Proposal for a Council Decision authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) under Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2005-10-05
Institutions: European Commission
Subjects: consumer information, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.10.2005 
COM(2005) 469 final 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of food containing, consisting of, or produced 
from genetically modified maize line 1507 (DAS-Ø15Ø7-1) under Regulation (EC) No 
1829/2003 of the European Parliament and of the Council 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

The attached draft proposal for a Council Decision concerns food containing, consisting of, or 
produced from genetically modified maize line 1507, for which a request for placing on the 
market was submitted by Pioneer Overseas Corporation and Dow AgroSciences Europe to the 
competent  authorities  of  The  Netherlands  on  15  February  2001,  under  Regulation  (EC)  No 
258/97 concerning novel foods and novel food ingredients.  

Following the initial assessment report from the Netherlands, who considered 1507 maize as 
safe  as  conventional  maize,  reasoned  objections  were  raised  by  some  Member  States.  As  a 
consequence, an additional assessment was required. 

Regulation  (EC)  No  1829/2003  on  GM  food  and  feed  is  applicable  from  18  April  2004. 
According to Article 46(1) of this Regulation, requests submitted under Regulation (EC) No 
258/97 before 18 April 2004 and for which an additional assessment report was required and 
has  not  been  transmitted  to  the  Commission  before  that  date,  must  be  transformed  into 
applications under Regulation (EC) No 1829/2003. 

On  3  March  2005,  the  European  Food  Safety  Authority  gave  its  opinion  that  there  is  no 
evidence  to  indicate  that  the  placing  on  the  market  of  the  food  products  presented  in  the 
application is likely to cause 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 food containing, consisting of, or produced from genetically modified 
maize  line  1507  was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and  Animal 
Health,  on  3  June  2005,  for  vote.  Eight  Member  States  (111  votes)  voted  in  favour,  nine 
Member States (69 votes) voted against and eight Member States (141 votes) abstained. 

The  Committee  delivered  no  opinion.  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, 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 containing, consisting of, or produced 
from genetically modified maize line 1507 (DAS-Ø15Ø7-1) under Regulation (EC) No 
1829/2003 of the European Parliament and of the Council 

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) thereof, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

On 15 February 2001, Pioneer Overseas Corporation and Dow AgroSciences Europe 
jointly  submitted  to  the  competent  authorities  of  the  Netherlands  a  request,  in 
accordance with Article 4 of Regulation (EC) No 258/97 of the European Parliament 
and  of  the  Council  of  27  January  1997  concerning  novel  foods  and  novel  food 
ingredients2, for the placing on the market of foods and food ingredients derived from 
genetically modified maize line 1507 as novel foods or as novel food ingredients (‘the 
products’). 

In  their  initial  assessment  report  of  4  November  2003,  the  Netherlands’  competent 
food assessment body concluded that the products are just as safe as foods and food 
ingredients  derived  from  conventional  maize  lines  and  may  be  used  in  the  same 
manner. 

The Commission forwarded the initial assessment report to all Member States on 10 
November  2003.  Within  the  60-day  period  laid  down  in  Article  6(4)  of  Regulation 
(EC) No 258/97, reasoned objections to the placing on the market of the products were 
raised in accordance with that provision. As a consequence, an additional assessment 
report was required. 

Article  46(1)  of  Regulation  (EC)  No  1829/2003  (hereinafter  referred  to  as  the 
Regulation)  provides  that  requests  submitted  under  Article  4  of  Regulation  (EC)  No 
258/97  before  the  date  of  application  of  the  Regulation,  i.e.  18  April  2004,  shall  be 
transformed  into  applications  under  Chapter  II,  Section  1  of  the  Regulation  in  cases 

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2 

OJ L 268, 18.10.2003, p. 1. 
OJ  L  43,  14.2.1997,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 

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(5) 

(6) 

(7) 

(8) 

(9) 

where  an  additional  assessment  report  is  required  in  accordance  with  Article  6(3)  or 
6(4) of Regulation (EC) No 258/97.  

The scope of Regulation (EC) No 258/97 is limited to the placing on the market within 
the  Community  of  novel  foods  or  novel  food  ingredients.  Consequently  the  present 
decision does not cover the placing on the market of feed containing, consisting of or 
produced from maize line 1507. 

A  notification  for  the  placing  on  the  market  of  feed  containing  or  consisting  of 
genetically  modified  maize  line  1507  has  been  submitted  under  Part  C  of  Directive 
2001/18/EC of the European Parliament and of  the Council on the deliberate release 
into  the  environment  of  genetically  modified  organisms3.  This  notification  should 
continue to be processed under this Directive in accordance with Article 46(3) of the 
Regulation. 

Feed produced from maize line 1507 has been placed on the market before the date of 
application of the Regulation, i.e. 18 April 2004. As a consequence, it is subject to the 
requirements  provided  for  in  Article  20  of  the  Regulation  and  may  be  placed  on  the 
market  and  used  in  accordance  with  the  conditions  laid  down  in  the  Community 
register of genetically modified food and feed. 

