New rules for placing novel foods on the European market

As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods (the new Regulation) is applicable. It repeals and replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017.

According to the new rules, all products previously approved are now included in a ‘Union List’ and these can be marketed ‘freely’ by any food operator, provided requirements on appropriate use and labeling are met. So the previous requirement for operators to request permission individually, has now been lifted. This will make the market more free and competitive. Exports and imports of chia seed and chia oil, for example, can now be conducted freely by any operator. For products to be authorised as novel food in the future, a clause on data protection may still lead to a period of exclusivity for the operator requesting authorisation. Please contact me at Mercadero for more information.

The following explanation is quoted from the European Commission website:

“The new Regulation improves conditions so that food businesses can easily bring new and innovative foods to the EU market, while maintaining a high level of food safety for European consumers.

The main features and improvements of the new Regulation are the following:

Expanded categories of Novel Foods: The Novel Food definition describes the various situations of foods originating from plants, animals, microorganisms, cell cultures, minerals, etc., specific categories of foods (insects, vitamins, minerals, food supplements, etc.), foods resulting from production processes and practices, and state of the art technologies (e.g. intentionally modified or new molecular structure, nanomaterials), which were not produced or used before 1997 and thus may be considered to be as novel foods.

Generic authorisations of Novel Foods: Under the new Regulation, all authorisations (new and old) are generic as opposed to the applicant-specific, restricted novel food authorisations under the old Novel Food regime. This means that any food business operator can place an authorised Novel Food on the European Union market, provided the authorised conditions of use, labelling requirements, and specifications are respected.

Establishment of a Union list of authorised Novel Foods: This is a positive list containing all authorised novel foods. Novel Foods which will be authorised in the future will be added to the Union list by means of Commission Implementing Regulations. Once a novel food is added to the Union list, then it is automatically considered as being authorised and it can be placed in the European Union market.
A simplified, centralised authorisation procedure manged by the European Commission using an online application submission system.

Centralised, safety evaluation of the Novel Foods will be carried out by the European Food Safety Authority (EFSA). The European Commission consults EFSA on the applications and bases its authorisation decisions on the outcome of the EFSA’s evaluation.

Efficiency and transparency will be improved by establishing deadlines for the safety evaluation and authorisation procedure, thus reducing the overall time spent on approvals.

A faster and structured notification system for traditional foods from third countries on the basis of a history of safe food use. To facilitate the marketing of traditional foods from countries outside the EU, which are considered novel foods in the EU, the new Regulation introduces a simplified assessment procedure for foods new to the EU. If the safety of the traditional food in question can be established on the basis of evidence of a history of consumption in the third country, and there are no safety concerns raised by EU Member States or EFSA, the traditional food will be allowed to be placed on the European Union market.

Promotion of innovation by granting an individual authorisation for five years based on protected data. Data protection provisions are included in the new Regulation. That means that an applicant may be granted an individual authorisation for placing on the market of a novel food. This is based on newly developed scientific evidence and proprietary data and is limited in time to 5 years.”