Brussels,
Belgium
7 November 2003
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 |
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
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 Evidence |
Notification |
Transmission
to
Member States |
|
1 |
AgrEvo 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 1997 |
24 June 1997 |
|
2a |
Plant 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 1997 |
24 June 1997
again
28
July 1998 |
|
2b |
Plant 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 1997 |
21 November 1997 |
|
4 |
Monsanto 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 1997 |
6 February 1998 |
|
5 |
AgrEvo 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 1998 |
6 February 1998 |
|
6 |
Novartis 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
genes |
ACNFP* Report on grain from maize genetically
modified for insect resistance |
30 January 1998 |
6 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 809 |
ACNFP* Report on genetically modified (GM) insect
protected maize Pioneer Hi-bred International line MON 809 |
14 October 1998 |
23 October 1998 |
|
8 |
Hoechst 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 40/90 |
BgVV*(9)*
Stellungnahme zur wesentlichen Gleichwertigkeit des aus der
transgenen, Glufosinat-toleranten Rapssorte Falcon GS/40/90
gewonnenen raffinierten Speiseöls |
21 October 1999 |
8/9 November 1999 |
|
9 |
Hoechst Schering,
AgrEvo GmbH
Industriepark Hoechst
AgrEvo-Haus K 607
D - 65926 Frankfurt am Main |
Processed oil from genetically modified oilseed rape derived
from Liberator L62 |
BgVV** Stellungnahme zur wesentlichen
Gleichwertigkeit des aus der transgenen,
Glufosinat-toleranten Rapssorte Liberator pHoe6/Ac
gewonnenen raffinierten Speiseöls |
21 October 1999 |
8/9 November 1999 |
|
10 |
Plant 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 RF3 |
BgVV** Stellungnahme zur wesentlichen
Gleichwertigkeit des aus der transgenen,
Glufosinat-toleranten Rapssorte MS8/RF3 gewonnenen,
raffinierten Speiseöls |
21 October 1999 |
8/9 November 1999 |
|
11 |
F. Hoffman La Roche Ltd.
Vitamins & Fine Chemicals
Regulatory Affairs
Bldg 241/283
CH - 4070 Basel |
Riboflavin from Bacillus subtilis as nutrient |
ACNFP* Report on Riboflavin from fermentation
using genetically modified (GM) Bacillus subtilis |
20 March 2000 |
26 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 cotton |
24 July 2002 |
19 December 2002 |
|
13 |
Monsanto 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 cottonseed |
24 July 2002 |
19 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 |
|
1 |
Monsanto Services
International S.A.
Avenue de Tervueren 270-272
B - 1150 Bruxelles |
Roundup Ready Maize line GA21 |
The Provisional Committee for the safety evaluation of novel
foods (VcVnv) |
24 July 1998 |
SCF opinion of 27 February 2002 |
|
2 |
Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B - 9000 Gent |
Liberty Link Soybean by AgrEvo |
Bioveiligheidsraad (B) |
2 February 1999 |
Initial assessment report pending. |
|
3 |
Novartis Seeds AG
Basel
CH - 4002 Basel |
Bt11
sweet maize |
Gezondheidsraad (NL) |
11 February 1999 |
SCF opinion of 13 March 2002 |
|
4 |
Monsanto Services
International S.A.
Avenue de Tervueren 270-272
B - 1150 Belgium |
MaisGard/RoundupReady |
Gezondheidsraad (NL) |
16 March 2000 |
Initial assessment report pending |
|
5 |
Monsanto 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
Beet |
Gezondheidsraad (NL) |
|
Initial assessment report pending |
|
6 |
Pioneer Overseas Corporation
Avenue Tedesco 7
B - 1160 Brussels |
Food products of genetically modified B.t. CRY1F
Maize line 1507 |
Gezondheidsraad (NL) |
26 February 2001 |
Initial assessment report pending |
|
7 |
Monsanto Services
International S.A.
Avenue de Tervueren 270272
B - 1150 Bruxelles |
Roundup Ready maize line NK603 |
Gezondheidsraad (NL) |
June 2001 |
Additional 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 2002 |
Additionalassessment required |
Annex
6
LABELLING OF GM-FOOD AND GM-FEED EXAMPLES
(10)
|
GMO-type |
EXAMPLE |
Labelling
Required
at present |
Labelling
required
in future |
|
GM plant |
Chicory(11) |
Yes |
Yes |
|
GM seed |
Maize seeds |
Yes |
Yes |
|
GM food |
Maize, Soybean sprouts, Tomato |
Yes |
Yes |
|
Food |
Maize flour
(12) |
Yes |
Yes |
|
produced |
Highly refined maize oil, soybean oil, rape seed oil
(13) |
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(14) |
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)* 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. |
