REACH regulation compliance for importers and exporters in EU trade

What REACH regulation compliance means for trade

REACH regulation compliance is not a single certificate or a one-time supplier statement. For companies involved in EU trade, it is a documented process for identifying chemicals in products, confirming the company’s legal role, screening restricted or high-concern substances, and keeping supply-chain information up to date. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It applies across the EU and the wider European Economic Area, including Iceland, Liechtenstein and Norway.

A non-EEA exporter is usually not directly responsible under EU REACH. In practice, however, its EU importer or appointed only representative may need the exporter’s composition data, safety data sheets, tonnage information and substance-use details. Without that information, the EU buyer may not be able to complete its own compliance work. For more trade regulatory updates, visit our Compliance section.

This article summarizes the core compliance points reflected in public guidance from the European Chemicals Agency, the European Commission, EUR-Lex and the UK Health and Safety Executive.

Start by defining the product and your role

Many REACH problems start because a company screens the wrong object. REACH treats substances, mixtures and articles differently. A solvent shipped in bulk, a paint formulation, a textile trim, a plastic handle, an electronic component and a complete machine can all trigger different questions. Before asking whether a product is “REACH compliant,” trade teams should confirm what is being supplied and who is placing it on the EEA market.

The practical point is straightforward: REACH compliance should be mapped by legal entity, supply-chain role, product form and substance. A broad declaration that a finished product is “compliant” is not enough unless it states the scope, list version, materials tested or declared, and the regulatory duties covered.

The main REACH obligations that affect imports and exports

Registration for substances at one tonne or more per year

Under REACH, EU or EEA manufacturers and importers generally must register substances with ECHA before manufacturing or importing them at one tonne or more per year. This applies to substances on their own and to substances contained in mixtures. In certain cases, it can also apply to substances in articles, especially where the substance is intended to be released under normal or reasonably foreseeable conditions of use.

For non-EEA exporters, the registration duty normally sits with the EEA importer, unless a qualified only representative established in the EEA has been appointed to take over the importer’s REACH registration responsibilities. This distinction matters commercially. An EU buyer may ask whether the tonnage it imports is covered by an existing registration or only representative arrangement. If it is not covered, the buyer may face delays, added costs or an inability to place the substance on the EEA market.

Candidate List and SVHC duties for articles

The Candidate List includes substances of very high concern, often called SVHCs. When an article contains a Candidate List substance above 0.1% weight by weight, suppliers must provide recipients with enough information to allow safe use of the article, including at least the name of the substance. Consumers may also request this information, and suppliers must respond within 45 days.

For complex products, the 0.1% threshold is assessed at the level of each article within the complex object, not only at the level of the final assembled product. This is a critical detail for importers of electronics, machinery, apparel, vehicles, furniture and consumer goods. A complete product may appear low risk when tested as a whole, while one gasket, cable, coating, plasticizer-containing part or metal component could still trigger communication duties.

EU producers and importers of articles may also need to notify ECHA if a Candidate List substance is present above 0.1% in relevant articles and the total quantity of that substance in those articles exceeds one tonne per year. Separate SCIP database duties under the Waste Framework Directive have applied to suppliers of articles containing Candidate List substances above 0.1% on the EU market since 5 January 2021.

Authorisation for substances in Annex XIV

Authorisation is different from Candidate List screening. A substance may move from the Candidate List to Annex XIV, known as the Authorisation List. After its sunset date, a listed substance cannot be used or placed on the market for a covered use unless an authorisation has been granted or an exemption applies. Authorisation is use-specific, so a substance authorised for one use does not automatically become lawful for every use.

Importers and downstream users should check whether their specific use is covered in the supply chain. If a downstream user relies on an authorisation granted to an upstream actor, it must comply with the conditions of that authorisation. ECHA guidance also notes that downstream users of an authorised substance must notify ECHA of their use within the required timeframe after first supply.

Restrictions under Annex XVII

Restrictions are often the most relevant REACH control for finished goods. Annex XVII restrictions can ban or limit the manufacture, placing on the market, import or use of a substance on its own, in a mixture or in an article. Unlike registration, a restriction may apply even below one tonne per year. It may also apply to a specific product category, concentration limit, consumer use, professional use or placing-on-the-market condition.

For trade compliance, this means an importer should not stop at the Candidate List. A product with no reportable SVHC above 0.1% may still fail REACH if it contains a restricted substance above the applicable limit or is sold for a prohibited use. Annex XVII screening should therefore be product-specific and substance-specific.

A practical workflow for REACH checks

A workable REACH program does not need to be complex, but it does need a clear structure. The following workflow is suitable for importers, exporters, sourcing teams and compliance coordinators handling chemicals, materials, parts or finished goods for the EU market. See also: Customs.

