The regulatory limit of hydroxytyrosol

There are certain differences in the food additive standards for hydroxytyrosol among the European Union, the US Food and Drug Administration (FDA), and China.

The European Commission's Implementing Decision (EU) 2017/2373 approves chemically synthesized hydroxytyrosol as a novel food. It can be added to food categories such as fish oil, vegetable oil (except olive oil and olive pomace oil), and fat - based spreads. The maximum addition level is 0.215 g/kg in fish oil and vegetable oil, and 0.175 g/kg in fat - based spreads. However, it is not allowed to be used in foods for children under 3 years old, lactating women, and pregnant women.

The US Food and Drug Administration (FDA) has granted GRAS (Generally Recognized as Safe) certification to hydroxytyrosol. Chemically synthesized and biosynthesized hydroxytyrosol, as well as phenolic preparations derived from olive fruits and hydrolyzed olive pulp extracts, are allowed to be used in foods. However, specific use limits are not clearly defined. It is generally considered safe within a reasonable range of use and can be used as an antioxidant/antibacterial agent in various foods.

In China, according to the announcement released by the National Health Commission on August 5, 2024, hydroxytyrosol is approved as a new variety of food additives. As an antioxidant, it can be added to vegetable oils (food category 02.01.01) with a maximum use level of 0.05 g/kg. Moreover, it is specified that this hydroxytyrosol should be prepared by a process of catalytic conversion of the fermentation broth of Corynebacterium glutamicum, separation, and purification, using tyrosine as the raw material.