Changes to specifications of parent strains for Lacto-N-neotetraose

Commission Implementing Regulation (EU) 2023/1583 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto-N-neotetraose (microbial source)

Update

The European Commission has approved changes in the specifications of Lacto-N-neotetraose (microbial source), allowing food business operators more flexibility to use authorised derivatives of Escherichia coli.

What is changing?

The EU list of novel foods (Implementing Regulation 2017/2470, Annex, Table 2) refers to specific genetically modified derivative strains of E. coli for the production of Lacto-N-neotetraose. This new Regulation removes references to these specific strains. E. coli K-12 and E. coli BL21(DE3) are both authorised as parent strains for the production of Lacto-N-neotetraose.

Why?

The change allows for more flexibility to use relevant authorised derivatives of E. coli strains. It aligns with the specifications of other novel foods of microbial origin, which do not mention specific derivative strains.

Timeline

The changes to the specifications of microbial sources for Lacto-N-neotetraose take effect on 22 August 2023.

What are the major implications for exporting countries?

Producers can now use both E. coli K-12 and E. coli BL21(DE3) as parent strains for the production of Lacto-N-neotetraose, without reference to specific genetically modified derivative strains.

Background

In 2016 the EU approved chemically synthesised Lacto-N-neotetraose as a novel food ingredient. The specifications of this novel food were later amended to include its production with genetically modified E. coli strain K-12 (in 2019) and strain BL21(DE3) (in 2021). EFSA (2020) concluded that the parent E. coli strains BL21(DE3) and K-12, and their genetically modified derivative strains, can be safely used in the production of Lacto-N-neotetraose.

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