PROBIOTA 2018 PANEL DEBATE: Regulation and policy: The shifting sands of Europe Barcelona, February 8th, 2018 Probiotics in Latin America. Regulation, Market and Trends Dr Javier Morán Director. IIA-Instituto Universitario de Innovación Alimentaria Director. San Antonio Technologies Universidad Católica de Murcia www.ucam.edu
Some preliminary Data
Latin America 20 countries, 17 from the Americas and 3 from the Caribbean region Almost 600 million inhabitants A non uniform region: great ethnical, political, econ omical, cultural and social differences Inequality and poverty are the main challenges of the region
Purchase by distribution channel and refrigeration at point of sale Purchases Refrigeration 98,40% 67,60% 41,60% 46,60% 23,80% 11,80% Modern Channel Traditional Channel Both Channels
Factors influencing food choice in Latin America 100% 90% 80% 70% 60% 50% 40% 3º 30% 2º 20% 1º 10% 0%
Socio-economic strata in Latin America, as a percentage of the population 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1997 1998 2008 2012 2016 6 5 4 3 2 1 0
Structure of the monthly expenditure of popular households Others 8% Dressing 4% Transport 16% Education 5% Entertainment 3% Housing 25% Food 34% Health 5%
The importance of the pyramid base (BOP) 72,70% 64,60% 36,70% 32,10% 35,90% 38,10% 47,40% 23,20% 24,30% 28,90% 32,10%
Latin American Consumer Health Concerns Stress Overweight/Obesity Others Osteoporosis Mental decline Lack of energy Joint health Intestinal regularity Immunity Hypertension Eye Health Cholesterol Cardiovascular D. Cancer Aging 0,00% 10,00% 20,00% 30,00% 40,00% 50,00% 60,00% 70,00% 80,00%
Positioning opportunities in Latin America 70% Cancer Eye health 60% Alzheimer's Heart disease Lack of focus Joint health Tiredness Concern ned With 50% 40% 30% 20% 10% High cholesterol Weak immune system Stress Osteoporosis GI problems Arthritis Overweight/obesity Hypertension Sleep problems High blood glucose Build-up of Toxins Depression Diabetes Lack of hydration Wrinkles/ signs of aging Macular degeneration Anemia Frequent colds, flus Metabolic syndrome Food allergies Other allergies Menopause Prostate problems Underweight Lactose intolerance Axes cross at median values 0% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Affected By
Market Trends
Probiotic Retail Value Sales by Country
Per capita average consumption (USD/year) of Probiotics 12,87 6,34 2,16 0,45 1,98 Asia Africa Europe Latam USA
Probiotic Retail Value in 2016: 5,18 billion USD
Probiotic Retail Value Growth by Country (last 5 years)
Expected market growth until 2024 (USD billion)
Top-selling products in Latin America Floratil (BR) Sinuberase (MX) Bion Intime (Chile) Activia (MX) Regeneris (CO) Yakult (BR)
Regulation
Regulatory status in Latin America Country Regulatory Status Regulation Observation/s Argentina Food Supplement RESOLUCION CONJUNTA 118/2008 Y 474/2008 UFC/g Bolivia Brasil Chile Drug Food Supplement Food Supplement LEY MEDICAMENTO 1737/1996 PROPOSTA ANVISA JUNHO 2017 DECRETO SUPREMO 977/1996 1x10e7 Genus and strains. No GMO. Culture collection. Safety and efficacy. Live and resistant Colombia Food Supplement DECRETO 3863/2008 1x10e6 Live and resistant Costa Rica OTC Drug OFICIOS NS 1742/99 y 1744/99 Ecuador Case by Case DECRETO EJECUTIVO 1583/2001 México Food Supplement LEY GENERAL DE SALUD 1984 1x10e9 Strain. Culture collection. Perú Food Supplement LEY 27821/2002 Venezuela Food Supplement COVENIN 10:12-001
Generic claims in Latin America Country Generic Regulation Generic Claims Argentina Bolivia Brasil NO NO YES Chile YES EXENTA 764/2009 Daily consumption of milk or dairy products containing these live bacilli contributes to maintaining the balance of intestinal flora and/or regulating intestinal transit and may help stimulate the immune system. Adequate nutrition and regular consumption of food or dietary Colombia YES RESOLUCION 3096/2007 supplements with probiotic microorganisms can help to normalize digestive functions, regenerate the intestinal flora, promote natural defenses, decrease the growth of bacteria that cause colon infections and reduce acidic conditions in the stomach, contributing to the formation of a protective layer. Costa Rica Ecuador NO NO México PROPUESTA NOM 086 Probiotic that naturally forms part of the intestinal flora. It provides the living microorganisms that naturally form part of the intestinal flora. Probiotic that contributes to healthy intestinal flora. Provides live microorganisms that contribute to healthy intestinal flora. (Name of the microorganism) contributes to the balance of the intestinal flora. Perú Venezuela NO NO
Request for new health claims Country New claims request Argentina YES DISPOSICION 2873/2012 Bolivia NO Brasil YES RESOLUÇAO 18/99 Chile YES EXENTA 764/2009 Colombia YES RESOLUCION 684/2012 Costa Rica Ecuador NO NO México YES PROPUESTA NOM 086 Perú NO Venezuela YES COVENIN 2952-1:1997
Differences between Regulatory Agencies Canadá USA Japón UE Latin America The scientific standards for the substantiation of claims may vary according to the claim category There is a guideline for the substantiation of claims YES YES YES No YES YES YES Only in Japanese Sí NO There is tolerance for claims based on "emerging evidence" YES YES YES No NO Include examples of claims approved for probiotics YES NO YES YES NO Probiotic characterization is critical to substantiate the claim YES It is assumed that yes It is assumed that yes YES YES
Evidence about probiotics in Latin America (last 10 years) Clinical Trials Country Total Published Ongoing Argentina 307 10 4 Bolivia 7 2 3 Brasil 437 3 26 Chile 72 6 7 Colombia 23 1 3 Costa Rica 1 0 0 Ecuador 4 0 0 México 120 9 13 Perú 16 3 4 Venezuela 2 0 0
Conclusions
Drivers for probiotic growth in Latin America Health and wellness trends Recommendations from Doctors Recommendations from friends and family Consumer education on probiotics Supplements of questionable origin still sold in internet exchange sites
Final thoughts OPPORTUNITIES Higher consumer interest on healthy lifestyles Demographic shift to an adult population who may require products to maintain digestive health CHALLENGES Regulation of health claims Cannibalization of sales High prices of probiotics supplements
Muchas gracias!!