In September 2022, the European Commission published a proposal for a delegated act under Regulation 1272/2008 on the classification, labelling, and packaging of substances and mixtures (CLP Regulation): COMMISSION DELEGATED REGULATION (EU) …/… of XXX amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.
As first announced in the EU Chemicals Strategy for Sustainability of October 2020, via the Delegated Regulation the European Commission is proposing to introduce new hazard classes and criteria for Endocrine Disruptors (EDs), persistent, bioaccumulative and toxic (PBT)/very persistent, very bioaccumulative (vPvB) substances and mixtures, and persistent, mobile and toxic (PMT) /very persistent, very mobile (vPvM) substances and mixtures.
The introduction of new hazard classes under the CLP Regulation is expected to trigger a set of compliance activities (and costs) on the part of chemicals manufacturers and importers – from reclassifying and relabelling substances and mixtures to updating Safety Data Sheets and REACH registration dossiers. Furthermore, the proposed changes are expected to impact downstream sectors and downstream legislation, such as cosmetics, toys, medical devices, plant protection products, and biocidal products. Reclassification under the CLP Regulation may also lead companies to decide to discontinue or substitute their products: the new hazard classes and the resulting identification of certain hazardous properties, when applied in conjunction with the so-called generic approach to risk management (GRA), may automatically trigger pre-determined risk management measures (e.g., restrictions or bans for some specific uses or all uses), without any assessment of exposure levels. The European Commission carried out an analysis of the impact of the introduction of new hazard classes under the CLP Regulation. Please find it here.
While the CLP Regulation is the piece of legislation that implements the Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) in Europe, the proposed changes represent a deviation from the UN GHS and, as such, may impact trade flows. The European Commission’s intention is to use the EU approach to steer relevant discussions and negotiations at UN GHS level.
Lastly, it is important to note that the introduction of new hazard classes was supposed to be part of the general revision of the CLP Regulation, which has however been further delayed.
In terms of next steps, the draft Delegated Regulation, and the new hazard classes and criteria therein, should be finalised and adopted by the end of the year. Transitional periods will be provided so as to allow manufacturers to adapt to the proposed changes. For further information, please click here.
Please do not hesitate to contact our office at EU@israeltrade.gov.il if you have any questions or require further information.