Novel Food Regulations in the EU
Introduction
Novel foods are now subject to simpler, clearer regulations and a more effective, fully centralized authorization procedure at the EU level thanks to Regulation (EU) 2015/2283 of the European Parliament and of the Council of November 25, 2015, which is in effect as of January 1, 2018. This allows safe and innovative foods to be quickly introduced into the EU market without compromising a high standard of public health. 1
Novel Food: What it means?
A novel food is defined in Regulation (EU) 2015/2283 as that food which was rarely used for human consumption in the European Union earlier to 15 May 1997, once the first novel food regulation came into effect owing to Regulation (EC) 258/97.
Novel foods come from a variety of sources, including minerals, microbes, plants, and cell cultures. Foods resulting from production processes and advanced practices and technologies (e.g., new or intentionally modified molecular structure, nanomaterials) can also be classified as novel foods. Examples of novel foods include insects, vitamins, minerals, food supplements, and other specific food categories that were not produced or used prior to 1997.
Justification of the ingredient status
When determining if a component is novel or not, a variety of literary sources can be helpful. Does the ingredient meet the requirements, usage guidelines, and other details of the newly approved new ingredients if it is listed on the Union list of novel foods and/or its revisions (Implementing Regulations)? A good place to start could be national positive listings and national authorities’ interpretations in the Member States, where the element is regarded as native before processing.
The Member States’ shared expertise regarding certain ingredients is listed in the Novel Food Catalogue. Thus, evidence of a substantial history of food use by humans in the European Union prior to May 15, 1997, can establish an ingredient’s classification as a Novel Food.
The regulation requires food business operators (EU) 2015/2283’s Article 4 to confirm whether the food they sell is innovative food or non-food. According to the implementing Regulation (EU) 2018/456, they must, in the event of uncertainty, it is mandatory to follow the consultation procedure for the determination of new food status.
The following factors should be described in the consultation procedure while seeking to prove the safety and efficacy of the novel food:
- Description and its chemical composition
- Historical data of its source
- Processes involved in production
- Proposed usage levels
- Bioavailability
- Toxicology and allergy (if any)
A NOAEL (No Observable Adverse Effect Level) and the absence of Genotoxicity in rodents are determined from the toxicity tests, from which the safe dose for human use will be determined with an uncertainty factor of 200 between the dose investigated/tested in animals and the dose permitted in humans.
EFSA will respond with its scientific opinion in a maximum time of nine months pertaining to extension on additional information.
