Latin America Webinar - Decernis€¦ · Latin America Webinar 34 Normas Andinas (NA) • Are voluntary and based on national Standards • Must be adopted by National Agencies BOLIVIA:

Latin America WebinarRecent changes and Trends in Labeling and Food Additives in Latin America

18 Oct 2017

Latin America Webinar18 Oct 2017

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

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Latin America:

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LATAM BLOCKS

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Latin America 2017

North Pacific Ocean

South Atlantic Ocean

NAFTA

COMIECO

MERCOSUR

CARICOM

NAFTA = Canada, Mexico, USA (Puerto Rico)

MERCOSUR = Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela

SIECA (COMIECO) = Costa Rica, El SalvadorGuatemala, Honduras, Nicaragua, Panama

CARICOM = 15 Members = Caribbean Islands

ALIANZA DEL PACÍFICO = Chile, Colombia, Mexico, Peru

COMUNIDAD ANDINA= Bolivia, Colombia, Ecuador, Peru

EUROPEAN UNION = Anguilla, Aruba, Bermuda, British Virgin Islands, Cayman Islands, Curaçao, Falkland Islands, French Guianea, Guadeloupe, Martinique, Montserrat, Sint Maarten, Turks and Caicos

=33 Countries15 Dependencies

http://www.worldometers.info/world-population/anguilla-population/

http://www.worldometers.info/world-population/turks-and-caicos-islands-population/


•MERCOSUR•Alianza del Pacífico•Comunidad Andina•SIECA-COMIECO•CARICOM•Trends & Conclusions

Review of Latin America Blocks

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MERCOSUR

7Mercosur & South America

MERCOSUR = 84% of SA GDPTotal Population: 309,385,059

Venezuela: July 2012*Bolivia: July 2015

Brazil209,600,000

Argentina 44,900,000

Venezuela 33,700,000

Bolivia 10,985,059

Paraguay 6,700,000

Uruguay 3,500,000

CountryUN Population Est.

1 May 2017Flag


MERCOSUR

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Associate members:• Chile• Colombia• Ecuador• Guyana• Peru• Suriname

Observers:• Mexico• New Zealand

2015


• 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

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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)

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Regulatory Framework

• 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 (Review)• Category 8 - Meat and meat products (Review)• 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

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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.


MERCOSUR- Labeling


MERCOSUR – LabelingStatus Subject GMC/RES Nº Title (Spanish)

Ingredients 06/94Declaración 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

Underreview

General Labeling 26/03

Rotulación de Alimentos EnvasadosServing Sizes 47/03 Porciones de Alimentos Envasados a los Fines del

Rotulado NutricionalUnderreview

Nutrition Labeling 44/0346/03

Rotulado Nutricional de Alimentos Envasados

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Argentine Food Code(Código Alimentario Argentino)


Chapter Description Articles LastRevised

I General definitions 1-11 9/2010

II Standards for factories and distributors 12 - 154 10/2010

III

ContaminantsCatering and ready mealsPreservation methods 155 - 183 1/2017

IV Food Packaging / Food Contact 184 - 219 1/2013

V Labeling 220 - 246 6/2013

VI Meat and related products (+poultry, fish eggs, etc) 247 - 519 1/2017

VII Oils and fats 520 - 552 8/2013

VIII Dairy foods 553 - 642 10/2014

IX Farinaceous (starchy) foods 643 - 766 04/2017

X Confectionery products (including honey and specialties) 767 - 818 9/2010

XI Vegetable foods 819 - 981 1/2017

XIIWatersNon-alcoholic beverages 982 - 1079 10/2012

XIII Fermented beverages (beer, cider, and wine) 1080 - 1107 2/2017

XIV Alcoholic beverages (distilled spirits, liquors, other alcoholic beverages) 1108 - 1136 7/2012

XV Stimulant/Fruit-Based Products (cocoa, tea, coffee, and ‘‘yerba mate’’) 1137 - 1198 2/2013

XVI Additive Components (spices, sauces, color additives, essences, etc.) 1199 - 1338 1/2017

XVII Dietetic foods 1339 - 1390 3/2013

XVIII Food Additives 1391 - 1406 1/2014

XIX Protein flours, concentrates, and isolates 1407 - 1412 9/2010

XX General Analytical methods 1413 - 1414 9/2010

XXI Product Recall procedures 1415 - 1416 9/2010

XXII Miscellaneous 1417 2/2017

Latin America Webinar18 Oct 2017 15

ALLERGENSCAA - Chapter V (Art. 235 séptimo) Modification Approved on 9 Oct 2017

365 days to adopt it.

Argentina

1. 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


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

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Brazil - LabelingCLAIMS

• 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, 1999 - Basic guidelines for food safety and risk assessment.- Resolution nº 18, of April 30, 1999 - Basic guidelines for the analysis and verification of functional and/or health properties alleged in food labeling.

