Experts from the European Botanical Forum (EBF) have put forward a regulatory model for herbal products that includes a negative list for botanical products and ingredients that fail to meet safety criteria.
The EBF, established by the European Responsible Nutrition Alliance (ERNA) and the European Federation of Associations of Health Product Manufacturers (EHPM) in 2004, hopes its model, based "on the current legal framework and the recently published legislation on food claims and fortification," will influence European Union rules pertaining to botanicals yet to be finalised within the Traditional Herbal Medicinal Product Directive (THMPD), the Food Supplements Directive, and the nutrition and health claims regulation.
The model suggests classifying botanicals in four categories:
- Generally regarded as safe botanicals conventionally used in foods or supplements
- Botanicals used in foods or supplements but at concentrations that would result in higher intake than under normal conditions
- Botanicals not conventionally used in foods and supplements
- Botanicals with toxic or pharmacological effects
A pan-European negative list is being formulated by the EBF, based on lists already in existence in Spain, the UK, Sweden, Finland, Latvia, Belgium, the Netherlands, Italy, Hungary, and the Czech Republic.
"Safety is key," said Dr Manfred Ruthsatz, chairman of the European Botanical Forum. "The aim of the negative list is to provide a document that is widely acceptable across the 27 EU member states to allow safe applications under food law on the principle that if there is no safety risk there should not be any regulation. The inclusion of botanicals into negative lists, however, should be considered with care since it would preclude use of the botanical entity for all food applications whereas the safety of derivatives, extracts or isolates can be frequently demonstrated."
The EBF was due to present its model to the European Council for formal assessment as FF&N went to press.