GPSR Requirements for EU Product Sales
What does GPSR require for selling products in the EU?
GPSR (Regulation (EU) 2023/988) has applied since 13 December 2024. It replaced Directive 2001/95/EC. Its core rule is that "economic operators shall place or make available on the market only safe products" (Article 5). Around that rule it sets duties by role: a risk analysis and technical documentation, product traceability and contact details, an economic operator established in the EU for every product, rules for online listings, accident and dangerous-product notifications, and recall and remedy rules [1][2][3].
Approach: I read the current consolidated English text of Regulation (EU) 2023/988 (the 29 May 2026 consolidation, which includes amendment M1, an emergency-procedures chapter). The tasks that Article 16 takes over from Regulation (EU) 2019/1020 Article 4(3) are not set out here, because I did not read that regulation.
Scope
- What it covers: consumer products, new or used, sold for payment or free. This includes products "likely… to be used by consumers even if not intended for them" (Art. 3(1); Art. 2(3)) [4][5].
- What it excludes: medicines, food, feed, plant protection products, animal by-products, living plants and animals, some aircraft and transport equipment, and antiques (Art. 2(2)) [5].
- Products under EU harmonisation legislation (CE-marked sectors, for example):
- Chapter II applies only to risks that the sector law does not cover.
- Chapter IIa, Chapter III Section 1, and Chapters V, VII and IX to XI do not apply at all (Art. 2(1)) [5].
- Online sales: an offer counts as making the product available in the EU if it is targeted at EU consumers, meaning the operator "directs, by any means, its activities to one or more Member States" (Art. 4) [6].
How safety is assessed
- Factors to weigh (Art. 6): design and composition, packaging, interaction with other products, labelling and warnings, vulnerable users, products that look like food or appeal to children, and, where the product's nature requires it, cybersecurity and evolving or learning functions [7].
- Presumption of conformity (Art. 7): a product is presumed safe if it meets European standards whose references are published in the Official Journal. Where no such standard exists, conformity with national law is the fallback. Authorities can still act if a product is dangerous despite the presumption [8].
- Where the presumption does not apply (Art. 8): other evidence counts, such as other standards, Commission guidelines, the state of the art, and reasonable consumer expectations [9].
- Crisis mode (Arts 8a-8b): wider presumptions apply only during an internal market emergency activated under Regulation (EU) 2024/2747, and only for products designated as crisis-relevant goods [10][11].
Duties by role
| Role | Key "shall" obligations |
|---|---|
| Manufacturer (Art. 9) | Before placing on the market: carry out an internal risk analysis and draw up technical documentation; keep it up to date and keep it for 10 years. Keep series production in conformity. Put a type, batch or serial number on the product. Give name, trade name or mark, and postal and electronic address on the product (or, if not possible, on the packaging or an accompanying document). Provide clear instructions and safety information in a language set by each Member State. Provide public complaint channels, investigate complaints, and keep a complaints and recall register (personal data at most 5 years). If a product is dangerous: immediately take corrective action, inform consumers, and notify authorities through the Safety Business Gateway [12] |
| Importer (Art. 11) | Before placing on the market: ensure the product complies with Art. 5 and that the manufacturer has met Art. 9(2), (5) and (6). Add its own name and address without hiding the manufacturer's label. Ensure instructions are present, keep a copy of the technical documentation for 10 years, and check that complaint channels exist (provide them if not). If a product is dangerous: notify through the Safety Business Gateway and ensure corrective action [13] |
| Distributor (Art. 12) | Verify the manufacturer and importer identification, labelling and instructions before selling. Do not sell non-conforming products. If a product is dangerous: inform the manufacturer or importer and ensure authorities are informed through the Safety Business Gateway [14] |
| Authorised representative (Art. 10) | Optional; the manufacturer "may" appoint one by written mandate. The mandate must cover at least: giving authorities information on request, informing the manufacturer of dangerous products, making notifications, and cooperating with authorities [15] |
| Own-brander or substantial modifier (Art. 13) | Treated as the manufacturer [16] |
| All economic operators | Have internal processes for product safety (Art. 14). Cooperate with market surveillance authorities. Be able to present risk information for 10 years and supplier and customer traceability information for 6 years (Art. 15) [17][18] |
EU responsible person (Art. 16)
- The rule: a product "shall not be placed on the market unless there is an economic operator established in the Union" who carries out the tasks in Article 4(3) of Regulation (EU) 2019/1020.
