From the times of Hamlet to the present day, the question endures—and it perfectly suits to the field of food. Today, our question is: how can we identify a novel food and be confident in that determination?
Fortunately, the Novel Food Regulation (EU) 2015/2283[1] comes to our rescue: the article 4 sets out a formal procedure for determining whether a food or food ingredient is considered novel before it is placed on the European Union market. This step is crucial for food business operators to clarify if their product falls within the scope of the regulation and thus requires pre-market authorisation.
How Article 4 Works
If a food business operator is uncertain about the novelty status of a food or ingredient—specifically, whether it was consumed to a significant degree within the EU prior to 15 May 1997—they may submit a consultation request to the competent authority of the EU Member State where they intend to first market the product:
- the request must comply with the administrative format and content requirements detailed in Commission Implementing Regulation (EU) 2018/456[2].
- Upon receiving a valid request, the recipient Member State has 4 months to decide on the novel food status of the product, with a possible extension of 4 additional months if justified.
- The Member State may consult other Member States and the European Commission during this period.
- Once a determination is made, the food business operator is informed, and the decision is published publicly on the European Commission’s website to ensure transparency.
The Technical Dossier for Novel Food status determination
A food business operator who intends to request an opinion from a Member State on the novelty status of their food product must prepare and submit a technical dossier to that Member State. This dossier is generally a shorter and simplified version compared to the full technical dossier typically required for a novel food application.
The technical dossier is structured into three sections:
- Section 1, which applies to all types of foods;
- Section 2, which is specific to extracts;
- Section 3, which covers foods derived from production processes not used for food production within the Union before 15 May 1997.
Each section contains several subsections requesting detailed information about the food product to enable the Member State to determine whether the food qualifies as novel or non-novel.
The main information requested includes a description of the food, its characterisation and/or source, conditions of use, and the production process.
Of particular importance is the subsection titled “History of human consumption of the food within the Union before 15 May 1997,” since the novelty status is primarily determined based on the extent of evidence showing significant consumer use prior to that date.
Various types of data may be submitted to support the non-novelty of the food product, such as historical sales records or import/export data documenting quantities marketed for food purposes; recipe books, cookbooks, and food preparation manuals referencing the food; product catalogues, advertisements, or brochures aimed at food markets; national or regional legislation recognizing the food in established food categories before 1997; and scientific literature or ethnobotanical studies describing traditional or common consumption within the EU.
What about your food product? Is it novel or not novel?
For more information and support, ask Chemsafe!
[1] Online available from https://eur-lex.europa.eu/eli/reg/2015/2283/oj/eng
[2] Online available from https://eur-lex.europa.eu/eli/reg_impl/2018/456/oj/eng
