4. Labeling Requirements

General Foods
Brazil

This section provides information on labeling requirements and the label approval process.

4.1 Mandatory Labeling Parameters

Resolution RDC N° 727/2022 [1] establishes that the labeling rules are applied to foods packaged in the absence of consumers, including beverages, ingredients, food additives, and processing aids, including those intended solely for industrial processing or food service use. According to such regulation, the labeling of all packaged foods, including donuts, must contain the following information:

I – Sales denomination

II – List of ingredients

III – Warnings* about the main foods that cause food allergies

Examples: 

a) “ALÉRGICOS: CONTÉM (NOMES COMUNS DOS ALIMENTOS QUE CAUSAM ALERGIAS ALIMENTARES)”;

a) “ALLERGIC: CONTAINS (COMMON NAMES OF FOODS THAT CAUSE FOOD ALLERGIES)”;

b) “ALÉRGICOS: CONTÉM DERIVADOS DE (NOMES COMUNS DOS ALIMENTOS QUE CAUSAM ALERGIAS ALIMENTARES)”; ou

b) “ALLERGIC: CONTAINS DERIVATIVES OF (COMMON NAMES OF FOODS THAT CAUSE FOOD ALLERGIES)”; or

c) “ALÉRGICOS: CONTÉM (NOMES COMUNS DOS ALIMENTOS QUE CAUSAM ALERGIAS ALIMENTARES) E DERIVADOS”.

c) “ALLERGIC: CONTAINS (COMMON NAMES OF FOODS THAT CAUSE FOOD ALLERGIES) AND DERIVATIVES”.

IV – Warnings* about lactose and gluten

Examples: CONTÉM LACTOSE, CONTÉM GLUTEN / NAO CONTÉM GLUTEN (CONTAIN LACTOSE, CONTAIN GLUTEN/DOES NOT CONTAIN GLUTEN)

V - New formula - if any significant change in the product formulation, the label needs to declare “New formula”, pursuant to the Resolution RDC N° 421/2020 (Not applicable for this case)

VI – Warnings* related to the use of food additives (related to flavors, colorings, and polyols)

VII – Nutritional labeling in accordance with Resolution RDC N° 429/2020 [2] and Normative Instruction IN N° 75/2020 [3]^

          The nutritional information table must contain the declaration of quantities of:

1. Energy value
2. Carbohydrates
3. Total sugars
4. Added sugars
5. Proteins
6. Total fat
7. Saturated fats
8. Trans fats
9. Dietary fiber
10. Sodium
11. Any other nutrient or bioactive substance that is the subject of nutritional claims, functional property claims, or health property claims
12. Any other essential nutrient added to the food, whose amount, per serving, is equal to or greater than 5% of the respective VDR defined in Annex II of the Normative Instruction - IN No. 75, of 2020
13. Any bioactive substance added to the food

VIII – Net content

IX – Identification of origin

The declaration of identification of origin must contain:

1. the name (corporate name) of the manufacturer or producer or fractionator or holder (owner) of the brand;
2. the full address;
3. the country of origin and municipality;
4. the registration number or identification code of the manufacturing establishment with the competent body; and
5. the name (corporate name) and address of the importer, in the case of imported foods.
6. Sole paragraph: To identify the origin, one of the following expressions must be used:

• "Fabricado em ..." - “Made in…”;
• "Produto ..." - “Product …”; or
• “Indústria …” - “Industry …”.

X – Batch identification

The batch identification declaration must be made in a visible, legible, and indelible form, by means of:

1. the letter “L” followed by a key code; or
2. the date of manufacture, packaging, or expiration date, followed at least by the day and month or the month and year, as per item II of art. 31 of this Resolution.

• The batch must be determined by the manufacturer, according to its criteria.
• The key code mentioned in item 1 must be available for consultation by the competent authority and be included in the commercial documentation when the exchange between countries takes place.

XI – Validity period

The declaration of validity must:

a) “consumir antes de…”; b) “válido até…”; c) “validade…”; d) “val:…”; e) “vence…”; f) “vencimento…”; g) “vto:…”; h) “venc:….”; ou i) “consumir preferencialmente antes de…”.

a) “consume before…”; b) “valid until…”; c) “validity…”; d) “val:…”; e) “expires…”; f) “expiration…”; g) “vexp:…”; h) “exp.:….”; or i) “preferably consume before…”. 

a) the day and month, for products that have a shelf life equal to or less than three months; or

b) the month and year, for products that have a shelf life of more than three months.

