Proposal for a Council Decision concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance
Date: 2004-03-26
Institutions: European Commission
Subjects: cereal product, genetically modified organism, maize, market approval, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.03.2004 
COM(2004)193 final 

. 

Proposal for a 

COUNCIL DECISION 

concerning the placing on the market, in accordance with Directive 2001/18/EC of 
the European Parliament and of the Council, of a maize product (Zea mays L. line 
NK603) genetically modified for glyphosate tolerance 

. 

(presented by the Commission) 

EN 

   EN 

 
 
 
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EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  Spanish  authorities 
received a notification (Reference C/ES/00/01) concerning the placing on the market 
of maize product (Zea mays L. line NK603), genetically modified for tolerance to the 
herbicide glyphosate. 

In  accordance  with  Article  14  of  the  Directive,  the  competent  Spanish  authority 
forwarded  to  the  Commission  its  assessment  report  of  the  notification,  which 
concluded  that  there  was  no  scientific  evidence  that  indicated  any  risk  for  human 
health or the environment in terms of the placing on the market of the product for the 
requested uses. 

The Commission forwarded the assessment report to all other Member States, certain 
ones  of  which  raised  and  maintained  objections  to  the  said  report  in  terms  of 
molecular  characterisation,  allergenicity,  monitoring,  labelling  and  detection  of  the 
product;  whereby  the  Commission,  in  accordance  with  Article  18  of  Directive 
2001/18/EC,  is  required  to  take  a  decision  in  accordance  with  the  procedure  laid 
down  in  Article  30(2)  of  the  Directive  to  which  Articles  5  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

A draft of the measures to be taken was submitted, in accordance with Article 5(2) of 
Decision  1999/468/EC,  for  opinion,  to  the  Committee  set  up  under  Article  30  of 
Directive 2001/18/EC. 

The Committee has not delivered an opinion, which requires that, the Commission, 
in  accordance  with  Article  5(4)  of  Decision  1999/468/EC,  must,  without  delay, 
submit to the Council a proposal relating to the measures to be taken and inform the 
European  Parliament,  which  may  consider  appropriate  to  take  a  position  in 
accordance with Article 8 of the above Decision. 

Article  5(6)  of  Decision  1999/468/EC  provides  that  the  Council  may,  where 
appropriate in view of any such position, act by qualified majority within a period set 
at three months in accordance with Article 30(2) of Directive 2001/18/EC. If within 
that  three-month  period,  the  Council  has  indicated  by  qualified  majority  that  it 
opposes the proposal, the Commission must re-examine it; whereas if, on expiry of 
that  period  the  Council  has  neither  adopted  the  proposed  implementing  act  nor 
indicated its opposition, then the proposed implementing act must be adopted by the 
Commission. 

2 

 
 
  
 
Proposal for a 

COUNCIL DECISION 

concerning the placing on the market, in accordance with Directive 2001/18/EC of 
the European Parliament and of the Council, of a maize product (Zea mays L. line 
NK603) genetically modified for glyphosate tolerance 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having regard 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/EEC1, and in particular first subparagraph of Article 
18(1) thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

Pursuant to Directive 2001/18/EC, the placing on the market of a product containing 
or  consisting  of  a  genetically  modified  organism  or  a  combination  of  genetically 
modified  organisms  is  subject  to  written  consent  being  granted  by  the  competent 
authority  of  the  Member  State  that  received  the  notification  for  the  placing  on  the 
market of that product in accordance with the procedure laid down in that Directive. 

A  notification  concerning  the  placing  on  the  market  of  a  genetically  modified  maize 
product  (Zea  mays  L.  line  NK603),  to  be  used  as  any  other  maize  but  not  for 
cultivation,  was  submitted  by  Monsanto  S.A.  to  the  competent  authority  of  Spain 
which  transmitted  it  to  the  Commission  and  to  the  competent  authorities  of  other 
Member States with a positive opinion. 

(3) 

The competent authorities of other Member States raised objections to the placing on 
the market of the product. 

