The Authorisation Process for Novel and Innovative Foods - In Short
23 September 2020
Authors: Elisabeth Vestin (Partner), Sarita Schröder (Managing Associate), and Itai Coleman (Associate)
With technology surging in the European food and agricultural industry, new and alternative food products are on the rise. However, food innovators are facing a comprehensive legal framework before their products can reach the intended consumer. In fact, all novel foods introduced on the EU market, including the Swedish and Finnish markets, are subject to a safety evaluation conducted by the EU Commission (the “Commission”) and the European Food Safety Authority (the “EFSA”). As of 1 January 2018 and the entry into force of Regulation (EU) 2015/2283 (the “New Regulation”), there has been a centralised and simplified authorisation procedure in place, allowing food business operators to bring innovative foods to the EU more easily without compromising public health and consumer safety.
What is novel food?
Novel food is defined as food that was not used for human consumption to a significant degree within the EU before 15 May 1997, when the previous regulation on novel food entered into force. To be considered a novel food, the product must also fall within a prescribed category, ranging from food consisting of, isolated from, or produced from plants, animals, microorganisms, fungi, cell cultures, minerals, etc., to food produced using new technologies and production processes.
Consequently, there is a wide variety of foods that fall within the scope of the New Regulation. The New Regulation applies to, for example, traditional foods from third countries, different extracts derived from plants and animals, and innovative food, such as UV-treated milk. However, the New Regulation does not apply to genetically modified organisms, food enzymes, food additives, food flavourings, and extraction solvents used or intended to be used in the production of foodstuffs or food ingredients.
Food business operators are responsible for determining whether the food – or an ingredient in the food – they intend to place on the EU market is novel, thus making it subject to a pre-market authorisation. It might be difficult for food business operators to navigate through the extensive scope of the regulation. However, the following tools are available to aid in the categorisation:
- The Commission’s Information & Guidance Document provides certain criteria for determining whether a type food has been used for human consumption to a significant degree, such as the intended purpose of consumption, the quantity of use, the size of the relevant population, and the geographical area.
- The Novel Food Catalogue is a non-exhaustive list containing information, submitted by applicants, on foods subject to the regulation, serving as an overview of the history of use of the product.
- Food business operators may also consult the relevant authorities in the Member State where they first intend to place the novel food on the market, e.g. the Swedish National Food Agency in the case of Sweden or the Finnish Food Authority in the case of Finland. The national authorities must conduct their assessment within 4 months, after which the assessment will be publicly available on the Commission’s webpage.
Authorisation of novel foods
Prior to placing a novel food on the European Union market, it must be proven safe to consumers and it must comply with the general labelling requirements as set out in Regulation (EC) No 1169/2011. Furthermore, the novel food must not be nutritionally disadvantageous compared to the food or food ingredient it is intended to replace. It should also be noted that the pre-market authorisation procedure differs depending on whether the food subject to the authorisation is a novel food or a traditional food from a third country.
A food business operator applying for the authorisation of a novel food must submit an online application to the Commission containing comprehensive data in accordance with Article 10 of the New Regulation. Within 1 month of checking the validity of the application, the Commission calls for a risk assessment by the EFSA. The EFSA must issue its opinion to the Commission within 9 months, after which the Commission has 7 months to deliver its final decision on approval.
However, a simplified assessment procedure is available for food business operators wishing to introduce a traditional food from a third country on the EU market. In such case, the operator must first submit an online notification to the Commission, as opposed to an application, in accordance with the requirements stated in Article 14 of the New Regulation. The notification must contain evidence of the history of consumption of the food, demonstrating that it has been used continuously for at least 25 years in the customary diet of a significant number of people in at least one third country. Thereafter, the Commission forwards the notification to the EFSA and to the EU countries, who may object to the placement of the food on the EU market within 4 months. If no reasoned safety objections are submitted, the Commission proceeds with authorising the food.
In the event of an objection, the food business operator may submit an application to the Commission containing the documented data relating to the duly reasoned safety objections. The application is then forwarded to the EFSA who must issue its opinion within 6 months, after which the Commission has 3 months to deliver its final decision on approval.
Upon having processed an application or notification, the Commission adopts an implementing act authorising the placing on the market of the novel food. Furthermore, authorised novel foods are generic and must be added to the Union list. Consequently, the applicant does not become the holder of exclusive rights – any food business operator may place a novel food product, subject to the Union list, on the EU market.
Novel foods in 2020
As opposed to its predecessor, the New Regulation explicitly states that insects and their parts fall within its scope and therefore require a novel food authorisation. However, a transition period has been established for food business operators in the Member States who interpreted the previous regulation as permissive of insects (e.g. Finland, Denmark, and the Netherlands) to continue with their commercialisation until authorisation has been granted. Currently, a number of applications for various species of insects are being processed. If the EFSA or the Commission do not raise any safety concerns, the European food and gastronomy market might undergo a fundamental change in the upcoming decade and further experiment with insects as a part of our diet.
As of January 2019, products containing cannabinoid are also considered novel foods. Similarly to the situation concerning insects, the classification was made despite the fact that cannabinoid products had already made a considerable entry on the EU market. The following decade will likely offer an increased debate on hemp-based foods as the Commission decides on such authorisations.
There are plenty of examples of novel foods previously introduced in the EU that are now considered commonplace, and if more is to come, food business operators should comply and stay up to date with the regulations and authorisations mentioned in this article.
The authorisation of a novel food
- Submittal of application. The Commission calls for a risk assessment by the EFSA within 1 month.
- The EFSA delivers its opinion within 9 months.*
- The Commission decides on approval or denial within 7 months*
Total: maximum of 17 months*
The authorisation of a traditional food from a third country
- Submittal of notification. The notification is forwarded to the EFSA and to EU Member States within 1 month.
- The EFSA and EU Member States may object within 4 months. The Commission proceeds with authorising the food if no reasoned objections are submitted.
- In the event of an objection, a new application must be submitted, which the Commission then forwards to the EFSA.
- The EFSA must deliver its opinion within 6 months.*
- The Commission decides on approval or denial within 3 months.*
Total: maximum of 5 or 14* months
*The processing time may be extended if the applicant is required to submit additional information.