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Council Directive 2013/59/EuratomShow full title

Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom

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ANNEX VII Exemption and clearance criteria as referred to in Articles 24, 26 and 30

1. Exemption

Practices may be exempted from notification either directly, on the basis of compliance with exemption levels (activity values (in Bq) or activity concentration values (in kBq kg-1)) laid down in section 2, or on the basis of higher values that, for specific applications, are established by the competent authority, satisfying the general exemption and clearance criteria set out in section 3. Practices subject to notification may be exempted from authorisation by law or general administrative act, or through an ad-hoc regulatory decision, on the basis of the information provided in conjunction with the notification of the practice and in line with general exemption criteria set out in section 3.

2. Exemption and clearance levels

(a)The total activity values (in Bq) for exemption apply to the total activity involved in a practice and are laid down in column 3 of Table B for artificial radionuclides and for some naturally-occurring radionuclides used in consumer products. For other practices involving naturally-occurring radionuclides, such values are, in general, not applicable.

(b)The exempt activity concentration values (in kBq kg-1) for the materials involved in the practice are laid down in Table A, Part 1, for artificial radionuclides, and in Table A, Part 2, for naturally-occurring radionuclides. The values in Table A, Part 1, are given for individual radionuclides, where applicable, including short-lived radionuclides in equilibrium with the parent nuclide, as indicated. The values in Table A, Part 2, apply to all radionuclides in the decay chain of U-238 or Th-232, but for segments of the decay chain, which are not in equilibrium with the parent radionuclide, higher values may be applied.

(c)The concentration values in Table A, Part 1, or in Table A, Part 2, also apply to the clearance of solid materials for reuse, recycling, conventional disposal or incineration. Higher values may be defined for specific materials or specific pathways, taking Community guidance into account, including, where appropriate, additional requirements, in terms of surface activity or monitoring requirements.

(d)For mixtures of artificial radionuclides, the weighted sum of nuclide-specific activities or concentrations (for various radionuclides contained in the same matrix) divided by the corresponding exemption value shall be less than unity. Where appropriate, this condition can be verified on the basis of best estimates of the composition of the radionuclide mix. The values in Table A, Part 2, apply individually to each parent nuclide. Some elements in the decay chain, e.g. Po-210 or Pb-210, may warrant the use of higher values taking Community guidance into account.

(e)The values in Table A, Part 2, may not be used to exempt the incorporation into building materials of residues from industries processing naturally-occurring radioactive material. For this purpose, compliance with the provisions of Article 75 shall be verified. The values laid down in Table B, column 3, apply to the total inventory of radioactive substances held by a person or undertaking as part of a specific practice at any point in time. However, the competent authority may apply these values to smaller entities or packages, for instance to exempt the transport or storage of exempted consumer products, if the general exemption criteria in section 3 are satisfied.

3. General exemption and clearance criteria

(a)The general criteria for the exemption of practices from notification or authorisation or for the clearance of materials from authorised practices are as follows:

(i)

the radiological risks to individuals caused by the practice are sufficiently low, as to be of no regulatory concern; and

(ii)

the type of practice has been determined to be justified; and

(iii)

the practice is inherently safe.

(b)Practices involving small amounts of radioactive substances or low activity concentrations, comparable to the exemption values laid down in Table A or Table B are deemed to fulfil criterion (iii).

(c)Practices involving amounts of radioactive substances or activity concentrations below the exemption values laid down in Table A, Part 1, or Table B, are deemed to comply with criterion (i) without further consideration. This is also the case for the values in Table A, Part 2, with the exception of the recycling of residues in building materials or the case of specific exposure pathways, for instance, drinking water.

(d)In the case of moderate amounts of material, as specified by Member States for specific types of practice, the activity concentration values laid down in Table B, column 2, may be used instead of the values laid down in Table A, Part 1, for the purpose of exemption from authorisation.

(e)For the purpose of exemption from notification or for the purpose of clearance, where amounts of radioactive substances or activity concentrations do not comply with the values laid down in Table A or Table B, an assessment shall be made in the light of the general criteria (i) to (iii) above. For compliance with the general criterion (i), it shall be demonstrated that workers should not be classified as exposed workers, and the following criteria for the exposure of members of the public are met in all feasible circumstances:

  • For artificial radionuclides:

    The effective dose expected to be incurred by a member of the public due to the exempted practice is of the order of 10 μSv or less in a year.

