Substances exempted from the obligation to register

Under Article 2 of the REACH Regulation, the obligation to register does not apply to:

  • radioactive substances within the scope of Directive 96/29/Euratom, now repealed by Directive 2013/59/Euratom;
  • substances under customs supervision;
  • non-isolated intermediates;
  • waste as defined in Directive 2006/12/EC, now repealed by Directive 2008/98.

Furthermore, a substance is exempt from registration when it is used exclusively in the following applications:

  • in medicinal products for human or veterinary use;
  • in foods or feedingstuffs, including as a food additive in foodstuffs, as a flavouring in foodstuffs, as an additive in feedingstuffs.

Finally, you are not required as a manufacturer or importer to register a substance with ECHA:

  • if you manufacture or import less than 1 ton of the substance per year;
  • if the substance is listed in Annex IV of the REACH Regulation
    (Annex IV includes all substances for which sufficient information is available and which, owing to their intrinsic properties, are considered to cause minimal risk.);
  • if the substance is listed in Annex V of the REACH Regulation
    (Annex V lists not only individual substances but also entire groups of substances. The exceptions often apply only under certain conditions, or are linked to processes. Detailed explanations of all these exemptions are provided by ECHA in the Guidance for Annex V.);
  • where the substance is a re-imported or recovered substance that has already been registered and you are able to demonstrate that your substance is identical to the substance already registered; or
  • where the substance is a polymer.

Articles 9 and 15 and Chapter 3 of the REACH Regulation make provision for further exemptions:

  • Substances in plant protection products and biocidal products are considered registered when they are used exclusively in these applications (REACH, Article 15).
  • Substances used for product-oriented and process-oriented research and development are also exempted from the general obligation to register, but only for a period of five years (extension is possible) (REACH, Article 9).
  • Although you are required to register isolated intermediates, the scope of the required information is generally limited (REACH, Chapter 3).