The statement referred to in item 2:

• must be written in numerals, in non-coded numerical order, except for the month, which can be abbreviated by means of its first three letters; and 
• can be replaced:
  1. by clearly indicating the place where the expiration date is declared, according to item II above;
  2. by perforations or indelible marks with the expiration date, as per item II of this article; and
  3. by the expression “end of…”, followed by the year, in the case of foods with an expiration date in December.

XII – Instructions for the conservation, preparation, and use of the food, when necessary

XIII – Other information required by specific rules

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* The warnings must be grouped immediately after or below the list of ingredients and with legible characters that meet the following declaration requirements:

1. Upper case
2. Bold
3. Color contrasting with the background of the label
4. Minimum height of 2 (two) mm and never lower than the letter height used in the list of ingredients

The declarations referred to in the caput of this article cannot be placed in hidden places, removable by opening the seal, or difficult to see, such as sealing and twisting areas.

In the case of packages with a main panel area equal to or less than 100 (one hundred) cm2, the minimum height of the characters is 1 (one) mm.

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^ The nutrition information table must be located on a single continuous surface of the package and on the same panel as the ingredient list.

1. It cannot be in hidden areas, deformed places, such as sealing and twisting areas, or areas that are difficult to see, such as edges, angles, corners, and seams.
2. In the case of packages with multiple sides with obtuse angles in which it is possible to follow the label information by the angles, two or more panels can be considered surfaces continuous.
3. When the packaging space is insufficient for the declaration of the information mentioned in the caput in the same panel, these must be arranged in adjacent panels. 

The nutritional information table formatting must:

1. Use 100% black characters and lines applied on a white background. Annex XII of Normative Instruction IN N°75/2020 [3] establishes the mandatory format for 5 models for nutrition labeling. In justified cases (lack of space on the label), a lineal model may be used. The regulation also establishes the corresponding format for this model. 
2. Observe the names of the constituents or their alternative names, and the respective order of declaration, indentation, and measurement units defined in Annex XI of the Normative Instruction IN N°75/2020 [3];
3. Use spacing between lines in order to prevent characters from touching or touching the bar, lines, or separating symbols, when existing;
4. Use a protective border, bars, lines, and symbols of separation and internal margins in accordance with the selected model; and
5. Follow the specific requirements for standard formatting defined in Annex XII of the Normative Instruction IN N°75/2020 [3].

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The information referred to above must be declared:

1. In Portuguese, without prejudice to the existence of texts in other languages.
2. With characters of adequate size, highlighting, and visibility.
3. With a minimum size of letters and numbers of 1 (one) millimeter (mm), unless otherwise specified such as in the case of Nutrition labeling where the size, type, etc. must follow those requirements provided by Normative Instruction IN N° 75/2020 [3].

When the information referred to here is not in Portuguese, a complementary label must be placed at the origin or destination before marketing, containing the mandatory information.

Non-Packaged Food and Food Preparations

There is no regulation on labeling of non-packaged foods and food preparations in Brazil. 

The general and nutritional labeling rules, as well as the labeling rules for allergens, GMOs, etc., only apply to pre-packaged industrialized foods, therefore they do not apply to non-packaged foods that are prepared or portioned in food services and sold at the point of sale at the consumer's request, nor to foods sold without packaging. Then any interest in labeling on menu boards or on label tags etc. will be up to the food services or stores. However, raw materials used in food preparations shall follow such rules. 

4.2 Languages

Raw materials

All mandatory information must be in Portuguese since this is the official language, and other languages like English are commonly used. When this information is not in Portuguese, a complementary label must be placed at the origin or destination before marketing, containing the mandatory information [1].

Food preparations

There are no specific provisions for food preparations, but they must always be in Portuguese since this is the official language, and other languages like English are commonly used. This is based on Article 31 of the Consumer Code [4]. The offer and presentation of products and services must ensure correct, clear, precise, ostensive information in the Portuguese language about their characteristics, quality, quantity, composition, price, guarantee, validity periods, and origin, among other data, as well as about the risks they present to the health and safety of consumers.

4.3 Mandatory Information on Stickers

Yes, it is acceptable to capture the mandatory labeling information mentioned above on additional stickers for imported packaged products. This must be placed on the pre-packaged product in origin or in the final destination before commercialization [1].

