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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-VI: EVALUATION
CHAPTER-4: Common provisions
| 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.
2. If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. The Agency shall inform the competent authority of the Member State in which the registrant or downstream user is located.
3. The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, shall inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. The Agency shall inform the competent authority of the Member State in which the registrant or downstream user is located.
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;
(b) where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.
- Referred by:
- ARTICLE 40: Examination of testing proposals
- ARTICLE 41: Compliance check of registrations
- ARTICLE 46: Requests for further information and check of information submitted