Brazil Regulatory News

On 9 May 2023 the Brazilian Chamber of Deputies approved Bill 6120/2019. The Bill will now move on to the Senate for consideration. It is now set to be reviewed by the Environment Committee (CMA) and ...

On 9 May 2023 the Brazilian Chamber of Deputies approved Bill 6120/2019. The Bill will now move on to the Senate for consideration. It is now set to be reviewed by the Environment Committee (CMA) and the Committee on Social Affairs (CAS). The Bill had been shelved since 2019 when President Bolsonaro came into office.

If Bill 6120/2019 is approved in Senate and signed into law it would:

• Establish a National Inventory of Chemical Substances

• Adopt GHS as the mandatory classification system

• Set up an Assessment Committee to assess the risks of the substances and recommend risk management measures

So far, the only Latin American countries that have implemented national chemicals legislation are Chile and Colombia. According to a statement made by Melissa Owen, founder of law practise Ambiente Legal, on LinkedIn there is ‘a distinct possibility that the Bill could be approved as early as this year’ making Brazil the third country in the region to adopt a national chemical legislation.

In March 2023 during the ChemCon the Americas 2023 Conference a half-day workshop was held in San Francisco that focused on the current state of chemical registration systems and the implementation of...

In March 2023 during the ChemCon the Americas 2023 Conference a half-day workshop was held in San Francisco that focused on the current state of chemical registration systems and the implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in Latin American countries. The workshop brought together experts from regulated industries, trade associations, and consultancies to discuss the latest developments in chemical regulations across the region.

Several Latin American countries, including Chile and Colombia, have already adopted mandatory industrial chemical registration systems, while others such as Argentina, Brazil, Peru, and Mexico are in the process of developing similar systems.

Overall, the workshop highlighted the need for continued vigilance and engagement from industry stakeholders and regulators to ensure that chemical management regulations in Latin America keep pace with global best practices. With some countries lagging behind in their efforts, there is a pressing need for greater coordination and cooperation between governments.

Name the table:

The Latin American region is facing a rapid evolution in chemical management regulations, which will have an impact on the manufacturing industry. This is due to an increased awareness of the potential environmental and health risks posed by chemicals. Governments in the region are taking steps to ensure that companies comply with appropriate regulations and standards when it comes to managing chemicals. Companies must be aware of these changes and take proactive steps to ensure they remain compliant with all relevant regulations.

Last month the Constitution, Justice, and Citizenship Committee at the Brazilian Parliament reopened the debate about bill PL 6120/2019. This is a bill that seeks to create the Inventário Nacional de...

Last month the Constitution, Justice, and Citizenship Committee at the Brazilian Parliament reopened the debate about bill PL 6120/2019. This is a bill that seeks to create the Inventário Nacional de Substâncias Químicas (The Chemical National Inventory of Brazil), a national database that will consolidate information on chemical substances produced or imported in the country.

The bill was approved by the Commission for Economic Development, Industry, Commerce and Services of the Brazilian Chamber of Deputies on November 23, 2022 and is still in the approval process.

This is a national framework for chemical legislation that is back on track. the Bill is under the consideration of the Constitution, Justice, and Citizenship  Committee. In this case, the Bill will not require a plenary vote after this last Committee, as it would be considered approved by the Chamber of Deputies and move on to the Senate.

Last month, the Committee reopened the amendment period for five additional sessions and discussed appointing a new rapporteur. However, time has run out on these sessions, and no changes were made. The original rapporteur's opinion still stands, and the Bill is ready for a decision in that Committee.

On 15 February 2023 Brazil's National Health Surveillance Agency (ANVISA) notified the WTO regarding a new resolution, RDC 774/2023, which entered into force on 1 March 2023. This resolution provi...

On 15 February 2023 Brazil's National Health Surveillance Agency (ANVISA) notified the WTO regarding a new resolution, RDC 774/2023, which entered into force on 1 March 2023. This resolution provides the conditions for the registration and labelling of sanitizing products with antimicrobial action.     

The requirements in the Resolution depend on the intended use of the sanitising product (general or specific use, use in food industry or hospital products). Substances that are designated as carcinogenic, mutagenic, and teratogenic for humans by the International Agency for Research on Cancer are prohibited under the Resolution. 

