In general, Foods can be introduced into the European market without prior authorisation. Novel foods and food ingredients are an exception. As they are a new addition to, at least the European menu, there is a lack of sufficient experience on the subject of safety and tolerability.
Novel foods must undergo a standardised safety assessment process before they can be marketed in the EU. These foods must not represent a risk to the consumer and they must not be misleadingly labelled. Furthermore, they must not differ from common foods and food ingredients to such an extent that their normal consumption would lead to nutritional deficiencies on the part of the consumer.
Novel foods are foods and food ingredients that have not been consumed to a significant degree by humans in the European Union prior to May 15th, 1997. Novel foods are foods and food ingredients that may be assigned to the following four categories:
- foods with a new or intentionally modified primary molecular structure (e.g. synthetic, calorie-free fat substitutes)
- foods consisting of or isolated from micro-organisms, fungi or algae, such as algae oil
- foods containing exotic plants not known in Europe or their parts (e.g. noni juice) or food ingredients isolated from animals
- foods resulting from a new, not commonly used production process which gives rise to changes in the composition or structure of the foods (e.g. high pressure pasteurized fruit products)
Food additives, food flavourings, genetically modified foods and extraction solvents used in the production of foodstuffs are not novel foods, as these fall within the scope of other legal provisions.
Examples of novel foods and food ingredients
Some examples of novel foods are new carbohydrates (e.g. tagatose), new micro-organism cultures (e.g. certain probiotic bacteria), exotic seeds or fruits (e.g. chia seeds or the fruit of the noni tree) or foods produced using new methods (e.g. UVC-treated milk).
New regulation from January 1st, 2018
The new European Novel Food Regulation came into force on December 31st, 2015. The Regulation (EU) 2015/2283 supersedes the Regulation (EC) No 258/97 which was previously in force.
The term novel food is defined more precisely.
This removes all ambiguities regarding the scope of the previous Regulation on novel foods. Whole animals such as insects, foods produced from cell or tissue cultures and food produced from material of mineral origin are some of the categories that now fall under the definition of the term and therefore within the scope of the Regulation. In addition, engineered nanomaterials are also clearly defined as novel foods and are therefore subject to evaluation and authorisation requirements, insofar as they do not fall within the scope of other EU regulations, including the corresponding authorisation requirements, as in the case of e.g. food additives.
The evaluation and authorisation procedures for novel food are simplified and expedited. Applications for authorisation, which were previously assessed in a decentralised process in the individual member states, will from now on be centrally assessed by the European Food Safety Authority (EFSA). Furthermore, authorisations that hitherto applied only to the applicant will be replaced by general (generic) authorisations that apply to all distributors. Authorisations that apply solely to the applicant can only be granted in duly substantiated exceptional cases to protect new scientific findings and thereby promote innovation and these shall be limited to five years.
Safety evaluations for traditional foods from third countries will be more efficient and their access to the EU market will be made easier. This is however subject to the provision that the safe use of these foods outside the EU can be demonstrated for a period of at least 25 years. In the event of any justified objection, the member states and the EFSA can lodge an appeal which means that the standard evaluation and authorisation procedures listed above will be opened, but with shorter deadlines.
The new Novel Food Regulation came into force on December 31st, 2015 and shall become legally binding on January 1st, 2018; until then, the old Regulation (EC) No 258/97 shall apply.
Information issued by the European Commission on Novel Foods
Information issued by the Federal Ministry of Health and Women's Affairs on Novel Foods
Previously submitted applications for authorisation
Previously submitted applications for approval