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 MON 863) genetically modified for resistance to corn rootworm
Date: 2005-04-26
Institutions: European Commission
Subjects: Germany, cereal product, genetically modified organism, maize, market approval

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.04.2005 
COM(2005)163 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 MON 
863) genetically modified for resistance to corn rootworm 

(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/02/09) concerning the placing on the market 
of maize product (Zea mays L. line MON 863 and hybrid MON 863 x MON 810), 
genetically modified for resistance to different insects. 

The notification covers importation and use as for any other maize grains including 
feed  but  not  food  use,  with  the  exception  of  the  cultivation  in  the  Community  of 
varieties  derived  from  the  MON  863  transformation  event  as  well  as  with  the 
exception of the cultivation in the Community of MON 863 x MON 810 hybrids. 

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 MON 863 maize as well as MON 863 x MON 810 maize 
should be withheld, if specific conditions are fulfilled. 

The Commission forwarded the assessment report to all other Member States, some 
of  which  raised  and  maintained  objections  to  the  said  report  in  terms  of  molecular 
characterisation,  agronomic  equivalence,  sampling  methods,  antibiotic  resistance 
marker gene, allergenicity, toxicity and monitoring of the product. 

Since objections were maintained, the Commission decided to consult the European 
Food  Safety  Authority  (EFSA).  The  EFSA  concluded,  in  an  opinion  adopted  on  2 
April  2004,  that  from  all  evidence  provided,  the  Zea  mays  L.  line  MON  863  is 
unlikely to have an adverse effect on human and animal health or the environment in 
the  context  of  its  proposed  use.  The  EFSA  also  found  that  the  scope  of  the 
monitoring plan provided by the applicant is in line with the intended uses of MON 
863.  

Concerning  hybrid  MON  863  x  MON  810,  the  EFSA  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  hybrid  MON  863  x  MON  810,  but  decided 
regarding 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. Thus, only the safety assessment of the maize line MON 863 
has been finalised. 

Under  such  circumstances,  Article  18  of  Directive  2001/18/EC  requires  the 
Commission 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. 

Since  both  the  German  authorities  and  the  EFSA  gave  a  positive  assessment 
concerning the placing on the market of MON 863 maize, the Commission prepared 
a draft Decision authorising the use of this product, with the exception of cultivation 
and uses as or in food, and its placing on the market subject to specific conditions. 
Regarding  hybrid  MON  863  x  MON  810,  the  Commission  decided  not  to  propose 
any  decision  pending  the  availability  and  assessment  of  the  scientific  information 
requested by EFSA. 

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The  draft  Decision  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 on 29 November 2004, which requires 
that,  the  Commission,  in  accordance  with  Article  5(4)  of  Decision  1999/468/EC, 
shall, without delay, submit to the Council a proposal relating to the measures to be 
taken and shall inform the European Parliament. 

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. line MON 
863) genetically modified for resistance to corn rootworm 

Text with EEA relevance) 
(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) 

(3) 

(4) 

1 

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). 

The  notification  covers  importation  and  use  as  for  any  other  maize  grains  including 
feed  but  not  food  use,  with  the  exception  of  the  cultivation  in  the  Community  of 
varieties  derived  from  the  MON  863  transformation  event  as  well  as  with  the 
exception of the cultivation in the Community of MON 863 x MON 810 hybrids. 

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  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 

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) 

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(5) 

(6) 

(7) 

(8) 

(9) 

which consent for the placing on the market of MON 863 maize as well as MON 863 
x MON 810 maize should be withheld, if specific conditions are fulfilled. 

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

The  opinion  adopted  on  2  April  2004  by  the  European  Food  Safety  Authority, 
concluded, from all evidence provided, that Zea mays L. line MON 863 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  applicant  is  in  line  with  the  intended  uses  of 
MON 863.  

Concerning  hybrid  MON  863  x  MON  810,  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 hybrid MON 863 x MON 810, but 
decided  regarding  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. Thus, only the safety assessment of the maize line 
MON 863 has been finalised. 

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  MON  863  will  adversely  affect  human  or  animal  health  or  the 
environment. 

A  unique  identifier  should  be  assigned  to  the  MON  863  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. 

(10)  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. 

(11) 

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.  

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4 

OJ L 268, 18.10.2003, p.24 
OJ L 10, 16.01.2004, p. 5-10 
OJ L 268, 18.10.2003, p.1 

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(12)  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.  

(13)  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  29  November  2004,  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 

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  resistance  to  the 
corn rootworm (Diabrotica spp.), derived from the Zea mays cell culture line AT824 
(initiated  from  immature  embryos  of  an  inbred  maize  line  AT),  which  has  been 
transformed  using  particle  acceleration  technology  with  a  MluI  DNA  restriction 
fragment isolated from plasmid PV-ZMIR13.  

The product contains the following DNA in two cassettes: 

(a)  Cassette 1: 

A  modified  cry3Bb1  gene  derived  from  Bacillus  thuringiensis  subsp. 
kumamotoensis,  which  confers  resistance  to  the  corn  rootworm  Diabrotica 
spp.,  under  the  regulation  of  the  4AS1  promoter  derived  from  Cauliflower 
Mosaic  Virus,  the  wtCAB  translation  enhancer  from  wheat  (Triticum 
aestivum), the transcription enhancer ract1 intron from the actin 1 gene of rice 
(Oryza sativa) and terminator sequences tahsp 17 3’ from wheat. 

(b)  Cassette 2: 

The  nptII  gene  from  E.  coli,  which  confers  resistance  to  aminoglycosides 
comprising  kanamycin  and  neomycin,  under  the  regulation  of  the  35S 
Cauliflower  Mosaic  Virus  promoter,  and  the  NOS  3’  terminator  sequences 
from  Agrobacterium  tumefaciens  as  well  as  the  non-functional,  truncated  ble 
gene from E. coli. 

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2. 

The  consent  shall  cover  grains  from  progeny  derived  from  crosses  of  maize  line 
MON 863 with any traditionally bred maize as or in products. 

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 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-ØØ863-5; 

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  organisms’  or 
‘This product contains genetically modified MON 863 maize’ 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, 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,  users,  national  agencies  for 
animal nutrition and feed research as well as veterinary services of the introduction 
of  MON  863  maize  into  the  Community  as  well  as  on  the  safety  and  general 
characteristics of the product and of the conditions as to monitoring. 

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 

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State  which  received  the  original  notification,  in  the  light  of  the  results  of  the 
monitoring activities.  

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 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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