Capsicum Annuum Fruit Extract
The Food and Drug Administration (FDA) includes capsicum (capsicum frutescens or capsicum annuum on its list of substances considered Generally Recognized As Safe (GRAS) as direct food additives. They are GRAS spices and other natural seasonings and flavorings, and GRAS essential oleoresins and natural extractives. Capsicum, capsicum resin and capsaicin are also approved for use as counterirritants in Over-The-Counter (OTC) external analgesic drug products. The safety of capsicum-derived ingredients has been assessed by the Expert Panel for Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that capsaicin, capsicum annuum extract, capsicum annuum fruit extract, capsicum annuum resin, capsicum annuum fruit powder, capsicum frutescens Fruit, capsicum frutescens fruit extract and capsicum frutescens resin were safe as cosmetics ingredients when formulated not to be irritating.
The Expert Panel acknowledged the large amount of data on capsaicin. They noted the wide use of hot peppers as food, and this use as well as oral laboratory studies supported the lack of systemic effects following dietary exposure to hot peppers. An ethanol extract of red chili was mutagenic in one strain of S. typhimurium, but not in another strain, or in E. coli.
Capsaicin and extracts from hot peppers have been shown to be irritating to mucosal tissues, including the stomach, as well as the skin. A skin irritation test of capsicum annuum fruit extract at concentrations ranging from 0.1 to 1.0% produced no irritation. Clinical findings include symptoms of cough, sneezing and runny nose in chili factory workers. Human respiratory responses to capsicum oleoresin spray include burning of the throat, wheezing, dry cough, shortness of breath, gaging, gasping, inability to breathe or speak, and, rarely, cyanosis, apnea, and respiratory arrest.
A trade name mixture containing 1 to 5% capsicum frutescens fruit extract induced very slight erythema in one of ten volunteers patch tested for 48 hours. Capsicum frutescens fruit extract at 0.025% in a repeated insult patch test using 103 subjects resulted in no clinically meaningful irritation or allergic contact dermatitis. One epidemiological study indicated that chili pepper consumption may be a strong risk factor for gastric cancer in populations with high intakes of chili pepper; however, other studies did not find this association. The Expert Panel noted that n-nitroso compounds had been detected in a number of pepper samples, and recommended that the derivatives of capsicum not be used in products where N-nitroso compounds may be formed.
More information about nitrosamines.
Link to the FDA Code of Federal Regulations and Federal Register for capsicum (capsicum furtescens or Capsicum annuum) and capsaicin
The capsicum-derived ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.
Link to the EU Cosmetic Regulation: