Pravano · Knowledge base · Product safety / GPSR

The responsible person in the EU under the GPSR (Article 16): a guide

Methodology: Marek Galetka, founder of Pravano. English translation of our Czech article, which a person approved before publication; every number, date and legal reference of the translation is checked automatically against the original.

Cross-checked as of 5 October 2026 · based on primary sources

Updated 5 October 2026. Based on Regulation (EU) 2023/988 (GPSR) and Czech Act No. 387/2024 Coll.. An informative readiness check, not a legal service or an official audit. Original: česká verze.

Since 13 December 2024, Regulation (EU) 2023/988 on general product safety (GPSR) has applied directly in all EU member states – without the need for national transposition. One of its most practical and at the same time most frequently underestimated obligations is Article 16: only a product for which there is a specific economic operator established in the EU may enter the EU market. If this person is missing, the product may not be on the market. Article 16 does not apply to products subject to specific requirements of EU harmonisation legislation – for products covered by the legislation listed in Article 4(5) of Regulation (EU) 2019/1020, a similar obligation follows from Article 4 of that regulation.

This article explains who can be the responsible person, what must be stated on the product or packaging, and what this specifically means for online shops importing goods from third countries or running dropshipping. It is general information, not individual legal advice for a specific company.

What applies with certainty from 13 December 2024

The GPSR has been binding and directly applicable since 13 December 2024. The regulation was adopted on 10 May 2023, published in the Official Journal of the EU on 23 May 2023 and entered into force on 12 June 2023 (on the twentieth day after publication under Article 52, first subparagraph); its application was deferred to 13 December 2024. It replaces and repeals Directive 2001/95/EC on general product safety (GPSD) – existing references to the repealed directive are construed as references to the GPSR.

The GPSR applies to non-food consumer products placed on the EU market, unless there are specific EU rules with the same safety objective for them (Article 2). For products with specific rules (for example toys or electrical appliances bearing the CE marking), the GPSR applies to the aspects and risks not covered by those rules, and Articles 19 and 20 and the recall rules (Articles 35 to 37), among others, also apply to them; Article 16 does not apply to them, and for products covered by the legislation listed in Article 4(5) of Regulation (EU) 2019/1020 the responsible person is governed directly by Article 4 of that regulation (Article 2(1)). Excluded from the scope are, for example, medicinal products, food and feed, live animals and plants, or antiques.

The basic rule is simple: economic operators may place or make available on the market only safe products (Article 5). Article 16 then adds a condition without which a product cannot be placed on the market at all – the existence of a responsible person in the EU.

Article 16 of the GPSR: four roles, one obligation

Article 16 of the GPSR provides that a product may be placed on the EU market only if at least one of the following operators established in the EU exists:

1. A manufacturer established in the EU – if you manufacture the product yourself in the EU, you are automatically the responsible person (Article 9).
2. An importer – a natural or legal person established in the EU who places a product from a third country on the EU market (Article 11).
3. An authorised representative – an operator established in the EU to whom a manufacturer outside the EU has given a written mandate to act on its behalf in GPSR matters.
4. A fulfilment service provider – if none of the operators above exists for the product, this role is taken over by a fulfilment service provider established in the EU.

The key words are established in the EU. Having customer service in the EU or a delivery address is not enough – the operator must have a real registered office or establishment in the EU.

The responsible person also carries out its own tasks (Article 16(1) and (2) of the GPSR in conjunction with Article 4(3) of Regulation (EU) 2019/1020): it verifies that the technical documentation has been drawn up and ensures that the market surveillance authorities can obtain it on request; on a reasoned request of an authority it provides the information and documentation demonstrating conformity in a language easily understood by the authority; where it has reason to believe that a product presents a risk, it informs the authorities; it cooperates with them and makes sure that immediate corrective action is taken, or action to mitigate the risks. In addition, with regard to the possible risks, it periodically checks whether the product complies with the technical documentation and with the requirements on marking and instructions (Article 9(5) to (7)), and on request submits evidence of the checks to the authorities. In the Czech Republic, a breach of these tasks is punishable by a fine of up to CZK 500,000, and failing to check marking and instructions (including the Czech-language requirement) or failing to submit evidence by up to CZK 1,000,000 (Section 10 of Act No. 387/2024 Coll.).

Obligations of a manufacturer in the EU (Article 9)

The manufacturer must ensure the safety of the product, carry out an internal risk analysis, and draw up and keep technical documentation. The product must bear the type, batch or serial number and the name, postal address and e-mail address of the manufacturer.

Obligations of an importer (Article 11)

Before placing a product on the market, the importer must ensure that the product complies with the general safety requirement and that the manufacturer has complied with its obligations under Article 9(2), (5) and (6) (risk analysis, technical documentation, marking; Article 11(1)). The importer also indicates its name and contact details on the product – and only where that is not possible, on the packaging or in an accompanying document (Article 11(3)) – relying only on the manufacturer's details is not enough.

