Kevin C. Kenny, J.D., LL.M Chief Operating Officer Decernis

LATAM Regulatory Update

Kevin C. Kenny, J.D., LL.MChief Operating Officer

Decernis

15 Jan 2020

Recent Changes and Trends

LatAm Regulatory Update

Decernis: Research + Systems for Global Compliance

• 100,000 Regulations, 218 Countries, 26 Economic Areas

• 40 languages, 5 million synonyms & identifiers

• Cooperations with 50 Governments

PRODUCTS & SERVICES

• Reference

• Horizon Scanning

• Formulation Compliance Analysis (Red Light/Green Light)

• Supply Chain Compliance Management

• Regulatory Consulting

• ENGLISH TRANSLATIONS

3


Agenda

Latin America• Harmonization Progress

• Additives & Labeling

• FOP Requirements

• Trends

4


LATAM Region

5

Covers four different geographic SUBREGIONS:

North America (1 Country)

Central America (7 countries)

Caribbean (13 countries & 15 Dependencies)

South America (12 countries)


LATAM Region

6

Cuturally speaking:

Latin America: ES + PT + FR

Iberoamerica: ES + PT

South America: South of Colombia

LATAM

Languages: Spanish, Portuguese,

French, English, Dutch

Latin America 2020

North Pacific

Ocean

South Atlantic

Ocean

NAFTA

COMIECO

MERCOSUR

CARICOM

NAFTA (USMCA) = Canada,

Mexico, USA (Puerto Rico)

MERCOSUR = Argentina, Bolivia, Brazil,

Paraguay, Uruguay, Venezuela

SIECA (COMIECO) = Costa Rica, El Salvador

Guatemala, 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 Guiana, Guadeloupe,

Martinique, Montserrat, Sint Maarten, Turks and

Caicos

=33 Countries15 Dependencies


•USMCA (new NAFTA)

•MERCOSUR

•Alianza del Pacífico

•Comunidad Andina

•SIECA-COMIECO

•CARICOM

Review of Latin America Blocks

8


US-Mexico-Canada Agreement (USMCA)

Updated version of NAFTA• Improvements in autos, labor and environmental standards

• 16-year sunset clause, subject to renewal every six years.

• Added 16 Dec 2019: Rapid-Response Mechanism (independent, three-person

panel of multinational experts for on-site verifications on questions whether workers

are being denied key labor rights (think Mexican Union Rules).

CURRENT STATUS

• Mexico approved in June 2019

• House of Representatives endorsed deal on 19 Dec 2019

• Will be voted on by US Senate end Jan 2020, expected to pass.

• Canada waiting on US approval before voting. If US ratifies, Canada is expected to follow suit.

9


Mexico

10

USMCA

• Population (1 Jan 2020): 127,575,529 GDP $1.29 Trillion• Largest US Trade Partner for much of 2019 (US-China trade

challenges)

LatAm Regulatory Update 11

• Baseline Food Law

- The Framework for foods consists of One base regulation:

Regulation on Sanitary Control of Products and Services (1999, revised 2016)

Two types of Standards:

NOM: Norma Oficial Mexicana (Mandatory)NMX: Norma Mexicana (Voluntary)

• Responsible Agencies to enforce the DecreeThe Secretariat of Health delegated to

COFEPRIS (Federal Commission for the Protection from Sanitary Risks)

responsibility for foods, including additive, labelling, packaging, etc

Mexico


Framework for Food Additives: One regulation:

Regulation on Sanitary Control of Products and Services (1999, revised 2016):Titles 23 and Appendix 21, setting basic rules for the use of food additives

And one Agreement:

Agreement of July 16, 2012: Additives and processing aids permitted in foods, drinks and dietary supplements, their use and sanitary provisions

Food regulations published in the Diario Oficial de la Federación (DOF)(Mexican equivalent of US

