Approval of novel food (6 cases)
According to the Official Journal of the European Union, the European Commission approved six novel foods (beta-glucan from paramylon, monosodium salt of L-5-methyltetrahydrofolic acid, 3'-sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637), protein concentrate, calcidiol monohydrate and isomaltulose powder), and revised the conditions of use and specifications of three cases of novel foods (astaxanthin-rich oleoresin from Haematococcus pluvialis algae, lactitol and galacto-oligosaccharides).
1. Beta-glucan (from paramylon)
Applicant: Kemin Foods L.C
Definition: Beta-glucan is derived from non-GMO paramylon and is a linear, unbranched beta-1,3-d glucan polymer. It is produced by fermentation followed by pH adjustment and homogenization to release the beta-glucan particles. The particles are separated by decantation and washing, followed by acidification and filtration. After drying, the product is ground. The process includes conditions such as alkaline pH value and a heat-killing step to ensure that no viable paramylon is present in the novel food.
2. Monosodium Salt of L-5-methyltetrahydrofolic Acid
Applicant: Merck & Cie KmG
Definition: Made by chemical synthesis and consists of L-5-methyltetrahydrofolic acid.
3. 3'-Sialyllactose (3'-SL) Sodium Salt (produced using a derivative strain of E. coli W (ATCC 9637))
Applicant: Kyowa Hakko Bio Co., Ltd.
Definition: 3'-sialyllactose sodium salt is a purified, concentrated white to off-white powder produced by microbial (genetically modified Escherichia coli W (ATCC 9637)) technology. It contains a certain amount of sialic acid, d-lactose, d-glucose, 3'-sialyllactulose and 6'-sialyllactose sodium salt.
4. Protein Concentrate from Lemna gibba and Lemna minor
Applicant: ABC Kroos BV
Definition: The substance is made from the plant species Lemna gibba (70%-100%) and Lemna minor (0%-30%). The production process of the protein concentrate involves mechanical separation of the protein fraction from the insoluble fibers, followed by precipitation under acidic conditions, pasteurization and spray drying. Its cultivation is carried out in pots in greenhouses under controlled conditions. The culture water is filtered and treated with UV light. The culture conditions are monitored to control the growth of algae, yeasts and fungi. The pH value is maintained between 5.5 and 6.5.
5. Calcidiol Monohydrate
Applicant: DSM Nutritional Products Ltd.
Definition: Calcidiol monohydrate contains the monohydrate form of the main circulating metabolite of vitamin D3 in the body and is a source of 1,25-dihydroxyvitamin D, the biologically active form of vitamin D. Its production process begins with yeast fermentation, during which the mixture of sterols is produced, of which trienols are the main sterols. After fermentation, purification and several chemical steps are carried out.
6. Isomaltulose Powder
Applicant: Evonik Operations GmbH
Definition: It is extracted from sucrose by microbial method using Serratia marcescens. The dry matter content is a mixture of monosaccharides and disaccharides, mainly composed of isomaltose (≥75%) and trehalose (≤13%), with small amounts of glucose, fructose, sucrose and oligosaccharides (trace amounts).
Revision of novel food (3 cases)
1. Lactitol
Applicant: H.C. Clover Productos y Servicios, S.L.
The conditions for its use were revised to no longer be limited to food supplements in the form of capsules, tablets or powders.
2. Astaxanthin-rich Oleoresin from Haematococcus pluvialis Algae
Applicant: Astareal AB
The revised content levels of several parameters in its specification involve modifying the content range of astaxanthin monoesters in oils and fats from 79.8-91.5 % w/w to 66.7-91.5 % w/w of the total carotenoids; the content range of astaxanthin diesters from 0.16-19.0 % w/w to 0.16-32.5 % w/w of the total carotenoids; the content range of astaxanthin 9-cis stereoisomer from 0.3-17.3 % w/w to 0.3-30.0 % w/w of the total carotenoids; and the protein content range from 0.3-4.4 % to 0.0-4.4 %.
3. Galacto-oligosaccharide
Applicant: FrieslandCampina Ingredients
Revised its specifications and removed the indicator of galactose. When consuming dairy products, galactose has a history of safe use as an ingredient in normal diet, allowed to exist in novel food at a minimum level without causing safety concerns, so the indicator was deleted.
Source: Antion
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