GMOS: EU COMMISSION AUTHORIZES IMPORT OF GM-MAIZE FOR USE
IN ANIMAL FEED
The European Commission authorized today the placing on the market of
the genetically modified maize known as NK603 for import and processing. This
decision is valid for 10 years and results from an application submitted by the
company Monsanto. Imports of the maize, whether in bulk shipments, bags or other
containers, will have to be labeled as containing genetically modified maize.
The NK603 maize is already widely used in other parts of the world with no reports
of any adverse effects on health or the environment. The authorization today,
which is backed by science, covers the specific use for imports of the GM maize
and processing for use in animal feed or for industrial purposes. A separate decision
in terms of authorization of the NK603 maize for use in food will be taken in
the coming months.
Margot
Wallström, Commissioner for the
Environment, said: "The NK603 maize has been subject to a rigorous
pre-market risk assessment. It has been scientifically assessed by the European
Food Safety Authority as being as safe as any conventional maize. Its safety
is, therefore, not in question, and neither is the question of user or consumer
choice. Clear labeling provides farmers and consumers with the information they
need to decide whether to buy the product or not. And robust post-marketing rules
will ensure that the product can be traced and monitored when put on the market.”
The NK603 maize is the first product to be assessed and approved after the entry
into force of Directive 2001/18/EC[1]. It
will be covered by the new strict labeling and traceability rules which came into
force in April[2]. When put on the market,
it will need be clearly labeled as containing genetically modified maize. Its
post-marketing monitoring will be assured through a unique identifier assigned
to the maize to enable its traceability. Today’s authorization covers the import
and the use as animal
feed, but not cultivation or food uses.
During the past 4 years, the EU has put in place a clear, transparent and stringent
system to regulate genetically modified food, feed and crops. The authorization
procedure under this new system ensures that only GMOs which are safe for human
and animal consumption and for release into the environment can be placed on the
European market. Individual authorizations are granted following appraisal of
the GMOs in question on a case-by-case basis. Requests for authorizations which
do not fulfill all criteria have been and will continue to be rejected.
Today’s decision grants approval for the use of NK603 maize in animal feed. However,
imports for this use can only commence once the equivalent approval has also been
granted for food use. A separate decision under the Novel
Foods Regulation is currently being considered by the Agriculture
Council. A decision is expected in the coming months.
See annex for lists of approved and pending GM products.
Note to editors:
In January 2001, Monsanto submitted a request, under Directive 2001/18/EC, to
the competent authorities of Spain for placing genetically modified maize line
NK603 on the market for import and processing for use in feed and for industrial
purposes. The NK603 maize is tolerant to the herbicide glyphosate. The product
involves a simple modification and does not contain an antibiotic resistance marker
gene.
The Spanish competent authority came to the conclusion that NK603 maize is as
safe as conventional maize. The European Food Safety Authority also appraised
the application and focused on the limited number of scientific issues raised
by competent authorities from the other Member States. Its opinion similarly concluded
that NK603 maize was as safe as conventional maize.
The Regulatory
Committee established under Directive 2001/18/EC did not give an opinion.
The Commission therefore submitted a proposal to the Council on 29 March 2004.
The Council was required to act within 3 months.
The proposal was considered by the Environment
Council on 28 June 2004. At that meeting, which included Ministers from the
new Member States, neither
a qualified majority vote in favor or against approval was obtained. This deemed
that the Council did not act within the requisite time limit and consequently,
the Commission under the legal procedure is obliged to adopt the Decision.
The methodology used for the safety assessment of the NK603 maize was entirely
that of the new regulatory framework, notably Directive 2001/18/EC. The Directive
also provides for mandatory measures to be applied to the product following approval.
This includes post-market monitoring of the continued safety of the product once
it has been placed on the market via use of surveillance systems. This monitoring
is required throughout the period of validity of the consent. The consent holder
is required to submit reports of this monitoring program to all Member States
and the Commission on an annual basis.
