News section
European Commission authorises import of canned GM-sweet corn under new strict labelling conditions - consumers can choose
Brussels, Belgium
May 19, 2004

The European Commission authorised today the placing on the market of sweet corn from genetically modified maize line Bt11. This decision is valid for 10 years and addressed to the company Syngenta. Any imports of the canned vegetable will have to show clearly on the labelling that the corn has been harvested from a genetically modified plant. Grain from the GM maize line Bt11 has been authorised for import into Europe since 1998 and is widely used in the EU in feed(1) and in derived food products(2), e.g. maize oil, maize flour, sugar and syrup, snack foods, baked foods, fried foods, confectionary and soft drinks. The authorisation today covers the specific use for imports of canned or fresh sweet corn (maize). The labelling will have to show clearly that the corn is a GMO in line with the new EU legislation. An authorisation for cultivation for Bt11 maize is pending and has not yet been granted.

David Byrne, Commissioner for Health and Consumer Protection, said: "GM sweet corn has been subject to the most rigorous pre-marketing assessment in the world. It has been scientifically assessed as being as safe as any conventional maize. Food safety is therefore not an issue, it is a question of consumer choice. The new EU rules on GMOs require clear labelling and traceability. Labelling provides consumers with the information they need to make up their own mind. They are therefore free to choose what they want to buy. The Commission is acting responsibly based on stringent and clear legislation."

The sweet corn from the GM maize Bt11 will be labelled in accordance with new laws agreed by Council and European Parliament over the past years and in force since 18 April 2004(3). Bt 11 sweet corn has undergone thorough safety assessment for any adverse impact on public health on the basis of international guidelines. It has been assigned a unique identifier to allow traceability and will be entered in the Community Register of genetically modified food and feed. The authorisation is valid for 10 years. The Commission took the decision as required in cases where the Council has neither adopted the Commission proposal, nor indicated its opposition to it.

The EU has put in place a clear, transparent and stringent system to regulate genetically modified food, feed and plants over the past four years. The legislation ensures that GMOs authorised in the EU are safe for human consumption and for release into the environment. Clear labelling rules allow farmers to choose what to plant and consumers to choose what to buy. It is therefore only logical that this safe system is applied in practice. Each authorisation is granted on its own merits and requests for authorisations which do not fulfil all criteria were and will be rejected. The decision enters into force the day when it is notified to the applicant. The decision enters into force the day when it is notified to the applicant.

Further information: http://europa.eu.int/comm/food/food/biotechnology/index_en.htm and MEMO/04/102 (Questions and Answers on the regulation of GMOs in the EU)

ANNEXES: Authorised GMOs in the EU and pending applications

BACKGROUND

On 11 February 1999, Novartis (in the meantime: Syngenta), submitted a request to the competent authorities of the Netherlands for placing sweet maize from genetically modified maize line Bt11 on the market as a novel food or as a novel food ingredient. The corn has been harvested from a plant genetically modified to produce Bt toxin, which is similar to that produced by bacteria and widely used as a natural insecticide for many years..

The Netherlands' competent food assessment body came to the conclusion that Bt11 sweet maize is as safe as conventional sweet maize as did the EU Scientific Committee on Food. The EU scientific opinion focused on the issues raised by Member States' authorities (e.g molecular characterisation and as well as toxicity studies as raised in the opinion of the "Agence française de sécurité sanitaire des aliments" (AFSSA).

The methodology used for the safety assessment of Bt11 was also in line with the recent guidelines prepared by the EU Scientific Steering Committee concerning the assessment of GMOs, GM food and GM feed and with the Codex Principles and Guidelines on Foods Derived from Biotechnology.

The Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a full validation study (ring-trial) following internationally accepted guidelines to test the performance of a quantitative event-specific method to detect and quantify the Bt11 transformation event in sweet maize. The method validated had been developed by the National Veterinary Institute of Norway and INRA, France. Both the method and the results of the validation have been made publicly available.

Sweet maize from genetically modified maize line Bt11 and food containing sweet maize from genetically modified maize line Bt11 as an ingredient shall be labelled in accordance with the provisions of Regulation (EC) No 1829/2003 and shall be subject to the traceability requirements laid down in Regulation (EC) No 1830/2003 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/EC.

Information on the identification of sweet maize from genetically modified maize line Bt11, including the validated detection method and the reference material, contained in the annex, shall be retrievable from the Register to be established by the Commission in accordance with Article 28 of Regulation (EC) No 1829/2003.

Genetically modified maize Bt11 has been notified to the Biosafety Clearing-House, pursuant to Articles 11(1) and 20(3)(c) of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

The Standing Committee on the Food Chain and Animal Health has not given an opinion. The Commission has therefore submitted a proposal to the Council on 4 February 2004 pursuant to Article 13, paragraph 4 b) of Regulation (EC) No 258/97 and in accordance with Article 5, paragraph 4 of the Council Decision 1999/468/EC, the Council being required to act within 3 months.

The proposal was considered by the Agriculture Council on 26 April 2004. At that meeting Ireland, Italy, the Netherlands, Finland, Sweden and the UK voted in favour. Denmark, Greece, France, Luxembourg, Austria and Portugal voted against. Belgium, Germany and Spain abstained. Since the Council had not acted within the required time limit, the Decision must now to be adopted by the Commission.

Under the rules of Regulation 1830/2003 on labelling and traceability, 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.

Regulation 1829/2003 on GM food and feed provides for comprehensive information by labelling all food and feed containing, consisting of or produced from a GMO. All food, including soya or maize oil produced from GM soya and maize, and food ingredients, such as biscuits with maize oil produced from GM maize must be labelled. The label has to indicate "This product contains genetically modified organisms" or "produced from genetically modified (name of organism)".

Annex 1

GMO PRODUCTS

APPROVED UNDER DIRECTIVE 90/220/EEC AS OF MARCH 2001

Product

Notifier

Date of Commission Decision(4) / Member State Consent(5)

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

Date of Commission Decision(8) / Member State Consent(9)

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

FOOTNOTES

(1) Authorisation granted on 22 April 1998 in accordance with Council Directive 90/220/EC
(2)
Notification of 6 February 1998 pursuant to Article 5 (substantial equivalence) of Regulation (EC) 258/97
(3) Regulation (EC) No 1829/2003 on GM food and feed Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms
(4) where objections were raised by Member State authorities
(5) in the absence of objections by Member State authorities
(6) linked to item 1 (same product, further uses)
(7) linked to item 5 (same product, further uses)
(8) where objections were raised by Member State authorities
(9) in the absence of objections by Member State authorities
(10) this product is the result of a different transformation event to that of No. 9.

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