March 4, 2021
Exponent supports preparation & submission of new & updated notifications
New requirements for European Chemicals Agency (ECHA) Poison Centre Notifications (PCNs) took effect on substances for commercial and professional uses starting January 1, 2021. Annex VIII to Regulation (EC) No 1272/2008 on classification, labelling, and packaging of substances and mixtures (CLP Regulation) standardizes the notification process and information requirements for mixtures classified for human health or physical hazards placed on the market in all EU Member States.
These requirements will extend to substances for industrial use starting January 1, 2024. For all previously notified products that are already on the market, notifications will remain valid until January 1, 2025, or until changes are made to the product. In accordance with Annex VIII to CLP, notifications must be submitted for all "new" mixtures that are classified for human health or physical hazards and not already notified under national legislation by importers and downstream users placing the products on the market.
Commission Regulation (EU) 2020/878, which amends Annex II of REACH, also imposed new requirements on the compilation of safety data sheets (SDSs) starting from January 1, 2021. The main changes include:
Requirements relating to unique formula identifier (UFIs).
Changes to the requirements in line with revisions to UN GHS (GHS Revision 6 and 7).
Addition of specific concentration limits, M-factors, and the acute toxicity estimates.
Addition of information on adverse health effects caused by endocrine disrupting properties.
Specific requirements for nanoforms of substances.
Under the new regulation, all new SDSs prepared after January 1, 2021, must comply with the new Annex II requirements, and existing SDSs prepared before January 1, 2021, must be updated to comply with the new Annex II requirements by December 31, 2022, with the exception of SDSs for mixtures supplied unpackaged for which a UFI is required in the SDS.
How Exponent Can Help
Exponent can provide support throughout the process of notification and submission of the data required for mixtures or products, including guidance on data requirements, assistance generating UFIs and preparing and submitting PCNs, and help preparing new or updated SDSs. Exponent can assist clients with the different approaches that can be taken to assigning UFIs to maximize efficiency for managing numerous formulations and for protection of confidential formulation details in the supply chain. We have several years' experience preparing national PCNs for most of the EU Member States, which makes us well placed to assist with your PCNs for the new EU standardized system.