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MEMO/03/221

Brussels, 7 November 2003

State of play on GMO authorisations under EU law

What is the EU regulatory framework for GMO authorisation?

Genetically modified organisms (GMOs) and genetically modified micro-organisms (GMMs) can be defined as organisms (and micro-organisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination.

Three main legal texts constitute EU framework on genetically modified organisms (GMO).

    The first one contains the rules regarding the deliberate release of GMOs into the environment (Directive 2001/18/EC, which replaces Directive 90/220/EEC). This Directive is applicable since 17 October 2002. 18 GMOs have been approved under Directive 90/220/EEC 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.

    The second is a Regulation on GM Food and Feed (Regulation (EC) No 1829/2003) which is in force since 7 November 2003 and will have to be applied after a transitional period as of April 2004. It replaces the GM part of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.

Already, products from 16 GMOs can legally be marketed in the EU (see Annex 2). 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.

    The third is a Regulation on traceability and labelling of GMOs and traceability of food and feed produced from GMOs (Regulation (EC) No 1830/2003) laying down comprehensive traceability requirements for GMOs as well as food and feed produced from GMOs. The Regulation enters into force on 7 November 2003.

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

Twenty one applications for the placing on the market of GMOs have been submitted into the authorisation procedure under Directive 2001/18/EC (Annex 3), e.g. maize, oil seed rape, sugar beet, soy beans, cotton, rice, fodder beet. Eleven of these applications have scopes restricted to import and processing, while the remainder also include cultivation as a requested use.

The procedure for authorisation as specified under Part C of Directive 2001/18/EC is divided into three main periods.

    (i)   A 'national period' where the lead Competent Authority (CA) has up to 90 days, from the date of receipt of the application, to prepare and submit an assessment report. During this 90-day period the 'clock' can be stopped if the lead CA is awaiting additional information from the notifier to complete the notification, thus extending the deadlines.

    (ii)  A 'Community period', which comprises a 105-day period, which can be sub-divided into two phases. During the first 60 days, the competent authorities of Member States can raise reasoned objections to the application. The final 45 days of the 105-day period is akin to a 'conciliation-type step', where the Commission, lead and objecting competent authorities can try and reach agreement.

    (iii) Consultation of the European Food Safety Authority (EFSA) if objections based on environmental or human health considerations are not withdrawn by all Member States at the end of the above 45-day period. The EFSA is required to provide an opinion within 90 days.

The most advanced of the above 21 applications in the procedure is the Monsanto NK603 GM maize, which is currently being reviewed by EFSA (step iii). This application is for import and processing. It does not include cultivation as a requested use. An EFSA opinion is expected on 4 December 2003 in line with the 90-day deadline.

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 EFSA deadline and the necessary administrative procedures, the Commission intends to call a meeting of the Regulatory Committee in early February of next year.

A further application (Monsanto GT73 oilseed rape) is shortly to be formally submitted to the EFSA for evaluation and an opinion is expected early in 2004. The scope of this application is also limited to import and processing. The remaining applications are currently being appraised by national authorities under periods (i) and (ii) above. It should be noted that the 'clock' can be stopped at various stages in the procedure, where further information is requested from the applicant, effectively extending the deadlines and making it difficult to predict a time-scale for possible approval of these products.

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 4). 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.

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 eight GM products pending authorisation under the Novel Food Regulation (for details see the list attached in Annex 5) e.g. maize, soybean and sugar beet.

The scientific risk assessment has been completed for two of the applications, a GM sweet maize from Syngenta (Bt11) and a GM field corn from Monsanto (GA21). An opinion with regard to the draft decision to authorise Bt11 under the conditions as specified above could be expressed as early as Monday 10 November or at the next meeting in December by the representatives of the Member States in the Standing Committee of the Food Chain and Animal Health by qualified majority. If no qualified majority is obtained, the decision will be referred to Council. Council has three months to act and to adopt or reject the proposed decision with qualified majority. Council could also decide not to act. In this case it will be upon the Commission to take a decision.

EFSA is currently evaluating an application from Monsanto concerning a GM maize line (NK603); the ESFA opinion is expected in December. The Commission is preparing the request for advice from the EFSA on two other maize lines from Monsanto (MON 863 and MON 810 X MON863). 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. It is therefore difficult to predict when these products would be ready for authorisation.

National safeguard measures 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 (SCF) 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.

The Commission has recently written to the Italian Government asking it to repeal the Decree of August 2000.

