Safety of Aloe Vera hydroxyanthracene derivatives for use in food (EU)

On March 4th 2020, the European Commission published?a draft regulation (EC No 1925/2006 )?stating that:

?Aloe-emodin?and all preparations in which this substance is present,

?Emodin?and all preparations in which this substance is present,

?Preparations from leaves of Aloe species containing hydroxyanthracene derivatives,

?Dantrone?and all preparations in which this substance is present.

These substances are added to Part A Annex III of Regulation (EC) No 1925/2006, meaning they might?be prohibited for use in food.

This decision came following a?scientific opinion?from the European Food Safety Authority that “hydroxyanthracene derivatives aloe-emodin, emodin and danthron as well as Aloe extracts containing hydroxyanthracene derivatives are considered genotoxic “

Exposure to hydroxyanthracene derivatives from food supplements has been estimated from the recommended daily doses of food supplements as provided by the interested parties and range from 2.25 to 24.83 mg/day for sennoside B, from 1.95 to 78.8 mg/day for rhein, from 13 to 26 mg/day for glucofrangulin A, from 1.2 to 24 mg/day for aloin (barbaloin) and from 17.9 to 51 mg/day for aloin A+B. However, the Panel noted that exposure to aloe-emodin and emodin is not known due to lack of data on these substances.

Regarding the information provided in this regulation, article 10 establishes that :

“During manufacture, hydroxyanthracene derivatives can be removed from the botanical preparations through a series of filtering processes resulting in products that contain those substances only at trace levels as impurities.”

Antraquinones present in all of our Innovaloe Aloe Vera Products meets the specifications stated by the European Regulations. We commonly report Aloin Content (Aloin A + Aloin B) at 0.1 ppm (in a 0.5% solution)

'The Committee has concluded that ready-to-use products after preparation in accordance with the manufacturer's instructions that contain a tested level greater than or equal to 1 ppm of aloe-emodin and / or 1 ppm of emodin and / or 1 ppm of Aloin A + Aloin B provide clear evidence of the presence of these substances in products and are therefore of public health concern. The sum of the analyzed contents of aloin A and aloin B can be used to quantify the total content of HADs in leaf preparations of Aloe species, since aloin A and B are the most common HADs in Aloe species. . Measures must be taken with regard to these products to ensure a high level of protection of human health.

The Commission noted, based on the advice of the LRUE, that the level of 1 ppm for aloe-emodin / emodin and the level of 1 ppm for the sum of aloin A and aloin B are for the moment the lowest levels that can be quantified of reliably in laboratories.

The Commission noted, based on the advice of the LRUE, that the level of 1 ppm for aloe-emodin / emodin and the level of 1 ppm for the sum of aloin A and aloin B are for the moment the lowest levels that can be quantified of reliably in EU laboratories and can therefore be presented as limits of quantification in a harmonized EU risk management approach. '

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The International Aloe Science Council (IASC)

While the text of the regulation does not define what is meant by “preparations from the leaf of Aloe species containing hydroxyanthracene derivatives,” the meeting summary from the October 5, 2020 meeting of the Standing Committee on Plants, Animals, Food, and Feed (SCOPAFF) contains a discussion of the work performed by the European Reference Laboratory (EURL) to examine analytical methods for these compounds and identify limits of quantification (LOQs) for botanical preparations. The Committee agreed to the following statement, as provided in the meeting summary:

“The Committee concluded that products ready for use after preparation in accordance with the manufacturer's instructions containing an analysed level higher than or equal to 1 ppm aloe-emodin and/or 1 ppm emodin and/or 1 ppm aloin A + aloin B provide clear evidence of presence of these substances in the products and are therefore of concern for public health. The sum of the analysed contents of aloin A and aloin B can be used to quantify the total HAD content in preparations from the leaf of Aloe species, since aloin A and B are the most commonly occurring HADs in Aloe species. Measures as regards such products should be taken to ensure a high level of human health protection.”?

At present, Aloe Vera preparations (finished products) having levels of aloin (total aloin A+B) of less than 1 ppm as “ready for use” would be considered to not have clear evidence of containing HADs, and would be acceptable under the new regulation. While this is the present expectation for enforcement purposes, it does not provide legal certainty for the aloe vera industry since a definitive threshold is not part of the regulation and it may be subject to change in the future.

?At AMB WELLLNESS we have established our LOD at 0.005ppm in a solution of 0.5% Total Solids of Aloe Vera, using UPLC UV as Analytical Method.

?So, with any problem AMB WELLNESS complies with regulation (EU) 2021/468 published on April 8, 2021.

EFSA comments:

“The LOQs apply to the product as consumed. More precisely, the LOQs apply to the product ready for use after preparation in accordance with the manufacturer's instructions. In case a range is provided, the highest concentration is to be used. In the absence of instructions for use, the LOQs apply to the product as sold.”?

AMB Wellness has always been concerned with the best interests of our clients. That′s why our processes have always been focused on developing products with high standards.

Content of Aloin and other HAD have always been important topics for us; with our decoloration proprietary process, we can offer Aloe Vera Raw Materials with very low traces of these compounds.

With a process known as decolorization, aimed to remove pigmented substances and HAD, this results in a purified product with only residual amounts of HAD as unavoidable impurities always complying with the European Regulations.

We have established our LOD to 0.005ppm on a solution of 0.5% Total Solids of Aloe Vera, 1ppm in dry weight, using UPLC UV as Analytic Method.?

If you have any concerns or questions please don’t hesitate to contact us. oscar@amb-wellness, Global Sales Manager o visit our web page