Brazil approves the National Chemical Inventory (Bill PL 6120/2019) and Its Impact on the Industry with LAW 15.022/24

Brazil approves the National Chemical Inventory (Bill PL 6120/2019) and Its Impact on the Industry with LAW 15.022/24

The President of Brazil endorsed Law 15.022/24, which is the sanctioned version of Bill PL 6120/2019. This bill, approved by the Social Affairs Committee of the Brazilian Senate, aims to create the National Inventory of Chemical Substances.

This regulation establishes a regulatory framework for the management of chemical substances in the country. The project addresses the need for a more effective and secure registry, aligning with international standards. The creation of this inventory is expected to improve transparency and protect public health and the environment.

Need for Chemical Regulations in Brazil

Brazil's chemical industry has seen significant growth, becoming a cornerstone of the nation's economy. However, the absence of a uniform registry for chemical substances has led to regulatory gaps, posing risks to both public health and the environment. Numerous potentially hazardous products lack adequate oversight. Therefore, it is crucial to establish a robust regulatory framework to effectively manage these substances.

The Need for a National Inventory of Chemical Substances

Brazil has encountered significant challenges in the management of chemical substances, underscoring the urgent need for a national inventory. This inventory will:

  • •Identify the chemical substances present in the market.
  • •Assess the potential risks associated with their use.
  • •Establish more effective control over their production and distribution.

The creation of this inventory aims to enhance transparency regarding chemical substances, aligning Brazilian practices with international standards and ensuring a safer environment for both the public and the ecosystem.

Influence of the REACH Regulation

Bill PL 6120/2019 was inspired by the European Union's REACH system (Registration, Evaluation, Authorization, and Restriction of Chemicals). This regulation has proven effective by establishing strict requirements for the information and evaluation of chemical substances. Brazil's intention to adopt a similar approach aims to enhance chemical safety in the country, aligning with international best practices and promoting responsibility within the chemical industry.

Creation of the National Inventory of Chemical Substances

The primary goal of this law is to establish a National Inventory of Chemical Substances. This registry will catalog all chemical substances used, produced, or imported in the country. With this organized and accessible information, it will be easier to control and monitor the chemical products present in the Brazilian market.

One of the most significant aspects of the project is the implementation of a system for evaluating and controlling the risks associated with chemical substances. To achieve this, a technical committee will be established to:

  • •Evaluate the toxicity of various substances.
  • •Classify and determine potential health and environmental risks.
  • •Issue recommendations for the safe and regulated use of these substances.

Transparency and Data Accessibility

A key goal of the project is to ensure transparency by providing easy access to information about chemical substances. From the National Inventory, a public database will be established, including:

  • •Detailed information on the properties of each substance.
  • •Data on safe handling practices and toxicity.
  • •Resources for researchers and regulators, enhancing the quality of information available to the public.

Information Registration in the Inventory

All companies that produce or import chemical substances greater than one ton per year require to register specific information in the National Inventory of Chemical Substances. This registration includes:

  • •Identification of the producer or importer.
  • •Quantities produced or imported.
  • •Hazard characteristics of the substances, in accordance with current Brazilian regulations.

Compliance with this registration is crucial to ensure traceability and proper management of the risks associated with these substances.

Penalties for Non-Compliance

The regulations enforce stringent measures for those who do not meet the established requirements. These penalties are designed to ensure compliance and safeguard public health.

Penalties can have a significant impact on companies, both financially and reputationally. The possibility of substantial fines and the suspension of activities can affect the viability of many organizations operating in the chemical sector. Therefore, it is crucial for manufacturers and importers to fulfill their obligations to avoid negative consequences for their operations.

Exceptions and Limitations of the Law

Bill PL 6120/2019 specifies certain exceptions and limitations that are essential for understanding its scope. These exceptions involve substances that are not subject to the national inventory, as well as existing specific regulations.

Substances Excluded from the National Inventory

The substances that will be excluded from the National Inventory of Chemical Substances have been clearly defined, based on safety considerations and existing regulations:

  • •Radioactive substances: Substances that emit radiation and are regulated by specific laws will be excluded from the inventory.
  • •Substances in the development phase: Any substance that is still in research or development and not yet commercialized will not be included in the registry.
  • •Substances for national defense.
  • •Waste substances.

The inventory will not apply to substances that are already regulated by other specific safety standards. This includes:

  • •Food: Food products and their additives are regulated by specific agencies, ensuring their safety.
  • •Medications: Drugs and their components are subject to strict controls, ensuring their efficacy and safety before approval and use.
  • •Veterinary products: Substances used in veterinary treatments, as well as medicinal products for animals, will not be included in the inventory.

The registry will not apply to:

  • •Mixtures
  • •Articles
  • •Polymers

The approval of this law is a crucial step towards better management of chemical substances, ensuring greater transparency and protection for public health and the environment. This positions Brazil, alongside Colombia as pioneers in Latin America in the registration of chemical substances.