- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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Changes over time for: Article 10
Changes to legislation:
There are outstanding changes not yet made to Regulation (EU) No 528/2012 of the European Parliament and of the Council. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to Article 10:
- Regulation applied (with modifications) by S.I. 2023/959 reg. 4(a) Sch. 1
- Art. 10(2) words substituted by S.I. 2019/720 Sch. 2 para. 71(2)
- Art. 10(3) words substituted by S.I. 2019/720 Sch. 2 para. 71(3)(a)
- Art. 10(3) words substituted by S.I. 2019/720 Sch. 2 para. 71(3)(b)
- Art. 10(5) words substituted by S.I. 2019/720 Sch. 2 para. 71(4)
Newidiadau ac effeithiau heb eu gweithredu eto ar yr eitem ddeddfwriaeth gyfan a’r darpariaethau cysylltiedig.
- Annex 3 para. 4 substituted by S.I. 2019/720 Sch. 2 para. 141(3)
- Annex 3 point 2 para. 4 words inserted by S.I. 2024/352 Sch. 2 para. 1(2)(b)
- Annex 3 para. 2 words omitted by S.I. 2019/720 Sch. 2 para. 141(2)(c)
- Annex 3 para. 2 words omitted by S.I. 2019/720 Sch. 2 para. 141(2)(d)
- Annex 3 para. 8 words omitted by S.I. 2019/720 Sch. 2 para. 141(5)
- Annex 3 para. 2 words substituted by S.I. 2019/720 Sch. 2 para. 141(2)(a)
- Annex 3 para. 2 words substituted by S.I. 2019/720 Sch. 2 para. 141(2)(b)
- Annex 3 para. 6 words substituted by S.I. 2019/720 Sch. 2 para. 141(4)
- Annex 3 point 2 para. 4 words substituted by S.I. 2024/352 Sch. 2 para. 1(2)(a)
- Annex 2 para. 4 substituted by S.I. 2019/720 Sch. 2 para. 140(3)
- Annex 2 para. 2 words omitted by S.I. 2019/720 Sch. 2 para. 140(2)(b)
- Annex 2 para. 8 words omitted by S.I. 2019/720 Sch. 2 para. 140(5)
- Annex 2 para. 2 words substituted by S.I. 2019/720 Sch. 2 para. 140(2)(a)
- Annex 2 para. 6 words substituted by S.I. 2019/720 Sch. 2 para. 140(4)
- Annex 4 para. 1.3 words omitted by S.I. 2019/720 Sch. 2 para. 142(b)
- Annex 4 para. 1.5 words omitted by S.I. 2019/720 Sch. 2 para. 142(c)
- Annex 4 para. 3.1 words omitted by S.I. 2019/720 Sch. 2 para. 142(d)
- Annex 4 para. 1.2 words substituted by S.I. 2019/720 Sch. 2 para. 142(a)
- Annex 6 para. 10 word substituted by S.I. 2019/720 Sch. 2 para. 143(6)
- Annex 6 para. 13 words omitted by S.I. 2019/720 Sch. 2 para. 143(9)(a)
- Annex 6 para. 15 words omitted by S.I. 2019/720 Sch. 2 para. 143(10)
- Annex 6 para. 1 words substituted by S.I. 2019/720 Sch. 2 para. 143(2)(a)
- Annex 6 para. 1 words substituted by S.I. 2019/720 Sch. 2 para. 143(2)(b)
- Annex 6 para. 6 words substituted by S.I. 2019/720 Sch. 2 para. 143(3)
- Annex 6 para. 8 words substituted by S.I. 2019/720 Sch. 2 para. 143(4)
- Annex 6 para. 9 words substituted by S.I. 2019/720 Sch. 2 para. 143(5)(a)
- Annex 6 para. 9 words substituted by S.I. 2019/720 Sch. 2 para. 143(5)(b)
- Annex 6 para. 11 words substituted by S.I. 2019/720 Sch. 2 para. 143(7)
- Annex 6 para. 12 words substituted by S.I. 2019/720 Sch. 2 para. 143(8)
- Annex 6 para. 13 words substituted by S.I. 2019/720 Sch. 2 para. 143(9)(b)
- Annex 6 para. 20 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 26 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 36 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 48 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 50 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 51 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 52 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 53 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 55 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 56 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 57 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 