Novel food: Schizochytrium oil
- Food safety
- Novel/traditional foods
Summary
In July 2025, the European Union (EU) authorised the use of oil produced from Schizochytrium limacinum strain ATCC-20889 as a novel food for use in infant/follow-on formula.
This follows the authorisation in April 2025 of new conditions of use for oil produced from Schizochytrium sp. strain FCC-3204 in protein products (excluding dairy analogues).
Over the next 5 years, only the companies that applied for these authorisations are permitted to market these novel foods in the EU. Other companies wishing to market these foods must seek permission from the relevant company or apply for EU authorisation.
EU authorises two strains of Schizochytrium oil as novel foods
Commission Implementing Regulation (EU) 2025/1515 of 28 July 2025 authorising the placing on the market of Schizochytrium limacinum (ATCC-20889) oil as a novel food and amending Implementing Regulation (EU) 2017/2470
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
In July 2025, the European Union (EU) authorised the use of oil produced from Schizochytrium limacinum strain ATCC-20889 as a novel food for use in infant/follow-on formula.
This follows the authorisation in April 2025 of new conditions of use for oil produced from Schizochytrium sp. strain FCC-3204 in protein products (excluding dairy analogues).
Over the next 5 years, only the companies that applied for these authorisations are permitted to market these novel foods in the EU. Other companies wishing to market these foods must seek permission from the relevant company or apply for EU authorisation.
Impacted Products
Protein products (excluding dairy analogues), infant nutrition, supplements
What is changing?
The EU has authorised new conditions of use for the novel food Schizochytrium sp. (FCC-3204) oil in protein products intended for the general population, excluding dairy analogues (products using plant-based ingredients that mimic dairy products). It has also authorised an additional strain of Schizochytrium limacinum (ATCC-20889) as a novel food for use in infant/follow-on formula.
Table 1 provides details of the strains, authorised uses, and companies that requested authorisation.
Only the companies that applied for these authorisations may market these novel foods for the uses authorised for a 5-year period (see Table 1), unless these companies provide permission to others to market, or if another company obtains a novel food authorisation for this use without reference to scientific data protected in the novel food authorisations.
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), and has provided a positive safety evaluation of S. limacinum strain ATCC-20889 (EFSA 2025).
Timeline
The use of Schizochytrium (FCC-3204) oil in protein products is permitted from 1 May 2025. The use of S. limacinum (ATCC-20889) oil in infant/follow-on formula is permitted from 18 August 2025.
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.
EFSA (2025) Safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 23(1): e9156.
Regulation 2021/1326 authorising the placing on the market of Schizochytrium sp. (FCC-3204) oil as a novel food
Regulation (EU) 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
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.
EU authorises two strains of Schizochytrium oil as novel foods
Regulation (EU) 2025/1515 authorising the placing on the market of Schizochytrium limacinum (ATCC-20889) oil as a novel food
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 in protein products intended for the general population, excluding dairy analogues (products using plant-based ingredients that mimic dairy products). It has also authorised a strain of Schizochytrium limacinum (ATCC-20889) as a novel food for use in infant/follow-on formula.
Table 1 provides details of the strains, authorised uses, and companies that sought these authorisations.
Only the companies that applied for these authorisations may market these novel foods for the uses authorised for a 5-year period (see Table 1), unless these companies have provided permission to others to market, or if another company obtains a novel food authorisation for this use without reference to scientific data protected in the novel food authorisations.
Timeline
The use of Schizochytrium (FCC-3204) oil in protein products is permitted from 1 May 2025. The use of S. limacinum (ATCC-20889) oil in infant/follow-on formula is permitted from 18 August 2025.
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.