International Probiotics Association – Anvisa Probiotic ... Conclusion.pdf · International...

“The Global Voice of Probiotics”“The Global Voice of Probiotics”

International Probiotics Association –Anvisa Probiotic Workshop Conclusion

George Paraskevakos, MBA

Executive Director, IPA November 2015


Our journey for this workshop�A two year work in process since Athens world congress


�Fast forward to this week

�And my detour through Rio

Our journey for this workshop

“The Global Voice of Probiotics”

Probiotics: The fasting growing supplements globally

*Euromonitor International


• Foods that contain live microbes are not necessarily probiotic• These foods may be healthy, but that does not make them probiotic

What qualifies a micro organism as a probiotic?


Probiotics; alone or together?

� Mono-strain probiotics

� Multi-strain probiotics

� Multi-species probiotics (is also multi-strain)


Single vs. Multiple strain

� What meta-analyses compare:

� Single strain (A) vs. Multiple strain (B + C)

� vs.

� What should be compared:

� Single strains (A, B) vs. their combination (A + B)

� vs. vs.


Unique as our DNA


The science around the world is the same


Regulations


Quick overview of the current regulatory FRAMEWORKfor probiotics supplements in global regions

• No positive lists • No FDA oversight

except for NDI or SF Claims (truthful)

• Intended use=food, supplement or drug

• QPS list • Notification (quick

market access)• No claim (except

Italy & Switzerland)

New framework • Generic claim

• Claims• Positive listsOnly limited by

pharma-like for sites

New framework• Claims possible • Quick market access(Evidence based notification)

• Positive list• Registration

(long)• Claims

• Positive list (monograph)

• Registration• Claims

No claims But market accessible

Existing

many regions

Existing category with specificities but easily achievable in many regions

issues in some areas

ROW achievable although limited by cultural trends/financial issues in some areas


Vitamins and Dietary Supplement

US$88.3 billion

Probiotic supplements

US$3.8 billion

Fortified Functional Packaged Foods

US$166.6 billion

Total Probiotic Yoghurt

US$30.8 billion

Probiotics: The fasting growing category globally



GERMANYGR 0%

$0.87 per capita spend

FRANCEGR 2%


ITALYGR 8 to 10%


BELGIUMGR 0%


W.Europe Probiotics supplements Growth rate and Per capita spending

Coincidence or Regulatory environment

Stagnating GrowthRussia -1%Poland 4%Ukraine -3%Finland 2%Norway -7%Sweden 1%

Mature market and probiotic guidelines for Italy


Y-on-y %

Growth

2008-

2009

2009-

2010

2010-

2011

2011-

2012

2012-

2013

2013-

2014

2014-

2015

Average in EU 20 4.5 3.4 -0.8 -2.0 -2.6 -1.3 -1.2

Probiotic yoghurt, Retail value year on year growth

Does the regulatory environment make a difference?


Probiotic regulations and claims ban


Approachable and Predictable


Workshop outcomes


Outcomes from today�More dialogue is needed

�Cooperation – Anvisa, Industry, IPA, Abifisa

�Share and discuss findings

�Should a review of the regulations be considered after today’s discussions

�…and hopefully to have a positive response to our invitation for the IPA world congress


Obrigado Pela Atencao.


�Contact:

�George Paraskevakos

[email protected]

+514.612.0472

+514.571.5949

Questions and Information

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