News section
State of play on GMO authorisations under EU law

Brussels, Belgium
28 January 2004
 

Source:
http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=MEMO/04/17|0|RAPID&lg=EN&display=

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MEMO/04/17

State of play on GMO authorisations under EU law

Existing approvals

Under the rules on the deliberate release of GMOs into the environment (Directive 2001/18/EC and previously Directive 90/220/EC) so far 18 GMOs have been approved for different uses, some for cultivation, some for import and processing, some as feed, some as food (see annex 1). In terms of crops species, these GMOs include maize, oil seed rape, soybean and chicory.

Under the regulation on GM food and Feed which cover novel food and novel feed ingredients, (Regulation (EC) No 1829/2003) products from 15 GMOs can legally be marketed in the EU (see Annex 4).

These are:

·     One GM soy and one GM maize approved under Directive 90/220/EEC prior to the entering into force of the Novel Food Regulation;

·     Processed foods derived from inter alia 7 GM oilseed rape, 4 GM maize and oil from 2 GM cottonseeds. These products have all been notified as substantially equivalent in accordance with the Novel Food Regulation.

Approval of new GMO products for environmental release and placing on the market

Twenty two applications for the placing on the market of GMOs have been submitted into the authorisation procedure under Directive 2001/18/EC (Annex 2), e.g. maize, oil seed rape, sugar beet, soy beans, cotton, rice, fodder beet. Eleven of these applications have a scope which is restricted to import and processing, while the remaining ones also include cultivation as a requested use.

The most advanced of the above 22 applications in the procedure is the Monsanto NK603 GM maize, on which the European Food Safety Authority (EFSA) has delivered a favourable opinion. This application is for import and processing. It does not include cultivation as a requested use. Directive 2001/18/EC requires the Commission to adopt a Decision following consultation of the Member States in a Regulatory Committee. Taking account of the above the favourable opinion from EFSA and the necessary administrative procedures, the Commission has called a meeting of the Regulatory Committee for 18 February.

Two further applications (Monsanto GT73 oilseed rape) and (hybrid maize MON 863 x 810) have been formally submitted to the EFSA for evaluation and opinions are expected soon. The scope of this application is also limited to import and processing. The remaining applications are currently being appraised by national authorities.

Approval of new GMO products as food

Article 46(1) of the Regulation 1829/2003 on GM Food and Feed provides that applications for the authorisation of a GM food made under the Novel Foods Regulation which have received a final scientific assessment before the coming into application of the new Regulation are still to be processed under the Novel Foods Regulation. Authorisation for a GM food will include labelling and traceability provisions as required by the new law.

There are currently nine GM products pending authorisation under the Novel Food Regulation (for details see the list attached in Annex 3) e.g. maize, soybean and sugar beet.

The scientific risk assessment has been completed for three of the applications, a GM sweet maize from Syngenta (Bt11), a GM field corn from Monsanto (GA21) and a GM maize from Monsanto (NK603). An opinion with regard to the draft decision to authorise BT11 under the conditions as specified was submitted to the Standing Committee on the Food Chain and Animal Health on December 8, 2003. As no qualified majority was reached by the Committee, the Commission has decided today to submit the proposal to the Council. The Council has three months to act and to adopt or reject the proposed decision with qualified majority. The Council could also decide not to act. In this case it will be upon the Commission to take a decision.

The Commission has referred two other maize lines from Monsanto (MON 863 and MON 810 X MON863) to EFSA for advice. In both cases, the Commission has to await the advice from the EFSA before proceeding with these applications.

The four remaining applications are currently in the first stage of the authorisation process and are still undergoing risk assessment by a competent authority in a Member State.

National safeguard measures on GMOs

Under environmental legislation

Directive 90/220/EEC under its Article 16 (known as the safeguard clause) provided that where a Member State has justifiable reasons to consider that a GMO, which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory.

