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Updates: On October 15, 2024, Brazil's REACH inspired chemical law (PL 6120/2019) passed the Plenary of the Federal Senate. The bill is now forwarded to the Executive Branch for final sanction by the President.
The approved bill included an amendment that would exclude medicines, active pharmaceutical ingredients, medicinal gases, preparations and substances intended for the prevention, diagnosis or treatment of health classified as medical devices.
On April 24, 2024, Brazil's Science, Technology, Innovation and IT Committee (CCT) in the Federal Senate nodded through the emerging REACH-like chemical law (PL 6120/2019).
At the 8th Meeting (Extraordinary), the "ad hoc" rapporteur, Senator Fernando Dueire, offered a favorable opinion to Amendment nº 1, authored by Senator Dr. Hiran.
The Amendment nº 1 introduces "preparations and substances intended for prevention, diagnosis or health treatment classified as medical devices" as chemical substances exempted from the Bill.
The Bill has now exempted the following categories of chemical substances:
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
Preparations and substances intended for prevention, diagnosis or health treatment classified as medical devices
Next, the Bill will be forwarded to the Environmental Committee (CMA) and Social Affairs Committee (CAS) successively for approval.
As Brazil's REACH-inspired Bill moves along the Senate with momentum, it is expected be enacted into law this year. Brazil will soon join its Latin counterparts Chile, Colombia and Peru to establish a modern chemical management framework.