Federal Register). https://www.dof.gob.mx;

http://www.economia-noms.gob.mx/noms/inicio.do

Before they reach the DOF, Updates are published in:https://www.gob.mx/cofepris/acciones-y-programas/aditivos-alimentarios-no-publicados-en-el-dof

Mexico – Food Additives


The Agreement of 2012 is divided in XI annexes:- ANNEX I: Additives with various functional classes and with an established ADI;

- ANNEX II: Additives with various functional classes that may be used according to GMP;

- ANNEX III: Colorants with an established ADI;

- ANNEX IV: Colorants that may be used according to GMP;

- ANNEX V: Purified substances to chew;

- ANNEX VI: Enzymes;

- ANNEX VII: Sweeteners with an established ADI;

- ANNEX VIII: Sweeteners that may be used according to GMP;

- ANNEX IX: Additives permitted in infant formula, follow-on formula and formula for special

nutritional needs;

- ANNEX X: Enhancing agents in production,

- ANNEX XI: FlavoringsPositive listed additives are allowed in foods, unless restricted or prohibited by a specific NOM

Mexico – Food Additives


Mexican Technical Standards

The Federal Law on Metrology and Standardization established two types of standards:

NOM, Official Mexican Standards (Mandatory)= Technical Regulations from Agencies and Ministries

http://www.economia-noms.gob.mx/noms/inicio.do

NMX, Mexican Standards (Voluntary)= Voluntary, from national standards bodies

https://www.sinec.gob.mx/SINEC/Vista/Normalizacion/BusquedaNormas.xhtml

Mexico – Labeling


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 PDP symbols system for :

• High levels of nutrients- Sugar, sodium, fats and

caloric content per portion

• Nutrition Stamp -Voluntary for low and medium calorie products-

Mexico – Labeling


MERCOSUR

16

MERCOSUR = 84% of SA GDP

Total Population: 306,366,059

Venezuela: July 2012*

Bolivia: July 2015


MERCOSUR

17

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

Observers:• Mexico• New Zealand

2015


• Created 26 March 1991

• Foundational members: Argentina, Brazil, Paraguay and Uruguay

• MERCOSUR resolutions require transposition into national legislation

• Differences exist in implementation and interpretation

• Resolutions are influenced by the EU, Codex and US FDA

• Harmonized SOI, Food Additives, Food Contact, Food Labeling, Food Contaminants, Cosmetics and other consumer products

• Political changes directly affect the regional entity

• Venezuela suspended since 2017. Bolivia still awaiting final approval

18

MERCOSUR


MERCOSUR

MERCOSUR (El Mercado Común del Sur)

MERCOSUL (O Mercado Comum do Sul)

Common Market of the South

Common Market Group Resolutions – Resoluciones Grupo Mercado Común (GMC)

Additives & labeling Groups

Food Commission

Technical Subgroup 3 (SGT 3) Technical Regulations and Evaluations of Conformity)

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Member Competent Authorities:

• Argentina: ANMAT - 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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MERCOSUR


Overview

• +/- Harmonized for Additives

• +/- Harmonized for general labeling and nutrition

• Partially harmonized for Claims

• No agreement for Allergens or GMO

• Under review: Resolutions for General and Nutrition labeling

• Discussion ongoing for harmonized Front of Pack

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MERCOSUR



GMC/RES Resolution No 31/92: Definitions of Ingredient, Food Additive, Processing Aid, Contaminant and fundamental principles of use

• Additives organized per food category (24 in total)

• Differences in national implementation and interpretation still exist.

