cosmetic regulations in brazil anvisa

Key Facts about Brazil’s Cosmetic Market

 

  • The consumption of cosmetics in Brazil represents more than 2% of the country’s GDP
  • Brazil is the fourth largest beauty market in the world
  • It is estimated to grow 6.57% over the next five years
  • Brazil represents 10% of global cosmetics Market

How Brazil Sees It?

Brazilian Heath Authority- ANVISA defines Personal Care Products, Cosmetics and Perfumes, as; “Preparations consisting of natural or synthetic substances, for external use on various parts of the human body, skin, capillary system, nails, lips, external genital organs, teeth and mucous membranes of the oral cavity, with the sole or main
purpose of cleaning them, perfuming them, altering their appearance, correcting body odors and or protecting or maintaining them in good condition.

It is classified as Class I and Class II products based on the risk involved

Class I Products

  • Products with basic or elementary properties
  • They do not require detailed information on their labeling regarding their mode of use and their restrictions of use
    • Skin moisturizers (without sunscreen; except those for stretch marks),
    • Face cleansing creams, lotions, gels and oils (except those for acne skin),
    • Perfumes, lipsticks (without sunscreen),
    • Eye and facial makeup preparations(without sunscreen),
    • Eyelash mascara
    • Fingernail polishes,
    • Cleansing shampoos and hair conditioners

Class II Products

Products have specific indications that require proof of safety and/or efficacy, as well as more information on their
labeling on their mode of use and restrictions of use.

    • Children’s products;
    • Products for straightening, Curling and/or dyeing hair
    • Products for wrinkles
    • Sunscreen lotions and creams
    • Antiseptic soap
    • Insect repellent products

Cosmetic Regulatory Authorities in Brazil

  • Ministry of Health
  • Brazilian Health Surveillance Agency (ANVISA) – Promotes the protection of the health of the population through the sanitary control of the production and consumption of products and services subject to sanitary surveillance, including cosmetic products. It is responsible for authorization of cosmetic registration in Brazil.
  • Hygiene, Perfume, Cosmetics and Sanitizing Products Management (GHCOS) – Coordinates, supervises, and controls the activities related to the registration, information, inspection, norms and standards establishments, compliance with regulations concerning the sanitary surveillance of personal care products, cosmetics, perfumes and sanitizers.

Regulatory Framework in Brazil

The Ministry of Health controls the manufacture and import of all Toiletries, Perfumes and Cosmetics in Brazil since the publication of Law no. 6.360 of September 23, 1976 and its Decree no. 79.094 of January 5, 1977, revoked by Decree no. 8077 of August 14, 2013. The intention is to ensure the safety and product quality for the population’s health protection.

 

The main authority responsible for documents in this is the Brazilian Health Regulatory Agency (Anvisa). Under the Directorate of Coordination of the National Health Surveillance System (DSNVS), their Department of Cosmetics addresses all pre market regulation matters concerning toiletries, cosmetics and perfumes, along with those relating to raw materials, labeling and technological innovations of such products. The Directorate of Health Control and Monitoring (DIMON) acts in conjunction with the state and municipal health surveillance secretariats in the authorization of the operation of manufacturers and importers and post-market matters at the national level, including compliance, enforcement and cosmetovigilance.

 

Brazil is a MERCOSUR Member State and most of the health requirements for Toiletries, Perfumes and Cosmetics products are harmonized and recognized by MERCOSUR regulations since 2004. MERCOSUR resolutions enter into force after being internalized through national mechanisms and published in the Official Journal of each Member State.

 

Only companies authorized by the Ministry of Health and licensed by the Health Agency of the Federal States where they are located can extract, produce, manufacture, process, synthesize, purify fraction, pack, repack, import, export, store or ship cosmetics in Brazil.

 

Marketing Authorization Process in Brazil

In the Brazilian Market there are two ways of product authorization – registration and prior notification of a product exempted of registration.

 

The legal act that recognizes the suitability of a product to sanitary legislation is registration, granted by the Brazilian Health Regulatory Agency. Prior to commercialization of products that could present higher health risks it is applied as a control. After reviewing  the  dossier,  the Agency publicizes the awarded registration in the Official Journal as proof of the concession by Anvisa. This permits the product to be sold in Brazil.

 

Prior notification of a product exempted of registration is the administrative procedure to be applied to inform Anvisa of the intention to commercialize a product exempted A Guide to Brazil Toiletry, Perfume and Cosmetic Products Compliance Requirements 10 from registration by means of electronic communication. About 97% of the Toiletries, Perfumes and Cosmetics products that have the commercialization authorized in Brazil follow this route.

