Second Amendment of Annex VIII published to facilitate compliance

Second Amendment of Annex VIII published to facilitate compliance

On November 13, the Second Amendment of Annex VIII to CLP was published in the Official Journal of the European Union. It was designed to improve the viability of the information requirements related to harmonized toxicological notification, which will come into effect on the next 1 January 2021.

The date on which importers and downstream users must begin to comply with the requirements for classification, labeling and packaging of hazardous substances and mixtures relative to the new harmonised information relating to emergency health response, is approaching, and many sectors have raised concerns about the workability of the new PCN format.

Thus, in order to help companies meet the requirements of the new regulations, , the new amendment introduces some changes:

  • With regards to the difficulty of knowing the exact composition of mixtures in cases where raw materials with a highly variable or unknown composition are used in the manufacture of the mixture, or in cases where toxicologically very similar components are used together, importers and downstream users are allowed to group toxicologically similar components of a mixture together in an interchangeable component group and provide information on the total concentration of those components present in the mixture, without having to specify their separate concentrations.
  • To alleviate the particular difficulties faced by the gypsum, ready-mixed concrete and cement sectors,, producers they may present their information by referring to a standard composition. However, they will only be able to benefit from this possibility if the classification of the mixture does not change (within the concentration ranges specified in the standard formula), and when the information on the composition is at least as detailed as that contained in the security data sheet (SDS).
  • With regard to the fuel sector, and taking into account that fuels placed on the market normally conform to a technical standard and that poisonings related to these substances are extremely rare, it will be possible to submit emergency health response information by reference to the information contained in the safety data sheet, as well as any other known information on the products’ chemical composition.
  • The document also tries to provide a solution to companies that sell paints with very specific shades,, since formulators are sometimes asked to formulate and supply paints on a bespoke basis at the point of sale. These bespoke paints could have an almost unlimited number of different compositions, and it would force formulators to either create unique formula identifiers (UFI) for all possible color combinations in advance or to postpone each dispensing until the information has been submitted and the UFI is created. The new annex provides for the possibility to exempt bespoke paints from the notification obligations in Annex VIII and from the requirement to create a UFI. However, the individual mixtures contained in bespoke paints should remain subject to all the requirements of that Annex.

You can read the full document here:: Second Amendment of Annex VIII to CLP

If you are also concerned about having to face similar challenges when complying with the requirements of the new toxicological notification, we recommend you to visit our CHEMETER web section, our safety data sheet software which has recently been updated to include a new MODULE for PCN notifications. It will allow you to prepare the notification for all your products in just a few minutes with just a few clicks, and it also includes an automatic UFI code generator. A SIMPLE and EFFECTIVE tool already available.