Portal de notificação dos centros antiveneno
The ECHA Submission portal is an online tool that supports both industry and authority users in fulfilling their obligations related to the notification of hazardous mixtures as required under Article 45 of the CLP Regulation.
The portal allows industry to prepare and submit poison centre notification (PCN) dossiers containing information on hazardous mixtures to appointed bodies. It is also a secure dispatch system by making the information available to appointed bodies for use by poison centres.
To prepare and submit information, you need a valid ECHA Account. With the account, you can do the following:
- Access the ECHA Submission portal: Select the user role ‘REACH Manager’ for full access to the service, or ‘REACH Reader’ for read-only access.
- Access IUCLID Cloud: Select the user role ‘IUCLID Full Access’ for full access to the service, or ‘IUCLID Read Only’ for read-only access.
For an overview on how to sign up for access, see Poison centre notifications: Guide to dossier preparation and submission.
For more information on how to manage an ECHA Account, see the ECHA Accounts manual.
A dossier can be prepared in a number of ways. Which is the most suitable will depend on your specific business needs and your IT systems.
- Online in the ECHA Submission portal: The portal features IUCLID Cloud, an online tool to guide you through the preparation of a dossier, allowing you to enter data manually through a series of step-by-step tasks and to store the information in the ECHA Cloud.
- Offline in IUCLID 6: In IUCLID 6, you can enter data manually using a specific poison centres notification interface. This option is available for companies using local installations of IUCLID. The desktop and server versions of the software can be downloaded from the IUCLID 6 website.
- Using the PCN format in your company’s own system: Under system preparation, a company can prepare and create a PCN dossier directly in their own systems, using the IUCLID-compatible PCN format. For more information on the format and the accompanying practical and technical documentation, see the Poison Centre Notification format pages on ECHA’s Poison Centres website.
A dossier can be submitted through the ECHA Submission portal in one of two ways:
- Online through the ECHA Submission portal: A dossier sent directly through ECHA’s Submission portal is made available to all Member States indicated in the notification. This means that a single submission can reach several Member States.
- Through a system-to-system (S2S) transfer from the company’s own system to the ECHA Submission portal: An automatic S2S transfer allows companies that have created PCN dossiers in their own systems to make their submission through the ECHA Submission portal. Dossiers are then forwarded from the portal to all the relevant Member States. The S2S functionality will be made available in the second half of 2019.
Note: Dossiers can be sent directly to a Member State through the submission systems maintained by the nationally appointed body. For further information, contact the appointed body or national CLP helpdesk of the relevant Member State.
According to Annex VIII to the CLP Regulation, submissions have to be made in the official languages of the Member States where the mixture is placed on the market, unless the Member State has specified otherwise.
The list of accepted languages for each Member State can be found in the Overview of Member States’ requirements for language(s) of notifications.
In your PCN dossier, indicate all the relevant languages. Free text fields will become available for the languages specified, for:
- toxicological information; and
- some classification and labelling information, e.g. affected organs.
For more information on how to prepare a dossier in multiple languages, see Poison centre notifications: Guide to dossier preparation and submission.
While the preparation of dossiers is fully harmonised based on PCN format, the process of submission is subject to implementation at the level of each Member State. The ECHA submission portal facilitates the submission process, however further modalities such as fees, acceptance criteria and acceptance timelines are at the discretion of each Member State.
For more details, see the Overview of Member States’ decisions in relation to implementation of Annex VIII to the CLP Regulation.
For more information, contact the appointed body or national CLP helpdesk of the relevant Member State.