Below is a quick review of the issues commonly faced by current and future manufacturers and distributors of so-called "novel foods".
1) When and what were the latest regulatory changes?
The new EU legislation on novel foods entered into force on 01 January 2018, replacing the previous legislation in force since 1997.
While the procedures for novel foods used to be carried out in Member States, the Community procedure has been launched with the aim of speeding up and simplifying procedures.
2.) What is a novel food?
a) A novel food is any product that was not consumed in significant quantities in the European Union before 1997.
However, this includes not only food in the strict sense (e.g. parts of plants/animals, food produced from them, etc.) or materials used in food, but also processes for the production of food.
What constitutes a significant amount, which is the determining factor for classification as a novel food, is dealt with in a separate article.
b) Within novel foods, there is a separate category of so-called "traditional foods", foods that have been traditionally consumed in a country outside the EU for at least 25 years. However, only certain types of food are included, such as mushrooms and plants.
c) However, food additives, flavourings, genetically modified foods, etc. are not considered novel foods under the legislation and are subject to separate regulation.
A food is not considered as novel food just because it has been produced with a new recipe.
3) How do I know if my product is a novel food?
It is the responsibility of the food business to ensure that the product it intends to market can be considered as a novel food.
And this can be found from several sources:
- EU list of novel foods
(list of authorised novel foods - mandatory)
- new food catalogue
(official classification of substances for their novel food status - not always mandatory)
- list of recognition procedures initiated
(information on pending applications)
- initiate consultations with the competent authorities in the Member States, in Hungary with NÉBIH.
The above lists are not always updated immediately, so it is essential to be thorough when checking the status of a food.
4) Who can initiate the procedure and who is the holder of the novel food?
If a new food was included in the EU list or its inclusion was initiated by the Member States, such a new food can be produced and marketed by anyone.
If a product is not included in the EU's basic list as a novel food, anyone can start the procedure to have it authorised.
The novel food authorised as a result of the procedure has exclusive rights for the applicant for 5 years.
5) What are the most important requirements for novel food?
The novel food must be safe. Proof of this is at the heart of the approval process, whether it is a novel food in the classical sense or a traditional food.
The safety of food must be backed up by scientific evidence, and the EFSA - the European Food Safety Authority - carries out the peer review of food safety.
6.) How to start the procedure?
The procedure shall be initiated electronically with the EU, after all the necessary annexes have been attached.
EFSA has issued specific guidance and a list of annexes to be included in the dossier (e.g. the scope of food information and how to provide it, information to be provided on production, etc.)
7.) How long do the procedures take and how much do they cost?
The authorisation procedure for a novel food takes about 1.5-2 years, while the notification procedure takes about 6 months.
The consultation process at the NÉBIH takes about 4 months.
Costs vary considerably depending on the product, with the biggest burden being the acquisition of various professional evidence (scientific studies).
Do you want to know if the product you want to manufacture or market is a novel food? We can help you decide!
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
