Europe: Annex VIII, provisional text of the 2nd amendment has been published

Posted By: Trace One

Annex VIII: what does that entail?

Europe: Annex VIII, provisional text of the 2nd amendment has been publishedAccording 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.

Annex VIII of CLP, added by 2017/542 Regulation, has the aim to harmonize, in terms of format and content, the information relating to emergency health responses in the EU market.

The European Commission has published the 2020/11 Regulation on January 10th which amends the Annex VIII, but a second amendment is already planned, whose publication is expected for the second half of this year. However, on May 14th the provisional text of this amendment has been published.

Solutions proposed in the provisional text 

According to the workability studies carried by ECHA in collaboration with trade associations, three main issues have been identified regarding the compliance to Annex VIII criteria for some specific industrial sectors:

  • Raw material provided by different suppliers, when the complete formulation is unknown (MiM)
  • Raw material of natural origin used in petroleum, cement and concrete sectors and with high variability in their composition.
  • The issue of point of sales paints and the high number of notifications required to cover all the combination of base paint and tinters.

These issues have been faced by proposing the following solutions, which are still under discussion.

  • Introduction of Interchangeable components (ICG), allowing the generic identification of similar raw materials provided by different suppliers.
  • Introduction of “standard formulas”, that refers to standard compositions for certain raw materials of natural origin that can be used for the notification.
  • Deviation from the standard notification criteria for point of sales paints consisting in printing the UFI code of the base paint and the UFI codes of the tinters on the label of the final mixture.

The provisional text is under consultation. Trace One is paying particular attention to the evolution of the regulatory situation and will keep you updated in this regard.

Click here to take a look at the current Trace One solution regarding Annex VIII.

To read the (EU) 2017/542 Regulation (Annex VIII of CLP) and the provisional text of the amendment, you can follow these links:

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