The product will also have to be identifiable every time that it is placed on
the market allowing individuals to choose whether or not to purchase and use the
product. This will be ensured via the labeling and traceability provisions of
the Directive and those of Regulation 1830/2003. Under this Regulation, business
operators must transmit and retain information about products that contain or
are produced from GMOs at each stage of the placing on the market. Traceability
provides the means to trace products containing or produced from GMOs through
the production and distribution chains. The Regulation also provides for comprehensive
information by its requirement for labeling of GMOs at all stages of the placing
on the market. The label has to indicate "This product contains genetically
modified organisms" or "This product contains genetically modified maize."
A validated detection method and appropriate reference material is available and
will allow for the physical detection of the NK603 maize in products enabling
labeling claims to be verified. Guidance as to sampling and testing to verify
the presence of GMOs in products has also been agreed to by Member States and
this will enable their inspection and control authorities to operate in a harmonized
manner throughout the EU.
ANNEX 1
GMO products
Approved under directive 90/220/EEC as of March 2001
Product
Notifier
Date of Commission Decision[3] / Member
State Consent[4]
1. Vaccine against Aujeszky's disease
Vemie Veterinär Chemie GmbH
18.12.92
2. Vaccine against rabies
Rhône-Mêrieux
C/B/92/B28 & C/F/93/03-02
19.10.93
3. Tobacco tolerant to bromoxynil
SEITA
C/F/93/08-02
08.06.94
4. Vaccine against Aujeszky's disease (further uses)[5]
Vemie Veterinär Chemie GmbH
C/D/92/I-1
18.07.94
5. Male sterile swede rape resistant to glufosinate
ammonium (MS1, RF1)
Uses : breeding activities
Plant Genetic Systems
C/UK/94/M1/1
06.02.96
6. Soybeans tolerant to glyphosate
Uses : import and processing
Monsanto
C/UK/94/M3/1
03.04.96
7. Male sterile chicory tolerant to glufosinate ammonium
Uses : breeding activities
Bejo-Zaden BV
C/NL/94/25
20.05.96
8. Bt-maize tolerant to glufosinate ammonium
(Bt-176)
Ciba-Geigy
C/F/94/11-03
23.01.97
9. Male sterile swede rape
tolerant to glufosinate
ammonium (MS1, RF1)[6]
Uses : import and
Processing
Plant Genetic Systems
C/F/95/05/01/A
06.06.97
(not finally approved by F)
Product
Notifier
Date of Commission Decision[7] / Member
State Consent[8]
10. Male sterile swede rape tolerant to glufosinate
ammonium (MS1, RF2)[9]
Plant Genetic Systems
C/F/95/05/01/B
06.06.97
(not finally approved by F)
11. Test kit to detect antibiotic residues in milk
Valio Oy
C/F1/96-1NA
14.07.97
12. Carnation lines with modified flower colour
Florigene
C/NL/96/14
01.12.97
(MS consent)
13. Swede rape tolerant to glufosinate ammonium (Topas
19/2)
Uses : import and processing
AgrEvo
C/UK/95/M5/1
22.04.98
14. Maize tolerant to glufosinate ammonium (T25)
AgrEvo
C/F/95/12/07
22.04.98
15. Maize expressing the Bt cryIA(b) gene (MON
810)
Monsanto
C/F/95/12-02
22.04.98
16. Maize tolerant to glufosinate ammonium and expressing
the Bt cryIA(b) gene (Bt-11)
Uses : import and processing
Novartis
(formerly Northrup King)
C/UK/96/M4/1
22.04.98
17. Carnation lines with improved vase life
Florigene
C/NL/97/12
20.10.98
(MS consent)
18. Carnation lines with modified flower colour
Florigene
C/NL/97/13
20.10.98
(MS consent)
ANNEX 2
GMO products
Notifications received by the Commission under directive 2001/18/EC
Product notification details
Company
Stage
1. Maize hybrid MON810 x NK603 (glyphosate-tolerant
and containing Bt toxin)
Received by UK under Dir 90/220/EC. (C/GB/02/M3/03)
Received by the Commission under Dir 2001/18 : 15/01/03
Uses : import and use in feed and industrial processing, not for cultivation.
