Novel Food Status Catalogue Updates

Below are the updates related to the new entries for the Novel Food Status Catalogue. These updates refer to the month of February 2025 and have impact on Food Supplements.

• Diosmectite:
• • Substance: Unauthorised Novel Food (includes Food Supplements)
  • Update: New entry

• DMAE (dimethylaminoethanol) and its salts:
  • Substance: Unauthorised Novel Food (includes Food Supplements)
  • Update: New entry

• Ophiocordyceps sinensis (Berk.) G.H. Sung, J.M. Sung, Hywel-Jones & Spatafora (syn. Cordyceps sinensis (Berk.) Sacc.):
  • Mycelium and fruiting body (sporophore): Not Novel in Food Supplements (any other Food uses may be considered as Novel).
  • Update: Addition of precisions

• Choline, succinate (2:1) salt solution:
  • Substance: Unauthorised Novel Food (includes Food Supplements)
  • Update: New entry

• Cordyceps militaris:
  • Mycelium and fruiting body: Unauthorised Novel Food (includes Food Supplements)
  • Update: Addition of precisions

Novel Food Consultations: February major changes with impact on Food Supplements

Below are the updates related to the new entries or new outcomes for Novel Food Consultations. These updates refer to the month of February 2025 and have impact on Food Supplements.

• Chaga (Inonotus obliquus): extract powder from the fruiting body
  • Considered as Not Novel in Food Supplements
  • Member State Assessment: Finland
  • Reference: Chaga Consultation

• Lion’s mane (Hericium erinaceus): extract powder from the fruiting body
  • Considered as Not Novel
  • Member State Assessment: Finland
  • Reference: Lion’s Mane Consultation

• Maitake (Grifola frondosa): extract powder from the fruiting body
  • Considered as Not Novel
  • Member State Assessment: Finland
  • Reference: Maitake Consultation

• Reishi (Ganoderma lucidum): extract powder from the fruiting body
  • Considered as Not Novel
  • Member State Assessment: Finland
  • Reference: Reishi Consultation

• Shiitake (Lentinula edodes): extract powder from the fruiting body
  • Considered as Not Novel
  • Member State Assessment: Finland
  • Reference: Shiitake Consultation

End of Data Protection for 5 Novel Food Ingredients in 2025

Data protection can be granted for a period of 5 years when requested by the initial applicant. During this period, the proprietary scientific evidence submitted by the applicant cannot be used for subsequent applications without their consent.

After the five-year period, other food business operators will be able to market the Novel Food ingredient in the specified food categories, as long as they comply with the requirements outlined in the Union list of Authorised Novel Foods published by the European Commission.

In 2025, 5 Novel Food Ingredients will have their data protection expired:

• Nicotinamide riboside chloride: data protection expired last month, the 20/February/2025
• Lacto-N-tetraose (‘LNT’) (microbial source): data protection will expire next month, on 23/April/2025
• Vitamin D2 mushroom powder: data protection will expire in summer, on 27/August/2025
• Dried Euglena gracilis: data protection will expire by the end of the year, on 23/December/2025
• Extract from Panax notoginseng and Astragalus membranaceus: data protection will expire by the end of the year, on 23/December/2025

EFSA’s call for expressions of interest for small and medium-sized enterprises

The European Food Safety Authority (EFSA) has launched a call for expressions of interest from small and medium-sized enterprises (SMEs) in the area of Novel Foods. This initiative invites all SMEs interested in receiving EFSA’s guidance on the application requirements for Novel Food authorization in the EU market.

The goal of this initiative is to facilitate SME access to the General Pre-Submission Advice service.

It will focus in two key stages that may be particularly relevant for SMEs with limited or no experience in novel food applications:

• Early development stage: occurs before initiating the studies that will be included in the application.
• Final preparation stage: when most of the information for the application is available.

This initiative is open to all SMEs working in the field of novel foods. You can find more information about this initiative here: EFSA Call of Interest

In April, expect again an insightful summary of the latest Novel Foods updates. We will keep you briefed as new information becomes available.