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 a substance, substantive reasons for those votes should be given by each Member State representative.
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, bi moral vsak predstavnik države članice podati utemeljitev za svoj glas.