Chapter 3, Article 11 · Commission Regulation (EU) 2024/1487

Contents

Article 11Data requirements for safeners and synergists#

In addition to the data requirements set out in Article 8 of Regulation (EC) No 1107/2009, an application for the approval of a safeners or a synergist shall include:

(a)the data as required for active substances pursuant to Regulation (EU) No 283/2013, and the supplementary data listed in Annex III to this Regulation;

(b)the data as required for plant protection products pursuant to Commission Regulation (EU) No 284/2013^note, and the supplementary data listed in Annex III to this Regulation;

(c)where relevant, the identification and proposal of a residue definition for the purposes of risk assessment;

(d)where relevant, a proposal for classification in one or more hazard classes in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council^note;

(e)where relevant, a justification for any IUCLID Validation Assistant check failures;

(f)the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009;

(g)an assessment according to the current scientific and technical knowledge of all information submitted;

(h)the identification and proposal for any necessary and appropriate risk mitigation measures;

(i)all relevant information related to the notification of the studies as required in accordance with Article 32b of Regulation (EC) No 178/2002.