1.   A person or a Member State considering that a biocidal product being placed on the market and containing only existing active substances is covered by Directive 98/8/EC and falls under one or more product-types for which Article 4 prohibits the placing on the market may submit a request to the Commission to allow the notification of the active substances contained in that product for the relevant product-types.

The request shall indicate the relevant active substance/product-type combinations, and a justification for the failure to submit a notification in accordance with Article 4(1) of Regulation (EC) No 1896/2000, or to indicate an interest in accordance with Article 5(3) of that Regulation, or to take over the role of participant in accordance with Article 12 of this Regulation, or to submit a complete dossier in accordance with Article 9(1) of this Regulation.

2.   Upon receipt of a request in accordance with paragraph 1, the Commission shall consult Member States on whether the request is acceptable.

The request shall be acceptable if the biocidal product is covered by Directive 98/8/EC and falls under one or more product-types for which Article 4 of this Regulation prohibits the placing on the market and, prior to submitting that request, the applicant held an objectively justified belief, induced by guidance published or written advice given by the Commission or by a competent authority designated in accordance with Article 26 of Directive 98/8/EC, that the product was excluded from the scope of Directive 98/8/EC or that it fell under a different product-type.

However, the request shall not be acceptable if the active substance/product-type combination concerned has already been the subject of a decision not to include it in Annex I or IA to Directive 98/8/EC based on an assessment report reviewed by the Standing Committee on Biocidal Products in accordance with Article 15(4) of this Regulation.

3.   Where, following a consultation in accordance with paragraph 2, the Commission finds the request acceptable, it shall accept it and allow the notification of the active substance for the relevant product-types.

However, where the dossier submitted to the Rapporteur Member State for the relevant active substance already contains all the data required for the evaluation of the relevant product-types for which Article 4 prohibits the placing on the market, and the participant which has submitted that dossier wishes to be considered as having notified the active substance for those product-types, the Rapporteur Member State shall inform the Commission thereof, and no additional notification shall be allowed pursuant to the first subparagraph.

The Commission shall inform the Member States thereof and publish that information electronically.

4.   A person intending to notify the active substance/product-type combination included in the electronic publication referred to in the third subparagraph of paragraph 3 shall declare that intention to the Commission no later than three months from the date of that electronic publication.’;

1.   Following the declaration of intention to notify, the person referred to in Article 3a(4) shall submit a notification of the active substance/product-type combination to the European Chemicals Agency established by Regulation (EC) No 1907/2006 (hereinafter referred to as the ‘Agency’) no later than 18 months from the date of the electronic publication referred to in the third subparagraph of Article 3a(3).

The notification shall be made through the Register for Biocidal Products referred to in Article 71 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (*1).

2.   The notification shall be submitted in IUCLID format. It shall contain all the information referred to in points 1 to 3 and the table in Annex II to Regulation (EC) No 1896/2000, and proof that the substance was on the market as an active substance of a biocidal product falling under the relevant product-type on the date of the electronic publication referred to in the third subparagraph of Article 3a(3).

3.   Unless a Rapporteur Member State has already been designated for the active substance in question, the notifier shall indicate to which competent authority of a Member State it intends to submit a dossier, 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 the Regulation adopted pursuant to Article 80(1) of Regulation (EU) No 528/2012. 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 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 thereof.

6.   Appeals against decisions of the Agency taken pursuant to paragraph 4 or paragraph 5 shall lie with the Board of Appeal established by Regulation (EC) No 1907/2006. Article 92(1) and (2), and Articles 93 and 94 of Regulation (EC) No 1907/2006 shall apply to such appeal procedures. An appeal shall have suspensive effect.

7.   The Agency shall without delay inform the Commission of whether the notification complies with the requirements of paragraph 2 or has been rejected.

1.   Where an active substance is considered notified in accordance with the second subparagraph of Article 3a(3), or where the Agency informs the Commission in accordance with Article 3b(7) that a notification complies with the requirements of Article 3b(2), the Commission shall accept the notification and:

2.   Where a declaration of intention to notify has not been received within the deadline referred to in Article 3a(4), where a notification has not been received within the deadline referred to in Article 3b(1), or where the Agency informs the Commission in accordance with Article 3b(7) that a notification submitted in accordance with Article 3b(1) has been rejected, the Commission shall inform the Member States thereof and publish that information electronically.’;