Update on the Regulatory Landscape of Probiotics – Preview of Dr Elinor McCartney’s Presentation at IPC2016

Posted 1 June, 2016

ipc2016-probiotics-and-prebiotics-scientific-conference-pen-tec-consulting

Regulation of probiotics and prebiotics in the EU – what’s new?

The big news this year is undoubtedly the increased pressure to reduce antibiotic use in both humans and animals. This is driving food, feed and pharmaceutical players to seek creative opportunities with probiotics. Creativity and regulation are not easy partners, so it is important to recognise and address legal obstacles and practical considerations at an early stage of project planning for new probiotic development or renewal of old registration dossiers.

Most live microbial strains used in EU foods and food supplements do not require a premarket safety assessment, due to traditional and safe use in fermented foods. However, EU regulators look to EFSA (European Food Safety Authority) for guidance on strain safety, particularly for food supplements, since these must be notified prior to marketing in most Member States. All live microorganisms used in animal nutrition must pass EFSA on strain safety prior to marketing and face a stringent safety assessment:

  • Strain identity – the use of modern molecular techniques to identify probiotic strains frequently results in taxonomy updates. A change in the taxonomy of a strain can result in regulatory challenges, especially if the new strain name is not listed as QPS (Qualified Presumption of Safety), updated annually by EFSA, or is no longer recognised as having a traditional use in fermented foods.
  • QPS – EFSA lists absence of toxin and virulence factors and antimicrobial resistance (AMR) as key qualifiers for strain safety. Current EFSA guidance on Bacillus safety illustrates the difficulty of deciding when a toxin is a toxin. The latest EFSA update on AMR was published in 2012, and sets cut-off values based on published data. There are also technical challenges in this area, for example the difficulty of setting appropriate cut-off values for “new” taxons with relatively few members.
  • Full genome – Exotic probiotic strains may be classed as “novel”, and could face evaluation by EFSA. For such strains, EFSA will require the full strain genome.
  • Strain identity – the use of modern molecular techniques to identify probiotic strains frequently results in taxonomy updates. A change in the taxonomy of a strain can result in regulatory challenges, especially if the new strain name is not listed as QPS (Qualified Presumption of Safety), updated annually by EFSA, or is no longer recognised as having a traditional use in fermented foods.

What’s new on strain efficacy?

Probiotics have still not succeeded in achieving a claim under the nutrition and health regulation, other than the generic claim for yoghurt bacteria, production of lactase and aid in digesting lactose in subjects with intolerance. It is interesting that the only approved probiotic claim in the EU is generic, since EFSA rejected most other generic probiotic claims on the grounds of lack of definitive strain identity. EFSA also insisted that probiotic efficacy is strain-specific. On the other hand there are around 40 probiotic strains approved for use in animal feeds, with several strains under EFSA evaluation. Demonstrating probiotic efficacy in animals to EFSA’s satisfaction is challenging, but possible. Perhaps there is room for more coherence across EFSA food and feed panels to allow best practices from both areas – human and animal?

If you wish to be informed on details of the probiotic regulatory landscape and learn about the golden rules of registration dossier preparation attend IPC this year.

 

Update on the Regulatory Landscape of Probiotics – Preview of Dr Elinor McCartney’s Presentation at IPC2016

Posted 1 June, 2016

ipc2016-probiotics-and-prebiotics-scientific-conference-pen-tec-consulting

Regulation of probiotics and prebiotics in the EU – what’s new?

The big news this year is undoubtedly the increased pressure to reduce antibiotic use in both humans and animals. This is driving food, feed and pharmaceutical players to seek creative opportunities with probiotics. Creativity and regulation are not easy partners, so it is important to recognise and address legal obstacles and practical considerations at an early stage of project planning for new probiotic development or renewal of old registration dossiers.

Most live microbial strains used in EU foods and food supplements do not require a premarket safety assessment, due to traditional and safe use in fermented foods. However, EU regulators look to EFSA (European Food Safety Authority) for guidance on strain safety, particularly for food supplements, since these must be notified prior to marketing in most Member States. All live microorganisms used in animal nutrition must pass EFSA on strain safety prior to marketing and face a stringent safety assessment:

  • Strain identity – the use of modern molecular techniques to identify probiotic strains frequently results in taxonomy updates. A change in the taxonomy of a strain can result in regulatory challenges, especially if the new strain name is not listed as QPS (Qualified Presumption of Safety), updated annually by EFSA, or is no longer recognised as having a traditional use in fermented foods.
  • QPS – EFSA lists absence of toxin and virulence factors and antimicrobial resistance (AMR) as key qualifiers for strain safety. Current EFSA guidance on Bacillus safety illustrates the difficulty of deciding when a toxin is a toxin. The latest EFSA update on AMR was published in 2012, and sets cut-off values based on published data. There are also technical challenges in this area, for example the difficulty of setting appropriate cut-off values for “new” taxons with relatively few members.
  • Full genome – Exotic probiotic strains may be classed as “novel”, and could face evaluation by EFSA. For such strains, EFSA will require the full strain genome.
  • Strain identity – the use of modern molecular techniques to identify probiotic strains frequently results in taxonomy updates. A change in the taxonomy of a strain can result in regulatory challenges, especially if the new strain name is not listed as QPS (Qualified Presumption of Safety), updated annually by EFSA, or is no longer recognised as having a traditional use in fermented foods.

What’s new on strain efficacy?

Probiotics have still not succeeded in achieving a claim under the nutrition and health regulation, other than the generic claim for yoghurt bacteria, production of lactase and aid in digesting lactose in subjects with intolerance. It is interesting that the only approved probiotic claim in the EU is generic, since EFSA rejected most other generic probiotic claims on the grounds of lack of definitive strain identity. EFSA also insisted that probiotic efficacy is strain-specific. On the other hand there are around 40 probiotic strains approved for use in animal feeds, with several strains under EFSA evaluation. Demonstrating probiotic efficacy in animals to EFSA’s satisfaction is challenging, but possible. Perhaps there is room for more coherence across EFSA food and feed panels to allow best practices from both areas – human and animal?

If you wish to be informed on details of the probiotic regulatory landscape and learn about the golden rules of registration dossier preparation attend IPC this year.