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MERCOSUR – Food Additives


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

• 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 and 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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MERCOSUR – Food Additives


MERCOSUR – Food AdditivesStatus Food Category/Function GMC/RES Nº Title (Spanish)

Definitions of Food Additive & Processing Aid

31/92 Definiciones de Ingrediente, Aditivo Alimenticio,

Coadyuvante de Elaboración, Contaminante y los

principios fundamentales de uso

Criteria to maintain thegeneral list

17/93 Criterios de mantenimiento de la lista general de

aditivos alimentarios

Defintion of thefunctions

83/93 Definiciones de diferentes Funciones de Aditivos

Alimentarios

Principale to transfer Additives

105/94 Principio de Transferencia de Aditivos Alimentarios

Bakery Products 50/97Aditivos para Categoría 7: Productos de Panificación y

Galletería

ReviewDraft

Meat Products 73/97 Aditivos para Categoría 8: Carnes y Productos cárnicos

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All 52/98 Criterios para Asignar Funciones de Aditivos, Aditivos y su

Concentración Máxima a todas las Categorías de

Alimentos

Confectionery and Cocoa Products

53/98 Aditivos para la Categoría de Alimentos 5: Caramelos,

pastillas, confites, chicles, turrones, productos de cacao y

chocolates, bombones, baños rellenos, etc

Desserts 54/98Aditivos para la Categoría de Alimentos 19: Postres

Addition of gelatin as Additive

55/98 Actualización de la lista general armonizada de Aditivos:

Gelatina

Soups and gravies 16/00 Aditivos para la Categoría de Alimentos 12: Sopas y

Caldos

Ready meals 51/00 Aditivos para la Categoría de Alimentos 21:

Preparaciones Culinarias Industriales

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Restriction of certainadditives

15/05

Restricción de Uso de Determinados Aditivos Alimentarios

Ice creams 07/06 Aditivos para la Categoría de Alimentos 3: Helados

Comestibles

Sauces and seasonings 08/06 Aditivos para la Categoría de Alimentos 13: Salsas y

Condimentos

Carbonated and Non Carbonated Non-alcoholic Beverages

09/06 Aditivos para la Categoría de Alimentos 16.2: Bebidas No

Alcohólicas, Subcategoría 16.2.2: Bebidas No Alcohólicas

Gasificadas y No Gasificadas

Flavors in all foods 10/06 Reglamento Técnico sobre Aditivos Aromatizantes/

Saborizantes

Under

Review

Harmonized additivesand its functions

11/06 Reglamento Técnico sobre Lista General Armonizada de

Aditivos Alimentarios y sus Clases Funcionales

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Cereals and basedcereal products

09/07Aditivos para la Categoría de Alimentos 6: Cereales y

Productos a base de cereales

Exclusion of certainadditives

34/07

Exclusión de uso de aditivos alimentarios

Snacks 02/08Aditivos para la Categoría de Alimentos 18. Productos

para copetín (Snacks)

Additives approvedunder GMP

34/10 Aditivos alimentarios autorizados para ser utilizados según

las Buenas Prácticas de Fabricación (BPF)

Maximum limits foradditives excluded ofGMP approved list

35/10 Límites Máximos para Aditivos excluidos de la Lista de

Aditivos Alimentarios Autorizados para ser utilizados

según las Buenas Prácticas de Fabricación

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

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

prémedidos

Under

review

General labeling 26/03

Rotulación de Alimentos Envasados

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

Rotulado Nutricional

Under

review

Nutrition labeling 44/0346/03

Rotulado Nutricional de Alimentos Envasados

Claims 01/12

Información Nutricional Complementar (INC)

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Mandatory Label Information (GMC No 26/03)

1. Name of food 2. List of ingredients 3. Net quantity of the food4. Business operator5. Country of origin6. Date of minimum durability7. Batch number (Lote)8. Conditions of use, when needed9. Nutrition declaration Mandatory (GMC No 46/03)

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MERCOSUR


MERCOSUR – Transposition (browse)https://www.mercosur.int/documentos-y-normativa/normativa/


MERCOSUR – Transposition (search)https://www.mercosur.int/documentos-y-normativa/normativa/


MERCOSUR - Transpositionhttps://www.mercosur.int/documentos-y-normativa/normativa/


