Transition Period for submissions in Poison Centre Notification (PCN)

According to paragraph 1.4 Part A of Regulation 542/2017, importers and downstream users who have submitted information on hazardous mixtures to a body appointed in accordance with Article 45 (1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.

By way of derogation from Section 1.4, importers and downstream users must comply with the requirements of Article 45 of the CLP Regulation before 1 January 2025 before placing the mixture on the market if there is an obligation to submit an update:

  • When the product identifier of the mixture (including UFI) changes
  • When the classification of the mixture has changed in terms of health or physical hazards,
  • When relevant new toxicological information required in section 11 of the safety data sheet
  • If a change in the composition of the mixture meets one of the following conditions:
  1. addition, substitution, or deletion of one or more components in the mixture that shall be indicated in accordance with Section 3.3;
  2. change in the concentration of a component in the mixture beyond the concentration range provided in the original submission;
  3. the exact concentration of a component was provided in accordance with Sections 3.4.1 or 3.4.2, and a change occurs to that concentration beyond the limits identified in the following Table.
Exact concentration of the component contained in the mixture (%) Variations (±) of the initial component concentration requiring a submission update
> 25 – ≤ 100 5 %
> 10 – ≤ 25 10 %
> 2,5 – ≤ 10 20 %
≤ 2,5 30 %

When the fragrances or perfumes in a group submission change, the list of mixtures and the fragrances or perfumes they contain as required in Section 3.1 of Reg. (EU) 2017/542 shall be updated.