Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the French and Dutch texts are authentic) (Text with EEA relevance)
Date: 2009-09-03
Institutions: European Commission
Subjects: United Kingdom, food safety, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, market approval

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 3.9.2009 
COM(2009) 443 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the French and Dutch texts are authentic) 
(Text with EEA relevance) 

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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  59122xNK603,  for  which  a  request  for 
placing  on  the  market  was  submitted  by  Pioneer  Overseas  Corporation  to  the  competent 
authority of the United Kingdom on 26 August 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 
and  consisting  of  59122xNK603  maize  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

On  25  November  2008,  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  containing, 
consisting of, or produced from 59122xNK603 maize 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. 

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 59122xNK603 was submitted to the Standing Committee on the Food Chain 
and  Animal  Health,  on  22  July  2009,  for  vote.  The  Committee  delivered  no  opinion: 
12 Member States (152 votes) voted in favour, 10 Member States (112 votes) voted against, 
4 Member States (77 votes) abstained and one Member State was not represented (4 votes). 

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 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the French and Dutch 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, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

(3) 

On  26  August  2005,  Pioneer  Overseas  Corporation  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, consisting of, or produced from 59122xNK603 maize 
('the application'). 

The application also covers the placing on the market of other products containing or 
consisting  of  59122xNK603  maize  for  the  same  uses  as  any  other  maize  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.  It  also  includes  a  monitoring  plan  for 
environmental effects conforming with Annex VII to Directive 2001/18/EC. 

On  25  November  2008,  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  containing,  consisting  of,  or  produced  from  59122xNK603  maize  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 uses3. In its opinion, 

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OJ L 268, 18.10.2003, p. 1. 
OJ L 106, 17.4.2001, p. 1.  
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-247 

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(4) 

(5) 

(6) 

(7) 

(8) 

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  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  foods,  food  ingredients  and  feed  containing,  consisting  of,  or 
produced  from  59122xNK603  maize.  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  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 for the use of the 
food  and  feed,  or  of  specific  conditions  for 
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. 

(9) 

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. 

(10)  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. 

(11)  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. 

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

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OJ L 10, 16.1.2004, p. 5. 
OJ L 268, 18.10.2003, p. 24. 
OJ L 287, 5.11.2003, p. 1. 

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(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, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically  modified  maize  (Zea  mays  L.)  59122xNK603,  as  specified  in  point  (b)  of  the 
Annex to this Decision, is assigned the unique identifier DAS-59122-7xMON-ØØ6Ø3-6, 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) 

1. 

2. 

1. 

2. 

foods and food ingredients containing, consisting of, or produced from DAS-59122-
7xMON-ØØ6Ø3-6 maize; 

feed  containing,  consisting  of,  or  produced  from  DAS-59122-7xMON-ØØ6Ø3-6 
maize; 

products other than food and feed containing or consisting of DAS-59122-7xMON-
ØØ6Ø3-6  maize  for  the  same  uses  as  any  other  maize  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 ’maize’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  DAS-59122-7xMON-ØØ6Ø3-6 
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 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. 

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Article 6 
Authorisation holder 

The  authorisation  holder  shall  be  Pioneer  Overseas  Corporation,  Belgium,  representing 
Pioneer Hi-Bred International, Inc., United States of America. 

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

Article 7 
Validity 

Article 8 
Addressee 

This  Decision  is  addressed  to  Pioneer  Overseas  Corporation,  Avenue  des  Arts  44,  B-1040 
Brussels – Belgium.  

Done at Brussels, 

For the Council 
The President 

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(a) 

Applicant and Authorisation holder: 

Name: 

Pioneer Overseas Corporation 

ANNEX 

Avenue des Arts 44, B-1040 Brussels - Belgium 

Address: 
On behalf of Pioneer Hi-Bred International, Inc. - 7100 NW 62nd Avenue – P.O. Box 
1014 – Johnston, IA 50131-1014 - United States of America. 

(b) 

Designation and specification of the products:  

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

59122-7xMON-ØØ6Ø3-6 maize; 

(2)  Feed  containing,  consisting  of,  or  produced  from  DAS-59122-7xMON-

ØØ6Ø3-6 maize; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  DAS-59122-
7xMON-ØØ6Ø3-6  maize  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

The genetically modified DAS-59122-7xMON-ØØ6Ø3-6 maize, as described in the 
application,  is  produced  by  crosses  between  maize  containing  DAS-59122-7  and 
MON-ØØ6Ø3-6 events and expresses the Cry34Ab1 and Cry35Ab1 proteins which 
confer  tolerance  to  certain  coleopteran  pests,  the  PAT  protein,  used  as  a  selectable 
marker, which confers tolerance to the glufosinate-ammonium herbicide and the CP4 
EPSPS protein which confers tolerance to glyphosate 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 ’maize’; 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  DAS-59122-7xMON-
ØØ6Ø3-6 maize referred to in Article 2(b) and (c) of this Decision. 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  quantitative  PCR  based  methods  for  genetically 
modified  maize  DAS-59122-7  and  MONØØ6Ø3-6  maize  validated  on  DAS-
59122-7xMON-ØØ6Ø3-6 maize; 

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: ERM®-BF424 (for DAS-59122-7) and ERM®-BF415 (for 
MON-ØØ6Ø3-6)  accessible  via  the  Joint  Research  Centre  (JRC)  of  the 
European Commission, the Institute of Reference Materials and Measurements 
at 
(IRMM) 
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm. 

(e) 

Unique identifier: 

DAS-59122-7xMON-ØØ6Ø3-6 

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(f) 

(g) 

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]. 

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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