Message 001
Communication from the Commission - TRIS/(2025) 2596
Directive (EU) 2015/1535
Notification: 2025/0532/CZ
Notification of a draft text from a Member State
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Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20252596.EN
1. MSG 001 IND 2025 0532 CZ EN 23-09-2025 CZ NOTIF
2. Czechia
3A. Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
Biskupský dvůr 1148/5
110 00 Praha 1
tel: +420 221 802 216
e-mail: eu9834@unmz.gov.cz
3B. Státní úřad pro jadernou bezpečnost
Senovážné náměstí 9,
110 00 Praha 1
Tel.:+420 221 624 746
e-mail: pravni.oddeleni@sujb.gov.cz
4. 2025/0532/CZ - B20 - Safety
5. Draft Decree amending Decree No 408/2016 on management system requirements
6. activities for the use of nuclear energy, activities in exposure situations, transport of radioactive and fissile substances, activities in the field of radioactive waste management, nuclear installation design, design or manufacture of selected equipment
7.
8. Draft amendment to Decree No 408/2016 – areas of change in the current text of the Decree:
• Correction of evident defects that have been discovered over the course of previous years.
• Adjustments related to novelties in international recommendations, in particular those of the International Atomic Energy Agency. These include recommendations in the area of the role of senior management, the tasks of senior management, recommendations in the area of managing discrepancies and implementing changes to the management system.
• Changes related to changes in international practice, reaction to findings that quality assurance for processes and activities and their outputs, i.e. items such as selected equipment, components of nuclear installations, in recent years not only in the Czech Republic, but also globally, suffers from certain shortcomings and so-called fraudulent items are being detected. Fraudulent items are a highly critical problem in the nuclear field as they can lead to quality degradation and consequently to impacts on safety assurance, i.e. nuclear safety, radiation protection, technical safety, radiation monitoring, radiation incident management and security.
• Adjustments in connection with planned new sources and their construction. New sources will to a significant extent make use of technologies that have not yet been implemented in practice, or that depend on the use of already implemented nuclear installation projects, but with a number of new developments. In this context, we can mention, for example, the new requirement (or rather assumption) that the construction of nuclear installations should ensure uniform clarity of documentation for the permitted activity and for the management system, a single communication platform or common language that is comprehensible to all entities involved.
• Modification of safety culture requirements - a complete and comprehensive revision of the provisions of § 13, which sets out more detailed requirements for safety culture.
• Modification of documentation for activity being permitted or the documentation for the management system. Clarification of how the documentation is to be formulated, what it is to contain and how it is to be accessed, in particular where the entity implementing the management system is at the same time the holder of a permit an activity involving the use of nuclear energy.
Keywords: quality, control, documentation, management, selected equipment, nuclear installation components.
9. Decree No 408/2016 concerns itself with regulating the details of the implementation and maintenance of a management system, the main objective of which is to ensure adequate quality of processes and activities carried out by permit holders and other critical entities in the field of peaceful use of nuclear energy and ionising radiation, so as to always ensure full nuclear safety, radiation protection, technical safety, radiation monitoring, extraordinary radiation event management, security and non-proliferation of nuclear weapons at all times.
The current decree, which has been in effect since 2017, has exhibited certain shortcomings over the duration of its application, which consist not only in the fact that existing regulation has proved in practice to be partly inaccurate, partly insufficient, but, in particular, has already become obsolete with regard to international requirements. Another important area in which the Decree has become obsolete is the area of practical implementation of certain processes and activities, in particular the component procurement process, their design and purchasing. There have been significant developments in this area in recent years, particularly in the effort to prevent so-called fraudulent items. Another area where significant progress has been made is the field of safety culture, where international recommendations and international good practices have significantly improved, systematised and new requirements have been introduced. International experience has shown that without a proper safety culture, technology cannot function flawlessly. The approach of people and their understanding, the understanding common goals and taking care that workers are properly managed, supervised, motivated and proactive is extremely important in the nuclear field.
Decree No 408/2016, which is currently being amended, introduces into the Czech legal code some provisions of Euratom Directives (Council Directive 2009/71/Euratom, Council Directive 2011/70/Euratom, Council Directive 2013/59/Euratom, Council Directive 2014/87/Euratom).
10. References to basic texts: 2016/0294/CZ
The basic texts were forwarded with an earlier notification:
2016/0294/CZ
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects:
The draft is a technical regulation or a conformity assessment
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
