Czechia Tightens Radiation Protection Equipment and Radionuclide Source Controls

Czechia has introduced updated safety and security requirements for radiation protection equipment and radionuclide sources, expanding oversight to include security devices as well.

Compliance Analysis: Updated Safety and Security Requirements for Radiation Protection Equipment and Radionuclide Sources in Czechia

The Czech Republic has expanded its regulatory framework for radiation protection and security of radionuclide sources through Decree No. 422/2016 Coll., as amended by the Decree of 22 January 2026. The amendments, which entered into force on 1 February 2026, introduce stricter oversight of radiation protection equipment and security devices, aligning with Council Directive 2013/59/Euratom and addressing gaps identified through international missions (e.g., IAEA IPPAS 2021, IRRS 2023) and domestic enforcement experience¹. Below is a structured breakdown of the key changes and obligations.

1. Scope of Updated Requirements

The decree applies to:

• Sources of ionising radiation, including radionuclide sources (e.g., medical, industrial, or research applications)¹.
• Workplace equipment containing such sources (e.g., X-ray machines, irradiators).
• Security devices associated with radionuclide sources, now explicitly subject to regulatory oversight¹.
• Natural sources of ionising radiation and existing exposure situations (e.g., radon in buildings)¹.

Exclusions: Radioactive substances in water (covered by Directive 2013/51/Euratom) are addressed separately under other regulations¹.

2. Key Regulatory Changes

A. Security of Radionuclide Sources

• Security Culture Requirements: New provisions mandate a formalised security culture for entities handling radionuclide sources, including risk assessments, access controls, and incident response plans¹.
• Categorisation Adjustments: Updated criteria for categorising sources of ionising radiation (e.g., based on activity levels or potential hazards) to reflect revised derived limits¹.
• Record-Keeping: License holders and registrants must maintain detailed records of source movements, transfers, and disposal, with stricter reporting timelines¹.

B. Radiation Protection Measures

• Controlled/Monitored Zones: Revised rules for entry/exit procedures, including mandatory training for personnel and visitors¹.
• Personal Monitoring: Expanded requirements for dosimetric monitoring of radiation workers and workplace vicinity, with adjusted derived limits for occupational exposure¹.
• Medical Exposure: New specifications for:
  • Acceptance tests, long-term stability tests, and operational stability tests for medical radiation equipment¹.
  • Clinical trials of radiopharmaceuticals: Mandatory notification to the State Office for Nuclear Safety (SÚJB) prior to authorisation¹.
• Radiological Events: Clarified reporting obligations for incidents (e.g., loss/theft of sources, overexposure), including timelines and escalation procedures¹.

C. Emergency Preparedness

• Foodstuffs and Products: Rules for consumption/distribution of locally produced or unprotected food in radiation-affected areas, including marketing restrictions¹.
• Documentation: Updated annexes specify conversion factors for volumetric activity and templates for reporting radiological events¹.

D. Administrative and Oversight Changes

• Supervising Entities: Limits on the number of workplaces under continual supervision by a single entity to prevent overburdening¹.
• Radiation Protection Programme (RPP): Revised documentation requirements for permitted/registered activities, including job descriptions for radiation protection officers¹.
• Natural Sources: Clarified rules for managing exposure from natural radiation (e.g., radon in workplaces)¹.

3. Compliance Timeline and Authorities

4. Enforcement and Penalties

• Non-Compliance: Violations may result in fines, suspension of licenses, or criminal liability under Act No. 263/2016 Coll. (Atomic Act)¹.
• Oversight: The State Office for Nuclear Safety (SÚJB) is the primary regulatory body, with powers to conduct inspections and enforce corrective actions¹.

Summary Answer

The Decree of 22 January 2026, amending Decree No. 422/2016, expands Czechia’s radiation protection and security requirements to include security devices for radionuclide sources, stricter record-keeping, personal monitoring, and emergency preparedness measures. Key changes include:

• Security culture obligations for entities handling radionuclide sources¹.
• Revised categorisation of ionising radiation sources and derived limits for occupational exposure¹.
• New reporting requirements for radiological events and clinical trials of radiopharmaceuticals¹.
• Updated documentation for radiation protection programmes and workplace supervision¹.

The decree entered into force on 1 February 2026, with compliance overseen by the State Office for Nuclear Safety (SÚJB)¹. Entities must align their practices with the updated rules to avoid penalties under Act No. 263/2016 Coll.¹. For full details, refer to the²(https://technical-regulation-information-system.ec.europa.eu/en/notification/27328).

Sources

1. ↩ Draft decree amending Decree No 422/2016 on radiation protection and security of radionuclide sources — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/CZE259.pdf&Open=True
2. ↩ Draft decree amending Decree No 422/2016 on radiation protection and security of radionuclide sources — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/CZE259A1.pdf&Open=True