Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the French, Dutch and English texts are authentic)
Date: 2007-07-09
Institutions: European Commission
Subjects: cereal product, consumer information, foodstuff, genetically modified organism, labelling, maize, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 9.7.2007 
COM(2007) 397 final 

Proposal for a 

COUNCIL DECISION 

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

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

(presented by the Commission) 

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

The attached proposal for a Council Decision concerns food and feed containing, consisting 
of, or produced from genetically modified 59122 maize, for which a request for placing on the 
market  was  submitted  by  Pioneer  Overseas  Corporation  to  the  competent  authorities  of  the 
Netherlands  on  24  January  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  59122  maize  for  the  same  uses  as  any  other  maize  with  the  exception  of 
cultivation. 

On 2 April 2007, 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  59122  maize  as  described  in  the  application  will  have  adverse  effects  on  human  or 
animal health or the environment1. 

Against  this  background,  a  draft  Commission  Decision  authorising  the  placing  on  the 
Community  market  of  products  containing,  consisting  of,  or  produced  from  genetically 
modified  59122  maize  was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and 
Animal  Health,  on  25  June  2007,  for  vote.  The  Committee  delivered  no  opinion:  fifteen 
Member  States  (197  votes)  voted  in  favour,  seven  Member  States  (52  votes)  voted  against, 
four  Member  States  (69  votes)  abstained  and  one  Member  State  (27  votes)  was  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. 

1 

http://www.efsa.europa.eu/en/science/gmo/gm_ff_applications/more_info/809.html 

EN 

2 

   EN 

 
                                                 
Proposal for a 

COUNCIL DECISION 

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

(Only the French, Dutch and English 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  feed2,  and  in  particular 
Articles 7(3) and 19(3) thereof, 

Whereas: 

(1) 

(2) 

On  24  January  2005,  Pioneer  Overseas  Corporation,  on  behalf  of  Pioneer  Overseas 
Corporation and Dow AgroSciences Europe, submitted to the competent authority of 
the  Netherlands  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 59122 maize ('the application').  

The application also covers the placing on the market of other products containing or 
consisting of 59122 maize for the same uses than 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/EC3 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  2  April  2007,  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  59122  maize  as  described  in  the  application  ('the 

2 

3 

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). 

EN 

3 

   EN 

 
 
                                                 
(4) 

(5) 

(6) 

(7) 

(8) 

products') will have adverse effects on human or animal health or the environment4. 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  its  opinion,  EFSA  also  concluded  that  the  environmental  monitoring  plan, 
consisting of a general surveillance plan, submitted by the applicants 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 organisms5.  

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  59122  maize.  However,  in  order  to  ensure  the  use  of  the  products 
within the limits of 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,  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 

(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/EC6,  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 Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the 

4 
5 
6 

http://www.efsa.europa.eu/en/science/gmo/gm_ff_applications/more_info/809.html 
OJ L 10, 16.1.2004, p. 5. 
OJ L 268, 18.10.2003, p. 24. 

EN 

4 

   EN 

 
                                                 
European Parliament and of the Council of 15 July 2003 on transboundary movements 
of genetically modified organisms7. 

(12)  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.)  59122,  as  specified  in  point  (b)  of  the  Annex  to 
this Decision,  is  assigned the  unique  identifier DAS-59122-7, 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 1829/2003, in accordance with the conditions set out in this Decision: 

(a) 

(b) 

(c) 

1. 

2. 

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

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

products, other than food and feed, containing or consisting of DAS-59122-7 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-59122-7 maize referred to 
in Article 2(b) and (c). 

Article 4 
Monitoring for environmental effects 

1. 

The  authorisation  holders  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. 

7 

OJ L 287, 5.11.2003, p. 1. 

EN 

5 

   EN 

 
                                                 
2. 

The  authorisation  holders  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 holders 

1. 

The authorisation holders shall be : 

(a)  Pioneer  Overseas  Corporation,  Belgium,  representing  Pioneer  Hi-Bred 

International, United States; 

and 

(b)  Dow  AgroSciences  Europe,  United  Kingdom,  representing  Mycogen  Seeds, 

United States, 

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 7 
Validity 

Article 8 
Addressees 

This Decision is addressed to: 

(a) 

Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels, Belgium 

and 

EN 

6 

   EN 

 
(b) 

Dow  AgroSciences  Europe  Ltd.,  European  Development  Centre,  3  Milton  Park, 
Abingdon , Oxon OX14 4RN, United Kingdom 

Done at Brussels, 

For the Council 
The President 

EN 

7 

   EN 

 
 
 
ANNEX 

(a) 

Applicants and Authorisation holders: 

Name: 

Pioneer Overseas Corporation  

Address: 

Avenue des Arts 44, B-1040 Brussels, Belgium 

On behalf of Pioneer Hi-Bred International, Inc., 7250 NW 62nd Avenue, P. O. Box 
552, Johnston, IA 50131-0552, United States; 

and 

Name: 

Dow AgroSciences Europe Ltd. 

Address: 

European  Development  Centre,  3  Milton  Park,  Abingdon, 
Oxon OX14 4RN, United Kingdom 

On  behalf  of  Mycogen  Seeds  c/o  Dow  AgroSciences  LLC,  9330  Zionsville  Road, 
Indianapolis, IN 46268-1054, United States.  

(b) 

Designation and specification of the products:  

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

59122-7 maize; 

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

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  DAS-59122-7 

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

The  genetically  modified  maize  DAS-59122-7,  as  described  in  the  application, 
expresses Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain 
coleopteran  pests  such  as  corn  rootworm  larvae  (Diabrotica  spp.)  and  the  PAT 
protein,  used  as  a  selectable  marker,  which  confers  tolerance  to  the  glufosinate-
ammonium herbicide. 

(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  DAS-59122-7  maize 
referred to in Article 2(b) and (c). 

EN 

8 

   EN 

 
 
 
 
 
 
(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  quantitative  PCR  based  method  for  genetically 
modified maize DAS-59122-7. 

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

Reference Material: ERM®-BF424 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 

(e) 

Unique identifier: 

DAS-59122-7  

(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. 

EN 

9 

   EN