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
Plant Sterols and Sterol Esters
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 Dutch CA for the placing on the market of products containing plant sterols and sterol esters derived from oil seed processing.
1. Several of the products, for which the applicant is seeking clearance, are perceived to be potentially desirable to children (for example yoghurts). Although it is acknowledged that the applicant has considered this matter, the issue of labelling the phytosterol-enriched products as being unsuitable for certain sections of the population is not fully discussed. As with previous consideration of other products that contain plant sterols, products should be appropriately labelled, for example, that they may be nutritionally unsuitable for certain sections of the population, including pregnant and breast-feeding women and children under the age of 5 years.
2. The applicant acknowledges that much of the intake data is based on calculations using the total phytosterol production and availability of foods and not on actual consumption. The Committee does not feel this to be acceptable, particularly when more accurate dietary survey information is available, especially for the UK. The basket consumption survey carried out in the Netherlands is also not applicable to the UK. The lack of intake data for salad dressings, health bars and health drinks has led to considerable variability and likely inaccuracy in projected phytosterol intakes. The Committee also considered that the intake of products such as sausages and salad dressings will differ widely across the EU, and, in the UK, are unlikely to contribute greatly to the total phytosterol intake.
3. The applicant is recommending a daily intake of between 1-3 grams of phytosterols, with up to 2.2g coming from an average serving phytosterol-enriched spread. The other products in the range will be fortified at a level providing 1g of phytosterol per serving. The applicant maintains that the target group for this product is nutritionally aware and is unlikely to consume multiple servings and exceed the recommended daily intake. The Committee did not agree with this statement, and considered the large diversity of products in the range will make it difficult for even nutritionally aware consumers to restrict their intake. Additionally, the information the applicant is suggesting to place on the label refers to advice given by Lipton’s Generally Regarded As Safe (GRAS) panel in the US, which states a maximum intake of phytosterols of 7.8g/day. This is at variance with the recommended effective daily dose of 2-3g and is, therefore, not appropriate.
4. The applicant refers to Unilever’s post market monitoring data to demonstrate that after one year of consuming phytosterols in yellow fat spread, a drop in plasma b- carotene levels is observed, although this lower level remains within normal ranges. However, the results from this survey are based on an average consumption of 2 grams of phytosterol per day, and the applicant is suggesting a possible daily intake of 7.4g, over 3 times greater than the amount consumed in Unilever’s survey.
5. It is noted that toxicological and nutritional data are based on Unilever’s application and post market monitoring data, and no studies were carried out on the actual product for which clearance is sought. However, it is acknowledged that the applicant claims “the extraction and purification steps used to manufacture phytosterols are similar to steps used traditionally by the food industry, including Unilever, in the EU”.
The UK Competent Authority broadly agreed with the Initial Opinion of the Dutch CA and therefore supports the marketing of the phytosterol-enriched yellow fat spread, subject to appropriate labelling of such products, as agreed for other phytosterol-containing products. However, the UK does not support the extension of the range to include salad dressings, health bars, health drinks, yoghurt type products and processed meats.