The Novel Food Regulation 258/97 provides detailed rules for the approval of novel food and novel food ingredients. The regulation defines novel food as food or food ingredient not previously or significantly consumed in the EU before May 15, 1997.
Under the current rules, 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 algea; 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 on the European Commission’s website.
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.
A new EU framework regulation 2015/2283 on Novel Foods was adopted in November 2015 and published in Official Journal L 327 on December 11, 2015. Regulation 2015/2283 will repeal the current Novel Foods Regulations 258/97 and 1852/2001. Most provisions of the new Novel Foods Regulation will apply from January 1, 2018. However, detailed rules for the implementation of several provisions in the new Novel Foods Regulation still need to be adopted by the European Commission.
Under the new regulation, a novel food is defined as food that has been not consumed to a significant degree in the EU before May 15, 1997 AND falls within at least one of the 10 categories listed in Article 3 of the new regulation:
- Food with a new or intentionally modified molecular structure
- Food consisting of, isolated from or produced from microorganisms, fungi or algae
- Food consisting of, isolated from or produced from material of mineral origin
- Food consisting of, isolated from or produced from plants or their parts obtained by non-traditional propagating practices if significant changes in the composition or structure of the food affect its nutritional value, metabolism or level of undesirable substances
- Food consisting of, isolated from or produced from animals or their parts obtained by non-traditional breeding techniques
- Food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae
- Food resulting from a new production process if significant changes in the composition or structure of the food affect its nutritional value, metabolism or level of undesirable substances
- Food consisting of engineered nanomaterials
- Vitamins and minerals and other substances used in accordance with Food Supplements Directive 2002/46/EC obtained by a new food production process or containing engineered nanomaterials
- Food used exclusively in food supplements within the EU before May 15, 1997, intended to be used in foods other than food supplements
An Information and Guidance Document on “human consumption to a significant degree” is posted on the Commission’s website http://ec.europa.eu/food/safety/novel_food/catalogue/index_en.htm.
An overview of the main elements of the new Novel Foods Regulation is provided in GAIN report “New EU Novel Food Regulation Adopted”.