August 23, 2023
By Rebecca Pickering, regulatory specialist, UL Solutions Supply Chain
The adoption of Regulation (EU) 2017/542 added an additional Annex to CLP (Annex VIII) which harmonized the information relating to emergency health response.
Under the new requirements, importers and downstream users who are placing on the market mixtures that have a physical or health hazard need to submit a Poison Centre Notification (PCN) to each Member State that the product is placed in. The new harmonized PCN format includes – amongst other data – the full chemical composition, toxicological information, a unique product identifier (UFI), and intended use, as described by the European Product Categorization System (EuPCS).
Poison Centre Deadlines
The date of applicability of the submission of information in the new harmonized format is dependent on the use type of the mixture.
The deadlines for consumer and professional products have already passed, but if you are putting products on the market for industrial use you must act now to ensure your products are compliant by the Jan. 1, 2024 deadline. You may be able to benefit from the transitional period (until 1 January 2025) if your mixture has already been notified to Member States in accordance with national legislation (as opposed to the new EU harmonized format).
If you are making a submission for industrial mixtures, you have the possibility to submit a ‘limited submission” as an alternative to the general submission requirements. In such cases, the information submitted may be limited to the information contained in the safety data sheet (SDS).
However, you will also need to provide additional detailed product information (e.g., compositional information) which must be rapidly available, on request, in the event of an emergency health incident. This information must be provided through a 24/7 accessible telephone number and available in the language(s) of the Member State where the mixture is placed on the market. In addition to rapid access contact details, a ‘limited submission’ must also include an email address for follow-up information between the submitter and responsible authority/medical personnel.
As well as benefitting from a ‘limited submission’, industrial mixtures are also exempt from the obligation to affix the UFI on the product label provided the UFI is included in the SDS (subsection 1.1.)
- Understand the end use of your products and your products’ downstream supply chain to determine whether a limited submission for industrial mixtures can apply.
- Prepare and submit a full or limited PCN submission for all industrial use mixtures that are not benefitting from the transitional period, and update labels or SDSs with UFIs by Jan. 1, 2024.
- Refer to our Poison Centres webpage if you need further information or support.
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