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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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There are currently no known outstanding effects for the Regulation (EU) No 528/2012 of the European Parliament and of the Council, CHAPTER IX.
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1.On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority F1.... In particular, the following shall be notified:
(a)new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;
(b)any data indicating the potential of the active substance for the development of resistance;
(c)new data or information indicating that the biocidal product is not sufficiently effective.
2.The competent authority F2..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
F33.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Words in Art. 47(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 94(a); 2020 c. 1, Sch. 5 para. 1(1)
1.Without prejudice to Article 23, the competent authority F4... shall at any time cancel or amend an authorisation it has granted where it considers that:
(a)the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied;
(b)the authorisation was granted on the basis of false or misleading information; or
(c)the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.
2.Where the competent authority F5... intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit. The [F6competent authority] shall take due account of those comments when finalising its decision.
3.Where the competent authority F7... cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder F8....
F9...
F10...
Textual Amendments
F4Words in Art. 48(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 95(2); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Art. 48(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 95(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Art. 48(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 95(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Art. 48(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 95(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Art. 48(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 95(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
At the reasoned request of an authorisation holder, the competent authority F11... shall cancel the authorisation. F12...
Textual Amendments
F11Words in Art. 49 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 96(a); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Art. 49 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 96(b); 2020 c. 1, Sch. 5 para. 1(1)
F131.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent [F14authority]. [F15The competent authority shall] decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.
The application shall be accompanied by the [F16appropriate fees].
3.An amendment to an existing authorisation shall fall under one of the following categories of changes:
(a)administrative change;
(b)minor change; or
(c)major change.
Textual Amendments
F13Art. 50(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 97(2); 2020 c. 1, Sch. 5 para. 1(1)
F14Word in Art. 50(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 97(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
Notwithstanding Article 89, where the competent authority F19... cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.
The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.]
Textual Amendments
F18Substituted 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).
F19Words in Art. 52 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 99; 2020 c. 1, Sch. 5 para. 1(1)
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