by UL Materials and Supply Chain
The obligation to submit a Poison Centre Notification (PCN) is dependent on your role in the supply chain and the products in your portfolio. The first step is to determine whether you are a duty holder. This will need to be determined on a case-by-case basis as your role may vary from product to product.
In the context of Article 45 of CLP and Annex VIII, duty holders, or “submitters”, are importers and downstream users that place hazardous mixtures on the market. Hazardous mixtures are those mixtures that (a) fall into the scope of CLP and (b) have a physical or health hazard classification.
Whilst distributors are not considered duty holders, they do need to comply with Article 4(10) of CLP, which stipulates that any substance or mixture that is placed on the market must comply with the CLP regulation. As such, if a distributor knowingly places on the market a mixture that has not been notified to the relevant appointed bodies in accordance with Annex VIII, they would be in breach of Article 4(10).
Some hazardous mixture may be exempt:
- Mixtures that are for scientific research and development
- mixtures that are for product and process oriented research and development
- Mixtures that are classified only as gases under pressure and/or explosives.
Products out of scope:
- Mixtures classified only for environmental hazards
- Mixtures that are only subject to supplemental labelling requirements (g. EUH208)
- Substances or mixtures out of scope of CLP (finished state medicinal, veterinary, cosmetic, medical devices, food and feeding stuffs or animal nutrition products; radioactive substances/mixtures, substances/mixtures subject to customs supervision, non-isolated intermediates, waste).
Poison Centres: What You Need To Know
For more information about Poison Centres, check out our dedicated Poison Centres Homepage, where you can find the latest resources, including White Papers, FAQs and Expert Articles to help you understand your obligations under Annex VIII. You can also learn more about our expert tools and services to help you meet your compliance requirements.
Need more assistance? Click on the button below, and complete the form to speak with one of our Regulatory Experts.