Annex 1

GMO PRODUCTS

APPROVED UNDER DIRECTIVE 90/220/EEC

Product

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

1. Vaccine against Aujeszky's disease

Vemie Veterinär Chemie GmbH

18.12.92
2. Vaccine against rabiesRhône-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

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/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 colourFlorigene C/NL/97/1320.10.98

(MS consent)

Annex 2

NOTIFICATIONS PURSUANT TO ARTICLE 5 OF REGULATION (EC) N° 258/97

OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Applicant

Description of

Food or Food Ingredient

Scientific EvidenceNotificationTransmission

to Member States

1AgrEvo UK Limited

Chesterford Park

Saffron Walden

UK - Essex CB10 1XL

Processed oil from genetically modified canola seed, transformation event TOPAS 19/2 and all conventional crossed“Report on oil from a genetically modified (GM) glufosinate ammonium tolerant oilseed rape”

(ACNFP)*(8)

9 June 199724 June 1997
2aPlant Genetic Systems N.V.

Jozef Plateaustraat 22

B - 9000 Gent

Processed oil from genetically modified oilseed rape seed derived from: i) male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses; ii) fertility restorer RF2Bn (B94-2) oilseed rape line and all conventional crosses; iii) hybrid combination MS1XRF2“Report on oil from a fertility restorer line for use in a hybrid breeding programme for genetically modified (GM) oilseed rape” (ACNFP)*10 June 199724 June 1997

again

28 July 1998

2bPlant Genetic Systems N.V.

Jozef Plateaustraat 22

B - 9000 Gent

Processed oil from genetically modified oilseed rape seed derived from: i) male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses; ii) fertility restorer RF1Bn (B93-101) oilseed rape line and all conventional crosses; iii) hybrid combination MS1XRF1“Report on oil from a fertility restorer line for use in a hybrid breeding programme for genetically modified (GM) oilseed rape” (ACNFP)*; and

“Report on oil from genetically modified oilseed rape” (ACNFP)*

10 June 1997

24 June 1997

again

28 July 1998

3

Monsanto Services

International S.A

Avenue de Tervueren 270-272

B - 1150 Brussels

Refined oil from glyphosate tolerant oilseed rape line GT73“Report on oil from genetically modified (GM) glyphosate tolerant oilseed rape” (ACNFP)*10 November 199721 November 1997
4Monsanto Services

International S.A

Avenue de Tervueren 270-272

B - 1150 Brussels

Food and food ingredients produced from maize flour, maize gluten, maize semolina, maize starch, maize glucose and maize oil derived from the progeny of maize line MON 810“Report on processed products from genetically modified (GM) insect protected maize” (ACNFP)*10 December 19976 February 1998
5AgrEvo France S.A.

Les Algorithmes

Bâtiment Thalès

Saint Aubin

F - 91197 Gif-sur-Yvette Cedex

i) Starch and all its derivatives; ii) crude and refined oil; iii) all heat-processed or fermented products obtained from hominys, grits and flour (dry milled fragments) obtained from the genetically modified maize, tolerant to glufosinate ammonium, transformation event T25 and all the varieties derived from“Report on processed products from genetically modified (GM) glufosinate ammonium tolerant maize” (ACNFP)*12 January 19986 February 1998
6Novartis Seeds AG

Schwarzwaldallee 215

CH - 4058 Basel

Food and food ingredient products derived from the original transformant Bt11 crossed with the Northrup King Company inbred line #2044 (maize), as well as from any inbred and hybrid lines derived from it and containing the introduced genesACNFP* Report on grain from maize genetically modified for insect resistance30 January 19986 February 1998

7

Pioneer Overseas Corporation

Avenue Tedesco, 7

B - 1160 Brussels

Novel foods and novel food ingredients produced from gentically modified maize line MON 809ACNFP* Report on genetically modified (GM) insect protected maize Pioneer Hi-bred International line MON 80914 October 199823 October 1998
8Hoechst Schering,

AgrEvo GmbH

Industriepark Hoechst

AgrEvo-Haus K 607

D - 65926 Frankfurt am Main

Processed oil from genetically modified oilseed rape derived from Falcon GS 40/90BgVV*(9)* Stellungnahme zur wesentlichen Gleichwertigkeit des aus der transgenen, Glufosinat-toleranten Rapssorte Falcon GS/40/90 gewonnenen raffinierten Speiseöls21 October 19998/9 November 1999
9Hoechst Schering,

AgrEvo GmbH

Industriepark Hoechst

AgrEvo-Haus K 607

D - 65926 Frankfurt am Main

Processed oil from genetically modified oilseed rape derived from Liberator L62BgVV** Stellungnahme zur wesentlichen Gleichwertigkeit des aus der transgenen, Glufosinat-toleranten Rapssorte Liberator pHoe6/Ac gewonnenen raffinierten Speiseöls21 October 19998/9 November 1999
10Plant Genetic Systems N.V.

