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)
Date: 2001-09-25
Institutions: European Commission
Subjects: consumer information, food additive, foodstuff, glucose, labelling, market approval

10.10.2001

EN

Official Journal of the European Communities

L 269/17

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)

(2001/721/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients (1), and in particular
Article 7 thereof,

Having regard to the request by Bioresco Ltd, Switzerland on
behalf of Hayashibara Co. Ltd, Japan to the competent authori-
ties of United Kingdom of 25 May 2000 for placing trehalose
on the market as a novel food or novel food ingredient,

Having regard to the initial assessment report drawn up by the
competent authorities of the United Kingdom.

Whereas:

(1) While trehalose extracted from yeast was approved for
use in foods (except for infant formulae and follow-on
formulae) in 1991 in the United Kingdom, it still has to
be considered as novel because significant amounts of
trehalose have not been marketed subsequently in the
United Kingdom or other Member States.

(2)

In their initial assessment report the United Kingdom's
competent food assessment body came to the conclu-
sion that the trehalose as specified by JECFA at its 55th
meeting is safe for human consumption within the
range of foodstuffs detailed by the company.

(3)

The Commission forwarded the initial assessment report
to all Member States on 16 October 2000.

(4) Within the 60 day-period laid down in Article 6(4) of
the Regulation, reasoned objections to the marketing of
the product were nevertheless raised in accordance with
that provision.

(5)

At a meeting on 12 March 2001 Bioresco provided
additional information responding to the comments and
objections raised by Member States.

(6)

(7)

(8)

On the basis of this additional
information and the
initial assessment report, it is established that trehalose
complies with the criteria laid down in Article 3(1) of
the Regulation.

The use of
trehalose in foods for particular uses is
governed by specific requirements in Community law.

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

HAS ADOPTED THIS DECISION:

Article 1

Trehalose as specified in the Annex, may be placed on the
market in the Community as novel food or novel food ingre-
dient 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.

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Official Journal of the European Communities

10.10.2001

α,α-trehalose

ANNEX

SPECIFICATIONS OF TREHALOSE

Synonyms

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

C12

H

22

O

11

· 2H

O (dihydrate)
2

Structural formula

Trehalose

Formula weight

378,33 (dihydrate)

Assay

Not less than 98 % on the dry basis.

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

Description

Characteristics

Identification

S o l u b i l i t y

Freely soluble in water, very slightly soluble in ethanol

S p e c i f i c r o t a t i o n
[α]D

20 + 199° (5 % aqueous solution)

M e l t i n g p o i n t

97 °C (dihydrate)

Purity

L o s s o n d r y i n g

Not more than 1,5 % (60 °, 5h)

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T o t a l a s h

Not more than 0,05 %

L e a d

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:

% trehalose = 100 × (R

U/RS) (WS/WU)

where

R

S =
R
U
W

peak area of trehalose in the standard preparation

= peak area of trehalose in the sample preparation
S = weight in mg of trehalose in the standard preparation

W
U

= 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.