Database of dangerous preparations and European Portal (PCNP)
ISS is the appointed body responsible for receiving information, including chemical composition, relating to certain hazardous mixtures placed on the Italian market (i.e. that are classified as hazardous on the basis of their health or physical effects).
This information is to be used by the Poison Centres (PCs) only to respond to requests of a health nature in view of preventative and curative measures in particular in the event of an emergency health response.
The same information can also be used by appointed bodies to perform activities of toxicovigilance.
In order to collect this information the Dangerous Preparations Archive (Archivio Preparati Pericolosi-APP) has been created at ISS.
Who is required to submit information?
According to Article 45 and Annex VIII to the CLP, importers and downstream users placing certain hazardous mixtures on the market are responsible for the submission of the information to appointed bodies.
In Italy there is also the obligation to notify for all types of detergents, even non-hazardous ones.
Downstream user means any natural or legal person established in the EU who uses a substance alone or, in mixture, in his industrial or professional activity. Manufacturers, importers, distributors and consumers are not covered by this definition. However, distributors must also ensure that the designated body of the Member State, in which the product is intended to be placed on the market, receives the notification information from the supplier and that these are correct.
Harmonization of the notification format
Article 45 of the CLP regulation gave the Commission the obligation to carry out a review to assess the possibility of harmonizing the information.
Following this review, Commission Regulation (EU) 2017/542 was adopted which adds a new Annex VIII to CLP, which entered into force on 12 April 2017, which harmonises the format for transmitting information on hazardous mixtures at Community level.
In addition, a supplementary identification system for mixtures has been introduced consisting of a unique 16-character alphanumeric code, to be printed or affixed to a product label. This code, called UFI, unambiguously links the information transmitted on a mixture (and therefore the information useful for the treatment of patients) to a specific product placed on the market.
Annex VIII also provides that the European Chemicals Agency (ECHA) facilitates the transmission of information. To this end, ECHA has made available a centralized portal (ECHA submission portal) for notifying PCs.
According to art. 1 of the Decree of 28 December 2020, amending paragraph 3 of Part A of Annex XI, of the Legislative Decree of 14 March 2003, no. 65, Italy adopted the notification in the new format through the centralized portal both for mixtures classified as dangerous and for detergents (including non-dangerous ones).
Consultation of notification dossier
ISS has implemented a system that allows to receive notifications submitted by companies to the ECHA submission portal in real time. Access to this information is allowed only to authorized personnel of the Italian PCs identified in accordance with the provisions of the State-Regions Agreement of 28 February 2008 (Rep. Acts no.56 / CSR) and only to respond to health requests in view of preventive and curative measures and, in particular, in emergencies.
The PCs access both the notifications present in the APP and those notified to the ECHA Submission portal through a specially implemented interface.
The Inspectors of the Authority for REACH and CLP controls can only access to check the date of any notification of a mixture but cannot access information on the composition.
The CNSC also provides technical, administrative, IT and scientific assistance to users who request it through its APP Helpdesk service
