GPSR

EU Regulation (EU) 2023/988 (GPSR) strengthens the obligations of all economic operators—manufacturers, importers, distributors, and online marketplaces. It requires risk assessment, an EU Responsible Person for consumer products, mandatory information on the product/packaging, and fast recall/withdrawal procedures with post-market monitoring. Importers/distributors must verify compliance before making products available, while marketplaces must ensure online visibility of required data and cooperate with authorities.
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1.

Obligations for Manufacturers

Manufacturers bear primary responsibility for ensuring that products placed on the market are safe.
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    Risk assessment before placing products on the market.
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    Technical documentation demonstrating product conformity.
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    Traceability: every product must be identifiable (code, batch, serial number).
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    Instructions and warnings must be provided in the language of the destination country.
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    Post-market control: system for monitoring and managing hazardous products.
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    Reporting obligations to authorities in case of serious incidents.
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    Cooperation with authorities for recalls, withdrawals, and investigations.

2.

Obligations for Importers

Importers must ensure that products coming from third countries meet all GPSR requirements.
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    Verification that manufacturers have conducted proper risk assessment.
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    Ensuring the presence of instructions, labeling, and identification data.
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    Indicating the importer’s name and address on the product or packaging.
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    Preventing unsafe or non-compliant products from being placed on the market.
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    Implementing post-market surveillance procedures (including possible recalls).
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    Maintaining sales and customer records for at least 10 years.

3.

Obligations for Distributors

Distributors must ensure that products are not modified and that they comply with the rules before being made available to consumers.
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    Ensuring products are correctly marked and accompanied by instructions and warnings.
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    Suspend distribution if there is reason to believe a product is unsafe.
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    Promptly report risks to manufacturers and authorities.
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    Cooperate in case of recalls or withdrawals.
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    Cooperate in case of recalls or withdrawals.
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    Keep safety-related documentation for a defined period.

4.

Obligations for Online Marketplaces

Digital platforms play an active role in consumer protection.
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    Appoint a Responsible Person for product safety.
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    Quickly remove hazardous products identified by authorities.
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    Ensure product information is visible and reliable (name, producer, warnings).
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    Activate a traceability system to support recalls.
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    Respond promptly to surveillance authority requests.

5.

Recalls and Notifications

All economic operators must activate quick, coordinated post-market safety procedures: identify/withdraw unsafe products, submit notifications via Safety Gate, inform consumers directly (email, notices, website), and respond to authorities within 2 working days in cases of serious incidents. This reduces risk and ensures transparency along the supply chain.
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    Collaborate to identify and withdraw unsafe products.
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    Use the Safety Business Gateway portal for rapid notifications to authorities.
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    Communicate with consumers effectively and directly (emails, notices, websites).
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    Provide responses within 2 working days in case of serious incidents.

6.

Sanctions and Market Surveillance

National authorities (e.g., MIMIT, Customs/ADM, Chambers of Commerce, Guardia di Finanza) monitor the market: they may carry out inspections, order seizures or sales suspensions, and impose administrative and criminal penalties for violations. They also coordinate EU-level surveillance activities through the Safety Gate system, enabling rapid, coordinated action.
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    Conduct inspections, seizures, or sales suspensions.
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    Impose administrative or criminal penalties in case of violations.
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    Coordinate EU-level market surveillance through the Safety Gate system.

Being Compliant with GPSR Pays Off

Turn compliance into a competitive advantage: strengthen quality control, manage risks effectively, and prevent penalties or reputational damage. We guide you through gap analysis and an operational plan.
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