China SELO production and filling licensing regulations were amended by the State Administration for Market Regulation (SAMR) on January 30, 2024.
The revised rules, forming the No. 2 Amendment to the ” Regulation for Production and Filling Licensing of Special Equipment (TSG 07-2019)”, will come into effect on June 1, 2024.
This announcement aims to further strengthen the supervision of special equipment production and filling units. The modifications primarily focus on enhancing the regulatory framework and ensuring compliance with relevant laws and regulations, including:
- “Special Equipment Safety Law of the People’s Republic of China”
- “Administrative Licensing Law of the People’s Republic of China”
- “Regulations on the Safety Supervision of Special Equipment”
- and others.
The revisions to China SELO production and filling licensing regulations underscore the importance of adhering to stringent quality and safety standards. They mandate the appointment of qualified personnel and establishing robust quality assurance systems to ensure compliance and mitigate risks associated with special equipment operations.
Furthermore, the amendments stress the role of regulatory bodies in overseeing the implementation of these rules and conducting regular inspections to enforce compliance. Regulatory affairs managers must stay updated on these amendments and ensure their organizations adhere to the revised regulations to maintain operational integrity and consumer safety.
Key modifications include:
Amendments to the main text
- Add subsections two and three to item 2.1.2:
- Special equipment manufacturing, installation, modification, and repair units are required to adhere to the stipulations outlined in the ‘Regulations on the Supervision and Management of Quality and Safety Responsibilities for the Production of Special Equipment’ and integrate these with their own quality assurance systems. This involves the designation of a Director of Quality and Safety and appropriate personnel.
- Furthermore, mobile pressure vessel and gas filling units must comply with the requirements outlined in the ‘Regulations on the Supervision and Management Responsibilities for Special Equipment,’ particularly regarding the appointment of Director of Safety and competent safety personnel.
Amendments to Appendix C
- Additional roles and responsibilities for quality and safety directors and personnel in units engaged solely in pressure vessel design.
- Renumbering of existing clauses.
- Clarification of duties for personnel in charge of filling safety.
- Additional requirements for identifying and mitigating pressure vessel safety risks.
- Revision of documentation requirements for Filling Certification.
These amendments enhance safety protocols and streamline responsibilities for pressure vessel design and filling operations.
Amendments to Appendix D
- Amendment to D2.1:
- Requirements for certification and relocation of filling are specified, including necessary permits and fire inspection reports.
- Amendment to D2.2:
- General requirements for personnel are outlined, including familiarity with safety regulations, organization of safety meetings, and qualifications for technical and safety personnel.
- Technical and safety personnel should possess knowledge of safety regulations, risk management skills, and compliance with relevant laws.
- Operating personnel should hold qualifications for filling operations and inspection duties.
- Addition of D2.6.2.1:
- Prohibition against simultaneous filling of liquefied petroleum gas and liquefied dimethyl ether at the same address.
- Renumbering of existing clauses.
- Amendment to D2.7.1.3:
- Control measures for the filling medium are specified, including the verification of product quality certificates and chemical analysis if necessary.
- Amendment to D2.7.3:
- Clarification of procedures for chemical property analysis of the medium.
- Amendment to D2.7.4:
- Specification of record-keeping for chemical property analysis.
- Addition of a clause to D2.8:
- Requirement for new or expanded filling operations to conduct on-site trial filling by certified personnel to ensure operational readiness and quality assurance.
Amendments to the appendix M
- Addition of responsibilities for special equipment production to establish a tailored quality and safety management system.
- Revision of roles and responsibilities for key personnel in production to ensure effective quality and safety supervision and control.
- Clarification and enhancement of duties for main responsible persons, quality assurance engineers, and quality control system personnel.
- Introduction of new roles for quality and safety directors and personnel, including regular risk assessment and training.
- Modification of existing clauses to align with updated requirements for quality and safety management.
- Inclusion of provisions for quality and safety personnel to cooperate with regulatory inspections and accident investigations.
The issuance of the second amendment to China’s SELO production and filling licensing regulations ” reflects the government’s commitment to enhancing safety standards and regulatory oversight in the special equipment industry.
Further information
Read the original China SELO product and filling licensing regulations amendments – No.2.
Read our previous blog post on China special equipment safety supervision – draft provisions released.
If you would like more information on how safety supervision requirements for Special Equipment affect your products, or to find out more about our special equipment product safety certification services, please contact us.
