Draft Endorsed by the FEEDAP Panel 18 May 2017 Submitted for public consultation 15 June 2017 End of public consultation 15 September 2017 Adopted by the FEEDAP Panel 21 February 2018 Implementation date 1 September 2018 * Sections 3.1 and 3.2 were also endorsed by the EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) on 18 May (GMO) and 7 June (CEF and ANS) 2017. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.

This Guidance document is intended to provide a method to identify resistance to antimicrobials of human and veterinary importance in bacterial strains intended for use as feed additives. Such tests should be made in a consistent manner using internationally recognised and standardised methods. As a basic requirement, the minimum inhibitory concentration of the antimicrobials should be determined for each of the following substances: ampicillin, vancomycin, gentamicin, kanamycin, streptomycin, erythromycin, clindamycin, tetracycline, chloramphenicol and, in specific cases, tylosine, apramycin, nalidixic acid, sulfonamide and trimethoprim. These antimicrobials are chosen to detect a wide range of determinants for resistance. The cut-off values identified by the FEEDAP Panel should be seen as a pragmatic response intended to introduce consistency in the separation of strains with acquired resistance from susceptible strains. These values are not intended for any purpose other than the assessment of microbial products for the possible presence of antimicrobial resistance. When a bacterial strain demonstrates higher resistance to a specific antimicrobial than the other strains of the same taxonomical unit, the presence of acquired resistance is indicated and additional information is needed on the genetic basis of the antimicrobial resistance. Any bacterial strain carrying an acquired resistance to antimicrobial that is shown to be due to the acquisition of genetic determinant presents the greatest potential for horizontal spread and should not be used as a feed additive.

Draft Endorsed by the FEEDAP Panel 22 March 2017 Submitted for public consultation 6 April 2017 End of public consultation 31 May 2017 Adoption by the FEEDAP Panel 26 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the target species.

Draft Endorsed by the FEEDAP Panel 16 May 2017 Submitted for public consultation 24 May 2017 End of public consultation 7 July 2017 Adoption by the FEEDAP Panel 27 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the identity, characterisation and conditions of use of the additives.

Draft Endorsed by the FEEDAP Panel 17 May 2017 Submitted for public consultation 24 May 2017 End of public consultation 21 July 2017 Adoption by the FEEDAP Panel 27 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the consumer.