Obligations of a distributor (Article 12)

The distributor (the one who resells the product without importing it) must verify that the product bears the required marking and information from the manufacturer and the importer. The distributor itself is not a responsible person under Article 16 – but if it finds that the marking is missing or incorrect, it may not supply the product further.

What must be stated on the product, the packaging or in the accompanying document

Article 16 of the GPSR expressly requires the name and contact details of the responsible person to be indicated on the product, its packaging, the parcel or an accompanying document. Specifically, this means:

• the name (business name or name of the natural person),
• the postal address (registered office or establishment in the EU),
• the e-mail address.

Article 16(3) requires them to be indicated on the product, on its packaging, on the parcel or in an accompanying document – having them only on the website or in an e-mail to the customer after the purchase is not enough. The requirement “easily visible and legible” is laid down by Article 9(5) for the identification of the product; Article 16(3) does not repeat it in this wording.

Example: you import decorative candles from a Chinese manufacturer and sell them under your own brand. The product or packaging must bear your business name, your postal address in the Czech Republic and your e-mail. If the product bears only the Chinese address of the manufacturer, the obligation under Article 16 is not met.

Obligations of an online shop in distance sales (Article 19)

Article 19 of the GPSR adds a further layer for online shops: the online offer must indicate clearly and visibly:

• the name, registered trade name or registered trademark of the manufacturer and its postal and electronic address – always (point (a)); and in addition, where the manufacturer is not established in the Union, the name and postal and electronic address of the responsible person (point (b)). Points (a) and (b) are cumulative, not alternatives.
• information allowing the identification of the product, including a picture of it and its type,
• any warning or safety information in a language determined by the member state in which the product is made available on the market.

This information must be available directly on the product page – hiding it in the terms and conditions or the website footer is not enough.

Impact on imports from third countries

If you import products from third countries (typically China, Turkey, India) and place them on the EU market, you are an importer and automatically become the responsible person under Article 16.

This brings specific obligations:

• Before the product is first placed on the market, ensure that the product is safe and that the manufacturer has carried out a risk analysis, has technical documentation and has marked the product (Article 11(1)).
• Indicate your name and contact details on the product and, where that is not possible, on the packaging or in an accompanying document (Article 11(3)).
• Ensure that the product is accompanied by clear instructions and safety information in Czech (Article 11(4); Section 8(1) of Act No. 387/2024 Coll.), unless the product can be used safely without them.
• Keep a copy of the technical documentation for ten years after the product has been placed on the market and ensure that the market surveillance authorities can obtain it on request (Article 11(6)).
• If you believe the product is dangerous, act immediately (Article 9(8) for manufacturers, Article 11(8) for importers, Article 12(4) for distributors – the regulation sets no deadline in days): take corrective measures, inform consumers under Article 35 or 36 and notify the market surveillance authorities through the Safety Business Gateway (the portal is established by Article 27).

Example: you order decorative candles from a Taiwanese manufacturer, receive them into your warehouse in the Czech Republic and sell them to customers in the EU. You are the importer. You must have documentation on the safety of the product from the manufacturer, the packaging must bear your company and address, and you bear responsibility for the product being safe.

Dropshipping: the biggest blind spot of the GPSR

From the point of view of Article 16 of the GPSR, dropshipping from third countries is the riskiest model – and at the same time the one where the responsible person is most often missing.

The classic dropshipping model looks like this: a Chinese manufacturer sends the goods directly to a customer in the EU, and an online shop in the Czech Republic only arranges the order. In such a case:

• the manufacturer is not established in the EU,
• the online shop does not physically receive the goods into the EU – this alone, however, is not decisive: if the online shop is established in the EU and is the first to sell a product from a third country to a consumer in the EU in its own name, it places the product on the market and is, by definition, the importer (Article 3, points (7) and (10)),
• no fulfilment provider in the EU is involved.

The result: in such a model, an online shop established in the EU is as a rule itself the importer and therefore the responsible person under Article 16 – with all the obligations under Article 11, including its details on the product or packaging, which it has practically no way of ensuring when the goods are shipped directly by the manufacturer. Until it meets them, the product may not be placed on the EU market.

