Proposal for a COUNCIL DECISION amending Commission Decision 2006/197/EC as regards the renewal of the authorization to place on the market existing feed produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) 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)
Date: 2011-02-03
Institutions: European Commission
Subjects: animal nutrition, food inspection, foodstuff, genetically modified organism, labelling, maize, market approval

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EUROPEAN COMMISSION 

Brussels, 3.2.2011 
COM(2011) 36 final 

2011/0016 (NLE) 

Proposal for a  

COUNCIL DECISION 

amending Commission Decision 2006/197/EC as regards the renewal of the 
authorization to place on the market existing feed produced from genetically modified 
maize line 1507 (DAS-Ø15Ø7-1) 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) 

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EXPLANATORY MEMORANDUM 

The  attached  proposal  for  a  Council  Decision  concerns  the  renewal  of  the  authorization  for 
continued marketing of existing feed produced from genetically modified maize 1507 (DAS-
Ø15Ø7-1),  for  which  a  request  was  jointly  submitted  by  Pioneer  Overseas  Corporation  on 
behalf of Pioneer Hi-bred International and Dow AgroSciences on behalf of Mycogen Seeds, 
on  12  April  2007,  in  accordance  with  Article  23  of  the  Regulation  (EC)  No  1829/2003  on 
genetically modified food and feed. 

This  proposal  amends  Commission  Decision  2006/197/EC  authorizing  the  placing  on  the 
market  of  food  containing,  consisting  of,  or  produced  from  genetically  modified  maize  line 
1507, by extending its scope to the continued marketing of existing feed materials and feed 
additives produced from genetically modified maize 1507. 

On  11  June  2009,  the  European  Food  Safety  Authority  gave  a  favourable  opinion  in 
accordance  with  Article  18  of  Regulation  (EC)  No  1829/2003.  It  considered  that  the  new 
information  provided  in  the  application  and  the  review  of  the  scientific  literature  published 
since the previous scientific opinions of the EFSA GMO Panel on 1507 maize, do not require 
changes of the previous scientific opinions on 1507 maize. Therefore it reiterated its previous 
conclusions that 1507 maize is unlikely to have an adverse effect on human and animal health 
or the environment in the context of its proposed uses.  

Against  this  background,  a  draft  Commission  Decision  amending  Commission  Decision 
2006/197/EC  as  regards  the  renewal  of  the  authorization  for  placing  on  the  market  existing 
feed produced from genetically modified 1507 maize (DAS-Ø15Ø7-1) was submitted to the 
Standing Committee on the Food Chain and Animal Health on 15 November 2010, for vote. 
The  Committee  delivered  no  opinion:  13  Member  States  (183 votes)  voted  in  favour, 
7 Member States (73 votes) voted against, 7 Member States (89 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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2011/0016 (NLE) 

Proposal for a  

COUNCIL DECISION 

amending Commission Decision 2006/197/EC as regard the renewal of the authorization 
to place on the market existing feed produced from genetically modified maize line 1507 
(DAS-Ø15Ø7-1) 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 on the Functioning of the European Union, 

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 of the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Commission  Decision  2006/197/EC  of  3  March  2006  authorising  the  placing  on  the 
market of food containing, consisting of, or produced from genetically modified maize 
line  1507  (DAS-Ø15Ø7-1)  pursuant  to  Regulation  (EC)  No  1829/2003  of  the 
European Parliament and of the Council2 does not cover the placing on the market of 
feed produced from maize line 1507 (DAS-Ø15Ø7-1) (hereafter 'maize line 1507'). 

Feed produced from maize line 1507 has been placed on the market before the date of 
application  of  Regulation  (EC)  1829/2003  and  notified 
in  accordance  with 
Article 20(1)(b) of that Regulation. 

On  12  April  2007  Pioneer  Overseas  Corporation  on  behalf  of  Pioneer  Hi-bred 
International and Dow AgroSciences on behalf of Mycogen Seeds jointly submitted to 
the  Commission  an  application,  in  accordance  with  Article  23  of  Regulation  (EC) 
No 1829/2003,  for  renewal  of  the  authorisation  for  continued  marketing  of  existing 
feed produced from maize line 1507. 

On  11  June  2009,  the  European  Food  Safety  Authority  ('EFSA’)  gave  a  favourable 
opinion  in  accordance  with  Article  18  of  Regulation  (EC)  No  1829/2003  and 
concluded that the new information provided in the application and the review of the 
scientific literature that has been published since the previous scientific opinions of the 

1 
2 

OJ L 268, 18.10.2003, p. 1. 
OJ L 70, 9.3.2006, p. 82. 

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EFSA  GMO  Panel  on  maize  line  15073  do  not  require  changes  of  the  previous 
scientific  opinions  on  maize  line  1507.  Furthermore,  EFSA  reiterated  the  previous 
conclusions  that  1507  maize  is  unlikely  to  have  an  adverse  effect  on  human  and 
animal health or the environment in the context of its proposed uses. This includes the 
use of feed produced from maize line 15074.  

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 Article 18(4) of that Regulation.  

