EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 10.11.2005 
COM(2005) 564 final 
  
Proposal for a 
COUNCIL DECISION 
concerning the placing on th e market, in accordance with Directive 2001/18/EC of the 
European Parliament and of th e Council, of a maize product ( Zea mays  L., hybrid MON 
863 x MON 810) genetically modified for res istance to corn rootworm and certain 
lepidopteran pests of maize 
(presented by the Commission) 
 
EN 2   EN EXPLANATORY MEMORANDUM  
1. In accordance with Articl e 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. 
2. 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 th e market of feed products containing, 
consisting of, or produced from MON 863  x MON 810 maize wa s covered in its 
application under Regulation (EC) No 1829/2003.  
3. 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. 
4. The Commission forwarded the assessment re port 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 resi stance marker gene a nd detection of the 
product; whereby the Commission in acco rdance 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. 
5. A draft of the measures to be taken was submitted, in accordance with Article 5(2) of 
Decision 1999/468/EC, for opinion, to th e Committee set up under Article 30 of 
Directive 2001/18/EC. 
6. The Committee has not delivered an opinion, which requires that the Commission, in 
accordance with Article 5(4) of Decisi on 1999/468/EC, must, without delay, submit 
to the Council a proposal relating to th e measures to be taken and inform the 
European Parliament (informed on 22 September 2005), which may consider 
appropriate to take a position in accordan ce with Article 8 of the above Decision. 
7. 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 accordan ce with Article 30(2) of Di rective 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. 
 
EN 3   EN Proposal for a 
COUNCIL DECISION 
concerning the placing on th e market, in accordance with Directive 2001/18/EC of the 
European Parliament and of th e Council, of a maize product ( Zea mays  L., hybrid MON 
863 x MON 810) genetically modified for res istance to corn rootworm and certain 
lepidopteran pests of maize 
(Only the German te xt is authentic) 
THE COUNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Community,  
Having regard to Directive 2001/18/EC of the Eu ropean Parliament and of the Council of 12 
March 2001 on the deliberate release into the en vironment 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) Pursuant to Directive 2001/ 18/EC, the placing on the mark et 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 accordan ce with the procedure laid down in that 
Directive. 
(2) A notification concerning the placing on th e market of two geneti cally 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 iden tifier (MON-ØØ863-5xMON-ØØ81Ø-6) has 
been assigned to the MON 863 x MON 810 mai ze 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 produ ced from genetically modified organisms 
and amending Directive 2001/18/EC
2 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 organisms
3. 
                                                 
1 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).  
2 OJ L 268, 18.10.2003, p.24. 
3 OJ L 10, 16.01.2004, p. 5. 
 
EN 4   EN (3) The notification originally covers importa tion and use as for any other maize grains 
including feed, with the ex ception of food use and cultiva tion in the Community of 
varieties derived from the MON 863 transformation event and of the MON 863 x MON 810 hybrid. 
(4) In accordance with the procedure provide d for in Article 14 of Directive 2001/18/EC, 
the competent authority of Germany prep ared an assessment report, which was 
submitted on 7 February 2003 to the Commissi on and the competent authorities of the 
other Member States. That assessment repor t concludes that no reasons have emerged 
on the basis of which consent for the plac ing on the market of MON 863 as well as 
MON 863 x MON 810 should be withheld, if  specific conditions are fulfilled. 
(5) The competent authorities of other Member States raised objecti ons to the placing on 
the market of MON 863 as well as MON 863 x MON 810. 
(6) The placing on the market of MON 810 maize is authorised in accordance with 
Commission Decision of 22 April 1998 concerning the pl acing on the market of 
genetically modified maize ( Zea mays  L. line MON 810), pursuant to Council 
Directive 90/220/EEC
4. 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 w ith 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. 
(7) On 2 April 2004, the European Food Safe ty Authority considered that it is 
scientifically valid to use the data fr om 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 wi th the maize hybrid in orde r to complete its safety 
assessment.  
(8) 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 layi ng down the general princi ples and requirements of 
food law, establishing th e European Food Safety Au thority 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 envir onment 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 li ne 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 applic ation 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. 
                                                
 
4 OJ L 131/33, 05.05.98, p. 32. 
5 OJ L 207, 10.08.2005, p 17. 
6 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). 
 
EN 5   EN (10) An examination of the information submitted in the notific ation, the objections 
maintained by Member States in the fr amework of Directiv e 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 Directiv e 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 neces sary measures to ensure its 
labelling and traceability at all stages  of its placing on the market, including 
verification by appropriate validated detection methodol ogy, should be applicable.  
(14) The Committee established under Artic le 30 of Directive 2001/18/EC has not 
delivered an opinion on the measures la id down in a draft Commission Decision, 
following its consultation, on 19 Septembe r 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 Co mmunity legislation, in partic ular Regulation (EC) No 258/97 
and Regulation (EC) No 1829/2003, written c onsent shall be granted by the competent 
authority of Germany to the placing on the ma rket, in accordance with this Decision, of the 
product identified in Arti cle 2, as notified by Monsanto Europe S.A. (Reference C/DE/02/9). 
The consent shall, in accordance with Articl e 19(3) of Directive 2001/18/EC, explicitly 
specify the conditions to which the consent is subject, which are set ou t 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 8 10. Descriptions of the MON 810 and MON 
863 maizes are provided for in Comm ission Decisions 1998/294/EC and 2005/608/EC 
respectively. 
                                                 
7 OJ L 268, 18.10.2003, p.1. 
 
EN 6   EN 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) the period of validity of the consent shall be 10 years starting from the date on which 
the consent is issued; 
(b) the unique identifier of the pr oduct shall be MON-ØØ863-5xMON-ØØ81Ø-6; 
(c) without prejudice to Arti cle 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 refere nce materials availabl e to the competent 
authorities and inspection services of Memb er States as well as to the Community 
control laboratories; 
(d) without prejudice to specific labelling requirements provided by Regulation (EC) No 
1829/2003 the words ‘This product contains ge netically 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 whic h such information is not required; 
(e) as long as the product has not been authorised for the placing on the market for the 
purpose of cultivation, the words ‘not for cul tivation’ shall appear either on a label or 
in a document accompanying the product. 
Article 4 
Monitoring 
1. Throughout the period of validity of the cons ent, the consent holde r shall ensure that 
the monitoring plan, contained in the no tification 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 environm ent arising from handling or use of the 
product, is put in place and implemented. 
2. 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 appropr iate management measures to be taken in case of 
accidental grain spillage. 
3. The consent holder shall submit to the Co mmission and to the competent authorities 
of the Member States annual reports on th e results of the monitoring activities.  
4. Without prejudice to Article 20 of Di rective 2001/18/EC the monitoring plan as 
notified shall, where appropriate and subjec t to the agreement of the Commission and 
the competent authority of the Member Stat e which received the or iginal 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 
 
EN 7   EN monitoring activities. Proposals for a revise d 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) that the monitoring networks as specifi ed in the monitoring plan contained in 
the notification collect the informati on relevant for the monitoring of the 
product and  
(b) 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 Commissi on 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 produc t 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 me thod, validated by the 
Community reference laboratory, for dete ction of the produc t is applicable. 
Article 6 
Addressee 
This Decision is addressed to the Federal Republic of Germany. 
Done at Brussels,  
 For the Council 
 The President