ISSUE FOCUS FEED & ADDITIVE MAGAZINE August 2022 35 When the mycotoxin binder is intended to be used in fish, the requirement would be for specific fish studies to be conducted. It is preferred that salmonids be used as sample species in these studies. Directive 2002/32/EC will give the maximum amount of aflatoxin B1 that should be included in the feed used in studies for each specific animal species. Commission Recommendation 2006/576/ EC will state the guidelines of amounts of deoxynivalenol, zearalenone, ochratoxin A and fumonisins B1 and B2 that should be included in the feed for the specific species of animal used in the studies. Commission Recommendation 2013/165/EU will give these specifications for T-2 and HT-2. If the mycotoxin does not have a guideline for maximum inclusion level established by the European Commission, then an inclusion level should be chosen to ensure that no adverse effects are observed in the animals used in the study. Naturally contaminated feed materials are favoured to be used as a source of mycotoxins, but artificial contamination with mycotoxins can also be used if it is justified. For each trial, a quantitative analysis of the mycotoxins in the feed should be provided. Studies must be experimentally designed to have a minimum of 2 trial groups: one group will represent the control, which will represent the contaminated feed. The other group will represent the feed that has been treated with the mycotoxin binder for which authorisation is being sought. An extra control group should be included for mycotoxins without a maximum recommended inclusion level. This is to ensure that no adverse effects are observed in the trial animals. The feed used in this group should not include mycotoxins and must have the same formulation as the feed used in the other two groups. TRUSTED REGULATORY SOLUTIONS FOR ANIMAL FEED & HUMAN NUTRITION OUR EXPERIENCED REGULATORY TEAM PROVIDES SOUND TECHNICAL ADVISE TO GUIDE YOU THROUGH THE COMPLEXITIES OF EU AND OTHER INTERNATIONAL REGULATORY LANDSCAPES Contact us at: info@pentec-consulting.eu www.pentec-consulting.eu Pen & Tec Consulting SLU Training offer at: www.pentec-academy.com MYCOTOXIN BINDER REGISTRATION GETTING TOO COMPLEX? ALLOW US TO POINT YOU IN THE RIGHT DIRECTION
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