Highlights of BaseClear’s Experts Meeting on Strain Safety Assessment for Regulatory Approval

The 2nd Experts meeting on Strain Safety Assessment for Regulatory Approval on April 21st 2020 was hosted as a complete online edition due to the measures related to the Covid-19 outbreak. Also in this online format the meeting was a great success with 64 participants from 44 companies & 35 countries.

The regulations around food, feed products and ingredients produced using microorganisms is currently being streamlined by various regulatory bodies such as EFSA, FDA and LATAM.  Microorganisms are now efficiently and sustainably used for the production of a variety of compounds, also many are  used as food ingredients due to the health benefits which they may provide. However, these regulations are a work-in-progress and with several open questions for the industry players. This Experts Meeting on Strain Safety Assessment for Regulatory Approvals is an attempt to get the key players, opinion leaders, and user for updates and information exchange on subjects like whole genome sequencing, nomenclature, antibiotic resistance factor genes databases, process, among others.

This experts meeting, organised by BaseClear, brought together leading scientists and regulatory affairs specialists. The presentations formed a storyline with a holistic view on the topic. Speakers from EFSA, BaseClear, Sandwalk BioVentures, Jennewein Biotechnologie, Chr. Hansen, Trouw Nutrition/Nutreco, Deerland Probiotics & Enzymes and Lallemand Health Solutions shared their insights and discussed regulatory frameworks, requirements and interpretation of the guidance.

EFSA requirements and interpretation

The experts meeting started with a presentation from Rosella Elisa Brozzi, Scientific Officer at the European Food Safety Authority (EFSA). She gave an excellent overview of the risk assessment of feed additives of microbial origin in the European Union. In the European Union, all feed additives need, by law, to undergo a risk assessment, which is conducted by EFSA. A proper characterisation of the microorganism is fundamental for its safety assessment. In 2018 EFSA issued a guidance document covering the complete set of data needed for the characterisation of microbial strains, both as products or as a source of them. The document streamlines the process of preparation and assessment of technical dossiers of microbial or microbial-based additives and aims to support applicants and assessors on the compilation and evaluation of technical dossiers for market authorisation purposes.

Her presentation was followed by a presentation from Dr. Adalberto Costessi (Product Manager Genomics & Regulatory Affairs, BaseClear) who elaborated on how to decode the EFSA requirements for microbial safety and the technical challenges. He discussed current requirements for EFSA safety assessment and technical approaches. Technical as well as regulatory challenges were presented. Examples included the availability of good databases for genome analysis, and the challenges of less standard microorganisms with increasing interest like algae and bacteriophages.

Food & feed applications

The meeting’s second session focused on Food & feed applications. The first speaker was Dr. Luis Gosálbez Cisneros-Miret, Managing Director at Sandwalk BioVentures. His presentation outlined how to bring novel microbes to market. He talked about the regulatory requirements for current and (potential) future applications, with a specific focus on how to deal with antibiotic resistance in novel probiotics and Live Biotherapeutic Products (LBPs).

Next up in line was Stephen O‘Rourke (Regulatory Affairs Manager, Jennewein Biotechnology) telling in detail about novel food applications and genetic engineering. He elaborated on the different regulatory requirements around the globe with a special focus on genetic engineering, and real-life examples were explored. Novel food applications, regardless of jurisdiction, require many details from the applicant. In this talk, the various agency requirements were discussed.

The last speaker for this 2nd session was Dr. Tiia Asukas, Senior Regulatory Specialist from Chr. Hansen. She shared her insights in the requirements to be met for securing the legality of use of microbial strains in food commercialized in EU, with special focus on their use as probiotics. Her presentation focused on the division between ingredients with a history of use and novel food ingredients, with a special focus on probiotics. Also areas, such as strain safety and safety towards a specific target group, were briefly surveyed.

Regulatory framework comparison (EFSA vs. FDA) and requirements

The 3rd session examined the different regulatory frameworks and different market (EFSA vs. FDA) requirements. Dr. Helena Oliveira, Regulatory Affairs Manager at Trouw Nutrition/Nutreco, explained about the Feed Additive Regulatory framework in the EU. During her presentation, Helena summarised all the requirements required by the industry to attain a successful feed additive authorisation in the EU.

Next Dr. John Deaton (Vice President of Science & Technology, Deerland probiotics & enzymes) spoke about the scientific testing requirements. He reviewed the steps necessary for approval for a Natural product number (NPN), Generally Recognized as Safe (GRAS), and Qualified Presumption List (QPS) for a bacillus probiotic.

The last presentation of the experts meeting was from Solange Henoud, (Regulatory Affairs Director, Lallemand Health Solutions) who discussed the probiotics food regulations outside of the EU and how they compare to the EU. Applicable regulations are highly variable from a country to another, from a category to another. She briefly reviewed the differences and compare to the EU, while highlighting the importance of the EU role in establishing gold standard references for safety and clinical studies.

Top learnings

The top learnings that came up at the meeting.

  • It’s important to match the regulatory approval strategy with the commercial strategy for a product.
  • The QPS listing should be updates and reflect the recent taxonomic nomenclature changes
  • The need to merge guidelines for safety assessment of microorganisms use in both food and feed is ever growing and the EFSA is soon to be implementing this.

Book of abstract

Download the book of abstract: Brochure Experts Meeting 21 april 2020

Upcoming Experts Meetings

BaseClear routinely organises experts meeting and this meeting will have a follow edition. We look forward to see what progress will have been made. For the complete overview of BaseClear’s Experts Meetings, visit https://www.baseclear.com/experts-meetings/ and follow us on LinkedIn (https://www.linkedin.com/company/baseclear) to keep up to date.

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