58 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 59 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 60 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 62 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 64 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 66 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 67 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 68 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 69 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 71 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 72 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 73 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 74 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 75 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 77 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 78 words substituted by S.I. 2019/720 Sch. 2 para. 143(11)
- Annex 6 para. 52 words substituted by S.I. 2019/720 Sch. 2 para. 143(12)
- Annex 6 para. 75 words substituted by S.I. 2019/720 Sch. 2 para. 143(13)
- Annex 6 para. 77 words substituted by S.I. 2019/720 Sch. 2 para. 143(14) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 143(14) substituted immediately before IP completion day by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 39(b))
- Annex 6 para. 77 words substituted by S.I. 2019/720, Sch. 2 para. 143(14) (as substituted) by S.I. 2020/1567 Sch. 2 para. 39(b)
- Annex 6 para. 52 words substituted in earlier amending S.I. 2019/720, Sch. 2 para. 143(12) by S.I. 2020/1567 Sch. 2 para. 39(a)
- Art. 1(2)(c) omitted by S.I. 2019/720 Sch. 2 para. 62(3)(b)
- Art. 2(b) words substituted by S.I. 2019/720, Sch. 2 para. 63(2)(b) (as substituted) by S.I. 2020/1567 Sch. 2 para. 22
- Art. 2(c) words substituted by S.I. 2019/720, Sch. 2 para. 63(2)(c) (as substituted) by S.I. 2020/1567 Sch. 2 para. 22
- Art. 2(k) substituted by S.I. 2019/720, Sch. 2 para. 63(2)(d) (as substituted) by S.I. 2020/1567 Sch. 2 para. 22
- Art. 3(1)(d) words inserted by S.I. 2019/720 Sch. 2 para. 64(2)(a)
- Art. 3(1)(e) words inserted by S.I. 2019/720 Sch. 2 para. 64(2)(b)
- Art. 3(1)(f) words omitted by S.I. 2019/720 Sch. 2 para. 64(2)(c)
- Art. 3(1)(k) words substituted by S.I. 2019/720 Sch. 2 para. 64(2)(d) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 64(2)(d) substituted immediately before IP completion day by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 23(a))
- Art. 3(1)(k) words substituted by S.I. 2019/720, Sch. 2 para. 64(2)(d) (as substituted) by S.I. 2020/1567 Sch. 2 para. 23(a)
- Art. 3(1)(m) words omitted by S.I. 2019/720 Sch. 2 para. 64(2)(e)(i)
- Art. 3(1)(m) words omitted by S.I. 2019/720 Sch. 2 para. 64(2)(e)(ii)
- Art. 3(1)(n) substituted by S.I. 2019/720 Sch. 2 para. 64(2)(f)
- Art. 3(1)(n) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 64(2)(f) by S.I. 2020/1567 Sch. 2 para. 23(b)
- Art. 3(1)(o) words omitted by S.I. 2019/720 Sch. 2 para. 64(2)(g)
- Art. 3(1)(p) words substituted by S.I. 2019/720 Sch. 2 para. 64(2)(h)(i)
- Art. 3(1)(p) words substituted by S.I. 2019/720 Sch. 2 para. 64(2)(h)(ii)
- Art. 3(1)(p) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 64(2)(h)(ii) by S.I. 2020/1567 Sch. 2 para. 23(c)
- Art. 3(1)(t) words inserted by S.I. 2019/720 Sch. 2 para. 64(2)(i)
- Art. 3(1)(x) omitted by S.I. 2019/720 Sch. 2 para. 64(2)(j)
- Art. 3(1)(af)-(ah) inserted by S.I. 2019/720 Sch. 2 para. 64(2)(k)
- Art. 3(1)(ai) substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 64(2)(k) by S.I. 2020/1567 Sch. 2 para. 23(d)(i)
- Art. 3(1)(aj) substituted for point (ah) the second time it occurs in earlier amending provision S.I. 2019/720, Sch. 2 para. 64(2)(k) by S.I. 2020/1567 Sch. 2 para. 23(d)(ii)
