ACNFP
THE ADVISORY COMMITTEE ON NOVEL FOODS AND PROCESSES
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
Multibene Phytosterol Products
The Competent Food Assessment Body for the UK Competent Authority (CA), the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the Finnish CA for the placing on the market of Multibene® Phytosterol products.
The Committee broadly agreed with the initial opinion of the Finnish Competent Authority, however there were several concerns raised by members. These are listed below:
1. Some of the products (for instance soft drinks and ice cream) to which it is proposed to add the phytosterol ingredient are perceived to be potentially desirable to children. There is concern that even if they are marketed at a premium price with an indication of the target population (middle aged people), there might still be consumption by children. Therefore, as agreed for other similar applications, products should be clearly labelled that they are not nutritionally suitable for certain sections of the population (pregnant and breast feeding women and children under the age of 5 years). In addition, there should be a consideration of whether there should be a restriction in the range of products to which phytosterols can be added.
2. There is a general concern that over-consumption of phytosterols above the dose of 2-3g per day that gives maximal reduction in blood cholesterol, could have an adverse affect on the absorption of -carotene. The data on estimates of average consumption suggests that eating a combination of Multibene¿ products in a day could easily provide more than this maximally effective dose. For instance if the anticipated intake of 100g of bakery products and 75g of meat products were combined, this would provide 3.5g of phytosterol, Similarly combining 100g bakery product, 25g dietary fats and 150g of yoghurt would provide 5g of phytosterol. Since there are no additional benefits, in terms of reducing serum cholesterol, from intakes of phytosterol above 2-3g/day, the levels of phytosterols added to an average serving of particular food product should be limited to provide 1 serving of phytosterol. In addition there should be labelling on the products to indicate that the recommended intake of such foods should be limited to 2-3 servings per day.
3. It was not clear whether patterns of consumption described in the application would be predictive for the UK population for all products (or in total). The data are based predominately on the patterns of consumption in Sweden, Finland & Denmark and as such might not be predictive for other EU MS due to the differences in intake patterns of these proposed food groups.
4. Concerns were raised about the possible allergenic potential of MultiBene¿ products because one of the sources of phytosterols could be peanuts. The Company should provide evidence to confirm that the processing of the vegetable oil derived plant sterols (phytosterols) consistently removes all traces of protein, at the limit of detection, using an acceptable method.
5. The fat levels in the proposed products appear to be low. Therefore the applicants should ensure that the products comply with international standards (e.g. CODEX) for the various product types.
The UK CA does not support the marketing of this ingredient in the range of products described until these factors have been addressed, and therefore formally objects to this application.
In addition we would wish to discuss in the Novel Food Competent Authority working group the outcome of the SCF consideration of the possible health implications of over-consumption of phytosterols/stanols so that a strategy for managing any risks identified can be developed.