Could latest health claims ruling boost botanicals? 'It's time for the European botanicals industry to use these opportunities'

By Katy Askew contact

- Last updated on GMT

Pic: Getty-Lisovskaya
Pic: Getty-Lisovskaya

Related tags: botanicals, Health claims

The latest ruling on health claims from the European Court of Justice is expected to boost the confidence of botanical manufacturers during the ‘on hold’ grey period after a health claim has been submitted to regulators but before approval has been secured.

Botanicals are a fast-growth area of the food and food supplement ingredient category across Europe. However, the health claims attached to some such ingredients cause a degree of controversy. This is particularly true of claims made during a ‘transitional period’ between the health claim application being made and European regulators ruling on whether it meets their requirements.

Can health claims be made during this grey period? And, if so, what level of supporting evidence is required? 

Sweden’s consumer ombudsman, Konsumentombudsmannen (KO), put the issue to the test when it brought action against Mezina to the Patents and Market Court of the District Court, Stockholm.

Mezina is active in the production and marketing of natural remedies and food supplements, including Movizin complex, which contains ginger, rosehip and boswellia; Macoform, which contains artichoke and dandelion; and Vistavital, which contain blueberries.

The company uses the following health claims to market its products: ‘Movizin complex — for your joints’; ‘Ginger can help to maintain joint mobility and add energy and vitality’; ‘Rosehip can help to maintain joint mobility’; ‘Rosehip can help me to protect my joints and help to keep them strong’; ‘Boswellia — the resin of this tree has long been used, particularly in India, to support natural joint mobility and flexibility’; ‘I make sure to take a daily dose of Movizin, which contains boswellia to help to maintain joint comfort’.

The KO sought an order prohibiting Mezina from using these health claims in marketing its products.

The ombudsman flagged that the claims related to specific substances fall under transitional arrangements since the Commission has not yet defined its position on the applications for the inclusion on the EU list of approved health claims. Some of these claims, KO’s legal team stressed, have ‘been the subject of an unfavourable opinion by EFSA’.

“Mezina has not shown that the presence of the nutrients in the products at issue in the main proceedings has a beneficial physiological effect, as established by generally accepted scientific evidence, within the meaning of Article 5(1)(a) of Regulation No 1924/2006, nor has it put forward scientific evidence to prove compliance with the provisions of that regulation, in accordance with Article 6(1) thereof, nor even established that the health claims are not inaccurate, ambiguous or misleading, in the light of point (a) of the second paragraph of Article 3 of that regulation,”​ court documents argued.

Nor should health claims that have not been explicitly linked to a particular ingredient be allowed, KO continued. These, the consumer watchdog suggested, constitute ‘specific claims’ that ‘have not been the subject of any application for inclusion in the list’ and therefore cannot be authorised

For its part, Mezina insisted the case should be dismissed.

The company argued health claims related to ingredients that fall under the transitional arrangements are not required to submit a scientific dossier and ‘higher evidential requirements’ than those which are to be met by health claims which are authorised by the Commission. “In particular, it would not be reasonable to require a food business operator to submit, for health claims falling under those transitional measures, a scientific dossier other than that on the basis of which the application for inclusion in the list provided for in Article 13(3) of that regulation was submitted.

“As for health claims which do not refer to a particular substance, Mezina submits that they are non-specific claims and that, since they are accompanied by specific claims which must be authorised under Article 28(5) of Regulation No 1924/2006, they comply with the conditions laid down in Article 10(3) of that regulation.”

Sweden’s Patents and Market Court passed the case along to the Court of Justice of the European Union, which published its judgement earlier this month.

EJC ruling a ‘win’ for traditional use proponents

Issuing its ruling, the Tenth Chamber of the Court of Justice noted Sweden’s Patents and Market Court concluded health claims included on the Commission’s list, which refer to the role of a nutrient in growth, development or bodily function, may be made without prior authorisation, provided that they are based on ‘generally accepted scientific evidence’ and are ‘well understood by the average consumer’.

However, the referring Court required the EJC to provide clarification as regards the ‘burden of proof of the veracity of and the standard of proof required in respect of such claims’ which have not yet been included in the EC list.

The EJC noted that health claims made under transitional arrangements may be made ‘under the responsibility of food business operators’ provided they comply with the European regulation and existing national provisions.

This is where the meaning of ‘generally accepted scientific evidence’ comes in.  

“The use of the expression ‘generally accepted scientific evidence’ means that such evidence should not be limited to beliefs, hearsay derived from popular wisdom, or the observations or experiences of persons outside the scientific community,”​ the Court ruled.

“On the contrary, the use of such an expression means that health claims should be based on objective and scientific evidence and that, in particular, there should be sufficient scientific agreement as to the benefits of the substances to which the health claims relate.

“In addition, and as required in recital 17 of that regulation, health claims must be ‘scientifically substantiated by taking into account the totality of the available scientific data and by weighing the evidence’.”

The ruling clarifies the rules on evidence of health claims on botanicals during the hold period. This is important, Luca Bucchini, managing director of Hylobates Consulting, told FoodNavigator, because national regulators have to date taken different approaches.

“Member States have taken different tacks,” ​he explained, citing ‘aggressive requirements for evidence’ including clinical trials, in the case of Germany or of former Member States such as the UK compared to a ‘much more relaxed approach’ in France or Italy.

“One key question was whether the highest EFSA standard of randomised clinical trials would be required; the Court could have said so, given some precedents in relation to EFSA's criteria, but it did not. It stressed the totality of the evidence, as ‘objective and scientific evidence and that, in particular, there should be sufficient scientific agreement as to the benefits of the substances’, though it made clear that it was up to the food business operator to collate such evidence.

“I would say it is a win for those arguing for the relevance of traditional use, even if the court left some room for national authorities to use their own criteria.”

Another important aspect of the ruling was the decision that, in case of conflict, health claims regulation prevails over general rules on advertising. “This is significant because it may mean that businesses cannot be investigated and fined under advertising rules if they conflict with the nutrition and health claims regulation. This may have implications in countries such as Italy were this was often the case,”​ Bucchini told this publication.

‘Use these opportunities’

The food industry consultant believes that this latest ruling will bolster the confidence of botanical manufacturers.

“It will boost the confidence of using on hold claims for botanicals. There has been lots of caution in using the claims listed on the Commission's website as on hold, especially for a multi-country product, in challenging markets such as the Nordic countries. I think, now, there is more confidence in building dossiers that would support such claims across countries, using the totality of the evidence.”

This increased clarity and higher confidence levels will help botanical innovators expand in Europe, Bucchini predicted.

“It's time for the European botanicals industry to use these opportunities. Even if there is some litigation at some point the Court has shown the path ahead - and EFSA may need to pay attention, too, particularly to the totality of evidence.”

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