Novel food: Schizochytrium oil
- Food safety
- Novel/traditional foods
Summary
The European Union (EU) has authorised the use of the novel food Schizochytrium (FCC-3204) oil in protein products, excluding dairy analogues, for the EU market. Over the next 5 years, only the company that applied for authorisation, Fermentalg, is permitted to market these protein products. Other companies wishing to use this novel food in protein products must seek permission from Fermentalg or apply for EU authorisation.
EU authorises use of novel food Schizochytrium oil in certain protein products
Commission Implementing Regulation (EU) 2025/688 of 9 April 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. (FCC-3204) oil
Update
The European Union (EU) has authorised the use of the novel food Schizochytrium (FCC-3204) oil in protein products, excluding dairy analogues, for the EU market. Over the next 5 years, only the company that applied for authorisation, Fermentalg, is permitted to market these protein products. Other companies wishing to use this novel food in protein products must seek permission from Fermentalg or apply for EU authorisation.
Impacted Products
Protein products, excluding dairy analogues
What is changing?
The EU has authorised new conditions to use Schizochytrium (FCC-3204) oil as a novel food in protein products intended for the general population, excluding dairy analogues (products using plant-based ingredients that mimic dairy products).
Only the company that applied for authorisation, Fermentalg, is authorised to put protein products using Schizochytrium oil on the EU market over the next 5 years, unless Fermentalg permits it, or if another company obtains a novel food authorisation for this use without reference to scientific data protected by Fermentalg.
Schizochytrium (FCC-3204) oil was already authorised (Regulation 2021/1326) to be used in:
- infant formula and follow-on formula
- food supplements for the general population above 3 years of age.
Why?
The European Food Safety Authority has concluded that the novel food Schizochytrium (FCC-3204) oil is safe when used in protein products intended for the general population, excluding dairy analogues (EFSA 2024).
Timeline
Fermentalg’s 5-year period of exclusive right to put this novel food on the EU market begins on 30 April 2025 and ends on 30 April 2030.
Background
This Regulation updates the Annex to Regulation 2017/2470 which lists authorised novel foods (see the Union list of novel foods). For further information on the EU novel foods authorisation process, see Novel foods explained.
Resources
EFSA (2024) Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC-3204) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 22: e9043.
Regulation 2021/1326 authorising the placing on the market of Schizochytrium sp. (FCC-3204) oil as a novel food
Regulation 2017/2470 establishing the Union list of novel foods
Regulation 2015/2283 on novel foods
Sources
Regulation 2025/688 amending Regulation 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. (FCC-3204) oil
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EU authorises use of novel food Schizochytrium oil in certain protein products
Regulation 2025/688 amending Regulation 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. (FCC-3204) oil
What is changing and why?
The European Union (EU) has authorised new conditions of use for the novel food Schizochytrium (FCC-3204) oil. Previously authorised for use in infant formula and food supplements, this oil may now be used in protein products excluding dairy analogues (products using plant-based ingredients that mimic dairy products). However, for a period of 5 years, only the company that applied for authorisation, Fermentalg, may put these products on the EU market. Other companies wishing to use this novel food in protein products must seek permission from Fermentalg or apply for a separate EU authorisation.
Timeline
Fermentalg’s 5-year period of exclusive right to put this novel food on the EU market begins on 30 April 2025 and ends on 30 April 2030.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.