The one-year delay to the harmonised poison centre notifications submission deadline for mixtures, for consumer use, is an opportunity for suppliers to address the new compliance requirements – not to relax.
The new regulation harmonises the requirements for poison centre notifications (PCN) for all EU member states. It amends the CLP regulation (EC) 1272/2008 and introduces the new annex VIII.
Postponement of the first deadline
Initially, three deadlines were scheduled for notifications with the new format:
- mixtures for consumer use by 1 January 2020;
- mixtures for professional use by 1 January 2021; and
- mixtures for industrial use by 1 January 2024.
During the transition period, already existing national poison centre notifications remain valid until 1 January 2025. Resubmission under the new harmonised format is not required until this date, unless changes to the mixture make it necessary.
The introduction of the new format, the submission system and guidance documents all experienced several delays and the first deadline, for the consumer use mixtures, was moved to 1 January 2021, coinciding with the deadline for professional use mixtures.
Most companies will therefore need to address the topic of harmonised PCN as soon as possible in order to prepare for the new requirements. One of the main new requirements is for a unique formula identifier (UFI) that will have to be included on the label of many hazardous mixtures, but the practical challenges listed below are just a selection of issues often encountered by companies while preparing for the new regulations.
Identify products with PCN relevance
Not all hazardous products fall under the new requirements. Exemptions exist, for example: mixtures that are only used in research and development under controlled conditions; medical devices; medicinal products; cosmetics; food/feed; radioactive mixtures and other product categories exempt from CLP; mixtures that are only classified as hazardous to the environment according to CLP, or only as gas under pressure. Assessing which products in your range may not require PCN could save you a lot of effort.
Expect your customers to ask you for UFIs
Even for mixtures that do not require PCN for themselves, there is a good chance that a supplier will be asked for the mixture’s composition by its customer. For example in a situation where you supply a mixture that does not require PCN itself, but your customer may use it in the formulation of a hazardous mixture. To fulfil the customer’s PCN obligation, you will be asked to provide the exact composition of the supplied mixture. In order to protect this confidential business information, you may consider performing a voluntary notification and only communicate the mixture’s assigned UFI to your customer, instead of the full composition.
Choose a suitable mode of submission
In general, there are three different ways to generate and submit a PCN dossier to Echa. Subscribers to the agency’s Iuclid cloud service can use the provided PCN assistant to manually enter all required information online, and then submit the generated PCN dossier directly from there. While Iuclid cloud is subject to a subscription fee, you can also download and install it locally, free of charge, generate your PCN dossier with the identical assistant and upload it via drag and drop to Echa’s submission portal. Hibiscus Prometheus SDS authoring software can also generate and export XML files directly to Poisons Centres in any Country within the EU.
Locate and assess the available data
Most of the information required for PCN submission will likely already exist in companies’ IT systems, for example EHS or SDS software or databases. However, some data may be more difficult to automatically retrieve or aggregate, such as all relevant packaging types and sizes for each product. Also, the available information from the SDS may be incomplete, such as missing pH values or composition information. As the new format only allows a limited number of basic colours and intensities like ‘light, ‘dark’ or ‘transparent’, a reduction or mapping to these possible values may be required. In addition to the UFI, at least one main use category according to the European Product Categorisation System (EuPCS) must be assigned to each mixture for PCN. Irrespective of the chosen mode of submission, this can be prepared well in advance.
Consider how to include the UFI on your labels
The UFI will be required to be displayed on the product label, and even slight changes to the classification or composition may trigger a resubmission and the assignment of a new UFI. Depending on how often your UFI can be expected to change, it might be necessary to consider in-line printing of the current UFI to a reserved blank area of the label. Also keep in mind that you might also need to resubmit and assign a new UFI if your supplier informs you of a change in the classification or composition of a raw material supplied to you. This is ever more relevant the further down in the supply chain you are located, and the more mixtures you use as raw materials.
Hibiscus Plc can provide various solutions in order to support you with the production of labels, and authoring of Safety Data Sheets, to allow a smooth transition into compliance from 2020 onwards.
Keep Up to Date
See the Echa: Poison centres website for information updates.
Call us regarding your labelling & SDS requirements on 0113 242 4272