Commission Decision

of 1 December 2003

authorising the placing on the market of salatrims as novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2003) 4408)

(Only the Danish text is authentic)

(2003/867/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,

Whereas:

(1) On 28 June 1999 Danisco, formerly Cultor Food Science, submitted to the competent authorities of the United Kingdom a request for placing salatrims on the market in the Community as novel food ingredients.

(2) Salatrims are a group of reduced calorie triacylglycerides developed for use as alternative fats.

(3) The competent authorities of the United Kingdom carried out the initial assessment. The Commission forwarded the initial assessment report to all Member States on 22 November 1999.

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

(5) The Scientific Committee on Food was consulted on the matter in accordance with Article 11 of the Regulation. On 13 December 2001, the Scientific Committee on Food delivered its opinion that salatrims are safe for human consumption.

(6) The Scientific Committee on Food noted the only adverse effects of salatrims observed in a number of human tolerance studies were gastro-intestinal complaints at high intakes (i.e. >30 g/day). Such inconveniences caused by gastro-intestinal intolerance are easily and commonly resolved by the individual abstaining from consumption when he or she becomes aware of the problem. It is therefore appropriate to provide a statement on the label which informs the consumer that excessive consumption may lead to gastro-intestinal problems.

(7) The Scientific Committee on Food also noted that no data had been generated on the effect of consumption of foods containing salatrims by children under 16 years, as this population group was unlikely to consume products intended for use mainly by persons aiming to control their weight by choosing an energy restricted diet. Therefore it is appropriate to provide a statement on the label which informs the consumer that products containing salatrims are not for use by children.

(8) The declaration of the energy value of foods and food ingredients is governed by Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(2).

(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Salatrims as specified in the Annex may be placed on the market in the Community as novel food ingredients for use in bakery products and confectionery.

Article 2

The designation "reduced energy fat (salatrims)" shall be displayed on the labelling of the product, as such, or in the list of ingredients of foodstuffs containing it.

There shall be a statement that excessive consumption may lead to gastro-intestinal disturbance.

There shall be a statement that the products are not intended for use by children.

Article 3

This Decision is addressed to Danisco A/S, Langebrogade 1, PO Box 17, DK-1001 Copenhagen K, Denmark.

Done at Brussels, 1 December 2003.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 276, 6.10.1990, p. 40.

ANNEX

SPECIFICATIONS OF SALATRIMS

Definition:

Salatrim is the internationally recognised(1) acronym for (short and long chain acyl triglyceride molecules).

Salatrim is prepared by non-enzymatic inter-esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunflower oil.

Description:

Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or rancid odour.

Glycerol ester distribution:

>TABLE>

Fatty acid composition:

>TABLE>

Triacylglycerol profile:

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(1) FAO/WHO Joint Expert Committee on Food Additives (2002) FAO Food and Nutrition Paper 52 Additive 10, page 23.