The guidance comes after five years of work by EFSA scientists, in consultation with industry, and suggests a two-tier system of proving the safety of herbs split between traditional use data and emerging data including clinical and animal studies.
“This approach consists of a first safety assessment level based on available knowledge and a subsequent level in which the safety assessment includes newly generated data,” EFSA said.
“A general framework for safety assessment is proposed by the Scientific Committee, in which botanicals or botanical preparations for which an adequate body of knowledge exists could benefit from a ‘presumption of safety’ without any need for further testing.”
Herbal safety template
The document is intended to be used as a template by EU member state authorities and food and ingredients companies that may be in the process of compiling safety data about particular herbal products.
But most trade groups and companies were still processing the document when NutraIngredients.com called for comment this morning.
But in the lead-up to the document being published industry groups such as the European Botanical Forum have been calling for traditional use data to be given more importance.
Broader influence
While the guidance does not relate directly to the 2006 nutrition and health claims regulation, it is thought it will influence safety and efficacy assessments being undertaken by EFSA scientists for herb-related health claims.
“The present guidance document is focussed on botanicals and botanical preparations intended for use in food supplements, although the approach chosen is, in principle, applicable also to other uses of botanicals and botanical preparations in the food and feed areas,” EFSA said.
The guidance includes a compendium of herbs about which safety conclusions have been drawn and is intended to be expanded over time to include, “botanicals not having any market history in Europe but having a documented history of use in their third country of origin.”
Vittorio Silano, the Chair of EFSA’s Scientific Committee, noted of the guidance: “Although many botanicals have a long history of use in Europe, for some of them safety concerns cannot be excluded. Risk assessors from the EU Member States have recognised the public health significance of this issue and worked together with EFSA experts to develop this scientific framework which makes it possible to systematically and effectively assess the safety of botanical ingredients.”
The guidance can be found here.