- Regular checks: where the product's risks make it appropriate, that operator must regularly check the product against the technical documentation and the Art. 9(5) to (7) requirements, and keep documented evidence of the checks.
- Labelling: its name and contact details must appear on the product, packaging, parcel or an accompanying document [19].
Selling online
- Sellers (Art. 19): each offer must clearly show:
- the manufacturer's details;
- the EU responsible person, if the manufacturer is not established in the EU;
- a picture, the product type and other identifiers;
- the warnings and safety information, in the local language [20].
- Online marketplaces (Art. 22):
- Single points of contact for authorities and for consumers, and registration on the Safety Gate Portal.
- Act on authority orders within two working days and process product-safety notices within three working days.
- A listing interface that lets traders provide the same four items and a self-certification.
- Suspend traders who frequently offer non-compliant products, after a prior warning.
- Notify affected consumers directly in recalls [21].
Accidents and recalls
- Accidents (Art. 20): the manufacturer must notify the authority of the Member State where the accident happened, through the Safety Business Gateway, "without undue delay". This covers accidents causing death or serious adverse effects on health and safety. Importers and distributors must tell the manufacturer. If the manufacturer is outside the EU, the responsible person ensures the notification is made [22].
- Telling consumers (Art. 35): notify identifiable affected consumers directly. If not everyone can be reached, use wide-reach channels such as the website, social media, newsletters and shops [23].
- Recall notice (Art. 36): it must carry the headline "Product safety recall" and must not use words such as "voluntary" or "precautionary" [24].
- Remedies (Art. 37): the remedy must be cost-free, and consumers get a choice of at least two of repair, replacement or a refund at least equal to the price paid. Only one may be offered if the others are impossible or would cost the operator disproportionately. Consumers never pay return shipping [25].
Other points
- Digital information (Art. 21): labelling information may be given digitally only in addition to the physical labelling, not instead of it [26].
- Traceability systems (Art. 18): the Commission may set up traceability systems for products likely to present a serious risk, by delegated act [27].
- Penalties (Art. 44): each Member State sets its own, and they must be "effective, proportionate and dissuasive" [28].
- Transition (Art. 51): products that conformed to Directive 2001/95/EC and were placed on the market before 13 December 2024 may still be sold [29].
If you tell me the product category and your role (for example, a non-EU brand selling through a marketplace), I can narrow this down to the obligations and any sector law that applies to you.
Who needs an EU responsible person?
Every consumer product within GPSR's scope needs an EU responsible person: it "shall not be placed on the market unless there is an economic operator established in the Union" who handles the Article 4(3) tasks of Regulation (EU) 2019/1020 for that product (GPSR Art. 16(1)). Strictly, the requirement attaches to the product, not to a type of company. In practice it only takes extra work for manufacturers established outside the EU. An EU-established manufacturer fills the role itself.
Approach: I read GPSR Articles 2, 10, 11, 16, 19 and 20 in the 29 May 2026 consolidated text. I could not open Regulation (EU) 2019/1020 itself on EUR-Lex, so who can act is taken from the Commission's official guidance on its Article 4, C(2021) 1461. That guidance is not legally binding.
Which products need one
- Products GPSR covers: Article 16(1) says Article 4(2) and (3) of 2019/1020 "shall apply to products covered by this Regulation". It also says references in Article 4(3) to "Union harmonisation legislation" are read as "this Regulation" [19].
