Paragraph 11 Ongoing EFSA assessments under Article 12 of Regulation (EC) No 396/2005I1

This paragraph applies where—

A competent authority may produce a reasoned opinion within a period of 36 months beginning with F2the day after the day on which IP completion day falls in respect of that active substance in relation to its constituent territory, except where sub-paragraph (3) applies.

Where at the end of the 36 month period described in sub-paragraph (2) there are outstanding renewals of authorisations under Article 43 of Regulation (EC) No 1107/2009 relating to that active substance in relation to its constituent territory, a competent authority may instead produce a reasoned opinion before the end of the period of 6 months beginning with the date on which the last of those outstanding renewals is concluded.

Articles 12(3) to (6) and 14 of Regulation (EC) No 396/2005 apply to a reasoned opinion under sub-paragraph (2) as they apply to a reasoned opinion under Article 12(1) of that Regulation.

In providing a reasoned opinion under sub-paragraph (2), the competent authority may also consider relevant information provided by an interested person, including (but not limited to)—

In sub-paragraph (5), “interested person” includes manufacturers, growers, importers and producers of products listed in a list in Part 1 of the MRLs register in relation to the competent authority's constituent territory.

In this Article, “Regulation (EC) No 1107/2009” means Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market.