The European Federation of Associations of Health Product Manufacturers (EHPM) indicates that due to the covid-19 circumstances, stakeholders did not have sufficient time to provide their feedback on the Commission proposal to restrict the use of hydroxyanthracene derivatives (see our blog item of 21 March). As a consequence, there was no reasonable opportunity to collect data to show the safe use of aloe food supplements.
Overall, EHPM claims that the Commissionâs proposal is disproportionate given the history of use, alleged shortcomings of the EFSA Opinion at the basis of the proposal and a number of scientific objections. In addition, reference is made to a 2013 EFSA Opinion that simply warns for prolonged use of botanical preparations with hydroxyanthracene derivatives. The Federation regrets that Aloe Vera products will be fully banned versus other plants extracts containing hydroxyanthracene derivatives which will be placed under scrutiny given that for both there is scientific uncertainty on the risks. EFSA has not been able to establish a maximum safe intake level of hydroxyanthracene.
For those reasons, EPHM requests the European Commission to halt the adoption of the proposal to allow food supplements companies and academics collect additional data demonstrating the safety of aloe extracts.
EHPM: EHPM contribution to the feedback mechanism of proposed Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives - Ares (2020)1357432 - link