Officials, academics, industry representatives and ingredient suppliers from across Europe met in Brussels last week to discuss key issues surrounding the future of botanical food supplements on the market.
Health claims, safety and quality predictably featured as hot agenda topics at the European Botanical Forum’s (EBF) fourth annual workshop on 4 December, but other aspects also came under scrutiny - the borderline between food and medicinal products and existing regulatory guidance on the issue, and the implementation of the new mutual recognition Regulation, which will enter into force on 13 May next year.
“It was impressive to have such a good turnout of speakers and participants at this event,” said Manfred Ruthsatz, EBF Chairman. “A number of issues that remain in desperate need of clarification and discussion were put on the table, not least, the distinction between food and medicinal products, and the new mutual recognition Regulation, which we urge manufacturers to begin actively applying when it comes into force.”
The meeting was attended by officials and academics from Belgium, France, Italy, UK, Germany, Hungary, Poland, Czech Republic, Turkey, EFSA and the European Commission.
Speakers included European Commission official Idaira Robayna-Alfonso, who highlighted the new mutual recognition Regulation; Penny Viner of the UK Herbal Forum, who gave an overview of the challenges for companies implementing the Traditional Herbal Medicinal Product Directive (THMPD); Patrick Coppens, EBF Secretary General, who gave an overview of the key regulatory aspects relating to botanical food supplements; and Bernard Bottex from EFSA’s scientific committee, who informed the participants of the Authority’s work in relation to the safety of botanicals and explained the work EFSA is undertaking in relation to claims.
David Richardson, based on his long-standing experience in the field of claims and scientific substantiation, elaborated on the sources and kinds of evidence that can be used to justify scientifically claims; and Jean Savigny from law firm Keller and Heckmann identified a number of legal considerations in relation to the claims Regulation.
EBF Secretary General Patrick Coppens said: “The meeting highlighted a number of issues, not least the concern that with EFSA applying pharmaceutical-type criteria for claims evaluations it is not considering the specificities of botanicals used in food supplements. These comprise the complexity to characterise botanicals which often have a long-standing traditional usage and other evidence of efficacy. The European Botanical Forum will continue to encourage debate among industry, governments and the scientific community on scientific and regulatory issues relating to botanical food supplements, not only for the substantiation of claims, but also to determine the optimum methodology for the safety assessment of botanicals and to clarify the borderline between the medicinal and food use of botanicals.”