EU Poison Center Notification Compliance

Background of PCN Requirements

According to Article 45(1) of the Classification, Labelling and Packaging (CLP) Regulation, Member States have appointed bodies responsible for receiving information from importers and downstream users regarding hazardous chemical mixtures placed on the market. Commission Regulation (EU) No 2017/542 amended the CLP Regulation by adding Annex VIII, which harmonizes the specific information required for emergency health responses. This regulation, which became applicable on January 1, 2020, introduces a mandatory requirement to include a Unique Formula Identifier (UFI) in the supplemental information on product labels.

PCN Exemptions

Mixtures placed on the EU market that are classified as hazardous based on their physical or health effects are subject to PCN requirements. However, several categories are exempt from these mandates:

• Isolated substances.
• Mixtures not covered by the scope of CLP.
• Mixtures classified solely for environmental effects.
• Mixtures used specifically for research and development or PPORD.
• Gases under pressure and certain explosives (unstable explosives and divisions 1.1 to 1.6).

While exempt, suppliers may still choose to conduct PCN submissions on a voluntary basis to protect confidential business information and assist emergency responders.

Who Should Submit PCNs

The obligation to submit notifications falls on importers and downstream users who place hazardous chemical mixtures on the EU market. While distributors who solely store and place mixtures on the market are generally not required to submit information, they must ensure notifications are completed if they modify labels, repackage mixtures, or launch products in Member States where upstream users have not submitted notifications. Companies may also entrust a third party to handle notifications, though the legal responsibility remains with the original duty holder.

Dates of Applicability

The submission of information follows a stepwise timeline based on the end-use of the mixture:

• Consumer Use: Hazardous mixtures must comply starting January 1, 2021.
• Professional Use: Hazardous mixtures must comply starting January 1, 2021.
• Industrial Use: Hazardous mixtures must comply starting January 1, 2024.

Information Contained in PCN Submission

A valid submission must include detailed data to facilitate rapid medical intervention during emergencies:

• Identification

This includes the product identifier, submitter details, and emergency contact information.

• Hazard Identification

This covers the classification of the mixture, label elements, toxicological information, and the mandatory UFIs.

• Compositional Data

Registrants must provide the concentration ranges and identities of mixture components, including those subject to specific submission requirements.

Proregulations' EU PCN Compliance Services

Our team offers professional technical support to ensure your chemical mixtures meet the harmonized standards of Annex VIII.

• Supply chain role identification
  We help determine your specific obligations based on your position as an importer, downstream user, or distributor.
• Product classification and data collection
  Proregulations assists in classifying your products and gathering the necessary toxicological and compositional information for submission.
• UFI assignment and management
  We provide strategic guidance on assigning and managing Unique Formula Identifiers (UFIs) based on your specific business needs.
• Notification submission and training
  Our experts manage the entire PCN notification process and provide training to help your team maintain internal compliance capabilities.
• SDS and label preparation
  We ensure your Safety Data Sheets (SDSs) and product labels are updated to include required supplemental information such as the UFI.

If you need to ensure your hazardous mixtures are fully compliant with EU PCN requirements or require assistance with UFI management, please contact us.