Dokumendiregister | Terviseamet |
Viit | 10.1-2/24/25-2 |
Registreeritud | 05.09.2024 |
Sünkroonitud | 06.09.2024 |
Liik | Väljaminev dokument |
Funktsioon | 10.1 Kemikaaliohutusega seotud toimingud |
Sari | 10.1-2 REACH ja CLP rakendamisega seotud kirjavahetus, info- ja muud dokumendid |
Toimik | 10.1-2/2024 |
Juurdepääsupiirang | Avalik |
Juurdepääsupiirang | |
Adressaat | Kerona Scientific Ltd. |
Saabumis/saatmisviis | Kerona Scientific Ltd. |
Vastutaja | Aigi Lahe (TA, Peadirektori asetäitja (1) vastutusvaldkond, Kemikaaliohutuse osakond) |
Originaal | Ava uues aknas |
From: CLP kasutajatugi
Sent: Thu, 05 Sep 2024 07:39:10 +0000
To: 'Chrysa Pateraki' <[email protected]>
Subject: Vs: PCN Notifications
Dear Dr Chrysoula Pateraki,
Thank you for your question.
Indeed, Estonian poison information centre accepts submissions via ECHA PCN portal only and we don’t confirm submission reports received. If the submission status is „Succeeded“ and ‘Dossier received by EE’ it is sufficient.
We don’t have national procedure for mixtures classified only for environmental hazards or even not classified mixtures (eg some detergents) but they can be notified on voluntary basis via ECHA portal.
We don’t have any fees for using poison information centre number in SDS or even on labelling.
https://www.terviseamet.ee/en/chemical-and-product-safety/data-for-safety-data-sheet
Regards,
Aigi Lahe
CLP Helpdesk
Department of Chemical Safety
Terviseamet +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
NB! Answers to your questions are recommendary and are not legally binding. Final decision is made by the company itself.
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Saatja: Chrysa Pateraki <[email protected]>
Saatmisaeg: teisipäev, 27. august 2024 13:05
Adressaat: CLP kasutajatugi <[email protected]>
Koopia: TA Info <[email protected]>
Teema: PCN Notifications
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 ‘ 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 LinkedIn: www.linkedin.com/company/kerona-scientific-ltd | |
The information contained in this e-mail and any files transmitted with it is confidential and may be subject to legal professional privilege. It is intended solely for the use of the addressee(s). If you are not the intended recipient of this e-mail, please note that any review, dissemination, disclosure, alteration, printing, copying or transmission of this e-mail and/or any file transmitted with it, is prohibited and may be unlawful. If you have received this e-mail by mistake, please promptly inform the sender by reply e-mail and delete the material. Whilst this e-mail message has been swept for the presence of computer viruses, Kerona Scientific Ltd does not, except as required by law, represent, warrant and/or guarantee that the integrity of this communication has been maintained nor that the communication is free of errors, viruses, interception or interference. |
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