Brussels, Belgium
April 18, 2005
Topics
(links are to EU website) |
|
The European Commission has published a
list of 26 genetically modified (GM) products which have been
legally on the EU market since before the new legislative
framework for authorising GM food and feed had entered into
effect. These so-called “existing products” were either approved
under former EU legislation, or did not require approval at the
time that they were put on the market. They have been added to a
specific section of the Community register of genetically
modified (GM) food and feed in order to clarify exactly which GM
products are legally permitted to be sold in the EU and to have
full information on these products.
Markos Kyprianou, Commissioner for
Health and Consumer Protection said: “This register is an
important tool to clarify the legal status of GMOs allowed for
sale in the EU before the current legislation entered into force
in April 2004. The register makes it clear which products can
legally be sold in the EU, although in reality many of these
products may not currently be on the EU market.”
Since the entry into force of
Regulation 1829/2003 on GM food and feed in April 2004, all GM
products seeking to enter the EU market as food or feed have to
undergo a thorough authorisation procedure, including a
scientific safety assessment by EFSA. However, there are certain
GM food and feed products which can be legally sold in the EU
according to the rules in place before Regulation 1829/2003.. In
order to cover these GM products, Regulation 1829/2003
stipulated that operators who wished to continue marketing an
“existing product” had to notify the Commission and submit
detailed information on the GMO before 18 October 2004.
Non-notified products will no longer be allowed on the EU
market. The Commission, in co-operation with the Joint Research
Centre, examined the validity of the notifications it received
and agreed to enter 26 GMOs into a specifically created section
of the Community register of genetically modified food and feed.
Once one of these “existing products” is on this register, it
can legally be sold in the EU for a set period of between 3-9
years, after which it has to resubmit an application for the
renewal of the authorisation.
Notification of existing products, entered in the Community
Register of GM food and feed.
Source:
http://europa.eu.int/comm/food/food/biotechnology/authorisation/register_notification/index.htm
links are
to the website of the European Union |
|
Transformation event |
Notifier |
Date of notification |
Designation |
Unique ID |
More info...
|
MON810 |
Monsanto Services
International S.A./N.V. |
12.07.2004 |
Insect-protected maize
line MON 810 |
MON-ØØ81Ø-6 |
|
MON863 |
Monsanto Services
International S.A./N.V. |
12.07.2004 |
Rootworm resistant maize
MON 863 generated by transformation of Zea mays |
MON-ØØ863-5 |
|
MON40-3-2 |
Monsanto Services
International S.A./N.V. |
13.07.2004 |
Glyphosate-tolerant
soyabean
40-3-2 |
MON-Ø4Ø32-6 |
|
NK603 |
Monsanto Services
International S.A./N.V. |
14.07.2004 |
Glyphosate tolerant NK 603
maize |
MON-ØØ6Ø3-6 |
|
NK603 x MON810 |
Monsanto Services
International S.A./N.V. |
15.07.2004 |
Hybrid maize NK603 X
MON810 tolerant to glyphosate (NK603) and resistant to
lepidopteran larvae of Sesamia spp. and
Ostrinia nubialis (MON810) |
MON-ØØ6Ø3-6
x
MON-ØØ81Ø-6 |
|
DAS1507 |
Pioneer Overseas
Corporation |
19.08.2004 |
Maize line 1507, with
resistance to the European corn borer and certain other
lepidopteran pests and with tolerance to the herbicide
glufosinate-ammonium |
DAS-Ø15Ø7-1 |
|
GT73 |
Monsanto Services
International S.A./N.V. |
31.08.2004 |
Oilseed rape (Brassica
napus L.), with tolerance to the herbicide
glyphosate |
MON-ØØØ73-7 |
|
MON531 |
Monsanto Services
International S.A./N.V. |
23.09.2004 |
Cotton (Gossypium
hirsutum) cultivar Coker 312, transformed using
plasmid PV-GHBK04 to be provided with insect resistance
trait |
MON-ØØ531-6 |
|
MON1445 |
Monsanto Services
International S.A./N.V. |
23.09.2004 |
Cotton (Gossypium
hirsutum) cultivar Coker 312 , transformed using
plasmid PV-GHGT07 to be provided with the resistance to
glyphosate trait |
MON-Ø1445-2 |
|
T25 |
Bayer CropScience GmbH |
01.10.2004 |
Maize (Zea mays L.)