Jozef Plateaustraat 22

B - 9000 Gent

Processed oil from genetically modified oilseed rape derived from: the male sterile MS8 (DBN 230-0028) oilseed rape line and all conventional crosses; the fertility restorer RF (DBN212-0005) oilseed rape line and all conventional crosses; the hybrid combination MS8 x RF3BgVV** Stellungnahme zur wesentlichen Gleichwertigkeit des aus der transgenen, Glufosinat-toleranten Rapssorte MS8/RF3 gewonnenen, raffinierten Speiseöls21 October 19998/9 November 1999
11F. Hoffman La Roche Ltd.

Vitamins & Fine Chemicals

Regulatory Affairs

Bldg 241/283

CH - 4070 Basel

Riboflavin from Bacillus subtilis as nutrientACNFP* Report on Riboflavin from fermentation using genetically modified (GM) Bacillus subtilis20 March 200026 April 2000

12

Monsanto Services

International

Avenue de Tervueren 270-272

B - 1150 Brussels

Cottonseed oil from genetically modified cotton line 1445 (herbicide resistant)ACNFP* Request for an Article 5 opinion on the substantial equivalence of cotton seed oil and food ingredients derived from Roundup Ready cotton24 July 200219 December 2002
13Monsanto Services

International

Avenue de Tervueren 270-272

B -1150 Brussels

Cottonseed oil from genetically modified cotton line 531 (insect protected)ACNFP* Request for an Article 5 opinion on the substantial equivalence of cottonseed oil and food ingredients derived from insect protected cottonseed24 July 200219 December 2002

______________________________

* ACNFP Advisory Committee on Novel Foods and Processes (UK)

Annex 3

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.

Annex 4

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 5

PENDING APPLICATIONS UNDER REGULATION (EC) N° 258/97

OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Applicant

Description of

Food or Food Ingredient

Initial Assessment

Carried out by

Application

Date

Status

By June 2002

1Monsanto Services

International S.A.

Avenue de Tervueren 270-272

B - 1150 Bruxelles

Roundup Ready Maize line GA21The Provisional Committee for the safety evaluation of novel foods (VcVnv)24 July 1998SCF opinion of 27 February 2002
2Plant Genetic Systems N.V.

Jozef Plateaustraat 22

B - 9000 Gent

Liberty Link Soybean by AgrEvo

Bioveiligheidsraad (B)

2 February 1999Initial assessment report pending.
3Novartis Seeds AG

Basel

CH - 4002 Basel

Bt11 sweet maize

Gezondheidsraad (NL)11 February 1999SCF opinion of 13 March 2002
4Monsanto Services

International S.A.

Avenue de Tervueren 270-272

B - 1150 Belgium

MaisGard/RoundupReadyGezondheidsraad (NL)16 March 2000Initial assessment report pending
5Monsanto Europe S.A.

Avenue de Tervueren 270-272

B - 1150 Brussels and;

Novartis Seeds AB, Box 302

S - 261 23 Landskrona

Foods and food ingredients derived from Roundup Ready Sugar BeetGezondheidsraad (NL)Initial assessment report pending
6Pioneer Overseas Corporation

Avenue Tedesco 7

B - 1160 Brussels

Food products of genetically modified B.t. CRY1F Maize line 1507Gezondheidsraad (NL)26 February 2001Initial assessment report pending
7Monsanto Services

International S.A.

Avenue de Tervueren 270272

B - 1150 Bruxelles

Roundup Ready maize line NK603Gezondheidsraad (NL)June 2001Additional assessment is being carried out by the European Food Safety Authority

8

Monsanto Services

International S.A.

Avenue de Tervueren 270-272

B - 1150 Bruxelles

Insect protected maize line

MON 863 and maize hybrid

MON 863 X MON 810

Robert Koch Institut (D)28 August 2002Additionalassessment required

Annex 6

LABELLING OF GM-FOOD AND GM-FEED EXAMPLES (10)

GMO-type

EXAMPLE

Labelling

Required

at present

Labelling

required

in future

GM plantChicory(11)YesYes

GM seed

Maize seedsYesYes

GM food

Maize, Soybean sprouts, TomatoYesYes

Food

Maize flour (12)YesYes

produced

Highly refined maize oil, soybean oil, rape seed oil (13)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(14)YesYes

Feed produced from a GMO

Corn 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)* ACNFPAdvisory Committee on Novel Foods and Processes (UK)

(9)** BgVVBundesamt für gesundheitlichen Verbraucherschutz und Veterinärmedizin (D)

(10) 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.

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

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

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

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


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