Brazil’s Chamber of Deputies has approved a consolidated draft of its national chemical framework bill, merging all past approved versions of the legislation into a singular text, and officially advancing it to the Senate for consideration.
If approved in the Senate and signed into law, the measure would establish a national chemicals inventory, prioritise risk assessment, require authorisation for certain substances and set out the agencies responsible for enforcement.
Its passage would also make Brazil the fourth country in the region to adopt national chemicals legislation, after Peru, Chile and Colombia.
The Chamber of Deputies’ Constitution, Justice and Citizenship Committee (CCJC) has been working to ensure the constitutionality of the bill (PL 6120/2019) since the committee initially cleared the bill in May. The CCJC officially published the measure on 26 September, signalling its final approval.
Miriam Mazza, a Brazilian licensed attorney with Beveridge & Diamond, told Chemical Watch that the back and forth is an example of the "checks and balances" in the legislative process, allowing all the parties to give their opinion on certain aspects of the law.
Chemical registry, inventory
Enactment of PL 6120/2019 would not automatically establish the country’s registry and inventory, Mazza said. The bill first would establish a national registry, which would serve as the basis of information for the national inventory.
Under the bill, the government would appoint a relevant authority to begin implementation duties. The authority would have:
- a maximum of 180 days from the law’s publication to begin implementing regulations; and
- a period of three years to establish and adapt relevant technological systems for the national registry and inventory.
From the date that the national registry becomes available, manufacturers and importers would have three years to submit information on chemicals produced or imported in quantities of one tonne or more per year. Submitters would have to provide:
- information on the chemical producer, supplier or importer;
- amount produced or imported annually;
- chemical identification, including CAS number and acronyms, if any;
- hazard classification, according to the Brazilian standards of the UN Globally Harmonised System (GHS); and
- recommended uses.
Manufacturers and importers also would have to keep chemical data current after the initial submissions, with any updates on the required information due by 31 March of the subsequent year.
Mazza said while regulated entities do not have to provide updates immediately, "companies must have processes in place" to ensure they do not miss the end of March deadlines.
Several substances would be exempt from registration in the national databases, mainly those regulated by separate legislation. Exempt substances would include:
- radioactive substances;
- substances exclusively intended for research;
- certain substances under development
- substances used in national defense; and
- waste.
Risk assessment
Chemicals in the national inventory would be selected and prioritised for risk assessment, under the legislation.
Prioritisation for review would be based on the following criteria:
- persistence, bioaccumulation and toxicity to the environment (PBTs);
- carcinogenicity, mutagenicity or toxicity to reproduction (CMTs);
- endocrine disrupting characteristics;
- potential for human or environmental exposure; and
- inclusion in an alert or international agreement to which Brazil is a signatory.
The government has not indicated whether any specific substances would be considered for risk assessment if the bill were to pass, although legislation proposing the regulation of per- and polyfluoroalkyl substances (PFASs) was introduced into parliament earlier this year.
Chemicals that do not fulfil the criteria could still be recommended for prioritisation by a new Substance Evaluation Technical Committee. Recommendations would be sent to the Substances Deliberative Committee, which would periodically publish work plans as it works through assessments. The government would be required to create both committees following the bill’s enactment.
Following any chemical risk assessment, the deliberative committee could then propose risk management measures to limit identified risks. In doing so, the committee would have to consult with federal bodies that would be impacted by risk management actions prior to the issuance of a decision. A public consultation would also be required prior to the final publication of any action.
Animal testing, foreign representatives
The consolidated version of the bill would also designate a supervisory body to develop strategic plans that promote alternative methods to animal testing. The country’s National Council for the Control of Animal Experimentation (CONCEA) passed a measure in March restricting the use of such testing, in cases where known effects are available.
Additionally, foreign manufacturers would have the opportunity to have an exclusive representative appointed to them to aid in compliance with the import obligations.
Next steps
The consolidated bill now heads to the Senate for consideration.
Mazza said if the Senate changes any component of the bill, it will be sent back to the Chamber of Deputies to analyse the differences. Legislators could accept the Senate changes or reinstate the text to the 26 September version, she said.
"As a rule, the House where the Bill was presented first has final say on its content, being able to accept or not the changes made in the other House," she said.
Following this, it would head to President Luiz Inácio Lula da Silva for final approval. Lula would have 15 working days to sanction or veto the bill, in whole or part. The bill would be considered adopted if he takes no action on the bill within that timeframe.
In the case of a veto, according to Mazza, the President would send a message to Congress within 48 hours specifying his reasoning. Senators and Deputies would then have 30 calendar days to deliberate the decision in a joint session.
"To reject the veto, an absolute majority of votes from Deputies and Senators is required, that is, 257 votes from deputies and 41 votes from senators, computed separately," Mazza said.