Brazil has approved a new national regulatory agenda for nuclear safety and health products, establishing updated standards for nuclear energy engineering and radiation safety.
Brazil Sets New Nuclear Safety and Health Standards
New ordinance creates framework for 2026-2027 regulatory agenda.
What changed
Nuclear engineering standards updated for design and operation compliance.
Radiation safety framework formalized with new risk mitigation guidelines.
Health supplement oversight extended under public health safety framework.
Public health governance structured for high-risk technical domains.
Who it affects
Nuclear energy operators must comply with updated engineering standards.
Radiation facilities must follow new safety guidelines and risk protocols.
Health supplement manufacturers fall under expanded regulatory oversight.
Pharmaceutical companies must align with new public health governance.
Key dates
Compliance Answer: Brazil’s Updated National Regulatory Agenda for Nuclear Safety and Health Products (2026–2027)
Brazil’s National Regulatory Agenda for Nuclear Safety and Health Products for the 2026–2027 biennium was approved under Portaria ANSN Nº 73, de 26 de junho de 20261. This agenda establishes updated standards for nuclear energy engineering, radiation safety, and the regulation of installations and activities involving radioactive materials. Below is a structured breakdown of the key regulatory priorities, requirements, and responsible authorities.
1. Scope and Legal Basis
The agenda is issued by the Autoridade Nacional de Segurança Nuclear (ANSN) under the authority of:
- Law No. 14.222/2021 (Art. 5º and 6º, I and IV)1, which governs nuclear safety and radiological protection.
- Decree No. 11.142/2022 (Art. 5º and Annex I, Art. 2º, I and IV)1, which outlines the ANSN’s regulatory powers.
The agenda covers 19 regulatory topics, categorized into:
- Nuclear installations (e.g., licensing, decommissioning, emergency planning).
- Radiological protection (e.g., medical, industrial, and research applications).
- Transport and certification of radioactive materials.
- Cybersecurity and aging management in nuclear facilities.
2. Key Regulatory Priorities and Requirements
The agenda distinguishes between new regulations (E) and revisions of existing norms (R). Below is a summary of the most critical topics, their status, and responsible authorities.
A. Nuclear Installations and Safety
| Regulation | Key Requirement | Status | Authority | Reference |
|---|---|---|---|---|
| Licensing of Nuclear Installations | Mandates licensing procedures for nuclear facilities, including site approval and operational permits1. | R | CGRE/DIASE | ANSN 1.04 |
| Decommissioning of Nuclear Fuel Cycle Facilities | Establishes safety and environmental requirements for decommissioning nuclear fuel cycle installations1. | E | CGCN | – |
| Probabilistic Safety Analysis (PSA) in Nuclear Power Plants | Requires PSA for risk assessment in nuclear power plants1. | – | CGRE | – |
| Local Emergency Plans | Defines emergency preparedness and response requirements for nuclear installations1. | – | CGRE | – |
| Long-Term Operation of Nuclear Installations | Sets safety criteria for extending the operational lifespan of nuclear facilities1. | – | CGRE | – |
| Aging Management in Nuclear Installations | Implements programs to monitor and mitigate aging-related risks in nuclear infrastructure1. | – | CGRE | – |
B. Radiological Protection and Health Products
| Regulation | Key Requirement | Status | Authority | Reference |
|---|---|---|---|---|
| Radiological Protection in Security Inspections | Regulates radiation safety for equipment used in security inspections (e.g., X-ray scanners)1. | E | DIAPI | – |
| Nuclear Medicine Services | Updates safety and radiological protection requirements for nuclear medicine facilities1. | R | DIAMP | ANSN 6.05 |
| Radiological Protection in Mining/Industrial Facilities | Sets safety standards for radiological protection in mining and industrial installations1. | R | COEXC | ANSN 4.01 |
| Radiological Protection for Nuclear Gauges | Establishes protection requirements for installations using radiation sources in measurement devices1. | – | DIAPI | – |
| Licensing of Research and Teaching Facilities | Defines licensing procedures for radiological installations in research and education1. | – | DIAMP | – |
C. Transport and Certification of Radioactive Materials
| Regulation | Key Requirement | Status | Authority | Reference |
|---|---|---|---|---|
| Safe Transport of Radioactive Materials | Updates regulations for the safe transport of radioactive materials, including packaging and labeling1. | R | DISFIT/CGSTR | ANSN 5.01 |
| Certification of Radioactive Materials and Packaging | Sets design and testing requirements for radioactive materials, packaging, and containers1. | R | DISFIT/CGSTR | ANSN 5.05 |
D. Cybersecurity and Emerging Risks
| Regulation | Key Requirement | Status | Authority | Reference |
|---|---|---|---|---|
| Cybersecurity for Nuclear and Radiological Facilities | Introduces cybersecurity requirements to protect nuclear and radiological installations from digital threats1. | E | CGRE | – |
3. Implementation and Compliance
- Effective Date: The agenda entered into force on 29 June 2026 (publication date in the Diário Oficial da União)1.
- Public Access: Detailed information on each regulatory topic is available on the ANSN website under the1(https://www.gov.br/ansn/pt-br/regulacao/regulacao/agenda-regulatoria/agenda-regulatoria-2026-2027/proposta_agenda_regulatoria_versao_junho_de_2026.pdf)1.
- Responsible Authorities:
- CGRE (Coordenação-Geral de Reatores e Ciclo do Combustível Nuclear): Nuclear installations and safety.
- DIAMP (Divisão de Instalações Médicas e de Pesquisa): Medical and research facilities.
- DIAPI (Divisão de Aplicações Industriais): Industrial and security applications.
- CGCN (Coordenação-Geral do Ciclo do Combustível Nuclear): Fuel cycle facilities.
- DISFIT/CGSTR (Divisão de Segurança no Transporte e Fiscalização): Transport and certification.
4. Summary Answer
Brazil’s 2026–2027 National Regulatory Agenda for Nuclear Safety and Health Products, approved under Portaria ANSN Nº 73/20261, introduces 19 regulatory priorities to modernize nuclear safety, radiological protection, and the licensing of installations. Key updates include:
- Revised licensing procedures for nuclear installations (ANSN 1.04) and new decommissioning standards for fuel cycle facilities1.
- Enhanced radiological protection for medical, industrial, and security applications (e.g., ANSN 6.05 for nuclear medicine)1.
- Stricter transport and certification rules for radioactive materials (ANSN 5.01 and 5.05)1.
- New cybersecurity requirements for nuclear and radiological facilities1.
- Emergency planning and aging management programs for nuclear installations1.
All details are publicly accessible on the ANSN website1. Compliance is mandatory for operators of nuclear and radiological facilities, with enforcement led by the ANSN and its specialized divisions.
Sources
- ↩ WTO TBT notification 26-03662 — Brazil https://members.wto.org/crnattachments/2026/TBT/BRA/26_03662_00_x.pdf