Article 16 has been invoked by Member States on nine separate occasions, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom (Annex 5). The scientific evidence provided by these Member States as justification for their measures, was submitted to the Scientific Committee(s) for opinion. In all of these cases, the Committee deemed that there was no new evidence which would justify overturning the original authorisation decision. National measures notified under Article 16 of Directive 90/220/EEC have now to be dealt with under the safeguard clause provision of Directive 2001/18/EEC (Article 23). In view of the new regulatory framework, the Commission has informed Member States that they should now withdraw their measures under Directive 90/220/EEC and lift the prohibitions.

On GM foods

Only one Member State has invoked the safeguard clause (Article 12) under the Novel Food Regulation. This took place in August 2000, when Italy suspended the trade in and use of products derived from four GM maize varieties (MON 810 from Monsanto; T25 from Bayer Crop Science; Bt11 from Syngenta and MON 809 from Pioneer) which had been notified under the simplified procedure for products considered as "substantially equivalent".

The Commission immediately sought an opinion from the Scientific Committee for Food which concluded, in September 2000, that the information provided by the Italian Authorities did not provide detailed scientific grounds for considering that the use of the GM foods in question endangered human health.

Co-existence

The cultivation of GM crops will logically have implications for the organisation of agricultural productions. Pollen flow between adjacent fields is a natural phenomenon and there will be some pollen flow from GM crops to conventional crops and vice versa. Because of the labelling requirements for GM food and feed, this may have economic implications for farmers who want to produce non-labelled food or feed products. Coexistence is about giving farmers the practical choice between conventional, organic and GM crop production in compliance with the legal obligations for labelling and purity standards.

On 5 March 2003, the Commission agreed that it should be up to the Member States to develop and implement management measures concerning co-existence, in accordance with the subsidiarity principle (see IP/03/314).

On 27 July 2003 the Commission has also adopted a Commission recommendation (2003/556/EC) on co-existence setting out guidelines for the development of national strategies and best practices to ensure co-existence (see IP/03/1096).

More information on EU policies and legislation on GMOs can be found at:

http://europa.eu.int/comm/food/food/biotechnology/gmfood/index_en.htm

ANNEX 1

GMO PRODUCTS

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

Product

Notifier

Date of Commission Decision(1) / Member State Consent(2)

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)(3)

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)(4)
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(5) / Member State Consent(6)

10. Male sterile swede rape tolerant to glufosinate ammonium (MS1, RF2)(7)

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

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

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

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

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

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

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

 

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

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

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

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

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

12. Oilseed rape (event T45) tolerant for glufosinate-ammonium herbicide
from UK C/GB/99/M5/2
Received by the Commission under Dir 2001/18: 10/02/03
Uses: import and use in feed and industrial processing, not for cultivation.

Bayer CropScience

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

 

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

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

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: import, feed and industrial processing, and
cultivation

'

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

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

19. Brombxnnil-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

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

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.

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

 

ANNEX 3

GENETICALLY MODIFIED (GM) FOODS PENDING AUTHORISATION IN THE EUROPEAN UNION

 

EVENT

CROP

APPLICANT

TRAIT

FOOD USES

INITIAL ASSESSMENT

SCIENTIFIC OPINION

LEGAL BASIS

1

Bt 11

Maize

Syngenta

Insect resistance

Processed sweet maize.

NL 27/04/2000

SCF 13.03.2002

Reg. (EC) 258/97 Art. 7

2

GA 21

Maize

Monsanto

Herbicide tolerance

Maize and maize derivatives

NL 21/12/1999

SCF 02.02.1999

Reg. (EC) 258/97 Art. 7

3

NK 603

Maize

Monsanto

Herbicide tolerance

Maize and maize derivatives

NL 13/08/2002

EFSA 04.12.2003

Reg. (EC) 258/97 Art. 7

4

MON 863

Maize

Monsanto

Insect protection

Maize and maize derivatives

DE 08/04/2003

EFSA - pending

Reg. (EC) 258/97 Art. 7

5

MON 863 x

MON 810

Maize

Monsanto

Insect protection

Maize and maize derivatives

DE 08/04/2003

EFSA - pending

Reg. (EC) 258/97 Art. 7

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) 258/97 Art. 4

8

RoundupReady Sugar Beat

Sugar Beat

Monsanto

Herbicide tolerance

Sugar Beat derivatives

NL - pending

'

