In this edition of the Weekly Compliance Digest, we provide more details on a proposed chemicals legislation in Brazil.
Registration, Evaluation and Control of Industrial Chemicals
What is it?
On June 30, 2016, Brazil’s Ministry of the Environment published a proposed legislation on the registration, evaluation and control of industrial chemicals produced in, or imported into, Brazil. The bill would establish a chemical regulatory framework composed of the following three main elements:
- A registry of chemicals produced in, and imported into, Brazil.
- A risk assessment process to select substances from the Registry and evaluate their environmental and health risks. The substances would be selected and evaluated based on the following criteria:
- Persistent, bioaccumulative and toxic to the environment.
- Carcinogenic, mutagenic or toxic to reproduction.
- Endocrine disruptors, based on scientific evidence.
- Relevant potential for human and environmental exposure.
- Appearance in alerts, international agreements or conventions to which Brazil is a signatory.
- A risk management program to regulate chemicals, based on the results of the risk assessment process. Different types of measures could be imposed, such as:
- Bans on the production, import, export, sale and use of the substance.
- Restrictions on the production, import, export, sale and use of the substance.
- Limits on the concentration of the substance in intentional mixtures or finished products.
- Requirement of prior authorization for production or import.
Who is affected?
The proposed legislation would apply to:
- Companies in Brazil that produce industrial chemical substances in quantities above one ton annually.
- Foreign companies that import into Brazil industrial chemical substances in quantities above one ton annually.
The proposed legislation defines an industrial chemical substance as “a chemical element and its compounds, in a natural state or obtained through a manufacturing process, including any additive necessary to preserve its stability and any impurity that derives from the process used, but excluding any solvent that can be separated without affecting the substance’s stability or modifying its composition.”
What are the requirements?
The proposed legislation would create the “National Registry of Industrial Chemical Substances“. Companies producing or importing a covered industrial chemical substance in a quantity of one ton or more annually would have to submit the following information:
- Information on the company.
- Substance name.
- CAS number of the substance and its structural formula (where applicable).
- Annual quantity of the substance.
- Uses of the substance.
- GHS hazard classification of the substance.
The deadline for registration would be three years after the date when the Registry is established. In addition, while the threshold quantity for submitting information to the Registry is one ton or above, lower threshold quantities may be established for particular substances based on their risks to the environment and human health.
The following would be excluded from the registration obligations:
- Radioactive chemical substances.
- Chemical substances in development or intended exclusively for research.
- Non-isolated reaction intermediaries, impurities, contaminants, and substances produced through unintentional reactions.
- Ores and their concentrates, and other rocks and minerals.
- Metals and alloys in forms used for structural purposes.
- Active ingredients of pesticides.
- Active ingredients of human and veterinary medicines.
What is next?
The proposed legislation was published in June 2016. A public consultation period was opened and will end on August 14, 2016. According to Chemical Watch, the final text of the proposed legislation is expected to be approved in November 2016, and will then be sent to the National Congress, which will decide whether to pass it into law.
Here are links to articles with additional information on Brazil’s proposed chemicals legislation:
- Brazil Maps Out Plans for Industrial Chemicals Policy, from Chemical Watch
- Brazil Proposes Sweeping Chemicals Legislation, from the law firm Beveridge & Diamond PC
- Brazil Proposes Chemicals Legislation, from the National Law Review
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