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TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-4: Common provisions for all registrations
ARTICLE 20: Duties of the Agency
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ARTICLE 20: Duties of the Agency
1. The Agency shall assign a submission number to each registration, which is to be used for all correspondence regarding the registration until the registration is deemed to be complete, and a submission date, which shall be the date of receipt of the registration at the Agency.
2. The Agency shall undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 or under Articles 17 or 18, as well as the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2), have been provided. The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.
The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the course of the two-month period immediately preceding that deadline.
If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.
The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.
3. Once the registration is complete, the Agency shall assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date. The Agency shall without delay communicate the registration number and registration date to the registrant concerned. The registration number shall be used for all subsequent correspondence regarding registration.
4. The Agency shall notify the competent authority of the relevant Member State within 30 days of the submission date, that the following information is available in the Agency database:
(a) the registration dossier together with the submission or registration number;
(b) the submission or registration date;
(c) the result of the completeness check; and
(d) any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.
The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established.
If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established. The other Member States where the production sites are established shall also be notified.
The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by the registrant is available on the Agency database.
5. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 2 of this Article.
6. Where additional information for a particular substance is submitted to the Agency by a new registrant, the Agency shall notify the existing registrants that this information is available on the database for the purposes of Article 22.
Referred by:
ARTICLE 7: Registration and notification of substances in articles
ARTICLE 9: Exemption from the general obligation to register for product and process orientated research and development (PPORD)
ARTICLE 21: Manufacturing and import of substances
ARTICLE 22: Further duties of registrants
ARTICLE 32: Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required
ARTICLE 38: Obligation for downstream users to report information
ARTICLE 91: Decisions subject to appeal
ARTICLE II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS