Novel foods

Why Biosafe

• Regulatory mastery: We possess an in-depth understanding of the EU’s novel foods regulation (EU) 2015/2283, as well as the challenging Transparency Regulation (EU) 2019/1381, ensuring your product dossier meets all legal requirements for safety, documentation, and traceability.
• Scientific excellence: Our team of experts leverages cutting-edge scientific research to substantiate the safety and efficacy of your novel food products, from concept to approval.
• Strategic support: We offer strategic insights into the novel foods approval process, including pre-application advice, dossier preparation, risk assessment, and post-market surveillance strategies.

1. Pre-application strategy: We help you identify the optimal pathway for your novel food's approval, considering your product’s unique attributes and the current regulatory landscape.

2. Dossier development and submission: Our experts meticulously prepare and submit your novel food application dossier to the European Commission, ensuring it is comprehensive, scientifically robust, and compliant with EU regulations.

3. Safety assessment and risk analysis: We conduct thorough safety assessments and risk analyses, providing the necessary scientific evidence to demonstrate your product's safety for EU consumers.

4. Regulatory liaison and advocacy: Acting as your advocate, we liaise with regulatory authorities, including the European Food Safety Authority (EFSA), to facilitate a smooth evaluation process, responding to queries and addressing any concerns.

5. Market access and compliance advice: Beyond approval, we offer strategic advice on market access, labelling, advertising, and post-market monitoring to ensure ongoing compliance with EU regulations.

6. Innovative food technologies consulting: Our expertise extends to cutting-edge food technologies, such as cellular agriculture, precision fermentation, alternative proteins, and synthetic biology, ensuring your innovative products navigate the regulatory process successfully.

The journey to bringing novel foods to the European market is complex but rewarding. With Biosafe's expert consulting services, you gain a partner committed to unlocking the full potential of your innovative food products.

Our strategic, science-based approach minimises regulatory hurdles and accelerates market entry, allowing you to focus on what you do best: creating the future of food.