Latin America Webinar

Transcription

1 Latin America Webinar Recent changes and Trends in Labeling and Food Additives in Latin America 18 Oct 2017

2 Decernis: Research + Systems for Global Compliance 90,000 Regulations, 210 Countries, 16 Economic Areas 40 languages, 5 million synonyms & identifiers PRODUCTS & SERVICES Reference Horizon Scanning & Issue Management Formulation Compliance Analysis (Red Light/Green Light) Supply Chain Compliance Management Market Entry Reports & Translations 18 Oct 2017 Latin America Webinar 2

3 Latin America: 18 Oct 2017 Latin America Webinar 3

4 LATAM BLOCKS 18 Oct 2017 Latin America Webinar 4

5 Latin America 2017 North Pacific Ocean NAFTA = Canada, Mexico, USA (Puerto Rico) NAFTA CARICOM = 15 Members = Caribbean Islands COMIECO CARICOM EUROPEAN UNION = Anguilla, Aruba, Bermuda, British Virgin Islands, Cayman Islands, Curaçao, Falkland Islands, French Guianea, Guadeloupe, Martinique, Montserrat, Sint Maarten, Turks and Caicos SIECA (COMIECO) = Costa Rica, El Salvador Guatemala, Honduras, Nicaragua, Panama ALIANZA DEL PACÍFICO = Chile, Colombia, Mexico, Peru COMUNIDAD ANDINA = Bolivia, Colombia, Ecuador, Peru MERCOSUR = Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela = 33 Countries 15 Dependencies MERCOSUR South Atlantic Ocean

6 Review of Latin America Blocks MERCOSUR Alianza del Pacífico Comunidad Andina SIECA-COMIECO CARICOM Trends & Conclusions 18 Oct 2017 Latin America Webinar 6

7 MERCOSUR Flag Country Brazil UN Population Est. 1 May ,600,000 Argentina 44,900,000 Venezuela 33,700,000 Bolivia 10,985,059 Paraguay 6,700,000 Uruguay 3,500,000 MERCOSUR = 84% of SA GDP Total Population: 309,385,059 Venezuela: July 2012* Bolivia: July Oct 2017 Mercosur & South America Latin America Webinar 7

8 MERCOSUR 2015 Associate members: Chile Colombia Ecuador Guyana Peru Suriname Observers: Mexico New Zealand 18 Oct 2017 Latin America Webinar 8

9 MERCOSUR Food Additives MERCOSUR resolutions require transposition into national legislation Differences exist in implementation and interpretation Resolutions are influenced by the EU, Codex and US FDA Cannot rely on EU or US approvals = MUST be on Mercosur Positive lists For new food additives, applicants must submit to the national agencies, which will subsequently forward the application to Mercosur's Sub Work Group #3 18 Oct 2017 Latin America Webinar 9

10 MERCOSUR Food Additives Member Competent Authorities: Argentina: CONAL (+INAL /SENASA /INV) Bolivia: SENASAG (National Service for Agricultural Health and Food Safety) Brazil: ANVISA (National Agency of Sanitary Surveillance) Paraguay: INAN (National Institute of Food and Nutrition ) Uruguay: MINSAL (Ministry of Health) Venezuela: SENCAMER (National Autonomous Standardization, Quality, Metrology and Technical Regulations Service) 18 Oct 2017 Latin America Webinar 10

11 MERCOSUR Food Additives Regulatory Framework Category 1 - Milk Category 13 - Sauces and seasonings Category 2 - Oils and fats Category 14 - Protein and yeast products Category 3 - Edible ice creams Category 15 - Special Purpose Food Category 4 - Fruits and vegetables Category 16 - Beverages Category 5 - Candies, confectionery, chocolate Category 17 - Coffee, tea, mate and similar herbs Category 6 - Cereals and cereal products Category 18 - Snacks Category 7 - Bakery products and biscuits (Review) Category 19 - Desserts Category 8 - Meat and meat products (Review) Category 20 - Industrial culinary preparations Category 9 - Fish and fishery products Category 21 - Fortified or fortified foods Category 10 - Eggs and derivatives Category 22 - Nutritional supplements Category 11 - Sugar and honey Category 23 - Preparations for adding to milk Category 12 - Soups and broths Category 24 - Other 18 Oct 2017 Latin America Webinar 11

12 MERCOSUR- Labeling Overview Harmonization for general labeling and nutrition completed Partial harmonization for Claims No agreement for allergens nor GMO Under review Resolution for General and Nutrition labeling. 18 Oct 2017 Mercosur & South America Latin America Webinar 12

