EU REACH Registration Services

1. Substance and Product Assessment

The first step is to identify the substances manufactured or imported into the EU or EEA.

For mixtures, each individual substance must be assessed separately. The mixture itself is not registered as a complete product.

The initial review normally covers:

• Chemical name
• CAS and EC numbers
• Composition
• Purity
• Impurities and additives
• Product type
• Annual quantity
• Country of manufacture
• Intended uses
• Importers and customers
• Available registrations
• Potential exemptions

This assessment determines whether registration is required and which legal entity should submit it.

2. Scope and Exemption Review

Some substances are outside the scope of REACH, while others may qualify for registration exemptions.

Examples may include:

• Substances listed in Annex IV
• Categories covered by Annex V
• Polymers
• Certain recovered substances
• Re-imported substances
• Non-isolated intermediates
• Substances used for product and process-oriented research and development
• Substances regulated for specific uses under other legislation

Each exemption is subject to conditions.

A company relying on an exemption should retain sufficient documentation to explain why the substance or use qualifies.

3. Registrant and Supply-Chain Strategy

The appropriate approach depends on whether the supplier is established inside or outside the EU or EEA.

Possible options include:

• Registration by an EU manufacturer
• Registration by an EU importer
• Appointment of an Only Representative
• Separate registrations by multiple importers
• A combined strategy for different products or supply routes

The decision should consider:

• Number of importers
• Annual quantities
• Confidentiality
• Commercial control
• Administrative cost
• Existing registration coverage
• Future supply plans

4. Substance Identity Assessment

Accurate identification is critical because companies registering the same substance are generally expected to participate in the same joint submission.

The identity profile may include:

• Chemical and trade names
• CAS and EC identifiers
• Molecular and structural formula
• Substance type
• Manufacturing information
• Typical concentration
• Impurity profile
• Additives
• Spectral data
• Chromatographic data
• Analytical methods and reports

The available evidence must be sufficient to demonstrate the composition and boundaries of the substance.

5. ECHA Inquiry

A potential registrant must generally submit an inquiry dossier before completing a new registration.

The inquiry allows ECHA to:

• Review the substance identity
• Determine whether the substance has already been registered
• Identify existing or potential registrants
• Facilitate data sharing

Following the inquiry, the company may need to contact the lead registrant, confirm substance sameness and obtain access to the relevant joint submission.

6. Data Sharing and Letter of Access

REACH follows the principle of “one substance, one registration.”

Registrants of the same substance are generally required to cooperate and submit certain information jointly.

This may include:

• Hazard information
• Study summaries
• Classification and labelling
• Testing proposals
• Guidance on safe use
• Elements of the Chemical Safety Report

A new registrant may need to purchase a Letter of Access to refer to existing data.

Before accepting a data-sharing proposal, the company should understand:

• Which studies are included
• Which tonnage band is covered
• Whether administrative charges apply
• Whether future dossier updates are included
• How cost-sharing has been calculated
• Whether additional data will be needed

Data-sharing arrangements must be fair, transparent and non-discriminatory.

7. Data-Gap Analysis

Information requirements increase with the annual tonnage band.

The principal bands are:

• 1–10 tonnes per year
• 10–100 tonnes per year
• 100–1,000 tonnes per year
• More than 1,000 tonnes per year

A data-gap analysis compares the available information with the applicable requirements.

The review may cover:

• Physicochemical properties
• Toxicological information
• Ecotoxicological information
• Environmental fate
• Exposure data
• Existing study reports
• Literature data
• Read-across options
• QSAR predictions
• Weight-of-evidence approaches
• Testing proposals

New testing should not be commissioned until existing data and alternative approaches have been evaluated.

8. IUCLID Dossier Preparation

The registration dossier is prepared in IUCLID.

It may include:

• Registrant identity
• Substance identity and composition
• Analytical information
• Manufacturing and use details
• Tonnage band
• Classification and labelling
• Guidance on safe use
• Study summaries
• Robust study summaries
• Exposure information
• Confidentiality claims
• Testing proposals
• Chemical Safety Report, where required

The member dossier must accurately reflect the individual registrant’s substance, uses, quantities and legal entity information.

9. Submission to ECHA

The completed dossier is submitted through REACH-IT.

ECHA then performs administrative and technical checks, which may include:

• Business-rules verification
• Technical completeness check
• Fee verification
• Company-size verification where reduced fees are claimed

Once the required checks are passed and the applicable fee has been paid, ECHA issues a registration number.

The registration number confirms successful submission but does not remove the registrant’s responsibility to maintain accurate and complete information.

10. Post-Registration Maintenance

A dossier must be kept up to date.

An update may be required when there is a change in:

• Company identity
• Legal entity details
• Substance composition
• Annual tonnage
• Identified uses
• Uses advised against
• Classification and labelling
• New hazard information
• Risk-management measures
• Study data
• Chemical Safety Report
• Importers covered by an Only Representative

Registrants should also monitor substances of very high concern, restrictions, authorization requirements and changes under the CLP Regulation.