On 23 March 2017 a new Annex VIII on harmonised information relating to health emergency response was added for the first time to CLP Regulation 1272/2008.
Annex VIII creates the legal framework for the requirements for a European harmonised product notification. In the Regulation, the harmonised product notification is referred to as a notification.
The regulation is valid from 1 January 2020 and will be implemented in subsequent steps according to the use of the products:
|Consumer products||from 1 January 2021|
|Products for professional use||from 1 January 2021|
|Products for industrial use||from 1 January 2024|
|Products already notified to an Appointed Body before 1 January 2021, if no intermediate change is required||by 1 January 2025|
For products with different end uses, the earlier date applies.
Requirements for notification
- The notification must be made before the product is placed on the market!
- It applies to mixtures with health and physical hazard characteristics /no pure environmental hazard!
- A Poison Center Notification (PCN) dossier is prepared.
- The XML format specified by ECHA must be used.
- The notification is first forwarded via the ECHA Submission Portal to the relevant member states and from there to the responsible Poison Information Centres in the respective distribution countries.
- Toxicity data of mixtures as well as placeholders in H and P phrases must be submitted in the published official language(s) of the distribution countries.
- The products must be assigned to a predefined category in a European Product Categorisation System (EuPCS)
- A unique recipe identifier (Unique Form Identifier / UFI) must be generated and assigned
With the help of the European Product Categorisation System EuPCS, ECHA has created a uniform matrix for uses of mixtures.
The uses are part of the notification to ECHA.
A PCN dossier can be generated in several ways
- Online in the ECHA Submission Portal
- Offline in IUCLID
- through system to system integration from own software systems
Common to all is the uniform XML format.
The contents of the dossier are defined in Annex VIII of the CLP Regulation as amended and are described in a separate guidance document. The completed dossier can be checked with the help of a validator.
The completed PCN dossier is sent via the ECHA Submission Portal to all Member States that have been entered in the dossier as distribution countries. The dossier passes through a further validator, which checks, for example, whether the ECHA has already been notified of reference UFIs of mixtures in mixtures. This ensures that the Poisons Information Centres have complete access to all necessary formula data in an emergency.