Decree No. 157 / 2025 Coll.
Decree amending Decree No. 379 / 2016 Coll., on type-approval of certain products in the field of peaceful use of nuclear energy and ionising radiation and the transport of radioactive or fissile substances
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Effective from 01.07.2025
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157
DECLARATION
of 22 May 2025
amending Decree No 379 / 2016 Coll., on type-approval of certain products in the field of the peaceful use of nuclear energy and ionising radiation and the transport of radioactive or fissile substances
The State Office of Nuclear Safety sets out, pursuant to Section 236 of Act No. 263 / 2016 Coll., Atomic Act, as amended by Act No. 83 / 2025 Coll., for the implementation of § 9 (4) (a) and (b), § 21 (3), § 137 (6), § 138 (6) (a) and (b) and § 141 (3) thereof:
Decree No. 379 / 2016 Coll., on the type-approval of certain products in the field of peaceful use of nuclear energy and ionising radiation and the transport of radioactive or fissile substances, is amended as follows:
1. in Article 2, point (c) is deleted;
Points (d) to (s) shall be renumbered (c) to (r).
2. in Article 2, point (l) is deleted;
Points (m) to (r) shall be renumbered as points (l) to (q).
3. Paragraph 3 (1) and (2) reads as follows:
"(1) Transport requiring authorisation pursuant to § 9 (4) (a) or (b) of the Atomic Act is transport
(a) nuclear fuels; and
(b) radioactive consignments of radioactive material of specific forms with an activity exceeding 3 × 103 of A1, a radioactive substance other than specific forms with an activity exceeding 3 × 103 of A2 or a radioactive substance with an activity exceeding 1 000 TBq, whichever is lower, except for transport under paragraph 2 (c).
(2) Transport requiring an authorisation pursuant to § 9 (4) (a) or (b) of the Atomic Act and, in the case of international transport, the authorisation of the competent authority of the State to which the transport relates shall be:
(a) radioactive or fissile substances containing radionuclides, the values of which are not listed in Table 2 of Annex 3 to this Regulation, have been determined by calculation in accordance with points 3 to 7 of Annex 3 to this Regulation;
(b) radioactive or fissile substances contained in the instrument or product and containing radionuclides, the values of which for the extraction of supplies listed in column 5 of Table 2 of Annex 3 to this Decree have been replaced by those calculated in accordance with the principles and methodologies set out in Annex 6 to this Decree;
(c) radioactive consignments of radioactive material of specific forms with an activity exceeding 3 × 103 of A1, a radioactive substance other than specific forms with an activity exceeding 3 × 103 of A2 or a radioactive substance with an activity exceeding 1000 TBq, whichever is the lower, in the package type B (M);
(d) radioactive or fissile substances in type B (M) packaging not designed for temperature range from minus 40 ° C to plus 70 ° C or designed to allow occasional controlled ventilation;
(e) radioactive or fissile substances by a vessel designated for this purpose;
(f) fissile substances as referred to in point 17 (f) of Annex 3 to this Decree;
(g) fissile substances where the sum of the indices of safe sub-criticism of radioactive consignments in one means of transport or container exceeds 50; and
(h) surface-contaminated SCO-III object. ';
4. The following Section 3a is inserted after Section 3, including the title:
Decision authorising the transport of radioactive or fissile substances
(Paragraph 21 (3) of the Atomic Act)
(1) In the decision to grant authorisation to transport radioactive or fissile substances, the Authority will refer to the requirements of international agreements relating to the transport of radioactive or fissile substances by which the Czech Republic is bound. In accordance with these requirements, it shall indicate:
(a) the unique transport identification number assigned by the Office;
(b) the instruction that the decision does not relieve the carrier of the obligation to comply with the requirements of the State to which or through whose territory the transport of radioactive or fissile material is carried out;
(c) the mode of transport and, where appropriate, its limitations, restrictions concerning the type of means of transport and containers and the necessary instructions for the planned journey;
(d) the additional operational checks required for the preparation, loading, transport, unloading and handling of the radioactive consignment to be carried out by the transporter or the body designated by it, including specific requirements for the location of the radioactive consignment on the means of transport for the safe removal of heat or maintenance of safe undercriticism;
(e) a reference to the information provided by the applicant concerning the use of the package or measures to be taken before the shipment begins;
(f) a reference to a product type-approval decision or other relevant decisions relating to shipments issued by the competent authorities of another State, where such decisions have been taken;
(g) a detailed description of the radioactive content, indicating its physical and chemical form, the total activity and activities of the various nuklid, if justified, including any restrictions which may not be apparent from the nature of the packaging; an indication of whether the radioactive substance is a specific form, a radioactive substance with a low variance, or a fissile substance meeting the requirements of one of the points (a) to (f) of point 17 of Annex 3 to this Regulation ("the fissile substance removed '), if justified,
(h) a reference to the approved emergency procedures; and
(i) a reference to the management system programme.
