Food and Feed (GMO)
The placing on the market of genetically modified organisms (GMOs) and foodstuffs containing these, whether they are intended for consumption by humans or animals, is regulated by a specific authorisation procedure.
This Regulation is stricter than the previous legislation. It supplements Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms (GMOs).
The Regulation applies to three types of product:
- genetically modified organisms for food and feed use;
- food and feed containing GMOs;
- food and feed produced from or containing ingredients produced from GMOs.
The Regulation provides for a single authorisation procedure for food products containing GMOs.
The industrial operator can submit his application in accordance with this Regulation for all food products containing GMOs in compliance with the provisions provided for by Directive 2001/18/EC on the deliberate release of GMOs into the environment.
The industrial operator submits a single application for food and feed uses and for cultivation. This means that a GMO which has obtained authorisation can be used not only in food and animal feed but also for cultivation or deliberate release into the environment.
Assessment (EFSA) and risk management (Commission)
Once the application has been made by an industrial operator, the national authority concerned acknowledges receipt in writing within 14 days and informs the European Food Safety Authority (EFSA), which is responsible for risk assessment in the food sector. The latter has 6 months in which to conduct this assessment.
The Commission is responsible for risk management. On the basis of the risk assessment carried out by the EFSA, the Commission draws up a draft decision accepting or rejecting the application within 3 months. It then submits this draft to the Standing Committee on the Food Chain and Animal Health. If this committee accepts the proposal, it is finally adopted by the Commission; if it does not, the proposal is assessed by the Council of Ministers. If the latter does not reach a position within three months or if it is unable to reach a qualified majority for or against, the Commission adopts its proposal.
The marketing authorisation is renewable for ten-year periods.
Food and feed products containing GMOs must be labelled as such. The words ‘genetically modified’ or ‘produced from genetically modified (name of the organism)’ must be clearly visible on the labelling of these products.
Food and feed products which contain a proportion of GMOs of less than 0.9 % of each ingredient are not labelled as GMO on the condition that the presence of the genetically modified organism is adventitious or technically unavoidable.
All genetically modified organisms and products thereof for food use must respect the labelling conditions provided for in this Regulation and also those laid down in Regulation (EC) No 1830/2003 concerning the traceability and labelling of GMOs.
GMO adventitious presence threshold
The presence of GMOs in traditional crops is difficult to avoid. Minute traces in food products are tolerated if their presence is accidental or the result of technically unavoidable contamination during growing, harvesting, transport or processing.
It is the responsibility of the farmer to demonstrate to the authorities the adventitious or technically unavoidable presence of a GMO in a food product.
This Regulation harmonises the legislation on the labelling of GMOs by amending or repealing the legislation in force.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1829/2003||
OJ L 268 of 18.10.2003
|Amending Act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1981/2006||
OJ L 368 of 23.12.2006
|Regulation (EC) No 298/2008||
OJ L 97 of 9.4.2008