Brazilian REACH Compliance Guide

I. Overview

Brazil's REACH Regulation (Law No. 15.022/2024) officially came into effect on November 15, 2024. It is a critical piece of legislation formulated by Brazil to strengthen the management of chemical substances. The regulation aims to conduct comprehensive assessments and risk controls on chemical substances produced, used, or imported within Brazil to mitigate their potential risks to human health and the environment.

The legislative journey of Brazil's REACH Regulation began with the submission of Bill No. 6120/2019 in 2019. After multiple rounds of deliberation and revisions by the Brazilian Chamber of Deputies and Senate, the bill was finally approved by the Senate on October 15, 2024. Subsequently, the President of Brazil officially signed and promulgated Law No. 15.022/2024 on November 15, 2024, signifying the official implementation of Brazil’s REACH Regulation.

To better implement regulatory requirements, Brazil plans to develop a new chemical registration system platform within the next three years to enhance the efficiency and transparency of chemical management. The enforcement of this regulation will have a profound impact on Brazil’s chemical industry, compelling enterprises to prioritize chemical safety management and driving sustainable development within the sector.

Link to the Official Regulation Text:

https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l15022.htm

II. Scope of Application

Brazil’s REACH Regulation applies to chemical substances produced, imported, or used within Brazil, including both new and existing chemicals. The core objective of the regulation is to minimize adverse impacts of chemicals on human health and the environment through risk assessment and management measures.

1. Applicable Entities

Chemical substances with an annual production/import volume equal to or exceeding 1 ton, or chemicals used as components in mixtures.

2. Exemptions

(1) Substances Exempt from Registration

I - Mixtures themselves;
II - Articles (finished products with specific shapes or designs);
III - Monomer units in polymers and additives added to maintain polymer stability;
IV - Polymers of Low Concern (PLC).

(2) Specific Exempted Substances

I - Radioactive substances;
II - Chemicals under development (not yet commercialized);
III - Chemicals exclusively for research purposes;
IV - Non-isolated reaction intermediates;
V - Substances for national defense;
VI - Waste materials;
VII - Chemicals, mixtures, and articles under customs supervision (without processing or transformation);
VIII - Unintentional reaction byproducts generated during storage of other substances, mixtures, or articles, or due to exposure to environmental factors (e.g., air, sunlight, moisture, or microorganisms);
IX - Products regulated under specific legislation, including:

1. Food;
2. Processing aids in manufacturing;
3. Food additives;
4. Pharmaceuticals, active ingredients, medical gases, and health-related devices;
5. Pesticides, pre-mixes, and technical products;
6. Cosmetics, personal hygiene products, and perfumes;
7. Disinfectants;
8. Veterinary products;
9. Animal feed;
10. Fertilizers, inoculants, and soil conditioners;
11. Wood preservatives;
12. Environmental remediation agents;

X - The following substances, unless chemically modified or containing components classified as hazardous under the Globally Harmonized System (GHS):

1. Minerals, mineral concentrates, coal, coke, crude oil, natural gas, and related components;
2. Natural substances (unchanged by chemical processes);
3. Fats, essential oils, and fixed oils extracted via pressing or extraction (if purified without altering their original properties);
4. Glass, ceramics, and porcelain;

XI - Narcotics, psychotropic substances, and immunosuppressants;
XII - Tobacco components and derivatives;
XIII - Structural metal alloys (e.g., sheets, foils, beams, ingots);
XIV - Explosives and related accessories.

III. Registration Entities

IV.  National Chemical Inventory (Inventário Nacional de Substâncias Químicas)

1. Pre-Registration

Companies must complete pre-registration within three years after the launch of Brazil’s chemical registration system.

Pre-registered substances will be listed in the National Chemical Inventory and classified as existing substances.

2. New Substance Registration

Substances not listed in the Inventory are considered new substances.

New substances will be added to the Inventory immediately upon submission of required information.

3. Annual Reporting

Producers, importers, or ORs handling Inventory-listed chemicals must submit annual updates (e.g., production/import volumes, usage) by March 31 of the following year.

4. Data Updates

Registrants must update information whenever changes occur, with final submissions due by March 31 of the following year.

5. Mandatory Registration Details:

I - Entity details (producer/importer/OR);

II - Annual production/import volume;

III - Chemical identification (e.g., CAS number, IUPAC name);

IV - Hazard classification under the GHS standards;

V - Intended uses of the substance.

V. Health and Environmental Risk Assessment

1. Standards for prioritizing chemicals for risk assessment:

I - Environmental persistence and toxicity;

II - Environmental bioaccumulation and toxicity;

III - Environmental persistence, bioaccumulation, and toxicity;

IV - Carcinogenicity, mutagenicity, or reproductive toxicity;

V - Endocrine-disrupting properties based on scientific evidence;

VI - Potential for human or environmental exposure;

VII - Precautions in international agreements or conventions where Brazil is a signatory.

2. Chemicals not meeting one or more of the criteria I to VII in paragraph 1 may be selected and prioritized on a case-by-case basis by the Technical Committee for Chemical Assessment if, based on scientific evidence, they may cause significant adverse health or environmental effects equivalent to those meeting the above criteria.

3. The Chemicals Review Committee will regularly publish the work program for chemical risk assessment.

4. Chemicals already assessed may be included again in the program mentioned in paragraph 1 for re-evaluation.

5. The Technical Committee for Chemical Assessment will use information and studies available from nationally and internationally recognized bodies and may request manufacturers and importers to provide data, studies, and supplementary safety data sheets.

VI. Data Requirements and Confidentiality

1. If undisclosed Brazilian studies are compiled for providing information, they shall enjoy a 10 - year property protection period.

2. Holders of Brazilian undisclosed studies may authorize third parties to use them and shall provide data access letters as a requirement for manufacturing or importing new chemicals.

3. Information submitted to the Brazilian Chemical Inventory will be publicly accessible, with personal data protected by law and industrial or commercial secrets classified as confidential.

4. When submitting undisclosed Brazilian studies to support chemical risk assessment or provide information on new chemicals, manufacturers or importers may indicate to the Technical Committee for Chemical Assessment the information they deem confidential, as constituting industrial or commercial secrets, to be protected from disclosure.

5. Manufacturers or importers may request protection from disclosure of the identity of a chemical and its CAS number for a maximum period of 5 years.

6. Unless specifically indicated otherwise, the following data will be regarded as public:

I - Identification of the chemical;

II - Declaration of recommended use;

III - Hazard classification;

IV - Results related to health and environmental impacts;

V - Conclusions of risk assessment.

VII. Regulatory Authorities

VIII. Administrative Penalties for Non-Compliance

Violations of the regulation will result in the following administrative sanctions:

I - Written warning;

II - One-time fine;

III - Daily fines (recurring penalties);

IV - Destruction or neutralization of non-compliant chemicals, mixtures, or articles;

V - Seizure or confiscation of non-compliant chemicals, mixtures, or articles;

VI - Suspension of sales and manufacturing of non-compliant products;

VII - Partial or full suspension of operations;

VIII - Permanent prohibition of activities;

IX - Suspension of registration for mixtures/articles (if applicable);

X - Revocation of registration for mixtures/articles (if applicable).