Data requirements for safeners and synergists
Article 11
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 ( 5 ) , 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 ( 6 ) ; (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.