- Latest available (Revised)
- Original (As adopted by EU)
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)
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Revised version PDFs
- Revised 20/11/20191.55 MB
- Revised 25/04/20141.29 MB
- Revised 23/09/20131.20 MB
This is a Regulation originating from the EU
This is a legislation item that originated from the EU
After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.
The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.
Changes over time for: Article 35
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 35:
- Regulation applied (with modifications) by S.I. 2023/959 reg. 4(a) Sch. 1
- Art. 32-46 omitted by S.I. 2019/720 Sch. 2 para. 93
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 35U.K.Referral of objections to the coordination group
1.A coordination group shall be set up to examine any question, other than matters referred to in Article 37, relating to whether a biocidal product for which an application for mutual recognition has been made in accordance with Article 33 or 34 meets the conditions for granting an authorisation laid down in Article 19.
All Member States and the Commission shall be entitled to participate in the work of the coordination group. The Agency shall provide the secretariat of the coordination group.
The coordination group shall establish its rules of procedure.
2.If any of the Member States concerned considers that a biocidal product assessed by the reference Member State does not meet the conditions laid down in Article 19, it shall send a detailed explanation of the points of disagreement and the reasons for its position to the reference Member State, the other Member States concerned, the applicant, and, where applicable, to the authorisation holder. The points of disagreement shall be referred without delay to the coordination group.
[F13. Within the coordination group, all Member States referred to in paragraph 2 of this Article shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known. Where they reach agreement within 60 days of the referral of the points of disagreement referred to in paragraph 2 of this Article, the reference Member State shall record the agreement in the Register for Biocidal Products. The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(3) or 34(6) as appropriate.]
Textual Amendments
F1 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Chapter
PrintThis Article only
You have chosen to open the Whole Regulation
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open Schedules only
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.