Botanicals

What has EFSA produced?

EFSA has developed a toolkit 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 by which to prioritise botanicals for safety assessment
  • A report containing 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

Why has EFSA produced a compendium of botanicals that may be of health concern?

The compendium lists botanicals that have been reported to contain substances that may be of health concern when used in food or food supplements. Its purpose is to draw the attention of manufacturers and food safety authorities to possible safety issues when these botanicals are used in food. There is no final judgment as to whether botanicals listed in the Compendium are safe or not safe for food use.

Is EFSA’s Compendium of botanicals complete?

No. The Compendium is a living database that will be updated on a regular basis.

Who is the toolkit for?

The toolkit is intended to assist risk assessors who want to consider the safety of a given botanical ingredient and food manufacturers who are responsible for ensuring that the products they put on the market is safe.

What about botanicals used as herbal medicines as well as in food?

Some botanicals are considered as traditional herbal medicinal plants and are used both in medicinal products and in food supplements. It is not EFSA’s role to determine the classification of a botanical as a medicine or a food supplement.

The European Medicines Agency (EMEA) is responsible for assessing both the safety and efficacy of herbal preparations when used as medicines. EFSA is co-operating closely with EMEA to share information and ensure consistency in the safety assessment of botanicals. However, when developing its scientific approach for the safety assessment of botanical ingredients, EFSA considered only data required to be able to conclude on safe use in foods.