Aloe: From Shelves to the Court

By Valeria Paganizza

Have you ever heard about botanicals? Most likely, you are thinking about plants, right? Indeed, the word “botanicals” can denote several meanings, depending on the area you are considering. If you are discussing spirits, you will undoubtedly refer to the blend of aromatic herbs or spices that characterize the aroma of the beverage. But you might instead be operating in the field of food supplements, which are, according to Article 2 of Directive 2002/46/EC, «foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities».

In the context of food supplements, the term “botanicals” evokes the expression «Botanical preparations» denoting preparations to be used in food supplements that «are obtained from botanicals (e.g. whole, plant parts, fragmented or cut plants) by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation). Botanical preparations include comminuted or powdered plants, plant parts, algae, fungi, lichen, tinctures, extracts, essential oils (other than the vegetable oils and fats (excluding butter and coconut oil) intended for direct human consumption or use as an ingredient in food), expressed juices and processed exudates». The definition in question can be found in footnote 13 of Commission Regulation (EU) 2023/915 from April 25, 2023, which sets maximum levels for certain contaminants in food and repeals Regulation (EC) No 1881/2006.

Besides some issues related to the definition of botanicals, there might be some concerns about the plants that can be used.

Do you know Aloe? Certainly yes. It is a plant that in the last decades has been acquiring more and more importance. Seven years ago, the European Parliament posed a question to the Commission (Question for written answer E-003875-17) regarding potential strategies to increase Aloe’s trade, given the plant’s raising success. The question reported that the worldwide trade amounted to some 61,000 tonnes, for a value that exceeded € 1.5 billion. The Commission’s answer was brief, only stating that aloe was not covered by the Regulation on the Common Organisation of the Markets in Agricultural Products.

Recently, a new question (P-002244/2024) focused on the trade of aloe, albeit for different reasons. The aforementioned inquiry stemmed from the enactment of Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives [HADs]. With such Regulation, due to risks to human health, the Commission prohibited the use of aloe-emodin, emodin and all preparations in which these substances are present, preparations from the leaf of Aloe species containing hydroxyanthracene derivatives, danthron and preparations in which it is present, including them in Annex III, Part A of Regulation (EC) No 1925/2006. The Regulation further included in the list of products under the Commission’s scrutiny (Part C of Annex III to the Regulation) the preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives, the preparations from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives, the preparations from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives, due to the scientific uncertainty on their safety. The Commission’s act was based on EFSA’s scientific opinion on the Safety of hydroxyanthracene derivatives for use in food. As reported by Recital no 7 of the Commission Regulation (EU) 2021/468, the Authority informed that «the hydroxyanthracene derivatives aloe-emodin and emodin and structurally related substance danthron have been shown to be genotoxic in vitro. Aloe extracts have also been shown to be genotoxic in vitro most likely due to hydroxyanthracene derivatives present in the extract. Furthermore, aloe-emodin was shown to be genotoxic in vivo. The whole leaf aloe extract and structural analogue danthron were shown to be carcinogenic». As a consequence, according to what is reported in Recital no 8, the scientific agency concluded that «hydroxyanthracene derivatives should be regarded as genotoxic and carcinogenic»: this determined «safety concern for extracts containing hydroxyanthracene derivatives» although uncertainty persisted. The Regulation adds, in Recital no 10, 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».

In the above-mentioned question, the European Parliament, expressing concern on the Commission’s approach to the theme, questioned in particular the EU Institution’s opening of new procedures before the General Court, on the topic, given no urgent safety concerns with the botanicals in question. It further asked if the Commission was finding it appropriate to apply Article 8 «to create a negative list of plants for food supplements», finally investigating the Commission’s awareness of the impact of the prohibition on the intentional use of these substances for their nutritional or physiological purposes on the European food supplement sector.

The Commission replied to the EU Parliament question on 26 November 2024, recalling the general purpose and conditions for the application of Article 8 of Regulation (EC) no 1925/2006, and confirming that, despite it being aware of the impact of the application of the mentioned provision, the fundamental aspect that must be considered is the need to protect human health.

The mentioned Regulation (and, implicitly, the Commission’s approach to the theme) was the subject of a recent Judgment of the General Court, in case T-302/21, on an action for annulment lodged by two Italian companies in the food supplement sector that, pending the adoption of the regulation, had replaced  with extracts from senna (Cassia angustifolia Vahl), rhubarb (Rheum palmatum L), cascara (Rhamnus purshiana DC) and Frangula (Rhamnus frangula L). A further applicant was the Portuguese association that represents food supplement industries, some of which place on the market products containing Aloe, as whole plants or extracts containing hydroxyanthracene derivatives.

The applicants relied on three pleas in law (point 23 of the Judgment), in which the distinction among substances, ingredients containing those substances and preparations is fundamental. 

