EFSA Releases Botanical Safety Guidance

PARMA, ItalyThe European Food Safety Authority (EFSA) published a guidance on assessing the safety of botanical ingredients intended for use in dietary supplements; while designed for regulators of such products, the guidance may also assist marketers and formulators in determining safety of possible ingredients. In addition, EFSA released an opinion from its Scientific Committee (ESCO) regarding the type and amount of data needed for safety assessments.

EFSA has been working on the guidance for five years, in consultation with industry. The result, which suggests a two-tiered scientific approach depending on the level of knowledge about a botanical and its active compounds, including traditional use data and more recent studies in animals or humans.

Vittorio Silano, chairman of ESCO, explained: 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 recognized 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.

In addition, EFSA compiled information on a number of botanicals that have raised certain safety concerns; EFSA intends to regularly update the compendium over time to highlight possible safety concerns with certain botanical ingredients or active compounds.