Brussels, Belgium
28 January 2004
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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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