Regulatory context

MERCOSUR

The Southern Common Market (Mercado Común del Sur, MERCOSUR) is a trade consortium comprised of five countries: Brazil, Argentina, Uruguay, Paraguay and Venezuela (who has, however, been suspended since 2017).

MERCOSUR was created in 1991 with the signing of the Treaty of Asunción.

MERCOSUR cosmetics legislation is based on various Resolutions put forth by the Grupo Mercado Común (GMC), the executive body of MERCOSUR.

These resolutions are incorporated into the legislation of each member state.

Definition

Through Resolution GMC n°110/94, cosmetic products are defined as “products for personal hygiene, cosmetics and perfumes, formulas consisting of natural or synthetic substances or a mixture of both, intended for external use on various parts of the human body, skin, capillary system, nails, lips and external genitalia or on the teeth and mucous membranes of the oral cavity, with the sole or main purpose of cleaning them, perfuming them, changing their appearance and/or correcting body odor and/or protect them or keep them in good condition.”

Classification

Cosmetics are classified under one of two grades through Resolution GMC n°07/05. The classification of each product is based on its probability of causing undesirable effects. Grade 2 products are considered to have a higher probability of triggering these effects.

The same Resolution provides definition for the two grades:

Grade 1 products: “personal hygiene products, cosmetics and perfumes which fall within the definition present in GMC Resolution n ° 110/94 and which are characterized by having basic or elementary properties whose verification is not initially necessary and which do not require detailed information as to their mode and restrictions of use, due to the intrinsic characteristics of the product.”

Examples: make-up remover, make-up without sun protection and face cream without sun protection.

Grade 2 products: “personal hygiene products, cosmetics and perfumes which fall within the definition present in GMC Resolution No. 110/94 and which have specific indications whose characteristics require verification of safety and/or efficacy, information, precautions, modes and restrictions of use. “

Examples: children’s products and sun products.

The registration process depends on the product grade and the country where the cosmetic will be sold. Based on these two factors, some products are required to be notified and some are required to be registered.

Lists of products within each grade are available in the Annexes of the Resolution.

Ingredients

MERCOSUR has its own ingredients lists:

• Prohibited substances: Resolution GMC n°62/14
• Restricted substances: Resolution GMC n°48/10 and n°24/11
• Authorized dyes: Resolution GMC n°16/12
• Authorized preservatives: Resolution GMC n°7/11
• Authorized UV filters: Resolution GMC n°44/15

Member states use these lists as a basis for their own lists.

Labels

Resolution GMC n°36/04 lists the information that’s required to be on the label:

• Name of the product and its group/type if not implied in the name
• Brand
• Product registration number
• Batch number
• Use by date
• Net contents
• Country of origin
• Manufacturer/Importer
• Address of the Manufacturer/Importer
• Instructions for use (if applicable)
• Warnings and usage restrictions (if applicable)
• Specific labels: additional mandatory warnings for some products
• Ingredients/Composition

Transpositions

The Resolution established by MERCOSUR is incorporated into its various member states’ regulations. Uruguay and Paraguay use the exact same regulation while Brazil and Argentina incorporate a few specific details.

How does it work?

BIORIUS can conduct a formula review and verification of the required information for cosmetic product labels.

1. Formula Review: A toxicological and regulatory assessment of the ingredients and impurities, based on the lists of ingredients and restrictions of each country, establishment of the INCI list and warnings.Upon conclusion of the analysis, a formula review report is issued, which highlights the following elements:
   • Ingredients
   • Percentages of each ingredient
   • Restrictions
   • Margins of Safety
   • INCI list
   • Warnings
   • Expert comments including strategic recommendations
2. Label Check: Verification of required information on the product label.Through these essential steps, BIORIUS assist with the preparation of the cosmetic registration file, which is needed for product launch.

Specifics

Regulatory context in Brazil

In Brazil, the governmental health authority responsible for cosmetics products is known as ANVISA.

Brazil uses product categories as defined by MERCOSUR. Products are also divided into two grades: Grau 1 and Grau 2.

In Brazil, only nine product categories (from Grade 2) are required to be registered (Resolution RDC n°237/2018 and n°409/2020):

• Tanning products
• Sun protection products
• Sun protection products for children
• Antiseptic hand gels
• Hair straightening products
• Hair straightening and dyeing products
• Hair curling products
• Insect repellent products
• Insect repellent products for children

Other categories are required to be notified.

Brazil uses the following lists of ingredients:

• Prohibited substances: Resolution RDC n°83/2016
• Restricted substances: Resolutions RDC n°3/2012 and RDC n°15/2013
• Authorized dyes: Resolution RDC n°44/2012
• Authorized preservatives: Resolution RDC n°29/2012
• Authorized UV filters: Resolution RDC n°69/2016

The documents required to register or notify a product can be found in Resolution RDC n°288/2019. They are as follows:

1. Qualitative-quantitative formula in INCI
2. Function of the ingredients in the formula
3. Bibliography and/or reference for the ingredients (only if the ingredient has no INCI name)
4. Organoleptic and physicochemical specifications of raw materials
5. Microbiological specifications of raw materials, if applicable
6. Organoleptic and physicochemical specifications of the end product
7. Microbiological specifications of the end product, if applicable
8. Manufacturing processes
9. Technical specifications of the packaging materials
10. Product stability test results
11. Codification system of the batch number
12. Label artwork
13. Data substantiating product claims
14. In use safety data
15. Intended product use
16. Working license (from the Brazilian company responsible for the product)
17. Original formula

Information required for labels is specified in Resolution RDC n°7/2015. It’s similar to what’s required by MERCOSUR but adds some specific elements (for warnings, for example).

For claims, there cannot be therapeutic indications or mentions.

Additionally, the label can’t have denominations and indications that can mislead the consumer regarding the origin, composition, purpose or safety of the product.

Product Registration Process in Brazil

BIORIUS can assist the customer with registering cosmetic products in Brazil.

However, the registration or notification must be carried out by a Brazilian company (importer) who is registered by ANVISA and has a working license.

1. Formula Review: A toxicological and regulatory assessment of the ingredients and impurities and the establishment of the INCI list and warnings.Upon conclusion of the analysis, a formula review report is issued, which highlights the following elements:
   • Ingredients
   • Percentages of each ingredient
   • Restrictions (based on the Brazilian lists)
   • Margins of Safety
   • INCI list
   • Warnings
   • Expert comments including strategic recommendations
2. End Product Appendices Review: Evaluation of the documents that will be sent to the Brazilian company for the notification/registration, based on Resolution RDC n°288/2019 as well as guides edited by ANVISA.
   • Required appendices
   • Whether the appendices are compliant or not
   • Expert comments, including strategic recommendations
3. Label & Claims Review: Evaluation of the product label (ingredients list, symbols, legal requirements, etc.) and claims substantiation.The labels & claims review is a report containing all the information required to appear on the label:
   • Required elements
   • Presence of required elements (primary packaging, secondary packaging & leaflet)
   • Final INCI list
   • Claims
   • Conclusions of each claim
   • Expert comments – strategic recommendations are provided for updating the label