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16 Nov 2024
Brazil's REACH Chemical Regulation Comes into Effect Today!
Keywords
On November 15, 2024, the Brazilian Official Gazette announced that Brazil's REACH regulation, Law 15.022, has officially come into force. This marks Brazil as the largest country in Latin America to implement a unified chemical management system.
Timeline and Implementation
Within three years of the regulation's publication, the Brazilian government will develop a chemical registration system. Companies will then have an additional three years from the system's launch to comply with registration requirements and help establish the National Chemicals Inventory. Substances not listed in the existing inventory will be classified as new substances and will require a new substance notification.
Exemptions
The following are exempt from the regulation:
- Radioactive substances
- Chemicals under development
- Substances for research purposes
- Non-isolated intermediates
- Substances for defense purposes
- Waste materials
- Substances, mixtures, and articles under customs control without processing or conversion
- Substances, mixtures, or articles that undergo unintended chemical reactions during storage or due to environmental factors (e.g., air, light, humidity, microbes)
Additionally, the following products governed by specific regulations are exempt:
- Food products
- Manufacturing aids for food products
- Food additives
- Pharmaceuticals, active pharmaceutical ingredients (APIs), medical gases, medical devices, and diagnostic materials
- Pesticides, related products, premixes, and technical products
- Cosmetics, toiletries, and perfumes
- Disinfectants
- Veterinary drugs
- Animal feed
- Fertilizers, inoculants, and corrective agents
- Wood preservatives
- Environmental remediation agents
Certain substances, unless chemically modified or defined under GHS standards as hazardous to health or the environment, are also exempt:
- Ores, concentrates, rocks, and minerals, including coal and coke
- Crude oil, natural gas, LPG, and natural gas condensates
- Gases and by-products from mineral production
- Naturally occurring substances
- Fats, essential oils, and fixed oils extracted by grinding, pressing, or expression that retain their natural properties
- Glass, frit, and ceramics
- Narcotics, psychotropics, and immunosuppressants
- Substances used solely in tobacco production
- Metal alloys in forms such as plates, sheets, strips, ingots, or beams
- Explosives and related accessories
Entities Required to Register
- Substances or components in mixtures produced or imported in quantities exceeding 1 ton annually over the past three years
- Polymers, except low-concern polymers (monomers and stabilizing additives are excluded)
- UVCB (Unknown or Variable Composition, Complex Reaction Products, and Biological Materials) substances, which must be registered as single chemicals
Who Must Register
- Manufacturers within Brazil
- Importers within Brazil
- Sole representatives (OR) designated by manufacturers outside Brazil
Information Required for Registration
1. Identity of the substance's manufacturer or importer
2. Annual production or import tonnage range
3. Substance details, including CAS number or IUPAC name
4. Hazard classification information based on GHS standards
5. Recommended use information
*For new substances, additional technical documentation and risk assessment reports are required.*
Next Steps
The Brazilian government will establish a working group during the next meeting of the National Chemical Committee (CONASQ) to draft detailed implementation guidelines. These supplementary regulations are expected to be published within 180 days.
Starting November 15, 2024, companies will have a 3-6 year grace period to transition and comply with the new requirements.
Disclaimer: Blooming reserves the right of final explanation and
revision for all the information.