24 Nov 2017 --- The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) has concluded that synthetic l-ergothioneine is safe under the proposed uses and use levels for the groups of the population which had been excluded by the applicant in the original application. Following a request from the European Commission, EFSA confirmed the safety of the powerful antioxidant for groups including infants, young children (i.e. toddlers), pregnant women and breastfeeding women.
On 26 October, 2016, the EFSA NDA panel adopted the scientific opinion on the safety of synthetic l-ergothioneine as a novel food pursuant to Regulation (EC) No 258/97.
In performing the safety assessment of the novel food, the NDA panel considered the proposed uses (i.e. food ingredient added to alcohol-free beverages; milk; “fresh” dairy products; cereal bars and chocolate; food supplements) and the proposed target population (i.e. children above 3 years of age and the general adult population, with the exception of pregnant and breastfeeding women).
Detailed information on the safety assessment of synthetic l-ergothioneine is provided in the published opinion which informs on the specifications of the novel food, its stability, the production process, the anticipated intake/extent of use in the proposed target population, nutritional information of the novel food, microbiological information, toxicological information (including absorption, distribution, metabolism and excretion), human studies and potential allergenicity of the novel food.
In 2016, the NDA panel considered a no-observed-adverse-effect level (NOAEL) of 800 mg/kg body weight (bw) per day of the novel food. Taking into account this NOAEL and the maximum estimated intake levels for l-ergothioneine from all sources (i.e. fortified foods, food supplements and background diet) of 1.7 mg/kg bw per day for adults and of 3.7 mg/kg bw per day for children, the panel concluded that the margins of safety of 470 for adults (excluding pregnant and breastfeeding women) and of 216 for children above 3 years of age are sufficient.
Findings extend to additional groups For the latest assessment, intake estimates were calculated for the specified groups and the following maximum anticipated daily intakes of l-ergothioneine from the NF, in addition to the background diet, were calculated: 2.82 mg/kg body weight (bw) per day for infants, 3.39 mg/kg bw per day for toddlers and 1.31 mg/kg bw per day for adults including pregnant and breastfeeding women.
The panel states that based on the overall toxicological data, the no-observed-adverse-effect level (NOAEL) of 800 mg/kg bw per day as established in the original assessment also pertains to pregnant and breastfeeding women as well as to young children (i.e., toddlers) and infants.
The corresponding margins of exposure (i.e., the ratio between the NOAEL and the maximum anticipated daily intakes) are 284 for infants, 236 for young children and 610 for pregnant and breastfeeding women. These margins of exposure are considered sufficient.
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