The first and main claims are lack of competence, an error of law, and/or infringement of essential procedural requirements (point 24 of the Judgment). According to the applicants, the Commission could not have relied on Article 8 for the amendment of Annex III to Regulation (EC) no 1925/2006. Just to facilitate the reader, we recall that Article 8 of the mentioned Regulation lays down a procedure to be followed when «a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers». The Commission has the authority to amend Annex III to the Regulation if all these conditions are satisfied. According to the applicants, however, the Article does not offer the possibility to prohibit «a foodstuff, the food itself or whole plants» (point 28) but just “substances” or “ingredients” that contain those substances and are added to foods or used in the manufacturing of food, thus excluding food that is consumed as such (even if processed) or whole plants. Commission Regulation (EU) 2021/468, instead, prohibits the use of “preparations” where aloe-emodin, emodin and danthron are present and preparations that contain hydroxyanthracene derivatives so, according to the applicants, it covers also whole plants, their extracts and «substances present in those plants in their natural state» and thus «foodstuffs per se» (point 29).

The second plea is twofold (point 25). On the one hand, the applicants argue that the Regulation’s provisions lack clarity in their scope and effects, thereby violating the principle of legal certainty. On the other hand, the principle of non-discrimination was also violated, since extracts used in food supplements were regulated in a different way, compared to the provisions on the marketing of plants in their “natural” form or ingredients used as flavourings.

The third plea, along with the claim of a legal error (point 26), stemmed from a failure to adhere to the principle of proportionality or essential procedural requirements. The applicants argue that the 2017 EFSA’s opinion, which did not identify «any harmful effect or the possibility of any harmful effect» of the substances and preparations at stake and did not establish a «safe level for the consumption» of hydroxyanthracene derivatives, should not have justified the amendments to the lists of Regulation (EC) no 1925/2006.

The Court considers the wording of Article 8 of Regulation (EC) no 1925/2006 that requires the prohibition of the addition to food or use in manufacturing of substances, when a harmful effect on health has been identified and their inclusion in Annex III part A of the Regulation, while it includes in the list of substances under scrutiny of part C those substances with regards to which harmful effects on health have been identified but scientific uncertainty persists. The Judge therefore confirms the lawfulness of the inclusion of aloe-emodin and emodin in Annex III, part A, since they are “substances” (point 40).

The Court then focuses on the inclusion of preparations containing hydroxyanthracene derivatives and on the possibility to consider “preparations” as having, for the purpose of Regulation (EC) no 1925/2006, the same meaning of “substance” or of “ingredient containing that substance”. In the absence of a clear definition, the General Court refers to consolidated case law, which emphasizes that interpretation should begin with the common understanding, the context of the provision, and its underlying reasoning. The judge interprets the phrase «substance other than vitamins or minerals» in Article 8 as «other substance», referring to a substance that has a nutritional or physiological effect under Article 2, par. 2 of the Regulation (point 45). Further, the General Court refers to Recital no 1 of Regulation (EC) no 1925/2006 to confirm that plants and herbal extracts must be considered as nutrients or ingredients under the scope of the act (point 47).

With reference to EFSA’s Guidelines on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, recalled by the Commission in its reasoning (point 32), the EU Judge reminds that, on the one hand, though being useful to interpret EU law, guidance documents are not legally binding with the consequence that any EU Court can decide irrespective of what the document states (point 49). It also adds that the Guidance document in question contains a simple non-exhaustive list of processes rather than a real definition of preparation. The General Court argues that the term “preparation” is wider than the word “substance” and that they cannot be used as synonyms, within the meaning of Regulation (EC) no 1925/2006. Also the word “ingredient” cannot be considered, according to the Judge, as a synonym for preparations, meaning the former the object of a manufacturing process and the latter the result of that process.

Given that the meaning of substance, ingredient and ingredient containing a substance is not the same as “preparation”, the General Court

 states that the «scope of a prohibition on the addition of ‘preparations’ to foods or on their use in the manufacture of foods cannot be the same as that of substances or ingredients containing substances» (point 56). So, if Article 8, par. 2, let. a), i) of Regulation (EC) No 1925/2006 recognizes the Commission’s power to include a “substance” or an ingredient containing that substance in Annex III part A, it does not automatically allow the EU Institution to include “preparations” containing that substance (points 57-58).

The General Court thus concludes that both the inclusion in Annex A of all preparations in which aloe-emodin and emodin are present, and of preparations from the leaf of Aloe species containing hydroxyanthracene derivatives, danthron and preparations in which it is present, and the inclusion in the list of products under Commission’s scrutiny (Part C of Annex III to the Regulation) of the preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives, the preparations from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives, the preparations from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives were adopted in breach of Article 8(2)(a)(i) and (b) of Regulation No 1925/2006 (points 58-60). It thus annuls such such provisions.

As for the third plea, the General Court emphasizes that there are two conditions for the prohibition of the addition or the use in food manufacturing of a substance or ingredient containing it. The first requires that the addition or use result in the ingestion of amounts of the substance «greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers». The second requirement is the identification of a harmful effect on health. The provisions of the Commission’s Regulation appear, however, not to meet the two conditions.

The General Court decides, therefore, to annul «the first and second entries in Article 1(1) of the contested regulation in so far as they use the words “and all preparations in which this substance is present”, the third entry of Article 1(1) of that regulation in so far as it refers to “preparations from the leaf of Aloe species containing [HADs]”, and Article 1(2)», this implicitly criticizing the Commission’s approach to the subject. 

‍