- Art. 3(3)-(7) substituted for Art. 3(3)(4) by S.I. 2019/720 Sch. 2 para. 64(3)
- Art. 5(1)(d) words substituted by S.I. 2019/720 Sch. 2 para. 65(a)
- Art. 6(5)(6) inserted by S.I. 2019/720 Sch. 2 para. 66(4)
- Art. 8(2A) inserted by S.I. 2019/720 Sch. 2 para. 68(5)
- Art. 8A inserted by S.I. 2019/720 Sch. 2 para. 69
- Art. 8A word substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 69 by S.I. 2020/1567 Sch. 2 para. 24
- Art. 9(1)(a) words substituted by S.I. 2019/720 Sch. 2 para. 70(2)(c)
- Art. 9(1)(b) words substituted by S.I. 2019/720 Sch. 2 para. 70(2)(d)
- Art. 9(1A) inserted by S.I. 2019/720 Sch. 2 para. 70(3)
- Art. 12(4) inserted by S.I. 2019/720 Sch. 2 para. 73(d)
- Art. 14(4)(a) words substituted by S.I. 2019/720 Sch. 2 para. 75(5)(d)
- Art. 14(4)(b) word substituted by S.I. 2019/720 Sch. 2 para. 75(5)(e)
- Art. 14(4A) inserted by S.I. 2019/720 Sch. 2 para. 75(6)
- Art. 14(4A) word substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 75(6) by S.I. 2020/1567 Sch. 2 para. 26
- Art. 14(5A) inserted by S.I. 2019/720 Sch. 2 para. 75(8)
- Art. 17A inserted by S.I. 2019/720, Sch. 2 para. 78A (as inserted) by S.I. 2020/1567 Sch. 2 para. 27
- Art. 19(1)(a) words substituted by S.I. 2019/720 Sch. 2 para. 80(a)
- Art. 19(4)(a) omitted by S.I. 2019/720 Sch. 2 para. 80(b)
- Art. 24A inserted by S.I. 2019/720 Sch. 2 para. 85
- Art. 25(1)(a) words substituted by S.I. 2019/720 Sch. 2 para. 86(a)
- Art. 25(1)(a) words substituted by S.I. 2019/720 Sch. 2 para. 86(b)
- Art. 26(2A)-(2C) inserted by S.I. 2022/1291 reg. 2(2)(a)
- Art. 26(3A)(3B) inserted by S.I. 2022/1291 reg. 2(2)(c)
- Art. 28(3)-(7) substituted for Art. 28(3)-(5) by S.I. 2019/720 Sch. 2 para. 89(c)
- Art. 29(1A)(1B) inserted by S.I. 2022/1291 reg. 2(3)
- Art. 29(2)(a) omitted by S.I. 2019/720 Sch. 2 para. 90(4)(b)
- Art. 29(2)(b) omitted by S.I. 2019/720 Sch. 2 para. 90(4)(b)
- Art. 30(1A)-(1C) inserted by S.I. 2022/1291 reg. 2(4)(b)
- Art. 30(2A) inserted by S.I. 2022/1291 reg. 2(4)(d)
- Art. 30(4) inserted by S.I. 2022/1291 reg. 2(4)(f)
- Art. 55(4)(d) and semicolon omitted in earlier amending provision S.I. 2019/720, Sch. 2 para. 102 by S.I. 2020/1567 Sch. 2 para. 28(a)
- Art. 55(7) Art. 55(9) renumbered as Art. 55(7) in earlier amending provision S.I. 2019/720, Sch. 2 para. 102 by S.I. 2020/1567 Sch. 2 para. 28(c)
- Art. 55(7)(8) omitted in earlier amending provision S.I. 2019/720, Sch. 2 para. 102 by S.I. 2020/1567 Sch. 2 para. 28(b)
- Art. 55(7) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 102 by S.I. 2020/1567 Sch. 2 para. 28(d)
- Art. 58(9) inserted by S.I. 2019/720 Sch. 2 para. 105(6)
- Art. 60(4)(5) inserted by S.I. 2019/720 Sch. 2 para. 107(3)
- Art. 60(4)(5) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 107(3) by S.I. 2020/1567 Sch. 2 para. 29
- Art. 69(2)(c) words omitted by S.I. 2019/720 Sch. 2 para. 115(3)(a)
- Art. 69(2)(o) words substituted by S.I. 2019/720 Sch. 2 para. 115(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 115(3)(b) substituted immediately before IP completion day by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 32)
- Art. 69(2)(o) words substituted by S.I. 2019/720, Sch. 2 para. 115(3)(b) (as substituted) by S.I. 2020/1567 Sch. 2 para. 32
- Art. 83A 83B inserted by S.I. 2019/720 Sch. 2 para. 125
- Art. 83B(1) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 125 by S.I. 2020/1567 Sch. 2 para. 35(a)
- Art. 83B(4)-(7) omitted in earlier amending provision S.I. 2019/720, Sch. 2 para. 129 by S.I. 2020/1567 Sch. 2 para. 35(b)
- Art. 88(2) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 129 by S.I. 2020/1567 Sch. 2 para. 36(a)
