REACH Registration for Chemical Exporters
Only Representative appointment and ECHA registration for manufacturers exporting chemical substances to the European Union. Pricing depends on your substance and annual tonnage.
What we handle
- ✓ Only Representative appointment
- ✓ ECHA registration dossier preparation
- ✓ SIEF participation and data sharing
- ✓ Safety Data Sheet (SDS) preparation
- ✓ SVHC notification and Candidate List monitoring
What Is REACH?
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European Union's primary regulation for chemical substances, established under EC Regulation 1907/2006 and enforced by the European Chemicals Agency (ECHA).
The core principle: no data, no market. Any chemical substance exported to the EU at 1 tonne or more per year must be registered with ECHA before it can enter the EU market. This applies equally to EU manufacturers and non-EU exporters — the difference is that non-EU manufacturers must act through an EU-based Only Representative.
Paints, solvents, adhesives, cleaning chemicals, food additives, dyes, and raw materials all fall within scope. If your substance is exported to the EU in commercial quantities, REACH applies.
Important
Chemical substances without a completed REACH registration can be stopped at EU borders. The rule applies to all non-EU exporters, and shipping without an Only Representative is a legal violation — not just a compliance gap.
Tonnage thresholds
How REACH Registration Works
Five stages from substance assessment to legal market access.
Chemical Identity Assessment
We verify the CAS number, EC number, and chemical identity of each substance. Registration obligations and tonnage thresholds are confirmed. Exemptions are evaluated.
Only Representative Appointment
FDABridge appoints an EU-based Only Representative on your behalf. This step must be complete before any substance can legally enter the EU market.
SIEF Participation and Data Sharing
Through the Substance Information Exchange Forum (SIEF), data sharing costs are split among companies registering the same substance — reducing your overall registration cost.
ECHA Registration Dossier
We prepare the chemical safety assessment, exposure scenarios, and supporting data in IUCLID format and submit the dossier to ECHA.
ECHA Number and Market Access
Once ECHA approves the registration, a registration number is assigned. All exports above the tonnage threshold are then legally compliant.
SDS Requirements Under REACH
Under REACH Article 31, all hazardous substances and mixtures require a Safety Data Sheet (SDS) prepared in the language of the destination EU country and provided to downstream users.
- Substance and supplier identification
- Hazard identification (GHS/CLP classification)
- Composition and ingredient information
- First aid and firefighting measures
- Exposure controls and PPE requirements
- Physical, chemical and toxicological properties
- Disposal and transport information
- Regulatory status and other information
Substances of Very High Concern
SVHC substances (carcinogens, mutagens, PBT/vPvB, endocrine disruptors) on ECHA's Candidate List carry additional obligations:
Notification obligation
When SVHC content exceeds 0.1% by weight in an article, ECHA notification is required.
Supply chain disclosure
EU customers must be informed about SVHC substances in products they receive.
Authorisation
Annex XIV substances require formal ECHA authorisation to continue using or importing them.
Common questions about REACH registration
What is REACH?+
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the primary EU law governing chemical substances (EC 1907/2006). Any chemical substance imported into the EU at ≥1 tonne per year must be registered with ECHA before it can enter the market.
What is an Only Representative?+
Non-EU manufacturers cannot register directly with ECHA. They must appoint an EU-based Only Representative (OR) who takes legal responsibility for the registration and all REACH obligations within the EU. FDABridge provides OR services through its EU network.
Which substances require REACH registration?+
Substances manufactured or imported into the EU at ≥1 tonne/year, substances intentionally released from articles, and substances in mixtures all fall under registration obligations. Most polymers are exempt, but the monomers they contain may require registration.
What are the tonnage thresholds?+
Registration data requirements scale with tonnage: ≥1 t/year (Annex VII — basic physicochemical and toxicology data), ≥10 t/year (Annex VIII — extended toxicology), ≥100 t/year (Annex IX), ≥1,000 t/year (Annex X — full chronic toxicology and ecotoxicology).
What is an SVHC substance?+
Substances of Very High Concern (SVHC) are carcinogenic, mutagenic, reprotoxic, persistent/bioaccumulative/toxic (PBT/vPvB), or endocrine-disrupting substances. They appear on ECHA's Candidate List and trigger additional notification and authorisation requirements.
How long does REACH registration take?+
With existing SIEF data available, registration typically takes 3–6 months. Where new studies are required, the timeline extends to 12–24 months. Only Representative appointment can be completed within 1–2 weeks.
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Share your substance name, CAS number, and annual export volume. We will confirm your registration obligations and provide a quote.
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