ISSUE FOCUS FEED & ADDITIVE MAGAZINE August 2022 33 • The binder should not mask the mycotoxin in the feed so that it cannot be established • Binders must be easily incorporated into commercial feed manufacturing operations • Efficacy and use of the binder should be easily verified Examples of mycotoxin binders are some potential absorbent materials which include activated charcoal, aluminosilicates (bentonite, clay, montmorillonite, phyllosilicates, zeolite), complex indigestible carbohydrates (cellulose, polysaccharides in the cell walls of bacteria and yeast such as glucomannans and peptidoglycans) as well as synthetic polymers such as cholestyramine, polyvinylpyrrolidone and derivatives.9 Mycotoxin binders need to obtain a registration with the European Commission in order to be commercially marketed and included in animal feed in the European Union. Let us take a brief look at the process involved to register these products: EU REGISTRATION PROCESS In the EU, “substances for reduction of the contamination of feed by mycotoxins” are classified within the “technological feed additives” category.2 This group of products must be registered following the rules described in Regulation EC 1831/2003, which lays out the procedure for the registration of feed additives. EFSA requires further scientific and technical requirements, and these are outlined in Commission Regulation EC 429/2008. The European Commission (EC) will decide on the approval of the feed additives for use in the EU after EFSA has performed the risk assessment. Feed additive approvals are granted for ten years and can be renewed. Below is a step-by-step summary of how the registration process works7. The application procedure for feed additives can be broken down into 4 phases: First is the pre-submission phase: 1. The potential applicant can optionally request general pre-submission advice 2. For renewals: the potential applicant notifies a list of intended studies which undergo a public consultation procedure 3. The potential applicant notifies studies commissioned or carried out as of 27 March 2021, prior to the study start Point 1 through 3 is completed by the applicant.
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