Below, we will quickly review the questions that are commonly asked by current and future manufacturers and distributors regarding so-called “novel foods”.
1.) When/what were the latest regulatory changes?
The new EU regulation on novel foods entered into force on 1 January 2018, replacing the previous regulation in force since 1997.
While procedures related to novel foods were previously carried out in the Member States, now the Community procedure must be initiated, the aim being to speed up and simplify the 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 foods in the strict sense (e.g. plant/animal parts, or foods made from them, etc.), or materials used in food, but also processes for producing food.
We will discuss what a significant quantity means, which is decisive for classification as a novel food, in a separate article.
b) A separate category within novel food is the so-called “traditional foods”, foods that have been traditionally consumed in a country outside the EU, i.e. for at least 25 years. However, only certain types of foods are included here, such as mushrooms and plants.
c) However, food additives, flavorings, genetically modified foods are not considered novel foods under the regulation, and separate regulations apply to them.
A food is not considered novel just because it was produced with a new recipe.
3.) How can I find out if my product qualifies as a novel food?
It is the responsibility of the food business to ascertain whether the product it intends to market is or may be classified as a novel food.
This can be obtained from several sources:
EU list of novel foods (list of authorized novel foods – mandatory)
New food catalogue (official classification of substances with regard to their novel food status – not mandatory in all cases)
List of initiated recognition procedures (information on applications that have not yet been decided)
Initiating consultation with the competent authorities in the member states, in Hungary with the NÉBIH.
The above lists are not always updated immediately, so it is essential to proceed carefully when checking the status of the given food.
4.) Who can initiate a procedure and who is the owner of the novel food?
If a novel food was already included in the EU list or its inclusion was initiated by the Member States, anyone can manufacture and market such a novel food.
If a product is not included in the EU basic list as a novel food, anyone can initiate a procedure to have it authorized. The applicant has an exclusive right to the novel food authorized as a result of the procedure for 5 years.
5.) What is the most important requirement regarding novel food?
Novel food must be safe. The verification of this is at the heart of the recognition procedure, whether it is a novel food in the classical sense or a so-called traditional food.
The safety of the food must be proven with scientific evidence, and the professional safety assessment of the food is carried out by EFSA – the European Food Authority.
6.) How to initiate the procedure?
The procedure must be initiated electronically with the EU, after all the necessary annexes have been attached.
EFSA has issued separate guidelines and a list regarding the content of the documentation and the annexes to be attached (e.g. the scope of data on food and the method of providing it, information to be provided regarding production, etc.)
7.) How long do the procedures take and how much do they cost?
The procedure for obtaining authorization as a novel food takes about 1.5-2 years, while the notification procedure takes about 6 months.
The consultation procedure at the NÉBIH takes about 4 months.
The costs depend significantly on the given product, the largest burden can be considered the acquisition of various professional evidence (scientific studies).
8.) Is there already a “new food” that has been authorized?
Yes, several new foods have already been authorized in 2021, e.g. sorghum syrup is licensed in Hungary.
Read our other articles on the topic of novel food!
Would you like to know whether the product you want to manufacture or distribute qualifies as a novel food? We’ll help you decide!