Ban on Aloe overturned by the European courts – Implications for Article 8!
Other past few months business has been very concerned over possible expansion of the list of ingredients that have found themselves on German HoC list as potentially unsafe. The issue at hand is will the European Commission add such ingredients onto the Article 8 list of restricted substances (Regulation 1925/2006) given the judgment from the European courts today?
A judgement delivered today (13th November 2024) suggests the Commissions current approach does not work and the outcome of the case should give confidence to business to not just accept the work of ‘opinions’ of EFSA (and other risk assessors) and the Commission without giving due regards to the legal framework they should be working within. This article explores todays judgement and its implications for future ingredient restrictions.
Background
Aloe Vera of Europe BV (Herein Aloe Europe) sells gel from that Aloe Vera plant in the form of beverages made from the inner jelly of Aloe vera leaves. Within the composition of the leaves is a group of chemicals - hydroxyanthracene derivatives (‘HADs’). In 2017, EFSA provided an opinion on the safety of HADs following a request by the Commission. EFSA concluded that HADs should be regarded as genotoxic and carcinogenic unless there is specific data to the contrary.
Importantly, EFSA was unable to provide advice on a daily intake of HADs that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population.
The result was that Aloe leaf and its preparations originating from Aloe species used in food supplements intended for laxative purpose’ in the list, in Part A of Annex III to Regulation No 1925/2006, of substances whose addition to foods or use in foods is prohibited (Commission Regulation 2021/468).
In recital 9 of that regulation the Commission state:
“Considering the severe harmful effects on health associated with the use of aloe-emodin, emodin, danthron and aloe extracts containing [HADs] in food, and that no daily intake of [HADs] that does not give rise to concerns for human health could be set, such substances should be prohibited. “
Aloe Europe then sought to seek an annulment of the regulation on the basis the opinion did not assess the specific HADs in its product (aloin A and aloin B) and thus there was no scientific certainty over the harm such preparations may cause. Therefore, the total ban was viewed as an afront to both procedural rules (Article 3(5) of Regulation 182/2011) and general principles of proportionality and non-discrimination.
Judgement
The case put forwards was that EFSA was unable to advise on the ADI because the mechanism of genotoxicity was unclear (was the concern present only in isolated HADs or still present in Aloe gel). Because EFSA itself for such reasons could not come up with an ADI due to lack of data the ban was in effect not as a result of threshold (Article 8(2)(a(i) – the harmful effect requirement) of HADs that could resulting in an unsafe intake but rather a concern about a lack of data.
In relation to the court’s role in scientific assessments para 42 of the judgement is of interest:
“ The limits to the review by the Courts of the European Union do not, however, affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it.”
Para 51 States there are two conditions that must be satisfied in order that a substance or ingredient of a food may be prohibited:
1. If it results in the ‘ingestion of amounts of [the substance in question] 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.
2. A ‘harmful effect on health has been identified’.
The Commission therefore appears to have taken the view that the insufficiency of data relating to a daily intake that does not give rise to concern for health allowed it to assume that there was no level for safe use of HADs, with the result that it could prohibit them entirely.
The court viewed that the absence of a threshold was contrary to Article 8(2)(a)(i) in that the harmful effect on health is to be identified when “‘ingestion of amounts of [that] substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet” (Para 59).
Whilst there is a burden of proof on food businesses for placing on the market safe foods. With respect to Regulation 1925/2006 this is only in cases where the addition of that substance as extracts or concentrates may result in intakes which are significantly higher than those that could be ingested through eating an adequate and varied diet. This is confirmed under Article 3(3) of Implementing Regulation No 307/2012 (a case-by-case basis of assessment).
Based on this issue the Courts upheld the fact the commission made a “manifest error of assessment”, and the contested regulation must be annulled and pay costs.
Implications
This judgement offers many facts and more than can be covered in this article but there are implications in the way novel foods are assessed (example blanket restriction on dose without assessment of specific compositional analysis). Importantly, any future restrictions under Reg 1925/2006; such as those currently been proposed on Ashwagandha may fail unless a case-by-case assessment is made. It will be now a key requirement to consider the composition of such products, potential dietary intakes of these goods (ADIs) and consideration of specific consumers.
Source:
German restricted list:
Case T-189/21:
#foodlaw #CJEU #aloe #article8 #1925/2006 #banned #eulaw #uklaw #EFSA #EuropeanCommission