International Probiotics Association Anvisa Probiotic …

1 The Global Voice of Probiotics The Global Voice of Probiotics International Probiotics Association Anvisa Probiotic WorkshopGeorge Paraskevakos, MBAE xecutive Director, IPA Monday November 30, 2015 The Global Voice of Probiotics The Global Voice of Probiotics Executive Summary Probiotics the fastest growing category Growth across all regions EU being the exception* Even though science is the same Regulations vary across all global regions Review and rethink Probiotic regulations Create a clear and concise path Stakeholder meetings Probiotic workshops Opinion calls IPA the global voice of Probiotics will lead the initiative worldwide The Global Voice of Probiotics The Global Voice of Probiotics Many industry associations all independent Geographic variability Their missions Intersecting and overlapping Governance varies Membership also intersecting and overlapping Information informally shared between associations via members Friendly yet competitive environment Result.

2 Probiotic Industry is not unified Credibility Confusion Industry needs a strong recognizable voiceProbiotic Associations the landscape The Global Voice of Probiotics The Global Voice of Probiotics The IPA -Who we are Non profit International organization Members 50+ member companies over 600 scientists researchers academics Bringing together the Probiotic sectors stakeholders: Researchers/Scientists Academics / Education providers Health Care Professionals Consumers Industry Regulators NGO status before Codex Alimentarius The Probiotic industries ombudsman The Global Voice of Probiotics The Global Voice of Probiotics The IPA -Mission Bringtogetherallstakeholdersintheprobiot icsectorandbetheuniqueplatformwhereallth esepeopleandentitiesinteractandcollabora tetoincreaseprobioticawarenessamongusers andhelpenabletheindustry ssustainablegrowth. The Global Voice of Probiotics The Global Voice of Probiotics IPA Objectives Reinforce our position as The Global Voice for Probiotics Be the Go to Probiotic Association for the sector Regulators, Press, Industry, End Users YOY Growth Member companies And scientific representation Instill credibility and confidence For Probiotic issues Market place queries Government agencies Market presence and inclusion IPA Member Companies engagement and participationoBoard and Committee Educators, HCP.

3 Consumers The Global Voice of Probiotics The Global Voice of Probiotics Initiatives to get there Increased IPA visibility Press releases IPA Member alerts Trade shows presence Speaking engagements Increase technical paper publications At risk populations guideline Probiotic Labelling best practices guideline Stability guidelines Criteria to qualify micro organisms as Probiotic Comment on stakeholder opinion calls Creation of Education platform for Consumer and HCP IPA WC and Probiota expansion The Global Voice of Probiotics The Global Voice of Probiotics Supported by Probiotic website for end users collaborating with WRBM Probiotic tool application for consumers IPA Board Participation Center for Digestive Health of the New Jersey Institute for Food, Nutrition and Health (IFNH), Rutgers U AEP Alliance for Education on Probiotics New IPA committee objectives Establishing global scientific standards Regional regulatory affairs teams Growing stakeholder meetings Market data initiative with Euromonitor, WRBM, others Webinars, education hubs The Global Voice of Probiotics The Global Voice of Probiotics IPA Organizational Chart Executive Director Board of Directors Executive Committee Scientific Committee Regulatory Affairs Committees Marketing & Education Committee Independent Scientific Advisory BoardNominating Committee The Global Voice of Probiotics The Global Voice of Probiotics IPA s BOD Geographical Composition The Global Voice of Probiotics The Global Voice of Probiotics The Global Voice of Probiotics The Global Voice of Probiotics Recent Merge International Probiotics Association (IPA) Global Alliance for Probiotics (GAP)

4 Yoghurt Live Fermented Milks Association (YLFA) A single representative platform in Europe: International Probiotics Association Europe (IPA Europe) The Global Voice of Probiotics The Global Voice of Probiotics Recent Merge IPA Europe Official launch date was September 30 2015 Brussels HQ Key stakeholders and European officials in attendance Head of Unit EFSA Head of Unit DG Sante MEP s Commitment for more dialogue Commitment to a framework towards a solution The Global Voice of Probiotics The Global Voice of Probiotics Market Overview from aGlobal Perspective The Global Voice of Probiotics Global (Retail Value 2015 Estimates) Probiotics : The fasting growing category globally*Euromonitor International Vitamins and Dietary SupplementUS$ billionProbiotic supplementsUS$ billionAmericasUS$ billionFortified Functional Packaged Foods US$ billionTotal Probiotic YoghurtUS$ billionAmericas Probiotic YoghurtUS$ billion The Global Voice of Probiotics Global (Retail Value 2015 Estimates) Probiotics : The fasting growing category globally*Euromonitor International Vitamins and Dietary SupplementUS$ billionProbiotic supplementsUS$ billionEUUS$ billionFortified Functional Packaged Foods US$ billionTotal Probiotic YoghurtUS$ billionEU Probiotic YoghurtUS$ billion The Global Voice of Probiotics Probiotics : The fasting growing supplements globally*Euromonitor International The Global Voice of Probiotics Global Brands.

