EFSA Publishes Guidance for Assessing the Safety of Botanicals

11 Sep 2009

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.

11 Sep 2009 --- The European Food Safety Authority (EFSA) 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. 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.

Following the discussion paper of the Scientific Committee on botanicals and botanical preparations adopted on 23 June 2004, the European Food Safety Authority (EFSA) asked in August 2005 the Scientific Committee to develop a two-level tiered approach for the safety assessment of botanicals and botanical preparations. 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.

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.

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. Issues that should be carefully considered in order to reach such a conclusion are discussed in detail in the present guidance document. Botanicals and botanical preparations for which a presumption of safety is not possible based on available knowledge would be subject to a more extensive safety assessment, requiring additional data to be provided.

It is not the objective of this opinion to produce a list of safe botanicals and botanical preparations intended for food supplement use, but only to provide guidance on how to assess safety of botanical ingredients.

The Scientific Committee developed criteria for prioritising botanicals for safety assessment and has compiled a Compendium of botanicals that are reported to contain toxic, addictive, psychotropic or other substances that may be of concern. The main purpose of the Compendium, which should be considered as part of this guidance document, is to draw attention to issues that would need to be taken into account when assessing the safety of botanicals used as ingredients in food supplements, and to facilitate the establishment of priorities for safety assessment.

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 - 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.

In June 2008, after an initial public consultation, the Scientific Committee of EFSA published a guidance document for the safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. Recommendation was made at the same time to test the proposed approach for safety assessment with a number of examples, and consider amending the Compendia) of botanicals reported to contain toxic, addictive or psychotropic substances and ii) of botanicals reported to have also a medicinal use.

An EFSA Scientific Cooperation (ESCO) Working Group composed of experts identified by the members of the Advisory Forum, and by the Scientific Committee was created to fulfill this request, and advise on the adequacy of the proposed approach for the safety assessment of botanicals and botanical preparations for EFSA and the European Member States’ needs. In addition the Working Group was asked to update the Compendia.

The ESCO Working Group considered six botanical preparations to test the science-based framework described the guidance document:) hydroalcoholic extract of dried peel of Citrus aurantium L. ssp. aurantium L.) dried green tea extract of Camellia sinensis (L.) Kuntze) dried leaves extract of Ocimum tenuiflorum L.) dried fruits water extract of Foeniculum vulgare Mill. ssp. vulgare var. vulgare) dried ripe seeds of Linum usitatissimum L., and) wheat bran from Triticum aestivum L. These examples were selected in order to address various safety issues, such as misidentification / adulteration, liver toxicity, possible presence of genotoxic and carcinogenic compounds. Based on the experience acquired through the examples, the ESCO Working Group identified a number of possible amendments and additions for the guidance document of the Scientific Committee.

Taking into account comments received during the public consultation, the ESCO Working Group merged the two compendia into a single one, after removing references made to possible medicinal use of botanicals. The resulting Compendium now focuses on toxicity aspects, listing botanicals reported to contain toxic, addictive, psychotropic, or other substances of concern. The Compendium aims at flagging plants or parts of plants or compounds of possible concern for human heath naturally present in the listed botanicals and that therefore require specific attention while assessing the safety of the product(s) containing such botanical(s). It is recommended that EFSA keeps updating the Compendium on a regular basis.

After possible update of the EFSA guidance document for the safety assessment of botanicals and botanical preparations by the Scientific Committee, based on the recommendations made in this advice, the guidance document and the Compendium will be made publicly available on the EFSA website.

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.