ANVISA: What are the regulatory requirements for Personal Hygiene Products, Cosmetics and Perfumes in Brazil
Brazil occupies the 4th position in the world ranking regarding the consumption of cosmetics with a gain of US$22,9 billion per year, according to ABIHPEC – Brazilian Association of the Personal Hygiene, Perfumery and Cosmetics Industry.
Although is a profitable market, the first thing companies need to know before investing is that products registration with ANVISA or notification of cosmetics is required for the import and commercialization in Brazil.
But, what is ANVISA exactly?
Linked to the Ministry of Health, ANVISA is a regulatory agency that supervises the production and consumption of products of some categories that needs sanitary surveillance. Medicines, pesticides and cosmetics that come to the Brazilian territory through the coordination of ports, airports, borders and customs facilities will need to be inspected.
ANVISA´s institutional purpose is to promote the protection of the population´s health, through the sanitary control which includes: environments, processes, inputs and technologies related to them, as well as the control of Brazil´s borders.
We have elaborated a check list of all the requirements a foreign company needs to get the permission and certification to export/import in Brazil.
1. You need to be a certified ANVISA company
Before registering Cosmetics with ANVISA, it is necessary to understand that in order to apply for any product, it is first necessary to regularize the company responsible for producing and/or import and distributing the products.
The ANVISA requires some documents for it. In the case of cosmetics producers and distributors, the documents required are:
Operating License (Licença de Funcionamento)
The Operating License for Cosmetics is issued by the Local Health Surveillance (Visa) where the company is headquartered. This is the document that guarantees that the company follows the required standards for the location. This document is extremely important for the Regulation of Cosmetics at ANVISA.
In short, this is the document that ensures that the place where the Cosmetics will be produced and/or stored follows all the requirements of the Ministry of Health.
Company Operating Authorization (Autorização de Funcionamento Empresa – AFE)
The Operating Authorization for a Cosmetics Company is another document that guarantees that the company operates in accordance with the Ministry of Health. It is issued by ANVISA only to companies that strictly follow all technical and administrative requirements according to RDC (Collegiate Board Resolution) No. 16/2014.
Good Cosmetic Manufacturing Practices (Boas Práticas de Fabricação de Cosméticos)
The Good Manufacturing Practices for Cosmetics are a series of rules and standards that apply to all areas of the company responsible for the Manufacturing and Distribution of Cosmetics.
After the Manual of Good Cosmetic Manufacturing Practices is ready, ANVISA issues a Certificate, attesting that the company complies with all Standard Operating Procedures.
2. You need to be a certified ANVISA company
When Registering a Cosmetic at ANVISA, the applicant is likely to come across the expression “Risk Degree”. The National Health Surveillance Agency separates products into risk grades (I to IV). Each grade has a different testing method to ensure both the effectiveness and safety of the product.
According to ANVISA, Grade I and Grade II products are cosmetics, perfumes and personal hygiene products composed of natural or synthetic substances for external use in different parts of the body, such as: hair, skin, nails, lips, teeth, mucous membranes of the mouth. These products have several functions such as: clean, perfume, change appearance, neutralize odors and protect your integrity.
There are specific guidelines for technical aspects, additional requirements for imported products and also on how the labeling should be, which should include the AFE number, among other issues.
What would be the difference between Grade I and Grade II product?
Grade I products are those that have basic properties, which do not need to be proven initially and do not require detailed information regarding their use and restrictions of use. Examples: perfumes, nail polishes, creams without photoprotective action.
Grade II products are characterized by having specific indications that require proof of safety and/or efficacy, information on care, mode and restrictions of use. Examples: acne products, anti-dandruff shampoo, makeup items with photoprotection
Why is there this difference?
This different classification results from the chance of unwanted effects from improper use of the product, due to its formulation, its purpose of use and areas of the body where they are applicable.
That is, the Grade I products, because they are simpler, are only notified and do not present all the documentation and analysis by which the Grade 2 products are submitted.
But, in both cases, there are chemical substances in the composition (authorized by ANVISA), which are components that, like any agent external to the body, can generate residues or by-products and thus bring health risks.
3. Register level ANVISA
Notification
The notification is a request to regularize personal hygiene products, cosmetics and perfumes that do not need registration, with a risk level of Grade I. For these products, it is sufficient for companies to previously communicate to ANVISA about the commercialization.
It consists of a prior communication that aims to inform ANVISA about the cosmetics that you intend to import and distribute. The notification can be sent in declaration format to the General Management of Cosmetics (GGCOS).
Products that are not part of Annex VIII of RDC No. 07/2015 are exempt from registration.
Register
Products classified as Grade II by ANVISA require specific procedures for registration. In the case of dermo cosmetics (which act on the deeper layers of the skin), for example, it is necessary to have stability studies for their approval.
The stability studies will guarantee the efficacy, safety and quality of a dermo cosmetic. These studies will also indicate the shelf life, that is, the time the product remains stable. Within the stability study there are three divisions:
Preliminary stability – carrying out tests in the initial phase of product development using different laboratory formulations and with reduced duration. It employs extreme temperature conditions with the aim of accelerating possible reactions of the components and the emergence of signals that must be observed and analyzed according to the specific characteristics of each product. This study is not intended to estimate the shelf life of the product, but to assist in the screening of the formulation. That is, to verify if, when subjected to stress, the product remained stable.
