Regulatory Affairs for Microbiome Based Products

EU regulatory aspects of Probiotics & Potential Synergy with other Feed/Food Components

Wednesday, 11 November 2020 16:00 CET


Dear Colleague,
In bridging the gap between academia and industry in microbiome research, the  14th INTERNATIONAL SCIENTIFIC CONFERENCE ON PROBIOTICS, PREBIOTICS, GUT MICROBIOTA AND HEALTH, taking place on 11 November will have a strong focus on regulatory affairs around probiotics, prebiotics and phages.

Registration is required. For the registration please click here.


Regulatory Workshops, hosted by Pen & Tec Consulting, at IPC 2020 include:


What’s New? How the EU transparency regulation will affect feed & food probiotic authorisations? 

Eliana Henriquez, Pen & Tec Consulting


  • What are the key changes & the main implications?
  • How will the new regulation affect future feed & food authorisations?
  • What do you need to do to prepare?


What should researchers know about the role of whole genome sequencing when seeking authorisation for probiotics in the EU?

Pauliina Halimaa, Biosafe

  • Role of WGS
  • What needs to be included in the dossier
  • EFSA updates


Key differences between probiotic food/feed approvals in EU & USA 

Elinor McCartney, Pen & Tec Consulting


  • Differences in regulatory pathways
  • Differences/similarities in data requirements
  • Differences/similarities in claims


What’s in a Name? How taxonomy changes will affect feed & food probiotic registrations in EU & US? 

Hannes Malfroy, Pen & Tec Consulting 

  • What are the key changes?
  • How will this affect existing authorisations in EU & USA & what do you need to do?
  • What do you need to know for future registrations


Bacteriophages as Food/Feed Ingredients? Regulatory considerations in the EU 

Justyna Pałasińska, Pen & Tec Consulting

  • Bacteriophages in animal feed - regulatory status & how to demonstrate safety & efficacy?
  • Bacteriophages in food - regulatory status & how to demonstrate safety
  • What you need to now if you are developing 


Who to participate: Small and medium enterprise representatives, scientists, researchers, technical supports, regulatory teams involved in the development and presentation of probiotic dossier submission for the European Food Safety Authority and the US FDA.

Why participate: Get an update on the current approaches of regulators to strain safety and permissible claims in humans and animals; to nutrition and health claims related to probiotics in foods, novel foods, dietary supplements, and nutraceuticals. You will also learn about common pitfalls and how to avoid rejection by EFSA or the USA FDA.


Chairman: Dr Hannah Lester
European Union Food Chain Legislation Expert Pen & Tec Consulting, Spain







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