Latest novel food authorisations, amendments, and extensions 2024

Authorisations

Commission Implementing Regulations 2024/2036, 2024/2049, 2024/2061, 2024/2090, 2024/2101

Amendments

Commission Implementing Regulations 2024/2044, 2024/2046, 2024/2048, 2024/2062, 2024/2102

Update

This report summarises recent EU decisions to authorise, amend, or extend the specifications or conditions of use of existing novel foods:

• 2'-FL obtained by microbial fermentation using a derivative strain of Escherichia coli by Kyowa Hakko Bio Co.
• LNFP-I/2'-FL mixture obtained by microbial fermentation using a derivative strain of E. coli
• Schizochytrium limacinum (TKD-1) oil
• Schizochytrium sp. (CABIO-A-2) oil
• Ashitaba stem juice.

The EU has authorised the following changes:

• extension of use of the novel food Yarrowia lipolytica yeast biomass to meal replacements for weight control intended for the adult population
• labelling requirements ‘Partially hydrolysed protein from barley and rice’ for foods containing partially hydrolysed protein from spent barley and rice
• specifications and conditions of use of protein extract from pig kidneys will only refer to the maximum authorised levels; its different forms are removed from the specifications
• lower levels of docosahexaenoic acid (DHA) in specifications of the novel food Schizochytrium sp. oil rich in DHA and eicosapentaenoic acid (EPA)
• authorised levels of 2'-FL will increase from current levels authorised in both infant formulae and follow-on formulae
• authorised levels of residual endotoxins for 2'-FL produced from derivative strain E. coli BL-21 will be aligned to levels already authorised under the same conditions of use for 2'-FL from E. coli K-12, and other milk oligosaccharides at similar residual levels in infant formulae and follow-on formulae.

Impacted Products

Milk products (pasteurised, sterilised, UHT), fermented milk-based products, flavoured beverages, cereal bars, infant formula, follow-on formula, processed cereal-based food and baby food, diet replacement foods (for weight control), special medical foods, food supplements

What is changing?

The European Commission has authorised the novel foods listed in Table 1 to be placed on the EU market. These foods will be included in the Union list of novel foods (Regulation 2017/2470). For certain novel foods, only the company applicants that were granted authorisation are permitted to sell them on the EU market over the next 5 years, unless they permit other companies to sell them, or if another company obtains a novel food authorisation without reference to the protected scientific data used by the original applicant (see footnote to Table 1).

The Commission has also authorised some changes to the specifications and conditions of use for certain novel foods that are already authorised and available on the EU market (see Table 2).

Why?

Only novel foods authorised and included in the Union list of novel foods may be placed on the market within the EU (Regulation 2015/2283).

The European Food Safety Authority (EFSA) evaluates novel food applications to ensure their safety under the proposed conditions and/or levels of use [see Resources 1–6].

Timeline

The newly authorised novel foods may be placed on the EU market from the date indicated in Table 1.

Changes to specifications and conditions apply from the dates shown in Table 2.

Background

For further information on the novel food authorisation process, see Novel foods explained.

Resources

Sources

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Regulation

Authorisations

Commission Implementing Regulations 2024/2036, 2024/2049, 2024/2061, 2024/2090, 2024/2101

Amendments

Commission Implementing Regulations 2024/2044, 2024/2046, 2024/2048, 2024/2062, 2024/2102

What is changing and why?

The European Commission has authorised the novel foods listed in Table 1 to be placed on the EU market.

The Commission has also authorised some changes to the specifications and conditions of use for certain novel foods that are already authorised and available on the EU market (see Table 2).

Timeline

The newly authorised novel foods may be placed on the EU market from the date indicated in Table 1.

Changes to specifications and conditions apply from the dates shown in Table 2.

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