FDABridge
EU market entry

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.

EU REACH compliance

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
EU chemicals regulation

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

≥ 1 t/yearAnnex VIIBasic physicochemical and toxicology data
≥ 10 t/yearAnnex VIIIExtended toxicology studies
≥ 100 t/yearAnnex IXAdvanced reproductive toxicology
≥ 1,000 t/yearAnnex XComprehensive chronic toxicology
Registration process

How REACH Registration Works

Five stages from substance assessment to legal market access.

1

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.

2

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.

3

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.

4

ECHA Registration Dossier

We prepare the chemical safety assessment, exposure scenarios, and supporting data in IUCLID format and submit the dossier to ECHA.

5

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.

Safety Data Sheet

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
SVHC and authorisation

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.

REACH FAQ

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.

Ready to register your chemical substance with ECHA?

Share your substance name, CAS number, and annual export volume. We will confirm your registration obligations and provide a quote.

Contact Us for a Quote →