BRAZIL : what s new in the Regulations for Nutrition? Ary Bucione Danisco / DuPont 1
Agenda Agenda Introduction with South America South America - Health status Brazil: Mortality status Regulatory Min. of Health - ANVISA Medical nutrition Functional Foods Other important nutrition aspects Additional nutritional labeling information Salt reduction program for industries LATAM regulatory future: Will Brazil lead? BRAZIL : what s new in the Regulations for Nutrition? 2
Introduction with overall status in South America South America is the south cone of LATAM 12 countries with GDP of USD 4,067 billion Language: Spanish (only Brazil - Portuguese) Brazil is the strongest economy Population: 190 million GDP (2010) of USD$ 2,297 billions (GDP EU Union US$16,400 billion) Mercosur is the common market of 4 countries of the south region Argentina, Brazil, Paraguay and Uruguay GT-3 Working group: food regulatory Mexico is within NAFTA (North America Free Trade Agreement). BRAZIL : what s new in the Regulations for Nutrition? 3
% South America Health status Digestive disorders (diarrhea, constipation, bloating, discomfort) are felt by everyone - owing to factors including diet, stress, demanding lifestyles and ageing. They are the 5 th principal cause of mortality in Latin America and the 4 th in South Africa The most common is constipation, considered a major public health issue 50 45 40 35 30 25 20 15 10 5-31 30 35 Ageing population drive digestive health market growth in SAMSA 21% of SAMSA is > 50 years old now, rising to 30% by 2020 1516 20 21 19 31 27 24 39 28 28 19 19 16 17 17 15 22 18 17 25 38 36 42 Colombia 21.7% * Its rate is 3x higher in women 2000 2005 2020 4 Source: Euromonitor 2011, Peppas et al., Journal of BMC Gastroenterology / WHO, Health in the Americas, 2007 18 16 26 11 10 10 12 12 13 16 15 21 Constipation Prevalence through the world Region Country Prevalence EUROPE Germany 5.4% United Kingdom 7.7% Italy 7.9% France 14% ASIA South Korea 16.7% China 15.2% Indonesia 12.9% AMERICAS US 17.7% Brazil 16.7% Argentina 14.2%
Mortality (per 100,000 individuals) Cenário atual: Participação das Non transmitted chronic diseases no adoecimento e óbitos da população: Brazil Mortality trend: 1996-2007. CNCD- chronic non-communicable with 72% of deaths in 2007 Reductions: -20% Mortality - 31% CVD Cardio Vascular -38% CRD Chronic respiratory +2% Mellitus diabetes CNCD CVD Cancer C R D Diabetes Other CNCD Fonte: Schmidt MI, Duncan BB, Silva GA, Menezes AM, Monteiro CA, Barreto SM, Chor D, Menezes PR. Health in Brazil 4. Chronic non-communicable diseases in Brazil: burden and current challenges. The Lancet 2011; 377.
Brazil - National Food and Nutrition Policy - 1999 Ensuring the safety and quality of foods and service: Health Surveillance. Monitoring of food and nutrition situation: SISVAN (markers of Dietary Intake), surveys and research. Promoting health: dietary practices and healthy lifestyles Healthy diet Prevention and control of (Biomarkers): nutritional disorders and diseases related to food and nutrition: obesity and overweight, chronic non-communicable diseases. BRAZIL : what s new in the Regulations for Nutrition? 6
Brazil Food and Nutrition CGAN - General Coordination of Food and Nutrition Responsible for the National Policy for Food and Nutrition. Promoting health nutrition - Review of PNAN: strengthening health surveillance, promotion of healthy eating, nutrition in health care and food security and nutrition. Plan to reduce chronic non-communicable diseases: Surveillance (Sisvan, surveys and research), Health Promotion and Health Care Food Sector Chamber (Anvisa and MS), good nutritional practices, consumer education, promotion of healthy eating. Food Guide for the Brazilian Population HEALTH has no price BRAZIL : what s new in the Regulations for Nutrition? 7
Brazil - Main regulatory characteristics Min of Health and Min of Agriculture ANVISA - National Health Surveillance Agency Is responsible for: Foods, Drugs, Cosmetics, Pesticides and Sanitizers Risk assessment and toxicology Blood and human body organs Health and test laboratories production and marketing of products and services ports, airports and boarders Min. of Agriculture: More related with food of animal and vegetal origin Pharmaceutical and foods are organized in different structures Example: functional foods must avoid mention of diseases names Main International regulatory references: CODEX (JECFA), EU (EFSA) and FDA BRAZIL : what s new in the Regulations for Nutrition? 8
Foods with Allegations of Functional and Health Properties Scientific-Technical Report Ingredients or nutrient content Referring to health (labeling): metabolic function in the body Allows reduction of risks claims Acceptance testing by: Toxicological Clinical Epidemiological Biochemical Mention of prevention or cure must be avoided. *Resolutions 16, 17, 18 and 19 of Apr 09 BRAZIL : what s new in the Regulations for Nutrition? 9
Main functional allegations approved Triglicerydes Omega Free radical Lycopene, lutein and Zeaxantin Intestinal benefit Probiotics Polydextrose and Dietary fibers, resistant starches, FOS and Inulin. Hydrolised Guar gums, lactulose Cholesterol absorption Phytosterols npsillium Soy protein Beta Glucan Fat absorption Chitosan Oral care Manitol / Xylitol / Sorbitol. BRAZIL : what s new in the Regulations for Nutrition? 10
Brazil other important nutrition aspects Sodium reduction program for industries Technical Cooperation Agreement improving the nutritional profile of processed food Free agreement : Min. of Health and ABIA ABIA Brazilian Food Industry association Started Nov 2007 and reviewed in April 2011 Additional Nutritional Information Being reviewed with Public Consultation 21 of 2011 Omega 3, 6 and 9 (new). Fat: total, saturated and trans (new) Carbohydrate, sugar, calories, fiber, protein, vitamin +minerals Changes the standards for the single portion sizes. Goes beyond single food labelling It limits the food publicity. BRAZIL : what s new in the Regulations for Nutrition? 11
LATAM regulatory future: Will Brazil lead? Brazil until now has leaded the regulatory initiatives Being present and vocal in all of the JECFA and CODEX meetings. Influenced by the internal economic growth Awareness of the importance of regulatory matters well known within the region with good level of quality of its laws Argentina has good position in regulatory However more overall internal harmonization is suggested Colombia and Chile have advanced lately INVIMA in Colombia is active and open for the regulated sector MINSAL is influenced by the international trade with USA. Mercosur is the virtual alternative for the south of the region Evolution has been slow due strong differences of every country Mexico will continue highly driven by FDA. BRAZIL : what s new in the Regulations for Nutrition? 12
Conclusions Foods are treated with exclusive structure. Food safety for nutrition has required more focus Regulated food sector claims for more participation Food producers have evolved and are more mature for contribution Food supplements requires new definition Until now mostly vitamins and minerals are permitted Industry currently working a new proposal (last 2 years) Medical nutrition in the food sector Still a gray area with lots of growing opportunities Currently food for infants are under assessment What ANVISA could learn from EFSA EFSA is equally respected as CODEX Although CODEX will continue playing stronger influence. BRAZIL : what s new in the Regulations for Nutrition? 13
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