  • For naturally-occurring radionuclides:

    The dose increment, allowing for the prevailing background radiation from natural radiation sources, liable to be incurred by an individual due to the exempted practice is of the order of 1 mSv or less in a year. The assessment of doses to members of the public shall take into account not only pathways of exposure through airborne or liquid effluent, but also pathways resulting from the disposal or recycling of solid residues. Member States may specify dose criteria lower than 1 mSv per year for specific types of practices or specific pathways of exposure.

For the purpose of exemption from authorisation, less restrictive dose criteria may be applied.

TABLE A Activity concentration values for exemption or clearance of materials which can be applied by default to any amount and to any type of solid material

TABLE A PART 1 Artificial radionuclides
a

Parent radionuclides, and their progeny whose dose contributions are taken into account in the dose calculation (thus requiring only the exemption level of the parent radionuclide to be considered), are listed in the following table.

Parent radionuclideProgeny
Fe-52Mn-52 m
Zn-69 mZn-69
Sr-90Y-90
Sr-91Y-91 m
Zr-95Nb-95
Zr-97Nb-97 m, Nb-97
Nb-97Nb-97 m
Mo-99Tc-99 m
Mo-101Tc-101
Ru-103Rh-103 m
Ru-105Rh-105 m
Ru-106Rh-106
Pd-103Rh-103 m
Pd-109Ag-109 m
Ag-110 mAg-110
Cd-109Ag-109 m
Cd-115In-115 m
Cd-115 mIn-115 m
In-114 mIn-114
Sn-113In-113 m
Sb-125Te-125 m
Te-127 mTe-127
Te-129 mTe-129
Te-131 mTe-131
Te132I-132
Cs-137Ba-137 m
Ce-144Pr-144, Pr-144 m
U-232Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208
U-240Np-240 m, Np-240
Np237Pa-233
Pu-244U-240, Np-240 m, Np-240
Am-242 mNp-238
Am-243Np-239
Cm-247Pu-243
Es-254Bk-250
Es-254 mFm-254
RadionuclideActivity concentration(kBq kg-1)
H-3100
Be-710
C-141
F-1810
Na-220,1
Na-241
Si-311 000
P-321 000
P-331 000
S-35100
Cl-361
Cl-3810
K-42100
K-4310
Ca-45100
Ca-4710
Sc-460,1
Sc-47100
Sc-481
V-481
Cr-51100
Mn-5110
Mn-521
Mn-52 m10
Mn-53100
Mn-540,1
Mn-5610
Fe-52a10
Fe-551 000
Fe-591
Co-5510
Co-560,1
Co-571
Co-581
Co-58 m10 000
Co-600,1
Co-60 m1 000
Co-61100
Co-62 m10
