Cosmetics Regulation in Brazil
Perfumes, cosmetics, toiletries and similar products need to be registered with the National Agency of Health Surveillance, ANVISA, which regulates the production, import and trade of perfumes, cosmetics, toiletries, etc. It has established the criteria for the composition of the products, permitted and restricted ingredients, instructions for labeling and other related measures.
By the resolution published in 2005, cosmetics and toiletries were classified according to their degree of risk. Perfumes, cosmetics and toiletries were characterized as: “any preparation made of natural or synthetic substances, for external use on various parts of the body, skin, hair, nails, lips, external genitalia, teeth and mucous membranes, the oral cavity with the exclusive or main purpose of cleaning them, perfuming them, changing their appearance or correcting body odors, protect them or just keep them in good condition.”
Cosmetic products are forbidden from claiming to have therapeutic gain or advertising stating that the products might heal illness or disease. The law forbids using names, symbols, pictures or drawings that might lead the consumer to any false interpretations.
ANVISA provide protection to the health of the population by exercising sanitary control in the production, marketing of products and services subject to sanitary surveillance. Also controlling ports, airports and borders linked to the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.
ANVISA itself, establishes specific rules for the cosmetic industry similar to the directives from the European Economic Community. These rules have been previously discussed and approved within the economic bloc Mercosul and adopted in Brazil. Cosmetics and personal care items are divided into 2 different categories, based on their latent risk.
Degree 1 of Risk
Degree 1 products are those with basic properties that have already been proven in the past. These products are not registered with ANVISA. They can be simply notified on ANVISA’s website through a simple form containing basic information about the product (composition data, physico-chemical, microbiological information, Free Sale Certificate, etc.), without payment of any fee to ANVISA. Generally, such products can be on the market one month after the online notification form is received. This means that such products can be imported at the time the local distributor notifies it on ANVISA’s website.
However, if for some reason ANVISA decide to analyze the notification process, and find some contradictory information that make them classify the product as Category 2, the distributor/importer is asked to clarify the information questioned and the notification may not be accepted.
Examples of Degree 1 products:
- Simple conditioners
- Shaving foams
- Aftershave lotions
- Body lotions with the aim of moisturizing and refreshing without vitamins and sunscreens
Degree 2 of Risk
Degree 2 cosmetics are those with more complex properties that require current proof of efficiency and safety. They are subject to Registration as they need to provide more detailed and specific instructions and show more consistency due to the increased degree of risk. Risk 2 products have to be submitted and approved by ANVISA before being on the market. It takes around 60 days before the first disclosure from the local agency happens.
Along with the product data, a fee needs to be paid to ANVISA by the importer. This fee varies according to the size of the company, that is, the larger the company the higher the tariff. The time to complete the analysis and to issue the documentation is 60-90 days if the process is not in need of any further information. Contrary to Risk 1, products submitted for registration, must await the publication of this report in the official gazette in order to start the import process and commercialization.
Examples of Degree 2 products:
- Anti-Dandruff shampoos
- Anti-Wrinkle creams
- Cream with sunscreen
- Eye creams
- Childrens cosmetics
According to Brazilian health legislation for perfumes and cosmetics there are 3 lists to specify the ingredient restrictions.
There is a list of ingredients with restricted use, that depending on the product and quantity can be used in moderation. There is also a list of Ultraviolet Filters listing which ones are allowed for products like sunscreens. And finally, a list naming all the substances prohibited in any perfume, cosmetic or personal hygiene product. This list contains a lot of substances and is available on the ANVISA website.
Dossiers made for both Risk 1 and 2 products include formula ingredients in exact quantities, label claims, stability and quality control results, with microbiology tests included. For Risk 2, cosmetics companies must also submit proof of efficiency and safety. For example hypoallergenic products and SPF tests must be in order. The local manufacturer or importer should have all the information and documents that constitutes the "Dossier of the Product", which must be submitted to ANVISA, and a copy should also be available during inspections of Health Surveillance. This inspection takes place once a year at any time and is performed by the local health authorities.
Notifications and Registration Expiry Date
Notification and Registration of cosmetics are valid for 5 years. Any late changes to the formulas or packaging needs to be presented before the improved products are manufactured or imported. Six months before expiration date, the revalidation application should be completed, another fee needs be paid for the renewal of the registration. If the notification or the registration are not renewed or revalidated, it will be automatically cancelled by ANVISA.
Though international analysis tests are accepted, the methodology has to be compatible with Anvisa’s standards. However, Brazilian consumers do appreciate social responsibility, sustainability and good morals in their relations.
In 2014, after a violent break in to free the animals at a animal testing lab, the São Paulo government started a legislation which is still pending that intends to ban animal testing in the state. The law would only limit cosmetics, not medicinal animal testing.
Even though organic cosmetics represent only 2% of the organic market, it has around USD 9 million in revenue all over the world. Organic products that are being produced are shampoos, creams, lotions, scrubs, oils and a broad portfolio of makeup products. They are produced without petrochemical ingredients with animal origins, artificial fertilizers, pesticides and are not animal tested.
In some cases a chemical component is allowed in a small percentage, but the raw material has to be as natural as possible. Biodiversity favour Brazil in this market because of its vast variety of plants, fruits and all kinds of natural resources. However Europe and North America together take up 90% of the market.
There are no regulations on the subject in Brazil. In Europe and the US there are also no specific laws, but there are clear criteria to certify an organic cosmetic. With ANVISAs lack of interest in regulating this, you are not allowed to advertise on any label that a product is an “organic product”.