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REACH and GPSR: importer obligations when bringing products into the EU

Two EU regimes catch many imported consumer and industrial goods that have nothing to do with CE marking: REACH, which regulates chemical substances, and the General Product Safety Regulation (GPSR), Regulation (EU) 2023/988, which sets the safety baseline for consumer products. Both place duties on the importer as the party that brings a non-EU product onto the EU market. The GPSR has applied since 13 December 2024. This guide summarises the importer's role; the legal texts and the official tools are the authority, so confirm the current wording before relying on any detail below.

By Hiram Trade Editorial Desk

Published

9 min read

REACH: what it is and where importers are affected

REACH is Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals. It applies to substances on their own, in mixtures, and in some cases in articles. The European Chemicals Agency (ECHA) administers much of it. Its logic is "no data, no market": the person who places a substance on the EU market must be able to show it has been registered where required.

Importers are affected in four main ways.

1. Registration of substances and mixtures

An EU importer of a substance, on its own or in a mixture, above the volume threshold set in the Regulation is, in general, the registrant and must register it with ECHA, unless an exemption applies or the non-EU manufacturer has appointed an only representative in the EU who registers on behalf of its importers. Whether a substance needs registration depends on its identity, the tonnage per year and the use. Check the current thresholds and exemptions in the Regulation and ECHA guidance; do not rely on a supplier's statement that the product is "REACH compliant".

2. Substances in articles

An article is an object whose shape, surface or design determines its function more than its chemical composition (a garment, a toy, a piece of furniture). For articles, REACH can impose:

  • registration where a substance is intended to be released from the article under normal use, above the threshold;
  • notification to ECHA and a duty to communicate information where an article contains a substance of very high concern (SVHC) from the Candidate List above the concentration and tonnage thresholds set in the Regulation;
  • a duty to inform recipients and, on request, consumers, when an article contains an SVHC above 0.1 percent weight by weight; confirm the current wording and the case-law on how the threshold is applied to complex products.

3. Restrictions (Annex XVII)

Annex XVII lists substances and groups of substances restricted in the EU, with conditions per use or article type. Restrictions apply regardless of volume: a restricted substance in a product can make it illegal to place on the market. Typical areas where importers meet them include certain metals and plasticisers in consumer goods, and certain dyes in textiles and leather. Check the current Annex XVII entries for the product category before ordering; they are amended periodically.

4. Authorisation (Annex XIV)

Substances on the Authorisation List may be used or placed on the market only under an authorisation granted for a specific use. Check the list for your inputs and for substances in mixtures you import.

Safety data sheets and downstream duties

For hazardous substances and certain mixtures, the supplier must provide a safety data sheet (SDS) in the language of the receiving country, and the importer passes the information on to its customers. Classification, labelling and packaging of substances and mixtures follow the CLP Regulation, Regulation (EC) No 1272/2008. An SDS or label from a non-EU supplier that is not in line with CLP and REACH is a common problem.

Only representative

A non-EU manufacturer can appoint an only representative established in the EU to carry out the registration duties of importers. If your supplier says its product is "pre-registered" or that it has an EU representative, ask for the registration number and for proof of the only representative's appointment. ECHA's public databases show registered substances, but not every importer relationship, so confirm with the supplier in writing.

GPSR: what it covers

The GPSR, Regulation (EU) 2023/988, replaced the General Product Safety Directive and has applied from 13 December 2024. It covers consumer products placed on the EU market, including online sales to EU consumers, to the extent they are not covered by more specific EU harmonisation rules on the aspects those rules regulate. For example, CE-marked toys follow the toy rules for their covered risks, while the GPSR fills gaps and adds duties, such as for online marketplaces and recalls. The rules for CE products are in CE marking when importing into the EU.

The core requirement is that only safe products may be placed on the market. A product is assessed taking into account its characteristics, packaging, instructions, effect on other products, the categories of consumers likely to use it, and foreseeable use and misuse.

