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
Application by Laboratoires Pharmascience to place the ingredient maize-germ oil high in unsaponifiable matter on the market
The Food Assessment Body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the French Competent Authority for the placing on the market of Maize germ oil High in Unsaponifiable matter. The UK Competent Authority wishes to make the following comments:
Mr A Klepsch
European Commission
DG-Sanco
Rue de la Loi 200
B-1049
Brussels
Belgium
18 March 2002
Reference: NFU 373
Dear Mr Klepsch
Application by Laboratoires Pharmascience to place the ingredient maize-germ oil high in unsaponifiable matter on the market.
The UK Competent Authority sought comments from the Advisory Committee on Novel Foods and Processes (ACNFP) on the initial opinion produced by the French Competent Authority (French CA) on the application to place the ingredient maize-germ oil high in unsaponifiable matter on the market. Although the Committee broadly agreed with the positive opinion given by the French CA, there were a number of concerns raised.
- The French CA’s recommendation that the applicant should reduce the daily intake of the novel food from 8g to 2g was based on their safe upper limit for vitamin E (a multiple of its recommended daily intake (RDI)). The Committee expressed doubts about this practice of setting safe upper limits for vitamins based on a multiple of the RDI since Member States are currently working to establish safe upper limits based on toxicity.
- The Committee was concerned about how the company would limit the intake of the novel food to 2g/day given the number of foods that could potentially contain the novel food.
- The Committee agreed with the French CA on the ambiguity of the product specification supplied by the applicant. They stated that it was unclear how many batches of the novel food had been used to establish the specification, and that the ranges of each component should be given instead of using ‘greater than’ and ‘less than’ symbols.
- The Committee agreed that no nutritional claims should be made regarding the phytosterol content of the novel food, but stated that any foods or food supplements containing the novel food should state on their labelling that they contain phytosterols. This will ensure that the at-risk groups in the population are aware of the phytosterol content of these foods and therefore give them the opportunity to avoid them.
The UK Competent Authority did not have any specific safety concerns on this product. However the UK CA is concerned that the intake and likely use of the product needs to be clarified. Therefore the UK CA is objecting to the marketing of this product until this issue and the other concerns listed above have been addressed.
Yours sincerely
Sue Hattersley
ACNFP Secretariat