Novel foods – what are they?
Insects, such as crickets and grasshoppers, have been considered as novel sources of protein for human consumption. Another good example is microalgae with the potential source of oils, proteins, and various micronutrients which can be used as alternatives or complementary to traditional foods. This is clearly attractive, noting that new foods are needed to feed the growing world population, at the same time when climate change makes traditional food and feed production harder.
A big hype in recent years has been around foods produced through precision fermentation. Many types of fermented foods with genetically modified microorganisms, such as bacteria and yeast, have undergone the European Union (EU) novel food authorisation process (e.g., novel proteins and human-identical milk oligosaccharides).
Much attention has also been generated by the discussion on cell-cultured meat grown in the laboratory. While most of the EU Member States (MSs) are in favour of this, some, such as Italy, France, and Romania, are against. To date, one novel food application on cell-cultured meat has been submitted for the EU pre-market approval.
The Netherlands appears to be the front runner with cell-cultured meat research, and the Brexited United Kingdom (UK), with its own regulatory framework, may also be soon ahead of the rest of Europe. However, in the EU, the very recent example of the cell-cultured novel food is cell-cultured apple biomass. Perhaps this paves the way for other cell-cultured food products in the future.
Legal basis of the EU novel foods
The classification of a food as novel depends on its history of consumption. Under the EU regulation on novel foods (Regulation (EU) 2015/2283), a novel food is defined as any food that was not commonly consumed to a significant degree within the EU before 15 May 1997. In addition, the novel food needs to fall under one of the ten novel food categories stipulated by the very regulation.
The EU’s novel food regulatory system also provides a simplified authorisation path for foods traditionally consumed outside of the EU countries. A useful element in the novel food regulatory framework is also a consultation possibility with an EU MS when it is unclear if the food is novel or not.
European consumers want their novel foods to be the safest of all
By the definition of the EU general food law, food is unsafe if it is “injurious to health or unfit for human consumption.” The extensive safety assessment and pre-market authorisation process for novel foods ensure their safety before they can be placed on the EU market.
Jurisdictions other than the EU, such as the UK (with the exception of Northern Ireland), have their own authorisation processes. Thus, since the UK is no longer an EU MS, a separate novel food application has to be made for the UK authorities. At the moment, the UK is simplifying their novel food authorisation process.
It is fair to say that the EU pre-market authorisation process for any foods and feeds is clearly the strictest in the world. It is also very evident that Europeans have wanted to have a strict food safety system. This is probably due to the food crises Europe had in the 90s which then promoted the establishment of the current EU food safety system in 2002. Worldwide, the EU food safety system is often regarded as the “golden standard”.
Free webinar: EFSA’s new novel food guidance – what to know about the updates
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.
The safety of the novel food assessed by the European Food Safety Authority (EFSA) is based on the information provided by the applicant
To obtain novel food authorisation in the EU, the food business operators (applicants) need to provide a comprehensive information and data package (an application dossier) to demonstrate the safety of the novel food. The dossier is submitted to the European Commission (EC) and then forwarded to EFSA for the scientific safety evaluation.
The safety is assessed by the EFSA external experts and the safety conclusion is drawn from the data such as composition, conditions of use, and toxicity. It is important to note that the data requirements vary depending on the nature of the novel food and its intended use. This implies that the applicant has to know which data are required. Therefore, many companies outsource the dossier preparation to regulatory consultants. Also, as research and development are very costly and time-consuming, it is better to know these requirements as early as possible. At the time of writing, EFSA has just published its updated scientific novel food guidance accompanied two other guidance documents in relation to novel foods. In these guidance documents EFSA gives more detailed guidance on the requirements. Also, the amount of data to be included in application dossiers increased such as on food contact materials used and allergenicity. The positive note is that more detailed considerations have to me made prior to embark any experimental animal testing.
EFSA has a legal obligation to assess the dossier and adopt the respected scientific opinion on the novel food within nine months. However, this EFSA risk assessment timeline is extended when EFSA requests additional information from the applicant.
