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
Rapeseed oil high in unsaponifiable matter
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 Rapeseed oil High in Unsaponifiable matter. The UK Competent Authority wishes to make the following comments:
Mr Andreas Klepsch
European Commission
DG-Sanco
Rue de la loi 200
B-1049 Brussels
Belgium
18 March 2002
Reference: NFU 368
Dear Mr Klepsch
Laboratories Pharmascience: Rapeseed oil high in unsaponifiable matter
The UK Competent Authority (CA) sought comments from the Advisory Committee on Novel Foods and Processes (ACNFP) on the Initial Opinion of the French CA on the application by Laboratories Pharmascience under the Novel Food Regulation (EC) 258/97. While the UK CA generally agreed with the Initial Opinion of the French CA they raised several additional points. These are listed below:
1. The French CA’s recommendation that the applicant should reduce the daily intake of the novel food from 5g to 1.5g 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.
2. The French CA commented on the slight ambiguity in the specification of the product. However the UK CA was of the opinion that the applicant needed to provide a more accurate specification which provides at least a maximum and minimum range for each component. This should include the specific erucic acid content of the product since the UK CA believe the Codex Standard for the erucic acid is less than 2% rather than less than 5%.
3. The UK CA was concerned that the applicant had not been specific enough in regards to the anticipated use of the product quoting a very broad range of intended food products. The incorporation of this novel ingredient into an unspecified number and variety of foods is of particular concern when the company has been requested to limit consumption of this ingredient. The UK CA does not consider that the applicant has satisfactorily demonstrated that it can limit consumption to a daily intake of 1.5g.
4. The UK agree with the French CA that the applicant should not be allowed to make cholesterol lowering health claims. However the UK point out that susceptible, high risk members of the population may still be affected by this product, therefore the label should incorporate wording to indicate that the product contains phytosterols.
The UK CA 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