Topics A-Z

Botanicals

Botanicals

Botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market in the form of food supplements. Examples include ginkgo, garlic, St. John’s Wort and ginseng. Such products are typically labeled as natural foods and a variety of claims are made regarding possible health benefits. They can be bought over the counter in pharmacies, supermarkets, specialist shops and via the Internet.

While most of these products have a long history of use in Europe, some concerns exist with regard to safety and quality. These include the risk of chemical or microbiological contamination and the need to ensure that concentrations of bioactive agents are within safe limits.

EU framework

The EU legal system does not set out any kind of authorization procedure centralised at EU level for the use botanicals and derived preparations in food. Nonetheless, the use of botanicals and derived preparations in food has to comply with the general requirements set out in the Regulation laying down general principles and requirements of food law and creating the European Food Safety Authority (Regulation (EC) No 178/2002). This inter alia assigns primary legal responsibility for the safety of the products placed on the market to business operators.

EFSA’s role and activities

EFSA’s work in this field aims to provide any organisation assessing the safety of botanical ingredients with a science-based approach. It provides the criteria that should be taken into account when undertaking work to establish the safe use of botanicals or derived preparations. This work was initiated when the members of EFSA's Advisory Forum underlined the need for science-based guidance for assessing the safety of botanicals.

In September 2009 EFSA published a toolkit to help assess the safety of botanicals and derived preparations which are intended for use in food supplements. This work was undertaken under EFSA’s own initiative. The toolkit is composed of:

  • A guidance document identifying the data needed to assess the safety of botanicals and suggesting a science-based approach for the safety assessment. It also provides a set of criteria to prioritise botanicals for safety assessment
  • A report with a number of examples illustrating how to apply the proposed scientific approach
  • A Compendium of botanicals that have been reported to contain substances that may be of health concern when used in food or food supplements

Timeline of EFSA’s work on botanicals

  • June 2004: EFSA’s Scientific Committee publishes a discussion paper on botanicals and botanical preparations widely used in food supplements and related products. It expresses concerns about quality and safety issues, and highlights the need for a better characterisation of the range of products on the market and for harmonising risk assessment and consumer information approaches.
  • October 2004: The discussion paper was brought to the attention of the members of the Advisory Forum, who confirmed the importance of the issues addressed by the paper for their countries.
  • August 2005: EFSA mandates its Scientific Committee to develop a science-based toolkit for the safety assessment of botanicals and botanical preparations.
  • December 2007 - February 2008: EFSA launches a public consultation on the proposed approach for the safety assessment of botanicals
  • April 2008: An ESCO Working Group on Botanicals and botanical preparations is created to test the proposed approach for the safety assessment with a number of botanicals, and to expand the Compendium on botanicals.
  • June 2008: EFSA publishes the updated guidance document along with the comments submitted by stakeholders and a summary report on how these were taken into account.
  • May 2009: The ESCO Working Group on Botanicals and botanical preparations delivers its recommendations to EFSA’s Executive Director consisting of:
    • An advice on the adequacy of the proposed approach for the safety assessment of botanicals and botanical preparations
    • A report illustrating how to apply the EFSA approach with a selected number of examples
    • An updated compendium of botanicals reported to contain substances that may be of health concern
  • July 2009: The Scientific Committee adopts its guidance document for the safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. The final document takes into account the recommendations made by the ESCO Working Group.
  • November 2009: EFSA held a workshop in Athens on botanicals and botanical preparations used as ingredients in food supplements, where the guidance document was presented. Representatives of Member States’ food safety authorities, the European Commission, the European Medicines Agency and plant-based food supplement manufacturers discussed how industry and competent authorities in EU Member States can apply the science-based method for safety assessment described in this document. EFSA invited the participants to use the proposed approach for the full safety assessment of botanical preparations and to provide feedback on possible improvements to the guidance document.
FAQs  
Botanicals
Events & Meetings  
EFSA Workshop on Botanicals

Athens, 24 November 2009