Proposal for a Council Decision concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC
Date: 1996-05-20
Institutions: European Commission
Subjects: genetically modified organism, labelling, maize, marketing, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  20.05.1996 
COM(96) 206 final 

Proposal  for  a 

COUNCIL  DECISION 

concerning  the  placing on the  market of genetically  modified 
maize (Zea mays L.) 
with  the combined  modification  for  insecticidal  properties  conferred  by  the 
Bt-endotoxin  gene and increased  tolerance  to the  herbicide glufosinate  ammonium 
pursuant to Council  Directive  90/220/EEC 

(presented  by the Commission) 

EXPLANATORY  MEMORANDUM 

1. 

2. 

3. 

4. 

5. 

6. 

In  accordance  with  Article  11  of  Directive  90/220/EEC,  the  French  authorities 
received  a notification  (réf.  C/F/94/11-03) concerning  the  placing on the market  of 
maize  (Zea  mays  L.)  which  has  been  genetically  modified  to  include  pesticide 
properties  (conferred  by  the  Bt-endotoxin  gene)  and  improved  tolerance  of  the 
herbicide  glufosinate  ammonium. 

In  accordance  with  Article  12  of  the  Directive,  the  competent  French  authority 
forwarded  the  dossier  to  the  Commission  with  a  favourable  opinion. 

The  competent  authorities  of  certain  other  Member  States  (A,  B, D, DK,  I,  S and 
UK)  raised  objections  regarding  specific  points, including  labelling,  the effects  on 
human  health  of the non-expressed  (3-Iactamase gene, the environmental  impact  of 
using  herbicides  on  plants  and  the  possible  development  of  resistance  to  the  Bt-
toxin.  The  Commission  must  therefore  take  a  decision  in  accordance  with  the 
procedure  laid  down  in  Article  21  of  Directive  90/220/EEC. 

A proposal  for  a decision  on the  measures  to  be taken  was  sent  for  opinion  to  the 
Committee  set  up  by  Article  21  of  the  Directive. 

The Committee has not delivered  an opinion, which means that, in accordance  with 
Article  21  of Directive  90/220/EEC,  the Commission  must,  without  delay,  submit 
to the  Council  a proposal  relating  to the  measures  to  be taken.  The  Council  must 
act  by  a  qualified  majority. 

The  same  Article  stipulates that  if,  on  the  expiry  of  a period  of three  months  from 
the  date  of  referral  to the  Council,  the  latter  has not  acted,  the  proposed  measures 
must  be  adopted  by  the  Commission. 

ft-

THE  COUNCIL  OF  THE  EUROPEAN  UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community, 

Having  regard  to Council  Directive  90/220/EEC  of 23 April  1990 on the deliberate  release 
into  the  environment  of  genetically  modified  organisms,1  and  in  particular  Article  13 
thereof, 

Having  regard  to  the  proposal  from  the  Commission, 

Whereas  Articles  10  to  18  of  Directive  90/220/EEC  lay  down  a  Community  procedure 
enabling  the competent  authority  of a  Member  State to give consent to the placing  on  the 
market  of  products  consisting  of  genetically  modified  organisms; 

Whereas  a notification  concerning  the  placing  on  the  market  of  such  a product  has  been 
submitted  to  the  competent  authority  of  a  Member  State  (France); 

Whereas  the  competent  authority  of  France  subsequently  forwarded  the  dossier  to  the 
Commission with a favourable  opinion; whereas the competent authorities of other Member 
States  raised  objections  to  the  said  dossier; 

Whereas,  therefore,  pursuant  to  Article  13(3),  the  Commission  had  to  take  a  decision  in 
accordance  with  the  procedure  laid  down  in  Article  21  of  the  Directive; 

Whereas,  having  examined  each  objection 
in  light  of  the  provisions  of  Directive 
90/220/EEC and analyzed the information  supplied in the dossier, the Commission  reached 
the  following  conclusions: 

• 

• 

• 

• 

The applicant provided information  on all the newly introduced genes, and not only 
those  expressed. 

The  risk assessment  took account of all the introduced  genes whether expressed  or 
not.  Assessment  was  also  made  in  this  case  of  the  risks  from  the  presence  of  the 
non-expressed  (3-lactamase  gene  with  a  bacterial  promoter. 

In  the  case  of  products  intended  for  use  as  human  food  or  animal  feed, 
the 
assessment  under  Directive  90/220/EEC  determines  whether 
risk 
genetic  modification 
harmful 
result 
effects  for  human  health  and  the  environment. 

toxic  or 

liable 

any 

in 

to 

is 

is  no 

reason 

There 
into  maize  will  have  any  adverse  effects  on  human  health  or 
environment. 

introduction  of 

to  believe 

these  genes 
the 

that 

the 

Possible  development  of  resistance  to  the  truncated  CrylA(b)  protein  in  insects 
cannot be considered an adverse environmental effect,  as existing agricultural  means 
of  controlling  such  resistant  species  of  insects  will  still  be  available. 