- Products outside GPSR: medicines, food, feed, plant protection products, living plants and animals, animal by-products, certain transport equipment and aircraft, and antiques. These are not caught by Art. 16 [5].
- CE-marked sector products: Article 4 of 2019/1020 already requires an EU operator for the sector laws it lists. The guidance names toys, electrical equipment, radio equipment, EMC, RoHS, ecodesign, gas appliances, construction products, machinery, outdoor noise, ATEX, pressure equipment, simple pressure vessels, pyrotechnics, recreational craft, measuring instruments, non-automatic weighing instruments, PPE and drones (guidance §2.1).
- Sectors with their own regime: cosmetics need a responsible person under Article 4 of Regulation 1223/2009, and marine equipment needs an authorised representative. The Article 4 guidance does not cover these (guidance footnote 3).
Who can be the responsible person
The guidance lists four types of operator, all established in the EU (guidance §2.2):
- The manufacturer, if it is established in the EU.
- The importer, where the manufacturer is not established in the EU.
- An authorised representative holding a written mandate from the manufacturer for the Article 4(3) tasks. Under GPSR, appointing one is something the manufacturer "may" do (Art. 10(1)) [15].
- A fulfilment service provider, but only where there is no EU manufacturer, importer or authorised representative.
How it works in each supply chain (Commission guidance)
- EU manufacturer: the manufacturer is the responsible person, unless it has mandated an authorised representative.
- Non-EU manufacturer selling through EU shops: the importer is the responsible person, unless there is a mandated authorised representative.
- Non-EU manufacturer selling online, with an EU fulfilment centre and no importer: the fulfilment service provider is the responsible person. It must first get from its client or the manufacturer what it needs to do the job, such as the declaration of conformity.
- Shipped from outside the EU directly to EU consumers: only a mandated authorised representative can fill the role. Without one, "the product may not be offered for sale to EU end-users."
- Made in the EU by a manufacturer established outside the EU: there is neither an EU manufacturer nor an importer. Only an authorised representative or a fulfilment service provider can act (guidance footnote 16).
- Non-EU company buying products made outside the EU and selling them under its own brand: that company is the manufacturer. An EU company doing the same is an EU manufacturer, and there is then no "importer" (guidance footnote 15).
What GPSR adds for the responsible person
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Checks: where appropriate given the product's risks, it "shall regularly check":
- that the product matches the technical documentation;
- that it meets the Art. 9(5) to (7) requirements on traceability, manufacturer contact details and instructions.
It must give market surveillance authorities documented evidence of these checks on request (Art. 16(2)) [19].
-
Label: its name and postal and electronic address must appear on the product, its packaging, the parcel or an accompanying document (Art. 16(3)). The guidance adds that a website may be given in addition to a postal address, but not instead of it.
-
Online listings: where the manufacturer is not established in the EU, the offer must show the responsible person's name and postal and electronic address (Art. 19(b)) [20].
-
Accidents: for a non-EU manufacturer, the responsible person who knows of an accident "shall ensure that the notification is made" (Art. 20(4)) [22].
-
Marketplaces: where an online marketplace only hosts third-party sellers, Article 4 places no specific obligation on it. It must still remove listings once it has actual knowledge that a product has no responsible person (guidance §2.4).
If you tell me your supply chain (where the brand owner is based, and whether you ship from stock in the EU or direct from outside it), I can say which of the four operators would be your responsible person.
How do I report a dangerous product?
How you report depends on who you are. Businesses (manufacturers, importers, distributors, online marketplaces and responsible persons) report to market surveillance authorities through the Commission's Safety Business Gateway web portal (GPSR Art. 27). Consumers and other interested parties can report to the Commission through a separate section of the Safety Gate Portal (Art. 34(3)), or complain to their national competent authority (Art. 33(4)) [30][31][32].