Monsanto
Consideration of assessment report and notification
by Member States (60 day period)
2. Oil seed rape – herbicide resistant GT 73
Received by the Netherlands (C/NL/98/11) under Dir 90/220/EC.
Received by the Commission under Dir 2001/18 : 16/1/03
Uses : import and uses in feed and industrial processing, not for cultivation.
Monsanto
EFSA Opinion published. Draft Decision pending submission
to Regulatory Committee.
3. Maize Roundup Ready NK603, tolerant to glyphosate
herbicide
Received by Spain (C/ES/00/01) under Dir 90/220 : 21/12/2000
Received by the Commission under Dir 2001/18 : 17/01/03
Uses : import and use in feed and industrial processing, not for cultivation.
Monsanto
Draft Proposal with Council
4. Potato with altered starch composition
from Sweden (C/SE/96/3501)
Received by the Commission under Dir 90/220: 20.05.98
Favourable opinion of EU Scientific Committee 18.07.02
Received by the Commission under Dir 2001/18/EC: 24/01/03
Uses : for cultivation and production of starch, not for use as human food.
AMYLOGENE HB
Consideration of assessment report and notification
by Member States (60 day period)
5. Oilseed rape (Ms8, Rf3)
from Belgium (C/BE/96/01)
Received by the Commission: under Dir 90/220 16.01.97
Favourable opinion of EU Scientific Committee 19.05.98
Received by the Commission under Dir 2001/18: 5/02/03
Uses: import and cultivation in the EU, uses in feed and industrial processing.
Bayer CropScience
Consideration of assessment report and notification
by Member States (60 day period)
6. Soybeans Glufosinate tolerant (Events A 2704-12
& A 5547-127)
from Belgium (C/BE/98/01)
Received by the Commission under Dir 2001/18: 5/02/03
Uses: import only, not for cultivation
Bayer CropScience
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
Received by the Commission under Dir 2001/18: 5/02/03
Uses: for cultivation and use in animal feed, processing of sugar and other
products.
Monsanto/
Syngenta
Withdrawn
8. Oilseed rape tolerant for glufosinate-ammonium
herbicides.
(FALCON GS40/90pHoe6/Ac)
from Germany (C/DE/96/5)
Received by the Commission under Dir 90/220: 25.11.96
Opinion of EU Scientific Committee 27.07.98
Received by the Commission under Dir 2001/18: 7/02/03
Uses: for import and cultivation
Bayer CropScience
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
9. Oilseed rape tolerant for glufosinate (Liberator
pHoe6/Ac)
from Germany (C/DE/98/6)
Received by the Commission under Dir 90/220: 29.10.98
Favourable opinion of EU Scientific Committee 30.11.00
Received by the Commission under Dir 2001/18: 7/02/03
Uses: for import and cultivation
Bayer CropScience
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
10. Roundup Ready Sugar Beet event H7-1 (tolerant
to glyphosate)
from Germany C/DE/00/8
Received by the Commission under Dir 2001/18: 7/02/03
Uses: for cultivation and use in processing of sugar and other processed
products.
KWS SAAT AG/Monsanto
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
11. Maize MON 863 X MON 810 (protection against certain
insect pests)
from Germany C/DE/02/9 (6788-01-09)
Received by the Commission under Dir 2001/18: 7/02/03
Uses: , for import and use of grain and grain products, not for cultivation.
Monsanto
EFSA Opinion published. Draft Decision pending submission
to Regulatory Committee.
12. Oilseed rape (event T45) tolerant for glufosinate-ammonium
herbicide
from UK C/GB/04/M5/4 (Replacing C/GB/99/M5/2 received by the Commission on 10/2/03
and withdrawn on 26/3/04).