 

To have Market Authorization, products subject to health surveillance, must comply with the criteria laid down by Brazilian laws and with the specific regulations established by Anvisa. These criteria aim at minimizing possible risks associated with the product in question. The manufacturer or importer company is responsible for the quality and safety of the products authorized by Anvisa. Mentioned below are process and documents required for cosmetic registration in Brazil.

 

Cosmetic Registration – ANVISA

Step 1: Company Registration

This is the first step to the Petitioning System and is often used to register private companies that provide products or services regulated by Anvisa and to register the users with bond of representation with these companies.

Step 2 – Change of the size of the company (optional)

According to the size of the company Anvisa calculates the fees applied to the process. Anvisa by default classifies all companies as big size and, if this variable differs, it can be changed in this step.

Step 3 – Request

It is recommended that the interested party identify the Subject Code related to their request, before accessing the Requesting System, since the entire request process will be developed under this code. The interested party will be driven to the type of applications of the chosen Subject Code during this process.

Step 4 – Fees

A payment document will be electronically generated at the end of the application process so that the taxes related to the process can be covered.

Step 5 – Document Protocol

The interested party must gather the documentation requested after payment of the GRU (Guia de Recolhimento da Uniao). This should be done according to the checklist of the chosen Subject Code and sent to Anvisa.

 

Publication of the awarded registration in the Official Journal represents proof of the concession by Anvisa. The product is then authorized to be sold in Brazil. The product must correspond according to what was evaluated in the registration process protocol by Anvisa. Even after granting its registration, Anvisa might at any time and in its discretion, require additional evidence or tests in case that new events raise concerns about the product. Registration is valid for a period of five years from the date of publication in the official Journal (DOU).

Documents Required for Cosmetic Registration in Brazil

  • In case of retinoids, ascorbic acid and products containing urea, proof of chemical stability of ingredients in the formula must be provided – in cases where final pH is above 7
  • For straightening products, pH of the formula must be provided
  • Final Artwork or Label with legitimate claims/statements (in Portuguese)
  • Statement of Responsibility signed by the Legal Representative and Technical Responsible
  • General company information
  • Original packaging or copy (primary, secondary packaging and leaflet)
  • Translated labels
  • Original formula of the product

Cosmetic Product Notification Process – ANVISA

The prior notification of a product exempted of registration must be requested by the interested company through two systems: the Petitioning System and System for notification of Toiletries, Perfumes and Cosmetics exempted of registration – SGAS following the steps below:

Step 1 – Company Registration

This is the first step to the Petitioning System and is often used to register private companies that provide products or services regulated by Anvisa and to register the users with bond of representation with these companies.

Step 2 – Change of the size of the company (optional)

According to the size of the company Anvisa calculates the fees applied to the process. Anvisa by default classifies all companies as big size and, if this variable differs, it can be changed in this step.

Step 3 – Request

The notification of a product exempt from registration must be made in System for notification of Toiletries, Perfumes and Cosmetics exempted of registration – SGAS following the steps required at the system.

Step 4 – Fees

A payment document will be electronically generated at the end of the application process so that the taxes related to the process can be covered. After processing the payment, the notification of the product will be publicized on Anvisa’s website. The product is then certified to be sold in Brazil. The product must necessarily correspond to what was notified to Anvisa. Even after granting its registration, Anvisa might at any time and in its discretion, require additional evidence or tests in case that new events raise concerns about the product. Registration is valid for a period of five years from the date of publication in Anvisa’s website.

 

Importation of Cosmetics in Brazil – ANVISA

For importing products in Brazil, the importer must have a legal establishment within the country. The importer must be well-appointed within the Company Operating Authorization (AFE) with the activity of importing the category of personal care products, cosmetics and perfumes. Import of cosmetics, personal care products and perfumes will be subject to the registration of Import Licensing in Foreign Trade Integrated System (SISCOMEX), submitting  to the supervision by the health authority before its customs release. Upon import goods    and products are subject to non-automatic licensing in SISCOMEX  and  must  beforehand have the express consent of ANVISA. ANVISA grants the import license before shipment of   the product to Brazil.

import document cosmetic brazil

  • Application (Petition) Form
  • Proof of payment of the Health Surveillance Fee (TFVS) Import Licensing
  • Access authorization for physical inspection, when applicable Commercial Invoice
  • Bill of Lading
  • Information about the product and the importing legal entity, such as product and company regularization and Import Licensing number
  • Declaration of the lots or departures, identified alphanumerically, when applicable   Declaration of the holder of the registration authorizing the import by a third party  Instrument of representation of the legal entity that holds the regularization of the product with Anvisa in favor of the legal representative
  • Document of registration referring to the proof of mooring of the product in the storage environment and its respective location, issued by the legal representative of the legal entity that manages the customs area where the product is stored.

