G/TBT/N/CZE/200  
 
20 October 2016  
(16-5689) Page: 1/6 
Committee on Technical Barriers to Trade  Original : English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : CZECH REPUBLIC   
If applicable, name of local government involved  (Article 3.2 and 7.2) : 
2. Agency responsible : State Office for Nuclear Safet y  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above :  
Czech Office for Standards Met rology and Testing  
WTO/TBT Enquiry Point  
P.O. Box 49  
Biskupsky dvur 1148/5  
110 00 Prague 1 -Czech Republic  
Telephone : (+420) 221 802 212  
Telefax : (+420) 221 802 440  
E-mail: wto.tbt@unmz.cz   
3. Notified under Ar ticle 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other : 
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable) : Sources of ionising 
radiation (including radionuclid e sources) and workplace equipment with a source of 
ionising radiation; Sources of ionising radiation used in healthcare; Construction materials; 
Drinking water (water intended for public supply) . Radiation protection (ICS : 13.280)  
5. Title, number of pag es and language(s)  of the notified document : Draft 
implementing decree on radiation protection and security of radionuclide sources  
(319 pages, in English; 307 pages, in Czech ) 
6. Description of content : Based on the authorising provisions in Act No 263/2 016, the 
draft implementing decree governs:  
 the list of changes influencing radiation protection, radiation situation monitoring 
and emergency management of a category III workplace and category IV workplace;  
 a list of  construction materials;  
 samples of re gistration applications;  
 a list and content of the documentation for the activity to be registered;  
 requirements for the content of documentation for licensed activities;  
 a list of quantities and facts relevant to radiation protection;  
 the scope, method an d time of monitoring, measuring, assessing, reviewing and 
recording of quantities and facts relevant to radiation protection and the period for 
which the information thereon needs to be kept;  
 the scope, method of and deadlines for the delivery of informati on on quantities and 
facts important  for radiation protection to the State Office for Nuclear Safety;  
 the scope, method and duration for which recorded documents on sources of ionising G/TBT/N/CZE/200  
 
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  radiation shall be archived, and the deadlines for their delivery to th e State Office for 
Nuclear Safety;  
 exposure of a patient considered to be erroneous for the purposes of defining a 
radiological event;  
 radionuclide activity at which a sealed radionuclide source is a high -activity source;  
 criteria for classifying sources o f ionising radiation into categories;  
 the method of classification of radionuclide sources in security categories;  
 the criteria for classifying workplaces in the appropriate category;  
 the rules for classifying staff into category A or B;  
 exposure limit val ues and the method of managing them;  
 reference levels;  
 the method of application of the reference levels;  
 procedures used when optimising radiation protection, including the method of 
determining the dose optimisation limits;  
 the value and method of applic ation of the exemption level;  
 the scope and frequency of tests performed pursuant to § 68(1)(f) of the Atomic 
Act; 
 the scope and frequency of operating stability tests performed by registered 
persons;  
 the rules for determining the scope and frequency of op erating stability tests 
performed by licence holders;  
 the persons performing operating stability tests;  
  the persons ensuring the fulfilment of the obligations under § 68(1)(g) of the 
Atomic Act;  
  the evaluation procedure of operating stability tests and t he method of dealing with 
the results thereof, including the method and duration for which the results are to be 
kept;  
 the criteria for evaluating long -term stability testing and the rules for eliminating 
defects detected by this testing, and the method of  setting a deadline for the 
removal of these defects;  
 the scope and content of information provided under § 68(1)(n) of the Atomic Act 
and the method of providing said information;  
 the scope and method of continuous training for exposed workers, the method  of 
verifying their knowledge and the frequency and method of documenting continuous 
training;  
 the scope and method of radiation protection assurance for the activity performed;  
 the types of sources of ionising radiation for which inventory checks shall be  
performed, the scope, method and frequency of inventory checks and the scope of 
results to be forwarded to the State Office for Nuclear Safety;  
 the methods of evidencing leak tightness of sealed radionuclide sources;  
 a list of changes connected with radia tion protection, radiation situation monitoring 
and handling of radiological emergencies at a workplace with a source of ionising 
radiation;  
 the scope and method of documenting and reporting to the State Office for Nuclear 
Safety modifications related to r adiation protection, radiation situation monitoring 
and radiological emergency management in a workplace with a source of ionising 
radiation;  
 the scope and method of completing the decommissioning of a category III 
workplace or a category IV workplace;  
 the job description of the person responsible for radiation protection of the 
registered person;  
 the procedures for ensuring radiation protection by registered persons when using 
sources of ionising radiation;  
 the scope and method of retaining records on sour ces of ionising radiation and G/TBT/N/CZE/200  
 
