The implementation report regarding Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, released in January, highlights “legal concerns about the continued use of the ‘on-hold’ claims under the transitional measures of the Nutrition and Health Claims Regulation (NHCR)”.
The report stresses the need for action to safeguard consumer protection, as identified by the 2020 Commission evaluation report on the NHCR.
“Continued use of the ‘on-hold’ claims under the transitional measures of the NHCR could mislead consumers and constitute a health risk for them, as they may falsely assume that the ‘on-hold’ claims have been scientifically assessed and risk managed,” the report warns.
Member states must co-operate to resolve botanical claims issue
The European Parliament calls on the Commission to reject those claims from the on-hold list that have already been assessed negatively and urges member states to establish a co-ordinated approach on botanical food supplements.
It also urges the Commission to provide guidance and, along with member states, establish an EU-level negative list of botanicals used in food, basing this on their toxicity or adverse health effects already identified in member states.
The lack of harmonisation at EU level concerning the classification of botanical substances as either food or medicine means that a plant substance can be labelled as “food” in one member state and as “medicine” in another.
These inconsistencies pose challenges to manufacturers and regulators – and may have implications for consumer safety and wellbeing, due to difficulties in distinguishing between traditional herbal medicines and botanical food supplements based on the same plant substance(s).
The “absence of a comprehensive list of beneficial or adverse health effects of botanicals” has resulted in “legislative disparities among the member states, market fragmentation, and potentially unsafe products reaching consumers”, the report adds.
The difficulty in distinguishing between health and medicinal claims
Closely related is the potential difficulty in defending “health” claims for botanicals in food products when compared to very similar “medicinal” claims in traditional herbal medicinal products.
“A medicinal claim is about providing a pharmacological or immunological effect often linked to some defined medicinal condition,” explained regulatory expert Dr Mark J Tallon.
“For example, synthetic melatonin at 1.5 to 3 mg for insomnia is a very high dose for a specific medical condition. The delivery of 0.5 mg of botanical containing melatonin to support healthy sleep could be argued to be non-medicinal.
“Similarly, use of theanine for anxiety vs. normal psychological function again differentiates. Thus, the indication of use and dose can be used to differentiate how we communicate the benefit to consumers.”
Tallon, who is also chief executive officer at the Legal Products Group, added: “The issue really lies in: can botanicals make health claims by relying on history of use data vs. only RCT [randomised controlled trial] and similar intervention studies?”
History of the long-running on-hold claims issue
There is currently no centralised authorisation system for the application of botanicals and derived preparations in foods.
However, use of botanicals and derived preparations in food must follow general principles and requirements of food law in each respective member state. This places legal responsibility for the product safety on business operators.
The EFSA Article 13.1 On-Hold Register provides details of botanical claims in foods that have been reviewed but have not been authorised nor rejected, hence the term “on hold”.
There are approximately 2,000 claims for botanicals substances that continue to be on hold since 2012.
Theoretically, these on-hold claims can be adopted by the manufacturer if they can provide proof to vouch for the levels found in the final product.
“I feel the botanicals issue is less topical for the EU to resolve but we will see court action from trade associations if food supplements are treated unfairly compared to the traditional herbal medicines market,” concluded Tallon.