In general terms, this applies to imported products to be sold as final products and raw materials. In case the foods were produced or prepared/handled in Brazil and prior to going to the point of sale, all the information shall be in Portuguese and not with a sticker since the final process of the production is local.

Not applicable to Food Preparations.

4.4 Product Legal Name

N/A

4.5 Product-specific Labeling Statements

Refer to Section 4.5 of specific product Guidebooks for product-specific requirements.

4.6 Authority Approval

Packaged and non-packaged food (including raw materials)

There is no specific approval process for the product labels; the label is either part of the product notification or the product registration process.

Similarly, there are no specific costs and duration for the label approval, as it is included either in the notification process or registration process.

Food Preparations

Not applicable as there is no authority to look into those labeling in stores with any approval process.

4.7 Vegan Dietary Requirements

In Brazil, there is not yet any specific regulation or guideline addressing the Vegan Diet. 

4.7.1 Types & Definitions of Vegan Diet

Since there are no regulations/guidelines on vegan diets, there are no types or definitions yet. 

4.7.2 Vegan Diet Requirements

Since there are no regulations/guidelines on vegan diets, there are no requirements yet.

4.7.3 Labeling and Claims, if any, on Vegan

In Brazil, there is not yet any specific regulation addressing the issue of labeling for the “vegan category”. What currently exists in the legislation for products of plant origin are RDC 268/2005 [5] - Technical Regulation for Protein Products of Plant Origin and RDC 272/2005 [6] - Technical Regulation for Vegetable Products, Fruit Products, and Edible Mushrooms, respectively. These resolutions do not specifically address labeling.

However, Brazil does have regulations regarding food labeling and allergen information which are relevant for vegans seeking to identify animal-derived ingredients in packaged foods. These regulations mandate that food manufacturers clearly state the presence of common allergens such as milk, eggs, fish, crustaceans, peanuts, soy, wheat, tree nuts, and sesame seeds on their product labels. This information can be helpful for vegans to identify if a product contains any animal-derived ingredients.

Additionally, there is currently a widely used resource to assist consumers in purchasing food that is not of animal origin: the "Vegan Seal", which is a certification created in 2013 by the Brazilian Vegetarian Society (SVB) [7]. However, this is a certification issued by a non-official agency, and in many cases, questioned by the industry and some stakeholders in Brazil. This seal is a voluntary labeling for any industry that requests it.

This is not applicable to food preparations which are exempted from the labeling rules and claim rules; only the raw materials used in the preparations shall follow the above.

4.7.4 Other Notes or Requirements

These are the three criteria to be met in order to apply for the voluntary "Vegan Seal" for packaged foods or raw materials:

1. Product without ingredients of animal origin*
2. Company does not test finished product on animals**
3. Supplier manufacturers do not test ingredients on animals**

*The possibility of the unintentional presence of animal waste in products is not a factor that prevents the product from obtaining the SVB Vegan Label certification. The analysis and verification of this criterion includes both the composition and the manufacturing process (even if the ingredient is not in the composition of the final product). 

**Considering the grace period of at least 5 years for animal testing for all products and ingredients in the certification process.

It is worth mentioning that this seal must not run against the labeling principles nor rules established in the regulation of packaged foods, and its permissibility will depend on the ANVISA’s approach at the moment of product registration/notification, considering that ANVISA is currently working on a regulatory proposal on plant-based foods.

4.8 Additional Notes on Labeling

Packaged food and raw materials

Front-of-pack labeling: According to Article 18 of Resolution RDC N° 429/2020 [2], it is mandatory to place on the label a front-of-pack labeling characterized by a magnifying glass with the phrase “HIGH IN” for those packaged foods exceeding the threshold for added sugars, saturated fats or sodium established in Normative Instruction IN N° 75/2020 [3]. Resolution RDC N° 429/2020 foresees all the provisions and exceptions for this front-of-pack labeling while Normative Instruction IN N° 75/2020 establishes all the technical requirements for these seals. Products exceeding the following nutrient profiles must bear this front-of-pack labeling:

Annex XVII of Normative Instruction IN N° 75/2020 provides for the models to be used for the front-of-pack labeling and Annex XVII provides the specific technical requirements regarding the type and size of words, etc. 

GMO labeling: in the case that a product intended for human consumption is or contains GMO derivatives, it must be labeled in accordance with Decree N° 4.680/2003 [8].  

