Brazil

Latest Updates of Chemical Regulations in Brazil

Little Pro on 2018-03-12 Views:  Update:2018-11-06

Currently, there is no REACH-like regulation or new chemical substance notification requirements for industrial chemicals in Brazil. As Brazil starts developing its own national existing substance inventory and new chemical management policy, we think it is necessary to summarize the latest developments and share with you what is likely to happen.

Background and Overview

In Brazil, there are specific laws that apply to pharmaceutical products, cosmetics, pesticides, sanitizing products and explosives. However, there is no law applicable to industrial chemicals. In Oct 2018, 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 law sets provisions on the creation of a national existing chemical substance inventory,  and on the evaluation and control of chemical substances. It also makes GHS mandatory for industrial chemicals at workplace. 

Scope

The draft law mainly applies to >=1t/y industrial chemical substances. According to the article 3 of the draft law, the following chemical substances are out of scope.

  • 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

National Inventory of Chemical Substances

The article 6 and 7 of the draft law requires that producers or importers of industrial chemical substances, including substances in mixtures, in an amount equal to or greater than 1 ton per year (based on three years' average), 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.

  • 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;
  • Recommended uses
  • GHS classification

It is expected that the deadline for submitting above info will be 3 years since the availability of a substance.

New Substance Registration

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.

Certain existing chemical substances on the inventory will be selected for evaluation (see next paragraph).

Evaluation

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.

Note: Industrial chemical substances which do not fulfill one or more of the criteria above but may give rise to a level of equivalent conern may also be subject to evaluation. 

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. 

GHS Implementation

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

References

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 Tags: Topics - BrazilREACH-like Regulation and Registration

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