Safety of dried fruits of Synsepalum dulcificum 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 dried fruits of Synsepalum dulcificum as a novel food ( NF ) pursuant to Regulation ( EU ) 2015/2283. The NF is pitted and dried (by lyophilisation) fruits of S. dulcificum . The NF contains the glycoprotein miraculin (≤ 2.5%) which causes sour and acidic foods to taste sweet. The fruits have a documented history of consumption in Africa and products thereof can be found in different markets worldwide. Information on the production process and the composition of the NF is sufficient and does not raise safety concerns. The applicant proposes to use the NF as or in food supplements for the adult population, excluding pregnant and lactating women, at a maximum daily amount of 0.9 g. Taking into account these conditions of use, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The provided genotoxicity studies do not raise concerns for genotoxicity of the NF . The Panel concludes that the only dose tested in a 90‐day oral toxicity study of 2,000 mg/kg body weight (bw) per day was not associated with adverse effects. By applying an uncertainty factor of 200, the Panel concludes that the NF is safe at an intake level of 10 mg/kg bw per day, corresponding to a maximum daily intake of 0.7 g of the NF for the target population, rather than 0.9 g/day as proposed by the applicant.

Inclusive Overview of Sweeteners Trends: Nutritional Safety and Commercialization

“…The fruit has been proposed as a treatment for flavor adjustments, experienced by some chemotherapy patients, requiring similar research in the flavoring industry. In the USA, a strike was promoted in 1970 to commercialize fruit extract low calorie or noncaloric sweetener, but it still has not been approved by the FDA or EFSA (European Foods Safety Authority). , Its sweetness is credited to the presence of glycoprotein “miraculin” that has specific binding properties with human tongue sweet receptors. Miraculin (combination of galactose, xylose, fucose, mannose and glucosamine sugars) is only 4.44% of total fruit weight but exhibits excellent flavoring, coloring and antioxidant properties.…”

Miracle fruit seed as a potential supplement for the treatment of learning and memory disorders in Alzheimer’s disease

“…After the 1960s, the mystery fruit was introduced to subtropical and tropical areas of China, including Hainan, Yunnan, Guangdong, Guangxi, and Fujian provinces ( Cheng, 2000 ). The miracle fruit is currently found to be of use and economic significance in a variety of industries and has been approved for safety in the European Union as a food supplement (excluding pregnant and lactating women adults) ( Turck, et al, 2021 ). The safety of miracle fruits was assessed by measuring their lectin levels, and it was found that miracle fruits can be taken orally without cooking like fruits such as blueberries ( Menéndez-Rey, et al, 2021 ).…”

Genome‐wide diversity analysis suggests divergence among Upper Guinea and the Dahomey Gap populations of the Sisrè berry (Syn: miracle fruit) plant (Synsepalum dulcificum [Schumach. & Thonn.] Daniell) in West Africa

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