Brazilian National Inventory of Chemical Substances Established

By Raissa Havens, regulatory specialist, Supply Chain team, UL Solutions

Following Chile, Colombia, and most recently Peru, another South American country takes a step towards a more sound chemical management program as Brazil adopts a national inventory of chemicals.

On November 21, 2019, bill 6120/2019 was introduced on the Chamber of Deputies by deputy Flávio Nogueira (PDT/PI), proposing the creation of a national inventory of chemical substances which aims to strengthen the chemical management nationwide.

On November 14, 2024, Law 15.022 of November 13, 2024, was published, specifying requirements for registration, evaluation and control of industrial chemicals, as well as the timeline for registration and sanctions that could be applied in case of infractions.

Manufactures and importers must register pure chemical substances or substances used in mixtures that individually reach a quantity equal to or greater than one metric tonne per year, considering the average of the last three years.

The registration of a chemical substance in the National Inventory of Chemical Substances must include the following information:

1. Identification of the producer or importer of the chemical substance;
2. Amount of the chemical substance produced or imported annually;
3. Identification of the chemical substance, including the Chemical Abstracts Service (CAS) number or the International Union of Pure and Applied Chemistry (IUPAC), by its acronym in English, when existent;
4. The hazard classification according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), in accordance with the current Brazilian standard;
5. The recommended uses of the chemical substance.

Exemptions include:

• Pesticides
• Fertilizers
• Cosmetics and personal hygiene products
• Food and food additives
• Substances and preparations for veterinary use
• Pharmaceuticals and preparations intended for health treatment classified as medical devices
• Radioactive substances
• Waste
• Substances in development or solely for research
• Substances used exclusively as ingredients of tobacco and derivatives
• Immunosuppressive, narcotic and psychotropic substances
• Other exceptions that are regulated by specific laws.

The Law also points out that the following do not require registration:

• Mixtures;
• Articles;
• Monomeric units when they are part of polymers and additives added to preserve the stability of the polymers; and
• Polymers of low concern, according to criteria defined in the regulation.

Risk assessment

Two new committees – the Deliberative Committee on Chemical Substances and the Technical Committee for the Evaluation of Chemical Substances - will be established to oversee chemical evaluation and deliberation.

Certain substances from the inventory will be selected for a risk assessment by these committees. The selection will be based on certain risk criteria to human health and the environment.

The risk assessments' conclusions and risk management measures proposed by the Technical Committee for the Evaluation of Chemical Substances will undergo public consultation before being officially published, in accordance with the regulations.

Foreign manufacturer

The foreign manufacturer may designate an exclusive representative in the country to fulfill registration obligations and responsibilities imposed on importers.

Animal testing

Similar to the REACH regulation, animal testing is considered a last resort in assessing the danger and risk of chemical substances. It would only be permitted after all possibilities of alternative methods have been exhausted.

Timeline

A new online registration platform will be developed within three years of the publication of this Law.

There will also be a three-year period from the launch of the registration platform for manufacturers and importers to register any chemicals subject to the new law. Companies will have until March 31st of the subsequent year to submit information on those substances as well as develop a registration strategy to comply with the new requirements.

Recommended action items

Review the chemical substances and amounts being used and/or handled within the Brazilian market and verify the following:

• Deadlines for submission of chemical substance information
• Risk assessment requirements and implementation of a management program of the substances used or handled at the workplace

References

Bill 6120/2019

Law 15.022/2024 (Portuguese only)