IS-39 revision 1: new CSN controls for radioactive packaging manufacturers

Key data

If your company manufactures packaging for radioactive material transport, or if you are a nuclear operator working with this type of packaging, this instruction has been binding on you since February 23, 2026. Instruction IS-39 in its revision 1, from the Nuclear Safety Council (CSN), updates the complete framework of control and monitoring applicable to the manufacture of these packages, with new technical requirements and inspection procedures that must be met to maintain manufacturing authorization.

The regulation was published in the BOE on April 9, 2026 with reference BOE-A-2026-8018, but its effective date is retroactive to February 23, 2026. This means that any affected company that has not already begun its adaptation process has accumulated weeks of delay with respect to the mandatory compliance date.

What does this regulation establish?

Instruction IS-39 revision 1 updates the control and monitoring framework that the CSN applies to the manufacture of packaging intended for radioactive material transport. The central elements of the instruction are as follows:

• Updated technical requirements: New technical criteria are established that packaging must meet to ensure they exceed current nuclear safety standards.
• Inspection procedures: The procedures that the CSN will apply to inspect and verify compliance during the manufacturing process are defined.
• Required documentation: Manufacturers must adapt their internal documentation to the new CSN criteria, not just their production processes.
• Alignment with international standards: The revision seeks to update Spanish regulations to align them with international standards for safe transport of radioactive materials.

This instruction is a revision of the previous IS-39, which means it replaces and updates the previous framework. Manufacturers who already operated under the previous version of IS-39 must review which specific points change their obligations.

Economic and operational impact

The impact of this instruction is primarily operational and regulatory compliance. No specific fees or economic amounts are established in the regulation, but the consequences of non-compliance are significant:

• Cost of process adaptation: Manufacturing companies will need to review and, if necessary, modify their production lines, quality control protocols and documentation systems to comply with the new CSN technical requirements.
• Documentation cost: Updating technical documentation and internal procedures requires dedication of specialized human resources and, in many cases, the intervention of consultants or nuclear safety technicians.
• Risk of paralysis: If the CSN detects non-compliance during an inspection, it can impose administrative sanctions or withdraw manufacturing authorization. Withdrawal of authorization implies total paralysis of the activity of manufacturing these packages, with the economic impact that entails.
• Competitive advantage: Companies that adapt quickly and demonstrate full compliance with the CSN strengthen their position against clients in the nuclear sector, who require suppliers with current and valid authorizations.

Who does it affect?

Instruction IS-39 revision 1 directly affects:

• Manufacturers of packaging for radioactive material transport: Any company that designs, produces or markets packaging intended to contain and transport radioactive material in Spain, regardless of its size.
• Nuclear operators: Entities that operate nuclear or radioactive facilities and that use or manage this type of packaging in their transport operations.
• Quality and production managers: Technical directors, quality managers and production managers of affected companies, who must lead internal adaptation.
• Regulatory compliance departments: Compliance teams and external advisors who manage CSN authorizations for these companies.

Practical example

A manufacturer of type B packaging (used to transport high-activity radioactive material) that operates under CSN authorization with IS-39 in its previous version must now review whether its production processes and technical documentation comply with the new technical requirements and inspection procedures established in revision 1.

If the CSN schedules an inspection and detects that the company has not updated its manufacturing control procedures or its documentation in accordance with the new instruction, it can initiate an administrative penalty proceeding or, in the most serious case, suspend or withdraw manufacturing authorization. This would mean that the company could not manufacture or market these packages until it regularizes its situation, with the consequent impact on its portfolio of nuclear sector clients.

The immediate action is to conduct an internal audit comparing the requirements of IS-39 revision 1 with current procedures, identify the gaps and establish a documented adaptation plan that can be presented to the CSN if required.

What should companies do now?

1. Verify the effective date: Instruction IS-39 revision 1 is in force as of February 23, 2026. If you have not started the adaptation, you are in a situation of potential non-compliance from that date.
2. Conduct an internal audit of processes and documentation: Compare the technical requirements and inspection procedures of the new instruction with your current production processes and documentation. Identify specific gaps.
3. Update technical documentation: Adapt all internal documents (procedures, control records, quality manuals) to the new CSN criteria established in IS-39 revision 1.
4. Adapt production processes: Implement necessary changes in the manufacturing line to comply with new technical requirements, with documentary traceability of each modification.
5. Communicate with the CSN if necessary: If you have doubts about the interpretation of any requirement or about the scope of changes compared to the previous version of IS-39, contact the CSN for guidance before a possible inspection.
6. Review the status of your manufacturing authorization: Ensure that your current authorization covers the updated processes and that there are no conditions that require notification to the CSN due to the changes introduced.