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The Dos and Don’ts in the Development of Novel Microbial Products
Speaker: Pauliina Halimaa, Managing Director, PhD, Biosafe
Microbial food products can improve food safety, sustainability, nutritional value, and self-sufficiency. However, the regulatory landscape is complex. This presentation addresses common questions producers have about developing microbial food products, offering insights into regulatory requirements and best practices.
At Biosafe — Biological Safety Solutions Ltd., we guide companies through food safety regulations in Europe and globally. Our expertise in laboratory testing, genome sequencing, and regulatory consulting ensures microbial food products meet high safety and compliance standards.
Key regulatory questions:
- Sample materials for safety assessment: Requirements for number, types, and quality of sample materials for pre-market safety assessments.
Scale requirements for regulatory testing: Differences between laboratory, pilot plant, and full-scale production, and their impact on product quality and compliance.
- Detail in manufacturing method: Level of detail required in manufacturing process descriptions and confidentiality concerns.
- Determining intended use: Defining intended use, considering target consumer groups, potential hazards, and further processing.
- Allowed genetic modifications: Types of genetic modifications permitted and safety assessment guidelines.
- Toxicology studies requirements: Guidelines for conducting toxicology studies, including test types and reporting standards.
- Timelines for Authorization: Steps and expected duration for product approval process.
Addressing these questions helps streamline product development, enhance safety, and achieve regulatory approval efficiently. This presentation offers valuable insights and practical advice for developing microbial food products.
