As per the CLP regulation Article 45 and Annex VIII, importers and downstream users placing hazardous mixtures will have to provide specific information in a harmonised notification format (PCN format) to the relevant national appointed bodies, who will make this information available to poison centres so that they can provide rapid medical advice in the event of an emergency.
This obligation applies to importers and downstream users of hazardous mixtures that are classified for human health or physical hazards, as per the EU CLP (including biocides and plant protection products) and excludes radioactive mixtures; medicinal and veterinary products; cosmetic products; food and feeding stuffs; mixtures used in scientific research and development; and mixtures subject to custom supervision.
Some of the new information requirements, as per the harmonised PCN format, include:
- Full chemical composition: Exact concentration of the hazardous and non-hazardous components of the product.
- Unique formula identifier (UFI): UFI is a unique code that is required both at the time of submission of information and during labelling or packaging of the hazardous mixture. UFI along with the product’s trade name will allow poison centres to identify the exact product and its composition involved in the emergency.
- Toxicological information: Based on the available information in section 11 of the safety data sheet (SDS).
- Product category: Based on its intended use, a product category needs to be assigned as per the European product categorisation system (EuPCS)
Based on the use types of each product, there are different information requirements and phased timelines, i.e., 1 January 2020 for consumer use; 1 January 2021 for professional use and 1 January 2024 for industrial use.
The duty holders can prepare for the submission either ‘offline’ (using IUCLID interface) or ‘online’ (through PCN portal – to be launched in Q1 of 2019); or via ‘system to system integration’ (i.e., by directly editing in the XML format) for more advanced users. Once prepared the dossiers maybe submitted via either the ECHA hosted Poison Centre Notification (PCN) Portal or dispatched to the relevant Member States’ appointed bodies. Some Member States may also offer the possibility to submit information to them directly through local submission systems.
Options such as ‘limited submission’ for industrial uses only (along with phone line accessible 24/7 for rapid access in case of an emergency) are required, and ‘group submissions’ for similar mixtures with similar hazard classifications from a single product category, which differ slightly in certain elements (e.g. colour or perfumes), are also available.
As the first deadline for submitting the information for consumer products is fast approaching, avoid any last minute rush in Q3 2019 and contact us for more help if you wish to prepare your notifications online or offline using IUCLID 6.