Brazil Update on Draft REACH Like Law

At the 15th extraordinary meeting held in September 2018, the Brazilian National Chemical Safety Commission (CONASQ) adopted a revised text of the draft law regulating the management of chemical substances. The revised text has recently been released as a preliminary draft. However, the legislative process is still ongoing and the text has yet to be examined by the Brazilian Congress prior to its final adoption.

The main objective of the law would be to establish the inventory, risk assessment and control of chemicals, in order to minimize the adverse impacts on health and the environment arising from their production, importation and use within the national territory.

Article 3 lists the substances which would be excluded from the application of this law.

The bill establishes the committees and the federal agency responsible for the evaluation of the risk management for prioritized substances and the related management measures.

A general responsibility is created on manufacturers, importers and downstream users of chemical substances when placing them in the national territory. In particular, manufacturers and importers of chemicals and mixtures must:

I – provide information to the National Chemicals Registry;

II – provide information, studies and complementary safety data sheets to support the chemical risk assessment, when required;

III – submit the information required for new chemical substances;

IV – update the information registered when there is a change in the data;

V – provide adequate and accurate information and keep it always available;

VI – comply with the risk management measures determined by the Deliberative Committee on Chemicals.

Downstream users and legal entities importing who act on behalf of third parties or by contract with an orderer, are not bound by the above obligations, with the exception of clauses V and VI.

Also, the foreign manufacturer of chemicals and mixtures exported to Brazil can designate a representative in the countries to fulfil the obligations indicated in clauses I to V.

The National Chemicals Registry will be implemented and maintained by the federal agency responsible for the environment, so that a National Inventory of Chemical Substances can be set up.

The chemicals and mixtures which reach a quantity equal or greater than 1 ton of production or import per year, as the average of the last three years, must be registered in the National Chemical Registry including the information listed in Article 7. Also, Article 8 lists the substances which, although covered by this law, don’t require registration.

The information must be included in the National Chemicals Registry within the time frame of three years from its availability, in order to form the National Inventory of Existing Chemical Substances. After the above period, producers and importers of chemicals listed in the inventory in quantities greater than 1 ton per year are obliged to provide the information as per Article 7 by 31 March of the following year.

With regard to new substances, information requirements are set out in Article 12.

Chemicals listed in the National Inventory and new substances will be selected and prioritized for risk assessment, according to the criteria listed in Article 14, before the Technical Committee for the Evaluation of Chemical Substances. As a result of the risk assessment, risk management measures may be determined.

Furthermore, the Bill covers the procedures for the enforcement of these obligations and the related sanctioning regime.

The draft, if finalized, will enter into force on the day of publication.

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