Ni-59100
Ni-63100
Ni-6510
Cu-64100
Zn-650,1
Zn-691 000
Zn-69 ma10
Ga-7210
Ge-7110 000
As-731 000
As-7410
As-7610
As-771 000
Se-751
Br-821
Rb-86100
Sr-851
Sr-85 m100
Sr-87 m100
Sr-891 000
Sr-90a1
Sr-91a10
Sr-9210
Y-901 000
Y-91100
Y-91 m100
Y-92100
Y-93100
Zr-9310
Zr-95a1
Zr-97a10
Nb-93 m10
Nb-940,1
Nb-951
Nb-97a10
Nb-9810
Mo-9010
Mo-9310
Mo-99a10
Mo-101a10
Tc-961
Tc-96 m1 000
Tc-9710
Tc-97 m100
Tc-991
Tc-99 m100
Ru-9710
Ru-103a1
Ru-105a10
Ru-106a0,1
Rh-103 m10 000
Rh-105100
Pd-103a1 000
Pd-109a100
Ag-1051
Ag-110 ma0,1
Ag-111100
Cd-109a1
Cd-115a10
Cd-115 ma100
In-11110
In-113 m100
In-114 ma10
In-115 m100
Sn-113a1
Sn-12510
Sb-12210
Sb-1241
Sb-125a0,1
Te-123 m1
Te-125 m1 000
Te-1271 000
Te-127 ma10
Te-129100
Te-129 ma10
Te-131100
Te-131 ma10
Te-132a1
Te-13310
Te-133 m10
Te-13410
I-123100
I-125100
I-12610
I-1290,01
I-13010
I-13110
I-13210
I-13310
I-13410
I-13510
Cs-12910
Cs-1311 000
Cs-13210
Cs-1340,1
Cs-134 m1 000
Cs-135100
Cs-1361
Cs-137a0,1
Cs-13810
Ba-13110
Ba-1401
La-1401
Ce-1391
Ce-141100
Ce-14310
Ce-14410
Pr-142100
Pr-1431 000
Nd-147100
Nd-149100
Pm-1471 000
Pm-1491 000
Sm-1511 000
Sm-153100
Eu-1520,1
Eu-152 m100
Eu-1540,1
Eu-1551
Gd-15310
Gd-159100
Tb-1601
Dy-1651 000
Dy-166100
Ho-166100
Er-1691 000
Er-171100
Tm-170100
Tm-1711 000
Yb-175100
Lu-177100
Hf-1811
Ta-1820,1
W-18110
W-1851 000
W-18710
Re-1861 000
Re-188100
Os-1851
Os-191100
Os-191 m1 000
Os-193100
Ir-1901
Ir-1921
Ir-194100
Pt-19110
Pt-193 m1 000
Pt-1971 000
Pt-197 m100
Au-19810
Au-199100
Hg-197100
Hg-197 m100
Hg-20310
Tl-20010
Tl-201100
Tl-20210
Tl-2041
Pb-20310
Bi-2061
Bi-2070,1
Po-20310
Po-20510
Po-20710
At-2111 000
Ra-22510
Ra-227100
Th-2261 000
Th-2290,1
Pa-23010
Pa-23310
U-23010
U-231a100
U-232a0,1
U-2331
U-23610
U-237100
U-239100
U-240a100
Np-237a1
Np-239100
Np-24010
Pu-234100
Pu-235100
Pu-2361
Pu-237100
Pu-2380,1
Pu-2390,1
Pu-2400,1
Pu-24110
Pu-2420,1
Pu-2431 000
Pu-244a0,1
Am-2410,1
Am-2421 000
Am-242 ma0,1
Am-243a0,1
Cm-24210
Cm-2431
Cm-2441
Cm-2450,1
Cm-2460,1
Cm-247a0,1
Cm-2480,1
Bk-249100
Cf-2461 000
Cf-2481
Cf-2490,1
Cf-2501
Cf-2510,1
Cf-2521
Cf-253100
Cf-2541
Es-253100
Es-254a0,1
Es-254 ma10
Fm-25410 000
Fm-255100