Received by the Commission under Dir 2001/18: 30/03/04
Uses: import and use in feed and industrial processing, not for cultivation.
Bayer CropScience
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
13. Maize herbicide and insect resistant (line 1507
-- CRY1F)
Received by the Netherlands (C/NL/00/10) under Dir 90/220/EC.
Received by the Commission under Dir 2001/18 : 12/02/03
Uses: import and processing, not for cultivation
Pioneer/
Mycogen Seeds
Submitted to EFSA for Opinion
14. Insect-protected Cotton expressing the Bt cryIA(c)
gene (line 531)
from Spain (C/ES/96/02)
Received by the Commission under Dir 90/220: 24.11.97
Favourable opinion of EU Scientific Committee 14.07.98
Received by the Commission under Dir 2001/18: 12/2/03
Uses : for import, processing and cultivation
Monsanto
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
15. Roundup Ready Cotton tolerant to herbicide (line
1445)
from Spain (C/ES/97/01)
Received by the Commission under Dir 90/220: 24.11.97
Favourable opinion of EU Scientific Committee 14.07.98
Received by the Commission under Dir 2001/18: 12/2/03
Uses : for import, processing and cultivation
Monsanto
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
16. Maize 1507 (or Bt Cry1F 1507)
Received by Spain (C/ES/01/01) 11/7/2001 under Dir 90/220/EC.
Received by the Commission under Dir 2001/18: 13/2/03
Uses : Cultivation
Pioneer/
Mycogen Seeds
Consideration of assessment report and notification
by Member States (45 day period)
17. Roundup Ready Fodder beet (line A5/15)
from Denmark (C/DK/97/01)
Received by the Commission under Dir 90/220: 09.10.97
Favourable opinion of EU Scientific Committee 23.06.98
Received by the Commission under Dir 2001/18/EC: 26/02/03
Uses : for cultivation and animal feed.
DLF-Trifolium, Monsanto and Danisco Seed
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
18. Maize tolerant to glufosinate ammonium and expressing
the Bt cryIA(b) gene (Bt-11)
from France (C/F/96/05-10)
Received by the Commission under Dir 90/220: 12.04.99 and 03.05.99 respectively
Favourable opinion of EU Scientific Committee 30.11.00
Received by the Commission under Dir 2001/18/EC: 16.6.2003
Uses : for cultivation, feed and industrial processing
Syngenta Seeds SAS
Submitted to EFSA for Opinion
19. Bromoxynil-tolerant cotton lines 10215 and 10222
from Spain (C/ES/99/01)
Received by the Commission under Dir 2001/18/EC: 18.07.2003
Uses : for importation and processing to non-viable products
Stoneville Pedigreed Seed Company
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
20. NK603 Roundup Ready® maize
from Spain (C/ES/03/01)
Received by the Commission under Dir 2001/18/EC : 22/07/2003
Uses : Cultivation
Monsanto
Application with lead competent authority (90 day
period)
21. Rice tolerant to glufosinate-ammonium, event LLRICE62
from UK (C/GB/03/M5/3)
Received by the Commission under Dir 2001/18/EC : 3/9/2003
Uses : import and use in feed and industrial processing, not for cultivation.
Bayer CropScience Ltd.
Consideration of assessment report and notification
by Member States (60 day period)
22. NK603 X MON 810 maize from Spain (C/ES/04/01)
Received by the Commission under Dir 2001/18/EC : 12/1/2004
Uses : import and use in feed and industrial processing, and for cultivation.
