Future global regulation of probiotics for humans and animals – preview of Dr Elinor McCartney’s presentation at IPC2017

Posted 22 May, 2017

If you are thinking of bringing a probiotic to market, you will need to have the right knowledge and understanding of how they are regulated before you take the plunge. Dr Elinor McCartney’s presentation at the International Scientific Conference on Probiotics and Prebiotics will give an insight into the latest regulatory developments and challenges facing probiotics, with special focus on EU legislation. Dr McCartney will also deliver an interactive workshop on “Probiotic efficacy in humans and animals – how to achieve success with EFSA,” an opportunity for delegates to broaden their knowledge, work on case studies and increase their chances of success.

The good, the bad and the ugly – future global regulation of probiotics for humans and animals

The good news

The good news is that the future of probiotics is bright. There is global pressure from consumers, scientists and regulators to reduce antibiotics in humans and animals, linked to increasing consumer appetite for healthier life-styles, encompassing diet, exercise, quality of life, and longevity. Human and animal probiotics contribute to all these goals.

The bad news

The bad news is that probiotics are not a “silver bullet”, nor a panacea for all global health and welfare issues. Probiotics do not “cure cancer”, not yet and not until GMO food probiotics gain consumer acceptance. Neither do probiotics solve metabolic syndrome – at least not until subjects with metabolic syndrome give up smoking, heavy drinking/drug abuse, over-eating, under-exercising and switch from a junk food diet to one based on wholemeal bread/pasta/rice, fish, fruits, vegetables, fresh salads, olive oil, and a moderate amount of dairy/meat/soy products.

More bad news for the probiotic industry is that regulatory hurdles for human and animal probiotics tend to increase, matching giant leaps in technology, for example the relative ease of mapping the full genome of microbial strains, with increasing demands in key areas:

  • Strain taxonomy,
  • AMR- Antimicrobial Resistance of probiotic strains, phenotypic and genotypic
  • Strain toxins and virulence factors
  • Strain efficacy/utility
  • Strain stability and minimum effective dose
  • Probiotic efficacy claims.

Some good news

For consumers, technology and regulatory scrutiny are both good news. It is essential that probiotic strains should be correctly identified; should not transfer AMR; should not transmit toxins or virulence factors; should confer benefit/s to animals, food products, and/or consumers; should be presented in effective minimum doses to the end of their shelf-life; and should not make fraudulent claims.

The ugly 

Potential “ugly” future challenges for probiotics lie within the complexities of technology:

  • GMM Food Probiotics – Why Not? For example, why not control Type II diabetes, often induced by unhealthy eating habits, with healthy eating habits, including dietary GMM probiotics that produce insulin? EU consumers are probably the most reactionary to GMM food probiotics.
  • The Microbial Genome is a double-edged sword. Increasingly, regulators are demanding a “clean” genome, which means no genes coding, or partially-coding, for AMR, toxins or virulence factors. Hence, strains previously accepted as “safe”, are ater rejected due to perceived genomic risk, e.g. Toyocerin (Bacillus toyonensis). Toyocerin, a feed probiotic, failed to pass EU/EFSA’s re-evaluation, despite satisfying SCAN and EFSA previously. Interestingly, EU food probiotics are not subject to an EU/EFSA pre-market safety evaluation, unless novel. Hence, in a good example of regulatory incoherence, EU food probiotics may be marketed with AMR profiles that would not pass EFSA’s safety assessment.
  • Lack of Global Coherence on Efficacy Claims. For example, the EU permits zootechnical production claims for feed probiotics, whereas the USA and Canada do not. The EU/EFSA have been tough on food probiotic efficacy claims, perhaps too tough, as well as inconsistent.


So far, so good, more work required globally.

For more information, please contact us or visit the conference website.