Short answer
REACH and CLP allocate duties by legal role. Under REACH, an EU manufacturer or importer normally registers each substance manufactured or imported at one tonne or more per year. The registrant supplies required hazard, use and exposure information, shares studies where required and proposes higher-tier tests. Vertebrate testing is a last resort.
A downstream user normally does not register a substance registered upstream. It checks that its use is covered, applies risk controls or makes the use known upstream. An uncovered use may require its own chemical safety report and an ECHA report.
CLP has a different trigger. Manufacturers, importers and downstream users classify before market placement. A formulator is usually a downstream user under REACH but a classifier and supplier under CLP. Distributors may generally rely on upstream classification; downstream users may do so if composition is unchanged.
Restrictions in REACH Annex XVII bind whoever manufactures, places on the market or uses the covered substance, mixture or article. Safety data sheets, labels, article information and poison-centre submissions divide communication duties further. As at 31 July 2026, selected reforms in Regulation 2024/2865 apply from 1 July 2026; its new distributor poison-centre submission duty starts on 1 January 2027, while revised advertising and distance-sales rules start on 1 January 2028.
Identify the legal role before the chemical duty
REACH distinguishes a manufacturer, importer, article producer, downstream user and distributor. A downstream user is an EU industrial or professional user other than the manufacturer or importer; distributors and consumers are excluded.
CLP uses “supplier” more broadly for any of those actors placing a substance or mixture on the market. A REACH downstream user formulating paint can therefore be the CLP supplier responsible for the finished mixture.
REACH registers substances, not mixtures as such. CLP classifies substances and mixtures; most articles fall outside its ordinary regime.
Registration: manufacturers and importers carry the main REACH burden
Article 5 establishes the “no data, no market” principle. Article 6 then states:
“any manufacturer or importer of a substance ... in quantities of one tonne or more per year shall submit a registration to the Agency.” —
Tonnage is assessed per registrant and year, subject to aggregation, exemptions and special regimes. The dossier covers identity, manufacture, uses, classification, safe use and tonnage-band information. At ten tonnes or more, the registrant generally adds a chemical safety report.
The recipient of imported goods is not automatically the REACH importer. In Triferto, C-654/22, the Court held that another EU-established person may assume responsibility for the import and register it. The operators involved must nevertheless exercise due diligence: the responsible person must have the knowledge and capacity to maintain a complete registration, the imported quantity must actually be registered, and the arrangement must not split tonnage to evade REACH thresholds.
Registrants of the same substance submit specified information jointly and share data. Each remains responsible for its separate information, tonnage, uses, exposure and updates.
A non-EU manufacturer may appoint an EU “only representative” under Article 8 to fulfil importers' Title II duties. Covered importers are then REACH downstream users. The mandate, quantities and importers need evidence; CLP remains separate.
Special rules apply to articles. A producer or importer registers a substance intended to be released from articles where the quantity exceeds one tonne per year, unless it is already registered for that use. Candidate List substances can also trigger Article 7 notification at the specified tonnage and 0.1% concentration thresholds.
Testing: generate what the dossier needs, but avoid duplication
The registrant first gathers available information, uses permitted adaptations and alternatives, and shares qualifying studies. Requirements rise with tonnage and depend on the evidence.
Article 25 provides a controlling limit:
“testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.” —
For Annex IX and X tests, a registrant normally submits a proposal first. ECHA seeks third-party information for vertebrate proposals and decides whether to require, modify or reject testing. In Germany v Esso Raffinage, C-471/18 P, the Court confirmed ECHA's power to make binding compliance findings after dossier evaluation; national authorities enforce them.
CLP is a classification system, not a second routine testing programme. New health or environmental tests follow only after other means are exhausted; tests on non-human primates and humans for CLP purposes are prohibited. Specified physical-hazard tests are required absent adequate information.
Classification: importers and formulators cannot simply pass the problem upstream
CLP Article 4 gives the core allocation:
“Manufacturers, importers and downstream users shall classify substances or mixtures ... before placing them on the market.” —
An Annex VI harmonised classification controls covered hazards, forms and physical states. The actor self-classifies uncovered hazards or forms. Other substances and mixtures are classified using available information and the applicable CLP methods.
