Article 50: Registrants' and downstream users' rights
1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. The Agency in turn shall inform the competent authority of the submission of the comments without delay. The competent authority (for decisions taken under Article 46) and the Agency (for decisions taken under Articles 40 and 41) shall take any comments received into account and may amend the draft decision accordingly.
4. Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:
(a)where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;