Joining or replacing participants by mutual agreement
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.
Participants' withdrawal
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 A participant shall be considered to have withdrawn its support for a substance/product-type combination in the review programme in the following cases:
(a)
where it has informed the Agency or the evaluating competent authority through the Register of its intention to withdraw;
(b)
where it has failed to submit an application within the time limits specified in Article 3(2);
(c)
where its application has been rejected pursuant to Article 4(1), Article 4(4) or Article 5(4);
(d)
where it has failed to provide the additional information within the time limits provided for by Article 6(5);
(e)
where it has otherwise failed to pay the fees payable to the evaluating competent authority or the Agency.
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.
Consequences of a timely withdrawal
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.
Redefinition of active substances
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.
Taking over the role of participant
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:
(a)
where all participants supporting the same substance/product-type combination have made a timely withdrawal pursuant to Article 11, and the role of participant for that combination has not previously been taken over;
(b)
following a redefinition pursuant to Article 13, in which case, the invitation shall only concern any substance covered by the existing identity in Annex II, but not by the new substance identity.
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.
Substance/product-type combinations eligible for inclusion in the review programme
Where a biocidal product covered by the scope of Regulation (EU) No 528/2012 and being placed on the market consists of, contains or generates an existing active substance which is neither approved, nor included in the review programme, for the product-type, and is not included in Annex I to that Regulation, that substance shall be eligible for inclusion in the review programme for the relevant product-type on any of the following grounds:
(a)
the person placing the product on the market has relied on guidance published by, or written advice received from, the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or Article 81 of Regulation (EU) No 528/2012, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Commission;
(b)
the substance has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007;
(c)
the biocidal product belongs under Regulation (EU) No 528/2012 to a different product-type than the one it belonged to under Directive 98/8/EC, as a result of a modification of scope of those product-types, and contains a substance included in the review programme for the original product-type but not for the new one.
Declaration of interest to notify
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:
(a)
to the Commission at the latest 12 months after the publication of the decision or guidance referred to in point (a) of Article 15;
(b)
to the Agency at the latest 30 October 2015 in cases referred to in point (b) of Article 15;
(c)
to the Commission at the latest 30 October 2015 in cases referred to in point (c) of Article 15.
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:
(a)
the relevant active substance is already included in the review programme;
(b)
one of the dossiers submitted to the evaluating Member State for the relevant active substance already contains all the data required for the evaluation of the product-type;
(c)
the participant which has submitted that dossier indicates an interest to support the substance/product-type combination.
Notification procedure
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:
(a)
where the notification has been submitted pursuant to Article 14(2) or (3), update the information in the Register with respect to the identity of the participant and, where relevant, of the substance;
(b)
where the notification has been submitted pursuant to Article 16(5), inform the Commission of the compliance.
Inclusion in the review programme
Where a substance/product-type combination is considered notified in accordance with Article 16(6), or where the Agency informs the Commission of compliance in accordance with Article 17(7)(b), the Commission shall include the substance/ product-type combination in the review programme.
Information on substances no longer supported under the review programme
Where no notification has been received within the time limit referred to in Article 16(5), or where a notification referred to in that Article has been received and subsequently rejected by the Agency pursuant to Article 17(4) or (5), the Agency shall inform the Member States thereof through the Register and publish that information electronically.
Commission decisions on substances no longer supported under the review programme
The Commission shall prepare a draft non-approval decision pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012 in the following cases:
(a)
where the Agency informs the Commission of all participants' timely withdrawal pursuant to Article 12(3) of this Regulation;
(b)
where no person has submitted a notification within the time limits provided for by Article 14(2) or 14(3) of this Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or 17(5) thereof;
(c)
where a notification has been submitted within the time limits provided for by Article 14(2) or 14(3) of this Regulation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification only covers part of the existing identity in Annex II to this Regulation.
In case referred to in point (c) of first paragraph, the draft non-approval decision shall cover any substance covered by the existing identity in Annex II to this Regulation, but not by the notification or any approval decision.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
