CHAPTER 3CHANGES OF ELEMENTS OF THE REVIEW PROGRAMME
Article 16Declaration of interest to notify
F11.
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.
2.
A declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) F2or (aa) 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) F3or (aa) of Article 15, and the F4competent authority finds, that paragraph 6 is not applicable, and, where relevant, that the conditions for notification listed in point (a) F5or (aa) of Article 15 are fulfilled, F6it shall update its records accordingly.
4.
Where F7the 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.
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 F8points (a) and (aa) 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 F9the competent authority 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.