5. Claim Requirements
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5. Claim Requirements
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General Foods
Brazil
This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.
5.1 Overview of Claims
According to Article 2 of Resolution RDC N° 429/2020 [1] which provides on the nutritional labeling of packaged food, and the corresponding rules on the use of claims in Brazil, such regulation only applies to packaged foods, and includes industrialized beverages, ingredients, food additives, and processing aids. Thus, it is understood that the claim rules explained below are not applicable to food preparations or beverage preparations.
5.1.1 Types & Definitions
Nutrition claims are ruled under Resolution RDC N° 429/2020 [1] and Normative Instruction IN N° 75/2020 [2]. According to this regulation, nutrition claims are defined as “any statement, other than the nutrition information table and nutrition labeling on the front, which indicates that a food has positive nutritional properties regarding its energy value or nutrient content, including absolute and comparative content and no-addition claims. According to this regulation the nutrition claims are classified as follows:
- Absolute content nutrition claims: nutrition claims describing the level or quantity of energy value and nutrients contained in the food.
- Comparative content nutrition claims: nutrition claims that compare the levels or quantity of energy value or of the same nutrients contained in the reference food.
- No-addition nutrition claims: nutrition claims describing that an ingredient has not been directly or indirectly added.
Functional and health claims are regulated under Resolutions RES N° 18/1999 [3] and Resolution RES N° 19/1999 [4]. The first establishes basic guidelines for the analysis and proof of functional and/or health claims on food labels, and the latter approves the technical regulation on procedures for the registration of foods with functional and/or health claims on their labels.
In Brazilian legislation, functional and health claims are described as "claims of functional properties" and "claims of health properties" respectively. The definitions for these two terms are as follows:
- Claim of functional properties: a claim related to the metabolic or physiological role that a substance (either a nutrient or not) has on the growth, development, maintenance, and other normal functions of the human body.
- Claim of health properties: a claim that states, suggests, or implies a relationship between a food or an ingredient with a disease or a condition related to health.
Other claims (such as GMO-free, Gluten-free, etc.) are optional labeling and they have no specific rules beyond those general provisions established in Resolution RDC N° 727/2022 [5]. According to such regulation, packaged foods can bear claims/statements/images provided that they do not conflict with the provisions of the Resolution. Quality denominations may only be declared when:
- Corresponding specifications have been established for a certain food in a specific standard;
- They are easily understandable and do not mislead the consumer; and
- They appear on the main panel of the food.
All the above-listed conditions must be met. If not, the optional labeling will be rejected by the authority.
It is worth mentioning that this only applies to packaged products, since the labeling of non-packaged foods (e.g. donuts) and food preparations is not subject to control, but good practices. In the event of any information on the label of unpackaged products/menu offerings, etc., that endangers the health of consumers, or is misleading, not only will the respective sanctions described in the laws related to the food sector be applied, but also the sanctions established in the Consumer Protection and Defence Code [6] will be applied.
5.1.2 List of Prohibited Claims
Nutrition claims
There is no list of prohibited nutrition claims. The Brazilian regulation is based on positive lists of nutrient claims with the conditions of use such as minimum or maximum limits, among others, then, in general terms, what is not listed in the regulation cannot be used.
Functional and Health claims
There is no list of prohibited health claims. The use of health claims that make reference to cure or disease prevention is not permitted. In addition, a label should not include claims that cannot be scientifically demonstrated.
Other claims
These are optional labeling and they have no specific rules beyond the general provisions established in Resolution RDC N° 727/2022 [5] as mentioned above. There is no list of prohibited claims noted for other claims. These will be rejected if the conditions above listed are not met.
5.2 Nutritional Claims
5.2.1 Permitted Claims
Annex XIX of Normative Instruction IN N° 75/2020 [2] foresees the corresponding nutrition claims and their synonyms. These are:
- Low
- Very low
- Does not contain
- No added
- High content
- Source
- Reduced
- Increased
The corresponding technical requirements for each claim are provided by Annex XX of said regulation.
5.2.2 Nutritional Claim Registration
Nutritional claims on the list of approved claims do not need to be registered. Their assessment is on the final product.
