How is new substance is regulated under Brazil

Once the national existing chemical substance inventory has been finalized, chemical substances which are not listed will be regarded as new chemical substances. Manufacturers and importers of >=1t/y new chemical substances need to register those new substances by submitting additional studies and risk assesment report. Data requirements will increase with tonnage bands.

Following substances are exempted under this regulation:

  • Radioactive substances
  • Substances in development or solely for research
  • Non-isolated intermediates
  • Narcotic and psychotropic substances
  • Pharmaceuticals
  • Agrochemicals
  • Cosmetics and personal hygiene products
  • Food and food additives

If the regulation comes into force, the new law will make GHS mandatory for industrial chemicals at workplace.

Mainly industrial chemicals

National Chemicals Safety Commission (Comitê Nacional Sobre Segurança Química, or CONASQ) , along with the Ministry of Environment (Ministério do Meio Ambiente, or MME)

New substances and certain existing industrial chemicals on the inventory will be selected for hazard evaluation by 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.

Producers and importers of >=1t/y 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.

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