ACNFP

THE ADVISORY COMMITTEE ON NOVEL FOODS AND PROCESSES

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ACNFP Secretariat
Food Standards Agency
Room 515b Aviation House
125 Kingsway
London WC2B 6NH

Tel: +44 (0)20 7276 8595
Fax: +44 (0)20 7276 8564

acnfp@foodstandards.gsi.gov.uk

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Use of Diminicol

2001: Letter advising the European Commission of the ACNFP view on plant sterol enriched fat ingredient Diminicol.

Re: Initial opinion from the Finnish CA on the application to place the Plant sterol enriched fat ingredient Diminicol® on the novel food market.

Dear Mr Klepsch

The UK Competent Authority (UK CA) sought comments from the Advisory Committee on Novel Foods and Processes (ACNFP) on the initial opinion from Finland under the 60-day rule of the Novel Food Regulation (EC) 258/97. Several concerns were raised as listed below:

1. The product is microcrystalline plant sterols/stanols, and not sterol/stanol esters. Consequently this material cannot be assumed to be substantially equivalent to plant sterol/stanol esters which have already been subject to toxicological testing.
2. Concerns were raised as to the allergenic potential of the Diminicol products due to one of the sources of the phytosterols being peanuts. The company should confirm that the processing of the vegetable oil derived plant sterols (phytosterols) removes all traces of protein, and thereby ensuring that any possible allergenicity of the source materials is removed.
3. The suggested labelling of the products containing the Diminicol ingredients was not satisfactory. The labelling should state clearly and specifically that these products are not nutritionally appropriate for pregnant or lactating mothers and young children.
4. Some of the plant sterol enriched products (yoghurts and fruit milk drinks) were perceived to be potentially desirable to children, and there was concern that even if they were marketed at premium price with an indication of the target population (middle aged people), there may still be consumption by children.
5. Data should be provided on the possibility of effects on the absorption (not blood level) of fat-soluble vitamins and carotenoids over the longer term. Similar concerns have been raised previously with other phytosterol/ester products. In addition effects on carotenoids such as lutein may have implications for deteriorating vision in the elderly.
6. In view of the number of applications for foodstuffs containing phytosterols and their esters being considered under (EC) 258/97, concerns have already been raised by the UK Competent Authority concerning the potential for the cumulative consumption of plant sterols from a range of different products. In view of this, there was concern that with the addition of a number of products containing plant sterols onto the market the potential for over consumption of plant sterols would be increased further.

The UK Competent Authority broadly agreed with the initial opinion of the Finnish Competent Authority and therefore does not support the marketing of these products until the concerns listed above have been addressed, and therefore formally objects to this application.

Yours sincerely

Sue Hattersley
Novel Foods Division