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  forwarding them to the State Office for Nuclear Safety;  
 the scope and method of performance of the activities of a supervising person;  
 the category of exposed workers in the case of a supervising person;  
 the scope and method o f performance of the activities of a person directly 
supervising radiation protection;  
 the method of classifying persons directly supervising radiation protection in the 
categories of exposed workers;  
 the scope and method of performing activities by a spec ialised radiation protection 
unit ensuring continuous surveillance of radiation protection at an energy -generating 
nuclear installation;  
 the scope and method of delineating a controlled area;  
 the scope of restrictions on entry into the controlled area;  
 the conditions for the performance of work in a controlled area;  
 the requirements for documenting the operation of a controlled area;  
 requirements regarding the documents connected with the operation of a controlled 
area;  
 the scope and method of delineating a  supervised area;  
 the method of radiation protection assurance in a supervised area;  
 the requirements for documenting the operation of a supervised area;  
 the conditions for the safe operation of a workplace with a source of ionising 
radiation with regard t o the type of the source of ionising radiation;  
 the clearance level for workplaces in which activities involving radiation are 
conducted, and the conditions under which they are considered exceeded;  
 the scope and method of delineating a supervised area in a temporary workplace;  
 the method of assurance of radiation protection of the general public, workers and 
the area surrounding the temporary workplace;  
 the scope and method of reporting to the State Office for Nuclear Safety the 
performance of activities i n a emporary workplace;  
 requirements connected with personal monitoring of a radiation  protection officer;  
 the procedures for evaluation of the quantities measured in the context of 
monitoring;  
 the rules for equipping exposed workers of category A with per sonal dosimeters and 
the handling thereof, as well as the duration of their evaluation;  
 the way in which the results of personal monitoring are provided to a 
radiation  protection officer;  
 the rules for issuing individual radiological monitoring documents, the deadline for 
the submission of applications and the validity duration for said documents;  
 the rules for handling the individual radiological monitoring document;  
 a specimen of the individual radiological monitoring document for outside workers;  
 the sco pe and method of updating the information in the individual radiological 
monitoring document;  
 the rules for the appointment of a representative person and the medical 
assessment of his/her radiation exposure;  
 the content of the optimisation study for estab lishing the authorised limit of 
exposure of the representative person;  
 the content of records on non -medical exposure kept by the licence holder and by 
the registered person;  
 the national diagnostic reference levels;  
 the content of records under § 84(4) an d (5) of the Atomic Act;  
 the scope and method of transmitting data on determining the distribution of 
medical exposure doses among the general public;  
 the requirements for sources of ionising radiation used in medical exposure and 
workplace equipment for x -ray diagnostics and radiotherapy;  G/TBT/N/CZE/200  
 
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   the method of therapeutic or diagnostic application of radionuclides;  
 the conditions for the release of a patient after therapeutic or diagnostic application 
of radionuclides;  
 the cases in which patients shall be provided  with written instructions on safe 
behaviour after therapeutic or diagnostic application of radionuclides;  
 the classification of radiological events according to their seriousness and the 
procedures in case of their occurrence;  
 the procedures for the  case of a radiological  event or a case in which a 
radiological  event could have arisen had the causes not been detected and 
eliminated in good time;  
 the period for which the records of investigations and records of the measures taken 
under § 87(3) shall be reta ined, as well as the content thereof;  
 the scope and the period for the provision of information about serious radiological 
events;  
 the radiation protection assurance requirements for mining, treating or processing 
radioactive minerals;  
 the method of identi fying and marking a high -activity source and its accessories;  
 a list of workplaces using a material with increased content of natural radionuclides;  
 the method, scope and frequency of the measurements to determine workers  
individual doses, the method of e stablishing workers  individual doses and the 
scope and method of recording -keeping of workers  individual doses;  
 the scope and content of information about the workplace to be reported to the 
State Office for Nuclear Safety, including the identification d ata of the operator of 
the workplace and the frequency  with which said information is reported;  
 the level which, when exceeded, radiation protection optimisation shall be ensured in 
workplaces using materials with an increased content of natural radionucli de; 
 the scope, method and frequency of measurements and evaluation of the 
radionuclide content of a radioactive substance discharged from the workplace;  
 the method of record -keeping of the results of the measurements of the radionuclide 
content of radioact ive substances discharged from the workplace, and the frequency 
with which said results are reported to the State Office for Nuclear Safety;  
 the content of internal regulations for the management of radioactive substances 
discharged from the workplace;  
 the clearance level for workplaces with potentially increased exposure to a natural 
source of radiation, and the onditions under which they are considered exceeded;  
 the conditions for classifying workplaces located on an underground or first ground 
floor of a  building as workplaces with potentially increased exposure to radon;  
 the scope, method and frequency of performing the measurements to establish the 
effective doses to workers in the workplace, and the rules for establishing a worker's 
effective dose;  
 the scope, method and duration of performing the measurements to establish the 
effective doses to workers in the workplace;  
 the scope and content of the information about the workplace to be reported to the 
State Office for Nuclear Safety, including the ident ification data of the operator of 
the workplace and the frequency with which said information is reported to the State 
Office for Nuclear Safety;  
 the method of determining the building site radon index;  
 the criteria for the preparation and evaluation of me asures intended to reduce the 
level of indoor exposure to natural sources of radiation;  
 the level of annual average radon activity concentration in the air which, when 
exceeded, owners of buildings with residential rooms or rooms intended to be 
occupied by  persons shall take measures reducing the level of exposure;  
 maximum permissible value of radon activity concentration in drinking water for 
public use and for making bottled water available on the market;  
 the reference level for natural radionuclide conte nt in drinking water for public use G/TBT/N/CZE/200  
 