By letter of 21 January 2010, the applicant confirmed that he is aware of the fact that 
renewing  the  authorisation  of  existing  feed  produced  from  maize  line  1507  by 
extending  the  scope  of  Commission  Decision  2006/197/EC  so  as  to  include  such 
product, would imply this category of products to be subject to the legal provisions of 
that Decision. 

On the basis of the EFSA opinion, no specific labelling requirements other than those 
provided for in Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary 
for feed produced from maize line 1507. 

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  feed,  as 
provided for in point (e) of Article 18(5) of Regulation (EC) No 1829/2003. 

(5) 

(6) 

(7) 

(8) 

(9) 

For  the  sake  of  transparency,  the  applicant  has  been  consulted  on  the  measures 
provided for in this Decision.  

(10)  Taking into account these considerations, renewal of the authorisation to place on the 

market existing feed produced from maize line 1507 should be granted. 

(11)  Since it is general practice to authorise the placing on the market of food and feed in 
the  same  decision,  the  renewal  of  the  authorisation  to  place  on  the  market  feed 
produced from maize line 1507 should be included in Decision 2006/197/EC. Decision 
2006/197/EC should therefore be amended accordingly. 

(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, 

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EFSA opinions published on: 
- 24 September 2004 for the placing on the market of maize 1507 for import and processing; 
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-011 
- 19 January 2005 for the placing on the market of maize 1507 for import, feed and industrial 
processing and cultivation; 
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-072 
- 19 January 2005 for the placing on the market of maize 1507 for food use 
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-087 
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2007-144 

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HAS ADOPTED THIS DECISION: 

Article 1 
Amendments 

Decision 2006/197/EC is amended as follows: 

(1) 

The title is replaced by the following: 

"Commission  Decision  of  3  March  2006  authorising  the  placing  on  the  market  of 
food  containing,  consisting  of,  or  produced  from  genetically  modified  maize  line 
1507  (DAS-Ø15Ø7-1)  and  renewing  the  authorisation  to  place  on  the  market  feed 
produced  from  such  maize,  pursuant  to  Regulation  (EC)  No  1829/2003  of  the 
European Parliament and of the Council" 

(2) 

Articles 1, 2 and 3 of Decision 2006/197/EC are replaced by the following: 

"Article 1 
Products 

This  Decision  covers  foods  and  food  ingredients  containing  and  consisting  of,  or 
produced  from  genetically  modified  maize  (Zea  mays  L.)  line  1507  and  feed 
produced from such maize (the products). 

Genetically  modified  maize  (Zea  mays  L.)  line  1507  as  further  specified  in  the 
Annex to this Decision is assigned the unique identifier DAS-Ø15Ø7-1, as provided 
for in Regulation (EC) No 65/2004. 

Article 2 
Placing on the market 

The placing on the market of  the products,  according to the conditions specified in 
this Decision and its Annex, is authorised for the purposes of Article 4(2) and Article 
16(2) of Regulation (EC) No 1829/2003. 

Article 3 
Labelling 

For the purposes of the specific labelling requirements provided for in Article 13(1) 
and Article 25(2) of Regulation (EC) No 1829/2003, the 'name of the organism' shall 
be 'maize'". 

(3) 

The Annex is amended as follows: 

(a)  Section (b) is replaced by the following: 

"(b) Designation and specification of the products: 

(i) 

Foods  and  food  ingredients  containing,  consisting  of,  or  produced  from 
DAS-Ø15Ø7-1 maize; 

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(ii)  Feed produced from DAS-Ø15Ø7-1 maize. 

The  genetically  modified  DAS-Ø15Ø7-1  maize,  as  described  in  the 
application,  is  resistant  to  the  European  corn  borer  (Ostrinia  nubilalis) 
and  certain  other  lepidopteran  pests  and  is  tolerant  to  the  herbicide 
glufosinate-ammonium.  The  genetically  modified  DAS-Ø15Ø7-1  maize 
contains the following DNA sequences in two cassettes: 

– 

cassette 1: 

A  synthetic  version  of  the  truncated  cry1F  gene  from  Bacillus 
thuringiensis  subsp.  aizawai,  which  confers  resistance  to  the 
European  corn  borer  (Ostrinia  nubilalis)  and  certain  other 
lepidopteran  pests,  under  the  regulation  of  the  ubiquitin  promoter 
ubiZM1(2)  from  Zea  mays  L.  and  the  ORF25PolyA  terminator 
from Agrobacterium tumefaciens pTi15955. 

– 

cassette 2: 

the  pat  gene 

A  synthetic  version  of 
from  Streptomyces 
viridochromogenes  strain  Tü494,  which  confers  tolerance  to  the 
herbicide  glufosinate-ammonium,  under  the  regulation  of  the  35S 
promoter  and  terminator  sequences  from  Cauliflower  Mosaic 
Virus." 

(b)  Section (c) is replaced by the following: 

"(c) Labelling: 

No  specific  requirements  other  than  those  provided  for  in  Article  13(1)  and 
Article 25(2) of Regulation (EC) No 1829/2003. 

For  the  purpose  of  Article  13(1)  and  Article  25(2)  of  Regulation  (EC)  No 
1829/2003, the 'name of organism' shall be 'maize'." 

This Decision is addressed to: 

Article 2 
Addressees 

(a) 

(b) 

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

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

Done at Brussels, 

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For the Council 
The President 

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