Importance of regulatory knowledge in transforming science to commercial food and feed products

Importance of regulatory knowledge in transforming science to commercial food and feed products

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In this blog I will give you a brief overview on how regulatory knowledge can assist in research and development (R&D) while converting your research to new commercial regulated food and feed products. The key is that the food or feed business operator has to demonstrate that its new product is safe.

An abundance of innovation, science and an array of scientific studies are needed throughout the research and development (R&D) process to create new food or feed products. New regulated food and feed products, such as novel foods, food and feed additives and food contact materials, require a pre-market authorisation before they can be lawfully sold on the market, for example in the European Union, United Kingdom, United States, Canada, Australia, Brazil, China or Singapore. In the EU, the European Commission (EC) grants the authorisation following the application, while in the UK, the UK Government ministers and in the US, the Food and Drug Administration (FDA) are the respective authorising bodies.

Technical and safety data form the major parts of the information required for authorisation

When applying for authorisation of a new regulated product, such as a food or feed additive, an application dossier with the relevant administrative, technical and safety information has to be supplied to the evaluating body. In the EU, the dossier is evaluated by the European Food Safety Authority (EFSA), in the UK by the Food Standards Agency (FSA) and in the US by the FDA. Technical information comprises, for example, data on the manufacturing process and chemical composition of the new food or feed product and its chemical and microbiological contaminants. Safety information ranges from toxicological data on humans, animals and farm animals to the data on the toxicological impacts on the environment. Also, data on nutrition, allergenicity and efficacy of the new product may be needed.

The above implies that the developer of the new food or feed product not previously authorised needs to know which data are required by the authorities as well as the quality of the required data. As R&D is very costly and time-consuming, it is better to know the data requirements at an early stage of the entire R&D project in order to get started on the right foot from the very beginning. The regulatory authorities provide detailed and extensive guidance documents on the technical and scientific data requirements. While these guides are very helpful, they also require a good deal of scientific, regulatory and risk assessment knowledge to interpret them. Sometimes the EC, FDA or FSA needs to be contacted directly to get the right legal interpretations.

High-quality methods and tests in data generation are highly important

It is of utmost importance for a successful application dossier that its scientific data are generated with high-quality methods, whether they be toxicological or analytical methods. Laboratory accreditation and proper method validation following the internationally accepted protocols are the key elements for success. Well-established targeted analytical techniques are very important in most analyses, while non-targeted analytical methods can provide highly useful tools both for compositional and toxicological studies.

As for the required toxicological studies, normally the testing guidelines issued by the Organisation for Economic Co-operation and Development (OECD) are to be followed. In order to ensure high quality and appropriate animal welfare, the toxicological studies have to be conducted in testing facilities which adhere to Good Laboratory Practice. Regarding feed additives, the EFSA and the FDA provide good guidance on the performance of target animal toxicity (tolerance) studies for farm and companion animals. These data are then compiled in the application dossier on a new regulated product and submitted to the evaluating body, such as the EFSA, US FDA, UK FSA or FSAs in Singapore, Canada, Australia, Brazil etc.

These food and feed regulatory aspects highlighted above are, among other things, our daily business at the Food & Nutrition and Feed Team at Medfiles Ltd. I hope you enjoyed reading this concise blog and that it gave you a little taste of how regulatory knowledge can assist in R&D when converting science to new commercial regulated food and feed products. We are always happy to talk more about these matters. Thank you for reading!


Author: Dr Mari Eskola, Senior Regulatory Affairs Expert, Food & Nutrition and Feed

Most of this blog was originally published as an abstract for a lecture in the Book of Abstracts of the 10th International Symposium on Recent Advances in Food Analysis, 06–09.09, 2022, Prague, Czech Republic, available here.

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