ISSUE FOCUS 34 FEED & ADDITIVE MAGAZINE August 2022 Second is the submission phase and completeness check: 1. Applicant submits the application via the E-submission Food Chain Platform 2. The European Commission checks the application and sends a mandate to EFSA who is responsible for the evaluation of the dossier 3. Receipt of the application by EFSA and completeness check within 30 working days. Missing information will delay the process and EFSA will request that applicants provide the required information. Point 1 is completed by the applicant, point 2 is completed by the EC and step 3 is completed by EFSA. Third is risk assessment phase: 1. EFSA validates the application 2. EFSA launches public consultation on the application dossier 3. EFSA performs thorough risk assessment 4. EFSA panel adopts the scientific output. Points 1 through 4 is completed by EFSA. The risk assessment phase can take up to 6 months. If EFSA requests additional information, this scientific risk assessment process will be put on hold until the applicant can supply the information. Last is the post-adoption phase: 1. EFSA publishes scientific output. 2. Based on ESFA´s advice, the risk managers at the Standing Committee on Plants, Animals, Food and Feed (ScoPAFF) take the decision on granting authorisation of feed additives for their placing or use in the European market. Point 1 is completed by EFSA and point 2 is completed by the EC and Member States representatives. GUIDELINES FOR TRIALS REQUIRED FOR REGISTRATION EFSA technical guidelines must be used when authorisation is sought for mycotoxin binders. This provides EFSA with sufficient scientific evidence on the additive’s characterisation, safety, and efficacy in order for them to make a recommendation. In relation to efficacy, the guidance document can be accessed via the EFSA Journal.8 The target species that will receive the feed additive as well as the mycotoxin against which the additive will be working should be stated. To provide proof of the planned effect of the additive, an array of in vitro studies should be submitted by the applicant. It is important to remember that in vitro studies do not adequately simulate the conditions in the gut or the differences between target animals and their metabolism. Therefore, for mycotoxin binders, in vivo studies are submitted to support in vitro studies. To demonstrate the efficacy at the lowest recommended dose of the additive, at least three autonomous studies should be performed in a minimum of two different locations. For additives designed to be used in all terrestrial species, studies should be conducted in vivo in three major species, in order to represent efficacy in different digestive systems. These would be poultry, a non-ruminant mammal and a ruminant. Studies must include the category of animal for which the lowest maximum content of a particular mycotoxin has been set in Directive 2002/32/ EC or in the Commission Recommendation 2006/576/EC.
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