EU assessment of enterococci as feed additives

Particular micro-organisms such as enterococcal strains are used as probiotics in feed. Observations indicate a positive effect of such strains on the gut flora, especially for young animals or during feed transition phases. This favourable effect is perceived by the farmers as a means of maintenance of the health status of the animals (e.g. less diarrhoea) and results in significant improvement of animal performance. Micro-organisms have been used since the end of the 1980s in animal feeds and were strictly regulated in 1993, when they were introduced under the scope of Council Directive 70/524/EEC of 23 November 1970 on additives in animal nutrition on feed additives. After a transition period, which ended in the year 2000, every microbial strain must now be assessed by the EU bodies and authorised by a Commission Regulation, before it can be placed on the market for use in feedingstuffs. Council Directive 70/524/EEC on feed additives is based on three main principles: (1) pre-market authorisation, (2) positive list principle, and (3) thorough risk assessment of the effect of a particular strain on human and animal health as well as on the environment. Therefore, before introducing a new enterococcal strain preparation or promote a new use of an approved product, a dossier has to be submitted to the authorities, following the guidelines, as published in Commission Directive 94/40/EEC [Commission Directive 94/40/EC of 22 July 1994 amending Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition]. These guidelines contain detailed evaluation methods. The safety requirements refer to (1) the target animal categories, (2) the consumer and the environment (presence of toxins and virulence factors as well as antibiotic resistance and transferability are assessed), and (3) the workers, based on requirements of Council Directive 89/391/EEC.