Which substances require registration?

Substances manufactured or imported in quantities of one tonne or more per year, on their own, in mixtures or in articles, require registration under Article 6(1) of REACH, whether or not they are classified as hazardous. The exemptions are listed in Annexes IV and V, including substances such as ascorbic acid, fructose, starch, minerals and ores.

Who must register, and when?

The manufacturer or importer must register as soon as the annual manufacturing or import volume reaches one tonne, taking the average of the most recent three calendar years into account.

Who is the registrant in an international company?

If subsidiaries are separate legal persons from the parent company under the applicable national law, each subsidiary must carry out its own registration.

How do we calculate a quantity above one tonne?

The calculation is made by calendar year, using the average of the last three years as the basis.

Can registration be completed free of charge?

No. A fee is payable to the European Chemicals Agency (ECHA), and access to the study data and registration dossier generally has to be purchased through a Letter of Access. Analytical testing and, where needed, external expert or consultancy fees may also arise.

Can we negotiate the price?

ECHA fees are set by EU legislation and depend on the annual quantity and company size. A lead registrant normally sets a uniform Letter of Access price for all purchasers, so that part is not negotiable. Other costs may vary according to the agreements between the parties.

How do I know whether the substance I use is already registered?

A registered substance has a four-part registration number, usually shown in section 1.1, 3.1 or 3.2 of the safety data sheet. Its format is XX-XXXXXXXXXX-XX-XXXX.

What does it mean if the identification number does not match that format?

A three-part number, or a number ending in XXXX, is likely a pre-registration number. It is no longer valid and does not demonstrate that the substance is registered.

What was pre-registration and what should be done now?

Before 2018, affected businesses could submit a free pre-registration. Under Commission Implementing Regulation (EU) 2019/1692, these pre-registrations ceased to be valid on 1 January 2020. Businesses must therefore register substances manufactured in the EU or imported into the EU above one tonne per year.

Where does the process start?

The registration dossier is prepared in IUCLID, the system created by ECHA for this purpose, and submitted through REACH-IT.

How long does REACH registration take?

It depends greatly on how quickly the lead registrant responds, but the complete process can typically be completed within a few months.

How can non-EU manufacturers help their importers?

Non-EU manufacturers are often familiar with the registration requirements in REACH. Ask them to help collect the correct identifiers, such as CAS or EC numbers, the substance name, analytical reports and information about impurities.

Which legislation sets out the REACH registration requirements?

The requirements are set out in Regulation (EC) No 1907/2006 of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemicals, commonly known as REACH.

Who checks substance registration in Hungary?

The public health department of the territorially competent district office is authorised to check whether substances have been registered.

REACH registration: 14 questions and answers

REACH registration – the most important questions and answers

REACH registration dossier with laboratory equipment and a map of Europe

In our experience, businesses working with chemicals often find it difficult to obtain clear answers about REACH registration. We have therefore collected the fourteen questions we hear most often and our answers to them.

What should you clarify first?

Is your company acting as a manufacturer, importer, distributor or user?
Does the annual quantity of the substance reach one tonne?
Does the supplier safety data sheet show a valid four-part REACH registration number?
Is the substance present on its own, in a mixture or in an article?
Are your safety data sheets up to date and do they contain the necessary identifiers?

The background to REACH registration

In the European Union, substances manufactured, imported or placed on the market on their own, in mixtures or in articles at quantities above one tonne per year may only be supplied if they have been registered in accordance with Regulation (EC) No 1907/2006, REACH. Manufacturers and importers are responsible for collecting information about the properties of the substances. To avoid every manufacturer repeating the same studies, particularly animal testing, REACH is based on the principle of “one substance, one registration”.

Legislation: Regulation (EC) No 1907/2006 (REACH)

When does the obligation arise and who fulfils it?

