EFSA Novel Food opinions: chitin-glucan and CMC

03-Aug-2010 - Last updated on 04-Aug-2010 at 10:45 GMT

In two novel food opinions for dietary supplement ingredients, the European Food Safety Authority (EFSA) has confirmed the safety of a fibre ingredient but said there was not enough evidence to demonstrate the safety of an ingredient for osteoarthritis.

Published last week, the opinions from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) assed the safety of cetyl myristoleate complex and a chitin-glutan ingredient.

Chitin-glucan

Submitted by KitoZyme, the first dossier related to the branded KiOnutrime-CG ingredient, which contains over 90 per cent chitin-glucan. The ingredient is intended to be used in dietary supplements in order to increase the daily intake of fibres.

Chitin-glucan is the main component in the cell walls of the mycelium of Aspergillus niger derived from a fermentation process. EFSA noted that the A. niger strain is non-toxic and non-pathogenic and has a history of safe use in production of food ingredients.

An examination of the compositional data and the manufacturing process did not give rise to concerns, it said.

The panel noted that a 13-week rat study revealed no adverse effects of the ingredient at dosages 80 times the maximum intended level of intake for humans on a g/kg body weight basis. The intended intake of chitin-glucan is 2 to 5g per day.

EFSA concluded that Novel Food KiOnutrime-CG is safe as a food ingredient at the proposed conditions of use and the proposed intake levels.

To access the full opinion, click here.

Cetyl Myristoleate Complex

In another opinion following a request from the European Commission, EFSA examined the safety of cetyl myristoleate complex (CMC), which was intended for use as a food supplement for people with osteoarthritis.

CMC powder consists of 50 per cent of cetylated fatty acids (CFA, including cetyl myristoleate), 48 per cent of corn starch and 2 per cent of silicon dioxide. The ingredient is produced in an industrial process where a fatty acid mixture extracted from beef tallow is esterified with cetyl alcohol obtained from palm oil.

EFSA noted that the individual components of the lipid part of the CMC such as cetyl alcohol, myristic acid, and myristoleic acid are present in the European diet.

The intended daily dose is 3.3g CMC, which corresponds to around 1.65g of CFAs.

However, the NDA panel said that the information provided in a rat study on the ingredient was lacking. No information was provided on the extent of intestinal hydrolysis of the CFA after oral intake, limited information was provided on the distribution of absorbed unhydrolysed CFA, and no information was provided on the metabolism and excretion of such intact CFA.

“In the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data are insufficient. The Panel notes that most of the human studies provided, were not design to study safety. Only one human trial studied safety endpoints but had considerable limitations, i.e. lower dose used compared to the proposed use, and a different product was tested,” said EFSA, concluding that the safety of the ingredient was not established.

To access the full opinion, click here.