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On May 9, 2023, Brazil’s Constitution, Justice and Citizenship Commission (CCJC) approved the National Chemical Law (PL 6120/19). The Bill will now be submitted to Senate for consideration. Once passed, the Bill will serve as the Brazil REACH Regulation and make Brazil the third country in South America to establish a chemical management law after Chile and Colombia.
As per the Bill, Brazil will set up a National Inventory of Chemical Substances (Inventory) to consolidate an information base on chemical substances with hazardous characteristics in accordance with GHS.
Registration
Businesses who produce or import chemical substances themselves, or used as mixture component that reach an amount equal to or greater than one 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.
In case of any change or new uses, the chemical must be re-registered by March 31 of the following year.
In addition, a batch of priority substances will be selected based on the following criteria:
Persistence in the environment;
Bioaccumulation in the environment;
Toxicity in the environment;
Carcinogenicity, mutagenicity, and reproductive toxicity;
Characteristics of endocrine disruptors;
Hazards exposure to human and environmental exposure;
Substances listed in an international agreement, treaty, or convention of which Brazil is a party or is included in an international alert; and
Not under risk assessment process.
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
According to André Passos Cordeiro, executive president of Brazil's chemical industry association (Abiquim), the approval of PL 6120/2019 is fundamental for the country to establish and formalize evaluation procedures and control instruments for risk management of chemical substances based on scientific evidence and with the participation of interested parties in decision-making.
The Bill is now set to be reviewed by the Environment Committee (CMA) and the Committee on Social Affairs (CAS) and is expected to be passed by the end of 2023.