For radionuclides not listed in Table A, Part 1 the competent authority shall assign appropriate values for the quantities and concentrations of activity per unit mass where the need arises. Values thus assigned shall be complementary to those in Table A, Part 1.

TABLE A PART 2 Naturally occurring radionuclides

Values for exemption or clearance for naturally occurring radionuclides in solid materials in secular equilibrium with their progeny:

Natural radionuclides from the U-238 series1 kBq kg-1
Natural radionuclides from the Th-232 series1 kBq kg-1
K-4010 kBq kg-1

TABLE B Total activity values for exemption (column 3) and exemption values for the activity concentration in moderate amounts of any type of material (column 2)

a

Potassium salts in quantities less than 1 000 kg are exempted.

b

Parent radionuclides, and their progeny whose dose contributions are taken into account in the dose calculation (thus requiring only the exemption level of the parent radionuclide to be considered), are listed in the following:

Parent radionuclideProgeny
Sr-90Y-90
Zr-93Nb-93 m
Zr-97Nb-97
Ru-106Rh-106
Ag-108 mAg-108
Cs-137Ba-137 m
Ba-140La-140
Ce-144Pr-144
Pb-210Bi-210, Po-210
Pb-212Bi-212, Tl-208 (0.36), Po-212 (0.64)
Bi-212Tl-208 (0.36), Po-212 (0.64)
Rn-220Po-216
Rn-222Po-218, Pb-214, Bi-214, Po-214
Ra-223Rn-219, Po-215, Pb-211, Bi-211, Tl-207
Ra-224Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Ra-226Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210
Ra-228Ac-228
Th-226Ra-222, Rn-218, Po-214
Th-228Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-229Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209
Th-234Pa-234 m
U-230Th-226, Ra-222, Rn-218, Po-214
U-232Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
U-235Th-231
U-238Th-234, Pa-234 m
U-240Np-240 m
Np237Pa-233
Am-242 mAm-242
Am-243Np-239
RadionuclideActivity concentration(kBq kg-1)Activity(Bq)
H-31 × 1061 × 109
Be-71 × 1031 × 107
C-141 × 1041 × 107
O-151 × 1021 × 109
F-181 × 1011 × 106
Na-221 × 1011 × 106
Na-241 × 1011 × 105
Si-311 × 1031 × 106
P-321 × 1031 × 105
P-331 × 1051 × 108
S-351 × 1051 × 108
Cl-361 × 1041 × 106
Cl-381 × 1011 × 105
Ar-371 × 1061 × 108
Ar-411 × 1021 × 109
K-40a1 × 1021 × 106
K-421 × 1021 × 106
K-431 × 1011 × 106
Ca-451 × 1041 × 107
Ca-471 × 1011 × 106
Sc-461 × 1011 × 106
Sc-471 × 1021 × 106
Sc-481 × 1011 × 105
V-481 × 1011 × 105
Cr-511 × 1031 × 107
Mn-511 × 1011 × 105
Mn-521 × 1011 × 105
Mn-52 m1 × 1011 × 105
Mn-531 × 1041 × 109
Mn-541 × 1011 × 106
Mn-561 × 1011 × 105
Fe-521 × 1011 × 106
Fe-551 × 1041 × 106
Fe-591 × 1011 × 106
Co-551 × 1011 × 106
Co-561 × 1011 × 105
Co-571 × 1021 × 106
Co-581 × 1011 × 106
Co-58 m1 × 1041 × 107
Co-601 × 1011 × 105
Co-60 m1 × 1031 × 106
