Novel food: 2'-Fucosyllactose from Corynebacterium glutamicum ATCC 13032
- Food safety
- Novel/traditional foods
Summary
The European Commission has authorised a new source of 2’-Fucosyllactose produced by a derivative strain of Corynebacterium glutamicum ATCC 13032 as a novel food.
European Commission amends Regulation on 2’-Fucosyllactose produced from Corynebacterium glutamicum ATCC 13032 as a novel food
Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2'-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032
Update
The European Commission has authorised a new source of 2’-Fucosyllactose produced by a derivative strain of Corynebacterium glutamicum ATCC 13032 as a novel food.
What is changing?
The EU has authorised 2’-Fucosyllactose produced by a derivative strain of Corynebacterium glutamicum ATCC 13032 as a novel food that may be placed on the EU market. Details on the permitted use are set out in the Annex to Regulation (EU) 2017/2470.
Only the company that applied for the authorisation, Advanced Protein Technologies Corporation, is authorised to place the novel food on the EU market for a period of 5 years, unless another company obtains an authorisation, or has the agreement of Advanced Protein Technologies Corporation.
Why?
EFSA has established that 2’-Fucosyllactose, produced by microbial fermentation using a genetically modified derivative strain of Corynebacterium glutamicum ATCC 13032, is safe to be placed on the market.
Timeline
The 5-year period of exclusive rights of Advanced Protein Technologies Corporation to put this novel food on the EU market ends on 16 May 2028.
Background
This Regulation updates the Annex to Implementing Regulation (EU) 2017/2470 which lists authorised novel foods. For further information on the authorisation procedure, see Novel foods explained.
Resources
EFSA (2022) Safety of 2′-fucosyllactose (2’-FL) produced by a derivative strain (APC199) of Corynebacterium glutamicum ATCC 13032 as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 20(12): 7647.
Sources
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European Commission amends Regulation on 2’-Fucosyllactose produced from Corynebacterium glutamicum ATCC 13032 as a novel food
Commission Implementing Regulation (EU) 2023/859
What is changing and why?
The EU has authorised 2’-Fucosyllactose produced by a derivative strain of Corynebacterium glutamicum ATCC 13032 as a novel food that may be placed on the EU market.
Actions
Only the company that applied for the authorisation, Advanced Protein Technologies Corporation, is authorised to place the novel food on the EU market for a period of 5 years, unless another company obtains an authorisation or has the agreement of Advanced Protein Technologies Corporation.
Timeline
The 5-year period of exclusive rights of Advanced Protein Technologies Corporation to put this novel food on the EU market ends on 16 May 2028.
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.