Food enzymes

Achieving EU market access for your food enzymes.

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The European Union's stringent regulatory framework for food enzymes requires a comprehensive understanding and strategic approach to navigate successfully.

At Biosafe, we specialise in consulting services that guide food enzyme products through the intricate approval process established by the European Commission and the European Food Safety Authority (EFSA). Our goal is to streamline your product's journey to market approval, ensuring compliance with EU regulations every step of the way.

Why Biosafe

Regulatory expertise: Our team is well-versed in Regulation (EC) No 1332/2008 on food enzymes, as well as the challenging Transparency Regulation (EU) 2019/1381, providing you with knowledgeable guidance to fulfill all regulatory requirements.
Scientific validation: We leverage our scientific expertise to substantiate the safety and efficacy of your food enzyme products, ensuring a solid foundation for EFSA's risk assessment.
Comprehensive support: From initial regulatory strategy to dossier submission and post-approval compliance, we offer end-to-end consulting services tailored to the unique needs of your food enzyme products.

Regulatory strategy and planning: We help you understand the specific regulatory pathway for your food enzyme, including identifying the necessary studies and documentation for a successful application.
Dossier preparation and submission: Our experts adeptly compile and submit your food enzyme dossier to the EC through the e-submission food chain platform, ensuring it meets all the criteria for a thorough safety evaluation by EFSA.
Safety assessment and risk analysis: We conduct rigorous safety assessments and risk analyses, providing the critical scientific evidence required to demonstrate your product's safety for EU consumers.
EFSA and EC liaison: As your regulatory partner, we act as a liaison with EFSA and the European Commission, facilitating communication and efficiently navigating the evaluation process.
Compliance and post-market support: Beyond the approval, we provide ongoing support to ensure your food enzyme products remain compliant with EU regulations, including labelling and monitoring requirements.
Innovation and development guidance: Our services extend to support the innovation and development of new food enzymes, offering insights into emerging technologies and scientific advancements that could impact regulatory requirements and market acceptance.

The approval process for food enzymes in the EU is complex, but with Biosafe as your consulting partner, you're equipped to navigate it with confidence.

Our comprehensive, strategic approach not only accelerates your product's time to market but also ensures long-term compliance and success in the competitive EU market.