1 

OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 of the European 
Parliament and of the Council (OJ L 268, 18.10.2003, p. 24).  

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

The opinion adopted on 25 November 2003 by the European Food Safety Authority, 
as established by Regulation (EC) No 178/2002 of the European Parliament and of the 
Council  of  28  January  2002  laying  down  the  general  principles  and  requirements  of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures  in  matters  of  food  safety2,  concluded  that  Zea  mays  L.  line  NK603  is  as 
safe  as  conventional  maize  and  that  its  placing  on  the  market  for  food,  feed  or 
processing is therefore unlikely to have an adverse effect on human or animal health 
or, in that context, on the environment.  

An examination of each of the objections in the light of Directive 2001/18/EC, of the 
information  submitted  in  the  notification  and  of  the  opinion  of  the  European  Food 
Safety Authority, discloses no reason to believe that the placing on the market of Zea 
mays L. line NK603 will adversely affect human or animal health or the environment. 

A unique identifier should be assigned to the product for the purposes 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/EC3. 

Adventitious  or  technically  unavoidable  traces  of  genetically  modified  organisms  in 
products are exempted from labelling and traceability requirements in accordance with 
thresholds  established  under  Directive  2001/18/EC  and  Regulation  (EC)  No 
1829/2003  of the  European Parliament  and of  the  Council  of  22  September  2003  on 
genetically modified food and feed4. 

Taking  account  of  the  opinion  of  the  European  Food  Safety  Authority,  there  is  no 
reason to establish specific conditions with regard to the handling or packaging of the 
product and the protection of particular ecosystems/environments and/or geographical 
areas.  

Prior to the placing on the market of the product, the necessary measures to ensure its 
labelling  and  traceability  at  all  stages  of  its  placing  on  the  market,  including 
verification by appropriate detection methodology, should be applicable. 

(10)  The Committee established under Article 30 of Directive 2001/18/EC has not given a 

favourable opinion, 

HAS ADOPTED THIS DECISION: 

2 

3 
4 

OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1642/2003 
(OJ L 245, 29.9.2003, p. 4). 
OJ L 268, 18.10.2003, p. 24. 
OJ L 268, 18.10.2003, p. 1 

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Article 1 
Consent 

Without prejudice to other Community legislation, in particular Regulation (EC) No 258/97 of 
the  European  Parliament  and  of  the  Council5  and  Regulation  (EC)  No  1829/2003  of  the 
European  Parliament  and  of  the  Council,  written  consent  shall  be  granted  by  the  competent 
authority  of  Spain  to  the  placing  on  the  market,  in  accordance  with  this  Decision,  of  the 
product identified in Article 2, as notified by Monsanto Europe S.A. (Reference C/ES/00/01). 

The  written  consent  shall,  in  accordance  with  Article  19(3)  of  Directive  2001/18/EC, 
explicitly specify the conditions to which the consent is subject, which are set out in Articles 3 
and 4. 

Article 2 
Product 

1. 

The  genetically  modified  organisms  to  be  placed  on  the  market  as  or  in  products, 
hereinafter ‘the product’, are grains of maize (Zea mays L.), with increased tolerance 
to  the  herbicide  glyphosate,  derived  from  the  maize  line  NK603  transformation 
event,  which  has  been  transformed  using  particle  acceleration  technology  with  a 
MluI restriction fragment  isolated  from plasmid  PV-ZMGT32L and which  contains 
the following DNA sequences in two intact cassettes: 

(a)  Cassette 1: 

A  5-enolpyruvylshikimate-3-phosphate  synthase  (epsps)  gene  derived  from 
Agrobacterium  sp.  strain  CP4  (CP4  EPSPS),  which  imparts  tolerance  to 
glyphosate, under the regulation of the rice actin 1 gene promoter, terminator 
sequences from Agrobacterium tumefaciens and the chloroplast transit peptide 
sequence from the epsps gene of Arabidopsis thaliana. 

