REACH compliance requirements for importers and exporters
What REACH compliance requirements mean for trade teams
REACH compliance requirements are the legal and documentary controls companies need before placing chemical substances, mixtures or certain finished goods on the EU/EEA market. For import and export teams, the practical issue is not simply whether a product has a test report. The team needs to know whether the right legal actor has registered the substance when registration is required, whether substances of very high concern have been communicated when articles exceed 0.1% weight by weight, whether restrictions and authorisation status have been checked, and whether usable safety information has moved through the supply chain. This guide focuses on operational decisions for cross-border shipments and complements our wider Compliance coverage.
The core framework is Regulation (EC) No 1907/2006, commonly known as REACH. It is supported by European Chemicals Agency guidance, European Commission explanations and the legal text published through EUR-Lex. REACH is built around registration, evaluation, authorisation and restriction. In trade operations, problems often arise when teams treat REACH as a single certificate instead of a set of product-specific obligations.
The first decision is role and product type
REACH duties depend on both the product and the company role. A substance is a chemical element or compound. A mixture is made of two or more substances, such as a coating, adhesive, cleaning product or ink. An article is an object whose shape, surface or design is more important to its function than its chemical composition, such as a screw, textile, cable, machine part, toy component or assembled electronic product.
The EU-established importer is usually the legal actor responsible for import obligations. A non-EU manufacturer or exporter cannot remove that responsibility with a generic declaration. However, a non-EU manufacturer, formulator or article producer may appoint an EU-based only representative for certain REACH obligations, including registration-related duties. Trade documents should identify the covered substances, importers, tonnage bands and uses. A statement that a supplier is “REACH compliant” is not enough if it does not show what has actually been covered.
When registration is required
The registration rule is often summarised as “no data, no market.” EU manufacturers and importers must register substances manufactured or imported at one tonne or more per year per company, unless an exemption applies. Registration applies to substances on their own, substances in mixtures and, in certain cases, substances in articles. ECHA explains that potential manufacturers and importers must submit an inquiry and register before manufacture or import begins.
| Situation | REACH trigger | Trade control |
|---|---|---|
| Substance on its own or in a mixture | Imported or manufactured at 1 tonne or more per year per legal entity | Confirm registration, substance identity, tonnage band, registered uses and importer or only representative coverage. |
| Article with intended release | Substance is intended to be released under normal or reasonably foreseeable use and exceeds 1 tonne per producer or importer per year | Check whether Article 7(1) registration is required or whether the use is already covered. |
| Registration dossier at 10 tonnes or more per year | Higher information and assessment duties apply | Confirm whether a chemical safety report and exposure scenarios are required and whether customer uses are covered. |
| Dossier information level | Annex VII for 1 to <10 tonnes, Annexes VII-VIII for 10 to <100, Annexes VII-IX for 100 to <1000, and Annexes VII-X for 1000 or more | Do not rely on a registration number alone; check whether the substance identity and tonnage band match the trade flow. |
Registration is not the same as product approval. It is a dossier-based system in which registrants gather information on intrinsic properties, uses, hazards and risk management. ECHA may examine dossiers through compliance checks, either randomly or because of a concern. Importers should therefore review registration assumptions when volume, use, composition or classification changes.
SVHC duties for articles are often the trade bottleneck
Finished goods can be outside registration but still inside REACH. The most common issue is the Candidate List of substances of very high concern, or SVHCs. ECHA announced on 4 February 2026 that n-hexane and 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts had been added to the Candidate List, bringing the list to 253 entries at that time. For importers, the key point is that the Candidate List changes, and new inclusions can create immediate communication duties.
Under Article 33, suppliers of articles containing a Candidate List substance above 0.1% weight by weight must provide enough information for safe use to industrial or professional recipients and distributors. At minimum, the substance name must be communicated. Consumers may request similar information, and suppliers must respond within 45 days free of charge.
The 0.1% threshold is applied at the article level. ECHA guidance reflects the 10 September 2015 Court of Justice of the European Union judgment that, in complex products, the threshold applies to each constituent article that keeps its own shape, surface or design. A bicycle, for example, is not assessed only as one total mass. Grips, cables, fasteners, coatings or other constituent articles may need separate review if they contain Candidate List substances.
Article 7(2) may also require notification to ECHA when a Candidate List substance is present in articles above 0.1% weight by weight and the total amount of that substance exceeds one tonne per producer or importer per year. The notification is generally due no later than six months after inclusion in the Candidate List, unless an exemption applies, such as the substance already being registered for that use or exposure being excluded under normal or reasonably foreseeable conditions, including disposal.
SCIP is another article-related obligation. Under the Waste Framework Directive, suppliers of articles placed on the EU market that contain Candidate List substances above 0.1% weight by weight must submit information to ECHA’s SCIP database. For trade teams, SCIP data should be part of product launch documentation rather than a task left until after customs clearance.
Restrictions, authorisation and safety data sheets are separate checks
REACH restrictions under Annex XVII are independent of registration. A restriction may limit or ban manufacture, placing on the market or use of a substance on its own, in a mixture or in an article. ECHA states that restrictions may apply even to substances that do not require registration, including cases below one tonne per year. This is why importers of textiles, jewellery, toys, electronics, coatings, adhesives, plastic materials and spare parts need restriction screening even when no registration dossier is expected. See also: Customs.
