On March 27th, Taiwan FDA passed the regulation The Use Restrictions and Labeling Requirements of Olive Fruit (Olea Europea) Extract Containing Hydroxytyrosol [1], which took effect immediately on the same day.
Detailed regulation
As revealed in this regulation, the olive fruit (olea europea) extract containing hydroxytyrosol which is used as the food ingredient shall abide by the following requirements:
This substance is extracted from the pomace of olea europaea, after the initial procedures of hot-water extraction, centrifugation, concentration, sterilization, dehydration, etc.
The content of hydroxytyrosol in this substance shall be between 15% to 40%.
The daily intake of this substance shall be less than 20 mg (calculated by hydroxytyrosol).
When using this substance in food, the container or outer package shall mark "孕婦及嬰幼兒不宜食用" in Chinese, which translates to "consumption is harmful to pregnant women and children".
Explanation of this regulation
Lin Xuyang, a senior technical specialist of Taiwan FDA said, they had received requests from enterprises who wanted to add this substance in health food products since 2016, prompting the government to develop the new regulation. The new Taiwanese RDA for hydroxytyrosol was developed using US, New Zealand and Australian guidelines as a reference.
Yang Zhenchang, director of Department of Clinical Toxicology & Occupational Medicine from Taipei Veterans General Hospital, explained that basically, this substance is nontoxic. However, during an expert consultation, it was revealed that in animal studies a large dose of hydroxytyrosol given to gestating animals resulted in fetal in utero growth restriction. Thus, they decided to add a warning for pregnant woman infants and children. (source from Taiwan Food Industry Foundation [2], etc)