Exporting chemical substances, mixtures, polymers, intermediates or articles with intended release to the EU or EEA market?
Under the EU REACH Regulation (EC) No 1907/2006, chemical substances manufactured or imported into the European Economic Area at one tonne or more per year must be registered with the European Chemicals Agency (ECHA), unless a specific exemption applies.
For companies established outside the EU/EEA, compliance is more complex. Non-EU legal entities cannot submit a REACH registration directly. A non-EU manufacturer, formulator or article producer may appoint an EU/EEA-based Only Representative (OR). If no OR is appointed, EU/EEA importers themselves must ensure that the substances they import are properly registered where required.
REACH24H provides integrated EU REACH registration and Only Representative services, helping global chemical companies assess registration obligations, appoint an OR, prepare and submit dossiers, manage LoA and data-sharing negotiations, and maintain long-term post-registration compliance.
EU REACH Registration at a Glance
Who needs REACH registration?
EU/EEA manufacturers and importers at 1 t/y or above;non-EU suppliers whose substances enter the EU/EEA through importers or an appointed OR.
What is registered?
Substances. Each constituent substance in a mixture must be assessed separately against the 1 t/y threshold.
Can a non-EU company register directly?
No. Non-EU legal entities cannot register directly. They may appoint an EU/EEA-based OR, or EU/EEA importers must register the substances they import where required.
What does an Only Representative do?
The OR assumes REACH registration obligations of importers for covered substances, tonnage bands, uses and supply chains.
Is registration a one-time task?
No. Registrants must keep dossiers updated and respond to ECHA compliance checks or evaluation decisions throughout the registration lifecycle.
Official reference:Your Europe — Registering chemicals under REACH
Does Your Product Require EU REACH Registration?
Registration obligations depend on the substance, annual tonnage entering the EU/EEA, product type, intended use, supply chain role, and whether an exemption or existing registration coverage applies.
In Scope:Product Types to Assess
| Product Type | REACH Registration Relevance |
|---|---|
| Substance on its own | Generally required at 1 t/y or above per manufacturer or importer, unless an exemption applies. |
| Mixture / formulated product | The mixture itself shall not be registered. Each constituent substance must be assessed individually at the 1 t/y threshold. |
| Article with intended release | Registration may be required for substances intentionally released during normal or reasonably foreseeable use, if total volume exceeds 1 t/y and no exemption applies. |
| Polymer | Polymers are generally exempt from registration. Monomers or other chemically bound substances may require registration under specific conditions. |
| Isolated intermediate | Reduced information requirements may apply if the substance qualifies as an on-site or transported isolated intermediate manufactured and used under strictly controlled conditions. |
| PPORD substance | PPORD may qualify for a time-limited exemption from registration if the conditions under REACH are satisfied. |
Common Exemptions to Check
Several substance categories may be fully or partially exempt from REACH registration. Exemptions should always be assessed case by case against the actual substance, use and supply chain.
| Category | Examples | Note |
|---|---|---|
| Exempt from REACH or certain REACH obligations | Radioactive substances, waste, non-isolated intermediates, substances under customs supervision | Conditions and scope must be reviewed carefully. |
| Exempt from registration for specific uses | Food/feed uses, medicinal product uses, Annex IV and Annex V substances | Other REACH or supply chain obligations may still apply. |
| Regarded as registered in specific cases | Certain active substances in biocidal or plant protection products | Only where REACH Article 15 conditions are met. |
| Defence-related exemptions | Substances covered by specific national defence exemptions | Member State conditions apply and should be assessed case by case. |
For a detailed explanation of product categories, exemptions and practical examples, see REACH24H's guide:EU REACH Registration Scope and Exemptions Explained.
Common Cases Requiring Extra Attention
Cosmetic ingredients
The EU Cosmetics Regulation does not provide a blanket exemption from REACH. Cosmetic ingredients require REACH registration if the relevant substance is manufactured or imported into the EU/EEA at 1 t/y or above and no exemption applies.
REACH and food contact frameworks address different regulatory requirements. Both should be assessed independently.
Articles containing SVHCs
Articles without intended release generally do not trigger registration for the article itself, but SVHC communication obligations (Article 33) and ECHA notification duties (Article 7(2)) may still apply.
New Updates:ECHA Adds Two Substances to SVHC List, Bringing the Total to 253 Entries
EU REACH Compliance Pathways for Non-EU Companies
Non-EU companies supplying substances to the EU/EEA generally need to ensure that their substances are registered either through an EU/EEA-based Only Representative, or through their EU/EEA importers, or through their own EU/EEA legal entity by acting as an importer or an OR.
