EFSA has updated its safety assessment of the food additive titanium dioxide (E 171), following a request by the European Commission in March 2020.
The updated evaluation revises the outcome of EFSA’s previous assessment published in 2016, which highlighted the need for more research to fill data gaps.
Prof Maged Younes, Chair of EFSA’s expert Panel on Food Additives and Flavourings (FAF), said: “Taking into account all available scientific studies and data, the Panel concluded that titanium dioxide can no longer be considered safe as a food additive. A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body”.
The assessment was conducted following a rigorous methodology and taking into consideration many thousands of studies that have become available since EFSA’s previous assessment in 2016, including new scientific evidence and data on nanoparticles.
"I would like one thing to be clear and reach consumers strongly: not all Aloe-based products are banned, but only those that contain hydroxyanthracenes". Antonino Santoro is the managing director of FederSalus, the most representative Italian association in the food supplements sector and president of EHPM, the
European federation that brings together 14 national associations of European countries and about 1600 companies.
This is the clarification released from Federsalus following the news reported in recent days by various newspapers. "In order to clarify the actual impact of the provision" writes the association, which represents the companies in the supplement sector, "it is necessary to specify that these molecules, considered unsafe by EFSA, the European Food Safety Authority, are contained only in a specific part of the plant, i.e. in the outermost parts of the leaf".
Federsalus notes that naturally hydroxyanthracen-free gel can continue to be used for the production of supplements. "The careful processing of the leaf by the manufacturers, in fact, ensures the extraction of the aloe pulp without risks related to the presence of prohibited substances".
Moreover, Federsalus observes, the same Regulation admits that there are uncertainties about the dangerousness of banned substances, so it would have been better to postpone the provision to "conduct more accurate and precise scientific studies for the consumers and the sector".
Appreciated for years, because considered one of the main natural remedies in the treatment of various deficiencies, aloe-based supplements become banned by the European Union.
The European Food Safety 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.
Given that aloe-emodin and emodin may be present in the extracts, the Authority concluded that hydroxyanthracene derivatives should be regarded as genotoxic and carcinogenic unless there are specific data to the contrary and that there is a safety concern for extracts containing hydroxyanthracene derivatives although uncertainty persists. The Authority was unable to provide advice on a daily intake of hydroxyanthracene derivatives that does not give rise to concerns for human health.
Considering the severe harmful effects on health associated with the use of aloe-emodin, emodin, danthron and aloe extracts containing hydroxyanthracene derivatives in food, and that no daily intake of hydroxyanthracene derivatives that does not give rise to concerns for human health could be set, such substances should be prohibited.
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