A distributor may use an upstream classification. A downstream user may rely on it if composition is unchanged. A formulator creating a new mixture must classify it.
Manufacturers and importers notify relevant substance classifications to ECHA within one month unless that notifier already supplied them in registration. This differs from mixture classification and poison-centre submission.
Since 1 July 2026, Article 4(11), inserted by Regulation 2024/2865, also requires an EU-established supplier identified on the label to fulfil CLP for every substance or mixture placed on the market, including through distance sales.
Communication moves both down and up the chain
Under REACH Article 31, the supplier provides a safety data sheet for hazardous substances or mixtures and specified additional cases. It uses an official language of the Member State of supply, includes required exposure scenarios and updates recipients when new hazards, authorisation or restriction require revision.
Article 32 can require information even without a safety data sheet. Article 34 sends new hazards and doubts about risk controls upstream. Workers receive access under Article 35.
Article 33 separately covers Candidate List substances in articles. In FCD and FMB, C-106/14, the Court of Justice held that the 0.1% threshold applies to each constituent article, not only to the assembled product. The supplier's duty is:
“to inform the recipient and, on request, the consumer, of the presence of that substance” —
The supplier gives at least the substance name and available safe-use information; consumer requests are answered free within 45 days.
Under CLP, the supplier labels and packages hazardous products. Digital labels have been permitted since 1 July 2026, but essential hazards remain physical and digital access must satisfy Article 34b. Regulation 2025/2439 postponed the revised advertising rules and the requirement for distance offers to show Article 17 label elements until 1 January 2028.
Importers and downstream users placing health- or physical-hazard mixtures on the market submit harmonised information for emergency health response under Article 45 and Annex VIII, including the unique formula identifier where required. From 1 January 2027, distributors must submit where they distribute into other Member States, rebrand or relabel and cannot show that the appointed body already has the same information.
Downstream use, authorisation and restriction are separate checks
A downstream user compares actual use with the exposure scenario. It may make that use known upstream. Otherwise it changes conditions, process, substance or supplier, or prepares an Article 37 chemical safety report. Article 38 requires an ECHA report in specified cases.
For Annex XIV substances, authorisation is a separate check. A downstream user may rely on an upstream authorisation only for its conditions and must notify ECHA within three months.
Annex XVII restriction is broader and independent of registration or authorisation. A restricted substance on its own, in a mixture or in an article may not be manufactured, marketed or used unless the restriction's conditions are met. A registration number, safety data sheet or upstream assurance does not override a restriction.
A workable compliance map
- Identify each EU legal entity and its role under both Regulations.
- Inventory substances, mixtures and articles, quantities and Member States.
- Confirm registrations, only-representative coverage, uses and current dossier data.
- Map tests and adaptations to information requirements; document data-sharing rights.
- Check harmonised classifications, self-classification and mixture calculations.
- Reconcile REACH dossiers, CLP notifications, labels and safety data sheets.
- Check Candidate List article information, Annex XIV authorisation and Annex XVII restrictions separately.
- Verify poison-centre submissions, unique formula identifiers and 2027 distributor transitions.
- Preserve supply-chain information and update it when composition, hazards, uses or law change.
Conclusion
REACH places registration and much of the information-generation burden on manufacturers and importers, while downstream users control whether their uses remain within the registered safety case. CLP makes manufacturers, importers and downstream users responsible for classification before market placement, permits limited reliance by unchanged downstream users and distributors, and makes suppliers responsible for compliant hazard communication.
The decisive questions are the legal entity's role, what it manufactures, imports, formulates, supplies or uses, annual substance tonnage, and the actual use. Registration, classification, communication, authorisation and restriction are linked, but none substitutes for the others.
Sources
This article provides general legal information, not advice for a specific matter. Laws, facts and procedural deadlines may change the result. Follow the linked primary sources and obtain local advice before acting.