2001/721/EC: Commission Decision of 25 September 2001 authorising the placing on the market of trehalose as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2001) 2687)

• CELEX: Regulation (EC) No 258/97
• Articles: 4

Article 1

Trehalose as specified in the Annex, may be placed on the market in the Community as novel food or novel food ingredient for use in foodstuffs.

Article 2

The designation "trehalose" shall be displayed on the labelling of the product as such or in the list of ingredients of foodstuffs containing it.

In a prominently displayed footnote related to the designation trehalose by means of an asterisk (*) the words "trehalose is a source of glucose" shall be displayed. The words shall have a typeface of at least the same size as the list of ingredients itself.

Article 3

This Decision is addressed to Bioresco Ltd Bundesstraße 29, CH-4054 Basel.

Done at Brussels, 25 September 2001.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 43, 14.2.1997, p. 1.

Schedules & Appendices

ANNEX

SPECIFICATIONS OF TREHALOSE

Synonyms

α,α-trehalose

Definition

A non-reducing disaccharide that consists of two glucose moieties linkes by an α-1,1-glucosidic bond. It is obtained from liquefied starch by a multistep enzymatic process. The commercial product is the dihydrate.

Chemical name

α-D-glucopyranosyl-α-D-glucopyranoside, dihydrate

CAS No

6138-23-4 (dihydrate)

Chemical formula

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(dihydrate)

Structural formula

Trehalose

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Formula weight

378,33 (dihydrate)

Assay

Not less than 98 % on the dry basis.

Description

Virutally odourless, white or almost white crystals with a sweet taste

Characteristics

Identification

Solubility

Freely soluble in water, very slightly soluble in ethanol

Specific rotation

[α]D20 + 199° (5 % aqueous solution)

Melting point

97 °C (dihydrate)

Purity

Loss on drying

Not more than 1,5 % (60 °, 5h)

Total ash

Not more than 0,05 %

Lead

Not more than 1 mg/kg

Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5(1), "Instrumental methods"

Method of assay

Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing standard trehalose

Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100-ml volumetric flask and add about 80 ml of purified, deionised water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron filter

Preparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obtain a solution having known concentration of about 30 mg of trehalose per ml

Apparatus: liquid chromatograph equipped with a refractive index detector and integrating recorder

Conditions:

Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent

- length: 300 mm

- diameter: 10 mm

- temperature: 50 °C

Mobile phase: water

flow rate: 0,4 ml/min

Injection volume: 8 μl

Procedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph. Record the chromatograms and measure the size of response of the trehalose peak

Calculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula:

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where

RS= peak area of trehalose in the standard preparation

RU= peak area of trehalose in the sample preparation

WS= weight in mg of trehalose in the standard preparation

WU= weight of dry sample in mg

(1) Food and nutrition paper 5 Rev.2 - Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA) 1991, 322p. English - ISBN 02991.