Authorisation is different. Substances on Annex XIV may not be used or placed on the market for a listed use after the sunset date unless an authorisation is granted or an exemption applies. This is especially relevant to EU manufacturers and importers of substances or mixtures. For imported finished articles, authorisation is often misunderstood: the imported article itself is not automatically an authorisation application, but the same substance may still create SVHC communication, SCIP or restriction concerns.
Safety data sheets are also a major trade document. Suppliers must provide SDSs for many hazardous substances and mixtures, and the SDS must be usable in the destination market. Commission Regulation (EU) 2020/878 updated REACH Annex II, and the previous transition period ended on 31 December 2022. In practice, importers should reject outdated SDS formats, missing exposure scenarios where required, inconsistent classifications and SDSs that do not align with product labels or the declared composition.
Evidence importers should collect before shipment
A useful REACH file is specific, dated and traceable. A short supplier statement may help, but it rarely proves compliance by itself. Importers should build an evidence file that connects the product sold, the substances used, the legal role, the destination market and the relevant REACH duty.
| Evidence | Why it matters |
|---|---|
| Substance inventory with CAS and EC identifiers | Allows screening against the Candidate List, Annex XIV, Annex XVII and registration status. |
| Bill of materials and article breakdown | Supports article-level 0.1% SVHC assessment for complex objects. |
| Supplier declaration with date and scope | Shows which Candidate List version, materials, models and factories are covered. |
| SDS or extended SDS | Provides classification, safe-use information, exposure scenarios and registration numbers where relevant. |
| Test reports for high-risk materials | Useful where supplier knowledge is weak, restricted substances are plausible or customer specifications require testing. |
| Tonnage and importer coverage record | Shows whether registration or Article 7 notification thresholds may be triggered. |
| Restriction and authorisation screening record | Documents that market-entry bans, limits and sunset dates were checked before shipment. |
A practical workflow for import and export operations
- Classify the product. Decide whether the item is a substance, mixture, article or complex object. Many consumer and industrial goods include more than one category.
- Map the legal actor. Identify the EU importer, distributor, downstream user, only representative or supplier responsible for each obligation.
- Build the substance list. Request composition data to the level needed for screening, using confidentiality agreements where necessary.
- Check registration triggers. Aggregate annual substance volumes across products and import channels for each legal entity.
- Screen SVHCs and article thresholds. Apply the 0.1% threshold to each relevant article, not only to the finished product weight.
- Review Annex XVII and Annex XIV. Confirm that the product can be placed on the market for the intended use and destination.
- Control documents before dispatch. Make SDSs, declarations, test reports, SCIP references and customer communication language part of the shipment release checklist.
The workflow should be repeated when the Candidate List changes, a material or supplier changes, volumes increase, a product enters a new EU market, or customer use differs from the use covered in supplier documentation.
Common mistakes that create REACH risk
- Assuming finished goods are outside REACH because they are not bulk chemicals.
- Using a whole-product SVHC calculation for a complex object instead of assessing each constituent article.
- Accepting a generic REACH compliant declaration with no substance list, date, product scope or responsible entity.
- Forgetting that several small shipments can exceed the one-tonne annual threshold when aggregated by substance and legal entity.
- Relying on RoHS, food-contact, CE or customer testing as a substitute for REACH screening. These frameworks may overlap but do not replace REACH.
- Keeping outdated SDSs after formulation, classification or legal format changes.
- Assuming an only representative covers every shipment without checking the appointment, substance identity, importers and annual volume.
Frequently asked questions
Do all imported finished goods need REACH registration?
No. Most finished articles do not need registration simply because they are imported. Registration may be required when a substance is intended to be released from the article and exceeds one tonne per year, or when the import is actually a substance or mixture. Finished articles may still trigger SVHC communication, Article 7 notification, SCIP or restrictions.
Is a REACH declaration enough for customs or customer compliance?
Usually not by itself. A declaration should be supported by composition data, article-level assessment, restriction screening, SDSs where relevant, and clear identification of the products and dates covered. Customers may accept different evidence levels, but legal responsibility remains with the relevant EU actor.
Is laboratory testing required for every shipment?
REACH does not impose universal batch testing for every import shipment. Testing is a risk-control tool. It is most useful for high-risk materials, restricted substance checks, new suppliers, weak declarations or products where recycled, coated, dyed, plasticised or metal-contact materials raise concern.
How does REACH differ from RoHS?
RoHS mainly restricts certain hazardous substances in electrical and electronic equipment. REACH is broader and can apply to substances, mixtures and articles across many sectors. Electronics may need both RoHS and REACH checks, especially for SVHC communication, SCIP and Annex XVII restrictions.
How often should REACH status be reviewed?
Review before first import, after supplier or formulation changes, when annual volumes change, when products enter new EU markets and after major Candidate List, restriction or authorisation updates. A yearly review is useful, but live regulatory changes and material changes should trigger review sooner.