Monsanto
Application with lead competent authority (90 day
period)
23. Cotton, insect resistant (281-24-236/3006-210-23)
from the Netherlands (C/NL/04/01)
Received by the Commission under Dir 2001/18/EC : 18/2/2004
Uses : import and use in feed and industrial processing, not for cultivation
nor feed use
Agrigenetics Inc.
d/b/a Mycogen Seeds, c/o Dow AgroSciences
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
24. Cotton (LLCotton25) glufosinate tolerant from
Spain (C/ES/04/02)
Received by the Commission under Dir 2001/18/EC : 26/3/2004
Uses : import and use in feed and industrial processing, not for cultivation
Bayer CropScience
Application to be transformed into an application
under Regulation 1829/2003 on GM Food and Feed
ANNEX 3
Genetically Modified (GM) foods authorised in the European
Union
include fried foods, baked products and snack foods.
24.06.1997
Reg. (EC) 258/97 – Art. 5
6
GT 73
Oilseed rape
Monsanto
Herbicide tolerance
21.11.1997
Reg. (EC) 258/97 – Art. 5
7
MON 810
Maize
Monsanto
Insect protection
06.02.1998
Reg. (EC) 258/97 – Art. 5
8
T 25
Maize
AgrEvo
Herbicide tolerance
Maize derivatives. These may include maize oil, maize
flour, sugar and syrup. Products made with maize
06.02.1998
Reg. (EC) 258/97 – Art. 5
9
Bt 11
Maize
Novartis
Insect protection
derivatives may include snack foods, baked foods,
fried foods, confectionary and soft drinks.
06.02.1998
Reg. (EC) 258/97 – Art. 5
10
MON 809
Maize
Pioneer
Insect protection
23.10.1998
Reg. (EC) 258/97 – Art. 5
11
Falcon GS 40/90
Oilseed rape
Hoechst / AgrEvo
Herbicide tolerance
08.11.1999
Reg. (EC) 258/97 – Art. 5
12
Liberator L62
Oilseed rape
Hoechst / AgrEvo
Herbicide tolerance
Rapeseed oil. Products made with rapeseed oil may
include fried foods, baked foods and snack foods.
08.11.1999
Reg. (EC) 258/97 – Art. 5
13
MS8/RF3
Oilseed rape
Plant Genetic Systems
Herbicide tolerance
26.04.2000
Reg. (EC) 258/97 – Art. 5
14
1445
Cotton
Monsanto
Herbicide tolerance
Cottonseed oil. Products made with cottonseed oil
may
19.12.2002
Reg. (EC) 258/97 – Art. 5
15
531
Cotton
Monsanto
Insect protection
include fried foods, baked foods and snack foods.
19.12.2002
Reg. (EC) 258/97 – Art. 5
16
pRF69/pRF93
Bacillus subtilis
F. Hoffmann - La Roche
Riboflavin
Vitamin B2
23.03.2000
Reg. (EC) 258/97 – Art. 5
ANNEX 4
Genetically Modified (GM) foods pending authorisation in
the European Union
EVENT
CROP
APPLICANT
TRAIT
FOOD USES
INITIAL ASSESSMENT
SCIENTIFIC OPINION
LEGAL BASIS / Stage of procedure
1
Bt 11
Maize
Syngenta
Insect resistance
Processed sweet maize.
NL – 27/04/2000
SCF – 13.03.2002
Reg. (EC) No. 258/97 – Art. 7
Back to Commission on 4 May 2004, since no qualified
majority was reached in Council
2
GA 21
Maize
Monsanto
Herbicide tolerance
Maize and maize derivatives
NL – 21/12/1999
SCF – 02.02.1999
Reg. (EC) No. 258/97 – Art. 7
Awaiting validation of detection method
3
NK 603
Maize
Monsanto
Herbicide tolerance
Maize and maize derivatives
NL – 13/08/2002
EFSA – 04.12.2003
Reg. (EC) No. 258/97 – Art. 7
Opinion by Member States on Commission proposal scheduled
for the meeting of the Standing Committee on the Food Chain and Animal Health
on 30 April 2004
European Union - Delegation of the
European Commission to the United States
2300 M Street, NW, Washington, DC 20037
Telephone: (202) 862-9500 Fax: (202) 429-1766
