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Recently, Brazil's emerging national chemical law has cleared the Chamber of Deputies and the final signed version was officially sent to Federal Senate for consideration. The Bill (PL 6120/2019), which resembles a simplified version of EU REACH, is now assigned to three separate Committees in the Senate for successive procedures:
the Committee on Science, Technology, Innovation, Communication first;
the Environment Committee second; and
the Social Affairs Committee third.
The advancement came when Brazil President Lula embraced ESG (Environmental, Social, and Governance) as a core focus of his newly elected government. On top of that, as Brazil is in the process of seeking accession to the OECD (Organization for Economic Co-operation and Development), which necessitates the establishment of a national chemical inventory system, there is a strong expectation that the long-waited REACH-like draft can materialize into a binding law.
National chemical inventory
As per the Bill, Brazil will set up a National Inventory of Chemical Substances to consolidate an information base on chemical substances produced or imported into Brazilian territory. A batch of prioritized chemical substances will be selected for rigorous risk evaluations. Similarly, substances for authorization will be identified and regulated accordingly.
Registration
After the National Inventory is in operation, any chemical substance that is not listed will be considered a new chemical substance. Businesses who produce or import new chemical substances themselves, or used as mixture component that reach an amount equal to or greater than 1 ton per year must register in the Inventory. The registration must include the following information:
Identification of the producer or importer;
Amount of production and annual importation the chemical substance;
Identification of the chemical substance, including the CAS number;
Content of Safety Data Sheet for chemical products;
Risk assessment analysis studies.
Specifically, chemical substances of unknown or variable-UVCB composition must be registered as a single chemical substance.
Exemption
The Bill specifies the following chemical substances that are exempted from registration in the Inventory:
Radiative
Non-isolated intermediates
For the purpose of national defense and research
Residuals
Result from an unintentional chemical reaction
Imported for export again
Temporary storage
Naturally existed substances
Narcotics, psychotropic and immunosuppressive drugs
Used exclusively as ingredients of tobacco and derivatives
Metal alloys for structural purpose
Explosives and their accessories
Pesticides, medicine, cosmetics and sanitizer
Confidential Business Information (CBI)
Generally, The information submitted to the National Inventory of Chemical Substances 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.
In exceptional cases, the manufacturer or importer may request protection in relation to the disclosure of the identity of the chemical substance and its CAS registration number with due justification under the terms of the Law.
With the successful transfer to the Senate, Brazil is one step closer in establishing its own chemical management law. Once enacted, it will undoubtedly introduces significant changes to chemical industries operating in Brazil. ChemLinked advises companies in the concerning sector to prepare in advance for the new chemical regulatory framework.
