Brazil REACH : Introduction

The Brazilian National Health Surveillance Agency (ANVISA) has launched a public consultation on the proposed regulatory framework for post-consumer recycled polyethylene terephthalate (PET-PCR) food-grade packaging materials. The consultation aims to revise the current sanitary requirements for these materials used in packaging that come into contact with food.

The proposed regulation is the result of ongoing negotiations within the Mercosur bloc and seeks to update the sanitary requirements for the recycling of post-consumer PET. This includes the incorporation of new parameters for chemical recycling processes. The new framework is designed to ensure that recycled PET meets stringent health standards while facilitating trade within Mercosur by harmonizing technical regulations.

Key Details of the Proposed Regulation:

• Consultation Period: March 28, 2025 – May 19, 2025

• Regulation Title: Requirements for Food-Grade Recycled PET Packaging (PET-PCR) for Food Contact

• Motivation: The proposal addresses advancements in chemical recycling technologies, ensuring the safety of recycled PET materials used in food contact packaging.
• Public Participation: Stakeholders are encouraged to participate in the consultation by submitting their contributions through the provided form. The feedback will play a crucial role in shaping the final regulatory text, aligning it with international standards, and ensuring the safety and efficacy of recycled PET in food packaging applications.

The MERCOSUR Regulatory Technical Regulation (RTM) on PET-PCR, which aims to replace the existing Resolution GMC 30/07, includes several important aspects regarding the safety and approval process for recycled PET used in food packaging.

• Regulation Scope: The updated regulation addresses recycled PET derived from post-consumer materials and industrial waste, focusing on ensuring the safety of recycled products intended for food contact.

• Approval and Compliance: The regulation requires the approval of both the recycling process and the establishments producing PET-PCR food-grade materials. It includes guidelines on contamination, process validation, and the quality assurance measures needed to ensure that recycled PET materials do not pose a health risk.

• Safety Standards: The proposed regulation sets clear limits for contaminants and requires the recycling process to meet stringent decontamination standards. This includes the validation of physical and chemical recycling technologies and the use of safety protocols that ensure the quality of the final products.

For more detailed information, the full documentation of the Regulatory Technical Regulation MERCOSUR on Recycled PET Packaging is available here (in Portughese). 

Accessing the Consultation: For more details and to submit contributions, access the consultation documents and submission forms can be found here (In Portughese). 

Brazil’s National Health Surveillance Agency (Anvisa) has opened Public Consultation No. 1,313, seeking public input on a proposed Normative Instruction that defines how companies must transmit and manage data under the Unique Device Identification (UDI) system for medical devices. Contributions can be submitted until May 26, 2025.

Background: What Is RDC No. 591/2021?

The consultation stems from Collegiate Board Resolution (RDC) No. 591, issued in December 2021, which introduced Brazil’s UDI framework for medical devices. The regulation aims to enhance the traceability, safety, and post-market surveillance of medical products by requiring that each device be assigned a unique identifier.

RDC 591/2021 mandated that UDI data must be transmitted to a centralized Anvisa database, but the obligation would only begin once Anvisa officially confirmed that its system was ready to receive such data.

Why This Public Consultation?

Public Consultation No. 1,313 fulfills that requirement. It:

• Announces that Anvisa’s UDI database (SIUD) is now operational and capable of receiving UDI data.

• Presents a draft Normative Instruction detailing the technical and procedural requirements for transmitting this data.

• Invites stakeholders—such as manufacturers, importers, and healthcare entities—to review and comment on the proposed framework before it is finalized.

Key Elements of the Draft Normative 

The Normative Instruction establishes:

• Two methods for UDI data transmission: individual or bulk submission.

• Company responsibilities, including the option to authorize third-party users to submit data on their behalf.

• Rules for data modification, publication, and device discontinuation.

• A timeline for mandatory compliance, based on the risk classification of each medical device as outlined in RDC 591/2021.

Devices already on the market may have their UDI data submitted voluntarily, even before mandatory deadlines apply.

How to Participate

Comments can be submitted via Anvisa Portal: Contribution Form

Submissions are public and will be available for review after the consultation closes.  Once the consultation period ends, Anvisa will analyze the input and publish the final version of the Normative Instruction, which is expected to take effect on July 1, 2025. The agency also plans to release detailed implementation guides and a user manual for the SIUD system.

This marks a significant step toward strengthening Brazil’s regulatory infrastructure for medical devices and aligning with international best practices for UDI implementation.