Feed additives

Streamlining the path to feed additive approval in the EU.

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The European Union sets the benchmark for feed additive safety and efficacy, necessitating a robust regulatory strategy for market entry.

Biosafe's consulting services offer unparalleled expertise and support to navigate the regulatory landscape for feed additives, aligning with Regulation (EC) No 1831/2003 and EFSA guidelines. Our objective is to facilitate your feed additive's approval process, ensuring compliance, safety, and efficacy to meet EU standards.

Why Biosafe

Regulatory mastery: With deep insights into EU feed additive regulations, as well as the challenging Transparency Regulation (EU) 2019/1381, we demystify the approval process, from application to authorization.
Scientific rigour: Our approach is grounded in science, leveraging in vitro tests for efficacy, PFGE for strain characterisation, and comprehensive environmental risk assessments to build a compelling case for your product's approval.
Full-spectrum support: From strategic planning to dossier compilation, submission, and post-market compliance, our services cover every phase of the regulatory journey for feed additives.

Regulatory strategy development: We devise a clear regulatory roadmap tailored to your feed additive, outlining all necessary steps for a successful EU market entry.
Dossier compilation and submission: Expertly navigating the e-submission process, we ensure your dossier meets EFSA's stringent requirements for a detailed safety and efficacy evaluation.
Efficacy testing and documentation: Utilising in vitro methods and other modern techniques, we generate robust data to demonstrate your feed additive's benefits, crucial for EFSA's efficacy assessment.
Environmental risk assessment: Recognising the growing importance of environmental sustainability, we conduct environmental risk analyses in line with EFSA's feed regulation, ensuring your product's safe use.
EFSA and EC liaison: Acting as your representative, we facilitate communications with regulatory bodies, addressing inquiries and ensuring a smooth evaluation process.
Post-approval regulatory compliance: Beyond approval, we offer ongoing advisory services to maintain compliance with EU regulations, including monitoring, reporting, and addressing any emerging regulatory changes.
Innovation and development support: As the feed additive sector evolves, we keep you ahead of scientific and regulatory advancements, advising on innovation and product development to meet future market demands.

The journey to feed additive approval in the EU is complex, but with Biosafe's guidance, it becomes navigable and efficient.

Our expertise ensures not only your product's compliance and market success but also its contribution to healthy animal nutrition and environmental sustainability.