with increased glufosinate ammonium tolerance |
ACS-ZMØØ3-2 |
|
MON531 x MON1445 |
Monsanto Services
International S.A./N.V. |
04.10.2004 |
Cotton hybrid MON531 x MON
1445 is produced to combine insect resistance trait (MON
531) with resistance to glyphosate trait (MON 1445). |
MON-ØØ531-6
x
MON-Ø1445-2 |
|
GA21 |
Monsanto Services
International S.A./N.V. |
04.10.2004 |
Maize (Zea maize
L.) line GA21 with increased tolerance to the herbicide
glyphosate |
MON-ØØØ21-9 |
|
Bt11 |
Syngenta Crop Protection
AG |
04.10.2004 |
Maize line Bt11 |
SYN-BTØ11-1 |
|
Bt176 |
Syngenta Crop Protection
AG |
04.10.2004 |
Maize line (Zea mays L.)
with the combined modification for insecticide
properties conferred by the Bt-endotoxin gene and
increased tolerance to the herbicide glufosinate
ammonium |
SYN-EV176-9 |
|
MS8/RF3 |
Bayer CropScience GmbH |
05.10.2004 |
Hybrid
swede-rape (Brassica napus L. oleifera Metzg.)
derived from crosses using:
(a) the progeny
of the male sterile swede-rape line MS8
(b) the progeny
of the fertility restoration swede-rape line RF3 |
ACS-BNØØ5-8
ACS-BNØØ3-6
ACS-BNØØ5-8
x
ACS-BNØØ3-6 |
|
GA21 x MON810 |
Monsanto Services
International S.A./N.V. |
06.10.2004 |
Hybrid maize GA21 x MON
810 produced to combine insect-protection (MON810) and
increased tolerance to the herbicide glyphosate (GA21) |
MON-ØØØ21-9
x
MON-ØØ81Ø-6 |
|
MS1/RF1 |
Bayer CropScience GmbH |
07.10.2004 |
Hybrid
swede-rape (Brassica napus L. oleifera Metzg.)
derived from crosses using:
(a) the progeny
of the male sterile swede-rape line MS1 (B91-4) cultivar
Drakkar
(b) the progeny
of the fertility restoration swede-rape line RF1
(B93-101) cultivar Drakkar |
ACS-BNØØ4-7
ACS-BNØØ1-4
ACS-BNØØ4-7
x
ACS-BNØØ1-4 |
|
MS1/ RF2 |
Bayer CropScience GmbH |
08.10.2004 |
Hybrid swede-rape (Brassica
napus L. oleifera Metzg.) derived from crosses
using:
(a) the progeny of the
male sterile swede-rape line MS1 (B91-4) cultivar
Drakkar
(b) the progeny of the
fertility restoration swede-rape line RF2 (B94-2)
cultivar Drakkar |
ACS-BNØØ4-7
ACS-BNØØ2-5
ACS-BNØØ4-7
x
ACS-BNØØ2-5 |
|
MON863 x MON810 |
Monsanto Services
International S.A./N.V. |
11.10.2004 |
Maize hybrid MON863 x
MON810 produced by conventional breeding to combine the
rootworm resistance trait in MON 863 with the
lepidopteran insect resistance trait present in GM
maize, MON 810 |
MON-ØØ863-5
x
MON-ØØ81Ø-6 |
|
TOPAS 19/2 |
Bayer CropScience GmbH |
11.10.2004 |
Canola (Brassica napus
L. spp. oleifera) derived from crosses between
non-genetically modified swede rape and a line resulting
from transformation event Topas 19/2 |
ACS-BNØØ7-1 |
|
pMT742 |
NOVO Nordisk A/S |
12.10.2004 |
NOVO Yeast Cream is a
product produced from genetically modified yeast strains
(Saccharomyces cerevisiae) cultivated on
substrates of vegetable origin |
... |
|
T45 |
Bayer CropScience GmbH |
13.10.2004 |
Oilseed rape
transformation event T45 modified to be tolerant to the
non-selective herbicide Liberty® |
ACS-BNØØ8-2 |
|
MON863 x MON603 |
Monsanto Services
International S.A./N.V. |
13.10.2004 |
Hybrid maize MON863 x
NK603 produced by conventional breeding to combine the
rootworm resistance trait in MON 863 and glyphosate
resistance trait in NK603 |
MON-ØØ863-5 x
MON-ØØ6Ø3-6 |
|
MON15985 |
Monsanto Services
International S.A./N.V. |
14.10.2004 |
Insect-protected cotton
containing event 15985 was developed from cotton line
531 |
MON-15985-7 |
|
MON15985 x MON1445 |
Monsanto Services
International S.A./N.V. |
14.10.2004 |
Cotton hybrid MON15985 x
MON1445 is produced to combine insect resistance trait
(MON 15985) with resistance to glyphosate trait (MON