5 Who is leading the way *Euromonitor International The Global Voice of Probiotics The Global Voice of Probiotics Distribution channels 34%36%30%N. AmericaFDMHFSD irect90%10%S. AmericaPharmacyAll other80%20%EuropePharmacyAll other60%40%AustralasiaHFSP harmacy*NBJand Research and MarketsConsumers dependant on HCP s counsel The Global Voice of Probiotics The Global Voice of Probiotics Pharmacy 100%Niche shops 50%50% Others: Pharmacy, MLM, , Mass 75%Pharmacy 25%TV shopping, Direct, MLM, 75%HFS, Pharmacy 25%Distribution channels *NBJand Research and Markets The Global Voice of Probiotics Probiotic supplements: US the largest growth market*Euromonitor International The Global Voice of Probiotics *Euromonitor International Probiotic supplements: Italy largest consumer usage The Global Voice of Probiotics Top countries Americas - Probiotic supplement valueTop three countries hold 96% of retail value share*Euromonitor International AmericasUS$ billion market The Global Voice of Probiotics Americas Probiotic supplements Growth rate and Per capita spendingUSA GR 14% to 24%$ per capita spend*Euromonitor International / NBJCANADAGR 13% to 15%$ per capita spend BRAZILGR 2% to 3%$ per capita spend The Global Voice of Probiotics Top countries EMEA Probiotic supplement value in 2015 Top five countries hold 80% of retail value share*Euromonitor International EUUS$ billion market The Global Voice of Probiotics *Euromonitor International GERMANYGR 0%$ per capita spend FRANCEGR 2%$ per capita spend ITALYGR 8 to 10%$ per capita spend BELGIUMGR 0%$ per capita spend supplements Growth rate and Per capita

6 SpendingCoincidence or Regulatory environmentStagnating GrowthRussia -1%Poland 4%Ukraine -3%Finland 2%Norway -7%Sweden1%Mature market and Probiotic guidelines for Italy The Global Voice of Probiotics Y-on-y % Growth2008-20092009-20102010-20112011-20 122012-20132013-20142014-2015 Average in EU yoghurt, Retail value year on year growth Does the regulatory environment make a difference?*Euromonitor International Probiotic regulations and claims ban The Global Voice of Probiotics -250-200-150-100-50 -201220132014201520162017201820192020 EUR million, fixed 2015 exchange ratesPotential Lost Retail Value Sales for SpoonableYoghurt 2012-2020 FranceNetherlandsUKEuromonitor International Research and Industry Demand Model, Data based on the Health and Wellness 2016 EditionDoes the regulatory environment make a difference? The Global Voice of Probiotics -250-200-150-100-50 -201220132014201520162017201820192020 EUR million, fixed 2015 exchange ratesPotential Lost Retail Value Sales for Probiotic Drinking Yoghurt 2012-2020 AustriaBelgiumFranceGermanyNetherlandsUK Euromonitor International Research and Industry Demand Model, Data based on the Health and Wellness 2016 EditionDoes the regulatory environment make a difference?

7 The Global Voice of Probiotics Digestive wellness platform -Erosion in the EU and explosion in China*Euromonitor International The Global Voice of Probiotics Markets particularly affected: Austria, Belgium, France, Germany, Netherlands and the UK The EU Probiotic claims ban will continue to constrain the market Estimate of what the ban has cost the yoghurt market in lost retail sales is valued at overEUR500 millionsince 2012 in these countries. Future outlook between 2015 and 2020 the market stands to losea further EUR1 billionin retail sales as a direct result of the restrictive regulatory the regulatory environment make a difference? The Global Voice of Probiotics The Global Voice of Probiotics News and Events The Global Voice of Probiotics The Global Voice of Probiotics USP meet Probiotic round table, USP HQ, Washington DC, Nov 20, 2015 The Food Chemicals Codex(FCC)

8 Model for Probiotic Monographs Strain Specificity Reference Materials-scientific literature Tests for Contaminating Microorganisms Identify and become more specific as per usage Enumeration / Overages / Label Claims Standards and guidelines which will be accepted with regulators and industry Next steps Summary, Framework, Timeline The Global Voice of Probiotics The Global Voice of Probiotics IPA meet at FDA HQ, Washington DC, Nov 19, 2015 IPA member companies and FDA workshop FDA presentation at IPA World Congress Revised NDI s notification draft publishing shortly How can we work efficiently Reduce workload for FDA and industry Logical solutions Commitment for more dialogue Public health and Consumer Top priorityFDA meet The Global Voice of Probiotics The Global Voice of Probiotics IPA World Congress 2016 Program details May 31, June 1&2, Chicago, Westin North Day One Women s health Workshop & Scientific frontiers posters Opening cocktail reception Day Two Regulatory track and round table with EFSA, Health Canada, FDA, FSANZ, Anvisa ?

9 Our Microbiome Probiotics and insights from Health Practitioners Standards Speed Networking and Opening diner reception Day Three Brand success stories Manufacturing and delivery forms Gut Brain Scientific frontiers presentation Panel Discussion The Global Voice of Probiotics The Global Voice of Probiotics References Euromonitor International NBJ/ New Hope media Research and Markets Disclaimer: Some of the information in this presentation is of a statistical nature and, while every attempt has been made to ensure accuracy and reliability, Euromonitor International cannot be held responsible for omissions or errors. Analyses may not totally reflect the companies opinions, viewer discretion is advised. The Global Voice of Probiotics The Global Voice of Probiotics Obrigado Pela Atencao. The Global Voice of Probiotics The Global Voice of Probiotics Contact: george and Informatio