IP/04/663
Bruxelles, den 19 maj 2004
Kommissionen tillader import af genmodificeret sukkermajs på dåse på grundlag af nye, strenge mærkningskrav – forbrugerne kan selv vælge
Europa-Kommissionen gav i dag tilladelse til markedsføring af sukkermajs af genetisk modificeret Bt11-majs. Beslutningen gælder i ti år og er rettet til virksomheden Syngenta. Det skal altid klart fremgå af mærkningen, at de importerede dåsemajs er høstet fra genetisk modificerede planter. Det har siden 1998 været tilladt at importere frø af genetisk modificeret Bt11-majs til EU, hvor majsen er meget anvendt i foder[1] og i fødevarer fremstillet heraf[2], som f.eks. majsolie, majsmel, snacks, bagværk, stegte fødevarer, konditorvarer og læskedrikke. Den nye tilladelse gælder specifikt import af sukkermajs på dåse og friske sukkermajs. Det skal af mærkningen klart fremgå, at majsen er en genmodificeret organisme (GMO), i overensstemmelse med den nye EU-lovgivning. En ansøgning om tilladelse til dyrkning af Bt11-majs er ved at blive behandlet, uden at tilladelsen foreligger endnu.
Kommissær for sundhed og forbrugerbeskyttelse David Byrne udtalte: "Genmodificeret sukkermajs har været underkastet verdens strengeste vurdering forud for markedsføringen. Den videnskabelige vurdering er, at den er lige så sikker som konventionel majs. Det er derfor ikke fødevaresikkerhed, det drejer sig om, men derimod forbrugernes valg. Med de nye EU-regler for GMO'er stilles der krav om tydelig mærkning og sporbarhed. Mærkningen sikrer forbrugerne de oplysninger, de skal bruge for at kunne træffe et bevidst valg. Det er således helt op til forbrugerne, hvad de vil købe. Kommissionen handler ansvarligt på grundlag af strenge og klare regler."
Sukkermajs af genmodificeret Bt11-majs vil blive mærket i overensstemmelse med de nye bestemmelser, som Rådet og Europa-Parlamentet har vedtaget i de senere år, og som har været gældende siden den 18. april 2004[3]. Bt11-sukkermajs har i overensstemmelse med internationale retningslinjer været underkastet en tilbundsgående sikkerhedsvurdering af de potentielle skadelige virkninger for folkesundheden. Den er blevet tildelt en entydig identifikator, som sikrer sporbarhed, og som opføres i EF-registret over genetisk modificerede fødevarer og foderstoffer. Tilladelsen gælder i ti år. Det var Kommissionen, der traf beslutningen, som det er påkrævet, når Rådet hverken vedtager eller forkaster Kommissionens forslag.
EU har i løbet af de seneste fire år indført et
letforståeligt, gennemskueligt og strengt regelsæt til regulering af
genetisk modificerede fødevarer, foderstoffer og planter. Lovgivningen
sikrer, at GMO'er, der tillades i EU, ikke udgør en sikkerhedsrisiko for
mennesker, og at det er sikkert at udsætte dem i miljøet. Klare
mærkningskrav gør det muligt for landbrugerne selv at vælge, hvad
de vil dyrke, og for forbrugerne selv at vælge, hvad de vil købe. Det
er derfor kun naturligt, at dette sikre system anvendes i praksis. Tilladelser
gives på grundlag af de omstændigheder, der gør sig gældende
i de enkelte tilfælde, og ansøgninger, der ikke opfylder alle
kriterier, vil blive afvist – ligesom de altid er blevet det. De relevante
beslutninger træder i kraft den dag, de bekendtgøres for
ansøgeren.
Der findes flere oplysninger på følgende
adresse:
http://ec.europa.eu/food/food/biotechnology/index_en.htm
og
i dokument
MEMO/04/102
("Reguleringen af GMO'er – spørgsmål og
svar").
Bilag: Tilladte GMO'er i EU og ikke færdigbehandlede
ansøgninger
NOTER:
Novartis (nu Syngenta) indgav den 11. februar 1999 en ansøgning til de kompetente myndigheder i Nederlandene om tilladelse til at markedsføre sukkermajs af genetisk modificeret Bt11-majs som et nyt levnedsmiddel eller en ny levnedsmiddelingrediens. Majsen er høstet fra en plante, som er genetisk modificeret til at producere Bt-toksin - dette minder om et bakterieproduceret stof, der i mange år har været flittigt anvendt som en naturlig insektgift.