(b)  Cassette 2: 

A  5-enolpyruvylshikimate-3-phosphate  synthase  (epsps)  gene  derived  from 
Agrobacterium  sp.  strain  CP4  (CP4  EPSPS),  which  imparts  tolerance  to 
glyphosate,  under  the  regulation  of  an  enhanced  35S  promoter  derived  from 
from  Agrobacterium 
cauliflower  mosaic  virus, 
tumefaciens and the chloroplast transit peptide sequence from the epsps gene of 
Arabidopsis thaliana. 

terminator  sequences 

The  MluI  restriction  fragment,  which  contains  the  two  cassettes  specified  in  points 
(a)  and  (b)  of 
the  neomycin 
phosphotransferase  type  II  gene  conferring  resistance  to  certain  aminoglycoside 
antibiotics or the origin of replication from Escherichia coli, although both sequences 
are present in the original plasmid PV-ZMGT32L. 

the  first  subparagraph,  does  not  contain 

5 

OJ L 43, 14.2.1997, p. 1.  

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2. 

3. 

The unique identifier of the product is MON-00603-6. 

The  consent  shall  cover  grains  from  progeny  derived  from  crosses  of  maize  line 
NK603 with any traditionally bred maize as or in products. 

Article 3 
Conditions for placing on the market 

The product may be used as any other maize, with the exception of cultivation and uses as or 
in food, and may be placed on the market subject to the following conditions: 

(a) 

(b) 

(c) 

(d) 

(e) 

1. 

2. 

3. 

the period of validity of the written consent shall be for a period of 10 years; 

the  unique  identifier  of  the  product  shall  be  MON-00603-6  in  accordance  with 
Article 2(2); 

without  prejudice  to  Article  25  of  Directive  2001/18/EC,  the  consent  holder  shall 
make control samples available to the competent authorities on request; 

the  words  ‘This  product  contains  genetically  modified  organisms’  or  ‘This  product 
contains genetically modified maize’ shall appear either on a label or in a document 
accompanying the product, save where other Community legislation sets a threshold 
below which such information is not required; 

As long as the product has not been authorised for the placing on the market for the 
purpose of cultivation, the words ‘not for cultivation’ shall appear either on a label or 
in a document accompanying the product. 

Article 4 
Monitoring 

Throughout the period of validity of the consent, the consent holder is responsible for 
ensuring that the general surveillance plan, as contained in the notification, for any 
adverse effects on human health or the environment arising from handling or use of 
the product is put in place and implemented. 

The  consent  holder  shall  directly  inform  the  operators  and  users  concerning  the 
safety and general characteristics of the product and of the conditions as to general 
surveillance. 

The  consent  holder  shall,  throughout  the  period  of  validity  of  the  consent,  without 
prejudice  to  Article  20  of  Directive  2001/18/EC,  submit  to  the  Commission  and  to 
competent  authorities  of  the  Member  States,  annual  reports  on  the  results  of  the 
general surveillance and, in the light of the results, proposals for a revised monitoring 
plan. 

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4. 

The consent holder shall be in the position to give evidence to the Commission and 
the competent authorities of the Member States that : 

(a)  The  surveillance  networks,  particularly  those  specified  in  table  1  of  the 
monitoring plan contained in the notification, collect the information relevant 
for the general surveillance of the product and 

(b)  That  these  surveillance  networks  have  agreed  to  make  available  this 
information  to  the  consent  holder  before  the  date  of  submission  of  the 
monitoring report to the Commission and competent authorities of the Member 
States in accordance with paragraph 3. 

Article 5 
Applicability 

This Decision shall not apply before both of the following acts are applicable: 

(a) 

(b) 

Regulation (EC) No 1830/2003; 

A  Community  Decision  authorising  the  placing  on  the  market  of  the  products 
referred to in Article 1 for uses as or in food within the meaning of Regulation (EC) 
No  178/2002  and  including  a  method,  validated  by  the  Community  reference 
laboratory, for detection of those products. 

This Decision shall apply from the later of the two dates of applicability. 

Article 6 

This Decision is addressed to the Kingdom of Spain. 

Done at Brussels, 

For the Council 
The President 

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