 
Labelling 

1. 

2. 

1. 

2. 

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 ’maize’. 

The  words  ‘not  for  cultivation’  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  MON-ØØØ21-9  maize  referred 
to in Article 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 the 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 plan.  

Article 5 
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 6 
Authorisation holder 

The authorisation holder shall be Syngenta Seeds S.A.S., France, representing Syngenta Crop 
Protection AG, Switzerland. 

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

Article 7 
Validity 

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Article 8 
Addressee 

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de l'Hobit 12, BP 27 – F-31790 
Saint-Sauveur - France. 

Done at Brussels, 

For the Council 
The President 

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ANNEX  

(a) 

Applicant and Authorisation holder: 

Name: 

Syngenta Seeds S.A.S. 

Address: 

Chemin de l'Hobit 12, BP 27 – F-31790 Saint-Sauveur – France 

On behalf of Syngenta Crop Protection AG - Schwarzwaldallee 215 - CH 4058 Basle 
- Switzerland  

(b) 

Designation and specification of the products:  

(1)  Foods and food ingredients containing, consisting of, or produced from MON-

ØØØ21-9 maize; 

(2)  Feed containing, consisting of, or produced from MON-ØØØ21-9 maize; 

(3)  Products other than food and feed containing or consisting of MON-ØØØ21-9 

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

The  genetically  modified  maize  MON-ØØØ21-9,  as  described  in  the  application, 
expresses the mEPSPS protein which confers tolerance to herbicide glyphosate 

(c) 

Labelling: 

(1)  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 ’maize’. 

(2)  The words ‘not for cultivation’ shall appear on the label of and in documents 
accompanying  products  containing  or  consisting  of  MON-ØØØ21-9  maize 
referred to in Article 2(b) and (c). 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  quantitative  PCR  based  methods  for  genetically 
modified maize MON-ØØØ21-9. 

Validated by the Community reference laboratory established under Regulation 
(EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm 

Reference Material: AOCS 0407-A and AOCS 0407-B accessible via the 
American Oil Chemists Society (AOCS) at http://www.aocs.org 

(e) 

Unique identifier: 

MON-ØØØ21-9 

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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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