13 MERCOSUR Labeling Status Subject GMC/RES Nº Title (Spanish) Under review Under review Ingredients 06/94 Declaración de Ingredientes en la Rotulación de Alimentos Envasados Net content 22/02 Reglamento técnico para expresar la indicación Cuantitativa del contenido neto de los productos premedidos General Labeling 26/03 Rotulación de Alimentos Envasados Serving Sizes 47/03 Porciones de Alimentos Envasados a los Fines del Rotulado Nutricional Nutrition Labeling 44/03 46/03 Rotulado Nutricional de Alimentos Envasados 18 Oct 2017 Latin America Webinar 13

14 Chapter Description Articles Last Revised I General definitions /2010 II Standards for factories and distributors /2010 III Contaminants Catering and ready meals Preservation methods /2017 IV Food Packaging / Food Contact /2013 V Labeling /2013 VI Meat and related products (+poultry, fish eggs, etc) /2017 VII Oils and fats /2013 VIII Dairy foods /2014 IX Farinaceous (starchy) foods /2017 X Confectionery products (including honey and specialties) /2010 XI Vegetable foods /2017 Waters XII Non-alcoholic beverages /2012 XIII Fermented beverages (beer, cider, and wine) /2017 Argentine Food Code (Código Alimentario Argentino) XIV Alcoholic beverages (distilled spirits, liquors, other alcoholic beverages) /2012 XV Stimulant/Fruit-Based Products (cocoa, tea, coffee, and yerba mate ) /2013 XVI Additive Components (spices, sauces, color additives, essences, etc.) /2017 XVII Dietetic foods /2013 XVIII Food Additives /2014 XIX Protein flours, concentrates, and isolates /2010 XX General Analytical methods /2010 XXI Product Recall procedures /2010 XXII Miscellaneous / Oct 2017 Mercosur & South America Latin America Webinar 14

15 Argentina ALLERGENS CAA - Chapter V (Art. 235 séptimo) Modification Approved on 9 Oct Cereals containing gluten, Wheat, Rye, Barley and Oats 2. Crustaceans 3. Eggs 4. Fish 5. Peanuts 6. Soybean 7. Milk (and lactose) 8. Nuts (almonds, hazelnuts, chestnuts, pine nuts, pistachios...) 9. Sulfur dioxide and sulphites (concentrations equal to or greater than 10 ppm 365 days to adopt it. 15

16 Brazil - Food Additives Regulatory framework Consolidated per food category (June 2015) Category 1 - Milk Category 2 - Oils and fats Category 3 - Edible ice creams Category 4 - Fruits and vegetables Category 5 - Candies, confectionery, chocolate Category 6 - Cereals and cereal products Category 7 - Bakery products and biscuits Category 8 - Meat and meat products Category 9 - Fish and fishery products Category 10 - Eggs and derivatives Category 11 - Sugar and honey Category 12 - Soups and broths Category 13 - Sauces and seasonings Category 14 - Protein and yeast products Category 15 - Special Purpose Food Category 16 - Beverages Category 17 - Coffee, tea, mate and similar herbs Category 18 - Snacks Category 19 - Desserts Category 20 - Industrial culinary preparations Category 21 - Fortified or fortified foods Category 22 - Nutritional supplements Category 23 - Preparations for adding to milk Category 24 - Other 18 Oct 2017 Latin America Webinar 16

17 Brazil - Labeling CLAIMS Nutrient Content: MERCOSUR Res. adopted Functional and Health Claims ANVISA List (Updated as of Dec 2016) Safety and Efficacy Assessment of Functional and/or Health Claims - Resolution No 17 of April 30, Basic guidelines for food safety and risk assessment. - Resolution nº 18, of April 30, Basic guidelines for the analysis and verification of functional and/or health properties alleged in food labeling. 18 Oct 2017 Latin America Webinar 17

18 Brazil - Labeling ALLERGENS Resolution RDC No 26 of ingredients Tartrazine: Resolution RDC No 340/2002 Gluten: Law No /2003 Lactose: Resolution RDC No 36/ Wheat 2. Rye 3. Barley 4. Oats and their hybridized strains 5. Crustaceans 6. Eggs 7. Fish 8. Peanuts 9. Soybean 10. Milk of all species of mammals 11. Almond (Prunus dulcis, sin.: Prunus amygdalus, Amygdalus communis l.) 12. Hazelnuts (Corylus spp.) 13. Cashew chesnut (Anacardium occidentale) 14. Brazil nuts (Bertholletia excelsa) 15. Macadamias (Macadamia spp.) 16. Walnuts (juglans spp.) 17. Hickorynuts (Carya spp.) 18. Chestnust (Castanea spp.) 19. Natural Latex 18 Oct 2017 Latin America Webinar 18

