EU PCN Inspections start in January 2025. Are you compliant with Article 45 of EU CLP?

  • September 25, 2024
  • Divanshu Chawla, Asst. Manager/ Chemical Regulatory affairs, REACHLaw India

Background

Article 45 of CLP requires importers and downstream users to notify hazardous mixtures to the appointed bodies (i.e. poison centers) using the harmonized format (Annex VIII) before placing the mixture in the EU-27. 

All deadlines specific to each end-user category, including professional, consumer, and industrial, have passed. With the provided transition time, authorities allowed companies to complete notifications in a timely manner. Now, enforcement authorities have decided to conduct inspections on the notifications submitted. Inspections will begin in January 2025 and will continue for six (6) months. Although the full scope of the inspection has yet to be defined in the coming months, below are some key agenda items:

  • Analyze PCN notifications performed qualitatively & quantitatively.
  • Verify Labels of mixtures and – where needed – Safety Data Sheets (SDS).
  • UFI related compliance and SDS update.


DECIDING TREE FOR PCN


Confidentiality provisions in PCN

Limited submission: Limited submission is a term that strictly applies to industrial use mixtures. Companies are granted the option of maintaining information related to composition or formula, with composition referring to Section 3 of the Safety Data Sheet (SDS). Nonetheless, it is mandatory to submit the full composition if the mixture is intended for consumer or professional use.

Role of Non-EU manufacturers/formulators in the notification process

A non-European Union (EU) entity is not obligated to perform the Poison Centre Notification (PCN) under the Classification, Labelling and Packaging (CLP) regulation. However, they may provide necessary information to an EU-based DU/importer to carry out the notification process.

If the non-EU entity wishes to keep the information confidential, they can assign an EU-based entity to perform a voluntary submission by generating a Unique Formula Identifier (UFI) by appointing a commercial agent in EU. The EU-based entity can then make their submission with reference to this UFI concerning the compositional information.

Tips to consider when preparing your PCNs

Please keep the following points in mind while handling hazardous mixtures:

  • Determine the correct category for the intended use of the mixture.
  • Accurately identify your role in the process.
  • Ensure the accuracy of the data submitted. If limited submission is required, ensure that the SDS is compliant with CLP.
  • Manage the UFI (Unique Formula Identifier) efficiently.
  • Comply with the deadline specified for the submission.
  • Consider notification updates to adopt changes.

REACHLaw Support

  • Strategic consultation on PCN (role in supply chain, duty holder, complex scenario evaluation)
  • Data/information gathering for PCN
  • Perform and Manage PCN submissions as per your role/duty
  • UFI management
  • Classification & Labeling of hazardous mixture
  • SDS authoring
  • Act as Commercial Agent in EU for Non-EU manufacturers

CONTACT

Should you need support with PCN related matters, do not hesitate to contact us at sales@reachlaw.fi

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