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., hybrid MON 863 x MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize
Date: 2005-11-10
Institutions: European Commission
Subjects: genetically modified organism, labelling, maize, marketing, marketing standard, plant health legislation, plant health treatment

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.11.2005 
COM(2005) 564 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., hybrid MON 
863 x MON 810) genetically modified for resistance to corn rootworm and certain 
lepidopteran pests of maize 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

In  accordance  with  Article  13  of  Directive  2001/18/EC,  the  German  authorities 
received a notification (Reference C/DE/02/9) concerning the placing on the market 
of  a  maize  product  (Zea  mays  L.,  hybrid  MON  863  x  MON  810),  genetically 
modified for resistance to corn rootworm and certain lepidopteran pests of maize. 

The notification originally covered importation and use as for any other maize grains 
including  feed,  with  the  exception  of  food  use  and  cultivation.  In  July  2005 
Monsanto  Europe  S.A.  agreed  to  limit  the  scope  of  the  notification  to  import  and 
processing,  given  that  the  placing  on  the  market  of  feed  products  containing, 
consisting  of,  or  produced  from  MON  863  x  MON  810  maize  was  covered  in  its 
application under Regulation (EC) No 1829/2003.  

In  accordance  with  Article  14  of  the  Directive,  the  German  competent  authority 
forwarded  to  the  Commission  its  assessment  report  of  the  notification,  which 
concluded  that  no  reasons  have  emerged  on  the  basis  of  which  consent  for  the 
placing on the market of the Zea mays L. hybrid MON 863 x MON 810 should be 
withheld, provided that specific conditions are fulfilled. 

The Commission forwarded the assessment report to all other Member States, some 
of  which  raised  and  maintained  objections  to  the  report  in  terms  of  molecular 
characterisation,  allerginicity,  toxicity,  inadequate  monitoring  plan,  accidental 
spillage,  presence  of  an  antibiotic  resistance  marker  gene  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 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  (informed  on  22  September  2005),  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 shall 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 shall be adopted by the 
Commission. 

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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., hybrid MON 
863 x MON 810) genetically modified for resistance to corn rootworm and certain 
lepidopteran pests of maize 

(Only the German text is authentic) 

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  the  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  a  Member  State,  in  accordance  with  the  procedure  laid  down  in  that 
Directive. 

A notification concerning the placing on the market of two genetically modified maize 
products  (Zea  mays  L.,  line  MON  863  and  hybrid  MON  863  x  MON  810)  was 
submitted  by  Monsanto  Europe  S.A.  to  the  competent  authority  of  Germany 
(Reference  C/DE/02/9).  A  unique  identifier  (MON-ØØ863-5xMON-ØØ81Ø-6)  has 
been assigned to the MON 863 x MON 810 maize 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/EC2  and  Commission  Regulation  (EC)  No  65/2004 
of  14  January  2004  establishing  a  system  for  the  development  and  assignment  of 
unique identifiers for genetically modified organisms3. 

1 

2 
3 

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).  
OJ L 268, 18.10.2003, p.24. 
OJ L 10, 16.01.2004, p. 5. 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

The  notification  originally  covers  importation  and  use  as  for  any  other  maize  grains 
including  feed,  with  the  exception  of  food  use  and  cultivation  in  the  Community  of 
varieties  derived  from  the  MON  863  transformation  event  and  of  the  MON  863  x 
MON 810 hybrid. 

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, 
the  competent  authority  of  Germany  prepared  an  assessment  report,  which  was 
submitted on 7 February 2003 to the Commission and the competent authorities of the 
other Member States. That assessment report concludes that no reasons have emerged 
on the basis of which  consent  for the placing on the market of MON 863 as well as 
MON 863 x MON 810 should be withheld, if specific conditions are fulfilled. 

The competent authorities of other Member States raised objections to the placing on 
the market of MON 863 as well as MON 863 x MON 810. 

The  placing  on  the  market  of  MON  810  maize  is  authorised  in  accordance  with 
Commission  Decision  of  22  April  1998  concerning  the  placing  on  the  market  of 
genetically  modified  maize  (Zea  mays  L.  line  MON  810),  pursuant  to  Council 
Directive  90/220/EEC4.  The  placing  on  the  market  of  MON  863  is  authorised  in 
accordance  with  Commission  Decision  of  8  August  2005  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 MON 863) genetically modified 
for resistance to corn rootworm5. 

On  2  April  2004,  the  European  Food  Safety  Authority  considered  that  it  is 
scientifically  valid  to  use  the  data  from  the  single  lines  MON  863  and  MON  810  to 
support the safety assessment of MON 863 x MON 810, but decided, with regard to 
the need for confirmatory data for the safety assessment of the hybrid itself, to request 
a  90-day  sub-chronic  rat  study  with  the  maize  hybrid  in  order  to  complete  its  safety 
assessment.  

The  opinion  adopted  on  8  June  2005  by  the  European  Food  Safety  Authority,  in 
accordance with 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  safety6,  concluded,  from  all  evidence  provided,  that 
MON  863  x  MON  810  is  unlikely  to  have  an  adverse  effect  on  human  and  animal 
health  or  the  environment  in  the  context  of  its  proposed  use.  The  European  Food 
Safety  Authority  also  found  that  the  scope  of  the  monitoring  plan  provided  by  the 
consent holder is in line with the intended uses of MON 863 x MON 810.  