19 Brazil Labeling UPCOMING CHANGES In August 2017 ANVISA is working on a draft to change requirements on labeling, based on the traffic light model and more warning labeling. 19

20 Uruguay Decree 315/944: National Bromatological Regulations: includes all additives and labeling from Mercosur resolutions Upcoming changes - Draft on Warning labelling (June 2017): Black octagon system (similar to a STOP sign) 20

21 Venezuela MERCOSUR member since 31 Jul MERCOSUR Adhesion Protocol established in Article 3 that Venezuela would have a period of four years to adopt the MERCOSUR Standards gradually. Venezuela has not yet fulfilled its 2012 transposition commitments. Thus, on 15 Sep 2016 Venezuela was denied Mercosur s rotating Presidency and is now suspended. In the mean time, both Mercosur adopted resolutions and national Venezuelan Standard promulgated by SENCAMER (Covenin standards), are still enforced. Draft Resolution "Rules Regulating the Labelling of Containers of Sodas and sugary drinks throughout the national territory" 21

22 Bolivia Mercosur Member since 31 Jul MERCOSUR Adhesion Protocol established in Article 3 that Bolivia will have a period of four years to adopt the MERCOSUR Standards gradually. Bolivia has no national Food Additives Regulations and would accept products which complied with Codex Standards. Today, compliance with Codex is still recommended. Approved Decree on Warning labelling: Based on Traffic light system (Law No. 775/2015: Healthy Food Promotion Act) 22

23 Bolivia 23

24 Alianza del Pacífico Countries: Colombia Chile Mexico Peru 24

25 Alianza del Pacífico Emerging trade block Created on 2014 Population of over 250 million inhabitants Free trade agreements for consumer products Move gradually towards the free movement of goods, services, capital and persons Has agreed to harmonize the regulations on priority sectors including cosmetics, medicines, medical devices, dietary supplements and processed foods and beverages Has requested the industry to develop and provide proposals for the regulatory harmonization 25

26 Mexico Mexican Technical Standards for Labeling: NOM-051-SCFI/SSA1-2010: General labeling and sanitary specifications for pre-packaged food and non-alcoholic beverages (amended in 2010 and 2014) 2014 amendment introduced the mandatory GDA system for : High levels of nutrients - Sugar, sodium, fats and caloric content per portion Nutrition Stamp -Voluntary for low and medium calorie products- 26

27 Mexico EXAMPLE OF A SINGLE PACK LABEL 27

28 Mexico EXAMPLE OF A FAMILY SIZE PACK LABEL: 28

29 Mexico ALLERGENS As per NOM-051 ( Art ): - Gluten, - Crustaceans products, - Eggs and egg products, - Fish and fish products, - Peanuts products, - Soy products (except oil), - Milk and dairy products, - Nuts and derivatives, - Sulfites in concentrations of 10 mg/kg or more. Must be declared in the ingredients list. HOW? Not defined + Phenylalanine 29

30 Mexico CLAIMS Mexico does not have a detailed regulation for Claims. COFEPRIS is working on the revision of NOM 086 Current version of NOM 086 contains very few nutrient content claims. Draft - NOM-086-SSA1-201 X, products and services. Food and non-alcoholic beverages with changes in its composition. Nutritional specifications. 30

31 Chile Decree 977: Food Sanitary Regulation - RSA Since June 2016: Warning labeling: Black octagon system Energy, Saturated fats, Sodium, Sugars 31

32 Chile ALLERGENS Resolution No 427/2010: Define the list as per Art 107 of the RSA Gluten-containing cereals: Wheat, oats, barley and rye, spelled or their hybrid strains, and products thereof. Crustaceans and their products. Eggs and their products. Fish and fishery products. Peanuts, soybeans and their products. Milk and dairy products (including lactose). Nuts and derivatives. Sulphites in concentrations of 10 mg/kg or more 32