Accelerated stability – intended to provide data to predict product stability, shelf life, and formulation compatibility with the packaging material. That is, it will check if there is interaction between the product and the bottle, determine the expiration date and how the formulation behaved, if it remained stable or if it degraded. Can be used to propose shelf life for the product.
Shelf life – study carried out within the validity period estimated in the stability studies. It is used to evaluate the product under normal storage conditions.
Validity period
Regulation and Registration of Anvisa Products is valid for 10 years. The term starts from the moment your registration is approved and published in the Official Federal Gazette (DOU) and the renewal must take place in the last semester of the last year of validity of the Registration.
4. Labelling: What are ANVISA requirements?
According to ANVISA, these are the information that the labeling for cosmetics, personal hygiene products, and perfumes must contain:
In primary packaging
Primary packaging is that one in direct contact with the products.
- Product name and group/type to which it belongs in case it is not implied in the name.
- Brand.
- lot or lot
- Instructions for Use (if applicable) in the primary or secondary packaging
- Warnings and Usage Restrictions
- Specific Labeling
In secondary packaging
It is the packaging intended to contain the primary packaging or primary packagings.
Product name and group/type to which it belongs in case it is not implied in the name.
- Brand.
- Product registration number.
- Expiration date
- Contents
- Country of origin
- Manufacturer/Importer/Holder
- Domicile of Manufacturer/Importer/Holder
- Usage Mode (if applicable)
- Warnings and Usage Restrictions
- Specific Labeling
- Ingredients/Composition
When there is no secondary packaging, all the information required must appear on the Primary Packaging. The Instructions for use may appear in an attached leaflet. In this case, it must be indicated on the primary packaging: – “See attached leaflet” (“Ver folheto anexo”).
When the package is small and does not allow the inclusion of warnings and restrictions on use, they may appear in an attached leaflet. It must be indicated on the primary packaging: – “See attached leaflet” (“Ver folheto anexo”).
Other requirements
For some specific products, ANVISA requires that some warnings appear on the label. A specific analysis of your products should be done to check what are the requirements.
See some of them as example:
- Aerosols
- Flammable. Do not spray near fire;
- Do not puncture or incinerate;
- Do not expose to the sun or temperatures above 50º C;
- Protect eyes during application;
- Keep out of the reach of children.
- Neutralizers, products for curling and straightening hair
- Do not apply if the scalp is irritated or injured;
- Keep out of the reach of children.
- Hair lightening agents and hair dyes
5. Import Process
Analysis of import processes by ANVISA
Currently, there are single Health Surveillance Points separated by subject, according to Service Guide No. 47/DIMON, of 04/09/2018. The entire analysis process is electronic and takes place through the use of digital attachment of documents (Portal Único Siscomex). Thus, regardless of where the process is filed, it will be analyzed by one of the four posts:
- Health Surveillance Post for Ports, Airports, Borders and Customs Enclosures for Health Products (PAFPS).
- Health Surveillance Post for Ports, Airports, Borders and Customs Enclosures for Medicines (PAFME).
- Health Surveillance Post for Ports, Airports, Borders and Customs in Food (PAFAL).
- Health Surveillance Post for Ports, Airports, Borders and Customs Enclosures in Cosmetics, Sanitizing, Hygiene and Others (PAFCO).
- PAFCO is where ANVISA analyzes the import processes of hygiene products, cosmetics and perfumes.
ANVISA’s Booklet for Electronic Import Petition (PEI)
The work environment for ANVISA’s inspectors is the DataVisa system, which is not yet integrated into the Single Siscomex Portal (computerized instrument, through which governmental control of Brazilian foreign trade is exercised).
Therefore, it is necessary to have a whole procedure to be carried out by the importer so that the ANVISA inspector can work in both systems: DataVisa and Siscomex Importação Web.
Thinking about this situation, ANVISA created a Booklet for Electronic Import Petition so that the importer, or his Legal Representative, can follow in order to speed up his work, as well as ANVISA’s inspection.
This booklet aims to present a step-by-step guide and general guidelines for sending documents electronically to ANVISA. Finally, what should the importer do to make his petition / LI (Import License) available in order to obtain ANVISA’s analysis / approval.
a. Documentation required
The import process with Anvisa must be instructed with the following documents, which must be attached to the Single Siscomex Portal:
- Petition for Inspection and Sanitary Release referred to in sub-item 1.2. of Chapter II of RDC No. 81/2008;
- Extract of Import License (LI)*
- Commercial Invoice – “Invoice” (original signed copy);
- Bill of Lading (original signed copy);
- Declaration of the Registration Holder (DDR), for imports whose importer is not the holder of the regularization of the product; and
* Note: Despite not being included in the legislation as mandatory, Anvisa’s guidance is that the annexation of the LI Extract promotes celerity in the analysis of the import process
b. ANVISA´s technical requirements
After the analysis of the LI, some requirements may occur, such as:
- Request for information or clarification on the documentation that instructs the petitions filed with Anvisa.
- Request for any information or document relevant to the risk of analysis of consent to the import process;
The deadline for complying with the requirement is thirty days, non-extendable, from the date of registration of the requirement at Siscomex.
Once the import is authorized by ANVISA, it can follow its normal course.
If you want to import health products in Brazil, we can help you all along te way.
