The document draws on a recent EC study evaluating Regulation (EC) No 1924/2006 on nutrition and health claims that calls for clarification of 'traditional use' in efficacy assessments of health claims on plants used in foods.
This action extends to possible implications the coexistence of Traditional Herbal Medicinal Products on the same plant substances may have on the EU market.
“In the light of these shortcomings about the smooth functioning of the internal market and the possible openness to the notion of 'traditional use' to substantiate health claims on plants, there are merits for further studying the potential EU harmonisation of the field of plants, including the safety aspect,” the document states.
According to Luca Bucchini an expert in food and supplement regulation and co-founder of the food consultancy Hylobates, the document should be seen as ‘positive’ with efforts by the Commission to move the discussion forwards.
“However, it will require lots of ability, focus and determination to find a solution that works for consumers and is acceptable to the Member States," he says.
“We need recognition of tradition on botanicals, for claims, with a positive list and conditions of use, as we do for other substances.
“We also need a regulation with a positive list of botanicals that can be used across Europe, which addresses quality, safety and labelling - most plants are known to be safe - and provides legal certainty on the medicine/food borderline (though giving up on this may be necessary to overcome the objections of the pharmaceutical industry).
“EMA and EFSA need to work together on safety and tradition so that the approaches are proportionate and consistent because implementation will be tricky.”
What is a working document?
The staff working document, whilst not legally binding, essentially represents the EC's plan of action and what the Commission believes will be the outcome, in this case of the REFIT exercise.
It’s publication comes just after the new Commission has been sworn in, and reflects the priorities set out in the Commission's communication "A Farm to Fork Strategy" which has just been published, despite the REFIT exercise ending several months ago.
On hold since 2012
The EU harmonisation of legislation concerning these plants has been an issue of contention since 2012, where the Commission established an 'on-hold' list of 2,078 health claims relating to plant substances, due to the absence of human intervention studies.
However, these health claims can be used in the EU if business operators comply with Claims Regulation general principles and conditions and the relevant national provisions, pending a final decision.
Here, the study argues it is not ‘coherent’ to have harmonised rules on health claims while the use of plants in foods is governed by national rules.
“The absence of a harmonised EU regulation on the use of plants in foods has mainly negative impacts for food business operators, particularly on product innovation and on the possibility to market the same product simultaneously in multiple Member States,” the document states.
“Although the classification (“food” versus “medicine”) would remain under the remit of Member States, EU harmonisation on plants used in foods through a positive or a negative list of plants would improve the situation with regard to safety and the smooth functioning of the internal market.”
The EC’s study goes on to say that in the current situation consumers continue to be exposed to unsubstantiated health claims from the on-hold list.
Additionally, the study believes the beneficial effects linked to the on-hold claims may have led consumers to believe the claims had been scientifically assessed and risk managed, which is not the case.
“The main drawback of the current situation in the implementation of the Nutrition and Health Claims Regulation (NHCR) in terms of ensuring a high level of consumer protection was found to derive from the fact that consumers have access to products bearing claims which have neither been assessed nor risk-managed,” the study suggests.
“This situation of legal uncertainty was found to hinder the objective achievement of promoting and protecting innovation in the food sector, and to hamper investments and innovation also in the herbal medicines sector.”
Bucchini said, “I think the situation is not acceptable, and it is welcome that the Commission has recognised that traditional herbal medicines had an unfair advantage on claims.
“Some sort of recognition of tradition on the food supplement side is more than reasonable. Some Member States, like the UK or Germany, have requested data to support on hold claims (in line with the Regulation) so enforcement has occurred.
“Few Member States just accept on hold claims as such, though it is true that the situation has led to some "mad" case-law (Italy’s Consiglio di Stato ruled that there were no rules on claims for botanicals) and there has been lots of confusion on how much and which plants you need to add for example.
“Indeed, in some Member States, the lack of conditions of use may have led to products with too little of the actual botanicals to have an effect.”
The working document also highlights the advantages the current situation affords to food business operators, who can continue using health claims on plant substances without having to undertake clinical trials to support the application for health claims.
Here, the study identifies costs for preparing and submitting a dossier under the assumption of inclusion of 'traditional use' in the range of €20,000 to €60,000.
This is in contrast to the pharmaceutical industry, who face higher production and regulatory costs than food firms producing food supplements containing the same plant substances.
These operators are free to include similar health claims, without being subject to the same requirements.
“This has been a shame for the Commission for years because there has been no single market for botanicals with the exception (and limitations) of the Belfrit list,” explains Bucchini.
“There have been negative impacts on consumers as well because of the lack of labelling or quality rules, especially in the "pro-pharma" Member States that have not produced national legislation.
“Unfortunately, with this working document, the Commission has accepted that "the classification (“food” versus “medicine”) would remain under the remit of Member", which would mean that countries such as Germany may continue to shield their home markets from botanicals in food supplements, because there will be no legal certainty.
‘Internal botanical market’
“Ideally, the Commission should make sure that botanicals listed as safe in any future regulations, under certain conditions of use, cannot be classified as medicinal by any Member State, as long as claims are compliant. That would be required to create an actual internal market for botanicals.
“The other concern is that EFSA has not yet developed a proportionate methodology to assess botanicals, as shown by novel foods application for extracts.
“We still have a situation where a botanical may be deemed more than acceptable in the traditional medicine context, though it is used in the same manner, and unsafe when used in food supplements, while the scientific framework is - on paper - the same.
“So, while EFSA should be commended on many things for its excellence, this is an area where further reflection is required; cooperation with EMA should be expanded.
“It is still unclear whether a suitable, balanced solution can be found on claims and on safety - however, solutions require a European spirit of promoting change in a way that is fair to all parties.”
The study goes on to describe the potential effects in terms of consumer protection as ‘controversial,’ arguing that traditional use inclusions could improve the provision of information as well as confirming and clarifying practices already in place.
However, the study points out that consumer associations consider this could potentially mislead consumers, given that traditional use does not prove the efficacy of a substance.
“The Regulation should stimulate research, and help consumer choice,” Bucchini concludes. “When traditional evidence is clearly explained to consumers, then I think it would be a step forward to recognise it for botanicals as well.
“But there should be a clearer path to support new research, where the Regulation is not delivering, and the Traditional Herbal Medicinal Product directive is not faring too well either.
“So, I think the question should be asked: why is this not happening? This reflection has not happened yet and is probably one for the future.”