Dokumendiregister | Terviseamet |
Viit | 10.1-2/24/25-1 |
Registreeritud | 27.08.2024 |
Sünkroonitud | 28.08.2024 |
Liik | Sissetulev 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 |
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 |
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