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European Commission publishes register of existing GM food and feed products
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.

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