Government Regulation no. 45 of 2023 concerning Safety of Ionising Radiation and Security of Radioactive Substances.

This Regulation, based on the provisions of article 16 of the Law no. 10 of 1997 concerning nuclear energy, in compliance with the development of the scientific knowledge, the technology and international standards, and the increasing demand for respect of the health of workers, and the protection of the environment, provides for: ensuring ionising radiation safety and radioactive material security. The Regulation covers the aspects of radiation safety, radioactive material security, radiation safety and security management, and inspection in the utilisation of nuclear energy, and therefore aims at achieving the protection of workers, public, and environment from the hazards of ionising radiation and the prevention of unauthorised access, sabotage, damage, loss, theft, or illicit trade of radioactive material. The Regulation provides for defining various terms related to radiation protection and security, such as: ionising radiation; radioactive material; planned exposure, as a a condition of exposure to the sources of ionising radiation originating from planned operations or activities; emergency exposure; occupational exposure; medical exposure; public exposure; safety culture; security culture, dose limit and constraint; social security and granting of social services; radiation protection and safety measures; emergency management and preparedness; nuclear emergency; consumer goods containing radioactive substances.
The Regulation specifies the requirements for radiation safety in planned exposure, which include radiation protection for occupational exposure and medical exposure, screening procedures for pregnant and breastfeeding women, research ethics for biomedical research, follow-up actions for medical errors, radiological review for medical exposure; the Regulation defines the principles of radiation protection, such as justification, optimisation, and limitation, and describes the several effects of radiation on human health, depending on the dose and duration of exposure. Concerning radiation protection in public exposure, the Regulation focuses on: radioactive waste management; controlling radioactive releases and emissions into the environment; protection of public and visitors; control of consumer goods, with information and instructions for the transport and storage of goods, and installation of proper labels on safety of the goods. Further matters covered by this Regulation concern: issuance of specific permits for nuclear installations and related activities; education and training programmes on the effects of radiation.
Final provisions the Regulation concerns: safety requirements of radioactive substances, including: classification of radioactive substances, safety programmes, safety level of radioactive substances; safety transport of radioactive substances; administrative sanctions; responsibilities of license holders.