As of January 2025, Poison Centre Notification (PCN) inspections across the EU will begin in full force. These inspections will focus on compliance with Article 45 of the EU CLP Regulation. Suppose your company is placing hazardous mixtures on the EU market. In that case, ensuring your PCN submissions are fully compliant is crucial—especially as enforcement authorities ramp up efforts to audit notifications and ensure adherence to regulations.

Understanding Article 45 and PCN Requirements

Under Article 45, importers and downstream users must notify hazardous mixtures to appointed Poison Centres before those mixtures are placed on the market in the EU. These notifications must follow the harmonised format set out in Annex VIII of the CLP Regulation. All relevant deadlines for consumer, professional, and industrial uses have now passed, leaving businesses little time to ensure full compliance before inspections begin.

Starting in January 2025, EU authorities will conduct PCN inspections over a period of six months, assessing both the quality and accuracy of submissions. With this in mind, companies must act swiftly to review their PCN processes and confirm that they meet all regulatory standards. Our team can help you promptly review your processes to ensure you meet all regulatory requirements.

What Will the Inspections Cover?

Although the full scope of the inspections is still being finalised, some key areas that are likely to be reviewed include:

• Qualitative and quantitative analysis of PCN submissions.

• Verification of labels on mixtures and Safety Data Sheets (SDS).

• Unique Formula Identifier (UFI) compliance and necessary SDS updates.

In preparation, businesses should ensure that their notifications are accurate, complete, and fully compliant with Annex VIII requirements.

PCN for Non-EU Entities: What You Need to Know

Non-EU companies are not directly obligated to submit PCNs under the CLP Regulation. However, to access the EU market, they must collaborate with EU-based importers or downstream users who are responsible for the notification process.

To maintain confidentiality, non-EU manufacturers can assign an EU-based entity to act as their legal representative. This entity can manage the PCN submission on its behalf, using a Unique Formula Identifier (UFI) to safeguard sensitive compositional information.

Key Steps to Prepare for PCN Compliance and Inspections

To stay ahead of the curve and avoid penalties, here are some key considerations for businesses preparing for the upcoming inspections:

• Identify the correct use category for your mixtures (consumer, professional, or industrial).

• Accurately determine your role in the supply chain—whether as an importer, downstream user, or non-EU manufacturer.

• Review and update your SDS to ensure it complies with CLP, particularly if using limited submission options for industrial mixtures.

• Ensure proper UFI management, and verify that your notifications align with Annex VIII requirements.

• Submit any updates or corrections before the December 31, 2024 deadline to ensure compliance ahead of the inspection period.

How Yordas Can Help

At Yordas, we offer a full suite of Poison Centre Notification services, tailored to meet the needs of both EU and non-EU companies. We can act as your legal entity within the EU, manage PCN submissions, and ensure all documentation is compliant with current regulations.

Our solutions are cost-effective and efficient, allowing you to focus on your core business while we handle the complex regulatory requirements. Whether you’re a non-EU entity looking for guidance or an EU-based company needing support with your submissions, Yordas is here to help.

Don’t Risk Non-Compliance—Act Now!

With the December 31, 2024 deadline fast approaching and inspections beginning in January 2025, time is of the essence. Ensure your business is fully prepared by partnering with Yordas for your PCN submissions and compliance needs.

Contact us today to ensure you meet the deadline! Get in touch with our team today for more information and visit our website for insight into our Hazard Communication Services.

• Request a Free Consultation: Our experts can help you navigate the requirements and ensure compliance. Request a consultation today!

• Contact our Support Team: Have a specific question or need immediate assistance? Contact p.redshaw@yordasgroup.com now.

About our experts

Fiona Moir
Managing Hazard Communication Consultant

Fiona Moir is the Managing Consultant for Hazard Communication at Yordas Group, responsible for overseeing strategic, commercial, and operational aspects of services such as SDS Manager and Hazard Communication services. With a background in bioscience and over a decade of experience in hazard communication, Fiona excels in setting strategic direction aligned with market needs. She leads product development and commercial management efforts, focusing on revenue growth and expanding Yordas' presence in the EHS sector. Fiona's leadership extends to team development and financial oversight, ensuring robust performance and sustainable business practices. Her expertise in regulatory standards, coupled with strong analytical and communication skills, drives innovation and business success within Yordas Group.

Nathan Town-Field
Senior Hazard Communication Consultant

Nathan Town-Field is a Senior Regulatory Consultant at Yordas, with a focus on global hazard communication. With six years of expertise in GHS and CLP classification and labelling of substances and mixtures, Nathan is well-versed in navigating the complex regulatory landscape surrounding chemical safety. A key responsibility for Nathan leading the team responsible for authoring Safety Data Sheets (SDS) to global standards, ensuring that they accurately communicate the hazards associated with chemicals and provide essential safety information to downstream users. Additionally, he is proficient in poison centre notification obligations, and as Yordas' lead eSDS author, Nathan plays a crucial role in extracting exposure scenarios from various sources.