Brazil’s Ministry of Environment and Climate Change (MMA) has released a draft implementing regulation for the government’s chemicals management law that provides stakeholders with a roadmap of how the national law will be carried out.
Enacted last November, Law 15.022 established a national inventory of chemicals and a framework for assessing and controlling the risk of substances made, used or imported in Brazil. The National Commission on Chemical Safety (CONASQ) followed up that effort by forming a working group to develop the draft implementing regulation, which it published ahead of schedule on 13 May.
The draft rule includes details for:
- registering chemical substances produced or imported into Brazil;
- prioritising chemical substances for risk assessment;
- assessing health and environmental risks; and
- defining and implementing risk management measures.
The MMA initially set a 13 June deadline for the public to comment on the draft, but temporarily suspended the deadline soon after publishing it. The agency said it will reopen the consultation period and extend the timeline for 60 days once it does. It advised the public to monitor its website for periodic updates, without giving a specific timeline.
National registry
Under the law, chemical substances that are produced or imported in amounts of one tonne or more per year must be registered in the National Registry of Chemical Substances system.
The national registry will contain:
- identification of the manufacturer, importer or exclusive representative of the foreign manufacturer;
- identification of chemical substances;
- data on production and import, including annual production or import quantity range; and
- data on the application and use of substances.
For certain polymers, the draft regulation states that the registration will be defined in a specific resolution to be published by the newly established Deliberative Committee on Chemical Substances.
Regarding the evaluation of substances, the draft calls for the Technical Committee for the Evaluation of Chemical Substances to be composed of a full representative and an alternate from several bodies including the MMA, which will coordinate the committee. An alternate will also be included from each of the following: Ministry of Health; Ministry of Development, Industry, Commerce and Services; Ministry of Labour and Employment; the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA); the Brazilian Health Regulatory Agency (Anvisa); the National Institute of Metrology, Standardization, and Industrial Quality (INMETRO); and the Jorge Duprat Figueiredo Foundation for Occupational Health and Safety (FUNDACENTRO).
The technical committee will have access to all available information, including confidential material, but it may not disclose the information.
Avoidance of animal testing
The draft emphasises that animal testing should be a last resort to determine information on the intrinsic properties of chemical substances and may only be used when the possibility of any alternative method has been exhausted.
It also specifies that once adequate information originating from animal tests for a given substance is received, the animal testing must not be repeated.
"We are excited to see forward-thinking elements incorporated in the current version of the BR Chemical Decree, including the requirement to use cutting-edge, non-animal technology for safety assessment over animal testing, and the mandate to develop a strategic plan to guide future scientific practices toward non-animal approaches," said Bianca Marigliani, senior strategist at Humane World for Animals, formerly known as the Humane Society International. Humane World contributed to the draft of the law and the decree.
"The current draft reflects a strong commitment to protecting human and environmental health while addressing industry needs and the imperative to move away from animal testing," she told Chemical Watch News & Insight. "We look forward to continued collaboration in making sure this bill is as protective and humane as possible."
More to come
The draft provides many of the answers to open-ended questions that were pending, including on the treatment of polymers, the criteria for prioritisation, as well as the definition of "product" for the exemptions that were subject to regulation already, Melissa Owen, founder of law practice AMBIENTELEGAL, told Chemical Watch News & Insight.
The public consultation process is an important development for both local and foreign entities that sell into the country, Owen said. She encourages stakeholders to submit comments if they have any pending questions or concerns about the draft text.
"The fact is that a decree, such as this draft regulation will become, [is] not easy to change once enacted", so this is the time to share insights and global knowledge with the authorities, Owen said.
Given the importance of the draft and the amount of interest it has generated, "I think we might expect even a few significant changes – not just tweaks" as the government reviews public comments, she said. "I would not want to venture what those might be, but I think that it is safe to say that lots of eyes will be on this."