Novel Food : An aqueous ethanolic extract of Labisia pumila recognized as safe by EFSA

Novel Food : An aqueous ethanolic extract of Labisia pumila recognized as safe by EFSA

A new novel food application managed by Nutraveris/FoodChain ID recognized as safe by EFSA

The company Medika Natura Sdn. Bhd., based in Malaysia, has submitted a novel food application to request the authorization to put on the EU market an aqueous ethanolic extract of Labisia pumila (Trade name of the extract: SKF7®). This application, managed by Nutraveris, has been evaluated positively by EFSA.

The extract is a standardized extract of the dried whole plant of L. pumila. No safety concern were associated with the production process and the compositional data. The safety evaluation consisted into 5 genotoxicity studies (AMES tests, one in vitro chromosome aberration test, one in vivo mammalian micronucleus test and two in vitro micronucleus test), one 90-day and one chronic oral toxicity study. The application also included one human study.

EFSA recognized that the novel food is safe for a use in food supplements at a daily intake of 350 mg. The novel food has been demonstrated to have significant beneficial effect on weight management.

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Maradona MP, Marchelli R, Neuhauser-Berthold M, Poulsen M, Schlatter JR, Albert O, Matijevic L and Knutsen HK, 2022. Scientific Opinion on the safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022;20(11):7611.