Det kompetente fødevarevurderingsorgan i Nederlandene konkluderede, at Bt11-sukkermajs er lige så sikker som konventionel sukkermajs; en vurdering, som EU's Videnskabelige Komité for Levnedsmidler tilsluttede sig. I den videnskabelige udtalelse fra EU-komitéen fokuserede man på de spørgsmål, der var rejst af medlemsstaternes myndigheder (bl.a. molekylær karakterisering og toksicitetsundersøgelser, som påpeget i udtalelsen fra "Agence française de sécurité sanitaire des aliments" (AFSSA)).
Den metodologi, der blev anvendt ved sikkerhedsvurderingen af Bt11, var ligeledes i overensstemmelse med EU's Videnskabelige Styringskomités seneste retningslinjer for vurdering af GMO'er og genetisk modificerede fødevarer og foderstoffer og med Codex Alimentarius' principper og retningslinjer for fødevarer fremstillet ved anvendelse af bioteknologi.
Europa-Kommissionens Fælles Forskningscenter (FFC) har i samarbejde med Det Europæiske Net af GMO-laboratorier (ENGL) gennemført en komplet valideringsundersøgelse (ringtest) efter internationalt accepterede retningslinjer for at undersøge ydeevnen for en kvantitativ begivenhedsspecifik metode til at påvise og bestemme Bt11-transformationsbegivenheden i sukkermajs. Den validerede metode er blevet udviklet af det nationale veterinærinstitut i Norge og INRA i Frankrig. Såvel metoden som resultaterne af valideringen er blevet offentliggjort.
Sukkermajs af genetisk modificeret Bt11-majs og levnedsmidler, der indeholder sukkermajs af genetisk modificeret Bt11-majs som ingrediens, skal mærkes i overensstemmelse med forordning (EF) nr. 1829/2003 og underkastes de krav til sporbarhed, der er fastsat i forordning (EF) nr. 1830/2003 om sporbarhed og mærkning af genetisk modificerede organismer og sporbarhed af fødevarer og foder fremstillet af genetisk modificerede organismer og om ændring af direktiv 2001/18/EF.
Fra det register, Kommissionen skal oprette i henhold til artikel 28 i forordning (EF) nr. 1829/2003, skal der kunne indhentes oplysninger om identifikationen af sukkermajs af genetisk modificeret Bt11-majs, herunder den validerede påvisningsmetode og referencematerialet, jf. bilaget.
Genetisk modificeret Bt11-majs er blevet anmeldt til clearinginstituttet for biosikkerhed, jf. artikel 11, stk. 1, og artikel 20, stk. 3, litra c), i Cartagena-protokollen om biosikkerhed til konventionen om den biologiske mangfoldighed.
Den Stående Komité for Fødevarekæden og Dyresundhed har ikke afgivet udtalelse. Kommissionen forelagde derfor den 4. februar 2004 Rådet et forslag i henhold til artikel 13, stk. 4, litra b), i forordning (EF) nr. 258/97, jf. artikel 5, stk. 4, i Rådets afgørelse 1999/468/EF, med en anmodning til Rådet om at reagere inden for tre måneder.
Forslaget blev behandlet på samlingen i Rådet (landbrug og fiskeri) den 26. april 2004. Irland, Italien, Nederlandene, Finland, Sverige og UK stemte for, mens Danmark, Grækenland, Frankrig, Luxembourg, Østrig og Portugal stemte imod. Belgien, Tyskland og Spanien undlod at stemme. Eftersom Rådet ikke reagerede inden for den fastsatte frist, vil beslutningen nu blive vedtaget af Kommissionen.
I henhold til forordning (EF) nr. 1830/2003 om sporbarhed og mærkning skal virksomheder videregive og opbevare oplysninger om produkter, der indeholder eller er fremstillet af GMO'er, på hvert enkelt stadium i markedsføringen. Sporbarhed er et middel til at spore produkter, der indeholder eller er fremstillet af GMO'er, i hele produktions- og distributionskæden.
Forordning (EF) nr. 1829/2003 om genmodificerede fødevarer og foderstoffer indeholder krav om omfattende oplysninger via mærkning af alle fødevarer og foderstoffer, der indeholder, består af eller er fremstillet af GMO'er. Alle fødevarer, herunder også soja- og majsolie fremstillet af genmodificeret soja og majs, og fødevareingredienser såsom kiks med majsolie, der er fremstillet af genmodificeret majs, skal mærkes. Produkterne skal være mærket "Dette produkt indeholder genetisk modificerede organismer" eller "fremstillet af genetisk modificeret [organismens navn]".
