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Regulatory
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Trace One
Article 45
According to article 45 of CLP Regulation, importers and downstream users who place hazardous mixtures in the market should submit relevant information in the event of emergency health response to designated appointed bodies. The Annex VIII of the same regulation defines the content and the harmonized transmission procedure for all Member States.
However, a certain degree of flexibility is left to individual countries regarding the communication channels of notification in the case of mixtures for industrial use only. Some Member States, including Italy, have in fact declared that as an alternative to the use of the ECHA portal and until the compliance date for mixtures intended for industrial use (January 1st 2024) it is possible to continue to notify in accordance with Article 45 of CLP according to national provisions (i.e. notification to the Dangerous Preparations Archive – “APP” for Italy).
Dangerous Preparations Archive’s transmission procedure
Therefore, for mixtures intended for industrial use it will be possible to proceed by notified to the Dangerous Preparations Archive via single notification ("Insert new preparation") or bulk upload ("Notification transmission" or by uploading the .zip notification package generated by your Trace One solution).
From a communication of last May 15th 2021 by the Italian national appointed body “Istituto Superiore di Sanità” (ISS), it should be noted that the possibility of using the bulk upload procedure will remain in force only until December 1st 2021 and no later than. After this date, only single notifications can be sent directly from the APP website.
The deactivation of the massive upload procedure by the “Istituto Superiore di Sanità” will therefore make the related Trace One solution (ISS Wizard / IOH Module) unusable. There are currently no updates to the technical format published on the ISS website; in any case, we will share any developments in this regard.
In any case, we would like to point out the possibility of proceeding from now on with the generation and transmission of the notification in accordance with Annex VIII via the ECHA portal.
For further information, please consult the following links:
- Hazardous Preparations Archive Communication / Home page
- ECHA PCN website
- Overview of Member States decisions in relation to implementation of Annex VIII
For further details about the Trace One solution on Annex VIII, contact our Customer Service at EU-customer-service@selerant.com.