For many non-EU manufacturers, appointing an independent Only Representative (OR) is a practical way to centralize REACH compliance, support multiple importers, and reduce reliance on any single EU customer.
| Pathway | Who Registers? | When It May Be Suitable | Key Considerations |
|---|---|---|---|
| Appoint an Only Representative (OR) | An EU/EEA-based OR appointed by the non-EU manufacturer, formulator or article producer | Suitable for non-EU companies seeking centralized REACH coverage and stronger supply chain control | OR coverage must be managed by substance, tonnage band, uses, importer and supply chain |
| Rely on EU/EEA Importers | Each EU/EEA importer registers the substances it imports where required | May be suitable for limited-customer or low-volume supply chains | Each importer is responsible for its own registration coverage, which may increase commercial dependency and compliance fragmentation. |
| Establish an EU/EEA Legal Entity | Your own EU/EEA subsidiary or branch office | May be suitable for companies with long-term EU operations and local infrastructure | Requires legal, tax, operational and compliance setup in the EU/EEA |
Official reference:ECHA guidance on Only Representatives
OR vs. Importer Registration:Key Decision Factors
If your company does not have its own EU/EEA legal entity, the key decision is usually whether to appoint an OR or rely on your importers.
| Decision Factor | Appointing an OR | Relying on EU/EEA Importers |
|---|---|---|
| Compliance control | Registration strategy and importer coverage can be managed centrally. | Each importer manages its own registration responsibilities. |
| Importer flexibility | Multiple covered importers can be supported under the OR arrangement. | Market access may depend on individual importers'registrations. |
| Commercial confidentiality | Helps reduce unnecessary disclosure of supplier relationships, volumes and formulation-related information to importers. | Importers may need more detailed substance and supply chain information to fulfil their obligations. |
| Tonnage management | Annual volumes can be tracked through OR coverage and importer reporting. | Tonnage is managed separately by each importer. |
| Long-term maintenance | OR can support dossier updates, tonnage changes and ECHA communication. | Responsibility remains with each importer or registrant. |
Note: Appointing an OR can help reduce unnecessary disclosure of sensitive business information to importers. However, REACH requires certain information to be submitted to ECHA, and some data may be made publicly available under REACH Article 119 unless a valid confidentiality claim is submitted to and accepted by ECHA.
EU REACH Registration Process:Step by Step
A typical EU REACH registration project with REACH24H follows the steps below. Actual timelines vary depending on substance complexity, data availability, LoA negotiation outcomes, testing needs, CSR preparation requirements and ECHA processing time.
Scoping and Strategy
Key Actions: Confirm product type, substance identity, tonnage band, supply chain structure and registration route
Purpose: Determine whether registration is required and whether OR appointment is appropriate
Substance Identification
Key Actions: Review composition, analytical data, impurity profile and sameness criteria
Purpose: Avoid incorrect substance identity submissions or failed inquiry outcomes
Inquiry Submission
Key Actions: Prepare and submit an inquiry dossier to ECHA via REACH-IT.
Purpose: Identify existing registrants, the Lead Registrant and relevant joint submission options.
Data Gap and LoA Review
Key Actions: Assess available joint submission data, LoA terms, cost allocation and additional data requirements.
Purpose: Manage cost, timeline and data-sharing risk before committing to testing.
Testing or Alternative Data Strategy
Key Actions: Generate required data or apply justified alternatives such as QSAR, read-across or weight-of-evidence approaches.
Purpose: Meet REACH information requirements while avoiding unnecessary testing where scientifically justified.
Dossier Preparation
Key Actions: Compile IUCLID dossier and Chemical Safety Report (CSR) where required.
Purpose: Build a complete, technically consistent registration dossier.
Submission and ECHA Processing
Key Actions: Submit through REACH-IT and respond to Technical Completeness Check (TCC) requests where applicable.
Purpose: Obtain a REACH registration number after successful processing.
Post-Registration Maintenance
Key Actions: Track tonnage, manage importer coverage, respond to ECHA evaluations and update dossiers when required.
Purpose: Maintain long-term compliance after initial registration.
