Commission Press Releasse (IP/05/439), 18 April 2005
The 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.
For the register of GM “existing products”, see: http://europa.eu.int/comm/food/food/biotechnology/authorisation/commun_register_en.htm
The following has also been provided by the Commission in a Memo (MEMO/05/130)
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.