Brazil

Latest Developments of Chemical Regulations in Brazil

Little Pro on 2018-03-12 Views:  Update:2018-04-02

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 June 2016, 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 Draft Law for the Registration, Evaluation, and Control of industrial Chemical Substances for public consultations. In 2017, CONASQ invited related stakeholders and held 2 meetings to discuss the developments of the new Draft Law. 

The Draft Laws sets provisions on the creation of a national existing chemical substance inventory,  and on the registration, evaluation and control of chemical substances. It also makes GHS mandatory for industrial chemicals at workplace. 

National Inventory of Existing Chemical Substances

The article 4 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, submit the following information to the CONASQ. All substances gathered will be used to build the national existing chemical substance inventory in Brazil. 

  • Company identification of producer or importer;
  • Substance identity such as name, CAS number, and, where applicable, its structural formula;
  • Quantity produced or imported per year;
  • Identified uses
  • GHS classification

It is expected that the deadline for submitting above info will be 3 years since the implementation date of the new Draft Law. It is not clear whether <1t/y susbtances are allowed to be added onto the inventory in the finalized text.

Registration

Once the national existing chemical substance inventory has been finalized, chemical substances which are not listed will be regarded as new chemical substances. It is not clear what the rules are for the new chemical substances.

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

Evaluation

Certain industrial chemicals on the inventory will be selected for 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.

What Might Happen Next

CONASQ has already received lots of comments during consultation stage. Several meetings were also held in 2017 to push for the development of this new law. Our prediction is that CONASQ will finalize the new law and submit it to congress for approval near the end of 2018. If everyting goes smoothly, the new law might be published and come into force in 2019. 

References

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 Tags: Topics - BrazilREACH-like Regulation and Registration

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