Co-611 × 1021 × 106
Co-62 m1 × 1011 × 105
Ni-591 × 1041 × 108
Ni-631 × 1051 × 108
Ni-651 × 1011 × 106
Cu-641 × 1021 × 106
Zn-651 × 1011 × 106
Zn-691 × 1041 × 106
Zn-69 m1 × 1021 × 106
Ga-721 × 1011 × 105
Ge-711 × 1041 × 108
As-731 × 1031 × 107
As-741 × 1011 × 106
As-761 × 1021 × 105
As-771 × 1031 × 106
Se-751 × 1021 × 106
Br-821 × 1011 × 106
Kr-741 × 1021 × 109
Kr-761 × 1021 × 109
Kr-771 × 1021 × 109
Kr-791 × 1031 × 105
Kr-811 × 1041 × 107
Kr-83 m1 × 1051 × 1012
Kr-851 × 1051 × 104
Kr-85 m1 × 1031 × 1010
Kr-871 × 1021 × 109
Kr-881 × 1021 × 109
Rb-861 × 1021 × 105
Sr-851 × 1021 × 106
Sr-85 m1 × 1021 × 107
Sr-87 m1 × 1021 × 106
Sr-891 × 1031 × 106
Sr-90b1 × 1021 × 104
Sr-911 × 1011 × 105
Sr-921 × 1011 × 106
Y-901 × 1031 × 105
Y-911 × 1031 × 106
Y-91 m1 × 1021 × 106
Y-921 × 1021 × 105
Y-931 × 1021 × 105
Zr-93b1 × 1031 × 107
Zr-951 × 1011 × 106
Zr-97b1 × 1011 × 105
Nb-93 m1 × 1041 × 107
Nb-941 × 1011 × 106
Nb-951 × 1011 × 106
Nb-971 × 1011 × 106
Nb-981 × 1011 × 105
Mo-901 × 1011 × 106
Mo-931 × 1031 × 108
Mo-991 × 1021 × 106
Mo-1011 × 1011 × 106
Tc-961 × 1011 × 106
Tc-96 m1 × 1031 × 107
Tc-971 × 1031 × 108
Tc-97 m1 × 1031 × 107
Tc-991 × 1041 × 107
Tc-99 m1 × 1021 × 107
Ru-971 × 1021 × 107
Ru-1031 × 1021 × 106
Ru-1051 × 1011 × 106
Ru-106b1 × 1021 × 105
Rh-103 m1 × 1041 × 108
Rh-1051 × 1021 × 107
Pd-1031 × 1031 × 108
Pd-1091 × 1031 × 106
Ag-1051 × 1021 × 106
Ag-108 m1 × 1011 × 106
Ag-110 m1 × 1011 × 106
Ag-1111 × 1031 × 106
Cd-1091 × 1041 × 106
Cd-1151 × 1021 × 106
Cd-115 m1 × 1031 × 106
In-1111 × 1021 × 106
In-113 m1 × 1021 × 106
In-114 m1 × 1021 × 106
In-115 m1 × 1021 × 106
Sn-1131 × 1031 × 107
Sn-1251 × 1021 × 105
Sb-1221 × 1021 × 104
Sb-1241 × 1011 × 106
Sb-1251 × 1021 × 106
Te-123 m1 × 1021 × 107
Te-125 m1 × 1031 × 107
Te-1271 × 1031 × 106
Te-127 m1 × 1031 × 107
Te-1291 × 1021 × 106
Te-129 m1 × 1031 × 106
Te-1311 × 1021 × 105
Te-131 m1 × 1011 × 106
Te-1321 × 1021 × 107
Te-1331 × 1011 × 105
Te-133 m1 × 1011 × 105
Te-1341 × 1011 × 106
I-1231 × 1021 × 107
I-1251 × 1031 × 106
I-1261 × 1021 × 106
I-1291 × 1021 × 105
I-1301 × 1011 × 106
I-1311 × 1021 × 106
I-1321 × 1011 × 105
I-1331 × 1011 × 106
I-1341 × 1011 × 105
I-1351 × 1011 × 106
Xe-131 m1 × 1041 × 104
Xe-1331 × 1031 × 104
Xe-1351 × 1031 × 1010
Cs-1291 × 1021 × 105
Cs-1311 × 1031 × 106
Cs-1321 × 1011 × 105
Cs-134 m1 × 1031 × 105
Cs-1341 × 1011 × 104
Cs-1351 × 1041 × 107
Cs-1361 × 1011 × 105
Cs-137b1 × 1011 × 104
Cs-1381 × 1011 × 104
Ba-1311 × 1021 × 106
Ba-140b1 × 1011 × 105
La-1401 × 1011 × 105
Ce-1391 × 1021 × 106
Ce-1411 × 1021 × 107
Ce-1431 × 1021 × 106
Ce-144b1 × 1021 × 105
Pr-1421 × 1021 × 105
Pr-1431 × 1041 × 106
Nd-1471 × 1021 × 106
Nd-1491 × 1021 × 106
Pm-1471 × 1041 × 107
Pm-1491 × 1031 × 106
Sm-1511 × 1041 × 108
