What are Novel Food Products?
As the food industry reacts to environmental and social changes, the market for novel food products is growing quickly, rising from just four in 2010 to 39 novel food applications in 2019.
Novel food products are controlled in the EU under Regulation (EU) 2015/2283 which applies to food that has not been consumed by humans, to a significant degree, in the EU before 15 May 1997. Novel food also refers to innovative food or ingredients that employ production processes or technology that is new.
Novel Food Testing - Laboratory Studies
In addition to the regular testing that food must undergo before entering the food chain, novel foods must also undergo analysis to include data on the compositional and toxicological properties of the novel food, plus information on the proposed production, uses, and consumption.
Before launching your product, a novel food testing laboratory will undertake studies to provide the relevant data which is used in your dossier preparation for submission to the appropriate regulatory body for approval.
“Superbrewed Food has been engaging the services of Charles River since 2020 for our entire novel food product range. Superbrewed’s mission is to provide sustainable solutions for human nutrition and health challenges. Our first product, Postbiotics Cultured Protein, serves as a nutritional ingredient in food. We choose to work with Charles River based on their reputation in the industry and their experience in evaluating novel food ingredients. They’ve conducted a range of testing for us including genotoxicity and oral toxicity studies. Throughout our studies, any problems that arose were addressed immediately. We found the team to be highly professional, very attentive, and flexible to our needs. We would highly recommend Charles River to other companies in the industry.”
- Alon Karpol
Regulatory Manager, Superbrewed Food
Novel Food Analysis and Food Toxicology – What’s Involved?
Charles River is the ideal partner to guide you through the novel food toxicology analysis process with the necessary regulatory guidance. We understand that your expertise lies in novel food product development and so you can rely on Charles River toxicological expertise.
With over 30 years experience in specialized toxicological laboratory analysis, Charles River has state-of-the-art global facilities equipped with the latest analytical techniques and experienced scientists specialized in toxicology assessments of novel food products, positioning us as the novel food testing laboratory of choice.
Novel food analysis includes:
- Toxicokinetics (in vitro and in vivo) and Absorption, Distribution, Metabolism and Excretion (ADME) studies (OECD 417)
- Genotoxicity: Ames study (OECD 471), In Vitro Mammalian Cell Micronucleus Test (OECD 487), in vivo micronucleus test (OECD 474), in vivo comet assay (OECD 489), transgenic rodent assay (OECD 488) or pigA assay
- Subchronic 90-d toxicity study (OECD 408)
- Chronic toxicity/carcinogenicity (OECD 451, 452 or 453)
- Developmental and Reproductive (OECD 414 and 443)
To discuss the next steps in your novel food product development or for guidance with toxicology testing of your product, contact the Charles River Novel Food expert team.