Countries: ColombiaChileMexicoPeru

Alianza del Pacífico


Emerging trade block• Created in 2014

• Population of over 250 million inhabitants

• Free trade agreements for consumer products

• Move gradually towards free movement of goods, services, capital and

persons

• Has agreed to harmonize regulations on priority sectors including

cosmetics, medicines, medical devices, dietary supplements and

processed foods and beverages• Has requested industry to develop and provide proposals for regulatory

harmonization

• No regulation has been harmonized as of today…

Alianza del Pacífico



Decree 977/96: Food Sanitary Regulation - RSA (Consolidated as of May 2019, 200 pp)

• Responsible Agencies to enforce the RSA

– MINSAL (Ministry of Health)

• Food additives are regulated by the Food Sanitary Regulation

- In Title III: Requirements and limits

- Flavors: Accepts FAO, EU, FDA, FEMA (Art. 155)

- Enzymes: Accepts Codex (Art. 158)

Chile – Food Additives


Decree 977: Food Sanitary Regulation - RSA

Paragraph II of Title II includes

a) Mandatory information

b) Nutrient content & Health Claims

c) Since June 2016: New FOP Warning labeling system (more later!)

Chile – Labeling


Countries: ColombiaEcuadorPeruBolivia

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…

Comunidad Andina


The Ministry of Health (MINSALUD) through

INVIMA (National Food and Drug Surveillance Institute)

• Publish regulations and decrees for Food Additives and food Standards

• Old regulations, still current but outdated in practice

• SEAB (Specialized group for food and beverages) established

- Codex as reference for food additives not included in national regulations

- JECFA and IOFI reference lists for permitted Flavors

• Various Drafts under discussion for years.

- Drafts refer mainly to Codex.

Colombia – Food Additives


• General: Resolution 5109 of 2005: Technical regulation on labeling

requirements for packaged food and food raw materials

• Nutrition declaration and claims: Resolution 333 of 2011: nutritional labeling

requirements to be fulfilled by foods packaged for human consumption

• New Claims: Resolution No 684 of 2012: Protocol for the Approval of New

Statements of Health Properties of Foods (Based on EU rules)

• RIEN - Resolution 3803 of 2016: By which Energy and Nutrient Intake

Recommendations (RIEN) established for Colombian population

• Responsible Agencies to enforce Resolutions

• The Ministry of Health (MINSALUD) through INVIMA (National Food and

Drug Surveillance Institute)

• SEAB (Specialized group for food and beverages) can solve queries on all food related questions

Colombia – Labeling



Supreme Decree No 007/98: Regulation on health

surveillance and control of food and beverages


–Ministry of Health ARCSA (National Agency for Regulation, Control and Surveillance of Health)

–INEN (National institute of Normalization) NTE(voluntary) vs RTE(mandatory)

• Adoption of codex Standard for Food Additives

Ecuador – Food Additives


• RTE

- RTE INEN 022:2014 Rotulado de productos alimenticios procesados, envasados y

empaquetados

• NTEs

- NTE INEN 1334-1:2014 Rotulado de productos alimenticios para consumo

humano. Parte 1. Requisitos


humano. Parte 2. Nutrition labeling. Requisitos


humano. Parte 3. Requirements for Nutrition and Health Claims

Ecuador – Labeling



Supreme Decree No 007/98: Regulation on health

surveillance and control of food and beverages


–MINSA - DIGESA (Directorate General for Environmental Health)

–INACAL (National Institute of quality)– Copyright Voluntary Standards

• No national list of Food additives, SD 007/98 refers to:

- Codex for food additives

- FDA, EU and FEMA for flavors

Peru – Food Additives


• Peruvian Technical Standards – (NTP) (Voluntary)

• General

- NTP 209.038:2014 Prepackaged Food. Labeling

- NTP 209.655:2016 Labeling. Trans fats content declaration

- NTP 209.652:2017 Prepackaged food. Nutrition labeling

• Claims

- NTP CODEX CAC/GL 23:2012 Labeling. Use of Nutrient Content and Health Claims

- NTP 209.650:2014 Labeling. Claims

Peru – Labeling


Countries: Costa RicaEl SalvadorGuatemalaHondurasNicaraguaPanama

COMIECO


• SICA: Secretary of Integration in Central America

• SIECA: Secretary of Economic Integration in Central America

• Created on 29 October 1993• Population of 47,8 million inhabitants

• Has harmonized Food Additives, labeling, Microbiological contaminants,

Dairy Products, Pesticides, Consumer goods

• RTCA: Reglamento Técnico Centroamericano

• Codex is its first external reference

• Panama joined on 2015

COMIECO


Main regulation:

