Understanding the REACH Registration Process

A Simple Guide for Beginners

Once a company understands what a “substance” means under the REACH Regulation (EC) No 1907/2006) and how tonnage bands influence regulatory obligations, the next important step is understanding REACH registration.

In the European Union, companies cannot manufacture or import chemical substances and place them on the market without first providing information about their safety. If a company manufactures or imports one tonne or more of a substance per year, the substance generally must be registered with the European Chemicals Agency (ECHA).

This requirement is based on the central REACH principle: “No data, no market.”
In simple terms, companies must demonstrate that their chemicals can be used safely before selling them in the EU.

Although the REACH registration process may appear complex at first, it becomes much easier to understand when broken down into its key elements.

Knowing Exactly What Your Substance Is

The first step in REACH registration is correctly identifying the substance being manufactured or imported. While this may sound straightforward, it is often one of the most critical parts of the process.

Companies must clearly define the substance’s chemical identity, including its name, CAS or EC number, composition, impurities, and supporting analytical data. REACH also categorises substances as:

• Mono-constituent substances

• Multi-constituent substances

• UVCB substances (Unknown or Variable composition, Complex reaction products, or Biological materials)

Accurate identification is essential because REACH follows the “One Substance, One Registration” (OSOR) principle. Companies dealing with the same substance must work together and share data during registration. Incorrect identification can lead to delays, disputes with other registrants, or even rejection of the registration dossier.

Understanding the Type of Registration Required

Not all substances require the same type of registration. The requirements largely depend on how the substance is used.

Most substances require full registration, where companies must submit detailed information about physical and chemical properties, human health effects, and environmental hazards. The amount of required data increases with higher tonnage bands.

However, REACH recognises that some substances are used only as intermediates in the manufacture of another chemical. Because these substances are typically handled under controlled industrial conditions, they may qualify for reduced information requirements.

REACH distinguishes between:

• On-site intermediates, used within the same manufacturing site

• Transported intermediates, sent to another facility for further processing

Determining whether a substance requires full registration or intermediate registration is important because it significantly affects the amount of information that must be submitted.

Gathering Existing Information About the Substance

Before conducting new studies, companies must collect all available information about the substance. This may include previous laboratory studies, published scientific literature, historical testing data, or internal company data.

REACH strongly encourages the use of existing data to minimise unnecessary testing and avoid duplicate animal studies. Only when sufficient data is not available may additional testing be required.

The collected data typically covers:

• Physical and chemical properties

• Human health effects

• Environmental hazards and behaviour

Working Together with Other Companies

A unique feature of REACH is its emphasis on data sharing and collaboration. When multiple companies manufacture or import the same substance, they are expected to share data and submit certain parts of the registration jointly.

Often, one company acts as the Lead Registrant, submitting the joint technical information for the substance, while other companies submit their company-specific information separately.

This approach reduces duplicate testing, lowers compliance costs, and ensures consistent hazard information across the EU market.

Preparing the Technical Registration Dossier

All the gathered information must be organised into a technical dossier using IUCLID, a software system designed for chemical regulatory data.

The dossier typically includes:

• Substance identity information

• Manufacture and use details

• Classification and labelling

• Summaries of studies describing hazards and properties

If a substance is manufactured or imported in 10 tonnes or more per year, companies must also prepare a Chemical Safety Report (CSR) to evaluate risks and describe how they can be controlled during use.

Submitting the Registration to ECHA

Once the dossier is ready, it must be submitted electronically through REACH-IT, the online platform used to communicate with the European Chemicals Agency.

The system performs automated checks to ensure the dossier meets required technical standards. After successful submission and payment of the registration fee, ECHA assigns a REACH registration number, confirming that the substance can legally be manufactured or imported in the EU.

Registration Is an Ongoing Responsibility

REACH registration is not a one-time process. Companies must keep their registration dossiers updated throughout the lifecycle of the substance.

Updates may be required when:

• New hazard data becomes available

• Production volumes increase to a higher tonnage band

• New uses of the substance are identified

Maintaining accurate information ensures the substance continues to be used safely and remains compliant with REACH requirements.

Why the REACH Registration Process Matters

The REACH registration system ensures that chemicals used in the European market are properly understood and responsibly managed. By requiring companies to generate and share safety data, REACH improves transparency and helps protect human health and the environment.

For businesses, understanding the REACH registration process is essential for maintaining access to the EU market and avoiding costly regulatory issues.