Distributor’s Obligations

Distributor’s Obligations
Distributor’s Obligations under Regulation (EU) 2023/988 (GPSR): A Practical Guide

Distributor’s Obligations under Regulation (EU) 2023/988 (GPSR): A Practical Guide

The GPSR assigns the distributor a crucial verification role for product safety. However, the most critical aspect is the shift in responsibility: a distributor who markets a product under their own name or trademark is legally considered a manufacturer. Consequently, they inherit all the manufacturer’s obligations, from drafting technical documentation to managing recalls, exposing themselves to operational risks and penalties in case of non-compliance.

Ing. Antonio Gargasole

AUTHOR: ENGR. ANTONIO GARGASOLE

Expert consultant in non-food product compliance.

20 years of direct experience in European Large-Scale Retail.

I help companies prevent risks and penalties.

The Strategic Role of the Distributor in the GPSR

The Regulation (EU) 2023/988 (GPSR) is not merely a regulatory update but a strategic shift that redefines the role and responsibilities of every operator in the supply chain, particularly those of the distributor. This figure, often perceived as a simple intermediary, is now tasked with a fundamental active surveillance duty to ensure the safety of products placed on the European market.

In a context where the supply chain is increasingly complex and globalized, the distributor’s responsibility is not a bureaucratic burden but a strategic imperative. Compliance with the GPSR becomes an essential tool to protect the company from concrete and costly risks: customs blocks that paralyze operations, economic penalties that impact liquidity, and reputational damage that undermines the trust of partners and consumers. Ignoring these obligations means exposing one’s business to unsustainable vulnerabilities.

To act strategically and prevent these risks, it is essential to define precisely who a distributor is according to the regulation and what their duties are.

Who is a Distributor According to the GPSR?

Correctly identifying your role in the supply chain is the first step toward building a solid compliance strategy and avoiding dangerous gaps in responsibility. An error in judgment at this initial stage can lead to an unintentional violation of the regulation, with all the operational consequences that ensue.

According to Article 3, point 11, of Regulation (EU) 2023/988, a “distributor” is defined as:

any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

In practical terms, if a company markets a product within the EU without being either the original manufacturer or the operator who first introduced it from a non-EU country (the importer), that company is the distributor. This role entails a series of fundamental verification obligations, designed to create an additional layer of control before the product reaches the consumer.

Distributor’s Obligations under the GPSR: The Basic Checks

The GPSR transforms the distributor into an essential control “checkpoint.” Their due diligence is the first line of defense preventing non-compliant products from circulating in the single market. Before making a product available on the market, the distributor has a legal obligation to perform a series of documentary and visual checks, as established by Article 12 of the Regulation.

These checks allow no room for superficiality and require careful and unequivocal factual verification.

  • Verification of traceability information: Check that the product (or its packaging/accompanying document) bears a type, batch, or serial number or another element allowing its unique identification, as required by Art. 9(5). This is the basis of traceability.
  • Verification of manufacturer’s data: Ensure that the name, trade name, postal address, and email address of the manufacturer are clearly indicated (Art. 9(6)).
  • Verification of importer’s data (if applicable): If the product comes from a non-EU country, it is mandatory to check that the contact details of the importer established in the Union are also present (name, postal and electronic address, as per Art. 11(3)).
  • Presence of safety instructions and information: Verify that the product is accompanied by instructions and information on safety (when necessary) written in a language easily understood by consumers in the Member State where it is sold.

Furthermore, the distributor is directly responsible for ensuring that, during the period the product is under their responsibility, storage or transport conditions do not compromise its safety and compliance with labeling requirements.

These obligations, however crucial, represent ordinary diligence. Yet, there is a scenario that propels the distributor into a completely different dimension of responsibility, transforming them from a checker into the sole guarantor of product safety.

When Does a Distributor Become a Manufacturer?

There is a specific circumstance in which a distributor ceases to be a simple intermediary and assumes, for all legal purposes, the full responsibility of a manufacturer. The rule defined by Article 13(1) of Regulation (EU) 2023/988 is absolute and unambiguous:

a natural or legal person is to be considered a manufacturer for the purposes of this Regulation and is to be subject to the obligations of the manufacturer pursuant to Article 9, if that natural or legal person places a product on the market under his or her name or trademark.

The implications of this rule are enormous. The moment a distributor affixes their logo or brand to a third-party product, they are not just performing a simple marketing operation, but a legal act that radically changes their status.

