Brazilian Legislative Draft on Industrial Chemicals
Brazil does not currently have a Reach-like regulation of new chemical substance notification requirements for industrial chemicals. While Brazil is developing its own national substance inventory, the following is a summary of its efforts to create one:
Brazil has specific regulations for pharmaceuticals, cosmetics, pesticides, sanitizing products and explosives, but as yet there are no regulations that apply for industrial chemicals.
In October 2018 Brazil started to create its substance inventory and new chemical management policy. The National Chemicals Safety Commission (Comitê Nacional Sobre Segurança Química, or CONASQ), along with the Ministry of Environment (Ministério do Meio Ambiente, or MME), published a Preliminary Bill for the Inventory, Evaluation, and Control of Chemical Substances.
The draft provisions are set on the creation of an existing national chemical substance inventory and the evaluation and control of chemical substances. The draft also makes GHS mandatory for industrial chemicals in the workplace.
The draft law mainly applies to an amount greater than or equal to 1 ton per year (>=1t/y) of industrial chemical substances. According to article 3 of the draft, the following chemical substances are out of scope.
- Radioactive substances
- Substances in development or solely for research
- Non-isolated intermediates
- Narcotic and psychotropic substances
- Cosmetics and personal hygiene products
- Food and food additives
- National Inventory of Chemical Substances
Articles 6 and 7 of the legislative draft requires producers or importers of industrial chemical substances, including substances in mixtures, in an amount equal to or greater than 1 ton per year (>=1t/y) based on three years’ average, to submit the following information to the National Register of Chemical Substances maintained by CONASQ. All substances gathered will be used to build the National Inventory of Chemical Substances in Brazil.
The following is also required:
Company identification of producer or importer;
Substance identity such as CAS name or IUPAC name and CAS number if available;
Quantity produced or imported per year;
The expected deadline to submit the above will be three (3) years from the availability of a substance.
New Substance Registration
Once the existing national chemical substance inventory has been finalized, chemical substances which are not listed will be regarded as new chemical substances.
Manufacturers and importers of greater than or equal to 1 ton (>=1t/y) per year of new chemical substances need to register those new substances by submitting additional studies and risk assessment report. Data requirements will increase with tonnage bands.
Certain existing chemical substances on the inventory will be selected for Evaluation
New substances and certain existing industrial chemicals on the inventory will be selected for hazard evaluation by an Industrial Chemicals Assessment Technical Committee if they meet the following criteria: Persistent, bio-accumulative or toxic to the environment; or Carcinogenic, mutagenic or toxic to reproduction; or Endocrine disruptors, based on scientific evidence; There are relevant potential exposure to humans and the environment; Controlled by international treaties or conventions of which Brazil is a member or signatory.
Note:Industrial chemical substances which do not fulfill one or more of the criteria above but may give rise to a level of equivalent concern may also be subject to evaluation. Producers and importers of greater than or equal to 1 ton per year of (>=1t/y) of industrial chemicals subject to evaluation will be required to submit certain information, studies, and safety data sheets to CONASQ to support risk assessment. Depending on the results of risk assessment, CONASQ may prohibit or restrict the production, import, trade or use of certain chemical substances. For additional information, visit: http://www.mma.gov.br/seguranca-quimica.html
Brazil is planning a national policy on industrial chemicals. The country intends to conclude the draft by the end of the year, and then it will be presented to the National Congress.
The proposed law, which includes a proposal to create a chemicals inventory, will list the obligations, mechanisms and institutional arrangements to meet the policy’s goals. These will include establishing a national chemicals inventory using information in official databases, such as those used in the EU and Canada and the UN Globally Harmonized System (GHS) of classification and labeling for classifying chemicals in its inventory.
A timeline for implementing Brazil’s plans has not yet been disclosed.
For additional information, please see: