Brazil Regulatory News

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. 

On June 10, 2022, the Organisation for Economic Cooperation and Development (OECD) approved specific roadmaps for States accession, after the first steps for accession discussions in January 2022. Fro...

On June 10, 2022, the Organisation for Economic Cooperation and Development (OECD) approved specific roadmaps for States accession, after the first steps for accession discussions in January 2022. From the original list, Brazil, Bulgaria, Croatia, Peru, and Romania were accepted; Argentina, unfortunately, was not accepted.

The roadmap has specificities for each country's ascension and establishes the process and defines the conditions for such. OECD will conduct technical examinations in areas such as trade, investment, anti-corruption, environmental information, and SME & Entrepreneurship.

For Brazil and Peru, the acceptance came as a recognition of their efforts to adhere to and align the countries’ standards with international best practices. Brazil confirms 112 adhered instruments out of 257 requested by the Organization, while Peru ratified its continuing endeavors.

What does it mean for chemicals?

While Latin American countries have been progressing towards sound management of chemicals, OECD has been a relevant influence in the region. Four Latin American countries – Chile, Costa Rica, Colombia, and Mexico – are already part of the organization, and not by coincidence, Chile and Colombia are the only ones to have recently enacted a chemical framework.

Even when considering non-OECD members, countries in close relation with the Organization are ahead. This is the case, for example, of Argentina, Brazil, and Peru, whereas all these countries have at least a draft of chemical management regulations that have been accessed by their respective legislators.

In relation to chemicals, OECD requires members states to comply with core principles, which are highlighted in the following examples:

• Acceptance of the Mutual Acceptance of Data and in accordance with the Principles of Good Laboratory Practice and Test Guidelines
• Harmonization of chemical and safety policies
• Implementation of a systematic and comprehensive industrial chemicals management system

From June 1-3, 2022, the Latin America Regulatory Cooperation Forum (LARCF) hosted a two-day event to exchange information and progress toward sound management of chemicals across the region. LARCF ha...

From June 1-3, 2022, the Latin America Regulatory Cooperation Forum (LARCF) hosted a two-day event to exchange information and progress toward sound management of chemicals across the region. LARCF has been front running with events and cooperation partnerships in Latin America, bringing together more than 100 regional industry members.

In the Virtual Annual Meeting, attendees learned more about the steps, challenges, and implementation of diverse instruments across several countries. To summarize a few, the meeting addressed the following:

• Colombia's fresh chemical framework implementation and the support from the National Industry Association (ANDI) in the development of chemical policy.
• Chile’s recent chemical regulation and chemical classification process aligned with their policy implementation.
• Insights from the chemical management in Asia-Pacific Economic Cooperation (APEC), including a regulatory convergence proposal.
• Peru’s chemical proposal has been updated and this indicates that it will soon be submitted to the executive power and there will be additional chemical efforts regarding international chemical instruments implementation.
• Past and future work performed by the Intergovernmental Network on Chemicals and Waste for Latin America and the Caribbean, aligned with United Nations Environment Programme support.
• Further capacity building and activities performed together with Strategic Approach to International Chemicals Management (SAICAM) and United Nations Institute for Training and Research (UNITAR) – tools, documents, and training programmes.

Latin American countries are aware of the importance of chemical instruments to trade, environment, and safety. Such meetings are crucial to strengthening management implementation and cooperation in the region.

It was also announced that LARCF plans to publish guidelines for chemical prioritization later this year, besides the Roadmap for Sound Management of Chemicals and Chemical Inventory Guidelines published in April 2021 and March 2022, respectively.

In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -...

In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -RDC) 692 . The change is intended to facilitate the process and reduce paperwork.

Referred to as "risk 1" sanitizers, the low-risk sanitizers are now required to notify the agency exclusively through the online notification system. In addition, risk 1 sanitizers are exempted from registration, and their notification is exempted from revalidation. The declaration of interest for continued commercialization lasts ten years.

Accordingly, "Risk 2" sanitizers had their registry validity extended for a similar period. The validity period of registration granted before is October 16, 2019, which is accordingly extended to 10 years, counted from the granting of the registration.

Risk 1 sanitizers differ from risk 2 sanitizers in the absence of corrosive characteristics, antimicrobial activity, disinfestation action, and they are not based on viable microorganisms, while these attributes are used for risk 2 sanitizers classification. In addition, risk 1 sanitizers may not contain inorganic acids [Hydrofluoric (HF), Nitric (HNO3), Sulfuric (H2SO4)] in their formulation or release related salts during product usage.

Accordingly, ANVISA updated the list of permitted preservative substances for the formulation of sanitizing products. The Normative Instruction (Instrução Normativa – IN) 153/2022 displays 46 substances by chemical name, CAS number, and maximum permitted concentration limit.