Regulation RTCA 67.04.54:10 Food Additives

- Adopted by all members but Panama

- Divided in IV annexes

- Amended on 2016 (Annex I & II)

- Automatic update when Codex Stan changes (Art 6.1)- More ambitious than MERCOSUR

COMIECO - Food Additives


NEW 2019 Regulation:Resolución No. 419-2019, Sustituye totalmente RTCA Alimentos y Bebidas Procesadas. Aditivos AlimentariosRegulation RTCA 67.04.54:10 Adopts Replacement Annex: RTCA 67.04.54:18, 1ra Revisión- Publication: 5 Dec 2019; Entry into force will be 5 Jun 2020- In process of adoption by all members

- More ambitious than MERCOSUR



RTCA 67.04.54:18, 1ra Revisión


NEW in 2019:RTCA 67.04.54:18, 1ra Revisión- Annex A “List of Permitted Additives” sets max limits for additives which differ

from conditions set by Codex Stan 192-1995 – adopts limits based on either FDA

or EU additives (documented).

- Annex B “Additives established in RTCA 67.04.54:10 which have not been

adopted by Codex.”

- Annex C Procedures for updating the lists of Additives

- Annex D Diagram of update procedure for Annexes A and B

- Hierarchy: First check RTCA, then check CODEX- Codex - Automatic update when Codex Stan changes (Art 6.1)



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 requirements for Nutrient Content Claims and Health Claims

GUIDANCE 2016: Guide for RTCA interpretation 67.01.07.10 General labeling of

Prepackaged Foods (28 pages)

COMIECO - Labeling


• Countries:

• Antigua &

Barbuda

• Bahamas

• Barbados

• Belize

• Dominica

• Grenada

• Guyana

• Haiti

• Jamaica

• Montserrat

• St Kitts & Nevis

• Saint Lucia

• St Vincent & Grenadines

• Suriname

• 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

- GMP

• 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 depending on relationshipwith foreign blocks.

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CARICOM – Food Additives


No Regulation – Emails

55

CARICOM – Food Additives


CARICOM Regional Org. for Standards and Quality (CROSQ)

• Regional (Copyright) standards for :

- Labeling: Including Nutrient Content and Health Claims!(CRS 5:2010)

- Labeling of Goods – General requirements (CRS 55-1: 2016)

Other related standards:

- Cocoa and Chocolate Products (CRS 34:2018)

- Carbonated Beverages - Specification (CRS 53:2018)

• Harmonization still under way for many areas

National Ministries refer to Codex, EU and FDA depending on theirrelationships with foreign blocks.

56

CARICOM - Labeling

FOP in Latin America


• Refers to the Principal Display Panel of product

• Focus on Nutrition Rating System & Symbols

• To fight obesity, overweight and diabetes, especially with children

• Always for SUGARS, SATURATED FATS and SODIUM

• Can be considered as opposite of Claims: Mandated by Governments

• Intended to help consumer make healthier choices, leading to healthier diets

• Having key nutrition information displayed prominently on the front of food packages could encourage manufacturers to reformulate products

• Global trend but mainly in the Americas - spreading also in Europe, Middle East, etc.

