Under the General Product Safety Regulation and for certain product categories like cosmetics and medical devices, brands must appoint a Responsible Person within the EU and UK to ensure compliance. This individual is responsible for product review, labelling, documentation, registration and notifying authorities if a product is found to be unsafe. Expandly provides expert support in managing these tasks, ensuring that your products meet all regulatory requirements before reaching the market.
The EU and UK require a locally established Responsible Person to ensure there is clear legal accountability within the market.
If your business is based outside the EU or UK, you cannot directly fulfil certain regulatory obligations. The Responsible Person acts as your official representative and:
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Ensures your product meets all safety and compliance requirements
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Holds and maintains required technical documentation
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Acts as the main contact for regulatory authorities
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Takes action if a product poses a safety risk
Without a Responsible Person, your products may be:
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Refused entry at customs
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Removed from marketplaces (e.g. Amazon, eBay)
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Subject to fines, recalls, or enforcement action
When do you need a Responsible Person?
You will typically need a Responsible Person if:
Even if you are using fulfilment providers or marketplaces, the legal responsibility still applies.
What does the Responsible Person do?
The Responsible Person plays a critical role in product compliance, including:
1. Compliance Verification
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Reviewing product information to ensure it meets legal requirements
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Checking labelling and packaging for compliance
2. Documentation Management
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Maintaining technical files (e.g. Product Information File for cosmetics)
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Ensuring documentation is available for inspection by authorities
3. Product Registration
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Submitting required notifications to regulatory systems (where applicable)
4. Post-Market Surveillance
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Monitoring product safety once it is on the market
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Investigating complaints or incidents
5. Authority Liaison
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Acting as the point of contact for regulatory bodies
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Managing communications in the event of audits, requests, or safety issues
Key Takeaway
A Responsible Person is not just a formality—it is a legal requirement for many products sold in the EU and UK. Appointing one ensures your products meet safety standards, remain compliant, and can be sold without disruption.
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