Annex VIII: what does that entail?
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 to 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 certain aspects of the harmonized submission, such as the accepted languages of the notification, any taxes or how this regulatory requirement interacts with other national regulations.
Focusing on Italy, last March 31st the Ministry of Health published the “December 28th 2020” Decree in the Official Journal, amending Annex XI of Legislative Decree 14 Marzo 2003 n. 65 and relevant to the transition to the new procedure of transmitting information related to the emergency health response.
The Decree: what’s new
The Italian national Decree focuses on the following topics:
- The transmission procedure of the harmonized information to the Italian appointed body (the CNCS-ISS) is to be carried out via PCN Portal either in Italian or in English
- For mixtures intended for industrial use and with a deadline in accordance with Annex VIII of January 1st 2024 it is still possible, as an alternative to the notification via PCN Portal, to notify to the APP (Archivio Preparati Pericolosi) until the deadline expires
- Regardless of the number of notifications, there is an annual fee of € 50
- The notification according to Annex VIII via the PCN Portal is required also for non-hazardous detergents
- It will be necessary to report the numbers of 10 national CAVs (Poison centers recognized as suitable for the processing of information relating to emergency health response) in section 1.4 of the SDS
This Decree entered into force on April 1st 2021, with the exception of the 10 CAVs in SDS requirement for which there is a transitional period of 18 months.
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