It is very notable that in the past years, it has taken EFSA around 1.5 to 3 years to issue its novel food opinions. This delay is caused by poorly prepared dossiers and a lack of knowledge of confidentiality obligations.
Pre-market authorisation is the remit of the EC and EU MSs
While it is the task of EFSA to evaluate the safety of novel foods and provide scientific opinions to the EC for its decision making, it is the ultimate task of the EC to grant the pre-market authorisation for the novel foods in the EU. The EC has seven months to draw up its draft implementing regulation. Like in any EU decisions, also in novel food authorisations, the EU27 has the final say.
After a novel food has been authorised, it can be placed on the market and sold within the EU.
Transparency of the authorisation process to enhance consumer trust
It is notable that consumer trust in food operators along the food chain has decreased. Only just over half of EU consumers trust that the EU, national authorities, and scientists can guarantee the safety of food. The lowest trust is in the food industry. Thus, in this respect, it is easy to understand that consumers might not be so open to new types of foods, such as insects or cell-cultured meat.
Also, due to the mistrust, European consumers have been demanding for a long time a more transparent food authorisation process. To this call, the EC and EU27 answered in 2021 by establishing Transparency Regulation. In essence, this new rule means that the entire application dossier is made publicly available and confidentiality is regarded as an exception.
For food businesses, the transparency obligations have generated a high additional workload. It also increased EFSA’s workload and has delayed the entire authorisation process.
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.
Concluding remarks
The novel food authorisation process is a lengthy undertaking. This is because it has been designed to provide high food safety for EU consumers. Recently, however, there has been strong debate that this tedious process hinders food innovations in Europe, and that it compels novel food companies to seek authorisation opportunities in other jurisdictions.
New innovations in the food sector are highly important for the EU. The new foods can provide not only much-needed diversification of foods in our daily diets but also income and new workplaces. These are desperately needed in the current economic, environmental, and political situation in the European continent.
Medfiles is happy to help you with all matters concerning the registration of novel foods and new ingredients. Our experts have extensive experience in classification, consultation and authorisation procedures. We write the product information, scientific section and holistic safety assessment of the application in accordance with legislation and guidelines.
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.
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.
References:
Alexander J, Benford D, Boobis A, Eskola M, Fink-Gremmels J, Fürst P, Heppner C, Schlatter J, van Leeuwen R. 2012. Risk assessment of contaminants in food and feed. EFSA Journal 2012;10(10):s1004 (special issue).
Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Available at: https://eur-lex.europa.eu/homepage.html?locale=en
EFSA (European Food Safety Authority). 2021. Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283. EFSA supporting publication 2021:EN-6488. 33 pp. doi:10.2903/sp.efsa.2021.EN-6488. Available at: https://www.efsa.europa.eu/en
EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). 2021. Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1). EFSA Journal 2021;19(3):6555, 27 pp. doi:10.2903/j.efsa.2021.6555. Available at: https://www.efsa.europa.eu/en
EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). 2021. Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU)2015/2283(Revision1). EFSA Journal 2021;19(3):6557, 21pp. doi:10.2903/j.efsa.2021.6557. Available at: https://www.efsa.europa.eu/en
Eskola M, Altieri A, Galobart J. 2018. Overview of the activities of the European Food Safety Authority on mycotoxins in food and feed. World Mycotoxin Journal 11(2), 277-289.
Eskola M, Elliott CT, Hajšlová J, Steiner D, Krska R. 2019. Towards a dietary-exposome assessment of chemicals in food: An update on the chronic health risks for the European consumer. Critical Reviews in Food Science and Nutrition, DOI: 10.1080/10408398.2019.1612320.
Eskola M, Kivimäki A, Lyyra M, 2023. Pre-market authorisation processes for cell culture-derived foods and feeds differ across the world. 1st International Cellular Agriculture Conference, 14-15.06.2023, Helsinki, Finland, Poster. Available at: https://shorturl.at/NV3ud
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Available at: https://eur-lex.europa.eu/homepage.html?locale=en
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001.
