Harmonised product registrations/notifications
On 23 March 2017, the Regulation (EU) 2017/542 has been published in the Official Journal L78. A new Annex VIII for harmonised information relating to emergency health response will be attached to CLP 1272/2008.
The Annex VIII sets a legal frame for
- the requirements for product registrations/notifications (described as submissions in the regulation)
- must happen before the placing on the market
- apply for mixtures with sanitary and physical hazard characteristics /no exclusive environmental hazard
- defined XML format
- submission to the national authorities
- in an official language of the Member State
- utilizing a provided product categorisation system
The final XML format and the product categorisation system is available under https://poisoncentres.echa.europa.eu/de/tools.
- group registrations/notifications (group submission)
- the introduction of a unique formula identifier (UFI)
The ECHA has provided a UFI generator incl. guidances under https://ufi.echa.europa.eu/#/create. All links can be retrieved under https://poisoncentres.echa.europa.eu/de/tools.
Important: The UFI must be applied on the label with the prefix „UFI“.
- contents of the product registration/notification
- identification of the mixture and the submitter
- details for classification of the mixture, the labelling elements and further toxicological data for the mixture and its components
- information for the mixture components
- specification of concentration ranges of hazardous ingredients
- specification of concentration ranges of ingredients which are not classified as hazardous
- specification for „mixture in mixture“
- the actualisation of product registrations/notifications
The regulation is valid from 1 January 2020. It will be implemented according to the use of the products in following steps:
|consumer products||from 1 January 2020|
|products for professional use||from 1 January 2021|
|products for industrial use||from 1 January 2024|
|Products already registrated/notified before 1 January, provided that no interim change is necessary||till 1 January 2025|
For products with different uses the respective earlier date is applicable.
The ECHA has ordered a feasibility study parallel to this publication, for entering a product registration/notification into a central ECHA portal. Further details are expected in Q1 2019.
Annex VIII is a legal frame – the concrete requirements for implementation are still missing!
- the final PCN format has been published in 2018
- the product categorisation system has been published in 2018
- the way of registration/notification via national/ ECHA portal may still change
- the national appointed bodies will wait with the IT restructure
- The UFI generator is available and can be integrated into your product processes. As retailer/rebrander, the handling of the UFI in the supply chain should be synchronised with the suppliers.