(11)Given the concerns detailed in recital 8, the derogation provided for in Article 4(7) to Regulation (EC) No 1107/2009 does not apply. The application of that derogation is also excluded on the grounds that it has not been established that any of the criteria set out in point 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are not satisfied.