1.   An application for approval or inclusion in Annex I to Regulation (EU) No 528/2012 may be submitted only by a participant whose notification has been found compliant by the Agency pursuant to Article 17(5) of this Regulation.

Where the application concerns inclusion in Annex I to Regulation (EU) No 528/2012, it may only concern category 1, 2, 3, 4, 5 or 6 of that Annex.

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

1.   The Agency shall inform the participant of the fees payable under Commission Implementing Regulation (EU) No 564/2013 (7) and shall reject the application if the participant fails to pay the fees within 30 days. It shall inform the participant and the evaluating competent authority accordingly.

2.   Upon receipt of the fees payable under Implementing Regulation (EU) No 564/2013, the Agency shall accept the application and inform the participant and the evaluating competent authority accordingly, indicating the date of the acceptance of the application and its unique identification code.

3.   An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the Agency taken pursuant to paragraph 1 of this Article.

4.   The evaluating competent authority shall inform the participant of the fees payable under Article 80(2) of Regulation (EU) No 528/2012 within 30 days after the Agency has accepted the application, and shall reject the application if the participant fails to pay the fees within 30 days. It shall inform the participant and the Agency accordingly.

1.   Where an application for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012 containing the data required in accordance with Article 6(1) and (2) thereof has been accepted by the Agency pursuant to Article 4(2) and the fee has been paid pursuant to Article 4(4) the evaluating competent authority shall validate the application within 30 days of the payment of the fees.

2.   Where the evaluating competent authority has received from the participant the dossier pursuant to Regulation (EC) No 1451/2007 but not yet accepted the dossier as complete pursuant to Article 13 thereof, the evaluating competent authority shall validate the application at the latest 3 January 2015.

3.   In the cases referred to in paragraphs 1 and 2, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

4.   Where the evaluating 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 evaluating 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 2.

The evaluating competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant and the Agency accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) of Regulation (EU) No 528/2012 shall be reimbursed.

On validating an application, the evaluating competent authority shall without delay inform the participant, the Agency and other competent authorities accordingly, indicating the date of the validation.

1.   This Article shall apply where any of the following conditions applies:

2.   The evaluating 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 send an assessment report and the conclusions of its evaluation to the Agency.

3.   Where several participants support the same substance/product-type combination, the evaluating competent authority shall draft only one assessment report. The assessment report and the conclusions shall be sent within either of the following time-limits, whichever is the later:

4.   Prior to submitting its conclusions to the Agency, the evaluating 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 evaluating competent authority shall take due account of those comments when finalising its evaluation.

5.   Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the participant to submit such information within a specified time limit, and shall inform the Agency accordingly.

The 365-day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the date the information is received. Unless it is justified by the nature of the data requested or by exceptional circumstances, the suspension shall not exceed the following time-limits:

6.   Where the evaluating competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (8) and include this as part of its conclusions.

7.   Upon finalisation of its hazard evaluation, the evaluating competent authority shall without undue delay and no later than at the time of submission of the assessment report pursuant to paragraph 3, as appropriate:

1.   This Article shall apply where either of the following conditions applies:

2.   Upon acceptance of the report, the Agency shall prepare and submit to the Commission an opinion on the approval of the substance/product-type combination or its inclusion in category 1, 2, 3, 4, 5 or 6 of Annex I to Regulation (EU) No 528/2012, or both, having regard to the conclusions of the evaluating competent authority.

The Agency shall start the preparation of the opinion within either of the following deadlines, whichever is the later:

The Agency shall submit the opinion to the Commission within 270 days of the start of the preparation.

1.   When preparing its opinion pursuant to Article 7(2), the Agency 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.

2.   Prior to submitting its opinion to the Commission, the Agency 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. The Agency shall take due account of the information received when finalising its opinion.

3.   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 Regulation adopted pursuant to the first subparagraph of Article 89(1) of that Regulation.

1.   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.

2.   A notification for the purpose of this Article shall be submitted jointly to the Agency by the prospective and the existing participant through the Register for Biocidal Products referred to in Article 71 of Regulation (EU) No 528/2012 (hereinafter ‘the Register’), and shall include all relevant letters of access.

3.   Upon receipt of a notification complying with paragraph 2, the Agency shall update the information in the Register with respect to the identity of the participant.

