Algiecel & Medfiles: Collaboration to shed light on the regulation of novel feed and cosmetic ingredients in the EU

Algiecel is a biosolutions company based in Denmark, founded to address the challenge of feeding the world in a more sustainable way by transforming Co2 into sustainable protein and oil. The company is developing a photobioreactor for microalgae that utilises CO2 from e.g a biogas plant as a carbon source. The resulting algae biomass and bio-oil can be used in animal feed, food and cosmetics.

Algiecel began working with Medfiles a couple of years ago when they required regulatory assistance with information for a novel food application.

“We chose you to investigate and ensure we had the correct information on how to apply for novel food status, research what is known about our algae in databases and articles and conduct a GAP analysis for our investors and ourselves.”

“This was only the beginning, and we realised that we also needed regulatory assistance related to feed material ingredients and cosmetic product ingredients. Our high-quality algae biomass, produced with climate-friendly technology, has a very high potential not only in the food market but also in the feed and cosmetic markets”, says Claus Rosensparre, PhD, Product Development Manager at Algiecel.

Claus works in several areas at Algiecel. His tasks include following Food and Feed EU Law Regulation, managing novel food applications, overseeing downstream processing, and handling sales and client communication. He also focuses on developing new products and engaging in dialogue with the government for certificates and applications.

Claus says that Algiecel has obtained valuable GAP analysis of feed, food and cosmetics from Medfiles, which they can continue to work on and use to build knowledge and data.

Medfiles delivered the initial GAP analysis reports, comprising regulatory information at the highest levels and outlining the principal details. These reports enabled the Algiecel experts to gain a basic understanding of the regulatory requirements and pathways to market. They also furnished valuable background information for the Algiecel decision-making process when selecting the optimal and most cost-effective regulatory route. The available budget for the research and development of the algae biomass and the expected revenue from its sales were crucial elements to consider.

Following these considerations, Algiecel commissioned a second set of GAP analysis reports, which included more detailed regulatory information, required tests and assays, and a list of contract research organisations. Medfiles delivered the reports in a timely manner. A literature search and review report (the Medfiles-regular literature review report) accompanied the comprehensive feed material and cosmetic ingredient GAP analysis reports. The cosmetic ingredient GAP analysis report also outlined the safety assessment, including the principles and factors to be included.

“We learnt that Medfiles is also capable of conducting the required safety and risk assessments for both animals and humans. So, when Algiecel needs them for the biomass use in animal feeds and/or for the biomass use in cosmetics for humans, we know whom to approach.”

Claus appreciates Medfiles’ knowledge and experience in food, feed and cosmetics. He describes the collaboration as very professional and pleasant.

“It was obvious that the Medfiles staff had a good knowledge base and the ability to translate the sometimes very complex regulatory language and jargon into a more understandable format and text”.  

“Medfiles provided timely responses to our questions, whether they were about an offer or any other aspect. The Medfiles regulatory specialists clearly knew what they were doing and were very organised. We felt that we could trust them and that they would be honest with us. They were also able to point out the regulatory pitfalls. We felt that if we needed to ask any further questions, we would choose Medfiles again”.

“It is always a pleasure to meet and discuss a subject. We got the outcome we wanted and the answers we were after. Medfiles also answered our ad hoc questions during the Teams meetings. This again gave us the feeling that they knew not only the content of the reports, but beyond.”

Medfiles’ Food & Feed & Cosmetics team offers a wide range of professional regulatory services to food, feed and cosmetics companies of all sizes. We provide services for different stages of product research and development process, regulatory reviews, regulatory registration, launch and marketing. Our services cover products already on the market, as well as new innovations in food, feed and cosmetics based on new sources.

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.

BLOG: For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics

The same novel food ingredient used in foods could equally be used as an ingredient in feeds and cosmetic products. Ingredients like proteins, fats, carbohydrates, vitamins, and antioxidants are important components in terrestrial and aquatic livestock feeds, pet foods, and human cosmetic products.

On her recent blog post, Dr Mari Eskola from Medfiles will reflect on this question – a question which is not often considered by novel food developers. 

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