Reg. (EC) 258/97 Art. 4

9

Liberty Link Soybean

Soybean

AgrEvo

Herbicide tolerance

Soybean derivatives

B - pending

'

Reg. (EC) 258/97 Art. 4

 ANNEX 4

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

ANNEX 5

GMO PRODUCTS

INVOCATION OF ARTICLE 16 UNDER DIRECTIVE 90/220/EEC

Member State and date of invocation

Product details and date of Scientific Opinion

1. France (20.11.98)

Male sterile swede rape resistant to glufosinate MS1/RF1
Uses: Cultivation for breeding activities (seed production)
Product approval: 1996
Scientific Committee Opinion: 18.05.99

2. Austria (14.02.97)

3. Luxembourg (17.03.97)

4. Germany (04.04.00)

Bt-maize tolerant to glufosinate ammonium (Bt-176)
Uses: All uses (cultivation, food and feed, processing)
Product approval: 1997
Scientific Committee Opinion: 21.03.97 (2 and 3 opposite)
10.04.97 (2 and 3 opposite)
12.05.97 (2 and 3 opposite)
09.11.00 (4 opposite)

5. Greece (03.11.98)

6. France (20.11.98)

Swede rape tolerant to glufosinate (Topas 19/2)
Uses: Import, storage and processing (no cultivation)
Product approval: 1998
Scientific Committee Opinion: 18.05.99

7. Austria (01.06.99

Maize expressing the Bt cryIA(b) gene (MON 810) Uses: All uses (cultivation, food and feed, processing)
Product approval: 1998
Scientific Committee Opinion: 24.09.99

8. Austria (08.05.00)

9. United Kingdom (13.07.01)

Maize tolerant to glufosinate (T25)
Uses: All uses (cultivation, food and feed, processing)
Product approval: 1998
Scientific Committee Opinion: 30.11.00 (8 opposite)
08.11.01 (9 opposite)

ANNEX 6

LABELLING OF GM-FOOD and GM-FEED EXAMPLES(8)

GMO-type

EXAMPLE

Labelling

required

at present

Labelling

required

in future

GM plant

Chicory(9)

Yes

Yes

GM seed

Maize seeds

Yes

Yes

GM food

Maize, Soybean sprouts, Tomato

Yes

Yes

Food

Maize flour(10)

Yes

Yes

produced

Highly refined maize oil, soybean oil, rape seed oil(11)

No

Yes

from GMOs

Glucose syrup produced from maize starch \* MERGEFORMAT 11

No

Yes

Food from animals fed on GM feed

Eggs, meat, milk

No

No

Food produced with the help of a GM enzyme

bakery products produced with the help of amylase

No

No

Food additive/flavouring produced from GMOs

Highly filtered lecithin extracted from GM soybeans used in chocolate \* MERGEFORMAT 11

No

Yes

GM Feed

Maize(12)

Yes

Yes

Feed produced from a GMO

Corn gluten feed, Soybean meal

No

Yes

Feed additive produced from a GMO

Vitamin B2 (riboflavin)

No

Yes

(1)where objections were raised by Member State authorities

(2)in the absence of objections by Member State authorities

(3)linked to item 1 (same product, further uses)

(4)linked to item 5 (same product, further uses)

(5)where objections were raised by Member State authorities

(6)in the absence of objections by Member State authorities

(7)this product is the result of a different transformation event to that of No. 9

(8)The examples include foods which have not been authorised for marketing in the EU. See Annex II for a list of products which can legally be marketed in the EU.

(9)One chicory has been approved for breeding purposes under Directive 90/220/EC, but not for food use

(10)DNA or protein of GM origin detectable in the final product.

(11)DNA or protein of GM origin not detectable in the final product.

(12)The current labelling rules entered into force in 1997, and do not include four GMOs approved prior to that date.

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