The regulatory pyramid is established within the legal framework, using laws and decrees to establish, adopt, promote or amend regulations and guides. All regulations of the regulatory system have to be in compliance with the State legal system. In fulfilling its statutory obligations, the regula­tory body establishes, promotes or adopts regulations and guides upon which its regulatory actions are based.

4.1.3 Regulations

The main purpose of regulations is to establish requirements with which all licensees must comply. In order to carry out the regulatory functions it is necessary to create a consistent and comprehensive set of regulations with adequate coverage commensurate with the associated radiation risks. The regulatory body notifies all interested parties and the public of the princi­ples and associated criteria for safety established in its regulations and guides, and makes the regulations and guides readily available.

The development of regulations involves consultation with all interested parties and also takes into account internationally agreed standards, such as the IAEA Safety Standards, and the feedback of relevant experience from national or international organizations.

In several cases it is necessary to clearly identify by the regulatory body the reference and criteria to be used for assessing compliance with the regulations. The criteria for compliance need to be understood by the licen­see from the beginning in order that it can carry out its activities correctly.

The production of regulations is included in the regulatory body’s man­agement system together with the process for establishing, revising and revoking regulations and guides. This process is established in accordance with the national legal system. The periodic review of regulations is also specified; changes need to be discussed with interested parties as appropri­ate but it must keep in mind that frequent changes in regulations can affect the stability or predictability of the regulatory system if the changes are not properly justified from a safety perspective.

4.1.4 Regulatory requirements

The regulations provide a framework for more detailed requirements or conditions that will be issued by the regulatory body during its activities. Requirements are also incorporated into licences as specific conditions or requirements as well as into individual authorizations or applications for licences within the licensing process. The regulatory body issues require­ments when necessary to improve safety. Requirements are also necessary to improve safety considering the day-to-day regulatory oversight.