Refined exposure assessment of extracts of rosemary (E 392) from its use as food additive

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific\ud opinion on the refined exposure assessment of extracts of rosemary (E 392) when used as a food\ud additive. Extracts of rosemary (E 392) was evaluated by the AFC Panel in 2008. Following this EFSA\ud evaluation, extracts of rosemary (E 392) was authorised for use as a food additive in the EU in several\ud food categories with maximum levels. In 2015, the ANS Panel provided a scientific opinion on the\ud safety of the proposed extensions of use for extracts of rosemary (E 392) in fat-based spreads. In\ud 2016, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated this food\ud additive and established a temporary acceptable daily intake (ADI) of 0–0.3 mg/kg body weight (bw)\ud for rosemary extract, expressed as carnosic acid plus carnosol. Based on the data provided by food\ud industry, the Panel was able to refine the exposure estimates of extracts of rosemary (E 392). The\ud highest mean refined exposure estimate (non-brand loyal scenario) was 0.09 mg/kg bw per day in\ud children (3–9 years) and the highest 95th percentile of exposure was 0.20 mg/kg bw per day in\ud children. Taking uncertainties into account, the Panel concluded that these exposure estimates very\ud likely overestimate the real exposure to extracts of rosemary (E 392) from its use as a food additive\ud according to Annex II. Margins of safety were estimated for children and adults using the refined\ud exposure estimate; these are higher than the ones calculated in 2015. Intake of carnosic acid and\ud carnosol from natural diet (herbs) was estimated. It was maximally 1.66 mg/kg bw per day (p95).