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||Duties of 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
or under Articles 17
, 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.
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.
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
(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
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.
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
5. An appeal may be brought, in accordance with Articles 91
, 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