4.   A person established in the Union 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.

1.   A participant shall be considered to have withdrawn its support for a substance/product-type combination in the review programme in the following cases:

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

1.   Where a timely withdrawal is known to the evaluating competent authority but not to the Agency, the evaluating competent authority shall without undue delay inform the Agency thereof through the Register.

2.   Where a timely withdrawal is known to the Agency, it shall update the information in the Register with respect to the identity of the participant.

3.   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, the Agency shall inform the Commission thereof through the Register.

1.   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 evaluating competent authority shall, after consultation with the participant concerned, establish a new substance identity. The evaluating competent authority shall inform the Agency thereof.

2.   The Agency shall update the information in the Register with respect to the identity of the substance.

1.   The Agency shall publish an open invitation to take over the role of participant for a substance/product-type combination where one of the following cases applies:

2.   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.

3.   Within 12 months from the date of entry into force of this Regulation, any person may notify a substance/product-type combination included in part 2 of Annex II pursuant to Article 17.

1.   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 Register by any person with an interest to notify a substance/product-type combination to one of the following recipients:

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

3.   Where a declaration has been made in a case referred to in point (a) or (c) of Article 15, and the Commission finds, in consultation with the Member States, that paragraph 6 is not applicable, and, where relevant, that the conditions for notification listed in point (a) of Article 15 are fulfilled, it shall inform the Agency thereof.

4.   Where a declaration has been made in the case referred to in point (b) of Article 15, or where the Commission has informed the Agency pursuant to paragraph 3, the Agency 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.

5.   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.

6.   In cases referred to in points (a) and (c) of Article 15, a substance/product-type combination shall be considered as notified by a participant, and shall not be eligible for additional notification where the following conditions apply:

1.   Notifications pursuant to Article 14(2) and (3) or Article 16(5) shall be made to the Agency through the Register.

2.   The notification shall be submitted in IUCLID format. It shall contain the information referred to in Annex I.

3.   Where no evaluating competent authority is indicated in Annex II for the active substance in question, the notifier shall inform the Agency of the name of its choice of competent authority designated in accordance with Article 81 of Regulation (EU) No 528/2012, and provide written confirmation that that competent authority agrees to evaluate the dossier.

4.   Upon receipt of a notification, the Agency shall inform the Commission thereof, and inform the notifier of the fees payable under Regulation (EU) No 564/2013. If the notifier fails to pay the fee within 30 days from the receipt of that information, the Agency shall reject the notification and inform the notifier and the Commission thereof.

5.   Upon receipt of payment of the fees, the Agency 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 Agency 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 Agency shall, within 30 days, either declare that the notification complies with the requirements of paragraph 2 or reject the notification, and inform the notifier and the Commission thereof.

6.   An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the Agency taken pursuant to paragraph 4 or paragraph 5.

7.   Where a notification has been found compliant pursuant to paragraph 5, the Agency shall without delay:

1.   A Member State may continue to apply its 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 points (b) and (c) of Article 15. In such cases:

2.   A Member State may continue to apply its 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 point (a) of Article 15. In such cases:

3.   A Member State may continue to apply its 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 the Agency has made a publication pursuant to Article 16(4) for the relevant product-type. In such cases:

1.   Without prejudice to Article 55(1) of Regulation (EU) No 528/2012, within 18 months of the date of a decision not to approve an existing active substance, where a Member State considers this existing active substance 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, that Member State may submit a reasoned application to the Commission for a derogation from the second subparagraph of Article 89(2) of that Regulation.

2.   The requesting Member State shall submit the reasoned application to the Agency through the Register. Where the application contains confidential information, the requesting Member State shall at the same time submit a non-confidential version.

3.   The Agency shall make the application or, where relevant, the non-confidential version, publicly available by electronic means. Member States or any other person may submit comments within 60 days of the publication.

4.   Taking account of the comments received, the Commission may grant a derogation from the second sub-paragraph of Article 89(2) of Regulation (EU) No 528/2012 allowing biocidal products consisting of, containing or generating the substance to be made available on the market of the requesting Member State and used in that Member State in accordance with national rules and subject to the conditions in paragraph 5 and any further conditions imposed by the Commission.

5.   The Member State to which the derogation is granted shall: