Obtaining an authorization for feed additives can be a long and difficult process. With the help of the expertise and experience of BaseClear, you can speed up the process, cut costs and manage risks. BaseClear is the preferred partner in feed additive safety assessment and offers years of experience in genomic analysis for regulatory dossiers filing.

Feed additives regulatory affairs support

BaseClear can support you through the product development and authorization process by offering all the safety assessment tests and consulting you require. We provide safety assessments particularly for microbiologically or biotechnologically produced feed additives. Our experts know which safety evaluations are required for additives, which allows for sensible and cost-effective planning of the required analyses.

QUESTIONS THE BASECLEAR SPECIALISTS CAN HELP YOU ANSWER

  • Which one of my many isolates is the safest to use for my product development?
  • Does it contain genetic elements of concern?
  • When used, can it lead to animal or human toxicity?
  • Can it spread antimicrobial resistance?
  • Does my product contain viable production organisms?
  • Does my product contain DNA from the production organism?

Assisting you at all steps of feed additives product registration

Registration is required before a feed additive can be marketed within the European Union or USA. For this purpose, an application is submitted to either the European Commission and European Food Safety Authority (EFSA) or the US Food and Drug Administration (FDA).

To prove the safety and efficacy of feed additives, a dossier with all the necessary evidence is included in the application. For the EU/EFSA, the dossier is assessed by the FEEDAP Panel, who also provides scientific advice and guidance documents to the applicants. If the feed additive fulfills the EFSA requirements, there is a high probability that it will pass the approval process also outside of the EU. BaseClear can assist you during the early stages of product development and in fulfilling the scientific and legal requirements, particularly for products based on microorganisms.

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Meet Adalberto Costessi!

Adalberto is our Product Managers Genomics & Regulatory Affairs. Adalberto graduated in Medical Biotechnology at the University of Trieste. He specialised in molecular biology and next-generation sequencing during his PhD at the Radboud University in Nijmegen, where he studied the transcriptonal mechanisms of cancer cells. Adalberto is BaseClear’s technical expert on short and long read NGS platforms, including the latest nanopore-based technologies, and how to best use them for specific applications.

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