As a result of globalisation, there is an increasing number of foods on the market, which makes it more difficult to distinguish between traditional (i.e. not novel) and novel foods. It is the responsibility of food companies to determine whether their food ingredient falls within the scope of the novel food regulation or can be considered a traditional food. There are instances, however, when it is not straightforward to verify whether a food item is novel or not novel.
It is undoubtedly in a company’s interest to avoid their products being classified as novel foods, because then the entire EU/UK regulatory authorisation processes can also be bypassed. In accordance with Regulation (EU) 2018/456, if a company is unable to ascertain the status of a new food ingredient through its own investigation, it may request an official classification from an EU Member State (MS) or UK competent food authority via a consultation request. This makes the consultation request a vital regulatory toolkit for companies to get a formal authority decision.
In this blog, Medfiles food experts, MSc Mari Lyyra and PhD Mari Eskola, outline what a consultation request means and requires. We also discuss benefits of such authority consultations.
Novel or not novel?
Novel foods are ingredients that have not been significantly consumed by humans before 15 May 1997 within the EU or those resulting from new production processes (Regulation (EU) 2015/2283). This category may include newly developed foods, innovative foods developed using new technologies and production processes, and foods traditionally eaten outside the EU.
In light of the ongoing developments in food technology and the increasing interconnectedness of global markets, the introduction of distinctive ingredients and exotic foods has become a more prevalent phenomenon. The classification of these foods frequently gives rise to queries regarding their novelty status, particularly when historical consumption data is limited or ambiguous.
It is evident that a significant number of foods derived from new sources are considered novel foods, whereas establishing the novelty of ingredients derived from traditional foods can be difficult. Moreover, the evolving nature of both food technology and consumption patterns can make it challenging to retrieve information on historical consumption prior to 1997.
Role and process of consultation requests in the EU and UK
The primary objective of a consultation request is to obtain a formal opinion from a MS or UK competent food safety authority on whether a food or ingredient should be classified as novel. The decision is based on a number of factors, including the nature of the food, its production process and the extent of its previous consumption within the EU or UK.
The process of making a consultation request typically comprises several steps. The first step for the requestor is to compile comprehensive information about the food or ingredient in question. This should include details of the product’s composition, intended use, production method and any historical consumption data. It is vital to provide exhaustive and accurate information, as this forms the basis for the food safety authority’s assessment.
The national authority conducts a thorough review of the submission, evaluating whether the food or ingredient meets the criteria for classification as novel food. This assessment may entail a comprehensive review of scientific literature, expert consultations, and a comparison with similar products on the market. In The EU, the evaluating MS can also consult the other MS food safety authorities.
Within four months, the national competent authority provides its conclusion to the requestor. This decision is also published on the website of the European Commission, or if the decision was made by the UK authorities, on the website of the UK Food Safety Agency.
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The new novel food guidance related to Regulation (EU) 2015/2283 brings new practices and requirements for companies applying for novel food authorisation. In our practical webinar you will learn what are the major changes of new novel food guidance compared to old guidance.
Benefits and drawbacks involved in the consultation requests
- For food companies and importers, it offers legal certainty and reduces the risk of recalls due to non-compliance.
- Having clarity on whether a product is considered novel or not novel enables businesses to plan better and execute their market entry strategies.
- The consultation process allows companies to engage proactively with regulatory authorities to determine the necessary regulatory pathways for market access.
- Since its introduction in 2018, over 110 conclusions have been issued in the EU, with ca. 40% classified as not novel. The UK has issued 3 not novel decisions after its Brexit.
- The consultation process can be lengthy and resource-intensive, requiring comprehensive documentation and specialised regulatory knowledge to navigate the process effectively.
As you can see, the benefits of submitting a novel food consultation request outweigh the drawbacks. With our long novel food experience, we at Medfiles find it consistently worthwhile to consult with the authorities whenever there is uncertainty about novel food regulatory status.
We hope that our blog presented some invaluable insight into the possibility to engage with regulatory authorities. Sailing the complicated regulatory waters of novel foods is our daily work, so feel free to get in touch – we will help set your sails in the right direction to reach your target harbour smoothly.
Author: Mari Lyyra, M.Sc.
Head of Operations, Unit on Food, feed and cosmetics
Mari Lyyra has worked for Medfiles since 2014 and led the Medfiles Food & Feed and Cosmetics team, consisting of 11 regulatory affairs experts, from 2019.
She graduated as an authorised nutritionist from the University of Kuopio, Finland, with a M.Sc. in Public Health, specialising in clinical nutrition. She has worked with food regulatory tasks for over 25 years, covering traditional foods, novel foods, food additives, food supplements and functional foods with health claims and innovative ingredients.
Since the beginning of her career in 1999, Mari has focused on novel foods, which has become her key competence area. Mari has extensive experience in expert and strategic consulting, with clients in various novel food projects, as well as in other regulatory tasks in the EU and the United States. She has also written numerous articles in food journals and participated in peer-reviewed articles in scientific journals. In recent years, Mari has given several lectures on food regulatory topics at various Nordic events.
Author: Mari Eskola, Ph.D.
Senior Regulatory Affairs Expert, Team leader of Regulatory Science and Reports, Unit on Food, feed and cosmetics
Mari Eskola is a former staff member of the European Food Safety Authority (EFSA) and joined Medfiles in 2021. Since then, she has been involved in several projects on food, feed and cosmetics conducted for Medfiles’ clients.
Mari is a food chemist specialised in analytical chemistry and in 2002, she obtained a PhD degree in food science. Mari has over 25 years of international expertise in the chemical and regulatory safety of food and feed from the European Union and European national organisations as well as from the industry. She has worked for 10 years at the EFSA, carrying out EFSA regulatory risk assessments of contaminants in foods and feeds, where she also worked as acting and deputy head of the EFSA Contaminants Unit.
In addition, Mari has food and feed research and regulatory expertise from various other European institutes, such as the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the Austrian University of Natural Resources and Life Sciences and the former Finnish Food Safety Authority. Mari has international experience in managing projects and people, and she has authored several scientific publications comprising also many scientific EFSA opinions and risk assessments.
Free Webinar: Novel food classification and route to novel food authorisation in the EU
In this practical webinar you’ll get an overview of the classification of potential novel foods, the official consultation procedure, as well as the novel food authorisation process and its requirements. We will also go through a success story of a marine novel food authorisation in which we assisted our client.
