The use of Aloe can be traced back to Ancient Egypt, and this natural plant has been safely consumed for centuries for its beneficial effects. The plant’s various properties mean it has been extensively used in the health industry. Specifically, consumers have been turning to Aloe as an option to maintain the physiological bowel function as it is deemed natural and healthier. A ban would curb our ability to choose these healthy natural products and force the use of medicinal and artificial ones when not necessary.
On 4 March 2020, the European Commission hastily submitted for public consultation a proposal to ban Aloe for presumed safety concerns. The draft regulation restricts certain substances, hydroxyanthracene derivatives (HADs), obtained from Aloe and other plants from being used in food supplements.
“A ban would curb our ability to choose these healthy natural products and force the use of medicinal and artificial ones when not necessary”
As the European Federation of Associations of Health Products Manufacturers (EHPM), we are deeply concerned by the consequences such restrictions would have on growers, businesses, and consumers. The most concerning worry being the shortcomings of the scientific evaluation that led to the drastic and disproportionate ban.
We have been delighted by the exceptional support we have received from national associations and companies dedicated to safeguarding consumers’ health and ensuring the highest quality of product availability in the EU.
Our petition, launched last month to bring awareness to the importance of Aloe, has received over 4,000 signatures. Additionally, our campaign has encouraged MEPs to raise crucial questions with the European Commission on the EU’s scientific practice for evaluating botanicals. Although the objection was not approved by the European Parliament, it was important to have a first and lively debate around this topic.
The regulation is a result of a 2017 scientific evaluation conducted by the European Food Safety Authority (EFSA). The study prematurely concluded that uncertainty around the safety of these substances existed due to lack of data. In the absence of data on the natural substances (HADs), the panel took into account studies conducted on synthetic isolated compounds, one even known to be toxic, danthron, and applied a “read-across” approach. They did not consider the matrix effect recognised by the same agency in the EFSA guidance on the safety assessment of botanicals and botanical preparations. Furthermore, the EFSA Panel did not take into account certain clinical studies that prove the safety of those substances. Moreover, other recent studies have confirmed the safety of Aloe and of the other substances banned by the Commission. Notably, the Italian Society of Toxicology shared with the Commission the outcome of these studies they have conducted. Yet, the European Commission did not transfer this information to EFSA for a further assessment on the basis of those new data.
The European Commission has suggested removing HADs from Aloe products as an alternative to maintain the use of the plant. However, doing so would filter out the physiological benefits derived from Aloe and other plants by removing the substances that aid bowel function. Consequently, products specifically used to help maintain the physiological bowel function would not have the desired effect. With the approval of the regulation, the entire category of food supplements beneficial for proper bowel function will disappear.
“With the approval of the regulation, the entire category of food supplements beneficial for proper bowel function will disappear”
The evident scientific shortcomings raise important concerns surrounding the EU’s evaluation of botanicals and we strongly believe that additional time needs to be given to producers to confirm the safety of Aloe. Our EHPM Director General, Livia Menichetti, writes:
“Considering the recent scientific studies refuting EFSA’s assumptions and the uncertainty in methodology, the European Commission should have allowed new scientific data to be submitted and evaluated before any decision on a more consistent scientific basis can be taken.”
The EHPM asks Members of the European Parliament to keep their focus on the issue of the assessment of natural substances, to help EFSA to adopt adequate criteria that take into account the characteristics of natural substances, to make sure that products containing natural substances will receive adequate treatment in the future.