Safety of phenylcapsaicin as a novel food pursuant to Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on phenylcapsaicin as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Phenylcapsaicin is a chemically synthesised analogue of capsaicin intended to be marketed in food supplements and in foods for special medical purposes to the general population above the age of 11 years old at a maximum level of 2.5 mg/day. The highest intake of the NF is 2.5 mg/day which corresponds to 36 μg/kg body weight (bw) per day for adults, and 58 μg/kg bw per day for adolescents (10–14 years). The Panel considers that there is no concern with respect to genotoxicity of the NF. The reference point derived based on a 13‐week rat study was the lowest of the model averaged BMDL20 values of 37.2 mg/kg bw per day in females for increased plasma alanine aminotransferase (ALAT) levels. The Panel concludes that the NF, phenylcapsaicin, is safe under the proposed uses and use levels.

Effects of different phenylcapsaicin doses on resistance training performance, muscle damage, protein breakdown, metabolic response, ratings of perceived exertion, and recovery: a randomized, triple-blinded, placebo-controlled, crossover trial

“…This reasoning may be aligned with the current European Food Safety Authority (EFSA) PC permitted limits for dietary supplements (i.e. 2.5 mg) [ 22 ].…”

“…However, previous research has reported intestinal discomfort after high-dose (HD) oral encapsulated capsaicin supplementation (25.8 mg) [ 21 ], which suggests that capsaicin may be irritating, in spite of the vehicle of administration used. Recently, a new synthetic analog called phenylcapsaicin (PC) has emerged as an alternative to traditional oral purified capsaicin supplementation [ 22 ]. PC is a microencapsulation of 98% of PC and 1–1.5% of cellulose and lipidic excipients as primary vehicles [ 22 ].…”

“…Recently, a new synthetic analog called phenylcapsaicin (PC) has emerged as an alternative to traditional oral purified capsaicin supplementation [ 22 ]. PC is a microencapsulation of 98% of PC and 1–1.5% of cellulose and lipidic excipients as primary vehicles [ 22 ]. Through hepatic glucuronidation, PC is fast presented in tissues such as the small intestine, stomach, and liver after 0.5 h of ingestion [ 22 ].…”

“…PC is a microencapsulation of 98% of PC and 1–1.5% of cellulose and lipidic excipients as primary vehicles [ 22 ]. Through hepatic glucuronidation, PC is fast presented in tissues such as the small intestine, stomach, and liver after 0.5 h of ingestion [ 22 ]. Therefore, it is supposed that microencapsulation might entail a lower pungency power, less digestive system mucosa irritation, and potentially a higher bioavailability [ 10 , 22 ].…”

“…Through hepatic glucuronidation, PC is fast presented in tissues such as the small intestine, stomach, and liver after 0.5 h of ingestion [ 22 ]. Therefore, it is supposed that microencapsulation might entail a lower pungency power, less digestive system mucosa irritation, and potentially a higher bioavailability [ 10 , 22 ]. Therefore, given that purified capsaicin ergogenic dose oscillates around 12 mg [ 6 ], PC might exert positive ergogenic effects with lower doses (i.e.…”