Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on hydroxytyrosol as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The assessment, which follows the methodology set out in Commission Recommendation 97/618/EC, is based on the data supplied in the original application, the initial assessment by the competent authority of Spain, the concerns and objections of a scientific nature raised by the other Member States and the responses of the applicant.
The NF that is subject of this application is hydroxytyrosol, which is chemically synthesised. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF.
The applicant intends to add hydroxytyrosol to fish and vegetable oils up to 215 mg/kg and to margarines up to 175 mg/kg. The target group is the general population which excludes children under 36 months of age, pregnant women and breastfeeding women.
The main dietary sources of hydroxytyrosol are olive oils and table olives. The daily intake of hydroxytyrosol from the consumption of olive oils and olives has been calculated based on a mean content of free hydroxytyrosol in these foods. The Panel notes that in olives and olive oils hydroxytyrosol is not only available in a free form, but also in the conjugated forms of oleuropein and oleuropein-aglycones, and that a wide range of content of free hydroxytyrosol and its conjugated forms in these foods, which depends on the variety and degree of ripeness of olives, has been reported. Since bioavailability studies on polyphenols from olives and olive oils show that also hydroxytyrosol from oleuropein and oleuropein-aglycone is bioavailable, the Panel considers that the total systemic exposure to hydroxytyrosol from olive oils and olives is higher than the exposure estimated on the basis of the content of free hydroxytyrosol only (approximately six and three times higher for olive oils and olives, respectively, based on a mean content of oleuropein and oleuropein-aglycone).
Overall, the provided data on the kinetics suggest that in both rats and humans hydroxytyrosol is quickly absorbed, has a half-life time of a few minutes and is eliminated by the kidneys as either free hydroxytyrosol or in oxidised or conjugated forms (glucuronide and sulfate derivatives).
Taking into account the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous.
Based on the studies provided, the Panel concludes that there is no concern with regard to potential genotoxicity of the NF. The NF was tested at dose levels of 5, 50, or 500 mg/kg body weight (bw) per day in a subchronic 90-day oral toxicity study in rats. Based on changes in body and organ weights in the highest dose group tested in this study, the Panel considers the dose of 50 mg/kg bw per day as the no observed adverse effect level (NOAEL). The findings in this 90-day study with the NF were supported by the observations in another 90-day oral toxicity study in rats with an olive extract which delivered different doses of hydroxytyrosol.
Considering the NOAEL of 50 mg/kg bw per day in the subchronic oral toxicity study with the NF and the maximum anticipated daily intake for the NF, the margin of exposure (MoE; i.e. the ratio between the NOAEL and the maximum anticipated daily intake of the NF) would result in 100 for children (3–9 years of age) and at least 200 for adolescents, adults (excluding pregnant and breastfeeding women) and elderly.
Taking into account that the anticipated daily intake of the NF would be in the range of or even less than the exposure of hydroxytyrosol from the consumption of olive oils and olives, which has not been associated with adverse effects, and considering the similar kinetics of hydroxytyrosol in rats and humans, the Panel considers that the MoE for the NF at the intended uses and use levels is sufficient for the target population.
The Panel concludes that the novel food, hydroxytyrosol, is safe under the proposed uses and use levels.