Poison Centre Submission Requirements For Non-EU Legal Entities: What You Need To Know
As companies outside the EU navigate the landscape of Poison Centre Notifications (PCN), understanding submission requirements is essential for compliance and market access. This article addresses frequently asked questions regarding the submission obligations for non-EU legal entities.
Are non-EU suppliers required to submit Poison Centre Notifications?
No, Poison Centre Notifications are not legally mandated for non-EU suppliers. The responsibility for submitting notifications lies with importers and downstream users, known as duty holders, within the EU. However, non-EU suppliers may choose to engage in voluntary notification to protect confidentiality regarding their product formulations.
Why would a non-EU supplier want to submit a notification voluntarily?
Non-EU suppliers may opt for voluntary notification to maintain confidentiality over product formulation details. By submitting a notification through an appointed EU-based legal entity, such as Yordas GmbH, suppliers can keep their formulation information secure while complying with regulatory requirements in the EU.
How can a non-EU supplier submit a Poison Centre Notification?
A non-EU supplier can appoint an EU-based legal entity to handle the submission process. This entity will:
Create a Unique Formula Identifier (UFI) for the product.
Prepare the necessary dossier.
Submit the notification to the relevant Member States where the EU importer plans to market the product.
The non-EU supplier can then communicate the UFI to the EU importer, allowing the importer to complete their mandatory submission.
What is the role of the EU importer in the notification process?
The EU importer plays a crucial role in the notification process. While the non-EU supplier can handle certain aspects of the submission, the EU importer remains the duty holder responsible for compliance with enforcement authorities. This includes ensuring that the product meets all obligations under the Classification, Labelling and Packaging (CLP) regulation, including its classification.
How can Yordas help?
Understanding the submission requirements for Poison Centre Notifications is vital for non-EU suppliers wishing to enter the EU market. By appointing an EU-based legal entity, suppliers can maintain confidentiality while ensuring compliance with regulatory obligations. Both non-EU suppliers and EU importers must work collaboratively to navigate these requirements effectively and mitigate any potential risks associated with non-compliance.
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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.