Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Union list of authorised novel foods
1. The Commission shall establish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 7, 8 and 9 (‘the Union list’). 2. Only novel foods authorised and included in the Union list may be placed on the market within the Union as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein.
General conditions for inclusion of novel foods in the Union list
The Commission shall only authorise and include a novel food in the Union list if it complies with the following conditions: (a) the food does not, on the basis of the scientific evidence available, pose a safety risk to human health; (b) the food's intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value; (c) where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Initial establishment of the Union list
By 1 January 2018 the Commission shall, by means of an implementing act, establish the Union list by including in it the novel foods authorised or notified under Article 4, 5 or 7 of Regulation (EC) No 258/97, including any existing authorisation conditions. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 30(2).
Content and updating of the Union list
1. The Commission shall authorise a novel food and update the Union list in accordance with the rules laid down in: (a) Articles 10, 11 and 12 and, where applicable, Article 27; or (b) Articles 14 to 19. 2. The authorisation of a novel food and updating of the Union list provided for in paragraph 1 shall consist of one of the following: (a) adding a novel food to the Union list; (b) removing a novel food from the Union list; (c) adding, removing or changing the specifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a novel food in the Union list. 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include the specification of the novel food and, where appropriate: (a) the conditions under which the novel food may be used, including in particular any requirements necessary to avoid possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption; (b) additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population; (c) post-market monitoring requirements in accordance with Article 24.
Articles on this page are reproduced verbatim from official open data. See the attribution line.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.