EU REACH Registration Cost:Key Drivers
EU REACH registration cost is project-specific, not a fixed price. It typically includes ECHA administrative fees, data-sharing or LoA fees, testing costs and professional service fees.
| Cost Driver | Why It Matters |
|---|---|
| Tonnage band | Higher tonnage bands require broader information sets and may trigger CSR obligations |
| Substance identity | Complex substances, UVCBs or unclear sameness require additional analytical work |
| Existing data availability | More complete existing data or joint submission data may reduce new testing needs |
| LoA / data-sharing fee | Negotiated with the Lead Registrant or consortium;varies significantly by substance and SIEF |
| Testing needs | Data gaps may require new GLP studies or alternative scientifically justified approaches |
| ECHA administrative fee | Determined by registration type, tonnage band, company size and submission type |
| SME status | Eligible SMEs may benefit from significantly reduced ECHA fees, subject to verified classification |
| OR and maintenance scope | Ongoing importer coverage, tonnage tracking and dossier maintenance affect long-term service cost |
ECHA fee levels are governed by applicable EU fee regulations, including Commission Implementing Regulation (EU) 2025/2067, which amends the rules on fees and charges payable to ECHA.
Detailed cost breakdown:EU REACH Registration Costs Guide
ECHA SME Fee Reductions and Verification
Qualifying SMEs may benefit from reduced ECHA administrative fees. Eligibility is assessed against EU SME criteria based on the relevant corporate group, including parent companies, partner enterprises, joint ventures and subsidiaries.
| Company Category | ECHA Fee Reduction | Documentation Focus |
|---|---|---|
| Large Enterprise | Standard fee — no reduction | Standard company information |
| Medium Enterprise | 30% reduction | Group structure, ownership and financial data |
| Small Enterprise | 60% reduction | Linked/partner enterprises, headcount and accounts |
| Micro Enterprise | 90% reduction | Strict headcount, turnover and balance sheet thresholds |
ECHA may verify SME declarations and request supporting documentation. Incorrect SME claims can result in payment of the fee difference and an administrative charge.
REACH24H provides SME verification support by reviewing corporate structure, financial statements and headcount data to help clients assess eligibility and prepare the required documentation.
Post-Registration Compliance:Registration Number Is Not the Finish Line
Obtaining a REACH registration number initiates an ongoing compliance obligation, not a one-time approval. Under Article 22 of REACH, registrants must update dossiers when relevant information changes, including tonnage band, substance composition, uses, classification or legal entity details.
Key post-registration issues to manage include:
Tonnage band and importer coverage updates;
Composition, impurity or manufacturing process changes;
New uses, exposure scenarios or risk management measures;
Updated classification and labelling information;
ECHA compliance checks, evaluation decisions and data requests.
REACH24H supports post-registration dossier updates, REACH-IT monitoring, importer coverage management, consortium communication and ECHA evaluation response.
Our EU REACH Registration and OR Services
REACH24H provides integrated EU REACH registration and Only Representative services across the full compliance lifecycle.
REACH Obligation Assessment
Review of product type, substance identity, tonnage band, intended uses, supply chain structure, existing registration status and applicable exemptions to determine whether and how registration obligations apply.
Only Representative (OR) Services
REACH24H acts as your EU/EEA-based Only Representative, supporting OR appointment documentation, importer coverage records, annual tonnage tracking, REACH-IT administration and supply chain communication.
Substance Identification and ECHA Inquiry
Support for substance identity analysis, composition and impurity review, UVCB assessment where applicable, analytical data strategy, inquiry dossier preparation and REACH-IT submission.
Data Sharing, LoA and Joint Submission Support
Support for Lead Registrant communication, joint submission participation, Letter of Access review and negotiation, data-sharing cost allocation and consortium coordination.
IUCLID Dossier and CSR Preparation
Preparation and technical review of IUCLID dossiers, endpoint data compilation, data gap analysis, testing strategy, Chemical Safety Report (CSR) for substances at 10 t/y or above.
Intermediate, Polymer and PPORD Strategy
Assessment of reduced intermediate requirements under strictly controlled conditions, polymer exemption applicability, monomer registration obligations and PPORD notification eligibility.
For innovation-related projects, see REACH24H's EU PPORD Notification Services.
SME Verification Support
Assessment of SME eligibility, preparation of supporting corporate and financial documentation, and review of global group structure to reduce the risk of incorrect declarations and administrative charges.
Post-Registration Maintenance
Post-registration maintenance, including dossier updates, tonnage tracking, importer coverage and ECHA communication.
Why Work With REACH24H?
REACH24H has supported chemical companies across Asia, the Americas and beyond with EU REACH compliance since 2009. Our track record includes over 3,000 global clients, more than 10,000 REACH registration dossiers submitted to ECHA, and an EU office in Ireland providing on-the-ground expertise aligned with ECHA current requirements.
