Overview:
Packaging is the first point of contact between the consumer and the product, directly influencing their initial perception of the brand. According to ANVISA, in addition to an attractive design, it is essential to ensure that the packaging offers safety, protecting the cosmetic from contamination or degradation, and follows sustainability standards. The choice of suitable materials and compliance with regulatory standards are fundamental to providing a quality experience and transmitting confidence to the customer.
Introduction:
As established by Collegiate Board Resolution (RDC) 81/2008, it is forbidden to sell imported products that have identification or labelling in a foreign language, except in specific situations described in that resolution. Labelling within national territory is authorized for imported products that are duly registered with the National Health Surveillance Agency (Anvisa), in accordance with the applicable legislation.
When displayed or made available for consumption, products must be properly labelled, sealed or have a safety seal, as required by current health legislation. The information on the labels must be approved by the competent health authority during the regularization process with Anvisa.
Important product information
The packaging is the main source of communication with the consumer. It provides important information about the product that will be used. In addition, the labeling of cosmetics must be standardized according to ANVISA regulations and other health agencies, guaranteeing the quality of the product and its safety.
Among the information contained on the label, the most common are:
Name and brand of the product: For identification
List of ingredients: Indicates all the substances present in the formula, it is important for individuals who have some kind of allergy
Instructions for use: guidance on how to apply or use the product correctly
Precautions: information on any precautions that should be taken when using the product, such as avoiding contact with the eyes or keeping out of the reach of children.
Expiry date: indicates the date until which the product is considered safe for use.
Manufacturer identification: name and address of the manufacturer or distributor responsible for the product.
Batch number : Identifies the specific batch of the product, useful for traceability in case of quality problems.
These are just some of the common pieces of information found on cosmetics labels and may vary according to local regulations and product specifics.
Labelling in a foreign language:
When an imported product enters national territory, the label in a foreign language must include the following information:
– Commercial name used abroad.
– Name of manufacturer and place of manufacture.
– Batch/part number or code.
– Date of manufacture (when required by applicable health legislation).
– Expiry date or expiry date (if applicable).
The health authority may request a translation of the label, duly signed by the technical manager and the person in charge or legal representative of the company responsible for regularizing the product with Anvisa.
Special Cases:
Cosmetics, Perfumes and Personal Hygiene Products: If the information on the date of manufacture and expiry is not present on the label in a foreign language, the importer must provide a declaration signed by the technical manager of the importing company, indicating the date of manufacture for each imported product. The inclusion of the expiry date is not compulsory.
In Vitro Diagnostic Products: In the absence of information on the date of manufacture, the importer must provide a declaration signed by the technical manager of the importing company, specifying the date of manufacture for each imported product, or an analytical quality control report, by batch or batch, signed by the technical manager.
Compliance with these guidelines is essential to ensure that imported products meet Brazilian health standards. Importers should familiarize themselves with the regulations and detailed procedures in order to avoid complications during the import process, thus guaranteeing the safety and quality of the products made available on the Brazilian market.
Conclusion
Importing products into Brazil is subject to a number of regulations, and proper labelling is essential if products are to enter the Brazilian market without any problems. However, it is important to emphasize that the importing company must be a qualified Brazilian company, duly licensed.
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.