G/TBT/N/BRA/821  
 
13 June 2018  
(18-3657) Page: 1/6 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: BRAZIL   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: Brazilian Health Regulatory Agency (Anvisa)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
https://pesquisa.anvisa.gov.br/index.php/981335?lang=pt -BR 
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Public 
Taking of subsidies  
5. Title, number of pages and language(s) of the notified document: Public Taking of 
subsidies n°  1 of 21 May 2018 - Portuguese   
6. Description of content: Brazil was one of the first countries to adopt mandatory nutrition 
labelling as part of the public health strategy to promote adequate and healthy food habits 
and to combat overweight.  
This measure provided consumers with a suitable profile of nutrients contained in the food 
and considered to be of nutritional importance so that a wise choice of food can be made. 
Additionally, it encouraged the voluntary reformulation of foods in a way that benefited 
public health.  
The process conducted by Anvisa helped to ensure consumers' right to information about 
the basic compositional characteristics of foods and contributed to Mercosur being the first 
economic bloc to have harmonized compulsory n utrition labelling, which has facilitated 
trade between countries.  
After the implementation of this regulatory measure, some inconsistencies and practical 
limitations of the regulation were identified and addressed through amendments in the 
legislation. H owever, the need for a more comprehensive review was identified.  
Thus, Anvisa provided the technical subsidies to support the request for revision of this 
issue in Mercosur and established a Physical Working Group on Nutrition Labelling, with the 
participa tion of several stakeholders, with the aim of assisting in the identification of 
problems in the transmission of nutritional information and alternatives that could help G/TBT/N/BRA/821  
 
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  improving the effectiveness of this information to consumers.  
The results of these st udies contributed to the inclusion of this topic in the Regulatory 
Agenda 2017/2020 and to the approval of the regulatory initiative for the revision of 
nutrition labelling regulations at the end of 2017.  
The subsidies obtained in this process identified that the main regulatory problem is the 
difficulty of Brazilian consumers in using the nutrition labelling. Several reviews of 
international scientific literature and researches in Brazil revealed that a significant portion 
of consumers have difficulty und erstanding and using nutrition labelling.  
This problem accentuates the information asymmetry, undermines consumers' ability to 
make wise food choices, reduces the effectiveness of nutrition labeling, and damages 
consumers' basic right to information on foo d composition.  
Different factors that contribute to this problem were identified: (a) the low level of 
education and nutritional knowledge of the Brazilian population; (b) confusions about the 
nutritional quality of foods that are generated by the nutriti on labelling model; (c) difficulty 
in visualizing, reading, processing and understanding the nutritional table; (d) 
inconsistencies in the veracity of the declared nutrition information; and (e) lack of 
nutritional information in many foods.  
In this sense , several regulatory causes that explain this scenario and that are within the 
legal competencies of Anvisa were diagnosed. Other causes of a non -regulatory nature 
have also been identified which require the involvement of other stakeholders and are 
essent ial for effective resolution of the regulatory problem.  
In this sense, the objective of regulatory intervention is to facilitate the use of nutritional 
labeling to make wise food choices by Brazilian consumers. To achieve this objective, six 
specific objec tives were defined: (a) improving the visibility and readability of nutritional 
information; (b) facilitate understanding of the main nutritional attributes of food; (c) 
reduce situations that create confusion about the nutritional composition of foods; (d ) 
facilitate nutritional comparison between foods; (e) improve the accuracy of declared 
nutritional values; and (f) broaden the scope of nutrition information.  
To identify the most appropriate alternatives, Anvisa conducted an evaluation of the 
proposals for improvement of nutrition labelling presented by several stakeholders and 
reviews of international regulatory experiences and of studies comparing the effects  of 
various front -of-pack nutrition labelling (FOPL) models on the attention, understanding and 
use of this information by consumers.  
This work showed that there is no regulatory and scientific consensus on the FOPL models 
that would be most effective for  each group of consumers. Beside that it was identified 
that the proposals presented to Anvisa had several limitations.  
In relation to the international regulatory scenario, it was noted that, in recent years, 
many countries have adopted actions to facilit ate the use of nutritional information by 
consumers, and that the adoption of FOPL models was the main alternative found.  
This approach communicates the main nutritional attributes of foods to consumers, in a 
simple, visible and easily understandable way.  The increase in this type of initiative 
constitutes a new stage in the regulation of nutrition labeling, fruit of the knowledge 
accumulated during more than two decades of researches and regulatory initiatives.  
The survey revealed that more than 40 count ries already have some type of FOPL models 
implemented and that there is no standardization of designs, nutrient profiles and 
approaches for their implementation (voluntary and mandatory).  
In part, this situation is explained by the fact that such models must meet the needs of the 
population of each country, considering their literacy levels, communication barriers and 
local culture, and that the information needs to be understood by all segments of the 
population.  
However, there has been a recent trend in  the adoption of semi -interpretive FOPL models, 
such as traffic lights and alerts, which focus on the qualification of nutrient content of 
greater relevance for health.  G/TBT/N/BRA/821  
 
