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Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title
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 and effects yet to be applied to Article 22:
- Regulation applied (with modifications) by S.I. 2023/959 reg. 4(a) Sch. 1
Changes and effects yet to be applied to the whole legislation item and associated provisions
- 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 22U.K.Content of authorisation
1.An authorisation shall stipulate the terms and conditions relating to the making available on the market and use of the single biocidal product or the biocidal product family and include a summary of the biocidal product characteristics.
2.Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:
(a)trade name of the biocidal product;
(b)name and address of the authorisation holder;
(c)date of the authorisation and its date of expiry;
(d)authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;
(e)qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;
(f)manufacturers of the biocidal product (names and addresses including location of manufacturing sites);
(g)manufacturers of the active substances (names and addresses including location of manufacturing sites);
(h)type of formulation of the biocidal product;
(i)hazard and precautionary statements;
(j)product-type and, where relevant, an exact description of the authorised use;
(k)target harmful organisms;
(l)application doses and instructions for use;
(m)categories of users;
(n)particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;
(o)instructions for safe disposal of the product and its packaging;
(p)conditions of storage and shelf-life of the biocidal product under normal conditions of storage;
(q)where relevant, other information about the biocidal product.
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