Brazil REACH Releases Draft Implementing Regulation (Updated on August 30, 2025)

Updates: Recently, Brazil's Ministry of Environment and Climate Change (MMA) published the official English version of Draft Regulation. 

 It should be noted that the public consultation has been permanentely closed. Any comments and suggestions may be sent via e-mail to [email protected].

On May 13, 2025, Brazil officially released a draft implementing regulation to Law No.15, 022 (also known as Brazil REACH) for public consultation. The interested parties will have until June 13, 2025 to submit their comments to the authority. 

The implementing regulation provides detailed procedures and standards for enforcing the Law No.15, 022, improving the Brazil REACH legislative framework by refining details on substance registration, registration fees, etc. 

Substance registration

Brazil REACH requires businesses that produce or import chemical substances or mixtures in amounts equal to or greater than 1 ton per year must register through the National Registry of Chemical Substances System. The obligated entities include manufacturers, importers or for "Only Representative" for foreign manufacturers.

The implementing regulation provides details on the required information for registration, including: 

• Identification of manufacturer or importer, including coporate name, Brazilian National Registry of Legal Entities (CNPJ) or Brazilian individual taxpayer registry (CPF), contact information, country of origin for imported substances, or municipality of manufacture for domestic production;

• Identification of chemical substances, including IUPAC name, CAS number, Common Nomenclature Codes of Mercosur (NCM), GHS classification according to the current Brazilian standard;
  

• Data on the range of annual production and import quantity: 1-10 t/yr, 10-100 t/yr, 100-1000 t/yr, >1000 t/yr;

• Data on the application and use of substances, including nature of recommended uses (industrial, professional, domestic), sectors of use, and product categories.

For the registration of polymers, there will be a specific regulation later published to define the details. 

Implementation timeline

Companies will have a 3-year window to register existing substances once the system is operational. In case there is any update to the registered information, the change should be made by March 31. 

Confidentiality

Manufacturers or importers may request confidential business information (CBI) protection for a maximum period of 5 years. The request for CBI protection must contain at least the following: 

• Identification of the applicant; 
  

• Specification on the protected information; 

• Period of protection.

The Technical Committee will decide within 90 days whether to approve or reject the request. 

For manufacturers and importers who conduct unpublished studies in Brazil to support the risk assessment of existing chemical substances or to provide information regarding new chemical substances, the CBI protection period can be extended to 10 years. 

Fees for registration, evaluation and CBI protection

The fees for registration, evaluation and CBI protection are determined as follows (Currency unit: Brazilian Real): 

Registration fees

Evaluation fees

CBI protection fees

Animal testing

The choice of chemical testing should prioritize the alternative methods of substitution (such as QSAR), moving on to alternative methods of reduction/refinement. Finally, the traditional methods with animal testing should be the last resort. 

For animal testing, it must not be repeated when there is adequate data or information from existing animal testing. The methods used shall be scientifically verified and present a degree of adequate reliability, including those recognized by the National Council of Animal Experimentation Control (CONCEA) and international competent bodies like OECD. 

The draft implementing regulation is available here for public comments.