EU-Based Only Representative Infrastructure
REACH24H supports eligible non-EU manufacturers, formulators and article producers through EU/EEA-based OR services, helping manage ECHA communication, REACH-IT submissions and importer coverage documentation.
Experience with Non-EU Manufacturers and Complex Supply Chains
We understand the practical challenges faced by non-EU suppliers, including multi-importer coverage, CBI concerns, LoA negotiations, tonnage tracking and downstream communication.
Integrated Regulatory and Technical Dossier Capability
Our team supports substance identity analysis, IUCLID dossier preparation, CSR development, data gap assessment and scientifically justified alternative data strategies, including QSAR, read-across and weight-of-evidence approaches.
Cost and Timeline Control
Through early scoping, LoA review, SME eligibility assessment and proactive data gap planning, REACH24H helps companies reduce avoidable cost and prevent unnecessary delays.
Global Chemical Compliance Network
REACH24H also supports related chemical compliance programs, including UK REACH, K-REACH, Turkey KKDIK, and China New Chemical Substance Registration under MEE Order No. 12.
Frequently Asked Questions
Q:Can non-EU manufacturers register under EU REACH directly?
A:No. Non-EU manufacturers cannot submit a REACH registration as non-EU legal entities. They may appoint an EU/EEA-based Only Representative, or EU/EEA importers themselves must register the substances they import where registration is required.
Q:What is an Only Representative under EU REACH?
A:An Only Representative is an EU/EEA-based natural or legal person appointed by a non-EU manufacturer, formulator or article producer to fulfil REACH registration obligations that would otherwise apply to importers — for covered substances, tonnage bands, uses and supply chains.
Q:Can a trading company or distributor appoint an OR?
A:No. Under Article 8 of REACH, the right to appoint an OR is held by non-EU manufacturers, formulators and article producers. A pure trading company or distributor usually needs the upstream manufacturer to formally appoint the OR. REACH24H can assist in structuring multi-party compliance arrangements to support supply chain coverage while protecting commercial relationships.
Q:Do mixtures need REACH registration?
A:Mixtures shall not be registered as such. Each constituent substance must be assessed individually. If a substance in a mixture is imported into the EU/EEA at 1 t/y or above and no exemption applies, registration may be required for that substance.
Q:Are polymers exempt from EU REACH registration?
A:Polymers are generally exempt from REACH registration. However, monomers or other chemically bound substances may require registration if the relevant conditions are met and no existing coverage applies.
Q:Do cosmetic ingredients require EU REACH registration?
A:Yes. Cosmetic ingredients require REACH registration if the relevant substance is manufactured or imported into the EU/EEA at 1 t/y or above and no exemption applies. The EU Cosmetics Regulation does not provide a blanket exemption from REACH.
Q:What affects EU REACH registration cost?
A:Main cost drivers include tonnage band, substance identity complexity, existing data availability, LoA or data-sharing fees, testing requirements, ECHA administrative fees, SME status and the scope of post-registration maintenance.
Q:How long does the EU REACH registration process take?
A:Timelines vary depending on substance identity, inquiry outcomes, LoA negotiation, data gaps, testing needs and ECHA processing time. Straightforward projects may progress within several months;complex substances or major data gaps can extend the timeline significantly.
Q:What are the obligations after obtaining a REACH registration number?
A:A registration number does not end compliance obligations. Under Article 22 of REACH, registrants must update dossiers when tonnage, composition, uses, classification or legal entity details change. ECHA conducts ongoing compliance checks and may request additional data.
Start Your EU REACH Assessment
Whether you are exporting a substance, a formulated mixture, a polymer, an intermediate or an article with intended release, early REACH assessment helps you identify obligations, plan registration timelines and avoid supply chain disruption.
REACH24H can help you answer the key questions before your products enter the EU/EEA market:
Does my product require EU REACH registration?
Should I appoint an Only Representative?
Which substances and tonnage bands require coverage?
What data, LoA or testing will be required?
What is the expected cost and timeline?
How should importer coverage be structured and documented?
Information to Prepare for Your Assessment
Substance name, CAS number and EC number, where available;
Full composition and impurity profile;
Annual export volume to the EU/EEA per substance;
Product type:substance, mixture, polymer, intermediate or article;
Intended uses and downstream industrial sectors;
EU/EEA importer list and estimated tonnage per importer;
Existing Safety Data Sheet, technical data sheet and analytical reports;
Available toxicological, ecotoxicological or physicochemical data;
Current or historical REACH registration information, if any;
Preferred compliance pathway:OR appointment or importer-led registration.
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