Decisions relating to the placing of GMOs on the market – Marketing authorisation for GMOs
The placing on the market of genetically modified organisms (GMOs) refers to selling GMOs or products containing GMOs to third parties. Trading is permitted for these GMOs; marketing authorisation has been granted. Due to the free movement of goods within the European Union (EU), decisions related to the placing on the market of GMOs are made at the level of the EU. These decisions are then compulsory for each individual Member State of the EU.
An overview of marketing authorisation
The way how a decision is reached is determined by the intended use of the GMOs when placed on the market. Here, one differentiates between use for food and feed and other intended uses.
Marketing authorisation for GMOs as food and feed
Source: Gloger/BVL
Marketing authorisations for genetically modified food and feed, including the generation of these through cultivation are governed by Regulation (EC) No 1829/2003 and documented in the “EU Register of Genetically Modified Food and Feed” of the European Commission. Notes on German entries from this database can be found here, at the BVL website. European decisions that refer to implementing Article 11 of the Cartagena Protocol are decisions on the placing on the market under Regulation (EC) No 1829/2003 mentioned above. Only genetically modified food and feed “produced from” GMO fall under the scope of Regulation (EC) No 1829/2003. Those produced “with” (the aid of) GMOs are not covered by gene technology regulations. Examples for food produced “with the aid of” GMOs are additives, flavours and vitamins.
Marketing authorisation for GMOs for other purposes
GMOs which are not intended to be used as food and feed (e.g. ornamental plants or trees) are authorised in accordance with Directive 2001/18/EC. You can find decisions pursuant to this placing on the market procedure, also in English, in a section of the extensive “GMO register” (in this case, for placing on the market) published by the European Commission.
Approval procedure and risk assessments
A GMO undergoes a sophisticated approval procedure before marketing authorisation is granted. Risk assessments play a central role here, as the GMO under application is evaluated for its safety and for potential adverse effects on the environment and human health. The European Food Safety Authority (EFSA) takes the lead for risk assessments of applications for marketing where decisions are reached at a European level.
For additional guidance on the sophisticated approval procedure please check the diagram on the BVL website, along with these explanatory notes provided here.
Further background information relating to the issue of placing on the market is compiled here, on the BVL website.
Notifications to the Biosafety Clearing-House (BCH) Central Portal
All GMOs authorised in Germany and Europe (particularly for placing on the market) are reported to the global information platform of the BCH Central Portal. The corresponding entries can be viewed here.
Notifications to the international BCH also include risk assessments for GMOs (particularly those relating to placing on the market). These can be found here.