 

Cosmetic Labeling Requirements in Brazil – ANVISA

Importers need to submit a translated original label/artwork of product for registration of cosmetics in Brazil. The product label should not include therapeutic indication which could possibly provide misleading or confusing information regarding the origin of product, product composition, use of product or safety. The product label must include Company Operating Authorization (AFE) number and the process number of the product, generated in the Anvisa system, which will correspond to the registration number. The date of expiry mentioned in ‘month and year’ format dispenses the recording of the date of manufacture. The label should include, statements such as ‘validity 1 years or 12 months’, and the manufacturing date. The packaging must include an instruction manual which can be printed in form of a leaflet, which is indicated on the primary packaging “see attached leaflet’. In case of products with small packaging that do not allow room for printing of warnings and restrictions of use, these may be printed on an attached leaflet.

 

The words listed below must be added to the primary and secondary packaging (Ref Annex VI of RDC 07/2015:):

  • Aerosols: “Avoid inhalation of this product”
  • Neutralizers, products for curling and straightening hair: “This preparation should only be used for its intended purpose, being DANGEROUS for any other use.”
  • Hair lightening agents and hair dyes: “CAUTION. Contains substances that may cause skin irritation to certain people. Before use, do the touch proof.”
  • Simulatory suntan lotion: “Warning: does not protect against solar action”.
  • Depilatory Products
  • Teeth And Mouthwashes With Fluoride Antiperspirant Products
  • Hair Tonics

Animal Testing for Cosmetics – ANVISA

The 2012 launched #BeCrueltyFree campaign by Humane Society International is the largest campaign in history to end cosmetics animal testing and trade globally. #BeCrueltyFree has received immense support in Brazil, it is joined by the Latin American consumer awareness group Te Protejo. Brazilian states of Amazonas, Mato Grosso do Sul, Minas Gerais, Para, Parana, Pernambuco, Rio de Janeiro and Sao Paulo which makes 70% of Brazil’s national cosmetic industry, have banned cosmetic tests o animals. The National Agency for Sanitary Surveillance (Anvisa) allows tests on animals to assess the toxicity of cosmetics. Some tests however have been recently abolished by the National Council for the Control of Animal Experiments (CONCEA). Please refer to ANVISA website for tests required for your products before applying for registration of cosmetics in Brazil.

 

Children Cosmetics – ANVISA

Brazil is on the world’s largest markets for children’s products. These products are made respecting the specific needs of this age group. Current regulations provide for the obligation to prove safety requirements for all categories of children’s products. Regulations amended under RDC 07/2015[1] states that companies need to adhere to every aforementioned regulation along with it the manufacturers will have to fulfill the technical requirements of ANVISA provided under RDC 15/15. Though the registration of children’s products has been discarded as they are low-risk products. Further, ANVISA has assured that the changes will not affect the safety of the children.

 

Key Timelines – Cosmetic Registration in Brazil / ANVISA

  • ANVISA takes 90 days to assess the application for approvals
  • 7 days to issue importation license
  • Products once approved, registration is valid for 10 years whereas products falling under notification has lifetime validity
  • Product validity renewal application must be filed 180 days prior to expiry
  • Prior communication is valid for 5 years, revalidation request need to be made 180 days prior to expiry
  • Import license is valid for 120 days

 

References:

http://portal.anvisa.gov.br/documents/10181/2867685/%283%29RDC_07_2015_COMP.pdf/b6bca3b2-454d-4b05-8749-
2a264b096bc8
http://portal.anvisa.gov.br/documents/10181/4881763/RDC_237_2018_.pdf/50b54103-1b51-41c5-8c92-af50f4444038
http://portal.anvisa.gov.br/documents/33880/2568070/rdc0081_05_11_2008.pdf/a02a1a3f-eaf1-4264-b1c0-084eb426fc37
http://portal.anvisa.gov.br/registros-e-autorizacoes/cosmeticos/produtos/comunicacao-previa-eletronica-sgas
http://portal.anvisa.gov.br/registros-e-autorizacoes/cosmeticos/produtos/registro
https://bit.ly/2Aok8r

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