Front of Package Labeling - FOP


FOP & Codex(2017)


• PAHO: Panamerican Health Organization recommends Black Octagon system

• MERCOSUR: No agreement on various aspects of labeling are creating delays on revisions and approval of new Resolutions

• Nothing in other clusters

• No harmonization in this field

FOP in LATAM


Three Systems:

1- Traffic Light

2- Octagons

3- Guideline Daily Amount (GDA)

FOP


Argentina

62Mercosur & South America


Argentine Food Code (Código Alimentario Argentino - CAA)

• Responsible Agencies to enforce the CAA

– ANMAT (National Administration of Drugs, Foods and Medical Devices)- for additives and labeling

– INAL (Food National Institute) – regulates consumer-ready food products, health supplements, and

both alcoholic and non-alcoholic beverages, with the exception of wine.

– SENASA (National Service of Agrarian Health and Quality) – for food contaminants

• Food labeling regulated by the Argentine Food Code,

– where all MERCOSUR Resolutions are transposed.


Argentine Food Code (Código Alimentario Argentino)

Source:http://www.conal.gob.ar/CAA_ultimas_modificaciones.php

See also:www.argentina.gob.ar/anmat/codigoalimentario

63

Chapter Description ArticlesLast

Revised

I General definitions 1-11 9/2010

II Standards for factories and distributors 12 - 154 8/2019

III

Contaminants

Catering and ready meals

Preservation methods 155 - 183 7/2019

IV Food Packaging / Food Contact 184 - 219 1/2019

V Labeling 220 - 246 10/2017

VI Meat and related products (+poultry, fish eggs, etc) 247 - 519 9/2019

VII Oils and fats 520 - 552 12/2018

VIII Dairy foods 553 - 642 3/2019

IX Farinaceous (starchy) foods 643 - 766 7/2019

X Confectionery products (including honey and specialties) 767 - 818 5/2019

XI Vegetable foods 819 - 981 10/2019

XII

Waters

Non-alcoholic beverages 982 - 1079 10/2012

XIII Fermented beverages (beer, cider, and wine) 1080 - 1107 12/2018

XIV Alcoholic beverages (distilled spirits, liquors, other alcoholic beverages) 1108 - 1136 7/2019

XV Stimulant / Fruit-Based Products (cocoa, tea, coffee, and ‘‘yerba mate’’) 1137 - 1198 12/2018

XVI Additive Components (spices, sauces, color additives, essences, etc.) 1199 - 1338 4/2019

XVII Dietetic foods 1339 - 1390 11/2018

XVIII Food Additives 1391 - 1406 9/2019

XIX Protein flours, concentrates, and isolates 1407 - 1412 11/2018

XX General Analytical methods 1413 - 1414 7/2019

XXI Product Recall procedures 1415 - 1416 9/2010

XXII Miscellaneous 1417 5/2019


• Public discussion on FOP – Focus on Childhood obesity

• A draft will be soon presented, presumably with the Octagon System

• Document from the Ministry of Health of Argentina Frontal Nutritional Food Labeling (Dec 2018)

• Discrepancy within Mercosur: Disagreement on various aspects of labeling creating delays on revisions and approval of new Resolutions

Argentina


• Three different models under public discussion

• More to come!

Argentina


• 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.

• A LONG way to go – Little from MERCOSUR has been officially adopted.

• Bolivia previously had no Food Additives Regulations and would accept

products which complied with Codex Standards. Codex still recommended.

• Nutrition labeling: Bolivian Voluntary Standard NB 314004:2009 Nutritional

Labeling

• Approved Decree on FOP labeling: Based on Traffic light system

(Law No 775/2015: Healthy Food Promotion law)

Bolivia


BoliviaLaw No 775/2015: Healthy Food Promotion law


Bolivia


In August 2017

ANVISA:- Started working on a draft to change requirements on labeling, making

mandatory the FOP.

- Public and private companies have been involved in the discussion.

Most popular the one based on the traffic light System.

Brazil


In August 2019 ANVISA- Presented a Draft to change requirements on nutrition labelling, making

mandatory the FOP.

- Public and private companies have been involved in the discussion.