(2) In the decision to issue a permit to transport radioactive or fissile substances, the Authority will specify the specific conditions concerning the way in which each type of transport is carried out,
(a) for the transport of radioactive or fissile substances under special conditions;
1. the specification of the package to be used for transport by reference to drawings or a description of the design type, including a reproducible representation of the appearance of a maximum size of 21 cm x 30 cm showing the composition of the radioactive consignment, a brief description of the parts of the package and the materials used for its manufacture, the approximate weight and the outer dimensions of the package,
2. for a package containing a fissile substance, the value of the Safe Subcription Index (CSI), the reference to a dossier that demonstrates the safe subcription of the radioactive consignment, the specific characteristics on the basis of which the absence of water in certain empty spaces, if justified, is assumed to change the calculation of neutron multiplication as a result of actual measurement of irradiated fissile properties, if justified, and the range of ambient temperatures for which transport was authorised under special conditions,
3. the justification for the shipment under specific conditions, including an indication of the legal requirements which cannot be met;
4. a description of the specific conditions for carriage replacing the requirements of the legislation which cannot be complied with; and
5. Provisions concerning temperature conditions in the vicinity of the packaging when transported under special conditions, unless the characteristics of the packaging comply with the requirements of the legislation on its thermal resistance;
(b) for the transport of fissile substances
1. a description of the restraint,
2. the value of the Safe Subcription Index (CSI),
3. Reference to documentation showing the safe undercriticism of the radioactive consignment,
4. the specific characteristics on the basis of which the absence of water in certain empty spaces is envisaged in the assessment of criticism, if justified;
5. the permitted value for changing the neutron multiplication calculation foreseen in the critical assessment as a result of actual measurements of irradiated fissile properties, if justified; and
6. the range of ambient temperatures for which transport has been authorised,
(c) for the transport of fissile material as referred to in point 17 (f) of Annex 3 to this Decree
1. a description of the fissile material removed;
2. a description of any restrictions on the fissile substance removed; and
3. a reference to the documentation demonstrating that the radioactive substance transported complies with the requirements of points 72 (a), 82 (a), 83 (b) and 84 (b) of Part I of Annex 1 to this Regulation and 17 (f) of Annex 3 to this Regulation;
(d) for the transport of radioactive or fissile substances containing radionuclides the values of which are not listed in Table 2 of Annex 3 to this Regulation have been determined by calculation in accordance with points 3 to 7 of Annex 3 to this Regulation;
1. a reference to the calculation of the activity values of the radioactive substance A1 and A2 to determine the limits of activity; and
2. a justification for not using the values set out in Table 2 of Annex 3 to this Decree;
(e) for the transport of radioactive substances contained in instruments or products and containing radionuclides, the values of which for the extraction of supplies listed in column 5 of Table 2 of Annex 3 to this Decree have been replaced by those calculated according to the principles and methodologies set out in Annex 6 to this Decree;
1. identification and description of the instrument or product;
2. a description of the design type of the instrument or product,
3. the specification of radionuclides contained in the instrument or product and the approved value for the extraction of the supply; and
4. a reference to the calculation of the individual benefits of the transport worker and the representative and the collective benefits under normal conditions and normal conditions of transport and the conditions of the transport accident, based on realistic delivery scenarios in accordance with the principles and methodologies set out in Annex 6 to this Decree,
(f) for the authorisation of the transport of radioactive or fissile material in type B (M) packaging not designed for temperature ranges from minus 40 ° C to plus 70 ° C or designed to allow occasional controlled ventilation;
1. a list of the requirements for type B (U) packaging files which the package B (M) does not meet; and
2. the range of ambient temperatures for which transport has been authorised;
(g) for the transport of radioactive or fissile material by a vessel designated for this purpose:
1. a description of the pre-determined location of the radioactive consignment or of the supply of radioactive consignments or of any other cargo in the vessel; and
2. a list of qualified persons in the field of transport of radioactive or fissile substances intended to supervise transport and all loading, transhipment and unloading. ';
5. in Article 4 (3) (a), "7 to 18" is replaced by "6 to 17" and "19 to 21" is replaced by "18 to 20."
