Little Pro on 2018-03-12 Views: Update:2019-11-16
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.
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.
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.
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.
It is expected that the deadline for submitting above info will be 3 years since the availability of a substance.
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).
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:
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.
If coming into force, the new law will make GHS mandatory for industrial chemicals at workplace.
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