An application for approval or inclusion in F7the Simplified Active Substance List may be submitted only by a participant whose notification has been found compliant by the F8competent authority pursuant to Article 17(5) of this Regulation.

Where the application concerns inclusion in F7the Simplified Active Substance List, it may only concern F9categories A or B of that F10list.

Applications referred to in paragraph 1 shall be submitted to the F8competent authority within two years of the declaration of compliance pursuant to Article 17(5).

Where an application for approval or inclusion in F15category B of the Simplified Active Substance List containing the data required in accordance with Article 6(1) and (2) of Regulation (EU) No 528/2012 has been accepted by the competent authority and the appropriate fee has been paid pursuant to Article 4 the competent authority shall validate the application within 30 days of that payment.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

In the cases referred to in F17paragraph 1, the F18... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the F19... competent authority considers that the application is incomplete, it shall inform the participant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F19... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph F201.

The F19... competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant F21... accordingly. In such cases, part of the F22appropriate fees paid shall be reimbursed.

On validating an application, the F19... competent authority shall without delay inform the participant, F23... indicating the date of the validation.

The F29... competent authority shall evaluate the application in accordance with Articles 4 and 5 of Regulation (EU) No 528/2012, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3) of that Regulation, and F30produce an assessment report and conclusions of its evaluation.

Prior to F34producing its conclusions F35... the F36... competent authority shall give the participant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The F36... competent authority shall take due account of those comments when finalising its evaluation.

This Article is applicable to applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019 for the entries 79, 85, 113, 171, 187, 188, 321, 345, 346, 458, 531, 554, 571, 599, 609, 1045, 1046 and 1047 of Annex II.

The evaluating competent authority of a Member State having replaced the competent authority of the United Kingdom in relation to an application that has been submitted before 30 March 2019 , shall inform the participant of the fees payable under Article 80(2) of Regulation (EU) No 528/2012 at the latest by 30 April 2019 , and shall reject the application if the participant fails to pay the fees within a period of time fixed by the evaluating competent authority. It shall inform the participant and the Agency accordingly.

This Article shall apply where the competent authority has produced an assessment report pursuant to Article 6(2) and, where relevant, a proposal or a consultation pursuant to Article 6(7).

The competent authority shall within 270 days of completion of the assessment report, prepare and submit an opinion to the Secretary of State and the Devolved Authorities on the approval of the substance/product-type combination or its inclusion in F50categories A or B of the Simplified Active Substance list or both.

The competent authority shall start the preparation of the opinion within 90 days of the completion of the assessment report and evaluation conclusions.

When preparing its opinion pursuant to Article 7(2), F51the competent authority shall examine whether the active substance fulfils any of the criteria listed in Article 10(1) of Regulation (EU) No 528/2012 and address the matter in its opinion.

Prior to submitting its opinion to F52the Secretary of State, F51the competent authority shall make publicly available, without prejudice to Articles 66 and 67 of Regulation (EU) No 528/2012, 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. F51The competent authority shall take due account of the information received when finalising its opinion.

Where the active substance is approved and fulfils one of the criteria laid down in Article 10(1) of Regulation (EU) No 528/2012, it shall be identified as a candidate for substitution in the F53decision made pursuant to Article 89(5) of that Regulation.

The role of participant may be taken over or shared by mutual agreement between an existing participant and a prospective participant, provided that the prospective participant has the right to refer to all the data submitted or referred to by the existing participant.

A notification for the purpose of this Article shall be submitted jointly to the F59competent authority by the prospective and the existing participant through F60the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 F61..., and shall include all relevant letters of access.

Upon receipt of a notification complying with paragraph 2, the F59competent authority shall update F62its records with respect to the identity of the participant.

A person established in the F63United Kingdom having taken over or joined the role of participant pursuant to this Article shall be considered as having submitted a dossier or a letter of access to a dossier for the purpose of Article 95 of Regulation (EU) No 528/2012.

A withdrawal shall be considered as timely unless it occurs after the date when the F68... competent authority submits its competent authority report to the applicant pursuant to Article 6(4) of this Regulation.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Where a timely withdrawal is known to F70the competent authority, it shall update F71its records with respect to the identity of the participant.

Where all participants supporting the same substance/product-type combination have made a timely withdrawal from the review programme, and where the role of participant for that combination has previously been taken over, F70the competent authority shall inform the F72Secretary of State and the Devolved Authorities F73...

Where the evaluation of an existing active substance does not allow for conclusions to be drawn relating to the substance as identified in Annex II, the F74... competent authority shall, after consultation with the participant concerned, establish a new substance identity. F75...

The F76competent authority shall update F77its records with respect to the identity of the substance.

Within 12 months from the date of the publication referred to in paragraph 1, any person may submit a notification for the combination pursuant to Article 17.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 by any person with an interest to notify a substance/product-type combination to the competent authority at the latest 12 months after the publication of the decision or guidance referred to in point (a) or (aa) of Article 15.

A declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) F87or (aa) of Article 15, the declaration shall provide a substantiated justification showing that all the conditions listed therein are fulfilled.

Where a declaration has been made in a case referred to in point (a) F88or (aa) of Article 15, and the F89competent authority finds, that paragraph 6 is not applicable, and, where relevant, that the conditions for notification listed in point (a) F90or (aa) of Article 15 are fulfilled, F91it shall update its records accordingly.

Where F92the competent authority determines that a declaration made under paragraph 3 is valid, the competent authority shall make that information publicly available by electronic means, mentioning the relevant substance/product-type combination. For the purposes of this Regulation, a publication made pursuant to the third subparagraph of Article 3a(3) of Regulation (EC) No 1451/2007 shall be considered as a publication made pursuant to this paragraph.

Within 6 months from the date of a publication referred to in paragraph 4, any person with an interest to notify the substance/product-type combination may do so pursuant to Article 17.

Notifications pursuant to Article 14(2) or Article 16(5) shall be made to the competent authority.

The notification shall be submitted F96in accordance with the format specified under Article 79 of Regulation 528/2012. It shall contain the information referred to in Annex I.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Upon receipt of a notification, the competent authority shall inform the notifier of the fee payable. If the notifier fails to pay the appropriate fee within 30 days from the receipt of that information, the competent authority shall reject the notification and inform the notifier.

Upon receipt of payment of the fees, the F99competent authority shall verify within 30 days whether the notification complies with the requirements of paragraph 2. If the notification does not comply with those requirements, the F99competent authority shall grant the notifier a period of 30 days in which to complete or correct the notification. After the expiry of that 30-day period, the F99competent authority shall, within 30 days, either declare that the notification complies with the requirements of paragraph 2 or reject the notificationF100...

An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the F99competent authority taken pursuant to F101... paragraph 5.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 F121Article 89(8) of that Regulation.

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.

Taking account of the comments received, the Secretary of State or a Devolved Authority may exercise a derogation from F122... 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.

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).

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).

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.

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.

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).

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.

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 F125assimilated law.

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.

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.

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

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.

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.

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.

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.

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.

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).