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  These approaches guarantee the transmission of information, in a more qualified and 
interpretive way, than the non -interpretive models and, more proportionally, than the 
interpretive models, since it keeps the autonomy of consumers to judge the nutritional 
quality of the food.  
Regarding the form of implementation, although most of the FOPL m odels have been 
adopted voluntarily, it was noticed a recent trend for the mandatory declaration of this 
information. Although the voluntary approach generates less commercial questions and 
opposition from food industry, this approach reduces the effective ness of the FOPL models 
due to the low adhesion of food industries. In addition, this situation allows for similar 
products are labeled differently, which induces consumers to deception.  
The review showed that the nutrients most commonly used in FOPL model s are sugars, 
sodium and saturated fats. The declaration of nutritional information per 100 grams or 
milliliters is the most frequent in these models.  
In most cases, no systematized information on the monitoring and impact of FOPL models 
has been identifie d. In part, this can be explained by the recent nature of these initiatives.  
However, some ex -ante and ex -post impact analyzes identified indicate that semi -
interpretative FOPL in the form of alerts have a favorable cost -benefit ratio. Other data 
suggest that such models help consumers understanding the nutritional content of foods 
and encourage manufacturers to reformulate their products.  
In relation to the review of scientific studies, it was observed that knowledge about the 
effects of different FOPL m odels on consumers ' ability to understand and use nutritional 
information still in development.  
The current panorama of publications reveals a growth of research in Latin America, 
following the regulatory changes taking place in the region. A similar situ ation was 
observed in France and in Australia and New Zealand, where the adoption of the Nutri -
Score and HSR models, respectively, was preceded by surveys with the local population 
that compared the effects of different alternatives.  
This scenario shows the importance of basing regulatory initiatives on nutrition labeling in 
current scientific evidence, to ensure that the selected alternative is effective and 
proportional to address the regulatory problem. This fact becomes more releva nt because 
of the high commercial sensitivity of this topic.  
The reviewed studies tested several FOPL models, through different methodologies that 
investigated the effects of these models in different stages of the processing and use of 
information.  
It should be noted that there are several limitations in these studies that make it difficult 
to extrapolate their results to Brazilian consumers. However, these findings allow an 
objective assessment of the potential differences among FOPL models.  
Among the FOPL models tested, those who did not use interpretive resources, such as 
GDA, were considered the most difficult to understand, being often used as a control in the 
studies. Most of the experiments sought to compare the performance of semi -interpretive 
and interpretive models, being more common the studies with qualitative traffic lights, 
octagonal alerts, HSR and Nutri -Score.  
Among the few studies conducted in Brazil, three used representative samples of the 
population. However, two presented considerable  methodological limitations. One of them 
evaluated only the opinion and the preference of the population, not providing data on 
parameters of understanding and use of the information. The other, although 
experimental, presented the models tested in locatio ns and with different presentation 
features in the packaging. Thus, there is no way to measure and isolate the effect of these 
differences on the results.  
The evidence reviewed shows that the semi -interpretative FOPL in the form of alerts have 
better perf ormance in relation to the traffic lights in relation to: (a) capture of attention; 
(b) understanding the information on high content of negative nutrients; (c) reduction of 
the perception of healthfulness of products with high content of negative nutrient s; (d) 
reduction in perceived frequency of consumption of foods with a high content of negative 
nutrients; (e) reduction in purchase intent of foods with a high content of negative G/TBT/N/BRA/821  
 
