Subject: PCN Notifications
From: "Chrysa Pateraki" <[email-masked]>
To: "CLP kasutajatugi" <[email-masked]>
Cc: "TA Info" <[email-masked]>
Date: Tue, 27 Aug 2024 13:04:31 +0300

Dear Sir/Madam,

My name is Chrysoula Pateraki and I am working as a regulatory consultant
at Kerona Scientific.

We, Kerona, as a consultancy we are often asked from our clients to submit
PCN notifications for their products on their behalf.

In most cases, we do this via our own REACH-IT account and we expand the
market area to include the countries of interest. We understand from this
document ‘
<https://poisoncentres.echa.europa.eu/documents/1789887/5674408/msd_en.pdf
/982d9115-58cb-75c8-80ae-8eb16f5c0009> Overview of Member States decisions
in relation to implementation of Annex VIII to CLP Regulation (Poison
Centre Notification) that Estonia accepts notifications for mixtures
classified as hazardous to health or with physical and chemical hazards
via the ECHA submission portal.

Could I please ask what is considered as confirmation in the submission
report that the dossier has been received? For example, we can see the
submission status as ‘Succeeded’ on the ECHA Submission portal and in the
‘Submission events’ it says ‘Dossier received by EE’. Is this sufficient
to serve as confirmation that the submission report has been received by
Estonia?

Additionally, could I also please ask if there is also a national
procedure we must follow and if we must also notify mixtures hazardous to
the environment perhaps via a national procedure? We are aware that
Article 45 does not make a PCN for mixtures hazardous to the environment
mandatory but some Member States may follow a different procedure via the
National route.

Could we also please ask if there are any fees involved for using the
emergency number of the poison centre on the SDS?

Thank you very much in advance for your help.

Kind regards,

Dr Chrysoula Pateraki

Regulatory Consultant

Kerona Scientific Ltd.

14 Thomas Hand Street

Skerries, Co Dublin, K34 A375

Ireland

Tel: +353 1 849 5284

E:  <mailto:[email-masked]> [email-masked]

W:  <http://www.kerona.ie/> www.kerona.ie

LinkedIn:  <http://www.linkedin.com/company/kerona-scientific-ltd>
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