ANNEX 1
GMO PRODUCTS
APPROVED UNDER DIRECTIVE 90/220/EEC AS OF MARCH 2001
|
Product
|
Notifier
|
|
|
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)[6]
|
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)[7] Uses : import and processing |
Plant Genetic Systems
C/F/95/05/01/A |
06.06.97
(not finally approved by F) |
|
Product
|
Notifier
|
|
|
10. Male sterile swede rape tolerant to glufosinate ammonium (MS1,
RF2)[10]
|
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
|
|
7. Roundup Ready sugar beet (event T9100152), glyphosate
tolerant
from Belgium C/BE/99/01 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 |
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
|
|
EVENT
|
CROP
|
APPLICANT
|
TRAIT
|
POTENTIAL FOOD USES
|
DATE
|
LEGAL BASIS
|
|
1
|
GTS 40/3/2
|
Soybean
|
Monsanto
|
Insect protection and herbicide tolerance
|
Soy foods. Soy foods include soy beverages, tofu, soy oil, soy flour, lecithin. |
03.04.1996
|
Dir. 90/220/EEC – Art. 13
|
|
2
|
Bt 176
|
Maize
|
Ciba-Geigy
|
Insect protection and herbicide tolerance
|
Maize foods. Maize foods include kernels, oil, maize flour, sugar, syrup. |
23.01.1997
|
Dir. 90/220/EEC – Art. 13
|
|
3
|
TOPAS 19/2
|
Oilseed rape
|
AgrEvo
|
Herbicide tolerance
|
|
24.06.1997
|
Reg. (EC) 258/97 – Art. 5
|
|
4
|
MS1 / RF2
|
Oilseed rape
|
Plant Genetic Systems
|
Herbicide tolerance
|
Rapeseed oil. Products made with rapeseed oil may |
24.06.1997
|
Reg. (EC) 258/97 – Art. 5
|
|
5
|
MS1 / RF1
|
Oilseed rape
|
Plant Genetic Systems
|
Herbicide tolerance
|
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
|
|
4
|
MON 863
|
Maize
|
Monsanto
|
Insect protection
|
Maize and maize derivatives
|
DE – 08/04/2003
|
EFSA – Opinion adopted on 2April 2004
|
Reg. (EC) No. 258/97 – Art. 7
Awaiting validation of detection method
|
|
5
|
MON 863 x
MON 810 |
Maize
|
Monsanto
|
Insect protection
|
Maize and maize derivatives
|
DE – 08/04/2003
|
EFSA - pending
|
Reg. (EC) No. 1829/2003 Art. 46.1
|
|
6
|
1507
|
Maize
|
Pioneer
|
Insect protection
|
Maize and maize derivatives
|
NL – 04/11/2003
|
EFSA - pending
|
Reg. (EC) 258/97 – Art. 7
|
|
7
|
MaisGard/RoundupReady
|
Maize
|
Monsanto
|
Insect protection and herbicide tolerance
|
Maize and maize derivatives
|
NL – pending
|
|
Reg. (EC) No. 1829/2003 Art. 46.1
|
|
8
|
RoundupReady Sugar Beet
|
Sugar Beet
|
Monsanto
|
Herbicide tolerance
|
Sugar Beet derivatives
|
NL – pending
|
|
Application withdrawn on 16 April 2004
|
|
9
|
Liberty Link Soybean
|
Soybean
|
AgrEvo
|
Herbicide tolerance
|
Soybean derivatives
|
B – pending
|
|
Reg. (EC) No. 1829/2003 Art. 46.1
|
[1] Tilladelse givet den 22. april 1998 i henhold til Rådets direktiv 90/220/EØF.
[2] Anmeldt den 6. februar 1998 i henhold til artikel 5 (i alt væsentligt svarende til eksisterende fødevarer) i forordning (EF) nr. 258/97.
[3] Forordning (EF) nr. 1829/2003 om genetisk modificerede fødevarer og foderstoffer
Forordning (EF) nr. 1830/2003 om sporbarhed og mærkning af genetisk modificerede organismer og sporbarhed af fødevarer og foder fremstillet af genetisk modificerede organismer.
