Brazil Regulatory News

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.

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.

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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.

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. 

Normative Instruction 11 of October 17, 2022, replaces Normative Instruction 5, of May 17 2010.  This new regulation adjusts the registration obligation of remedial products, prior consent for import...

Normative Instruction 11 of October 17, 2022, replaces Normative Instruction 5, of May 17 2010.  This new regulation adjusts the registration obligation of remedial products, prior consent for importation, and authorization to carry out research and experimentation. These procedures are adopted by the Brazilian Institute for the Environment and Renewable Natural Resources. 

The Instruction enters into force on November 1, 2022. The National Council for the Environment will update its classification (Resolution 464 of 2014) of environmental remedial products concerning their nature: chemical or physical-chemical remediators, bioremediators, phytoremediators, biostimulators, and physical process agents. Currently, the last three are exempt from registration. 

Failure to comply with the provisions of this Normative Instruction and other legal rules applicable to activities involving remedial products will subject violators to the sanctions provided for in Act 9,605/1998. 

For more information please visit: https://www.gov.br/ibama/pt-br 

To access Normative Instruction 11 of October 17, 2022, in Portuguese please visit: https://tratamentodeagua.com.br/instrucao-normativa-ibama/  

To access to the list of remedial products in Portuguese, visit: https://ibamagovbr-my.sharepoint.com/:x:/g/personal/07612330679_ibama_gov_br/EbFO464p94VPqAkXPgOwBHwBAL2tckoEl4hM5LzfBqBWqg?rtime=77NBCWHN2kg 

On 3 October 2022 the Brazilian National Health Surveillance Agency (ANVISA) published a new Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA on the regularization of personal hygiene products, cosmetics...

On 3 October 2022 the Brazilian National Health Surveillance Agency (ANVISA) published a new Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA on the regularization of personal hygiene products, cosmetics, and perfumes which came into force directly.

On 19 September 2022, the Brazilian National Health Surveillance Agency adopted Resolution 752/2022. It entered into force on 3 October 2022. Resolution 752/2022 requires labelling adaptations which demand the addition of customer service information, particular definitions for tanning products, hypoallergenic goods, personal hygiene products, and specific wrapping features.

Resolution 752/2022 is the result of adapting several directives of the Common Market of the South (MERCOSUR). Therefore, it is an effort of the Brazilian government to standardize regulations in the region and simplify the trade of those goods within the MERCOSUR region and towards it. 

In addition to technical requirements and regularization as well as labelling and packaging procedures, the new standard defines the parameters for the microbiological control of these products. In this regard the Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA for contains guidance to meeting the mandatory requirements for microbiological specifications of the finished product, provided for in item III of Article 8 of Resolution 752/2022.This Note points out the technical requirements and procedures concerning microbiological control. In this regard, two possible options could occur:

• if a product is keen to pollute in a microbiological dimension, the product shall comply with several parameters set in Chapter V of Resolution 752/2022.
•  if a product is potentially not a harm in a microbiological dimension such condition should be demonstrated technically under ISO29621:2017.

Existing product registration  must be adapted before 3 October 2025 and new products have to comply with the novel regulation. For more information in Portuguese visit: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/anvisa-divulga-orientacoes-sobre-controle-microbiologico-de-cosmeticos

On 5 September 2022, the Brazilian Chemical Industry Association (Abiquim) signed , in the Brazilian capital, Brasília, a protocol of intent with the Ministry of the Environment. This document intend...

On 5 September 2022, the Brazilian Chemical Industry Association (Abiquim) signed , in the Brazilian capital, Brasília, a protocol of intent with the Ministry of the Environment. This document intends to collaborate, among other issues, in the elaboration of the National Climate Change Mitigation Plan and chemical management.  

This happens in the context of draft bill 6.120/2019 which was approved on 6 December 2021 by the Environment Committee of the Brazilian Chamber of Deputies. The intent of this is to set inventories, risk assessments, and authorization requirements for chemicals to protect human health and reduce environmental damage. This entails the production, importation, and use of chemicals in the Brazilian territory. If the protocol is approved in the parliament,  a database would be established in the country with all the industrial chemicals used in Brazil with a quantity of more than one tonne per year. 

In this context, Abiquim and the Ministry of Environment are advancing in the Brazilian management of chemical substances.  This is already in progress through Bill 6.120/2019 whose enactment was paused under Bolsonaro’s government. However, a representative of Abiquim expects that this bill will be approved and believes that its effects will be positive for the chemical industry in Brazil.  

The United Nations has funded a project with the cooperation of the Brazilian Ministry of the Environment, to monitor hazardous chemical substances in order to establish and create a national chemical inventory. It is estimated that this project will start in early 2023. Currently, the Bill is waiting to be approved by all committees of the Brazil National Congress, and after the final approval, it will be sent to the Brazilian senate.