Regulatory Support for Novel Foods

Providing in-depth regulatory expertise to ensure novel food products meet the highest standards of safety, quality, and market compliance, from development to distribution.

Navigating Novel Food Regulatory Requirements

Understanding and complying with novel food regulations is crucial for businesses aiming to introduce innovative products to the market. We outline essential steps and considerations in the approval process, covering key authorities, safety standards, labelling requirements, and post-market surveillance.

Novel Food

According to EU regulations, novel food is any food not significantly consumed before May 1997 in Europe.

Pre-market authorisation is required prior to placing novel food on the market. To obtain this authorisation, a novel food application must be submitted to the authorities.

Products requiring this application include new foods, food from new sources, new substances used in food, and new technologies and methods for producing food.

Before introducing a novel food to the European market, the food business must determine if the product is covered by the novel food regulation and then submit a pre-market authorisation to the European Commission (EC).

The application must include information on the product, such as its name and description, production process, composition, and scientific evidence demonstrating that the product does not pose any danger to human health.

It should be noted that there are specific rules for traditional foods from a third country that are considered novel foods in the EU.

Applicants unsure whether their products qualify as novel foods may consult the national authorities of the market concerned. The national authority may also consult colleagues in other European countries or the EC. The EC publishes a positive list of authorised novel foods named the “Union list of authorised novel foods”.

The Union list is regularly updated and shows the authorised novel foods, the conditions under which the novel food may be used, additional specific labelling requirements and other requirements.

In the United Kingdom (UK), the EU novel food legislation and authorisation process applies to novel food products intended to be placed on the Northern Ireland market under the current terms of the Protocol on Ireland/ Northern Ireland (Annex Il). The assimilated Regulation (EU) 2015/2283 applies to novel food products being placed on the Great Britain (GB) market.

For novel food products intended to be marketed in GB, the EFSA guidance remains relevant, and food businesses need to apply for authorisation using the regulated products application service.

Novel Food Regulatory Support and Services

Navigating the complexities of novel food compliance can be challenging, but our expert services are here to simplify the process. From application preparation to post-approval monitoring, we provide end-to-end support to ensure your products meet all regulatory requirements.

Evaluating whether the food qualifies as a novel food based on its manufacturing process and specifications.

Conducting assessments on the dossier to identify any gaps in the required information.

Providing guidance on developing a strategy for successful applications.

Performing literature reviews to establish the historical usage and safety of the ingredients.

Dossier compilation and submission.

Engagement with the authorities.

Our Novel Food Compliance Process
Step 1

Production and information gap analysis and strategy formation.

Step 2

Generation of new scientific data

Step 3

Dossier Compilation

Step 4

Submission to EFSA/FSA