Sm-1531 × 1021 × 106
Eu-1521 × 1011 × 106
Eu-152 m1 × 1021 × 106
Eu-1541 × 1011 × 106
Eu-1551 × 1021 × 107
Gd-1531 × 1021 × 107
Gd-1591 × 1031 × 106
Tb-1601 × 1011 × 106
Dy-1651 × 1031 × 106
Dy-1661 × 1031 × 106
Ho-1661 × 1031 × 105
Er-1691 × 1041 × 107
Er-1711 × 1021 × 106
Tm-1701 × 1031 × 106
Tm-1711 × 1041 × 108
Yb-1751 × 1031 × 107
Lu-1771 × 1031 × 107
Hf-1811 × 1011 × 106
Ta-1821 × 1011 × 104
W-1811 × 1031 × 107
W-1851 × 1041 × 107
W-1871 × 1021 × 106
Re-1861 × 1031 × 106
Re-1881 × 1021 × 105
Os-1851 × 1011 × 106
Os-1911 × 1021 × 107
Os-191 m1 × 1031 × 107
Os-1931 × 1021 × 106
Ir-1901 × 1011 × 106
Ir-1921 × 1011 × 104
Ir-1941 × 1021 × 105
Pt-1911 × 1021 × 106
Pt-193 m1 × 1031 × 107
Pt-1971 × 1031 × 106
Pt-197 m1 × 1021 × 106
Au-1981 × 1021 × 106
Au-1991 × 1021 × 106
Hg-1971 × 1021 × 107
Hg-197 m1 × 1021 × 106
Hg-2031 × 1021 × 105
Tl-2001 × 1011 × 106
Tl-2011 × 1021 × 106
Tl-2021 × 1021 × 106
Tl-2041 × 1041 × 104
Pb-2031 × 1021 × 106
Pb-210b1 × 1011 × 104
Pb-212b1 × 1011 × 105
Bi-2061 × 1011 × 105
Bi-2071 × 1011 × 106
Bi-2101 × 1031 × 106
Bi-212b1 × 1011 × 105
Po-2031 × 1011 × 106
Po-2051 × 1011 × 106
Po-2071 × 1011 × 106
Po-2101 × 1011 × 104
At-2111 × 1031 × 107
Rn-220b1 × 1041 × 107
Rn-222b1 × 1011 × 108
Ra-223b1 × 1021 × 105
Ra-224b1 × 1011 × 105
Ra-2251 × 1021 × 105
Ra-226b1 × 1011 × 104
Ra-2271 × 1021 × 106
Ra-228b1 × 1011 × 105
Ac-2281 × 1011 × 106
Th-226b1 × 1031 × 107
Th-2271 × 1011 × 104
Th-228b1 × 1001 × 104
Th-229b1 × 1001 × 103
Th-2301 × 1001 × 104
Th-2311 × 1031 × 107
Th-234b1 × 1031 × 105
Pa-2301 × 1011 × 106
Pa-2311 × 1001 × 103
Pa-2331 × 1021 × 107
U-2301 × 1011 × 105
U-2311 × 1021 × 107
U-232b1 × 1001 × 103
U-2331 × 1011 × 104
U-2341 × 1011 × 104
U-235b1 × 1011 × 104
U-2361 × 1011 × 104
U-2371 × 1021 × 106
U-238b1 × 1011 × 104
U-2391 × 1021 × 106
U-2401 × 1031 × 107
U-240b1 × 1011 × 106
Np-237b1 × 1001 × 103
Np-2391 × 1021 × 107
Np-2401 × 1011 × 106
Pu-2341 × 1021 × 107
Pu-2351 × 1021 × 107
Pu-2361 × 1011 × 104
Pu-2371 × 1031 × 107
Pu-2381 × 1001 × 104
Pu-2391 × 1001 × 104
Pu-2401 × 1001 × 103
Pu-2411 × 1021 × 105
Pu-2421 × 1001 × 104
Pu-2431 × 1031 × 107
Pu-2441 × 1001 × 104
Am-2411 × 1001 × 104
Am-2421 × 1031 × 106
Am-242 mb1 × 1001 × 104
Am-243b1 × 1001 × 103
Cm-2421 × 1021 × 105
Cm-2431 × 1001 × 104
Cm-2441 × 1011 × 104
Cm-2451 × 1001 × 103
Cm-2461 × 1001 × 103
Cm-2471 × 1001 × 104
Cm-2481 × 1001 × 103
Bk-2491 × 1031 × 106
Cf-2461 × 1031 × 106
Cf-2481 × 1011 × 104
Cf-2491 × 1001 × 103
Cf-2501 × 1011 × 104
Cf-2511 × 1001 × 103
Cf-2521 × 1011 × 104
Cf-2531 × 1021 × 105
Cf-2541 × 1001 × 103
Es-2531 × 1021 × 105
Es-2541 × 1011 × 104
Es-254 m1 × 1021 × 106
Fm-2541 × 1041 × 107
Fm-2551 × 1031 × 106

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