Novel food status assessment

Starting from the composition, origin and history of use of the product or ingredient, the opinion determines whether any of the grounds that bring it within the novel food regime are met: no significant degree of human consumption within the Union before 15 May 1997; a production process not used before that date, even where the ingredient itself is known; or membership of one of the specific categories listed in Article 3 of the Regulation, such as engineered nanomaterials, vitamins, minerals and other substances obtained from a new source or by a new process, or food consisting of or produced from microorganisms, fungi, algae or cell cultures.

The conclusion is checked against the European Commission's Novel Food Status Catalogue and the available status precedents. Where the answer is positive, the opinion identifies which of the two routes in the Regulation applies — the general authorisation procedure under Article 10, or the notification of a traditional food from a third country under Article 14, with its objection period — and whether a generic authorisation or an authorisation with data protection for the applicant is the better option.

For an operator outside the Union, this is usually the first question to settle: the status of an ingredient that is traditional in its home market says nothing about its status in the EU, where the reference point is consumption within the Union before 1997.

The opinion does not include preparing or submitting an authorisation application to the European Commission and EFSA, which falls outside the scope of the practice's services, nor the toxicological or safety studies such an application may require. Where the scientific evidence on the ingredient needs to be assessed in order to reach a conclusion on its status, the opinion may draw on external specialists.

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, together with Commission Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.

Through the quote form, the company provides a description of the product or ingredient, its composition and origin, and any available evidence of its use in the Union before 1997. The documentary analysis is carried out against the Regulation and the Novel Food Status Catalogue, and the opinion is delivered with the status conclusion and, where relevant, the authorisation route.

If the doubt is not whether the food is novel but whether a substance sits on the borderline between food and medicinal product because of its function or presentation, the right service is the borderline products assessment.

If the product contains or consists of a genetically modified organism, it falls outside the scope of Regulation (EU) 2015/2283, whose Article 2(2)(a) expressly excludes genetically modified food within the scope of Regulation (EC) No 1829/2003. That is a different authorisation regime, also linked to Directive 2001/18/EC on deliberate release into the environment; please use the general quote form.