How to solve it

There are basically three routes:

• You actually fulfil the importer's obligations – you physically receive the goods into the EU (into a warehouse in the Czech Republic or through a logistics partner), fulfil the importer's obligations and indicate your details on the packaging. This means you take on full responsibility.
• You arrange an authorised representative in the EU – the manufacturer outside the EU gives a written mandate to an operator established in the EU to act on its behalf. This representative then acts as the responsible person. Beware: the representative must really exist and be reachable – a fictitious address is not enough.
• You involve a fulfilment provider in the EU – if there is neither a manufacturer in the EU, nor an importer, nor an authorised representative for the product, the role of responsible person is taken over by the fulfilment service provider. A fulfilment service provider established in the EU bears this role directly under the regulation for the products it handles where none of the preceding operators is established in the EU (Article 4(2)(d) of Regulation (EU) 2019/1020 in conjunction with Article 16(1) of the GPSR) – it does not depend on its consent, but agree on the performance of the tasks with it in advance.

What delegated acts will still specify (outlook)

One area of Article 18 of the GPSR has not yet been fully specified: for products that may present a serious risk to health and safety, the Commission may introduce a traceability system. The specific scope, conditions and categories of products to which this system will apply will only be laid down by delegated acts of the Commission. As at 30 September 2026, no such act had been adopted, so no specific obligation follows from Article 18 yet – follow developments on the Commission's website.

Penalties and supervision in the Czech Republic

The GPSR itself does not set specific amounts of fines. Article 44 requires member states to lay down effective, proportionate and dissuasive penalties – their amount and type are governed by national law. In the Czech Republic, supervision of the general safety of non-food consumer products is usually carried out by the Czech Trade Inspection Authority (ČOI), unless another authority is competent for the type of product concerned.

The practical impact of a missing responsible person: the ČOI may order the immediate withdrawal of the product from sale. In a product recall, the economic operator must directly inform all affected consumers who can be identified and offer them a choice of at least two of the three remedies – repair, replacement or an adequate refund of the value of the product, amounting to at least the price paid (Article 37(2)) – the remedy must be effective, free of charge and timely (Article 37(1)), and the consumer does not bear the cost of returning the product (Article 37(5)).

30/60/90-day action plan

First 30 days: map the situation

1. Draw up a list of all the products you place on the EU market and identify for each who is the responsible person under Article 16.
2. For products imported from third countries, check whether you have technical documentation and a risk analysis from the manufacturer.
3. Check the physical marking of products and packaging – do they bear your name, postal address and e-mail?
4. Go through the product pages of your online shop – do they visibly state the name and address of the responsible person (Article 19)?

31–60 days: close the gaps

1. For products where the responsible person is missing or not correctly indicated, decide: will you become the importer, arrange an authorised representative or involve a fulfilment provider?
2. Have labels or packaging redesigned so that they contain the required details – plan ahead, a reprint or new packaging takes time.
3. Update the product pages of your online shop with the mandatory information under Article 19.
4. Register with, or verify your access to, the Safety Business Gateway (Article 27) in case you need to notify a dangerous product (Article 9(8), Article 11(8), Article 12(4)) or an accident (Article 20).

61–90 days: set up processes

1. Introduce an internal procedure for every new product: before it is placed on the market, verify the responsible person, the marking and the documentation.
2. Set up a procedure for the case that you discover a dangerous product – who reports, where and by when.
3. Run a quick GPSR compliance check: free check.

Common misconceptions

Misconception 1: “It is enough if the manufacturer from China sends a declaration of conformity.”
A declaration of conformity (if it exists at all) does not replace the obligation to have a responsible person established in the EU. Article 16 requires a physically existing operator in the EU with a specific address – not a document.

Misconception 2: “As a distributor I do not have to deal with the responsible person – that is the manufacturer's or importer's concern.”
The distributor itself is not a responsible person, but it may not supply the product further if it finds that the marking is missing or incorrect (Article 12). A distributor that knowingly sells a product without a responsible person exposes itself to the risk of sanctions by the ČOI.

Misconception 3: “For dropshipping it is enough to state the address of the Chinese supplier on the website.”
An address outside the EU does not meet the condition of Article 16. The responsible person must be established in the EU. Stating the foreign address of the manufacturer as the “responsible person” is in direct conflict with the regulation.

Summary

Since 13 December 2024, Article 16 of the GPSR has been a hard condition for every non-food consumer product that is not subject to specific requirements of EU harmonisation legislation to enter the EU market: there must be a specific economic operator established in the EU that is responsible for the product. This operator can be the manufacturer in the EU, the importer, an authorised representative or – only if none of them is established in the EU – a fulfilment provider. Its name, postal address and e-mail must be indicated on the product, the packaging, the parcel or in an accompanying document – and for online shops also visibly on the product page.

For importers from third countries, this means direct responsibility and an obligation to have documentation. For dropshippers, it means a fundamental rethink of the model – without a responsible person in the EU, a product cannot lawfully enter the EU market.

If you are not sure whether your specific case meets the requirements of Article 16, start with the free check.

This article is a general explanation, not individual legal advice. A specific overview for your company (Pravano Kompas) comes with the free check – in writing, within 2 working days.