An ECJ ruling on two cases brought against the European Commission (EC) could mean an eventual end to the current regulatory deadlock for botanicals in Europe – but not for the reasons initially expected.
In a ruling that dismissed two cases brought against the EC relating to botanicals, the court said that the current situation – which sees thousands of botanical health claims placed ‘on hold’ – is not acceptable.
As such the ECJ has put the Commission on notice that a solution to the current regulatory stalemate needs to be found, says Luca Bucchini, director of the food safety and nutrition consultancy firm Hylobates.
The two cases, initially reported on by NutraIngredients back in 2015, had previously been touted as a potential legal grenade that could break the botanical blockade.
In the first case it was claimed the EC acted unfairly by refusing tradition of use for food supplements containing botanical ingredients, while allowing traditional herbal medicines containing the same ingredients to make claims based on tradition.
A second case claimed that the Commission had no right to put botanical claims on hold.
At the time Bucchini told us that if the first case succeeded, it would likely mean the way the European Food Safety Authority (EFSA) had looked at claims ‘is at least partially wrong’ – and would mean EFSA “may need to look at tradition and evidence other than human intervention studies to approve claims - which would be a fresh start for botanicals.”
"On the other hand, if the second lawsuit succeeds, all botanicals will be rammed through the current system of assessment, and all health claim applications will be rejected,” he said.
One way or another, it was predicted that the ECJ rulings would bring an end to the deadlock.
New rulings … but not as expected
Last week, the ECJ did make a ruling on the cases, however the result was not as clean-cut as previously been predicted.
“The ECJ [actually] said something rather different,” Bucchini told us. “It said that the two companies had no legal standing because one is not a user of health claim (it is consulting firm) and the other has not provided proof of sales of food supplements (they currently sell herbal medicines) - so they are not directly affected by the health claims regulation.”
While throwing out the two cases the ECJ did, however, warn that the current ‘on hold’ situation is not satisfactory – stating that on hold claims are not in the same position as authorised claims since the aims of harmonisation and protection of consumers are not achieved with on hold claims.
This is because on hold claims have, by definition, not been assessed at the EU level. As such individual Member States can therefore restrict their use.
In contrast authorised, or indeed rejected, claims bring a harmonised approach to the EU, where all Member States would follow the same rules, Bucchini noted.
“For the court - and this is a bit chilling - a rejected claim is better than an on hold claim because it provides legal certainty, which is an aim of the regulation,” he said.
“If you wish to summarise it, the ECJ believes that a rejected claim is better than an on hold claim.”
While there is no legal consequence of the ECJ ruling – since both cases were dismissed – Bucchini warned that the ECJs comments that the current situation is not acceptable, and that it goes against the aims of harmonisation and legal certainty, could be used in a new case.
Furthermore, the ruling makes it clear that a solution to the current deadlock situation must be found soon, and suggests a solution based on the REFIT evaluation is urgent.
“It is clear that the ruling suggests that the European Commission needs to finish its assessment of botanical claims with new proposals, or the ECJ may force its hand,” he said. “The Commission may soon lose its indefinite timeframe for defining the issue, but the implications may extend to caffeine”.
The ruling also could mean it is easier for authorities and companies to take legal action over botanical claims, since the ECJ also clarified in its ruling that botanical health claims - though on hold - should be examined in "national administrative and judicial proceedings.”