This follows the European Commission’s similar ban on aloe extracts and other hydroxyanthracene derivatives announced last year.
Under Taiwan’s new regulation, aloe vera raw materials used in food must be derived from the leaves of the species of Aloe Ferox and Aloe Vera.
In addition, the skin of the leaves must be completely peel before it could be processed for use.
Another change is that aloin – derived from the sheath cells of the leaves, should not be present in more than 10 part per million (ppm) in a food product.
Precaution statements, such as “not for use in pregnant women” should also be labelled on the products, unless the product has been tested to contain less than 1ppm of aloin.
Aloin, a bioactive found in aloe vera, is said to be a strong laxative which can cause stomach cramps.
The Taiwan FDA had made the announcement on the “Use Restrictions and Labelling Requirements of Aloe as a Food Ingredient” on March 17.
“Aloe vera leaves contain the bioactive aloin, which belongs to the hydroxyanthracene deriatives.
“Relevant international scientific research reports have pointed out that the long-term consumption of hydroxyanthracene deriatives foods or dietary supplements is linked to safety concerns. As such, the FDA has set a new regulation on its use,” the regulator said.
The announcement was made after the regulator had conducted a public consultation last September.
Both locally produced and imported products present in the market before Jan 1, 2023 could still be sold in the market until the products’ expiry date.
The FDA also warned that companies that did not meet the regulatory requirement could face a fine of between NTD$30k and NTD$3m.
Regulations elsewhere
Aside from Taiwan and Europe, South Korea is also considering a ban on the use of aloe leaf in health functional foods.
In the case of the European Commission, the reasoning is that these derivatives are either genotoxic in vitro or in vivo.
“The Authority found that the hydroxyanthracene derivatives aloe-emodin and emodin and structurally related substance danthron have been shown to be genotoxic in vitro.
“Aloe extracts have also been shown to be genotoxic in vitro most likely due to hydroxyanthracene derivatives present in the extract.
“Furthermore, aloe-emodin was shown to be genotoxic in vivo. The whole leaf aloe extract and structural analogue danthron were shown to be carcinogenic,” it said in officials documents.
In South Korea, the authorities said in March that it intend to remove whole aloe leaf from the list of generic functional ingredients approved for use in health functional foods.
This is because whole aloe leaf contains aloe latex, which the authority said could cause adverse effects linked to liver toxicity when consumed in the long run.
The Korea Consumer Agency last year also urged the Ministry of Food and Drug Safety to re-evaluate the use of aloe vera whole leaf extract in health functional foods.