OJ  L  117,  8.5.1990,  p.  15.  Directive  as  last  amended  by  Commission  Directive 
94/15/EC  (OJ  L  103, 22.5.1994,  p. 20). 

-2  -

There  are  no  safety  grounds  for  mentioning  on  the  label  that  the  product  has  been 
obtained  by  genetic  modification  techniques. 

• 

The  label  should  indicate  that  the  plants  have  increased  tolerance  to the  herbicide 
glufosinate  ammonium; 

Whereas  authorization  of chemical  herbicides  and  assessment  of how their use  impacts on 
human  health and the environment  are governed  by Council  Directive 91/414/EEC  of July 
1991  concerning  the  placing  of  plant  protection  products  on  the  market,2  and  not  by 
Council  Directive  90/220/EEC; 

Whereas  the  product  under  consideration  has been  notified  for  unrestricted  use,  including 
human  food  and  animal  feed; 

Whereas  this  decision  does  not  exclude  the  application,  in  compliance  with  Community 
law,  of  Member  State  provisions  on  human  food  or  animal  feed  safety  to  the  extent  that 
they  are  not  specifically  related  to  the  genetic  modification  of  the  product  or  its 
components; 

Whereas  Article  11(6)  and  Article  16(1)  of  Directive  90/220/EEC  provide  additional 
safeguards  if  new  information  on  risks  of  the  product  becomes  available; 

Whereas  the  Committee  set  up  by  Article  21  of  Directive  90/220/EEC  and  consulted  by 
written procedure  on 8  March  1996 has not delivered an opinion on the measures laid down 
in  a  draft  Commission  decision, 

OJ L  230,  19.08.1991, p.  1. Directive  as last amended  by  Directive 93/43/EC  (OJ 
L  227,  p.  31). 

-3  -

HAS  ADOPTED  THIS  DECISION: 

Article  1 

1. 

Without  prejudice  to other Community  legislation  and  subject  to the conditions  set 
out  in paragraphs  2 and  3, the  French  authorities  shall  give consent  to the  placing 
on  the  market  of  the  following  product,  notified  by  Ciba-Geigy  Limited  (Ref. 
C/F/94/11-03),  in  accordance  with  Article  13 of  Directive  90/220/EEC. 

The  product  consists of  inbred  lines  and  hybrids  derived  from  a maize  (Zea  mays 
L.)  line  (CG  00256-176)  which  has  been  transformed  using  plasmids  containing: 

(i) 

(ii) 

one  copy  of  the  bar  gene,  from  Streptomyces  hygroscopisus,  (encoding  a 
phosphinothricin  acetyltransferase),  under  the  regulation  of  the  35S 
promoter  and  the  35S  terminator  from  the  cauliflower  mosaic  virus 
(CaMV); 

two copies of a synthetic truncated  gene encoding  an insect control  protein 
representing  the active  portion  of the CrylA(b)  8-endotoxin,  from  Bacillus 
thuringiensis  subsp.  kurstaki  strain  HD1-9  and  containing  intron  #  9  from 
the  maize  phosphoenolpyruvate  carboxylase  gene; 

the  first  copy  is  under  the  regulation  of  a  promoter  from  the  maize 
phosphoenolpyruvate  carboxylase  gene and the CaMV 35S terminator,  and 
the  second  copy  under  the  regulation  of  a promoter  derived  from  a  maize 
calcium-dependent  protein  kinase  gene  and  the  CaMV  35S  terminator; 

(iii) 

the prokaryotic  gene bla (coding  for  a j3-lactamase  conferring  resistance  to 
ampiciilin)  under  prokaryotic  promoter. 

2. 

3. 

This  consent  covers  any  progeny  derived  from  crosses  of  this  product  with  any 
traditionally  bred  maize. 

Without  prejudice  to  other  labelling  required  by  Community  legislation,  the  label 
of  each  package  of  seeds  shall  indicate  that  the  product: 

protects  itself  against  corn  borers* and, 
has  increased  tolerance  to  the  herbicide  glufosinate-ammonium. 

- 4-

This  Decision  is  addressed  to  the  Member  States. 

Article  2 

Done  at  Brussels, 

For  the  Council 

ISSN  0254-1475 

COM(96) 206  final 

DOCUMENTS 

EN 

03  15 

Catalogue number  : CB-CO-96-216-EN-C 

ISBN 92-78-03901-2 

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