(9) 

On  8  July  2005,  Monsanto  Europe  S.A.  agreed  to  limit  the  scope  of  the  present 
Decision  to  import  and  processing.  An  application  for  the  placing  on  the  market  of 
food and feed containing, consisting of, or produced from MON 863 x MON 810 has 
been made by Monsanto Europe S.A. under Regulation (EC) No 1829/2003. 

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OJ L 131/33, 05.05.98, p. 32. 
OJ L 207, 10.08.2005, p 17. 
OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No1642/2003  (OJ  L  245, 
29.9.2003, p. 4). 

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(10)  An  examination  of  the  information  submitted  in  the  notification,  the  objections 
maintained  by  Member  States  in  the  framework  of  Directive  2001/18/EC,  and  the 
opinion of the European Food Safety Authority, discloses no reason to believe that the 
placing on the market of MON 863 x MON 810 will adversely affect human or animal 
health or the environment. 

(11)  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 feed7. 

(12) 

In the light of the opinion of the European Food Safety Authority, it is not necessary to 
establish  specific  conditions  for  the  intended  uses  with  regard  to  the  handling  or 
packaging of the product and the protection of particular ecosystems, environments or 
geographical areas.  

(13)  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 validated detection methodology, should be applicable.  

(14)  The  Committee  established  under  Article  30  of  Directive  2001/18/EC  has  not 
delivered  an  opinion  on  the  measures  laid  down  in  a  draft  Commission  Decision, 
following  its  consultation,  on  19  September  2005,  in  accordance  with  the  procedure 
laid down in Article 30(2) of that Directive, 

HAS ADOPTED THIS DECISION:  

Article 1  
Consent 

Without prejudice to other  Community legislation, in particular Regulation (EC) No 258/97 
and  Regulation  (EC)  No  1829/2003,  written  consent  shall  be  granted  by  the  competent 
authority of Germany 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/DE/02/9). 

The  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 

The genetically modified organisms to be placed on the market as or in products, hereinafter 
‘the  product’,  are  grains  of  maize  (Zea  mays  L.  MON  863  x  MON  810),  obtained  by 
conventional breeding of MON 863 and MON 810. Descriptions of the MON 810 and MON 
863  maizes  are  provided  for  in  Commission  Decisions  1998/294/EC  and  2005/608/EC 
respectively. 

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OJ L 268, 18.10.2003, p.1. 

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Article 3 
Conditions for placing on the market 

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

(a) 

(b) 

(c) 

(d) 

(e) 

1. 

2. 

3. 

4. 

the period of validity of the consent shall be 10 years starting from the date on which 
the consent is issued; 

the unique identifier of the product shall be MON-ØØ863-5xMON-ØØ81Ø-6; 

without  prejudice  to  Article  25  of  Directive  2001/18/EC,  the  consent  holder  shall, 
whenever  requested  to  do  so,  make  positive  and  negative  control  samples  of  the 
product,  or  its  genetic  material,  or  reference  materials  available  to  the  competent 
authorities  and  inspection  services  of  Member  States  as  well  as  to  the  Community 
control laboratories; 

without prejudice to specific labelling requirements provided by Regulation (EC) No 
1829/2003  the  words  ‘This  product  contains  genetically  modified  maize’  or  ‘This 
product contains genetically modified MON 863 x MON 810’ shall appear either on 
a label or in a document accompanying the product, except 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 shall ensure that 
the  monitoring  plan,  contained  in  the  notification  and  consisting  of  a  general 
surveillance  plan,  the  objective  of  which  is  to  check  for  any  adverse  effects  on 
human  and  animal  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 
monitoring,  including  the  appropriate  management  measures  to  be  taken  in  case  of 
accidental grain spillage. 

The consent holder shall submit to the Commission and to the competent authorities 
of the Member States annual reports on the results of the monitoring activities.  

Without  prejudice  to  Article  20  of  Directive  2001/18/EC  the  monitoring  plan  as 
notified shall, where appropriate and subject to the agreement of the Commission and 
the competent authority of the Member State which received the original notification, 
be  revised  by  the  consent  holder  and/or by  the  competent  authority  of  the  Member 
State  which  received  the  original  notification,  in  the  light  of  the  results  of  the 

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monitoring activities. Proposals for a revised monitoring plan shall be submitted to 
the competent authorities of the Member States. 

5. 

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

(a) 

(b) 

that the monitoring networks as specified in the monitoring plan contained in 
the  notification  collect  the  information  relevant  for  the  monitoring  of  the 
product and  

that  the  members  of  these  networks  have  agreed  to  make  available  that 
information  to  the  consent  holder  before  the  date  of  the  submission  of  the 
monitoring  reports  to  the  Commission  and  competent  authorities  of  the 
Member States in accordance with paragraph 3.  

Article 5 
Applicability 

This  Decision  shall  apply  from  the  date  on  which  a  Community  Decision  authorising  the 
placing on the market of the product referred to in Article 1 for uses as or in food and feed 
within the meaning of Regulation (EC) No 178/2002 and including a method, validated by the 
Community reference laboratory, for detection of the product is applicable. 

Article 6 
Addressee 

This Decision is addressed to the Federal Republic of Germany. 

Done at Brussels,  

For the Council 
The President 

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