2000/500/EC: Commission Decision of 24 July 2000 on authorising the placing on the market of 'yellow fat spreads with added phytosterol esters' 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(2000) 2121) (Only the English text is authentic)

• CELEX: Regulation (EC) No 258/97
• Articles: 5

Article 1

Yellow fat spreads with added phytosterol esters as specified in the Annex, hereinafter called the products, may be placed on the market in the Community as novel foods or novel food ingredients.

The addressee shall ensure that the products meet the requirements of Article 2.

Article 2

Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, the following additional specific labelling requirements shall apply:

(a) The product shall be labelled as: margarine (or vegetable fat spread) with plant sterol esters, in conformity with Council Regulation (EC) No 2991/94.

(b) The content of plant sterol esters shall be declared on the list of ingredients.

(c) There shall be a statement that the product is for people who want to lower their blood cholesterol levels.

(d) There shall be a statement that patients on cholesterol lowering medication should only consume the product under medical supervision.

(e) There shall be an easily visible and legible statement that the product may not be nutritionally appropriate for certain sections of the population (pregnant and breast-feeding women and children under the age of five years).

(f) Advice shall be given that the product should be used as part of a healthy diet, including regular consumption of fruit and vegetables (to help maintain carotenoid levels).

Article 3

Unilever shall establish a surveillance programme accompanying the marketing of the product. This programme should encompass, in particular, information on individual intakes of the product. This programme shall be submitted for approval by the Commission prior to the placing on the market of the product.

The data collected should be made available to the Commission and Member States in order to estimate the extent to which the product is reaching its target group, people who try to control their elevated blood cholesterol, and to estimate exposures to phytosterols from this source in other population groups.

Article 4

This Decision is addressed to Unilever (UK) Central Resources Limited, Unilever House, Blackfriars, London, United Kingdom.

Done at Brussels, 24 July 2000.

For the Commission

David Byrne

Member of the Commission

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

Schedules & Appendices

ANNEX

Specifications of yellow fat spread with added phytosterol esters

1. The margarine/vegetable oil spread may contain up to 8 % w/w of added phytosterols (equivalent to 14 % w/w phytosterol-esters).

2. The composition of the phytosterols is specified in the table below:

Table 1: Composition of phytosterols

>TABLE>