EFSA Publishes Guidance for Assessing the Safety of Botanicals

The European Food Safety Authority has published advice for food authorities on how to assess the safety of botanical materials and preparations which are intended for use in food supplements[1]. The work, which was undertaken under EFSA’s own initiative, will also help food manufacturers in their consideration of the safety of ingredients that they may use in their products.

The opinion from EFSA’s Scientific Committee specifies what data are needed to carry out such safety assessments. It also suggests a two-tiered scientific approach depending on the existing level of knowledge on a given botanical and the substance(s) it contains. This marks the conclusion of a five year EFSA project, which included a public consultation, to help improve the basis on which the safety of widely-marketed plant-based products can be assessed.

Vittorio Silano, the Chair of the Scientific Committee, 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 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 also provides a set of criteria to help prioritise the safety assessment of botanical ingredients which are in use. A related report - produced by an ad hoc working group of experts identified partly by EFSA and partly by national authorities[2] - gives a number of examples explaining how the proposed approach could be applied under different circumstances.

Working together with EU Member States, EFSA has also compiled the available information on a large number of botanicals which have been reported to contain substances that may be of health concern when used in food or food supplements. This compendium, which will be regularly updated, is intended to assist manufacturers and food safety authorities by highlighting possible safety issues which may require further consideration.

EFSA is due to hold a conference in Athens this November to present the work that it has done on this issue so far and discuss possible future developments with the EU Member States and other stakeholders.

[1] Botanical materials include whole and fragmented or cut plants, algae and fungi. Botanical preparations are substances obtained from these materials, for example through pressing, distillation or fermentation.
[2] EFSA’s Scientific Committee has been working on this issue since 2004 with the close involvement of EFSA’s Advisory Forum, which brings together food safety representatives from the EU member states, and an EFSA Scientific Cooperation (ESCO) Working Group which was established in April 2008.

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