6. in Paragraph 4 (3) (b), "22" is replaced by "21."
7. In Paragraph 4 (3) (c), "23 to 30 'is replaced by" 22 to 29'.
8. in Paragraph 4 (3) (d), "31 to 33" is replaced by "30 to 32" and "34" is replaced by "33."
9. in Paragraph 4 (3) (e), "35 to 51" is replaced by "34 to 50."
10. in Article 4 (3) (f), "52 to 66" is replaced by "51 to 65";
11. in Article 4 (3) (g), "67 and 68" is replaced by "66 and 67."
12. in Article 4 (3) (h), "69 to 72" is replaced by "68 to 71."
13. in Paragraph 4 (4), the words "73 to 86" are replaced by the words "72 to 85," after the words "only" the word "shall be inserted" and the words "satisfying the requirements of one of the points (a) to (f) of point 17 of Annex No 3 to this Regulation (" the fissile substance removed ") shall be deleted;
14. in Article 6 (1) (b) (2), "84 to 86" is replaced by "83 to 85";
15. in Article 7 (2) (d), at the end of point (d), comma is replaced by "a."
16. in Article 7 (2), point (e) is deleted;
Point (f) shall be renumbered as point (e).
17. in Article 7 (2) (e), "81 to 88" is replaced by "80 to 87."
18. in Paragraph 11 (1) (b), "34" is replaced by "33."
19. in Paragraph 11 (1) (c), "67" is replaced by "66."
20. Paragraph 11 (2) reads:
"(2) Approval of a product type shall be subject to:
(a) a radioactive substance in a specific form having the characteristics listed in points 1 to 3 of Part I of Annex 1 to this Regulation; and
(b) a low-dispersive radioactive substance having the characteristics listed in point 4 of Part I of Annex 1 to this Regulation; in the case of international transport, type-approval shall also be required by the competent authority of the State to which the shipment relates. ';
21. in Paragraph 12 (2) (b), "2 to 4" is replaced by "1 to 3";
22. in Paragraph 12 (2) (c), "5" is replaced by "4."
23. In Annex 1, Part I, point 1, including heading I.1.1, is deleted.
Subheadings I.1.2 to I.1.4 shall be renumbered as headings I.1.1 to I.1.3.
Points 2 to 86 shall be renumbered as points 1 to 85.
24. In Annex No 1, Part I, point 2 (c), the text "ISO 9978: 1992 (E) 'is replaced by" ISO 9978: 2020 (E)'.
25. in Annex 1, Part I, point 5 (a), "73" is replaced by "72."
