Directive 2013/59/Euratom - protection against ionising radiation
The Directive integrates several directives on occupational and public exposure and radiation protection repealed in 2018. This summary focuses exclusively on occupational health and safety aspects of the Directive (i.e. mostly on Chapter VI). The Directive is directly addressed to Member States that have to put in place national implementing laws.
This Directive establishes uniform basic safety standards for the protection of the health of individuals subject to occupational exposures, besides the medical and public exposures against the dangers arising from ionising radiation. Sources of ionising radiation can be processed radioactive materials, nuclear installations, natural radionuclides, x-ray machines and cosmic radiation.
The Directive applies inter alia to the manufacture, production, processing, handling, disposal, use, storage, holding, transport of radioactive material and certain radiation emitting installations as well as the exposure of workers to radiation.
Art. 3 exempts from the scope of the Directive the exposure to the natural level of radiation, to cosmic radiation of workers other than crew and to radionuclides present in the undisturbed earth's crust above the ground.
In Article 4, the Directive provides an extensive list of definitions on relevant terms: “Absorbed dose” “accelerator” “accidental exposure” “activation” “activity” “apprentice” “becquerel” “building material” “carers and comforters” “clearance levels” “clinical audit” “clinical responsibility” “committed effective dose” “committed equivalent dose” “competent authority” “consumer product” “contamination” “controlled area” “diagnostic reference levels” “disused source” “dose constraint” “dose limit” “dosimetry service” “effective dose” “emergency” “emergency exposure situation” “emergency management system” “emergency occupational exposure” “emergency response plan” “emergency worker” “environmental monitoring” “equivalent dose” “exemption level” “existing exposure situation” “exposed worker” “exposure” “extremities” “health detriment” “health screening” “high-activity sealed source” “individual detriment” “inspection” “intake” “interventional radiology” “ionising radiation” “licence” “medical exposure” “medical physics expert” “medical radiological” “medical radiological installation” “medical radiological procedure” “members of the public” “natural radiation source” “non-medical imaging exposure” “normal exposure” “notification” “occupational exposure” “occupational health service” “orphan source” “outside worker” “planned exposure situation” “potential exposure” “practical aspects of medical radiological procedures” “practice” “practitioner” “processing” “protective measures” “public exposure” “quality assurance” “quality control” “radiation generator” “radiation protection expert” “radiation protection officer” “radiation source” “radioactive material” “radioactive source” “radioactive substance” “radioactive waste” “radiodiagnostic” “radiotherapeutic” “radon” “exposure to radon” “reference level” “referrer” “registration” “regulatory control” “remedial measures” “representative person” “sealed source” “sievert” “storage” “supervised area” “source container” “spacecraft” “standard values and relationships” “thoron” “undertaking” “unintended exposure”
The Member States’ system of radiation protection shall be based on the principles of the following:
- justification (benefits outweigh risks);
- optimisation (exposure to as few, and as low as possible: dose constraints) and
- dose limitation (on the individual's level).
The age limit for occupational exposure is set to 18 years. Dose limits for occupational exposure are as follows:
- for effective dose limit: 20 mSv in any single year;
- in special circumstances: upto 50 mSv in a single year (the average annual dose over any five consecutive years must not exceed 20 mSv);
- for the lens of eye: 20 mSv in a year or 100 mSv in any five consecutive years (the average annual dose over any five consecutive years hall not exceed 50 mSv);
- for the skin and extremities: 500 mSv per year;
- or an unborn child: 1 mSv (preferably zero);
- for breastfeeding workers: no radionuclide intake or bodily contamination;
- for apprentices and students aged between 16 and 18 years: 6 mSv per year
The undertaking and/or the employer shall be responsible for ensuring the workers’ radiation protection. The undertaking shall ensure that outside workers benefit from an equivalent protection to exposed workers employed on a permanent basis.
Exposed workers shall be informed on radiation health risks and protection procedures, the relevant procedures, precautions and emergency response plans and procedures and the importance of complying with requirements. They shall be aware of the importance of making an early declaration of pregnancy. Emergency workers are specially addressed by the Directive. Equally, workers potentially exposed to orphan sources (untracked, “lost” radioactive materials) shall be advised and trained.
Operational protection of exposed workers shall be achieved through prior evaluation, optimisation of radiation protection, classification of exposed workers, control measures and monitoring, medical surveillance and education and training. Undertakings shall consult with a radiation protection expert. Arrangements shall be made at workplaces where the workers’ exposure may exceed the effective dose of 1 mSv or an equivalent dose of 15 mSv (for the lens of the eye) or 50 mSv (for the skin and extremities). For workplaces where the effective dose of 6 mSv (or corresponding radon exposure) is exceeded (planned exposure situation), the appropriate requirements shall be determined by the Member State.
At workplaces a distinction shall be made between controlled areas and supervised areas, on the basis of an assessment of the expected annual doses and the probability and magnitude of potential exposures. These areas are subject to radiological surveillance that may comprise measurements. For the purposes of monitoring and surveillance, exposed workers shall be divided into “Category A” (annual effective dose > 6 mSv or for the lens of the eye > 15 mSv or for skin and extremities > 50 mSv) and “Category B” (non-A). The individual monitoring of exposed workers shall be based on the category in question. Medical surveillance of exposed workers shall include pre-employment and periodic assessments; unfit workers shall not be employed. Monitoring and surveillance data are subject to special provisions. Radon measurements shall be carried out in workplaces such as basements or undergrounds. The Directive also provides on specially authorised exposures and emergency occupational exposure.
The institutional infrastructure and regulatory framework required are specified in Chapter IX.
The deadline for national transposition of the Directive was set for 6 February 2018. Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom were repealed with effect from the same date.
- Reference levels for public exposure
- Radiation and tissue weighting factors
- Activity values defining high-activity sealed sources
- Justification of new classes or types of practices involving consumer products
- Indicative list of practices involving non-medical imaging exposure
- List of industrial sectors involving naturally-occurring radioactive material
- Exemption and clearance criteria
- Definition and use of the activity concentration index for the gamma radiation emitted by building materials
- Indicative list of information for licence applications
- Data system for individual radiological monitoring
- Emergency management systems and emergency response plans
- Information to members of the public about health protection measures to be applied and steps to be taken in the event of an emergency
- Indicative list of types of building materials considered with regard to their emitted gamma radiation
- Information to be provided in the records for high-activity sealed sources (HASS)
- Requirements for undertakings responsible for a high-activity sealed source
- Identification and marking of high-activity sealed sources
- Indicative list of types of existing exposure situations
- List of items to be considered in preparing the national action plan to address long-term risks from radon exposures
- Correlation table