When the obligation arises	Who is responsible	Where it is fulfilled
The manufactured or imported quantity reaches one tonne per year, based on the last three-year average	An EU manufacturer or importer, separately for each legal entity	Dossier prepared in IUCLID and submitted through REACH-IT
A non-EU manufacturer places the product on the Union market	The importer or the manufacturer's sole representative	The same ECHA procedure, using data obtained from the manufacturer
The substance is listed in Annex IV or V of REACH	No registration obligation applies	The exemption is documented in the company's records

Roles and common first checks

Role	Typical question	First check
EU manufacturer	Does substance manufacture reach one tonne per year?	Manufactured quantity, substance identifiers and existing registration data
Importer	Does the substance or mixture arrive from outside the EU?	Supplier SDS, registration number and imported quantity
Distributor	Is the correct, current document being passed on?	SDS version, language and identifiers
User	Is documented compliance available for the substances used?	Supplier SDS, internal records and workplace risk assessment

What should you do now?

The first step is to establish your company's role in the supply chain and check whether the substances you purchase have a valid four-part registration number. You can usually find this in suppliers' safety data sheets. If your data sheets are outdated or incomplete, start there: our safety data sheet preparation guide explains what information is needed and how quickly a document can be prepared.

If the immediate question is not a new registration but whether your current documentation supports lawful supply, a chemical safety audit is usually the faster first step.

Do you have another question about REACH registration? and we will help you understand what applies to your product portfolio.

Éva Juhász

Éva Juhász is a chemical engineer, certified chemical safety inspector and head of regulatory affairs at InnovaTox. She worked for 13 years as a chemical safety inspector and head of public health at the Veszprém County Institute of the Hungarian public health authority. She has 25 years of regulatory and consulting experience and has prepared more than 4,500 safety data sheets and notifications.

Last updated: 2026-10-06

Frequently asked questions

Which substances require registration?: Substances manufactured or imported in quantities of one tonne or more per year, on their own, in mixtures or in articles, require registration under Article 6(1) of REACH, whether or not they are classified as hazardous. The exemptions are listed in Annexes IV and V, including substances such as ascorbic acid, fructose, starch, minerals and ores.
Who must register, and when?: The manufacturer or importer must register as soon as the annual manufacturing or import volume reaches one tonne, taking the average of the most recent three calendar years into account.
Who is the registrant in an international company?: If subsidiaries are separate legal persons from the parent company under the applicable national law, each subsidiary must carry out its own registration.
How do we calculate a quantity above one tonne?: The calculation is made by calendar year, using the average of the last three years as the basis.
Can registration be completed free of charge?: No. A fee is payable to the European Chemicals Agency (ECHA), and access to the study data and registration dossier generally has to be purchased through a Letter of Access. Analytical testing and, where needed, external expert or consultancy fees may also arise.
Can we negotiate the price?: ECHA fees are set by EU legislation and depend on the annual quantity and company size. A lead registrant normally sets a uniform Letter of Access price for all purchasers, so that part is not negotiable. Other costs may vary according to the agreements between the parties.
How do I know whether the substance I use is already registered?: A registered substance has a four-part registration number, usually shown in section 1.1, 3.1 or 3.2 of the safety data sheet. Its format is XX-XXXXXXXXXX-XX-XXXX.
What does it mean if the identification number does not match that format?: A three-part number, or a number ending in XXXX, is likely a pre-registration number. It is no longer valid and does not demonstrate that the substance is registered.
What was pre-registration and what should be done now?: Before 2018, affected businesses could submit a free pre-registration. Under Commission Implementing Regulation (EU) 2019/1692, these pre-registrations ceased to be valid on 1 January 2020. Businesses must therefore register substances manufactured in the EU or imported into the EU above one tonne per year.
Where does the process start?: The registration dossier is prepared in IUCLID, the system created by ECHA for this purpose, and submitted through REACH-IT.
How long does REACH registration take?: It depends greatly on how quickly the lead registrant responds, but the complete process can typically be completed within a few months.
How can non-EU manufacturers help their importers?: Non-EU manufacturers are often familiar with the registration requirements in REACH. Ask them to help collect the correct identifiers, such as CAS or EC numbers, the substance name, analytical reports and information about impurities.
Which legislation sets out the REACH registration requirements?: The requirements are set out in Regulation (EC) No 1907/2006 of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemicals, commonly known as REACH.
Who checks substance registration in Hungary?: The public health department of the territorially competent district office is authorised to check whether substances have been registered.