26. In Annex No 1, Part I, point 5 (b), "84 'is replaced by" 83' and "85 'is replaced by" 84'.
27. In Annex 1, Part I, point 5 (c), "83 'is replaced by" 82'.
28. In Annex 1, Part In point 8, "8 'is replaced by" 7';
29. In Annex 1, Part In point 12, the current text becomes paragraph 1 and the following paragraph 2 is added:
'2. The design type of radioactive consignment shall take into account ageing processes. ';
30. In Annex 1, Part I, point 21 reads as follows:
"21. The excluded consignment shall be so constructed as to meet the requirements of paragraphs 6 to 17, the requirements of paragraph 35, if it contains an exempted fissile substance, and the requirements of paragraphs 18 to 20, if it is intended for air transport. ';
31. In Annex 1, Part In point 22, "7 to 18 and 36 'is replaced by" 6 to 17 and 35' and "19 to 21 'is replaced by" 18 to 20';
32. In Annex 1, Part In point 23 of the introductory part of the provision, the words "under point 23 'are replaced by the words" under point 22'.
33. In Annex 1, Part In point 24, "23 'is replaced by" 22' and "37 to 49 'is replaced by" 36 to 48'.
34. in Annex 1, Part I, point 25 (a), "23" is replaced by "22."
35. in Annex 1, Part I, point 26 (a), "23" is replaced by "22."
36. In Annex 1, Part In point 27 of the introductory part of the provision, the words "gaseous or liquid 'are deleted.
37. in Annex No 1, Part I, point 27 (a), "23" is replaced by "22."
38. In Annex No 1, Part I, point 28 (b), "23 'is replaced by" 22'.
39. In Annex 1, Part I, point 28 (c), "ISO 1496: 1990 (E) 'is replaced by" ISO 1496-1: 2013 (E)'.
40. in Annex 1, Part I, point 29 (a), "23" is replaced by "22."
41. In Annex 1, Part In point 30, "34 'is replaced by" 33', "ISO 7195: 2005 (E) 'is replaced by" ISO 7195: 2020 (E)' and "32 and 33 'is replaced by" 31 and 32'.
42. in Annex 1, Part I, point 31 (a), the text "ISO 7195: 2005 (E)" is replaced by "ISO 7195: 2020 (E)" and the number "34" is replaced by "33."
43. In Annex No 1, Part I, point 31 (c), "34 'is replaced by" 33'.
44. in Annex 1, Part I, point 33 (a), "ISO 7195: 2005 (E)" is replaced by "ISO 7195: 2020 (E)."
45. In Annex 1, Part I, point 33 (c), "32 'is replaced by" 31'.
46. In Annex 1, Part In point 33 of the final part of the provision, "31 to 33 'is replaced by" 30 to 32'.
47. In Annex 1, Part In point 34, "7 to 18, 36 to 51 'is replaced by" 6 to 17, 35 to 50' and "19 to 21 'is replaced by" 18 to 20'.
48. In Annex 1, Part In point 49 of the introductory part of the provision, "48 'is replaced by" 47'.
49. In Annex No 1, Part I, point 51, "7 to 18, 36 to 47, 48 (b), 49, 53 to 66 and the requirements of points 19 to 21 'is replaced by" 6 to 17, 35 to 46, 47 (b), 48, 52 to 65 and the requirements of points 18 to 20'.
50. in Annex No 1, Part I, point 52 (1) (a), "56 and 57" is replaced by "55 and 56."
51. in Annex 1, Part I, point 53 (a), "56" is replaced by "55."
52. In Annex 1, Part I, point 54 (1) of the introductory part of the provision, is replaced by "18 '.
53.In Annex 1, Part I, point 54 (1) (a), "56" is replaced by "55."
54. In Annex 1, Part In point 57, "19 to 24 'is replaced by" 18 to 23' and "59 (1) (b) (I) 'is replaced by" 58 (1) (b)'.
55. In Annex 1, Part I, point 66 (1), "52 'is replaced by" 51'.
56. In Annex No 1, Part I, point 66 (2), the words "37, 55 to 57 and 60 to 66. The requirements for radioactive consignment type B (U) referred to in points 55 and 60 to 66 are replaced by" 36, 54 to 56 and 59 to 65. Requirements for radioactive consignment type B (U) referred to in points 54 and 59 to 65 '.
