Latest novel food authorisations – April 2024

Commission Implementing Regulation (EU) 2024/1037 of 9 April 2024 authorising the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid as a novel food and amending Implementing Regulation (EU) 2017/2470

Commission Implementing Regulation (EU) 2024/1046 of 9 April 2024 authorising the placing on the market of beta-glucan from Euglena gracilis microalgae as a novel food and amending Implementing Regulation (EU) 2017/247

Commission Implementing Regulation (EU) 2024/1047 of 9 April 2024 authorising the placing on the market of 3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637) as a novel food and amending Implementing Regulation (EU) 2017/2470

Commission Implementing Regulation (EU) 2024/1048 of 9 April 2024 authorising the placing on the market of protein concentrate from Lemna gibba and Lemna minor as a novel food and amending Implementing Regulation (EU) 2017/2470

Update

The EU has authorised the sale of the following novel foods on its market:

• a monosodium salt of L-5-methyltetrahydrofolic acid
• beta-glucan from Euglena gracilis microalgae (paramylon)
• a 3′-sialyllactose sodium salt obtained by microbial fermentation using Escherichia coli NEO3
• a protein concentrate from water lentil (Lemna gibba and Lemna minor).

Impacted Products

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

What is changing?

The EU has authorised placing on the market the following novel foods:

• a monosodium salt of L-5-methyltetrahydrofolic acid (company applicant: Merck & Cie KmG)
• beta-glucan from Euglena gracilis microalgae (Kemin Foods L.C.)
• a 3′-sialyllactose sodium salt from Escherichia coli NEO3 (Kyowa Hakko Bio Co., Ltd)
• calcidiol monohydrate from water lentil (DSM Nutritional Products Ltd).

These novel foods will be included in the Union list of novel foods (Regulation (EU) 2017/2470). Only the company that applied for authorisation may sell the respective novel food on the EU market over the next 5 years, unless they allow other companies to sell it, or if another company obtains a novel food authorisation without reference to the scientific data used by the original applicant, which is data protected.

Why?

The European Food Safety Authority (EFSA), in its scientific opinions (2023a, 2023b, 2023c, 2023d), concluded that these novel foods are safe under the applicants’ proposed conditions of use.

Timeline

The novel foods may be placed on the market from 30 April 2024. The applicant companies data protection rights end on 30 April 2029.

Background

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).

On 28 December 2018, ABC Kroos BV submitted an application to place protein concentrate from water lentil (Lemna gibba and Lemna minor) on the EU market.

On 15 August 2019, Kemin Foods L.C. submitted an application to place beta-glucan from Euglena gracilis microalgae (paramylon) on the EU market.

On 12 November 2020, Merck & Cie KmG submitted its application for authorisation to place the monosodium salt of L-5-methyltetrahydrofolic acid on the EU market as a novel food and a source of bioavailable folate.

On 25 March 2021, Kyowa Hakko Bio Co., Ltd submitted its application for authorisation to place the 3′-sialyllactose (3′-SL) sodium salt, obtained by microbial fermentation using Escherichia coli NEO3, on the EU market.

Resources

Sources

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Regulation

Regulation (EU) 2024/1037 authorising the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid as a novel food

Regulation (EU) 2024/1046 authorising the placing on the market of beta-glucan from Euglena gracilis microalgae as a novel food

Regulation (EU) 2024/1047 authorising the placing on the market of 3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637) as a novel food

Regulation (EU) 2024/1048 authorising the placing on the market of protein concentrate from Lemna gibba and Lemna minor as a novel food

What is changing and why?

The EU has authorised the placing on the market the following novel foods:

• a monosodium salt of L-5-methyltetrahydrofolic acid (company applicant: Merck & Cie KmG)
• beta-glucan from Euglena gracilis microalgae (Kemin Foods L.C.)
• a 6′-sialyllactose sodium salt from Escherichia coli NEO3 (Kyowa Hakko Bio Co., Ltd.)
• calcidiol monohydrate from water lentil (DSM Nutritional Products Ltd.).

These novel foods will be included in the Union list of novel foods (Regulation (EU) 2017/2470). Only the company that applied for each authorisation can sell the novel food on the EU market over the next 5 years, unless they give permission other companies to sell them, or if another company obtains a novel food authorisation without using the scientific data used by the original applicant, which is data protected.

Timeline

ABC Kroos BV, Merck & Cie KmG, Kemin Foods L.C., and Kyowa Hakko Bio Co., Ltd. have exclusive rights to put their novel foods on the market from 30 April 2024 until the end date of the data protection, 30 April 2029.

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