Registrants must show that the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA) or EU authorities have approved the active ingredients in the sanitising products. When these bodies have approved the product’s active ingredients manufacturers will need to submit the data specified in Annex I of Resolution RDC 774/2023.  

Information needed to register a sanitising product with ANIVSA: 

Resolution RDC 774/2023 prescribes the following new labelling requirements for sanitizing products: 

The labelling for corrosive or caustic products must contain the following 13 mandatory phrases:   

On 1 March 2023, Resolution 58/2023 restricting animal testing for cosmetics and other personal care products in Brazil was introduced by the National Council for the Control of Animal Experimentation...

On 1 March 2023, Resolution 58/2023 restricting animal testing for cosmetics and other personal care products in Brazil was introduced by the National Council for the Control of Animal Experimentation (CONCEA).

To reduce the use of animals, the resolution makes it mandatory in Brazil to employ alternative methods for “known ingredients”.

As per the response from Humane Society International (HSI)government affairs specialist in Brazil can include another way “that reduce the many animals' quantity in each experiment and rectify another way to implement each test and it is indicated that this resolution is only a partial ban as it depends on the theory of Reuse, Refine and Recycle.

However, as a domestic testing ban, it cannot prevent import or sale of newly animal-tested cosmetics from other countries.

CONCEA does not have the legal jurisdiction to include certain important issues in its resolution, including a restriction on marketing cosmetics that rely on new animal data. Thus, there is still a lot to include.

As per Humane Society International, the work will be continued to approve the bill and soon it is expected to be discussed by the chamber of deputies.

The issue of animal testing at national level will be effectively settled, and the ministry of science, technology and information proposed entire ban is no longer “necessary”.

On 17 March 2023 the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) published the Regulatory Instruction No. 10 of March 17, 2023, that establishes an updated list of c...

On 17 March 2023 the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) published the Regulatory Instruction No. 10 of March 17, 2023, that establishes an updated list of classification of harmful or dangerous substances according to the risk they produce when coming into contact with water. The standard conforms to the International Code for Chemical Products in Bulk (ICCPB) adopted by Annex II of the International Convention for the Prevention of Pollution by Ships (ICPPS) of the Committee for the Protection of the Marine Environment of the International Maritime Organization (IMO).

This regulation classifies chemical products according to the medium or moderate risk to human health or the environment and grants the Brazilian Institute of the Environment and Renewable Natural Resources, as the authority in the case, the power to classify the products in the corresponding category of the International Code of Chemical Products in bulk or in another category resulting from the risk assessment of the mixture of harmful  substances. To do this, the institute must consider the best technical information available at the time of the evaluation.

On 26 December 2022 the Brazilian National Health Surveillance Agency (ANVISA) published Resolution RDC 772/2022 which provides a new simplified procedure for the registration of personal hygiene prod...

On 26 December 2022 the Brazilian National Health Surveillance Agency (ANVISA) published Resolution RDC 772/2022 which provides a new simplified procedure for the registration of personal hygiene products, cosmetics, and perfumes.  The resolution entered into force on 2 January 2023. The initiative aims to reduce the number of post-registration applications for personal hygiene products, cosmetics, and perfumes pending the ANVISA’s response. On its official website, ANVISA estimated that the impact of implementing the new measure would reduce the queue by up to 20%. 

The change represents the simplification of the ordinary procedure. This means that requests will automatically be approved when complying with Article 3 of RDC 772/2022.  

The aim of this new regulation is to bring legal certainty to ANVISA’s actions and favor the optimization of the analysis of requests with less risk to health. Additionally, it is logical to understand that access to regularized personal hygiene products, cosmetics, and perfumes in Brazil will be expanded, based on the principle of presenting all the technical and legal documentation required by ANVISA.  

Moreover, this regulation incorporates elements concerning confidentiality. Another important aspect is that this regulation also deals with the commitment, participation, and legal responsibility of the companies holding registries in the country, establishing the corresponding sanctions in case of non-compliance with the norm. 

Article 3 of the new RDC establishes post-registration requests subject to the simplified procedure. These are changes in labelling, registration cancellation, registration petition withdrawal, presentation of the registered product, manufacturer indication, modification of the formula, manufacturer change, tone name change, reduction of the validity term, replacement of the presentation of the registered product, and others.