57. in Annex No 1, Part I, point 68, the words "7 to 21, 36 to 47, 48 (b), 49, 53 to 57, 61 to 66 and 70 to 72" shall be replaced by "6 to 20, 35 to 46, 47 (b), 48, 52 to 56, 60 to 65 and 69 to 71."
58. In Annex 1, Part In point 69, "59 (b) 'is replaced by" 58 (1) (b)' and "63 'is replaced by" 62'.
59. In Annex No 1, Part I, point 72 (b) (1), "36 'is replaced by" 35'.
60. In Annex No 1, Part I, point 72 (b) (3), "37 'is replaced by" 36'.
61. In Annex No 1, Part I, point 72 (b) (4), "76 to 86 'is replaced by" 75 to 85' and "74 or 75 'is replaced by" 73 or 74'.
62. In Annex 1, Part In point 73 of the introductory part of the provision, "76 to 86 of Part I 'is replaced by" 75 to 85'.
63. In Annex No 1, Part I, point 73 (c) (2), the words "Part II 'are inserted after" 19 to 24'.
64. In Annex 1, Part "74 'is replaced by" 73'.
65. In Annex 1, Part In point 74 of the introductory part of the provision, "76 to 86 'is replaced by" 75 to 85';
66. In Annex 1, Part In point 75, "80 to 85 'is replaced by" 79 to 84';
67. In Annex 1, Part In point 76 of the introductory part of the provision, "80 to 85 'is replaced by" 79 to 84'.
68. In Annex No 1, Part I, point 79 (a), "85 'is replaced by" 84'.
69. In Annex No 1, Part I, point 79 (b) (1), the word "stopper 'shall be inserted after the word" valve'.
70. In Annex No 1, Part I, point 79 (b) (2), "85 'is replaced by" 84' and the words "and stoppers' are inserted after the word" valves'.
71. In Annex 1, Part In point 80, "82 'is replaced by" 81' and "85 'is replaced by" 84'.
72. In Annex 1, Part In point 81 of the introductory part of the provision, "80 and 81 'is replaced by" 79 and 80'.
73. In Annex 1, Part I, point 81 (b), "84 'is replaced by" 83'.
74. In Annex No 1, Part I, point 81 (c), "85 'is replaced by" 84'.
75. In Annex No 1, Part I, point 82 (b), "82 'is replaced by" 81' and "80 'is replaced by" 79'.
76. In Annex No 1, Part I, point 84 (c), "85 'is replaced by" 84'.
77. In Annex 1, Part in point 85, "84 and 85 'is replaced by" 83 and 84';
78. In Annex No 1, Part II, point 1 (a), the words "low-activity radioactive substances LSA III, 'are deleted.
79. In Annex No 1, Part II, to heading II.2, the words "LSO- III AND FOR LOSS-COMPLETE ACTIVITIES 'are deleted.
80. In Annex No 1, Part II, point 11 (b), the text "ISO 9978: 1992 (E) 'is replaced by the text" ISO 9978: 2020 (E)'.
81. In Annex No 1, Part II, point 12, "5 'is replaced by" 4'.
82. In Annex No 1, Part II, point 16 (c), "73 to 86 'is replaced by" 72 to 85'.
83. In Annex No 1, Part II, point 27, last sentence, "59 to 85 'is replaced by" 58 to 84'.
84. In Annex No 1, Part II, point 31, "80 to 85 'is replaced by" 79 to 84'.
85. in Annex No 2, point 4 (a), "7 to 11 and 13 to 16" is replaced by "6 to 10 and 12 to 15."
