The court’s decision was issued after considering four different legal actions brought against the European Commission (EC) following the issuance of the regulation in March 2021.
In short, the General Court annulled all the relevant parts of the regulation banning food products with aloe preparations containing HADs. The annulment may also impact other laxative botanicals containing HADs, such as Senna, which were also expected to be prohibited.
“In essence, after the judgments, the regulation no longer “exists.” As many have claimed, such products can now return on the market,” Luca Bucchini, PhD, Managing Director of Hylobates Consulting, told NutraIngredients.
“The victory for the aloe and botanicals industry is clear, after years of disappointment,” he said. “It’s important to keep in mind that all Member States except Italy voted in favor of the Regulation, and EFSA had rejected all scientific evidence challenging its conclusions. So, it’s a strong rebuke to the approach used by EFSA in the scope of the regulation, to the Commission for its approach and also for how the regulation was written, despite reasonable concerns of stakeholders about it.”
Dr. Bucchini stressed that the ruling was not from the Court of Justice but the General Court of the EU. “The General Court adjudicates matters related to EU institutions, and its judgments can be appealed to the actual Court of Justice. It’s not a detail - it means that the rulings can still be appealed by the Commission, and potentially overturned,” he explained.
“There are four very similar rulings (Aboca and Others v Commission, Synadiet and Others v Commission, Ortis v Commission and Aloe Vera of Europe v Commission) with similar arguments advanced by parties, adjudicated by the same panel of judges and with a similar outcome,” he added.
Criticism of the Commission and EFSA
Dr. Bucchini notes that the rulings are straightforward in some parts and “byzantine” in others.
“In essence, the Court held that the legal instrument used by the Commission to ban such preparations does not apply to botanical preparations or plants in general, but only to substances, which botanicals are not.”
The Court said the Commission should have set a specific limit for HAD and was not entitled to take a “zero tolerance” approach. “Here, the criticism of EFSA is implicit but clear: it was EFSA who decided not to try to use any of the scientific tools to address similar compounds in this case,” said Dr Bucchini.
Considering what may happen next, Dr Bucchini notes that the Commission may decide to appeal or regulate HADs under other legal instruments.
Consequences of a legal void
“There is now a legal void, and the Commission may consider rewriting the regulation in a way that the Court will approve of,” he said, noting that many of the issues raised by the Court were with the letter and potentially solved by better legal advice to the Commission.
“If the Commission does not act, the so-called article 8 process will take a very significant hit, and the ability to regulate botanicals at the EU level will be severely dented, meaning national rules will apply even more broadly,” he explained.
“In my view, it’s not very likely that the Commission will not turn its back and say that, after all EFSA’s opinions on HADs, there is no issue after all. So the matter is not settled, and it’s important to reiterate 27 Member States had supported the regulation”.
See the General Court judgements here: