The model, published in the Annals of Metabolism and Nutrition at the end of 2006, was devised in order to give a scientific basis for the use of botanicals in food supplements and to give industry, researchers and legislators guidance on the need for safety evaluation and claims substantiation.
Botanicals have been considered in the context of several new and recent pieces of EU legislation, such as the Traditional Herbal Medicinal Product Directive, the General Food Law Regulation, the 2002 Food Supplements Directive, and the nutrition and health claims regulation.
The model sets out the wherewithal to classify botanicals on a case-by-case basis into four categories, based on available safety data: Botanicals conventionally used in foods or supplements and recognised as safe under conventional conditions of use; botanicals with conventional food or supplement use but at concentrations that would result in higher intake than under normal conditions; botanicals that are not conventionally used in foods and supplements; botanicals that it would be dangerous to use in food or food supplements because of their toxic or pharmacological effects.
The list of botanicals not to be used is currently being prepared, based on lists already existing in a number of EU countries, including Spain, the UK, Italy, Belgium and The Netherlands.
Dr Manfred Ruthsatz, chairman of the European Botanical Forum, said: "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."
But he stressed that the exercise was not one to enter into lightly.
"The inclusion of the botanicals into negative lists 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 frequently be demonstrated."
Reference: Annals of Metabolism and Nutrition "The Use of Botanicals in Food Supplements: Regulatory scope, scientific risk assessment and claims substantiation" DOI: 10.1159/000098146 Authors: P. Coppens, L. Delmulle, O. Gulati, D. Richardson, M. Ruthsatz, H. Sievers, S. Sidani