ORBIS Compliance

Brazil Introduces Bill N° 6.120-E for Chemical Substance Regulation

Published /Brazil

Overview

Brazil's Bill N° 6.120-E, effective since September 20, 2023, introduces significant regulations concerning health and the environment. One of its key provisions is the establishment of the National Inventory of Chemical Substances, aimed at rigorously evaluating and managing the risks associated with chemical substances to safeguard public health and the environment.

This legislation mandates the creation of a comprehensive database covering chemicals used, produced, or imported in the country. It places the responsibility of providing crucial information, including chemical composition, usage, and potential risks, squarely on the shoulders of manufacturers and importers. Additionally, the law integrates international data, allowing assessments based on studies conducted abroad.

With a 120-day deadline for information submission, extendable for valid technical reasons, Bill N° 6.120-E seeks to strengthen regulatory oversight, enhance risk assessment processes, and ensure the well-being of Brazilian citizens and the environment.

Recent Updates

On March 5th, 2023, a revision was made to the law, further emphasizing the Public Power's role in:

  • Designating the authority responsible for enforcing the law (Art. 11)
  • Enacting the regulatory framework within 180 days (Art. 12)
  • Developing or adapting computer systems necessary for implementing the National Inventory of Chemical Substances within three years from the law's publication (Art. 13)

Article Excerpts

  • Art. 11. The Public Power will designate the authority in charge of the application of this law.
  • Art. 12. The Public Power must proceed with the normative regulation of this Law within a maximum period of 180 days.
  • Art. 13. The Public Power will have a maximum period of 3 (three) years after the publication of this Law to develop or adapt the computer systems necessary for the implementation of the National Inventory of Chemical Substances.

Regulatory Impact

  • Top Priority: No
  • Type of Certificate: Yes
  • Spectrum Bands: No
  • Import Changes HS Codes: No
  • Standard Changes: No
  • Product Changes: Yes
  • Label Changes: No

Link to Source - https://www25.senado.leg.br/web/atividade/materias/-/materia/160711

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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