The Novel Food Regulation 258/97 provides detailed rules for the approval of novel foods and novel food ingredients, including foods derived from or containing genetically modified organisms (GMOs). The regulation defines novel food as food or food ingredient not previously or significantly consumed in the EU before May 15, 1997. Regulation 1829/2003 on genetically modified food and feed and Regulation 1830/2009 concerning the traceability and labeling of GMOs have separate provisions for dealing with the authorization and traceability of novel foods and novel food ingredients, derived from or containing GMOs .
Novel food categories consist of food and food ingredients:
- with a new intentionally modified primary molecular structure; or
- consisting of, or isolated from micro-organisms, fungi or algae; or
- consisting of, or isolated from plants or animals, except for foods and food ingredients obtained by traditional propagating or breeding practices with a history of safe use; or
- to which a production process not currently used has been applied, where that process changes the composition or structure of the food or food ingredient significantly.
The full list of novel food applications and authorizations/rejections/withdrawals is available at: http://ec.europa.eu/food/food/biotechnology/novelfood/app_list_en.pdf.
Negative List for Novel Foods and Ingredients: This GAIN report provides an overview of the current novel foods regulatory environment and uses the Rapid Alert System for Food and Feed (RASFF) alerts to construct a negative list of substances and ingredients not authorized under the current novel foods framework.
Proposal for a revision of the current rules
On December 18, 2013, the European Commission presented the long awaited new proposal for a revision of the current Novel Foods Regulation 258/97. The main objectives of the draft regulation are to replace the current mutual recognition system with an EU centralized authorization procedure, to establish a simplified authorization procedure for traditional foods with a history of safe use from third countries, the establishment of an EU list of authorized novel foods and to update the current provisions for novel foods in line with new technological – e.g. nanotechnology – and scientific developments. Authorizations would be generic but the draft regulation provides for a 5-year data protection period under certain conditions. For detailed information please see GAIN report “Proposal for a New Novel Foods Framework Regulation”. The Novel Foods proposal follows the ordinary legislative procedure (ex co-decision) and is expected to be adopted at the end of 2015.
A Commission proposal for a new Novel Foods Regulation, presented in 2008 to the European Parliament (EP) and Council, could not be adopted because it failed to win the required consensus in the co-decision process. In March 2011, in the final phase of the co-decision process, the EP and Council were unable to reach agreement over amendments on cloning that the EP wanted to introduce. Although the EP and Council disagreed on the introduction of mandatory labeling requirements for all foods from animal clones and offspring, both parties agreed on the need for separate legislation on cloning outside of the scope of the Novel Foods Regulation. On December 18, 2013, the Commission presented a new Novel Foods proposal together with two legislative proposals on animal cloning. For more information on the animal cloning proposals see http://www.usda-eu.org/topics/animal-cloning/.