There is no procedure to apply for new nutrition claims or those not already approved in Brazil since the positive list comes from the harmonized Regulation From MERCOSUR. Then any changes on the list must be discussed and approved at that level. Only official agencies such as Anvisa as member states can apply for the MERCOSUR regulation to be discussed and changed. For that purpose, a request from the food industry association must be submitted to Anvisa.
5.3 Functional & Health Claims
5.3.1 Permitted Claims
Functional and health claims - "Claims of functional properties" - on the role of a nutrient or non-nutrient in the growth and development of the normal functions of the organism are permitted by demonstration of its efficacy. In these cases, the guidelines established in Resolution RES N° 17/1999 [7] for the assessment of the risk and safety of foods have to be followed.
However, when nutrients have a wide recognition of their effects within the scientific community, it is not necessary to prove their efficacy for their use in a claim. ANVISA has clarified that for the use of this type of claim, which does not require an assessment, the following criteria must be met:
- It is related to the intrinsic nutrients of the product, which need to be contained in at least the amount established for the attribute "source of", as indicated in the regulation for the complementary nutrition information.
- Being specific to the function of the nutrient claimed.
- It is linked to a food that is regularly consumed among the population and is not sold in a pharmaceutical form such as capsules, tablets, or pills.
Resolution RES N° 18/1999 [3] does not provide for a positive list of claims. However, for some nutrients, such as vitamins and minerals, Normative Instruction IN 28/2018 provides the list of those health claims allowed for food supplements, which can be extrapolated for foods in general, being considered as a reference of recognized claims. However, it is important to note that not all claims included in this regulatory framework fall within the concept of fully recognized claims.
5.3.2 Functional & Health Claim Registration
Since there is no positive list, all functional and health claims must be assessed for Anvisa approval.
Claims of functional and health properties are evaluated during the registration of the final product. The assessment for the validation of claims with functional and/or health properties is also contained in Resolution RES N° 19/1999 [4]. For the registration of foods bearing claims of functional and health properties, and new foods and ingredients, in addition to the general documentation required for the usual registration of foodstuffs, a Technical Scientific Report needs to be presented with the following information:
- Legal name of the product
- Purpose of use
- Recommended intake indicated by the manufacturer
- Scientific description of the ingredients of the product, according to species of botanical, animal, or mineral origin, when appropriate
- Chemical composition with molecular characterization when appropriate, and/ or formulation of the product
- Description of the analytical methodology for evaluation of the food or ingredient that is the object of the claim
- Text and copy of the label of the product which must be compliant with the labeling regulations and with the Guidelines [8] for the analysis and assessment of claims with functional and/or health properties on food labels
- Any information or claims of functional or health properties related to a food or ingredient, advertised by any media, cannot be different in meaning from the information approved on the label
- Applicable scientific evidence, as appropriate, to prove the functional and/or health claim:
- Nutritional and/or physiological and/or toxicological trials in lab animals
- Biochemical trials
- Epidemiological studies
- Clinical trials
- Evidence of traditional use observed in the population, without risk to health
- Comprehensive evidence from the scientific literature, international health organizations, and internationally recognized legislation on the characteristics of the food or ingredient
More details about the registering process (steps and forms) can be found in Portuguese at https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/alimentos/arquivos/OrientaesparaApresentaodeDocumentosnoPeticionaentodeRegistroePsRegistrodeAlimentos_230621.pdf.
5.4 Other Notes or Requirements for Claims
None.
5.5 References
1. Resolution RDC N° 429/2020 Nutrition labeling of packaged foods
2. Normative Instruction IN N° 75/2020 Establishes the technical requirements for the declaration of nutrition labeling on packaged foods
3. Resolutions RES N° 18/1999. Technical Regulation for analysis and proof of functional and/or health properties claimed in food labelling
4. Resolution RES N° 19/1999. Technical Regulation for registration of foods with functional or health properties claimed in their labelling
5. Resolution RDC N° 727/2022. Rules for the general labelling of pre-packaged foods
http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_727_2022_.pdf
6. Consumer Protection and Defence Code
https://www.procon.df.gov.br/wp-content/uploads/2019/08/Codigo-do-consumidor-FINAL.pdf
7. Resolution RES N° 17/1999. Technical Regulation for risk assessment and food safety
8. Guidelines for the assessment of health and functional property claims for bioactive substances present in foods and dietary supplements. ANVISA. 55/2021 1st version
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