Guidance document on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption

The BIOHAZ Panel of EFSA revised the joint AFC/BIOHAZ guidance on the submission of data for the evaluation of the efficacy of substances for the removal of microbial surface contamination of foods of animal origin. The guidance is intended to provide guidelines for dossiers of applications to be for authorisation of the substances mentioned above.

This guidance requires data and information about the safety and efficacy of the substances, as well as examples of study designs at the laboratory and at the slaughterhouse in order to demonstrate these attributes. Also it includes the factors that should be considered when monitoring the safety and efficacy of a substance that has already been authorized and used.

In addition all the factors related to the potential occurrence of acquired reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials and the issues related to the environmental risk due to the use of such substances are considered in this guidance. The evaluation of these aspects is divided into pre-market and post-market evaluation.

In relation to the environmental risk, the guidance indicates the type of data and/or studies that an application should address on the impact of the disposal of the substances, with particular reference to the biological and chemical risk for the environment, the residues or their by-products in the carcasses and the potential development and dissemination of resistant strains.