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The Federal Senate approved Brazil’s REACH-inspired bill for the President’s final approval.
Brazil’s REACH-inspired chemical law (PL 6120/2019) was approved by the Federal Senate Plenary on October 15, 2024. The law has now been sent to the Executive Branch for the President’s final approval.
A change to the passed law would bar medications, pharmaceutical active components, medicinal gases, and preparations and materials used for health prevention, diagnosis, or treatment from being categorized as medical devices.
The new REACH-like chemical law (PL 6120/2019) was approved by the Federal Senate’s Science, Technology, Innovation, and IT Committee (CCT) on April 24, 2024.
The “ad hoc” rapporteur, Senator Fernando Dueire, expressed support for Amendment No. 1 (written by Senator Dr. Hiran) during the 8th Meeting (Extraordinary).
“Preparations and substances intended for prevention, diagnosis or health treatment classified as medical devices” are now exempt from the Bill thanks to Amendment No. 1.
The Bill has now exempted the following categories of chemical substances:
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- 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-Update
The bill will then be sent for approval to the Social Affairs Committee (CAS) and the Environmental Committee (CMA), in that order.
Brazil’s REACH-inspired bill is anticipated to become law this year as it gains traction in the Senate. Soon, Brazil will join Chile, Colombia, and Peru in establishing a contemporary framework for chemical management.