Brazil: Environment Commission Approves National Inventory of Chemical Substances

The Environment Commission (CMA) took another step towards enhancing chemical safety in Brazil by approving Bill PL 6.120/2019 on 11 September 2024. The Bill establishes the National Inventory of Chemical Substances, which will evaluate and control the risks associated with chemical substances used across the country. Originating from the Chamber of Deputies, the proposal received a positive endorsement from Rapporteur Beto Faro (PT-PA), who had also supported the measure in the Commission on Science, Technology, Innovation, and Information (CCT). In the CMA, Senator Fabiano Contarato (PT-ES) served as an ad hoc rapporteur, presenting Faro’s report. The bill now moves to the Social Affairs Commission (CAS) for final analysis, before being sent to the president for sanction.

Creation of Registry to Protect Health and the Environment

The primary goal of the Bill is to reduce the harmful impacts of chemical substances on both human health and the environment. To achieve this, the Bill establishes a Technical Committee for the Evaluation of Chemical Substances and a Deliberative Committee of Chemical Substances, both composed of experts in environmental science, health, chemistry, trade, and metrology. Additionally, the creation of a Chemical Substances Registry will serve as the foundation for the inventory, creating a publicly accessible database of substances that are imported or produced in Brazil.

Key Provisions and Responsibilities

The Bill outlines the criteria and deadlines for including substances in the registry and assigns responsibilities to manufacturers, importers, and professional users of these chemicals. It also introduces penalties for non-compliance, including warnings, fines, and in severe cases, suspension of the substance’s production along with potential seizure. Fines can vary significantly, ranging from 5% of the minimum wage to up to 40,000 times the minimum wage.

The registry will include information about the producer or importer, the quantity produced, the hazard classification based on Brazilian regulations, and usage recommendations. Manufacturers and importers will have up to three years to submit the necessary information after the registry is made public. For newly produced substances, the deadline will be March 31st of the following year.

Substances produced or imported in volumes of one tonne or more per year will need to be registered. However, certain exceptions apply, including radioactive substances, substances in development, those intended for national defense, and products regulated by specific laws, such as food, medicines, pesticides, cosmetics, fertilizers, and veterinary products.

Intellectual Property Protection and Risk Evaluation

For new substances that require unique studies conducted in Brazil to generate necessary information, the bill grants intellectual property rights for up to 10 years over these studies. Third parties may register a substance only if authorized by the study's owner to access the data.

Substances included in the registry will undergo a risk evaluation process led by the Technical and Deliberative Committees. This evaluation will be based on criteria such as environmental toxicity, carcinogenic potential, and effects on human reproduction. The bill also places restrictions on animal testing, only allowing it when all scientifically reliable alternative methods have been exhausted.

Introduction of New Fees

To finance the regulatory process, the Bill introduces a Registration, Evaluation, and Supervision Fee for Chemical Substances. The specific amounts will be determined by the future regulation. The fee will be charged for the registration of substances, those subjected to risk assessments, and in cases where protection of a substance’s identity is requested due to trade or industry secrecy concerns.