EFSA Issues Feed Additives Guidance on Renewal of Authorizations

The European Food Safety Authority’s (EFSA) Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP) has issued guidance to assist applicants “in the preparation and submission of technical dossiers for the renewal of the authorization of additives for use in animal nutrition.” According to EFSA, EU regulations require applicants to renew feed additive authorizations every 10 years by submitting stand-alone dossiers that take into account “the most up-to-date scientific knowledge” as well as “the current scientific/methodological approaches.” Although the information included in each dossier will depend on “the additive nature, the functional group, the substance itself, the target animals, and the conditions of use,” the submission must enable regulators to assess the additive in question “based on the current state of knowledge” and to determine whether the additive complies with the “fundamental principles for the renewal of authorization.”

“During the last years, the FEEDAP Panel has developed several guidance documents to assist applicants in the preparation and presentation of dossiers for the authorization of feed additives,” notes the FEEDAP Panel, which developed the guidance after conducting a public consultation. “These guidance documents have been prepared mainly to help applicants in the preparation of technical dossiers for the authorization of new feed additives/new uses of a feed additive (Article 4), the reevaluation of feed additives already authorized (Article 10) or the modification of terms of an authorization (Article 13). However, no guidance has been developed so far to help applicants in the preparation of dossiers for the renewal of the authorization (Article 14).”