Approach: I read Articles 9, 11, 12, 20, 22, 25 to 27, 33 and 34 of Regulation (EU) 2023/988, in the 29 May 2026 consolidated text.
If you are a business: what goes through the Safety Business Gateway
Article 27(1) lists what the Gateway is for: the reports under Art. 9(8)-(9), 10(2)(c), 11(2) and (8), 12(4), 20 and 22 [30].
| Role | Trigger | What you "shall" do |
|---|---|---|
| Manufacturer (Art. 9(8)) | You consider, or have reason to believe, that a product you placed on the market is dangerous | Immediately: (a) take corrective measures, including withdrawal or recall as appropriate; (b) inform consumers under Art. 35 and/or 36; (c) inform the market surveillance authorities of every Member State where the product was made available, through the Gateway. Give the risk, the corrective measures already taken and, if available, the quantity still on the market in each Member State [12] |
| Importer (Art. 11(2), (8)) | Same trigger | Immediately: inform the manufacturer, make sure corrective measures are taken (and take them yourself if they have not been), make sure consumers are informed, and notify the authorities through the Gateway with the same details [13] |
| Distributor (Art. 12(4)) | A product is dangerous, or lacks the required traceability, contact or instruction information | Immediately inform the manufacturer or importer. Make sure corrective measures are taken. Make sure the authorities are immediately informed through the Gateway, with the risk, the number of products and any measures taken [14] |
| Online marketplace (Art. 22(12)(d)-(e)) | Actual knowledge that dangerous products were offered on its interface, or an accident it is told about that caused serious risk or actual damage | Immediately inform the authorities through the Gateway about dangerous products. Notify such accidents without undue delay through the Gateway, and inform the manufacturer [21] |
Accidents (Art. 20)
- Who reports: the manufacturer "shall ensure" the accident is notified through the Gateway, without undue delay from the moment it knows about it.
- Where: to the competent authorities of the Member State where the accident happened.
- What triggers it: an occurrence that resulted in someone's death, or in serious adverse effects on their health and safety, permanent or temporary. This includes injuries, other damage to the body, illnesses and chronic health effects.
- Content: the product type and identification number, and the circumstances if known.
- Importers and distributors: they must tell the manufacturer without undue delay. The manufacturer then notifies, or instructs one of them to do it.
- Non-EU manufacturer: the EU responsible person who knows of the accident "shall ensure that the notification is made" [22].
Alerting consumers
The Commission must make sure that manufacturers can provide consumer alerts through the Gateway, and that these appear on the Safety Gate Portal without undue delay (Art. 9(9)) [12].
If you are a consumer or other interested party
- Safety Gate Portal (Art. 34(3)): you can inform the Commission of products that might present a risk. The Commission checks the information is accurate, forwards it to the relevant Member States where appropriate, and tells you what it did. The detailed modalities are set by implementing act (Art. 34(4)) [31].
- National authorities (Art. 33(4)): Member States "shall" let you complain to the competent authorities, including about unsatisfactory recall remedies. Complaints "shall be followed up appropriately", and you get information on the follow-up [32].
- Directly to the company: manufacturers must publish channels (phone, email or a website section) for complaints and accident reports (Art. 9(11)). Importers must provide them if they are missing (Art. 11(9)) [12][13]. Marketplaces must have a single point of contact for consumers on product safety (Art. 22(2)) [21].
What happens next (authority side)
- National authorities: they notify corrective measures on serious-risk products through the Safety Gate Rapid Alert System within four working days after the measure is taken (Art. 26(1), (4)) [33].
- Single national contact point: each Member State designates one to check notifications are complete before they are submitted to the Commission (Art. 25(2)) [34].
- The Commission: if it identifies likely serious-risk products that no Member State has notified, including from consumer reports, it informs the Member States, which must verify (Art. 26(8)) [33].
If you tell me your role and the Member States where the product was sold, I can set out the exact notification sequence and who in your supply chain files it.