Brazil REACH

On November 14, 2024, the President of Brazil sanctioned the Brazil’s chemical law (Law No.15, 022), commonly known as “Brazil REACH”.

This law establishes a comprehensive regulatory framework for registration, prioritization, risk assessment and risk management of chemicals, aiming to minimize their adverse impacts on human health and the environment.

While the new law lays the groundwork, it still needs additional regulatory infrastructure to become fully operational. The detailed implementing regulations will be subsequently developed by the authority within 180 days of the law’s publication.

#English Translations

Brazil REACH: Law No. 15,022 of November 13, 2024 On November 14, 2024, the President of Brazil sanctioned the Brazil’s chemical law (Law No.15, 022), also known as "Brazil REACH". The law establishes the National Inventory of Chemical Substances and the assessment and risk control of chemical substances used, produced or imported in the national territory, with the aim of minimizing adverse impacts on health and the environment.

Scope

This chemical law is applicable to all chemical substances used, produced or imported in the Brazilian territory, except for the followings:

• Radioactive substances;

• Chemical substances under development;

• Chemical substances intended exclusively for research;

• Non-isolated intermediates;

• Substances usable in national defense;

• Waste;

• Result from an unintentional chemical reaction (e.g., air, sunlight, humidity, microorganisms)

• Subject to customs supervision that are not subject to any type of treatment or transformation;

• Food and food additives, manufacturing technology adjuvants, pesticides, cosmetics, sanitizing agents, substances used for veterinary use, substances intended for animal feed, fertilizers, inoculants and correctives, wood preservatives, environmental remediators;

• Medicines, active pharmaceutical ingredients, medicinal gases and preparations and substances intended for prevention, diagnosis or health treatment classified as medical devices;

• Ores and their concentrates, as well as other rocks and minerals(including coal and coke, crude oil, natural gas, liquefied petroleum gas, natural gas condensate and gases and components of mineral production processes), naturally existed substances, fats, essential oils and fixed oils, glass, frit and ceramics, except those that are chemical modified or consist of substances classified as hazardous to health or environment in accordance with GHS classification;

• Narcotics, psychotropic and immunosuppressive drugs;

• Used exclusively as ingredients of tobacco and derivatives;

• Metal alloys in the form of sheets, foils, strips, billets, ingots, beams and similar products for structural purposes;

• Explosives and their accessories.

Who is effected

Manufacturers or importers of chemical substances have legal obligations to comply with Brazil REACH. Foreign manufacturer exporting to Brazil are allowed to designate an exclusive local representative to assume the responsibilities under Brazil REACH, similarly to the EU’s “Only Representative”.

Registration

Businesses who produce or import chemical substances in amounts equal to or greater than 1 ton per year must register through the registration system. 

Companies will have a 3-year window to register existing substances and establish the National Inventory of Chemical Substances (INSQ)  once the system is operational.

The substances registered before the deadline will form the National Inventory of Chemical Substances (INSQ). Any chemical substance that is not listed will be considered a new chemical substance. New chemical substances manufactured or imported in amounts equal to or more than 1 ton per year shall be registered in the registration system.

Here is the registration timeline:

The registration must include the following information:

• Identification of the producer or importer;

• Amount of production and annual importation of the chemical substance;

• Identification of the chemical substance, including the CAS number or IUPAC name;

• GHS hazard classification in accordance with current Brazilian standard; and 

• Recommended uses. 

The followings are exempt from registration:

• Mixtures (except for chemical substances used as ingredients)

• Articles

• Monomeric units as part of polymers and additives added to preserve polymer stability

• Polymers of low concern

Note: Chemical substances of unknown or variable-UVCB composition must be registered as a single chemical substance. Polymers shall be registered, except those of low concern.

Prioritization and Evaluation

The registered chemical substances and new chemical substances will be selected and prioritized for risk assessment regarding human health and the environment based on the following criteria:

• Hazard properties (PBT, carcinogenicity, mutagenicity, reproductive toxicity, and endocrine disruptors);

• Relevant exposure to human health or the environment;

• Forecast in alert, listed under any international agreement, treaty or convention to which Brazil is a signatory.

To support the risk assessment, manufacturers and importers may have 120 days to submit the additional information at the request of the Technical Committee for the Assessment of Chemical Substances.

Based on the risk assessment results, the Deliberative Committee on Chemical Substances may determine the relevant risk management measures, such as restrictions, authorizations and prohibitions.

Confidential Business Information (CBI)

Generally, the information submitted to the INSQ shall be publicly accessible.

The following data will not be considered confidential under the Law:

• Identification of the chemical substances;

• The declaration of recommended uses;

• The hazard classification;

• The results related to the impact on health and the environment;

• The conclusions of the risk assessments.

Manufacturers or importers may request, for a maximum period of 5 years, protection from disclosure of the identity of the chemical substance and its CAS number.