Basic notification
1. Any producer wishing to secure the inclusion of an active substance referred to in Annex I to this Regulation, in Annex I to the Directive shall so notify to the body referred to in Annex V. The Commission will regularly follow up the tasks mentioned in Annex V entrusted to the body designated in that Annex. In accordance with the procedure laid down in Article 19 of the Directive it may be decided to designate another body where it would appear that the tasks are not adequately performed.
2. Notification must be submitted for each active substance separately within three months of the date of entry into force of this Regulation in accordance with the model notification as shown in part 1 of Annex III hereto including a written commitment to present a dossier.
3. Any producer who has not notified any given active substance referred to in paragraph 1 within the deadline referred to in paragraph 2 or whose notification was rejected in accordance with the provisions of Article 6 will be permitted to participate in the review programme only collectively with one or more notifiers of the active substance (including a Member State which has notified in accordance with Article 6(2)), whose notification was accepted in accordance with Article 6, in submitting a joint dossier.
Full notification
1. Any producer wishing to secure the inclusion of an active substance referred to in Annex II to this Regulation, in Annex I to the Directive shall so notify to the body designated in Annex V.
2. Notification must be submitted for each active substance separately, as follows:
(a) within three months of the date of entry into force of this Regulation, a first notification, in accordance with the model notification as shown in Annex III, part 1 hereto, and
(b) within six months of the date of entry into force of this Regulation, a second notification, in accordance with the model notification as shown in Annex III, part 2 hereto, including a written commitment to present a complete dossier.
3. Any producer who has not notified any given active substance referred to in paragraph 1 within the deadline referred to in paragraph 2 or whose notification was rejected in accordance with the provisions of Article 6 will be permitted to participate in the review programme only collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with Article 6(2), whose notification was accepted in accordance with Article 6, in submitting a joint dossier.
Examination of basic notifications and full notifications
1. The Commission shall, within two months after the deadline referred to in Article 4(2) and Article 5(2)(a), inform the Committee on the notifications submitted before the deadline.
2. For any active substance for which no producer has submitted a notification, a Member State may declare its interest in securing the inclusion of that active substance in Annex I to the Directive by notifying the body designated in Annex V in accordance with Article 4 or 5. Such notifications must be submitted as soon as possible, and no later than three months after the Commission has informed the Member States that no notification was submitted for that substance. A Member State submitting a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.
3. The Commission shall, at the latest six months after the deadlines referred to in Article 4(2) and Article 5(2), inform the Committee on the admissibility of the notifications received taking into account the criteria referred to in Annex IV, parts 1 and 2.
4. Detailed provisions concerning the submission of dossiers, the deadline(s) for their submission and the fee regime for the active substances for which an admissible notification was received shall be established by the Commission in a Regulation to be adopted in accordance with the second subparagraph of Article 8(2) of the Directive.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of the Directive, not to include in Annex I to the Directive active substances referred to in Annex I or II to this Regulation for which no admissible notification has been submitted within the established time limit. The decision shall state the reasons for the non-inclusion. Member States shall withdraw authorisations of plant protection products containing these active substances within the period prescribed in the Decision.
CHAPTER 3
FEES
