Chemical Check - European Office for Safety and Health

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

 

Schedule

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 usefrom 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.


Conclusion:

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.

 

 

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