ECHA now require notified NONs NONs Dossiers Upgrade Required for REACHDossiers to be upgraded to allow for dissemination through the ECHA website.
ECHA is now going to be making the NONs dossiers publically available on the ECHA CHEM portal. This means that any missing information, incorrect information or potentially unclaimed confidential sections of your NONs dossier will be published as is unless you, the registrant, take steps to update your dossier.
Currently these NONs dossiers (dossiers of substances notified under Directive 67/548/EEC, Notification of New Substances) are not available on the ECHA website of registered substances.
As NONs notifications were originally submitted in a format different from that of the current IUCLID format, the migration tool could not perform a seamless transition to a REACH complaint registration dossier. Therefore there are sections that are missing information, e.g. section 3.5 on identified uses and other that are deficient, e.g. endpoint study records, confidentiality claims etc.
Under REACH, NONs dossiers are considered to be registered (if claimed by the notification’s owner) and do not need to be fully modified unless a tonnage band update is needed. In the case of a tonnage band update, the new dossier must fully comply with all REACH requirements for that tonnage band. For other updates, only selected information needs to be updated, e.g. classification and labelling (IUCLID section 2.1) per the CLP regulations. Therefore many sections of your NONs dossiers are still in a non-REACH format but yet are still considered valid registrations.
ECHA is now making the NON’s dossiers publically available on the ECHA CHEM portal so that registrants can update them to the new REACH format. ECHA is performing the dissemination in a stepwise approach, to give NONS registrants the required time to adapt the different parts of their dossier to the REACH format.
As NONS registrants who have claimed their notification, you may have already been contacted by ECHA via REACH-IT with specific advice on the method and timing for potential registration updates in response to the second and third dissemination steps. ECHA urges all NONS registrants to act promptly on the advice received.
What Are My Obligations Now?
Updating of confidentiality claims and identification/composition sections will be required, inclusion of section 2.1 CLP (if not already done) and section 3.5 identified uses, as well as verifying the information in section 11- guidance on safe use will be necessary. The endpoint study records will also be out of date (not passing the technical completeness check) and updating to a TCC passable RSS should be considered.
Finally “safety data sheet information” will now be disseminated for all registration dossiers including NONs dossier unless claimed as confidential. This includes the registration number and company names. A full review of the sections to be disseminated verses the current information in your NONs dossier is strongly advised.
How can H2 Help you and your Company?
H2 Compliance can help you in determining your NONs dossier requirements as well as preparing the updated dossiers in IUCLID on your behalf. Please feel free to contact us if you have any questions by filling in a query form for a free 30min, no obligation consultation, calling us directly (021-486 8120) or by direct email (firstname.lastname@example.org)
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Link to the press release: Click here…