Importer duties under the GPSR

According to the Regulation, before placing a product on the market the importer must, in summary:

  1. verify the manufacturer has carried out its duties: the internal risk analysis and technical documentation, and that the product bears the required identification and information;
  2. put its own details on the product (name, registered trade name or trademark, postal and electronic address), or, if that is not possible, on the packaging or an accompanying document;
  3. ensure instructions and safety information accompany the product in a language easily understood by consumers in the Member State of sale, where such information is required;
  4. keep the technical documentation (or a copy) at the disposal of market surveillance authorities for the period set in the Regulation and be able to provide it on request; confirm the current period;
  5. keep a register of complaints, recalls and non-compliant products and inform the manufacturer and distributors;
  6. take corrective action when it considers or has reason to believe a product is not safe, including withdrawal and recall, and notify authorities through the Safety Business Gateway when a product presents a risk;
  7. cooperate with authorities and, on request, provide information and documentation necessary to demonstrate conformity;
  8. ensure storage and transport conditions do not jeopardise the product's safety while the product is under its responsibility.

The Regulation also covers distance and online sales: offers must carry product and manufacturer identification and safety information. An importer selling through its own website or a marketplace should check these information requirements.

Responsible person in the EU

Under EU product safety law there must be an economic operator established in the EU for each product, so authorities have someone to contact. For GPSR products the responsible economic operator is, in order, the manufacturer if established in the EU; otherwise the authorised representative, the importer, or a fulfilment service provider established in the EU. Where the manufacturer is outside the EU, the importer is normally that person unless an authorised representative has been appointed in writing. Related market surveillance rules are in Regulation (EU) 2019/1020. Confirm the current wording of the provisions before assigning roles in a contract.

This means an importer cannot treat compliance as only the supplier's problem. If you are the importer of record for a non-EU manufacturer's product, you are, in law, the responsible party in the EU unless the manufacturer has an EU representative.

When the importer becomes the manufacturer

An importer that places a product on the market under its own name or brand, or modifies a product in a way that may affect its safety, is treated as the manufacturer and takes on the manufacturer's duties, including the risk analysis and technical documentation. This is common in private-label trade. See also CE marking when importing into the EU.

Documentation to request from the supplier

For both regimes ask before ordering, and put the commitments in the contract:

  • Product identification: model, batch or serial number, materials, components, intended users.
  • REACH: registration numbers or the only representative's details for substances and mixtures; the SVHC declaration for articles, against the current Candidate List; safety data sheets and CLP labelling for hazardous mixtures; test reports for restricted substances relevant to the category.
  • GPSR: the manufacturer's internal risk analysis; technical documentation including a general description, components and materials, relevant standards applied, test reports; instructions and warnings in the destination language; batch or type identification.
  • Corrective action cooperation: the supplier's duty to respond to incident reports and recalls, and to provide documents requested by authorities.
  • Change control: notification of any material change in composition or design.

Test reports and certificates should come from named, independent laboratories with the scope and date stated. A report for a different model is not evidence for yours. A pre-shipment inspection can include label, instruction and sample checks.

Customs and classification

Market surveillance and customs authorities cooperate at the border. Goods can be held when documentation is missing or a risk is suspected. Prepare the importer details and documentation before arrival. Tariff classification does not decide REACH or GPSR scope, but the correct code helps identify which rules may apply; see HS/CN classification, and for the import process itself see EU customs clearance and EORI.

Checklist

  • Product classified: substance, mixture or article; consumer product or not; any harmonisation act (CE) that applies.
  • REACH: registration status, only representative or own registration, SVHC check against the current Candidate List, Annex XVII and Annex XIV checked.
  • CLP classification and labelling, and SDS in the language of the country of sale, where hazardous.
  • GPSR: manufacturer's risk analysis and technical documentation seen or access secured.
  • Importer name and address on the product, packaging or accompanying document.
  • Instructions and safety information in the language of the country of sale.
  • Responsible economic operator in the EU identified in the contract.
  • Complaints and recall procedure and register set up; contact for authorities named.
  • Supplier commitments on documentation, test reports and change control written into the contract.

Hiram does not verify documents, test reports or compliance status; responsibility for product compliance lies with the manufacturer and the importer. You can compare suppliers and their offers on the Hiram market.

This article is informational and not legal advice. REACH, CLP and GPSR are amended and supplemented by guidance; check ECHA, the European Commission and the legal texts for current requirements, and consult a compliance specialist for chemicals and higher-risk products.

Sources

This article is for information only and is not legal, tax or customs advice. Rules and rates change: check the current official sources or consult an adviser before you decide.

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