Its 93-page submission highlights the ability of the extract – dihydrocapsiate (DHC) – to boost energy and fat oxidation and therefore benefit weight management.
Ajinomoto said it plans to produce the DHC compound synthetically because chilli peppers only produce small amounts of it.
Baked goods, beverages, confectionary, cereals and desserts are the targeted food matrices with a suggested DHC dosage of 3mg per serving.
The application will be assessed by the FSA-appointed Advisory Committee on Novel Foods and Processes (ACNFP) which said that, “under a conservative set of assumptions” typical intakes were unlikely to exceed 0.2 to 0.4 mg/kg body weight/day for an adult or 0.4 to 1mg/kg bw/day for a child, well within standard safety limits.
ACNFP said a study with healthy male individuals showed no obvious events at doses of 12mg per day – four times the level proposed by Ajinomoto.
“An extensive package of toxicology conducted by the oral route has shown no evidence of toxicity or pathogenicity at dose levels of up to 1000mg/kg bw/day over 26-weeks, and teratology and genotoxicity studies did not indicate the potential for adverse effects,” ACNFP noted.
“Placebo controlled human studies with DHC of up to four weeks duration involving bolus oral administration were well tolerated with no evidence of clinically significant findings.”
In the US, DHC has GRAS (generally recognised as safe) status in the food supply at levels between 1-3g per day.
“A chilli pepper extract, known as CH-19 Sweet extract, contains capsinoids of which DHC represents approximately 20 per cent,” ACNFP said. “This extract is sold by Ajinomoto as a food supplement in the USA and Japan under the name of Capsiate Natura.”
ACNFP concluded: “The evidence from safety studies presented in this application together with calculations of anticipated usage and use levels indicate that DHC will be safe for consumers when incorporated into specified food items as a food ingredient at concentrations designed to provide a maximum of 3mg per serving or portion of food.”
The application can be found here.