Decree Law No. 108/2018
- Issuer: Presidency of the Council of Ministers
- Diploma Type: Decree Law
- Number: 108/2018
- Pages: 5490 - 5543
Summary in plain english
This decree-law updates the standards regarding radiological protection, adapting them to the new rules imposed by the European Union on the protection against the dangers of exposure to ionising radiation.
It appoints the competent authority and the supervisory authority for radiological protection and establishes its powers.
Ionising radiation means the transfer of energy in the form of particles or electromagnetic waves, able to direct or indirectly generate ions.What is going to change?
The legal regime applicable to the practices and activities which involve the use of ionising radiation and provoke situations of exposure to this radiation is updated:
- Manufacture, production, use, storage, detention and transport of radioactive material
- Manufacture and exploitation of electrical equipment which emit ionising radiation
- Human activities which involve a strong presence of natural radiation sources (aircraft and space vehicles operations)
- Workers’ exposure to radon inside the buildings
- Situations of planned exposure (situations generated by the planned operation of a radiation source or by a human activity which provokes the people or environment’s exposure, such as the use of radiation sources in medicine or industry)
- Situations of existing exposure (in which there is already exposure to radiation when the decision to control is taken. In such cases, the adoption of emergency measures is not required.)
- Situations of emergency exposure (derived from radiological emergency situations, for instance.)
The Portuguese Environment Agency (APA) is now the competent authority for the radiological protection regulation, comprising the powers previously assigned to different entities. It is responsible to:
- Exercise, independently, the supervisory functions provided on the European rules.
- Ensure the existence of a high level of radiological protection and nuclear safety.
- Grant the registry and licenses of practices.
The General-Inspection of Agriculture, Sea, Environment and Territorial Planning (IGAMAOT) is now the authority which inspects the compliance with this legal regime. It is responsible to:
- Inspect the practices covered by this decree-law.
- Establish and instruct the administrative offence proceedings.
- Apply penalties in the case of non-compliance. The environmental offences may be:
- extremely severe
- Verify if the corrective actions are taken.
The Regulatory Commission for the Safety of Nuclear Installations (COMRSIN) is extinguished, replaced in its duties and powers by APA and in its powers regarding inspection by IGAMAOT.Regulatory control system
APA and IGAMAOT exercise the regulatory control to which the practices and activities provided in this decree-law are subject.
This control is carried out in two ways:
- simple prior notice - it is a simple manifestation of the intention to exercise a practice or activity covered by this decree-law.
- Industrial practices which involve natural radioactive materials, such as the production of oil, gas and cement.
- The holder of the practice subject to the prior notice must inform the competent authority of:
- the name or tradename and registered office,
- the type of practice and its location
- the practice’s justification, among other indications.
- prior administrative control - this control may be carried out through:
- the compulsory registration (practice of operation of dental medicine equipment, for instance)
- the compulsory licensing (such as the case of operation of radiation generators or the administration of radioactive substances to people and animals for medical diagnosis purposes, for instance).
- issues, within 20 days, a preliminary rejection order
- asks for the request’s improvement. In such case, the holder has 60 days to improve the request. If they do not so, the request is rejected.
- The holder of the practice subject to the registration or licensing must submit a request to the competent authority, before the beginning of the practice or activity to develop.
- If the request and its instructive elements are not in accordance with the law, the competent Authority:
- If the request is accepted by APA, it has 30 days to carry out the registration on the national holders inventory (in the case of practices subject to compulsory registration) or to grant a license (in the case of practices subject to compulsory licensing).
This decree-law allows to focus, on a single competent authority and on a single inspection authority, the regulatory authority powers regarding the protection against radiation which were disperse through several entities of different ministries.
It allows the adaptation of the national legal framework to the European Union’s obligations on safety matters, regarding the protection against the dangers derived from the exposure to ionising radiation.
It reinforces and extends the safety criteria on the use of ionising radiation.When does it enter into force?
This decree-law enters into force 120 days following its publication.
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