Če se država članica v roku iz člena 32(4) ne more strinjati s poročilom o oceni, povzetkom glavnih značilnosti, označevanjem in navodilom za uporabo zaradi potencialnega resnega tveganja za zdravje ljudi ali živali ali za okolje, predloži referenčni državi članici, drugim državam članicam in predlagatelju podrobno navedbo razlogov.
If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant.