CHAPTER 4U.K.TRANSITIONAL MEASURES

Article 21U.K.Transitional measures for substances referred to in Article 15

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2.[F2The] current system or practice of making available on the market and using a biocidal product consisting of, containing or generating an existing active substance referred to in [F3point (a) or (aa) of Article 15 shall continue to apply]. In such cases:

[F4(a)The biocidal product shall no longer be made available on the market with effect from 24 months after the notification or publication of the decision or guidance referred to in point (a) or (aa) of Article 15.

(b)Use of existing stocks of the biocidal product may continue until 30 months after the notification or publication of the decision or guidance referred to in point (a) or (aa) of Article 15.]

3.[F5The] current system or practice of making available on the market or using a biocidal product consisting of, containing or generating an existing active substance for which [F6the competent authority] has made a publication pursuant to Article 16(4) for the relevant product-type [F7shall continue to apply]. In such cases:

(a)The biocidal product shall no longer be made available on the market with effect from 12 months after the date when [F6the competent authority] has made the electronic publication referred to in Article 19; and

(b)Use of existing stocks of the biocidal product may continue until 18 months after the date of that publication.

Textual Amendments

[F8Article 22U.K.Essential use

1.Without prejudice to Article 55(1) of Regulation No 528/2012, within 18 months of the date of a decision not to approve an existing active substance, where the competent authority considers this existing active substance to be essential for one of the reasons referred to in points (b) or (c) of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012, the competent authority may submit a reasoned application to the Secretary of State or a Devolved Authority for a derogation from [F9Article 89(8)] of that Regulation.

2.The competent authority shall make the application, or where relevant, the non-confidential version, publicly available by electronic means. Any person may submit comments within 60 days of publication.

3.Taking account of the comments received, the Secretary of State or a Devolved Authority may exercise a derogation from F10... Article 89(8) of Regulation (EU) No 528/2012 allowing biocidal products consisting of, containing or generating the substance to be made available on the market and used in Great Britain subject to the conditions in paragraph 8 and any further conditions imposed by the Secretary of State or a Devolved Authority if they have competence to exercise the derogation within the meaning of paragraphs 4 to 6.

4.The Secretary of State has competence to exercise the derogation if, or to the extent that, the exercise of the function to take that measure—

(a)relates to England;

(b)relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);

(c)relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006)

5.The Scottish Ministers have competence to exercise the derogation if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

6.The Welsh Ministers have competence to exercise the derogation if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

7.Where the Secretary of State exercises the derogation under paragraph 3, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises the derogation under paragraph 3, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision.

8.The competent authority shall:

(a)ensure that continued use is limited to such cases where and such time during which the conditions of paragraph 1 are fulfilled;

(b)impose appropriate risk mitigation measures to ensure the exposure of humans, animals and the environment is minimised;

(c)ensure that alternatives are being sought, or that an application for approval of the active substance is being prepared for submission in accordance with Article 7 of Regulation (EU) No 528/2012 in due time before the expiry of the derogation.]

Textual Amendments

[F11Article 22AU.K.Transitional measures for ongoing applications submitted before IP completion day

1.This Article applies where an application was made before IP completion day to a Member State in accordance with Article 3 and accepted under Article 4 of Regulation (EU) No 1062/2014 or Article 9 of Regulation (EC) No 1451/2007 as they had effect immediately before IP completion day and where a decision on approval has not been made before IP completion day.

2.The application will be treated as having been received under Article 4 of this Regulation as it has effect in [F12assimilated] law if the participant resubmits their application and supporting dossier to the competent authority within:

(a)90 days after IP completion day where the United Kingdom competent authority was the evaluating competent authority prior to 30 March 2019; or

(b)180 days after IP completion day where the United Kingdom competent authority was not the evaluating competent authority prior to 30 March 2019.

3.Where the applicant does not meet the requirements of this Article, the application is to be treated as having been withdrawn under Article 11(1)(b).

Textual Amendments

Article 22BU.K.Declaration of interest to notify

1.This Article applies where a declaration of interest to notify was submitted before IP completion day under Article 16 of Regulation (EU) No 1062/2014 as it had effect immediately before IP completion day.

2.Where a declaration of interest to notify made pursuant to Article 16(1) was declared compliant under Article 16(3) or (4) it will be treated as being compliant under this Regulation as it has effect in [F13assimilated] law.

3.If a declaration of interest to notify was made pursuant to Article 16(1) but no decision on whether the declaration is compliant has been made before IP completion day, the person with an interest to notify may submit their declaration of interest under Article 16 of this Regulation to the competent authority within 180 days of IP completion day.

4.In circumstances where the time period for declarations of interest to notify as specified in Article 16(1)(a) of Regulation (EU) 1062/2014 has not expired before IP completion day, applications for declarations of interest to notify may be made to the competent authority under this Regulation at the latest 365 days after the publication of the decision or guidance referred to in point (a) of Article 15 of Regulation (EU) 1062/2014.

Where a declaration of interest is made in compliance with paragraph 3 or 4 the declaration shall be treated as having been made under Article 16 of this Regulation.

Textual Amendments

Article 22CU.K.Notification procedure pursuant to Articles 14(2) and 16(5)

1.This Article applies in relation to notifications made under Article 14(2) or 16(5) of Regulation (EU) 1062/2014.

2.Where a notification made under Article 14(2) or Article 16(5) was declared compliant under Article 17(5) before IP completion day, the notification will be treated as if it were compliant under this Regulation. The Secretary of State must update Annex II to this Regulation in accordance with Article 89(2) of Regulation 528/2012 if:

(a)a declaration of interest to notify is resubmitted to the competent authority; and

(b)the information as detailed within Annex I to this Regulation is resubmitted to the competent authority within a period of 180 days of IP completion day.

3.The applications referred to in Article 3(1) must be submitted to the competent authority within two years of the notification of the declaration of compliance made under Article 17(5) of this Regulation.

4.Where a notification made pursuant to either Article 14(2) or Article 16(5) was made in accordance with Regulation (EU) 1062/2014 before IP completion day but for which no declaration of compliance pursuant to Article 17(5) was made before IP completion day, the person may within 180 days of IP completion day resubmit their notification to the competent authority under Article 16 of this Regulation.

5.Where the relevant notification deadline as specified within Article 14(2) or Article 16(5) of Regulation (EU) 1062/2014 has not passed before IP completion day, a person may submit their notification to the competent authority under Article 16 of this Regulation, provided the notification is submitted before that notification deadline has passed.

6.A declaration of compliance made in accordance with paragraph 3 or 4 shall be considered as having been made under Article 17(5) of this Regulation.

Textual Amendments

Article 22DU.K.Dossiers submitted to Rapporteur Member States before IP completion day

1.This Article applies where a dossier was submitted before IP completion day for evaluation by a Member State in accordance with Article 14 of Commission Regulation (EC) No 1451/2007.

2.The application will be treated as having being made under this Regulation if the applicant resubmits their application and supporting dossier to the competent authority within:

(a) 90 days of IP completion day, where the United Kingdom competent authority was the evaluating competent authority before 30 March 2019, or

(b)180 days of IP completion day, where the United Kingdom competent authority was not the evaluating competent authority before 30 March 2019.

3.Where the applicant does not meet the requirements of this Article, the application will be treated as having been withdrawn under Article 11(1)(b). ]

Textual Amendments