Do you need to register a chemical substance?
  1. YES, if you plan to produce, import or trade within EU more than 1 ton of chemical substance a year
  2. YES, if your substance is not already registered to ECHA EU Agency
Who is entitled to register a substance?
  1. EU manufacturer or importer of substances on their own or in a mixture
  2. EU producer or importer of articles meeting the criteria explained in the Guidance on requirements for substances in articles
  3. "Only representative" established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfill the registration obligations of importers
How to register a substance?
  1. register to REACH-IT EU system
  2. ​install IUCLID App and submit/exchange data with ECHA EU Agency

Basic information

Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance are obligated to submit their registration jointly.

Accurate identification of a substance is important in the registration process to ensure that registrants of the same substance belong to the same joint registration. It also sets the scope of the joint registration.

Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance.

This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.

Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles. Chemical substances that are already regulated by other legislation such as medicines, or radioactive substances are partially or completely exempted from REACH requirements.

Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. The analytical and spectral information provided should be consistent and sufficient to confirm the substance identity.

For substance registration a fee is usually charged.

Subtances to be registered: Phase-in substances

There is a special transitional regime for substances which were already manufactured or placed on the market before REACH entered into force. Such substances are called phase-in substances. 
 
Companies benefit from the transitional regime if they per-registered their substances by 1 December 2008 (or in certain circumstances, made a later per-registration before the relevant registration deadline).
 
Substances that fulfill at least one of the following criteria may be considered as phase-in substances in accordance with REACH: 
  • Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) 
  • Substances that have been manufactured in the EU (including the countries that joined on 1 January 2007) but have not been placed on the EU market after 1 June 1992
  • Substances that qualify as "no-longer polymer''

For these substances, the REACH Regulation sets the following registration deadlines:
 
The type of your substance is the main factor in determining when you need to register.
  • If you have a newly invented substance, it needs to be registered before you place it on the market in the European Economic Area. These are called non-phase-in substances.
  • Substances that have been on the European market for a long time are called phase-in substances.
  • The most hazardous phase-in substances and those in the highest volumes are already registered. The last registration deadline is on 31 May 2018 and is for substances in volumes between 1 and 100 tonnes a year.

 
Substances to be registered: Non-phase-in substances

All substances that do not fulfil any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances have not been manufactured, placed on the market or used in the EU before 1 June 2008, (unless they were notified under the Dangerous Substances Directive (67/548/EEC)).
 
Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance before they can manufacture or import the substance.
 
All substances notified under the Dangerous Substances Directive (also called NONS) are considered to be registered under REACH and ECHA has assigned registration numbers to all the notifications. The owners of the notifications can claim the registration numbers from ECHA.


Exemption for Research and development activities (PPORD)

To further encourage innovation, substances used in scientific research and development (SR&D) in amounts of less than one tonne a year are also exempted from authorisation and restriction.

Substances used above one tonne a year for product and process orientated research and development (PPORD) can also be exempted from the obligation to register for a period of five years.
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To benefit from this exemption, a PPORD notification must be submitted to ECHA.
In the PPORD notification, companies have to include:

  • information on the substance identity,
  • its classification,
  • information related to the PPORD programme, and
  • the quantity of the substance expected to be manufactured or imported during the five-year period of exemption.

ECHA assesses the PPORD notification and may impose conditions to the PPORD exemption. The manufacturer or importer of the substance has to comply with the imposed conditions and must inform relevant customers involved in the PPORD.
If a substance used for PPORD is subject to restriction or authorisation, the respective decisions will specify how they apply to PPORD. They will also define the maximum quantities of the substance that can benefit from a PPORD exemption.
Here the guides of ECHA EU Agency...
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​...and the documentation:
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