As of June 30, 2024, the European Food Safety Authority announced assessment conclusions of a total of 8 cases of Novel Food. Antion sorted out the relevant revisions and approvals as follows for your reference.

EFSA assessment conclusions (8 cases)

Include 1 case of scientific and technical assistance (calcidiol monohydrate); 5 cases of new authorized applications [calcidiol monohydrate, Mg L-threonate, isomaltulose syrup (dried), ashitaba sap, Helix Complex snail mucus (HSM), Vitamin D2 mushroom]; 1 case applied for expansion of the scope of use (Isomalto-oligosaccharide); 1 case of notification of traditional food from the third country (Vigna subterranea); The EFSA assessment concluded that only the safety of HSM cannot be determined, and the rest were safe for use under the proposed conditions. The specific assessment conclusions are as follows:

1 case of scientific and technical assistance

Calcidiol Monohydrate

Applicant: DSM Nutritional Products Ltd.

EFSA assessment conclusion: Under the proposed conditions of use (used for food supplements, up to 10μg/day is safe for children and adults older than 11 years (including pregnant and lactating women) and up to 5μg/day is safe for children aged 3-10 years.

5 cases of new authorized applications

1. Mg L-threonate

Applicant: Company AIDP Inc.

EFSA assessment conclusion: Under the proposed conditions of use (used for food supplements, the consumption people are adults other than pregnant and lactating women, the maximum daily dosage is 3000mg, equivalent to about 250mg of magnesium and 2730mg of L-threonine per day), Mg L-threonate is safe as a bioavailable source of magnesium.

2. Isomaltulose Syrup (Dried)

Applicant: Evonik Creavis GmbH

EFSA assessment conclusion: Consumed in the general population as an alternative to sucrose in food categories other than infant and older children formula, processed grain-based foods, and infant and toddler foods, isomaltulose syrup (dried) with the same safety as sucrose.

3. Ashitaba Sap

Applicant: Japan Bio Science Laboratory (JBSL)-USA, Inc.

EFSA assessment conclusion: Under the proposed conditions of use (used for food supplements (capsules, tablets and powders), the consumption people are adults except pregnant and lactating women), at a daily intake of 137mg, equivalent to 35mg per day of the proposed listed product, the novel food is safe.

4. Helix Complex Snail Mucus (HSM)

Applicant: Helix Pharma Srl

EFSA assessment conclusion: The safety of Helix Complex snail mucus (HSM) is uncertain. It is proposed to be used for food supplements (syrup), whose consumption people are adults except pregnant women, with consumption amount of ≤45mL (3 tablespoons)/day. Equivalent to about 0.64 mL/kg BW per day for adults.

5. Vitamin D2 Mushroom

Applicant: Luxidum GmbH

EFSA assessment conclusion: For consumption in the general population, it is used in general foods (22 categories of foods including breakfast cereals, milk powder, whey and cheese, the amount of use ranges from 2.61mg to 214mg per 100g), food supplements and food for special medical purpose (over 1 year old) (the maximum dosage is 15μg/day). Vitamin D2 mushroom is safe as a novel food under the proposed use range and dosage.

1 case applied for expansion of the scope of use

Isomalto-oligosaccharide

Applicant: BioNeutra North America Inc.

EFSA assessment conclusion: For consumption in the general population, it is used in general foods (21 categories of foods including Instant coffee beverages, cakes and flavored milk, the amount of use ranges from 2.5g to 100g per 100g) and food supplements (for people over 10 years old, the maximum dosage is 30g/day). Isomalto-oligosaccharide is safe as a novel food under the proposed use range and dosage.

1 case of traditional food from the third country

Vigna Subterranea

Applicant: WhatIF F&I Pte Ltd (Singapore)

EFSA assessment conclusion: For consumption in the general population, the use is expected to be similar to other beans and their flours, consumed as a whole food (cooked seeds) or as flour. The applicant intends to sell it to end consumers and the food industry. EFSA believes that its dried seeds should be soaked and boiled before consumption like other dried beans, and that the available data on the traditional food component and history of use in the third country do not raise safety concerns. Based on the available data, EFSA has not raised a safety objection to the placing of Vigna subterranea on the EU market.

Source: Antion

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