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  and for making bottled water available on the market;  
 the scope, frequency and method of systematic measurement and evaluation of the 
natural radionuclide content of water;  
 the scope and method of record -keeping of the r esults of measurements and other 
data, including the identification data of a water supplier and a producer and 
supplier of bottled water, and the frequency with which said results are reported to 
the State Office for Nuclear Safety;  
 the reference level fo r construction materials;  
 the method of calculating and the value of the activity concentration index 
for construction materials;  
 the scope and method of systematic measurement and evaluation of the natural 
radionuclide content of building materials;  
 the scope and method of record -keeping of the results of measurements and other 
data, including the identification data of a producer and supplier of  construction 
materials, and the frequency with which said results are reported to the State Office 
for Nuclear Safety;  
 the conditions for the introduction and withdrawal of, and the requirements for, 
protective action;  
 the method of informing emergency workers about the risks associated with 
response actions and the method of providing evidence of voluntary partici pation in 
a response action;  
 basic characteristics of personal protective equipment and accessories for 
emergency workers;  
 the period for which the records and data referred to in § 104(5)(a), (b), (c) and (g) 
of the Atomic Act shall be retained;  
 the scope  and time of forwarding to the State Office for Nuclear Safety of the data 
on the magnitude of exposure in response actions obtained from individual 
monitoring;  
 the requirements regarding the method of ensuring security of radionuclide sources, 
including r adionuclide sources of security categories 1 to 3.  
7. Objective and rationale , including the nature of urgent problems where applicable : 
The aim of the implementing decree is to establish the elements of the obligations set out 
by the Atomic Act concernin g the peaceful use of ionising radiation. At the same time, the 
Atomic Act governs the security obligations for persons working with radionuclide sources, 
i.e. protection against the misuse of said radionuclide sources in activities posing a threat 
to secu rity, e.g. sabotage, acts of terrorism, theft, etc.  
The draft implementing decree lays down detailed requirements for various exposure 
situations and the methods and aspects of use of, and protection against, ionising radiation 
– e.g. requirements regardin g workplace equipment and sources of ionising radiation, or 
parameters and grounds under which the  obligations stipulated in the Atomic Act are 
applied (e.g. exposure limits, categories of sources of ionising radiation and categories of 
workplaces with sou rces of ionising radiation, or classification of exposed workers). The 
draft lays down the security of radionuclide sources such that the misuse or damage of 
radionuclide sources by unauthorised persons is prevented. The implementing decree thus 
forms a ne cessary complement to the Atomic Act, as a number of radiation protection and 
security institutes set by the act would not apply without the specific technical details set 
out by the implementing decree.  
At the same time, the implementing decree transposes  into the Czech legal  framework the 
requirements of the legislation of the European Atomic Energy Community, namely Council 
Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for 
protection against the dangers arising from expo sure to ionising radiation, and repealing 
Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 
2003/122/Euratom and Council Directive 2013/51/Euratom of 22 October 2013 laying 
down requirements for the protection of the health of the  general public with regard to 
radioactive substances in water intended for human consumption.  
The implementing decree is also necessary for the implementation of the international G/TBT/N/CZE/200  
 
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  recommendations of the International Atomic Energy Agency contained in the IAEA Safety 
Standards : Radiation Protection and Safety of Radiation Sources : International Basic 
Safety Standards, GSR Part 3.  
8. Relevant documents : – 
9. Proposed date of adoption : derived from the date of adoption of the new Atomic Act 
(which is the la w authorizing the adoption of the Decree in question), estimated date : 
3 months following the notification  
Proposed date of entry into force : derived from the date of entry into force of the new 
Atomic Act; estimated date : 1 January 2017  
10. Final date fo r comments : 60 days from notification  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body : 
If there will be a problem with downloading document, you can co ntact us : 
Czech Office for Standards Metrology and Testing  
WTO/TBT Enquiry Point  
P. O. Box 49  
Biskupsky dvur 1148/5  
110 00 Prague 1 -Czech Republic  
Telephone : (+420) 221 802 212  
Telefax : (+420) 221 802 440  
E-mail: wto.tbt@unmz.cz  
http://members.wto.org/crnattachments/2016/TBT/CZE/16_4392_00_e.pdf   
http://members.wto.org/crnattachments/2016/TBT/CZE/16_4392_00_x.pdf