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  nutrients (results found only with the use of scales).  
In contrast to the interpretive models, the alerts perform better than HSR and similar, but 
with small advantages to the Nutri -Score, mainly regarding the perception of healthfulness 
of foods viewed as healthy, but that have versions with high content of negative nutrients.  
The most tested FOPL models were black octagons alerts. Only two studies tested the 
triangle model in the same color, with few differences in the effectiveness of this format 
when compared to the octagon.  
The alert in the form of red circle proposed for implementation in Brazil, which has also 
been studied and has a similar approach being implemented in Israel, has not been tested 
in the Brazilian population.  
In addition, few studies have focused on the factors related to the location and visibility of 
the models, key characteristics that influence the ability of the consumer to perceive the 
information conveyed.  
The revisions and the complementary information submitted to Anvisa by stakeholders 
made it possible to analyze different non -normative and norm ative options to deal with the 
regulatory problem.  
In this sense, two non -normative alternatives were identified to solve some factors that 
explain this problem: (a) co -regulation to deal with the lack of information about the 
nutritional composition of fo ods in food services a nd e -commerce services; and 
(b) education and information actions to address the disarticulation of nutrition education 
measures about the use of labeling and the difficulties of manufacturers and the SNVS in 
determining and monitorin g the nutritional value of foods. Such actions are under partial 
governance of Anvisa, and require the involvement of other institutions.  
The main alternatives proposed were normative, considering that most causes have a 
regulatory nature due to gaps, inconsistencies and outdated normative framework on 
nutritional food labeling.  
It was suggested to make the following changes in the nutritio n table: (a) to change the 
nutritional value declaration base to 100 grams or milliliters; (b) to modify the list of 
mandatory nutrients to exclude trans fats acids and to incl ude total and added sugars; 
(c) to restrict the declaration of nutrients to the mandatory list of nutrients and to the 
nutrients that are object of fortification or of nutrition and health claims; (d) to maintain 
the %DV (Daily Value) statement, updating the NRV (nutrient reference values) and 
changing the footnote to indicate which  %DV values are considered high and low.  
One of the main changes proposed was the adoption of a FOPL model that: (a) is applied 
in a mandatory way and complementary to the nutrition table; (b) informs the high 
content of added sugars, saturated fats and so dium, in a simple, ostensible, 
understandable way; (c) uses colors, symbols and qualitative descriptors instead of the 
%DV; (d) is based on the amount per 100 g or ml of the food , to ensure consistency with 
the nutrition table; (e) uses the most restricti ve nutrient profile model developed by the 
Anvisa for the classification of high in added sugars ( ≥ 10 g for solids and ≥ 5 g for 
liquids), saturated fats ( ≥ 4 g for solids and ≥ 2 g for liquids) and sodium ( ≥ 400 mg for 
solids and ≥ 200 mg for liquids) . 
With reference to nutrition claims, it was proposed to: (a) change the basis for the 
determination of criteria to 100 grams or milliliters; (b) modify the composition criteria to 
ensure consistency with Anvisa's nutritional profile model and to avoid its  use in foods with 
low nutritional quality; (c) define criteria for the provision of such information, to avoid 
nutrition claims being made more emphasized than FOPL; (d) prohibit nutrition claims on 
trans fat acids.  
Specific recommendations concerning th e scope of nutrition labeling were also presented, 
especially and rules for precision of nutritional values.  
However, there are still gaps that need to be addressed in rel ation to the definition of: 
(a) threshold values for the declared nutritional value; (b) criteria for the presentation of 
nutrition labeling, including the legibility rules and the design of FOPL; (c) criteria for the 
presentation of nutrition claims consistent with FOPL; and (d) deadlines for implementing 
the proposed changes.  G/TBT/N/BRA/821  
 
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  It was also  identified the need to investigate, in a more systematized way, how the 
different FOPL models in the form of alert are evaluated and understood by the Brazilian 
population, which is intended to be done through the researches selected in the Notice 
CNPq/An visa n ° 17/2017.  
The possible impacts of the recommended alternatives are also discussed. It should be 
noted that the costs of regulating nutrition labeling have not been identified as a relevant 
issue by countries implementing mandatory nutrition labeling  and FOPL.  
Some possible benefits and additional costs for consumers, government and food industry 
of the proposed non -normative and normative measures were raised. The document also 
addresses the perspectives and challenges for the implementation, monitor ing and 
enforcement of the proposed actions.  
Documents related:  
Preliminary Regulatory Impact Analysis Report on Nutrition Labeling – link: 
http://portal.anvisa.gov.br/documents/33880/2977862/Análise+de+Impacto+Regulatório
+sobre+Rotulagem+Nutricional_versão+final+3.pdf/2c094688 -aeee-441d-a7f1-
218336995337  
Annex I Preliminary R eport of Reg ulatory Impact Analysis – link: 
http://portal.anvisa.gov.br/documents/33880/2977862/Relatorio_AIR_AnexoI/d14779f4 -
d2ae-427d-9cc5-b23ee16bae82  
Regulatory Acts related to Nutrition Labeling – link: 
http://portal.an visa.gov.br/documents/33880/2977862/Atos+normativos+relacionados+à
+Rotulagem+Nutricional.pdf/c0103d35 -d1c6-43b6-88ac-ee690513d273  
Frontal Nu trition Labeling Models – link: 
http://portal.anvisa.gov.br/documents/33880/2977862/Atos+normativos+relacionados+%
C3%A0+Rot ulagem+Nutricional.pdf/c0103d35 -d1c6-43b6-88ac-ee690513d273  
Public Call Notice No. 3, dated 22 May 2018 – link: 
http://portal.anvisa.gov.br/documents/33880/2977862/Edital_TPS_Rotulagem_Nutricional
.pdf/ecb7052f -d529-47d5-9490-be0e6c0d8ed1  
The Public Subsidies Taking is a consultation mechanism, open to the public, to collect 
data, information or evidence on the Prelimi nary Regulatory Impact Analysis Report, in 
order to assist regulatory decision -making by Anvisa. More information available in 
http://portal.anvisa.gov.br/tomada -publica -de-subsidios  in Portuguese only.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Relevant documents are referenced in item 6   
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed date of entry into force:  To be determined after the end of the consultation 
period.  
10. Final date for comments: 9 September 2018  G/TBT/N/BRA/821  
 
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  11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462 .5402  
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/tomada -publica -de-subsidios