September 12, 2018

European Risk Management Activity on Aloe Products Containing Hydroxyanthracene Derivatives (HADs)

On November 2, 2017 the German safety agency BfR released an opinion titled "Food supplements with whole-leaf Aloe preparations containing anthranoids are associated with health risks" (BfR Opinion No. 032/2017). While the BfR opinion renders a conclusion regarding the safety of the use of whole leaf preparations of Aloe arborescens and anthranoid-free gel or inner pulp of Aloe species (mostly Aloe barbadensis or Aloe vera), it does not specifically mention the use of decolorized whole leaf preparations of Aloe vera, which are also present in the international marketplace.
In early 2018, the European Food Safety Authority (EFSA) released a scientific opinion regarding the use of botanicals in food that contain hydroxyanthracene derivatives (HADs), which concluded that as a class of compounds HADs are genotoxic and carcinogenic unless demonstrated otherwise. The opinion declined to identify a safe daily intake of HADs in food supplement products.
The EU Commission held a working group meeting with Member States in June 2018 to discuss the risk management measures to be taken following the EFSA safety assessment of the HAD content in food supplement products intended to improve bowel function (e.g., laxative effect). Per the EFSA scientific opinion, the levels of HADs in these products ranges from 24 mg/day to 79 mg/day assuming a 70 kg adult consumer, based on data provided by interested parties. 
The primary concern for the Member States was the high HAD content in food supplement products used for laxative purposes. However, EFSA's opinion did not clearly separate out the aloe products based on decolorized gel and whole leaf or the inner leaf gel from the non-decolorized whole aloe leaf laxative products. Therefore, a concern has been raised that decolorized whole leaf aloe not marketed for laxative purpose might also be captured by the risk management measure. At issue is the EFSA scientific position that if HADs are carcinogenic and genotoxic, no level is a safe level, even for the non-laxative aloe vera products containing very low levels of aloin that have been safely used by consumers.
European industry representatives have had discussions with the EU Commission (risk manager) and European Food Safety Authority (EFSA - risk assessor), and data has been shared with the two authorities in support of the safety of the products formulated with decolorized whole leaf aloe and gel that have low aloin content.
Even if the low aloin-content products are not included in the immediate risk management measure, there is a risk that a restriction on aloin content may eventually be considered for such products, including those with aloin content up to 10 ppm, the current limit for IASC certified products.
While the text of any specific risk management measure has yet to be shared with industry, it is understood that aloe vera used for laxative purposes will be placed in Part A for Prohibited substances of Annex III of European Union Regulation 1925/2006 titled "Substances whose use in foods is prohibited, restricted, or under Community scrutiny," which means it would be banned for use in food and food supplement products. However, a number of Member States are concerned that the term 'for laxative purposes' is not appropriate, because it could result in companies continuing to sell high HAD-containing products without making such a claim, thereby making enforcement difficult. Therefore, the Member States want this reference removed. If this reference is removed, there is a risk that the draft proposal could inadvertently ban all aloe products, so industry is proposing to Member State Authorities wording either in the recitals or articles of the text to specifically exclude the other types of aloe products that contain minimal to no HAD, i.e. the products of commercial interest to most of industry.

IASC member Herbalife Nutrition contributed to this article. If you have any questions about this issue, please contact Jane Wilson, Executive Director, at 734-476-9690 or by email at