Food and food ingredients intended for human or animal consumption that contain or are produced from genetically modified organisms must be informed on their labels of the transgenic nature of the product. Products containing more than 1% of the GMO/transgenic material must bear the GMO labeling implemented. 

This information must be on the main panel of the label by means of one of the following expressions:

• "Contains (name of ingredient(s)) transgenic(s)"
• "Product produced from (name of product) transgenic"

In addition, the gene donor species must be next to the list of ingredients of the product.

Symbols: The Ordinance N°. 2658/2003 [9] of the Ministry of Justice defines the symbol which must be on the Main Panel of the label. The area occupied by the transgenic symbol must represent at least 0.4% of the main panel area.

Non-packaged food and food preparations

As above-mentioned, non-packaged foods and food preparations are exempted from the labeling rules established for packaged foods, then the allergen declaration, and other statements on the product container or on menu boards, etc. are up to the establishments.

It is important to mention that, in Brazil, some regions have created local laws [10][11][12] that make it mandatory to report the presence of gluten mainly in food prepared and served in restaurants, bars, and similar establishments to protect the health of allergic consumers. Specifically in Belo Horizonte, it is mandatory to inform about the presence of gluten, lactose, and sugar [12]. However, these measures are not implemented at the national level and there is no requirement for these sorts of establishments to implement an allergen management program. Another point is that only gluten was covered in the local laws, while the other allergens are still pending to be added to this list.

Therefore, it is necessary to observe any specific labeling laws in the region of interest where the food establishment is placed.

4.9 References

1. Resolution RDC N° 727/2022. Rules for the general labeling of pre-packaged foods

http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_727_2022_.pdf 

2. Resolution RDC N° 429/2020. Nutrition labeling of packaged foods

http://antigo.anvisa.gov.br/documents/10181/3882585/RDC_429_2020_COMP.pdf/2ed9794e-374c-4381-b804-02b1f15d84d2 

3. Normative Instruction - IN N° 75, of 2020. Establishes the technical requirements for the declaration of nutrition labeling on packaged foods

http://antigo.anvisa.gov.br/documents/10181/3882585/%283%29IN_75_2020_COMP.pdf/e5a331f2-86db-4bc8-9f39-afb6c1d7e19f 

4. Consumer Protection and Defence Code

https://www.procon.df.gov.br/wp-content/uploads/2019/08/Codigo-do-consumidor-FINAL.pdf

5. Resolution RDC 268/2005 - Technical Regulation for Protein Products of Plant Origin

https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2005/rdc0268_22_09_2005.html

6. Resolution RDC 272/2005 - Technical Regulation for Vegetable Products, Fruit Products and Edible Mushrooms

https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2005/rdc0272_22_09_2005.html 

7. Brazilian Vegetarian Society (SVB)

https://svb.org.br/selovegano/ 

8. Decree N° 4.680/2003. Regulates the right to information as regards foods and food ingredients intended for human or animal consumption that contain or are produced from genetically modified organisms

http://www.planalto.gov.br/ccivil_03/decreto/2003/d4680.htm 

9. Ordinance MJ N° 2658/2003. Regulation on the use of the transgenetic logo

https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/arquivos-alimentacao-animal/legislacao/portaria-no-2-658-de-22-de-dezembro-de-2003.pdf/@@download/file 

10. Law Nº 10.110/2017 – Mandates the identification of gluten-containing products on the menus of establishments serving meals. State of Espírito Santo https://www3.al.es.gov.br/Arquivo/Documents/legislacao/html/LO10110.html 

11. Law Nº 6.159/2017 – Provides for the obligation to inform about the presence of gluten and its derivatives in foods prepared and served in restaurants, bars and similar, in the Municipality of Rio de Janeiro

https://leismunicipais.com.br/a/rj/r/rio-de-janeiro/lei-ordinaria/2017/616/6159/lei-ordinaria-n-6159-2017-dispoe-sobre-a-obrigatoriedade-de-informar-quanto-a-presenca-de-gluten-e-seus-derivados-nos-alimentos-preparados-e-servidos-nos-restaurantes-bares-e-afins-no-municipio-do-rio-de-janeiro 

12. Law Nº 11.116/2018. Provides for nutritional information to the consumer, in the forms mentioned. Municipality of Belo Horizonte

https://leismunicipais.com.br/a/mg/b/belo-horizonte/lei-ordinaria/2018/1112/11116/lei-ordinaria-n-11116-2018-dispoe-sobre-informacao-nutricional-ao-consumidor-nas-formas-que-menciona