86. In Annex 3, Table 2, the following is inserted:
„
“.
| Radionuklid (atomové číslo) | A1 (TBq) | A2 (TBq) | Meze hmotnostní aktivity pro vyjmutí látky (Bq/g) | Meze aktivity pro vyjmutí dodávky (Bq) |
|---|---|---|---|---|
| Ba-135m | 2 × 101 | 6 × 10-1 | 1 × 102 | 1 × 106 |
| Ge-69 | 1 × 100 | 1 × 100 | 1 × 101 | 1 × 106 |
| Ir-193m | 4 × 101 | 4 × 100 | 1 × 104 | 1 × 107 |
| Ni-57 | 6 × 10-1 | 6 × 10-1 | 1 × 101 | 1 × 106 |
| Sr-83 | 1 × 100 | 1 × 100 | 1 × 101 | 1 × 106 |
| Tb-149 | 8 × 10-1 | 8 × 10-1 | 1 × 101 | 1 × 106 |
| Tb-161 | 3 × 101 | 7 × 101 | 1 × 103 | 1 × 106 |
87. In Annex 3, the following is added at the end of the text of explanatory note (b) to Table 2:
"Note: For Th natural is default radionuclide Th-132, for U natural is default radionuclide U-238."
88. In Annex 3, point 9 (4), introductory part of the provision, the words "which satisfy the requirements of point 1 of Part I of Annex 1 to this Decree and 'shall be deleted.
89. In Annex 3, point 9 (4), at the end of point (a), comma is replaced by "a 'and point (b) are deleted.
Point (c) shall be renumbered (b).
90. in Annex 3 (12) (a):
"(a) is a solid object which is not in itself radioactive but on whose surface a radioactive or fissile substance is dispersed;"
91. In Annex 3, point 13 (1):
"1. The surface contaminated article shall be classified in the group SCO- I, SCO- II or SCO- III. ';
92. In Annex 3 (13) (2) (c) and (3) (c), the words "the sum of unfixed and fixed contamination on an inaccessible surface of an area of 300 cm2 on average 'are replaced by the words" the sum of unfixed and fixed contamination on an inaccessible surface of an area of 300 cm2'.
93. In Annex 3, point 13, the following paragraph 4 is added:
"4. A large fixed object shall be assigned to the SCO-III group, which cannot be transported in any type of packaging pursuant to Paragraph 4 (1) due to its size and which:
(a) all closures are closed in order to prevent radionuclides from leaking under the conditions set out in point 20 (e) of Annex 4 to this Regulation;
(b) the interior of the article is dried to the maximum practicable extent;
(c) the level of non-fixed contamination on its external surface does not exceed the limits laid down in point 8 of Annex 4 to this Decree; and
(d) the sum of the non-fixed and fixed contamination on an inaccessible surface averaged from an area of 300 cm2 does not exceed 8 × 105 Bq / cm2 for beta and gamma radiators and alpha lamps with low toxicity, or 8 × 104 Bq / cm2 for all other alpha lamps. ';
94.In Annex 3, point 15 (a), "2 to 4 'is replaced by" 1 to 3';
95.In Annex 3, point 16 (a), "5" is replaced by "4."
96. In Annex 3, point 16 (c), "65 'is replaced by" 64'.
97. In Annex 3, point 17 of the Introductory Part of the provision, "36 'is replaced by" 35'.
98. In Annex 3, point 17 (f), "6 'is replaced by" 5'.
99. In Annex 3, point 23, at the end of point (c), the word "a 'is deleted.
100. In Annex 3, point 23, at the end of point (d), the dot is replaced by "a 'and the following point (e) is added:
"(e) where a radioactive consignment contains a fissile substance, this requirement shall be met by one of the points (a) to (f) of point 17.";
101. In Annex 3, point 24, at the end of point (a), the word "a 'is replaced by a comma.
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Regulation Information
| Citation | Decree No. 157 / 2025 Coll., amending Decree No. 379 / 2016 Coll., on the type-approval of certain products in the field of the peaceful use of nuclear energy and ionising radiation and the transport of radioactive or fissile substances |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 03.06.2025 |
|---|---|
| Effective from | 01.07.2025 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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