33 Comunidad Andina Countries: Colombia Ecuador Peru Bolivia 33

34 Comunidad Andina Normas Andinas (NA) Are voluntary and based on national Standards Must be adopted by National Agencies BOLIVIA: Instituto Boliviano de Normalización y Calidad - IBNORCA ECUADOR: Instituto Ecuatoriano de Normalización - INEN COLOMBIA: Instituto Colombiano de Normas Técnicas y Certificación - ICONTEC INTERNACIONAL PERU: Instituto Nacional de Calidad INACAL Do not cover additives nor labeling National regulations apply A draft to harmonize labeling has been under discussion for years. 34

35 Colombia The Ministry of Health (MINSALUD) through INVIMA (National Food and Drug Surveillance Institute) Old regulations for food additives, still current but outdated in practice Various Drafts for food additives under discussion for years. They mainly refer to Codex In the meantime SEAB (Specialized group for food and beverages) established on Codex as reference for food additives not included in national regulations - JECFA and IOFI reference lists for permitted Flavors Draft on Warning labelling under discussion. Black octagon system 35

36 Ecuador INEN (National institute of Normalization) NTE(voluntary) vs RTE(mandatory) Adoption of codex Standard for Food Additives Established Traffic light system for warning labelling (RTE 022:2014) 36

37 Ecuador RTE 022:2014 Labeling of Processed and Packaged Food Products 37

38 Peru Mandatory Regulations - Law No 30021/2013: Promotion of Healthy Food for Children and Adolescents [comida chatarra] - Supreme Decree No SA: Approves the Regulation of Law No , Law of Promotion of Healthy Food Draft under discussion to establish specific rules (August 2017): - High in Sodium, Sugars, Saturated fats; Contains Trans Fats + Avoid excessive Consumption - Should be approved in October and implemented in two stages: 6 months/39 months 38

39 Peru Draft (August 2017): 39

40 COMIECO Countries: Costa Rica El Salvador Guatemala Honduras Nicaragua Panama 40

41 COMIECO Main regulation: Regulation RTCA :10 Food Additives - Adopted by all members but Panama - Amended on 2016 (Annex I & II) - Automatic update when Codex Stan changes (Art 6.1) - More ambitious than MERCOSUR 41

42 COMIECO General: Regulation RTCA :10 General Labeling of Prepackaged Foods - Adopted by all members. - Very close to Codex Stan Nutrition Labeling: RTCA : 10 Nutrition labeling of prepackaged foodstuffs for human consumption for the population from 3 years of age - Includes Nutrient content and Health claims requirements GUIDE 2016: Guide for RTCA interpretation General Labeling of Prepackaged Foods (28 pages) 42

43 COMIECO ALLERGENS Regulation RTCA :10 General Labeling of Prepackaged Foods (Art and Art ) Gluten-containing cereals: Wheat, oats, barley and rye, spelled or their hybrid strains, and products thereof. Crustaceans and their products. Eggs and their products. Fish and fishery products. Peanuts, soybeans and their products. Milk and dairy products (including lactose). Nuts and derivatives. Sulphites in concentrations of 10 mg/kg or more 43

44 CARICOM Countries: Antigua & Barbuda Bahamas Barbados Belize Dominica Grenada Guyana Haiti Jamaica Montserrat St Kitts & Nevis Saint Lucia St Vincent & Grenadines Suriname Trinidad and Tobago 18 Oct 2017 Latin America Webinar 44

45 CARICOM CARICOM Regional Org. for Standards and Quality (CROSQ) Regional standards for : - Brewery Products - Food Hygiene - Fruit and Fruit-based products Harmonization still under way for main areas - No Regional Standards for Food Additives - No National Standards for Food Additives National Ministries refer to Codex, EU and FDA depeding on relationship with foreing blocks. 18 Oct 2017 Latin America Webinar 45

46 Latin America: Trends and Conclusions Development of blocks underway, but in different velocity Increasing Harmonization Additives: Based on Codex and EU Labeling: - Claims under regulated - New trend on Warning Labeling: 3 Models Traffic Light GDA Black octagon 18 Oct 2017 Latin America Webinar 46

47 Gracias! Thanks to: Elvira Gonzalez, Decernis LATAM Co-Researcher Kevin C. Kenny, J.D., LL.M. Chief Operating Officer Decernis LL.C Connecticut Avenue NW, #200 Washington, D.C Tel US Mobile +1 (301) Int. Mobile +49 (163) Adrián Varela Álvarez Team Leader Americas Decernis LL.C. Mobile Oct 2017 Latin America Webinar 47