Statement on the preparation of guidance for the assessment of plant/herbal products and their constituents used as feed additives

The European Food Safety Authority (EFSA) asked the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to prepare a background paper on the biological effects of botanical products and their constituents on livestock (including horses, companion animals and game birds), highlighting the issues of likely importance in risk assessment. The FEEDAP Panel was also asked to undertake further work including the development of guidance for applicants seeking authorisation for feed additives based on botanical extracts or their constituent phytochemicals. The FEEDAP Panel tendered for the preparation of the background paper. The tender was awarded to a Consortium led by the University of Veterinary Medicine, Vienna, and a report ‘Study on the assessment of plants/herbs, plant/herb extracts and their naturally or synthetically produced components as “additives” for use in animal production’ was produced. On the basis of this document and protocols developed elsewhere in EFSA for the assessment of botanicals extracts/components used as food/food supplements, the FEEDAP Panel was able to propose the approach to botanicals eventually incorporated into Commission Regulation (EC) No 429/2008 (the detailed rules for the implementation of Regulation (EC) No 1831/2003). In addition, the FEEDAP Panel also developed a series of detailed guidance documents intended to further support applicants in the preparation of dossiers. Botanical extracts and the components of botanical extracts are primarily dealt with in the guidance document on the category of sensory additives – flavouring compounds. However, since some applications have been made under the technological and zootechnical categories, the relevant guidance documents for those categories of feed additives also make provision for botanically-derived products.