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228.—(1) Article 16 is amended as follows.
(2) For paragraph 1, substitute—
“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 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.”
(3) In paragraph 2, after “referred to in point (a)” insert “or (aa)”.
(4) In paragraph 3—
(a)for “or (c)” substitute “or (aa)”;
(b)for “Commission finds, in consultation with Member States” substitute “competent authority finds”;
(c)after “listed in point (a)” insert “or (aa)”;
(d)for “it shall inform the Agency thereof” substitute “it shall update its records accordingly”.
(5) In paragraph 4, for “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” substitute “the competent authority determines that a declaration made under paragraph 3 is valid, the competent authority”.
(6) In paragraph 6—
(a)for “points (a) and (c)” substitute “points (a) and (aa)”;
(b)in point (b), for “the evaluating Member State” substitute “the competent authority”.
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