Substances exempted from the obligation to register

The REACH Regulation does not apply to:

  • Radioactive substances falling within the scope of the 96/29/Euratom Directive
  • Substances under customs supervision
  • Non-isolated intermediates
  • Waste as defined in Directive 2006/12/EC

Provided they are used in corresponding applications, substances are exempted from registration:

  • Medicinal products for human and veterinary medicinal use
  • In food or feedingstuffs, including use as foodstuff additives, flavourings in food products, and additives in feedingstuffs

The following are also exempted from the obligation to register:

  • Substances produced or imported in quantities of less than 1 t per annum
  • Substances listed in Annex IV, since sufficient information is available on these substances and due to their inherent properties they cause minimal risk only
  • Substances listed in Annex V, for example including certain substances occurring in nature, if they are not chemically modified, such as natural gas or coal, and also chemical elements the hazardous properties and risks of which are well known, such as hydrogen, oxygen
  • Reimported or recovered substances which have already been registered
  • Polymers

(Extract from the REACH Regulation, Article 2)

Substances in plant protection and biocidal products are regarded as being registered when they are used solely in such products.
(REACH Regulation, Article 15)

Notification in accordance with Directive 67/548/EEC (new substances notification procedure) is also regarded as registration. Up until 1 December 2008, the Agency assigned a registration number. Further information must be provided in accordance with the REACH Regulation, however, depending upon the quantity threshold.
(REACH Regulation, Article 24)

Substances employed for product-oriented and process-oriented research and development are also exempted from general obligation to register, but only for a period of five years (which may be extended).
(REACH Regulation, Article 9)

Isolated intermediates must be registered, but only a limited amount of information is generally required in this case.