On 3 March 2005, the European Food Safety Authority (‘Authority’) gave its opinion 
in accordance with Article 6 of the Regulation that there is no evidence to indicate that 
the placing on the market of the products is likely to cause adverse effects on human 
or animal health or the environment4. In giving its opinion, the Authority considered 
all specific questions and concerns raised by the Member States. 

Accordingly, the Authority advised that no specific labelling requirements other than 
those provided for in Article 13(1) of the Regulation are necessary. The Authority also 
advised that no 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,  and  no  specific  conditions  for  the  protection  of  particular 
ecosystems/environment  and/or  geographical  areas,  as  provided  for  in  point  (e)  of 
Article 6(5) of the Regulation, are required. 

(10) 

In  its  opinion,  the  Authority  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. 

(11) 

In the light of the above considerations, the authorisation should be granted. 

(12)  A  unique  identifier  should  be  assigned  to  maize  line  1507  as  provided  for  in 
Commission Regulation (EC) No 65/2004 establishing a system for the development 
and assignment of unique identifiers for genetically modified organisms5. 

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4 

5 

OJ L 106, 17.4.2001, p. 1. 
http://www.efsa.eu.int/science/gmo/gm_ff_applications/more_info/503/op_gm07_ej182_1507 
_opinion_nl_doc2_en1.pdf 
OJ L 10, 16.1.2004, p. 5. 

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(13)  All  information  contained  in  the  Annex  to  this  Decision  on  the  authorisation  of  the 
products  should  be  entered  in  the  Community  register  of  genetically  modified  food 
and feed as provided for in the Regulation. 

(14) 

In accordance with Article 4(2) of the Regulation, the conditions for authorisation of 
the product bind all persons placing it on the market. 

(15)  This Decision should 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. 

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

Health, 

HAS DECIDED AS FOLLOWS: 

Article 1 
Products 

This Decision covers foods and food ingredients containing, consisting of, or produced from 
the genetically modified maize (Zea mays L.) line 1507 further specified in the Annex to this 
Decision (‘the products’) and 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) of Regulation (EC) No 
1829/2003. 

Article 3 
Labelling 

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

Article 4 
Monitoring for environmental effects 

1. 

The  authorisation  holders  shall  ensure  that  the  monitoring  plan  for  environmental 
effects, as specified in the Annex to this Decision, is put in place and implemented. 

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OJ L 287, 5.11.2003, p. 1. 

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2. 

The  authorisation  holders  shall  submit  to  the  Commission  annual  reports  on  the 
implementation and the results of the monitoring activities.  

Those reports shall clearly state which parts of the reports are considered to be confidential, 
together  with  a  verifiable  justification  for  confidentiality  in  accordance  with  Article  30  of 
Regulation (EC) No 1829/2003.  

Confidential parts of such reports shall be submitted in separate documents. 

Article 5 
Community Register 

The information 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 

The authorisation holders are: 

(a) 

(b) 

Pioneer  Overseas  Corporation,  Belgium,  representing  Pioneer  Hi-Bred 
International, United States, and 

Dow  AgroSciences  Europe,  United  Kingdom,  representing  Mycogen  Seeds, 
United States, 

both of which are responsible for fulfilling the duties of authorisation holders provided for in 
this Decision and in Regulation (EC) No 1829/2003. 

Article 7 
Validity 

This Decision shall be valid for a period of 10 years from the date of its adoption. 

Done at Brussels,  

For the Council 
The President 

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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.,  400  Locus  Street,  Suite  800,  Des 
Moines, IA50309, United States 

and 

Name: 

Dow AgroSciences Europe Ltd. 

Address: 
4RN, United Kingdom. 

European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 

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:  

Foods  and  food  ingredients  containing,  consisting  of,  or  produced  from  genetically 
modified  maize  (Zea  mays  L.)  line  1507  as  described  in  the  application,  unique 
identifier  DAS-Ø15Ø7-1,  with  resistance  to  the  European  corn  borer  (Ostrinia 
nubilalis)  and  certain  other  lepidopteran  pests  and  with  tolerance  to  the  herbicide 
glufosinate-ammonium. The genetically modified maize DAS-Ø15Ø7-1 contains the 
following DNA sequences in two cassettes: 

(a) 

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. 

(b) 

cassette 2: 

A  synthetic  version  of  the  pat  gene  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. 

(c) 

Labelling: 

No other specific requirements than those provided under Article 13(1) of Regulation 
(EC) No 1829/2003. 

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For the purpose of Article 13(1) of Regulation (EC) No 1829/2003, the ‘name of the 
organism’ shall be ‘maize’. 

d) 

Method for detection: 

–  Event specific real-time quantitative PCR based method for genetically modified 

maize DAS-Ø15Ø7-1. 

–  Validated  by  the  Community  reference  laboratory  established  under  Regulation 
(EC)  No  1829/2003,  published  at  http://gmo-crl.jrc.it/detectionmethods/TC1507-
WEB-Protocol-Validation.pdf 

the  European  Commission, 

–  Reference Material:  ERM®-BF418 accessible via the Joint Research Centre (JRC) 
the  Institute  of  Reference  Materials  and 
at 

of 
Measurements 
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm 

(IRMM) 

(e) 

(f) 

Unique identifier: DAS-Ø15Ø7-1 

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,  before 
publication in the OJ]  

(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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