What substances must be registered?

If you manufacture chemical substances or import chemical substances into the EU in quantities of one ton or more per year , you must register these substances with ECHA before placing them on the market for the first time. Chemical substances in this context may be discrete substances in their own right, in mixtures, and under certain circumstances in articles.

Registration procedure

The REACH Regulation provides for data sharing (REACH, Article 25). This is an important instrument for avoiding tests on animals.

Before you as a manufacturer or importer register your substance with ECHA, you must therefore enquire at ECHA whether the substance concerned has already been registered (REACH, Article 26). Where the substance has already been registered, you should become a party to its joint submission; should the substance have been registered only individually, you should set up a joint submission. Should you conduct studies on vertebrate animals, you are obliged to share data (REACH, Article 27).

The registration process requires you to submit a registration dossier to ECHA. The dossier must include a technical dossier containing data on the substance and information on appropriate risk management measures. The requirements for information are based on the quantities produced or imported per year (REACH, Article 12). For substances produced or imported in quantities of 10 tons or more per year, the registration dossier must also include a chemical safety report (REACH, Article 14).

You must also state the intended uses of a substance in the registration dossier. As the manufacturer or importer, you must therefore address the risks associated with all uses notified to you by downstream users. You are however not obliged as the manufacturer or importer to register a substance for a use that is not intended by you.

The IUCLID format is used at ECHA for preparation of the registration dossier.

Once ECHA has recognized the registration dossier as complete, you are issued a registration number for the registration in question (REACH, Article 20).

More detailed information on the registration procedure can be found on ECHA's help pages.

Particular aspects of the obligation to register

Certain substances are exempted under REACH from the obligation to register.

  • Isolated intermediates must be registered; the information required may however be limited (REACH, Chapter 3).
  • Substances intended to be released under an article's normal conditions of use must be registered when they exceed the respective tonnage threshold (REACH, Article 7).
  • Substances released unintentionally during normal use of an article must be notified to ECHA when they are classified as dangerous and exceed the respective tonnage threshold (REACH, Article 7).
  • Substances of very high concern (SVHC) require authorisation (REACH, Articles 55 ff).

Obligations following registration

As long as you, as the registrant of a substance, continue to manufacture or import it, you are obliged to keep the registration dossier up to date at all times (REACH, Article 22).

Should you have registered a substance jointly with other manufacturers/importers (joint submission), your obligation to share existing data continues to apply after registration (REACH, Articles 11 & 19).