From the moment the brand is applied, the company’s entire legal and operational framework for that product must change. The company is no longer required only to perform basic checks, but inherits the entire package of legal obligations and responsibilities that the GPSR assigns to the manufacturer.

To understand the scope of this change, let’s analyze a very common practical case.

The Practical Example: The “Private Label” Product and the Customs Risk

Let’s consider a common operational scenario: an Italian distribution company commissions the production of a batch of goods in China. Once imported, the company affixes its own brand to the product and markets it on the European market through its sales channels.

In this situation, under European law, the Italian company is no longer a distributor or a simple importer: it is, for all intents and purposes, the manufacturer of the product. This legal qualification exposes it directly to the most concrete and immediate operational risk: the blocking of goods at customs.

When the goods arrive at the EU border, customs authorities can stop the shipment. At that point, they will not turn to the Chinese producer, but to the Italian company whose name appears on the product. The latter will have to demonstrate, with documentary evidence, the full compliance and safety of the product according to European regulations. Being unprepared for this request means the paralysis of the supply chain.

What Obligations Does the “Distributor-Turned-Manufacturer” Inherit?

Assuming the role of a manufacturer is not a simple increase in tasks, but the inheritance of an entire compliance management system. It is no longer about verifying others’ documents, but about creating, validating, and legally and technically defending the safety of the product from conception to the final consumer. Based on Article 9 of the GPSR, the distributor who affixes their own brand inherits, among others, the following fundamental obligations:

  • Risk analysis and technical documentation: It is mandatory to perform an internal risk analysis related to the product and to draw up complete technical documentation demonstrating its safety (Art. 9(2)). This file must contain the product description, hazard analysis, and the solutions adopted to mitigate them.
  • Serial production procedures: It is necessary to ensure that serial production maintains a constant level of compliance and safety, by implementing adequate control procedures (Art. 9(4)).
  • Management of dangerous products: If a product proves to be dangerous, the “distributor-turned-manufacturer” has the obligation to immediately take all necessary corrective measures, such as withdrawal from the market or recall from consumers. They must also directly inform consumers and notify the competent authorities through the European Safety Business Gateway portal (Art. 9(8)).
  • Complaints management: It is necessary to establish accessible communication channels (such as a phone number or email address) to allow consumers to file complaints and report incidents. Furthermore, an internal register of such complaints, recalls, and corrective measures taken must be kept (Art. 9(11) and (12)).

These duties impose a structured and proactive approach to compliance, far different from simple commercial intermediation. Ignoring even one of these obligations does not just mean risking a penalty; it means operating outside the law, with all the consequences that arise for management and business continuity.

Frequently Asked Questions (FAQ)

1. I distribute a product made in the EU by another company, but I just apply my own logo sticker. Do I become the manufacturer?

Yes. According to Article 13(1) of the GPSR, anyone who markets a product under their own name or trademark is considered a manufacturer for the purposes of the regulation. Consequently, they assume all the obligations and responsibilities, including drafting the technical documentation and managing any recalls.

2. If I become a ‘manufacturer’, what document is the main proof of conformity?

Unlike other product regulations that require a Declaration of Conformity, the key document required by the GPSR is the technical documentation. As specified in Article 9, this documentation must be based on an internal risk analysis and contain all the necessary information to demonstrate that the product is safe.

3. What is meant by ‘substantial modification’ of a product? Does this also make me a manufacturer?

Yes. A ‘substantial modification,’ according to Article 13(2) and (3) of the GPSR, is a change (physical or digital) not made by the consumer that: 1. affects the safety of the product in a way not foreseen in the original manufacturer’s initial risk analysis; 2. creates a new hazard or increases the level of an existing risk. Anyone who makes such a modification is considered a manufacturer and assumes all related responsibilities.

4. What should I do if a product I distribute under my brand turns out to be dangerous?

The procedure, defined by Article 9(8), is clear and requires immediate action. You must:
1. Immediately take the necessary corrective measures (withdrawal from the market or recall from consumers).
2. Immediately inform consumers of the risk.
3. Notify the market surveillance authorities of the concerned Member States through the European Safety Business Gateway portal.

5. Does my role as a distributor require me to keep track of who supplied me with the product and to whom I sold it?

Yes, upon request from the authorities. Article 15(3) of the GPSR states that all economic operators must be able, on request from surveillance authorities, to identify the economic operator who supplied them with the product and those to whom they have supplied it. This obligation is essential to ensure full traceability throughout the entire supply chain in case of safety issues.

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