• 15 July 2020 - Günther Sidl – [P-004203/2020] - Subject: Amendment to Annex III of Regulation (EC) No. 1925/2006
Aloe Barbadensis Miller (Aloe Vera) has a long history as a herbal remedy, and there are numerous references in the literature documenting its use for over 3 500 years. In connection with food and food supplements, I support the precautionary approach that any risks to human health must be fully taken into account when assessing safety. Hydroxyanthracene derivatives (HAD) are found not only in Aloe Vera products, but also in normal vegetables such as beans, coleslaw or peas.
It is not clear from the proposed amendment whether Aloe Vera products are to be banned in principle or only those products that are obtained from the unpeeled leaves of Aloe Arborescens and contain Anthranoids classified as harmful to health.
1. Does the proposed change ensure that preparations and products made from Anthranoid-free gel or the inner pulp of the leaves of some types of Aloe (mostly Aloe Barbadensis or Aloe Vera) can continue to be used in foods, as food additives and in cosmetics?
2. Some impurities are technically unavoidable and manufacturers can demonstrate that everything has been done to avoid them. Have any limit values been set for such impurities which may not be exceeded?
Answer given by Ms Kyriakides on behalf of the European Commission (13 August 2020):
«The European Food Safety Authority concluded in its scientific opinion that certain hydroxyanthracene derivatives (HAD), namely aloe-emodin, emodin and danthron, and plant preparations containing them, are genotoxic and cause cancer in the intestine. In line with this safety assessment, the Commission proposes to prohibit the use of these harmful substances in foods including food supplements, and the scope of this prohibition is not intended to cover their use for technological purposes as food additives, or in cosmetic products.
The Commission is aware that it is possible during manufacturing to remove HAD from the botanical extracts, but that impurities of these substances may be present. In this context, the Commission has asked the EU Reference Laboratory on mycotoxins and plant toxins for assistance in establishing a validated analytical method and its limit of quantification for HADs in botanical preparations of Aloe species.».
 EFSA Journal 2018;16(1):5090.