Brazil’s Senate approves EU Reach-like rules to increase chemicals control

LIMA (ICIS)–Brazil’s Senate approved on 15 October the creation of a National Inventory of Chemical Substances aiming at “reducing negative impacts” of toxic chemicals on human and environmental health.

The inventory and the associated public bodies to ensure compliance will put Latin America’s largest economy close to the EU’s Reach regulatory system regarding chemicals.

In the 27-country EU, the stringent Reach has since its inception at the end of the 2000s banned several chemicals and put hundreds of others in the so-called list of Substances of Very High Concern (SVHC).

While industry has repeatedly said it support the Reach principles, increased costs associated with complying with the regulation has put a burden in some small- and medium-sized enterprises (SMEs), a burden their peers in jurisdictions such China or the US do not have to face.

Industry has also argued that while Reach may indeed avoid the entry of many toxic chemicals into the EU, those same chemicals are nonetheless still used in the manufacturing of many goods in overseas jurisdictions which end up entering the EU.

On Tuesday, the trade group representing Brazil’s chemicals producers Abiquim welcomed the measure, arguing it had lobbying for the creation of the registry since 2014.

The bill, called in Parliament’s jargon PL 6120/2019, now awaits presidential sanction from Brazil’s President Luiz Inacio Lula da Silva, and after that it will come into force.

“[The Inventory] establishes rules for the assessment and control of the risk of substances used in the national territory, to be determined by committees of experts, and defines criteria for the manufacture, import, and use of chemical components,” said the Senate after passing the bill.

“The bill creates the Technical Committee for the Evaluation of Chemical Substances and the Deliberative Committee on Chemical Substances, made up of experts with knowledge in the areas of the environment, health, trade and metrology. It also establishes the Registry of Chemical Substances, which will form the inventory and the public access database on substances imported or produced in Brazil.”

The parliamentarians added that it will fall on manufacturers and importers of chemical substances to provide information to the inventory.

If they do not comply in an orderly and timely manner, they will be subject to fines of up to 40,000 minimum wages – in 2024, Brazil’s minimum wage was set at Brazilian reais (R) 1,412/month ($249/month). The maximum fine, thus, would stand at nearly $10 million.

However, the aim to control what chemicals are used and how in Brazilian manufacturing will stop at some substances which the regulators thought were of national interest, and the law does not apply to radioactive substances or substances intended for national defense, for instance.

It will not apply either to products subject to control by specific legislation, such as food, medicines, pesticides, cosmetics, fertilizers, and veterinary products, among others.

“In the case of new substances that require unprecedented studies in Brazil for the information to be made available, the bill guarantees the right to ownership of the studies for up to ten years,” said the Senate.

“Other provisions of the project impose criteria for the evaluation of substances by the responsible committees, establish restrictions on the performance of tests on animals and establish the Registration, Evaluation and Inspection Fee for Chemical Substances.”

BROAD DAYLIGHT CHEMICALS
In 2023, when the draft proposals were already gaining traction in Parliament, a consultancy focused on chemicals regulation, the Chemical Inspection and Regulation Service (CIRS) Group, summarized the regulation’s main point in a report titled “Brazil’s REACH-like Regulation is Approaching”.

In it, it said from now companies’ declarations on the chemicals they use in their manufacturing processes must include the following aspects:

– The identification data of manufacturers and importers specified in regulations
– The annual production and import amount of chemical substances
– The exact identification of chemicals including names and CAS number (if they exist) issued by the Chemical Abstracts Service (CAS) or the International Union of Pure and Applied Chemistry (IUPAC)
– Hazard classifications made under the Globally Harmonized System (GHS) and current Brazilian regulation
– Recommended uses of chemical substances

You can read CIRS Group’s report here.

CLARITY, TRANSPARENCY, PREDICTABILITY
Abiquim welcomed on Tuesday the bill with open arms. It is worth noting the trade group represents large producers – Braskem has a commanding voice in the group, for instance – which tend to be the players more capable of dealing with new and extra regulation.

According to Abiquim’s CEO, Andre Passos, the new bodies created with the bill will help optimize the use of public resources, as well as bring positive impacts to competitiveness, innovation and economic growth, he said.

“We will be able to count on a regulatory model that, in fact, provides the sector with greater clarity of its requirements, transparency in its processes, and long-term predictability, thus allowing the chemical industry to define future investments in the country,” he said.

“[With this measure] Brazil joins a select list of the most developed and economically sustainable nations.”

Abiquim said several studies have backed having a strict registry of chemicals because official control – with companies collaboration – has helped reduce negative impacts some chemicals can have on human and environmental health.

The trade group said the EU had been its paramount source of inspiration, but added that several jurisdictions, following the former’s example, have implemented or are aiming to implement similar regulations.

“Based on these initiatives, whose monitoring of health and environmental results demonstrated a positive trend, we presented a proposal to the CONASQ [Brazil’s National Commission for Chemical Safety] Working Group that could be applied in Brazil,” said Camila Hubner, the trade group’s manager for regulatory affairs and sustainability.

According to Abiquim, similar regulatory frameworks have been implemented or are in the phase of doing so in the following jurisdictions: the US, the EU’s 27 countries, Australia, New Zealand, Japan, South Korea, China, Switzerland, the UK (which, for now, has basically applied Reach post-exit from the EU), Turkey, the Eurasian Economic Union (which includes Russia, Kazakhstan, Belarus, and Armenia), Canada, Costa Rica, Ecuador, Chile, and Colombia.

After naming the parliamentarians who lobbied hard to have these regulations approved, Abiquim’s Passos said: “It is very important to remember these names because they understood that regulation was needed based on science and the risks that chemical substances can present, prioritizing human health and the environment.

“On behalf of the chemical industry, I would like to thank each congressman who made an effort.”

Front page picture: Brazil’s Senate approves the creation of the National Inventory of Chemical Substances, 15 October 2024
Picture source: Brazil’s Senate news services (Agência Senado)

Focus article by Jonathan Lopez