Brazil


Decree 977: Food Sanitary Regulation - RSA

• Since June 2016: FOP labeling: Black Octagon System

Energy

Saturated fats

Sodium

Sugars

Chile


Chile


• Draft on Warning labeling under discussion: Guideline Daily Amount (GDA) system

proposed by industry:

Colombia


• Model Suggested by OPS & National Ministry of Health (Minsal)

Colombia


• INEN (National institute of Normalization)

NTE (voluntary) vs RTE (mandatory)

• RTE 022:2014 - labeling of Processed

and Prepackaged Food Products

Established Traffic light system for Front of Pack

Ecuador


Ecuador


Mandatory GDA System adopted on 2014:

Introduced by amendment to Mexican Standard: NOM-051-scfi-2010

• High levels of nutrients- Sugar, sodium, fats and

caloric content per portion

• Nutrition Stamp -Voluntary for low and medium calorie products-

Mexico


Mexico


EXAMPLE OF A SINGLE PACK LABEL

Mexico


Mexico


• 10 Oct 2019 Draft Amendment to NOM-051-SCFI/SSA1-2010 published in Federal Official Gazette: Labeling requirements for prepackaged foods and non-alcoholic beverages:

- New Definitions: sugar added and sugar-free, natural or artificial sweetener, front labeling system, warning stamps, etc.

- Extensive new restrictions on advertising

- Adopts new Front Labeling System

Mexico

Final Date for Comments:10 Dec 2019

“Excess calories”“Excess sugars”….“Contains sweeteners”“Contains caffeine”“Avoid on children”


UPDATE 8 November 2019: Mexican Congress approves amendment to General Health Law to introduce clearer FOP.

Article 66Amendment requires Mexican health authorities oversee to establish official standards to protect

health of Mexican school-age population. Must promote nutritious food and physical activity.

Article 115Establishes nutritional standards that meet basic food consumption needs, avoiding high content

of sugar, saturated fats, trans fats and sodium.

Article 210MOH shall consider International Treaties and Conventions and also ensure labeling complies with

provisions of Political Constitution of Mexico.

Mexico


UPDATE 8 November 2019: Mexican Congress approves amendment to General Health Law to introduce clearer FOP.

Article 212Labeling must include nutritional info which is easy to understand, accurate, direct, simple, and

visible. FOP Labeling Warning Signs required for products that exceed max levels of energy

content, added sugar, saturated fat, sodium, and others established. MOH can require inclusion

of legends and pictograms when it considers doing so necessary.

Article 215FOP Labeling nutritional information should be easy to understand, accurate, direct, simple, and

visible. This article deems critical nutrients to be food components that can be a risk factor for

chronic non-communicable diseases (NCDs) as determined by the Ministry of Health

Mexico


• 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

- Manual on Advertising Warnings published in June 2018: High in Sodium, Sugars, Saturated fats; Contains Trans Fats

+ Avoid Excessive Consumption

Peru


Peru


Winner: MOH

In force from 17 June 2019

Peru


Uruguay

• Decree 315/944: National Bromatological Regulations: includes all additives and labeling from Mercosur resolutions

• Modified on Sept 2018 by

Decree 272, that made Black Octagon

System mandatory

• Entry in force postponed to 2020.


Uruguay


• Development of blocks (5) underway, but in different velocity Increasing Harmonization

• Additives: highest level of Harmonization

• Allergens: Vary from country to country

• Labeling: - Claims under regulated

- New trend on FOP labeling: 3 Models

Traffic Light GDA Black octagon

Latin America: Trends and Conclusions

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Thank you!Kevin C. Kenny, J.D., LL.M.Chief Operating OfficerDecernis LL.C.1250 Connecticut Avenue NW, #700Washington, DC 20036 USATel. +1 301-240-1800US Mobile +1 (301) 535-2234EU Mobile +49 163-435-2234E-Mail: [email protected]

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Special thanks to:

• Adrian Varela & Estefania Garcia, Latin America Specialists

• Julie Holt and Llaine Groninger, Labeling and Additive Specialists

Kevin C. Kenny, J.D., LL.M Chief Operating Officer Decernis

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