1. Confirm the market and legal entity. Identify whether the shipment is destined for the EU or EEA, and which legal entity will act as importer, distributor, downstream user or article supplier.
2. Classify the product form. Decide whether the item is a substance, mixture, article or complex object. Do not treat all finished goods as exempt from chemical rules.
3. Collect substance-level data. Request CAS numbers, EC numbers, concentration ranges, SDS documents, material declarations and supplier evidence. For articles, collect component-level data where possible.
4. Check registration coverage. For substances and mixtures, verify whether annual import volume reaches the one-tonne threshold and whether the substance is covered by the correct registrant or only representative.
5. Screen the Candidate List. Check whether any article or component article contains SVHCs above 0.1% weight by weight, and prepare recipient or consumer communication where needed.
6. Screen Annex XIV and Annex XVII. Review authorisation and restriction status separately. A substance can create risk through one list even when another list does not apply.
7. Prepare customer-facing documents. Use precise declarations that state the product scope, date of review, substance list checked, threshold applied, and evidence basis.
8. Set an update trigger. Review compliance when suppliers, materials, formulations, manufacturing sites, product uses, shipment volumes or regulatory lists change.

This workflow also supports purchasing controls. Buyers should require suppliers to disclose material changes, support updated SVHC screening and provide documentation quickly enough to answer EU customer or consumer requests.

Documents buyers commonly request

There is no official “REACH certificate” that automatically proves all obligations are satisfied for every product. In practice, buyers often request a document package that supports a compliance conclusion. The right package depends on the product type.

• REACH declaration. A supplier statement should define the product, date, substance lists checked, threshold, and whether it covers SVHC communication, restrictions, registration status or all three.
• Safety data sheet. An SDS is central for hazardous substances and mixtures, and extended SDS information may include exposure scenarios and risk management measures.
• Material declaration. Component-level declarations are especially important for electronics, machinery, textiles and other complex products.
• Laboratory test report. Testing can support due diligence for targeted substances, but it cannot replace full supply-chain knowledge for every possible SVHC or restricted substance.
• Only representative confirmation. Where a non-EEA exporter uses an only representative, EU buyers may need confirmation that the relevant substances, uses, importers and tonnage are covered.
• SCIP-related data. If articles contain Candidate List substances above 0.1%, EU suppliers may need information suitable for SCIP notification and downstream communication.

A useful declaration avoids vague wording. Instead of saying “all products are REACH compliant,” it should say which product codes were reviewed, which regulatory lists were checked, what concentration threshold was used, and whether the statement relies on supplier declarations, formulation knowledge, testing or a combination of evidence.

Common mistakes that increase compliance risk

REACH enforcement is handled by national authorities in EU and EEA countries. Documentation quality can therefore matter during customer audits, marketplace reviews, customs-related checks or market surveillance. These mistakes commonly create avoidable risk:

• Treating REACH as a one-page certificate. A certificate without substance scope, date and evidence may not answer the real legal question.
• Checking only the final assembled product. Article duties may apply to individual component articles inside a complex product.
• Ignoring restrictions after passing SVHC screening. Candidate List status and Annex XVII restrictions serve different purposes.
• Assuming low volume removes all obligations. Low volume may affect registration, but restrictions and communication duties can still apply.
• Using outdated supplier statements. The Candidate List and restriction entries can change, so old declarations may not reflect current requirements.
• Confusing EU REACH and UK REACH. Great Britain operates UK REACH separately, while EU REACH continues to be relevant for the EU market and Northern Ireland under current UK guidance.
• Not linking compliance to purchasing controls. If suppliers can change formulations without notice, the importer may lose the evidence needed for accurate declarations.

For importers and exporters, the best control is not a bigger file. It is a file that answers the right questions. The evidence should connect the product, material, substance, supplier, market, date and applicable REACH duty.

Frequently asked questions

Does REACH apply to finished goods?

Yes. REACH can apply to finished goods when they are articles or complex products placed on the EU or EEA market. The most common issue is whether any article within the product contains a Candidate List substance above 0.1% weight by weight, or whether an Annex XVII restriction applies to a substance in the product.

Is a REACH certificate legally required?

REACH does not work like a simple product certification scheme. Buyers may request a REACH declaration, but the value of that document depends on its scope and supporting evidence. A reliable declaration should identify the product, review date, substance lists, thresholds and evidence basis.

Who is responsible when a non-EEA company exports to the EU?

The direct REACH obligations generally fall on the EU or EEA importer, downstream user, supplier or appointed only representative. However, a non-EEA exporter often has a practical responsibility to provide composition, safe-use and supply-chain information. Without that information, the EU customer may be unable to complete its own compliance duties.

How often should REACH compliance be reviewed?

At minimum, companies should review REACH status when a material, supplier, formulation, manufacturing process, product use, importing legal entity or annual tonnage changes. A scheduled review is also important because the Candidate List, Authorisation List and Restriction List can be updated over time.

Do EU REACH and UK REACH use the same registration?

No. UK guidance states that UK REACH and EU REACH operate independently where both regimes are relevant. Great Britain has its own UK REACH system, while EU REACH remains important for goods placed on the EU market. Companies trading with both markets should check both regimes rather than assuming one review covers all sales.

Bottom line for trade compliance teams

REACH regulation compliance is a supply-chain discipline. Importers and exporters should move from broad supplier assurances to substance-level evidence, component-level article screening and documented list checks. The most useful compliance file shows who is responsible, what product was reviewed, which substances and thresholds were considered, and how the conclusion will be kept current when regulations or materials change.