The European Food Safety Authority (EFSA) has issued a scientific opinion on the safety of glucosyl hesperidin (GH) as a novel food (NF) ingredient, following a request from the European Commission. This evaluation was conducted in accordance with Regulation (EU) 2015/2283, which governs the introduction of novel foods into the EU market.
Novel Food Characteristics
Glucosyl hesperidin, produced through enzymatic reactions from hesperidin and dextrin, is primarily composed of monoglucosyl hesperidin (MGH) and unreacted hesperidin. These two components constitute up to 92.8% of the product on a dry basis. The applicant, Hayashibara Co., Ltd., proposed using this novel food in various hot beverages, non-alcoholic drinks, confectionery, and as a food supplement. The target population for this NF includes the general population, with specific consideration for children from one year of age and adults in the case of food supplements.
Safety Assessment and Methodologies
EFSA's safety assessment was based on data provided by the applicant, supplemented by additional information requested by the authority. The methodology adhered to EFSA's guidance on novel food applications and the principles outlined in relevant guidance documents. EFSA focused solely on the risks associated with the consumption of the NF under the proposed usage conditions, rather than evaluating any potential health benefits.
Toxicological Evaluation
A critical aspect of EFSA's assessment involved a 90-day oral toxicity study, which identified a No Observed Adverse Effect Level (NOAEL) at approximately 1000 mg/kg body weight (bw) per day. Applying an uncertainty factor of 200, EFSA determined that a safe intake level for humans would be 5 mg/kg bw per day. Moreover, human intervention studies involving GH/MGH at doses up to 3 g/day for 12 weeks did not report any clinically significant changes in haematological or clinical chemistry parameters.
Highlights
- EFSA has confirmed the safety of glucosyl hesperidin (GH) as a novel food ingredient.
- The NF is intended for use in various beverages, confectionery, and as a food supplement, with the general population as the target demographic.
- A 90-day oral toxicity study identified a NOAEL of 1000 mg/kg bw per day, leading to a recommended safe intake level of 5 mg/kg bw per day.
- Human studies showed no significant adverse effects at supplemental doses up to 3 g/day for 12 weeks.
- EFSA's evaluation concluded that the NF is safe for its intended uses and consumption levels.
