EFSA Novel Food opinions: sardine peptide and mushroom extract

By Lorraine Heller

- Last updated on GMT

Related tags Novel food ingredient European food safety authority

In two further novel food safety opinions, the European Food Safety Authority (EFSA) has confirmed the safety of a sardine peptide and a mushroom extract, intended for use in functional food or supplement products.

Published last week, the opinions from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) related to the branded Lentinex and Valtyron ingredients.


The dossier on Lentinex, submitted by GlycaNova, requested an assessment of the safety of an extract of the Shiitake mushroom Lentinula edodes.

The intended use of the ingredient is in a range of products including dietary supplements, yoghurts, soft drinks, cooked and processed foods, and baked goods. Proposed intake levels were of 2.5 mL Lentinex containing 1 mg lentinan (β-glucan)/mL, which corresponds to 41.7 g/kg body weight per day for a 60 kg person.

The aqueous extract is​cultivated in a submerged fermentation and consists of approximately 98 per cent water and 2 per cent dry matter. The dry matter is composed of the principle extract of the food ingredient, the β-glucan lentinan (approximately 1g/L), free glucose and of N-containing constituents (e.g. proteins, amino acids).

EFSA noted that the human studies submitted in the dossier were carried out primarily to determine the ingredient’s efficacy rather than its safety, and it therefore considered these to be of “supporting but only limited value”​ in its safety assessment.

However, the panel said that the ingredient was “highly diluted”​ and that intake of β-glucan from the proposed usage levels was “low” ​compared to the intake estimated from the consumption of the mushroom Lentinula edodes ​and of other β-glucan sources.

It therefore said that the risk should not be higher than that of the normal consumption of the fruiting body of the Shiitake mushroom.

The panel concluded that the ingredient was safe for use, but highlighted the potential allergenic risk to sensitive consumers.

The full opinion can be accessed here​.

Sardine peptide product

Submitted by Cantox on behalf of Senmi Ekisu, the dossier on the sardine peptide product related to the ingredient Valtyron.

This was proposed for use in dairy products, soups, stews and soup powders, beverages and breakfast cereals at a proposed maximum intake of 0.6 g/serving.

The ingredient is a peptide mixture containing no less than 85 per cent peptides. A yellowish white powder, the ingredient is obtained by an alkaline protease catalysed hydrolysis of the muscle of sardine (Sardinops sagax​) and by chromatographic separation of the desired fraction.

EFSA noted that animal studies conducted on the ingredient “did not provide reasons for concern, but were of limited value in assuring the safety”​ of the product.

No gentoxicity concerns were raised, and clinical studies did not indicate any adverse effects on blood pressure in people with normal and elevated blood pressure.

“Based on the data provided, and considering the source and the nature of the proposed novel food ingredient, it is considered that a large portion of the ‘Sardine Peptide Product would be hydrolysed in the small intestine to the individual constituent amino acids prior to absorption and only a small fraction would be available for systemic uptake,”​ noted EFSA.

The panel said that the ingredient raises no safety concerns for adults, children or pregnant and lactating women, and concluded that it is safe for use at the proposed intake levels.

The full opinion can be accessed here​.

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