- Art. 88(3)(d) omitted in earlier amending provision S.I. 2019/720, Sch. 2 para. 129 by S.I. 2020/1567 Sch. 2 para. 36(b)
- Art. 88(6) Art. 88(8) renumbered as Art. 88(6) in earlier amending provision S.I. 2019/720, Sch. 2 para. 129 by S.I. 2020/1567 Sch. 2 para. 36(d)
- Art. 88(6) words substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 129 by S.I. 2020/1567 Sch. 2 para. 36(e)
- Art. 88(7)(8) omitted in earlier amending provision S.I. 2019/720, Sch. 2 para. 129 by S.I. 2020/1567 Sch. 2 para. 36(c)
- Art. 89(7) words inserted by S.I. 2022/1291 reg. 2(5)(a)
- Art. 89(7A)-(7C) inserted by S.I. 2022/1291 reg. 2(5)(b)
- Art. 89(8) words substituted by S.I. 2022/1291 reg. 2(5)(c)
- Art. 89(9) words inserted by S.I. 2022/1291 reg. 2(5)(d)
- Art. 89(9A) inserted by S.I. 2022/1291 reg. 2(5)(e)
- Art. 89(12) inserted by S.I. 2022/1291 reg. 2(5)(f)
- Art. 92(1A)-(1C) inserted by S.I. 2019/720 Sch. 2 para. 133
- Art. 93(a) word substituted by S.I. 2019/720 Sch. 2 para. 134(3)(a)
- Art. 93(a) words substituted by S.I. 2019/720 Sch. 2 para. 134(3)(b)
- Art. 93(b) word substituted by S.I. 2019/720 Sch. 2 para. 134(4)
- Art. 94(1)(a) words substituted by S.I. 2019/720 Sch. 2 para. 135(2)(b)
- Art. 94(1)(a) words substituted in earlier amending S.I. 2019/720, Sch. 2 para. 135(2)(b) by S.I. 2020/1567 Sch. 2 para. 37
- Art. 95(8) inserted by S.I. 2019/720 Sch. 2 para. 136(6)
- Art. 95A-95L inserted by S.I. 2019/720 Sch. 2 para. 137 (This amendment not applied to legislation.gov.uk. Sch. 2 para. 137 omitted immediately before IP completion day by virtue of S.I. 2020/1567, reg. 1(2), Sch. 2 para. 38)
- Art. 95A-95N inserted by S.I. 2019/720, Sch. 4 para. 2 (as inserted) by S.I. 2020/1567 Sch. 4
- Art. 95B(4A) inserted by S.I. 2022/1291 reg. 2(6)
- Art. 95C(4A) inserted by S.I. 2022/1291 reg. 2(7)
- Art. 95H(4A) inserted by S.I. 2022/1291 reg. 2(9)
- Art. 95FA and cross-heading inserted by S.I. 2022/1291 reg. 2(8)
Article 10U.K.Active substances which are candidates for substitution
1.An active substance shall be considered a candidate for substitution if any of the following conditions are met:
(a)it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);
(b)it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;
(c)its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;
(d)it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;
(e)there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;
(f)it contains a significant proportion of non-active isomers or impurities.
2.When preparing its opinion on the approval or renewal of the approval of an active substance, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion.
3.Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the Commission, the Agency shall make publicly available, without prejudice to Articles 66 and 67, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. The Agency shall take due account of the information received when finalising its opinion.
4.By way of derogation from Article 4(1) and Article 12(3), the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.
5.Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in the relevant Regulation adopted in accordance with Article 9.
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Mae’r holl gynnwys ar gael dan Drwydded Llywodraeth Agored v3.0 ac eithrio ble nodir yn wahanol. Yn ychwanegol mae’r safle hwn â chynnwys sy’n deillio o EUR-Lex, a ailddefnyddiwyd dan delerau Penderfyniad y Comisiwn 2011/833/EU ar ailddefnyddio dogfennau o sefydliadau’r UE. Am ragor o wybodaeth gweler ddatganiad cyhoeddus Swyddfa Gyhoeddiadau’r UE ar ailddefnyddio.