1445). |
MON-15985-7
x
MON-Ø1445-2 |
|
pCABL |
Ajinomoto Eurolysine SAS |
18.10.2004 |
Bacterial protein,
by-product from the production by fermentation of
L-Lysine HCl obtained from (Brevibacterium
lactofermentum) the recovered killed microorganisms |
... |
|
The
authorised food and feed are entered in the Community Register
of GM food and feed.
Transformation event |
Authorisation
holder |
Date of authorisation |
Designation |
Unique ID |
More info... |
Bt11 |
Syngenta Seeds BV |
19.05.2004 |
Sweet maize, fresh or
canned
|
SYN-BT
Ø11-1 |
|
NK603 |
Monsanto Europe S.A. |
26.10.2004 |
Foods and food
ingredients derived from genetically modified maize
|
MON-00603-6 |
|
Questions & answers on GMO
‘existing products’ register
What are GM existing
products?
“Existing products” are GMOs
that were lawfully placed on the EU market before the entry into
force of Regulation 1829/2003 on GM food and feed on 18 April
2004. They were either authorised under the EU environmental
legislation and/or food and feed legislation applicable at the
time, or were allowed to be placed on the market without any
specific authorisation procedure. For example, before the new
legislative framework for authorising GMOs entered into effect,
feed materials or food additives produced from GMOs did not need
specific authorisation.
Why has the Commission
compiled a register of existing products?
Regulation 1829/2003 on GM food
and feed required all existing products to be notified to the
Commission before 18 October 2004. In their notifications,
operators had to submit similar information as is required for
an application for a new product authorisation under the
Regulation. The Commission and Joint Research Centre then
examined the information to decide whether or not the GMO
existing product should be added to the register. The aim of the
register is to provide a clear picture of all GMOs that were on
the EU market before the new legislation entered into force.
Does this mean there are
unauthorised GMOs being sold in the EU?
All the GMOs on this register
can be legally sold in the EU, and complied with the rules
applicable at the time of entering the market. The publication
of this register represents a formal recognition of these
products under the EU’s new legislation on GMOs.
What GM existing products
are listed in the register?
Twenty-six GM products have
been included in the register - 12 varieties of maize, 6 of
oilseed rape, 5 of cotton and one of soybean, one biomass and
one yeast cream.
Are all GM existing products
included in the register?
A few GM existing products were
not notified to the Commission by the deadline, and therefore
cannot be sold in the EU. The primary reason that notifications
were not submitted for these products is that they are no longer
sold in the EU. Therefore, they do not need to be included in
the register and their withdrawal is therefore a purely
procedural act.
Are all the existing
products on the register now being sold in the EU?
No. The register clarifies what
GMOs were lawfully put on the market before the entry into force
of the new Regulation. However, in some cases, these GMOs are
not currently being sold in the EU.
Once on the register, what
are the terms for staying on the EU market?
Once entered in the register,
the existing products can remain on the market for a set period
of between 3 and 9 years. After this time, an application for
renewal of the authorisation must be submitted. The existing
products on the register are also subject to the strict
labelling and traceability rules for all GMOs under the new EU
legislation.
|