Novel food application

Introduction

A novel food application must demonstrate the safety of the novel food/ingredient and will be forwarded to the authorities for evaluation. The objective of such a dossier is to characterise the ingredient and prove its safety through toxicological testing.

The application must provide the elements for the description of the novel food, its production process, composition, specifications, proposed uses and levels of use and intended consumption. Data concerning its history of use and/or source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity are also expected.

It is expected that the toxicity tests will show an absence of genotoxicity and a NOAEL (No Observable Adverse Effect Level) in rodents and from which the safe dose for human use will be calculated with an uncertainty factor of 200 between the dose studied/tested in animals and the dose allowed in humans.

This procedure is now much quicker than under the previous regulation and EFSA must deliver its scientific opinion within nine months, which may be extended depending on requests for additional information.

In addition to these deadlines, the Commission must publish the authorisation in the EU list within a maximum of seven months. Experience has shown that EFSA’s assessment of applications which result in a positive opinion and authorisation of the new ingredient is almost always positive, unless there is a clear toxicity problem.

The complete procedure for novel foods

A novel food application must demonstrate the safety of the novel food/ingredient and will be forwarded to the authorities for evaluation. The objective of such a dossier is to characterise the ingredient and prove its safety through toxicological testing.

The application must provide the elements for the description of the novel food, its production process, composition, specifications, proposed uses and levels of use and intended consumption. Data concerning its history of use and/or source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity are also expected.

It is expected that the toxicity tests will show an absence of genotoxicity and a NOAEL (No Observable Adverse Effect Level) in rodents and from which the safe dose for human use will be calculated with an uncertainty factor of 200 between the dose studied/tested in animals and the dose allowed in humans.

This procedure is now much quicker than under the previous regulation and EFSA must deliver its scientific opinion within nine months, which may be extended depending on requests for additional information. In addition to these deadlines, the Commission must publish the authorisation in the EU list within a maximum of seven months. Experience has shown that EFSA’s assessment of applications which result in a positive opinion and authorisation of the new ingredient is almost always positive, unless there is a clear toxicity problem.

The simplified procedure for traditional foods from third countries

It is appropriate to facilitate the placing on the market in the Union of traditional foods from third countries where it has been demonstrated that they have a history of safe use as food in a third country.

Such food must have been consumed in at least one third country for at least 25 years as part of the normal diet of a significant number of people. To this end, information is requested on the description, production process, composition, specifications, history of use and proposed conditions of use of the traditional food for the EU market.

The references used may be scientific publications, expert scientific opinions, monographs, information from international or national organisations, government documents, values on cultivation/harvesting, sales and marketing.

Additional information can be obtained from cookbooks, recipes and other anecdotal data. This procedure is very fast, as is the consultation procedure and EFSA has to deliver its scientific opinion within four months from the date on which it decides on the validity of the application.

Experience shows that EFSA’s assessment is almost always positive, unless it is impossible to conclude on the safety of use (Leaf powder of Moringa stenopetala, maqui berry), of applications that lead to a positive opinion and the authorisation of the new ingredient.

Our experts are at your disposal to guide you through the regulations. With more than 10 years of experience in the industry and success, we offer a complete and tailor-made service in Novel Food dossiers.