Novel Food services

Food products are designated as Novel Food when they have not historically been consumed in the country we intend to commercialize them. In many areas of the world, this translates into a specific regulation and pre-market authorization process.

What are Novel food products in Europe?

In Europe, these products are regulated by the Regulation (EU) 2015/2283 on Novel Food products, which is applicable from 2018. It replaces a former European regulation that was in place since 1997. Other similar regulations are applicable in other areas of the world (see section on Novel food regulations outside EU).

The European Commission, through this regulation, aims at controlling the safety of the product for consumers and evaluate its applications and benefits for consumers, before being authorized on the market. The EFSA is responsible for conducting the risk assessment and delivering the scientific outputs.

For example, if the product intends to replace meat products, it can be evaluated whether the product provides similar or better nutritional values than meat and benefits the health of consumers.

This regulation concerns food products that “had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation (EC) No 258/97 on novel food came into force”.

How to get Novel Foods approved in Europe?

In Europe, the European Food Safety Authority (EFSA) is in charge of conducting the risk assessment of Novel food products. This risk assessment is based on a dossier submitted by applicants. This process is quite long and complex. In order to obtain an approval & go on the market quickly, the dossier needs to be carefully prepared and fully answer every requirement of EFSA. 

This process can be summarized in three phases:

How can we help?

Mérieux Nutrisciences supports food, ingredients and pharmaceutical companies that wish to put on the market products that fall under the Novel food regulation.

• Our experts start with a preliminary assessment: it is needed to determine if the product is considered a novel food or not and to build a technical dossier in support;
• Then, the consultation process can be started, according to Regulation (EU) 2018/456;
• Quickly, the evaluation and experimental plan can be designed according to EFSA requirements. It mainly considers these elements:
  • Nutritional information: nutritional characterization and contaminants;
  • Composition data: physico-chemical and nanomaterials characterization;
  • ADME & Pre-clinical test evaluations;
  • Toxicological information: genotoxicity tests;
  • Clinical studies.

Our team provides all the analysis considered in the experimental plan.

• We then prepare the dossier and submit it;
• We get ready to answer all possible questions and requests of EFSA.

Why working with Mérieux NutriSciences?

Mérieux NutriSciences’ team has supported numerous food & ingredient companies throughout the Novel food process until dossier approval and has an extensive knowledge of the process, the regulation and the requirements.

Our team is working closely with EFSA to anticipate their questions and understand evolutions of requirements, in order to submit dossiers that are as complete as possible.

Additionally, what differentiates us from most companies in this field is that we not only provide guidance on the process and dossier completion, we also provide all the necessary data you will need to answer EFSA requirements, thanks to our laboratory capabilities and scientific experience.