By way of derogation from paragraph 3, where the basic act concerns the protection of the health or safety of humans, animals or plants and the draft implementing act for which the basic act provides involves proposing to grant authorisation for a product or substance, in the absence of a positive opinion voted by the majority provided for in Article 5(1), the Commission shall not adopt that draft implementing act and the authorisation shall be deemed to have been refused.”
Če temeljni akt zadeva varovanje zdravja ali varnost ljudi, živali ali rastlin in osnutek izvedbenega akta, ki ga ta temeljni akt predvideva, vključuje predlog odobritve proizvoda ali snovi, Komisija z odstopanjem od odstavka 3 ne sprejme osnutka izvedbenega akta, če večina iz člena 5(1) ni izglasovala pozitivnega mnenja, pri čemer se šteje, da je bila odobritev zavrnjena.“