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Brazil - LabelingALLERGENS

• Resolution RDC No 26 of 201519 ingredients

• Tartrazine: Resolution RDC No 340/2002• Gluten: Law No 10.674/2003• Lactose: Resolution RDC No 36/2017

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1. 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


UPCOMING CHANGES

• In August 2017ANVISA is working on a draft to change requirements on labeling, based on the traffic light model and more warning labeling.

Brazil – Labeling


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)

http://www.dni.gub.uy/documents/22028/0/PROYECTO%20DE%20DECRETO_Rotulado%20de%20Alimentos%20Envasados.pdf#filename=RotuladodeAlimentosEnvasados.pdf


• MERCOSUR member since 31 Jul 2012.

• 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"

Venezuela

http://spgoin.alejandria.biz/cgi-win/be_alex.cgi?Documento=T028700003583/0&Nombrebd=spgoin&CodAsocDoc=195&Sesion=1852301225#filename=20161006_moh_rules_regulating_the_labelling_of_containers_of_sodas_and_sugary_drinks.pdf


• Mercosur Member since 31 Jul 2015.

• 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)

Bolivia


Bolivia


Countries: ColombiaChileMexicoPeru

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 andprocessed foods and beverages

• Has requested the industry to develop and provide proposals for the regulatory harmonization

Alianza del Pacífico


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-

Mexico


EXAMPLE OF A SINGLE PACK LABEL

Mexico


EXAMPLE OF A FAMILY SIZE PACK LABEL:

Mexico


ALLERGENSAs per NOM-051 ( Art 4.2.2.2.3):- 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

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.

Mexico

http://www.canilec.org.mx/Circulares%202015/85del15/NOM-086_DTB_2015-06-29.pdf


Decree 977: Food Sanitary Regulation - RSA

• Since June 2016: Warning labeling: Black octagon system

Energy,

Saturated fats,

Sodium,

Sugars

Chile


ALLERGENSResolution 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

Chile


Countries: ColombiaEcuadorPeruBolivia

Comunidad Andina


Normas Andinas (NA)

• Are voluntary and based on national Standards

• Must be adopted by National AgenciesBOLIVIA: Instituto Boliviano de Normalización y Calidad - IBNORCAECUADOR: Instituto Ecuatoriano de Normalización - INENCOLOMBIA: Instituto Colombiano de Normas Técnicas y Certificación - ICONTEC INTERNACIONALPERU: 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.

Comunidad Andina

http://www.ibnorca.org/

http://www.inen.gov.ec/

http://www.icontec.org.co/

http://www.indecopi.gob.pe/


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 2016

- 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

Colombia


• 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)

Ecuador


• RTE 022:2014 Labeling of Processed and Packaged Food Products

Ecuador


• Mandatory Regulations- Law No 30021/2013: Promotion of Healthy Food for Children and Adolescents

[comida chatarra]

- Supreme Decree No 017-2017-SA: Approves the Regulation of Law No. 30021, 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

Peru


• Draft (August 2017):

Peru


Countries: Costa RicaEl SalvadorGuatemalaHondurasNicaraguaPanama

COMIECO


Main regulation:

Regulation RTCA 67.04.54:10 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

COMIECO


General:Regulation RTCA 67.01.07:10 General Labeling of Prepackaged Foods- Adopted by all members. - Very close to Codex Stan

Nutrition Labeling: RTCA 67.01.60: 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 67.01.07.10 General Labeling of Prepackaged Foods (28 pages)

COMIECO


ALLERGENSRegulation RTCA 67.01.07:10 General Labeling of Prepackaged Foods(Art 5.2.1.4 and Art 5.2.1.4)

• 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

COMIECO


• Countries:• Antigua &• Barbuda • Bahamas• Barbados • Belize• Dominica• Grenada• Guyana

• Haiti• Jamaica • Montserrat • St Kitts & Nevis• Saint Lucia • St Vincent &

GrenadinesSuriname

• Trinidad and Tobago

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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 AdditivesNational Ministries refer to Codex, EU and FDA depeding onrelationship with foreing blocks.

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CARICOM


• 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 ModelsTraffic Light GDA Black octagon

Latin America: Trends and Conclusions

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¡Gracias!Thanks to: Elvira Gonzalez, DecernisLATAM Co-Researcher

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Kevin C. Kenny, J.D., LL.M.Chief Operating OfficerDecernis LL.C.1250 Connecticut Avenue NW, #200Washington, D.C. 20036Tel. +1 301-240-1800US Mobile +1 (301) 535-2234Int. Mobile +49 (163) 435-2234E-Mail: [email protected]

Adrián Varela ÁlvarezTeam Leader AmericasDecernis LL.C.Mobile +34 637 58 69 69E-Mail: [email protected]

mailto:[email protected]

mailto:[email protected]

Documents

Latin America Webinar - Decernis€¦ · Latin America Webinar 34 Normas Andinas (NA) • Are voluntary and based on national Standards • Must be adopted by National Agencies BOLIVIA: