ECHA Proposes Poison Centre Notification (PCN) <br>For Professional/Consumer-use and Industrial Use Products

Chemical mixture importers and downstream users in the EU are obliged to comply with Article 45 to the Classification, Labelling and Packaging (CLP) Regulation if their mixture bears physical or human health-hazardous classification. For products meant for professional and consumer use, Poison Centre Notification (PCN) must be followed from 1st Jan 2021, while for industrial-use products, the timeline is 1st Jan 2024. Existing products for which notifications are already submitted locally are not required to submit it again, following the PCN format till Jan 2025. However, if the same product enters other markets where local notification is not already submitted, a new harmonized PCN is required. Same holds in case of any update on formulation or classification of the product.

Having a new harmonized PCN format instead of country-specific Poison Control Centre (PCC) format simplifies the job for industry giving multiple benefits such as there is no need to present similar details in multiple formats and languages to every different country, but you can combine the required details of the mixture in just one harmonized format and present it to different authorities in just one single submission. This way it helps the chemical companies in reducing the Regulatory procedures and associated cost.

The PCN format is XML-based and compatible with IUCLID. The information required includes:

  • Notifier contact detail
  • Product composition and trade name
  • Packaging type and size
  • Product category
  • Unique Formula Identifier (UFI)
  • Toxicological information

The Unique Formula Identifier (UFI) (16 alphanumerical characters) is a new submission requirement that must be included on the product label. It establishes the link between specific products on the market to the submitted mixture information. Notifier must generate the UFI through ECHA’s online UFI generator tool using the company’s VAT number and mixture-specific formulation number.

A UFI is assigned to 1 (and only 1) mixture composition, while 1 mixture composition may have multiple UFIs assigned to it. Along with several benefits of UFI for mixture identification, it can be safely used in the supply chain to protect confidential mixture composition.

Hence, the manufacturers of consumer products must align with the PCN before 1st Jan 2021 and the manufacturers of industrial-use products must align before 1st Jan 2024. Decode the Regulatory requirements and take action now. You can also opt for expert consultation in the Chemicals Regulatory Affairs for successful compliance. Stay informed. Stay compliant.

Category: