Choose Biosafe as your safety assessment specialist
Getting an authorization for a feed additive can be a long and difficult process. With the help of our expertise and experience, you can speed up the process, cut costs and manage risks.
Biosafe is the preferred partner in feed additive safety assessment. We 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.
In addition to the analytical methods available in Biosafe laboratory, we have a constantly growing network of partners and collaborators in Finland and abroad. This guarantees customer-friendly and effective planning and performing of the studies required.
Assisting you at all steps of product registration
Registration is required before a feed additive can be marketed within the European Union. For this purpose, an application is submitted to the European Commission. To prove the safety and efficacy of the feed additive, a dossier with all the necessary evidence is included in the application. This dossier is assessed by the FEEDAP Panel of the European Food Safety Authority (EFSA), who also provides scientific advice and guidance documents to the applicants. If the feed additive fulfils the EFSA requirements, there is a high probability that it will pass the approval process also outside of the EU.
Biosafe assists you during the product development and in fulfilling the scientific and legal requirements, particularly for products based on microorganisms:
- Early stage research: Which one of my many microorganism isolates would be the safest to continue to the product development? Does it contain elements of concern? When used, can it lead to animal or human toxicity? Can it spread antimicrobial resistance?
- Product characterisation: Does my product contain viable production organisms? Does my product contain DNA from the production organism?
- Studies and expert reports on e.g.:
- Bioinformatic analysis of whole genome sequence of microorganisms for taxonomic identification, antimicrobial resistance genes, toxin and virulence factors and secondary metabolism biosynthetic pathways.
- Absence of viable production organism and DNA in the product.
- Minimal inhibitory concentration (MIC) of antimicrobials
- Cytotoxicity test