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MEMO/04/17

Brussels, 28 January 2004

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://ec.europa.eu/food/food/biotechnology/gmfood/index_en.htm

ANNEX 1

GMO PRODUCTS

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

Product

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

    1. Vaccine against Aujeszky's disease

Vemie Veterinär Chemie GmbH18.12.92
2. Vaccine against rabiesRhône-Mêrieux C/B/92/B28 & C/F/93/03-0219.10.93
3. Tobacco tolerant to bromoxynilSEITA C/F/93/08-0208.06.94
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 activitiesPlant Genetic Systems C/UK/94/M1/106.02.96
6. Soybeans tolerant to glyphosate Uses : import and processingMonsanto C/UK/94/M3/103.04.96
7. Male sterile chicory tolerant to glufosinate ammonium Uses : breeding activitiesBejo-Zaden BV C/NL/94/2520.05.96
8. Bt-maize tolerant to glufosinate ammonium (Bt-176)Ciba-Geigy C/F/94/11-0323.01.97
9. Male sterile swede rape

tolerant to glufosinate

ammonium (MS1, RF1)(4)

Uses : import and

processing

Plant Genetic Systems C/F/95/05/01/A06.06.97 (not finally approved by F)

Product

NotifierDate 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/B06.06.97 (not finally approved by F)
11. Test kit to detect antibiotic residues in milkValio Oy C/F1/96-1NA14.07.97
12. Carnation lines with modified flower colourFlorigene C/NL/96/1401.12.97

(MS consent)

13. Swede rape tolerant to glufosinate ammonium (Topas 19/2) Uses : import and processingAgrEvo C/UK/95/M5/122.04.98
14. Maize tolerant to glufosinate ammonium (T25)AgrEvo C/F/95/12/0722.04.98
15. Maize expressing the Bt cryIA(b) gene (MON 810)Monsanto C/F/95/12-0222.04.98
16. Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b) gene (Bt-11) Uses : import and processingNovartis (formerly Northrup King) C/UK/96/M4/122.04.98
17. Carnation lines with improved vase lifeFlorigene C/NL/97/1220.10.98

(MS consent)

18. Carnation lines with modified flower colourFlorigene C/NL/97/1320.10.98

(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

CROPAPPLICANTTRAITFOOD USESINITIAL ASSESSMENTSCIENTIFIC OPINIONLEGAL BASIS
1Bt 11MaizeSyngentaInsect resistanceProcessed sweet maize.NL 27/04/2000SCF 13.03.2002Reg. (EC) 258/97 Art. 7
2GA 21MaizeMonsantoHerbicide toleranceMaize and maize derivativesNL 21/12/1999SCF 02.02.1999Reg. (EC) 258/97 Art. 7
3NK 603MaizeMonsantoHerbicide toleranceMaize and maize derivativesNL 13/08/2002EFSA 04.12.2003Reg. (EC) 258/97 Art. 7
4MON 863MaizeMonsantoInsect protectionMaize and maize derivativesDE 08/04/2003EFSA - pendingReg. (EC) 258/97 Art. 7
5MON 863 x

MON 810

MaizeMonsantoInsect protectionMaize and maize derivativesDE 08/04/2003EFSA - pendingReg. (EC) 258/97 Art. 7
61507MaizePioneerInsect protectionMaize and maize derivativesNL 04/11/2003EFSA - pendingReg. (EC) 258/97 Art. 7
7MaisGard/RoundupReadyMaizeMonsantoInsect protection and herbicide toleranceMaize and maize derivativesNL - pending'Reg. (EC) 258/97 Art. 4
8RoundupReady Sugar BeatSugar BeatMonsantoHerbicide toleranceSugar Beat derivativesNL - pending'Reg. (EC) 258/97 Art. 4
9Liberty Link SoybeanSoybeanAgrEvoHerbicide toleranceSoybean derivativesB - pending'Reg. (EC) 258/97 Art. 4

 ANNEX 4

Genetically modified (GM) foods authorised in the European Union

EVENT

CROPAPPLICANTTRAITPOTENTIAL FOOD USESDATE LEGAL BASIS
1GTS 40/3/2SoybeanMonsantoInsect protection and herbicide tolerance

Soy foods. Soy foods include soy beverages, tofu, soy oil, soy flour, lecithin.

03.04.1996Dir. 90/220/EEC Art. 13
2Bt 176MaizeCiba-GeigyInsect protection and herbicide tolerance

Maize foods. Maize foods include kernels, oil, maize flour, sugar, syrup.

23.01.1997Dir. 90/220/EEC Art. 13
3TOPAS 19/2Oilseed rapeAgrEvo Herbicide tolerance '24.06.1997Reg. (EC) 258/97 Art. 5
4MS1 / RF2Oilseed rapePlant Genetic SystemsHerbicide toleranceRapeseed oil. Products made with rapeseed oil may 24.06.1997Reg. (EC) 258/97 Art. 5
5MS1 / RF1Oilseed rapePlant Genetic SystemsHerbicide toleranceinclude fried foods, baked products and snack foods.24.06.1997Reg. (EC) 258/97 Art. 5
6GT 73Oilseed rapeMonsantoHerbicide tolerance'21.11.1997Reg. (EC) 258/97 Art. 5
7MON 810MaizeMonsantoInsect protection'06.02.1998Reg. (EC) 258/97 Art. 5
8T 25MaizeAgrEvoHerbicide toleranceMaize derivatives. These may include maize oil, maize flour, sugar and syrup. Products made with maize06.02.1998Reg. (EC) 258/97 Art. 5
9Bt 11MaizeNovartisInsect protectionderivatives may include snack foods, baked foods, fried foods, confectionary and soft drinks.06.02.1998Reg. (EC) 258/97 Art. 5
10MON 809MaizePioneerInsect protection'23.10.1998Reg. (EC) 258/97 Art. 5
11Falcon GS 40/90Oilseed rapeHoechst / AgrEvoHerbicide tolerance'08.11.1999Reg. (EC) 258/97 Art. 5
12Liberator L62Oilseed rapeHoechst / AgrEvoHerbicide toleranceRapeseed oil. Products made with rapeseed oil may include fried foods, baked foods and snack foods.08.11.1999Reg. (EC) 258/97 Art. 5
13MS8/RF3Oilseed rapePlant Genetic SystemsHerbicide tolerance'26.04.2000Reg. (EC) 258/97 Art. 5
141445CottonMonsantoHerbicide toleranceCottonseed oil. Products made with cottonseed oil may19.12.2002Reg. (EC) 258/97 Art. 5
15531 CottonMonsantoInsect protectioninclude fried foods, baked foods and snack foods. 19.12.2002Reg. (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 (01.06.99Maize 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 plantChicory(9)YesYes
GM seedMaize seedsYesYes
GM foodMaize, Soybean sprouts, TomatoYesYes
FoodMaize flour(10)YesYes
producedHighly refined maize oil, soybean oil, rape seed oil(11)NoYes
from GMOsGlucose syrup produced from maize starch \* MERGEFORMAT 11NoYes
Food from animals fed on GM feedEggs, meat, milkNoNo
Food produced with the help of a GM enzymebakery products produced with the help of amylaseNoNo
Food additive/flavouring produced from GMOsHighly filtered lecithin extracted from GM soybeans used in chocolate \* MERGEFORMAT 11NoYes
GM FeedMaize(12)YesYes
Feed produced from a GMOCorn gluten feed, Soybean mealNoYes
Feed additive produced from a GMOVitamin B2 (riboflavin)NoYes

(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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