Nutraceutical, dietary, or food supplement products, also known as “Health Supplements” have been in use since many years to maintain, enhance and improve the healthy function of human body. These may contains one or more, or a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances. Each country differs in their regulatory requirements for registration and marketing approval for such products. European Union (EU) classifies these products as Food Supplements and they are regulated as food.
The European Commission has established harmonized legislation that regulates the vitamins and minerals, and the substances used as their sources. Substance other than vitamins and minerals, which are intended to be used in food supplements and does not have a history of safe use in the EU before 1997, are classified as ‘Novel Food’.
In this blog, we will explore what Novel Food is and what the legislative requirements for obtaining marketing approval of such products are. The new regulations were introduced from 1st January 2018 for obtaining approval of Novel Food from the EU.
For the first time, the EU regulatory body introduced a centralized, and more efficient, authorization procedure for Novel Food products, which are managed by the European Commission (EC). The new process made it a lot easier and transparent for nutraceutical companies, to get a formal opinion from one regulatory body, which can be used across the European states and it can greatly expedite the process and reach the market. European Food Safety Authority (EFSA) plays a key role in this evaluation process and provides a safety assessment of the product.
What is Novel Food?
European Union defines “Novel Food” as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first regulation on Novel Food came into force.
Novel Food is
- newly developed, innovative food,
- food produced using new technologies and production processes,
- as well as food which is or has been traditionally eaten outside of the EU
Traditional Food from a third country is the product where the history of safe food use in a third country has been demonstrated.
- Those foods have been consumed in at least one-third country for at least 25 years as a part of the customary diet of a significant number of people.
- The history of safe food use should not include non-food uses or uses not related to normal diets.
With this regulatory recast, the extended definition of Novel Food, gave a chance to nutraceutical companies to market the innovative Novel Food products and traditional products from non-European countries to Europe, while maintaining a high level of food safety for European consumers.
How does the sponsor determine the Novel Food status of a product?
- Sponsor/ food business operators should ascertain whether the food which they intend to place on the market falls within the scope of this regulation?
- When they are unsure about the scope of this regulation, sponsor/food business operators can contact the member state where they first intend to place the Novel Food. Sponsor/food business operators should provide the necessary information to the member state to enable them to determine whether or not a food falls within the scope of this regulation.
- In order to determine whether or not a food falls within the scope of this regulation, member states may consult the other member states and the Commission.
What is the current Novel Food legislation in Europe?
In November 2015, the European Parliament and the Council had agreed to adapt EU Regulation (EC) 2015/2283 replacing Regulation (EC) No 258/97 of the European Parliament and Regulation (EC) No 1852/2001 of the Council and Commission.
This regulatory revamp of the Novel Food sets out harmonized rules for placing the Novel Food on the EU market.
The main features and improvements of the new regulation are listed below
1. Expanded categories of Novel Food
It’s foods originating from
- cell cultures,
- minerals, etc.,
- specific categories of foods (insects, vitamins, minerals, food supplements, etc.),
- foods resulting from production processes and practices, and state of the art technologies (e.g. nanomaterials, intentionally modified or new molecular structure,),
which were not produced or used before 1997 and thus may be considered as Novel Foods.
2. Established Union list of authorized Novel Foods
A list containing all authorized Novel Foods permitted to market in the EU. For future Novel Food authorization, new Novel Food products will be added to the Union list by means of Commission implementing regulations. Once a Novel Food is added to the Union list, then it is automatically considered as being authorized and it can be placed in the European Union market.
3. Generic authorizations of Novel Foods
Under the new regulation, all authorizations (new and old) are generic as opposed to the applicant-specific. This means that any sponsor/food business operator can place an authorized Novel Food on the European Union market, provided the authorized conditions of use, labeling requirements, and specifications are kept similar to the original product.
4. A simplified, centralized authorization procedure
A centralised and online application submission system were introduced with this reform and it is managed by the European Commission.
5. Centralised, safety evaluation of the Novel Foods
Risk and safety assessment will be carried out by the European Food Safety Authority (EFSA). The European Commission consults EFSA on Novel Food applications and provides its opinion based on the EFSA’s evaluation.
6. Efficiency and transparency
It was greatly improved by establishing deadlines for the safety evaluation and authorization procedure, thus reducing the overall time spent on approvals.
7. A faster and structured notification
This was mainly introduced for traditional foods from third countries on the basis of a history of safe food use. To facilitate the marketing of traditional foods from countries outside the EU, the new regulation was introduced, with a simplified assessment procedure for foods new to the EU.
If the safety of the traditional food in question can be established on the basis of evidence of a history of consumption in the third country, and there are no safety concerns raised by the EU countries or EFSA, the traditional food will be allowed to be placed on the European Union market.
8. Promotion of innovation
Granting an individual five years of exclusivity based on newly developed scientific evidence and proprietary data. An applicant may be granted individual authorization for placing Novel Food on the market.
Underlying EU principles for Novel Food review process
In the interest of the safety of the European consumers, the European Commission will only authorize and include a Novel Food in the Union list, if it fulfills certain conditions. These criteria for authorization of Novel Food in the Union list are
- Safety of the product – On the basis of the scientific evidence available, the food should not pose a safety risk to human health
- Product Label – product label and its use should not mislead the consumer. The sponsor needs to ensure proper labeling of the product. Special attention needs to be given when the food is intended to replace another food and there is a significant change in the nutritional value.
- The intention of use – when the food is intended to replace another food, it should not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Authorization procedure of Novel Food approval
Regulation (EU) 2015/2283 sets out the requirements for placing Novel Food products on the EU market by two means:
- New Novel Food
- Traditional food from a Non-EU country
Based on the product, the sponsor has to adapt to the registration process. Both pathways have their own requirements. New Novel Food requires complete dossier submission whereas traditional food from Non-EU countries can go through the notification process. For successful and timely submission and approval, the sponsor needs to ensure where his products fit, else it can increase the chances of delay if queries are raised from EFSA or the Member States.
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Check out the pathways documentation requirement, Novel food authorization process flow, and timelines associated with the Novel Food application in the next part of this series.