Division Circumstances in which required

Further testing shall be required where significant effects are seen following laboratory testing in accordance with the requirements set out in point 8.4.2.1 of Part A of the Annex to Regulation (EU) No 283/2013 or in accordance with point 10.4.2.1 of this Annex and where risk is indicated following the relevant risk quotient analysis.

The need to perform such studies and the type and conditions of the studies to be performed shall be discussed with the F1... competent authorities.