Novel Foods

Pursuant to Article 3(2)(a) of Regulation 2015/2283, novel food is “any food that was not used for human consumption to a significant degree within the Union before 15 May 1997” regardless of the dates of accession of Member States to the Union. They can be newly developed, innovative food or food produced using new technologies and production processes.

Traditional foods originated from third countries and having a history of at least 25 years of safe human consumption also fall into the category of novel foods. 

Yes, Article 3(2)(a) of Regulation 2015/2283 further sets up ten categories, which fulfil the definition of novel foods.   

Yes, they fall within the definition of novel food as food ingredients isolated from animals.

Whole insects as well as their parts for instead legs, wings and head fulfil this definition.

Pursuant to Article 3(f) of Regulation 2015/2283, they are intentionally produced engineered nanomaterials with one or more dimensions of 100 nm or composed of distinct parts which may have dimensions of 100nm or less.  Nanomaterials are also defined as engineered nanomaterials with structures, aggregates, and agglomerates which may have dimensions over 100nm.

The current definition is meant to be revised in the light of new scientific evidence and knowledge and/or internationally agreed definition. For proof, as they are a relatively new invention, nanomaterials have been coined by the Codex Alimentarius yet.

Pursuant to Article 4 of Regulation 2015/2283, food business operators shall verify whether the food they intend to place on the European Union market falls within the scope of this regulation. If they are unsure, they will have to consult the Member State where they first intend to place the novel food by providing them the necessary information. The Member State may also consult other Member States and the Commission to determine the status of the food.

Following, Article 5 of Regulation 2015/2283 stipulates that the Commission may decide upon a request by a Member State or on its own initiative whether a particular food fulfil the definition of novel foods.

Article 6 of Regulation 2015/2283 defines it as the positive list of all authorized novel foods which can be placed on the European Union market. General conditions of inclusion of novel foods in the Union are then further specified in Article 7.

The content of the Union list is regularly updated by adding and removing novel foods as well as their specifications, conditions of use or additional specific labelling requirements that can be added, removed or changed as prescribed by Article 9. Such modifications can also result from post-market monitoring requirements carried out pursuant to Article 24.

Based on information provided by the Member States, the Union catalogue only bears an informative function. It gathers products of animal and plant origin and other substances subject to Regulation 2015/2283. This list is non-exhaustive and serves as orientation on whether a product will an authorization under the regulation.

In some cases, it displays information on the history of use of food supplements and ingredients used exclusively in food supplements in Member States. As a result, if foods or food ingredients were solely used in food supplements, new uses in other foods required authorization under the regulation.

The food business operator, hereafter the applicant, shall fill out an application to the Commission containing the mandatory information required by Article 10 (2) of Regulation 2015/2283. In particular, the application must describe the novel food, the production process(es) and provide scientific evidence demonstrating that the novel food does not posed a safety risk to human health.

The administrative and scientific requirements for applications are further detailed in the Commission Implementing Regulation 2017/2469. 

It is be submitted online through a dedicated system where the applicant has to create an EU login account. A user guide has also been developed by the Commission to assist and help applicants through the application process. The applicant will be able to access a private board where they can create, submit and manage their own applications.

The Commission holds the primary responsibility to assess the application review and retains the right to authorize a novel food. Nevertheless, the European Food Safety Authority (EFSA) may, upon request by the Commission perform a risk assessment as to ensure the safety of the novel food. The assessment should be based on information provided by the applicant and on criteria laid down in Article 11 of Regulation 2015/2283.

In the event, EFSA does not raise safety concerns, the Commission will authorize the novel food and update the Union list.

Usually, if an application is deemed valid by the Commission and EFSA has not raised safety concerns, the authorization may be granted after around 17 months from the time the application is submitted.

Some delays may occur when EFSA requests additional information form the applicant in order to carry out its risk assessment.

No, when the Commission refuses to authorize a novel food, its decision cannot be appealed.

Nevertheless, the applicant may reapply in light of new pieces of information and scientific studies which could support their application.  

Yes, under certain circumstances pursuant to Article 23 of Regulation 2015/2283, such as to foster research and development within the agri-food industry, and thus innovation, the investment made by the applicant in gathering the information and data to support their application can be protected.

Nonetheless, confidentiality does not apply to the following information as described by paragraph 4 of the same article. For instance, available information that serves to protect human health shall not be kept confidential.

Yes, according to Article 26 of Regulation 2015/2283 provided that the scientific evidence supporting the application have been newly developed, the applicant may be granted an individual authorization for five years based on protected data.

In other words, it means that the applicant will have the exclusive authorization for placing the novel food on the market and is to be specified in the Union list as explained in Article 27 of Regulation 2015/2283.

Yes, in the same fashion as newly developed scientific evidence, applicants may fill a request for data protection under Article 28 of Regulation 2015/2283 in case of a parallel application for the authorization of a health claim of the novel food.

An application for the authorization of a health claim is governed by Article 15 or 18 of Regulation 1924/2006 and the request for data protection must follow the requirements of Article 21 of that regulation.

Yes, apart from the five year limited exclusive authorization presented above, authorizations of novel foods are generic under Regulation 2015/2283. It differs from the repealed Regulation 258/97 which granted individual authorizations.

The authorizations granted under the previous regulation are no longer applicant-specific and applications that haven’t been finalized by January 2018 are treated as applications under the current regulation.

Yes, pursuant to Article 24 of Regulation 2015/2283, the Commission may, based on the opinion rendered by EFSA, impose post-market requirements.

Any food business operator who placed a novel food on the market shall report to the Commission any new scientific or technical information which might influence the evaluation of the safety of use of the novel food as required by Article 25 of Regulation 2015/2283. Likewise, the food business operator shall inform the Commission about any prohibition or restricted imposed by a third country in which the novel food is placed on the market.

No, traditional foods coming from third countries are not regulated by Article 10 but by Article 14 of Regulation 2015/2283.

The applicant submit a notification of the food they intent to place on the European Union market to the Commission through the e-submission system also used for applications for novel foods. In case of uncertainties, applicants can use the e-submission system user guide developed by the Commission.  

The application must contain among other information the documented data demonstrating the history of safe food use in a third country and a proposal for the conditions of intended use and for specific labelling requirements.

Yes, pursuant to Article 15 of Regulation 2015/2283, if the Commission deems the notification valid, it will forward it to Member States and EFSA.

Yes, when the Commission forward the valid application to EFSA, Member States also receive it.

Like EFSA, they can raison duly reasoned safety objections which de facto prevent the authorization and the update of the Union list by the Commission.

On the other hand, if no objection was reported to the Commission, the traditional food will be authorized and included in the Union list.

No, but they can nonetheless apply for the authorization of the traditional food if they provide in addition of the information already submitted for the notification documented data relating to the safety objections pursuant to Article 16 of Regulation 2015/2283.

It will usually take around 4 months and up to 6 more months to obtain an authorization of a traditional food. Some delays may occur if the EFSA requests additional information from the applicant in order to give its opinion.

 Likewise novel foods, the peculiarities of traditional foods are also listed in the Union list and post-market monitoring requirements may be put in place as presented in Article 19 of Regulation 2015/2283.

No, pursuant to Article 26 (3) of Regulation 2015/2283, such a protection cannot be applied to traditional foods. In the same fashion, a health claim for a traditional food cannot benefit from data protection.