What is the REACH Scope?

• Substances on their own
• Substances in Preparations (a mixture or solution composed of two or more substances)
• To some extent, Substances in Articles (an object with a shape, surface or design that determines its function)
• Key exclusions from scope of the Directive: 
  • Non-isolated intermediates
  • Radioactive substances, substances under customs supervision
  • Waste
    
• Examples of exemptions from Registration and Evaluation are:
  
  • Substances manufactured/imported below 1 ton/yr (per manufacturer / importer)
  • Annex IV Substances (sufficient information and considered to cause minimum risk because of their intrinsic properties, eg. Certain Fatty acids, sugars, vegetable oils.
  • Annex V Substances including substances occurring in nature, if not chemically modified, eg. Natural gas, crude oil.
  • Polymers (but monomers & additives are subject to REACH requirements)
  • Substances for product and process-oriented research and development 
    • Notification required; exemption period of 5 years (renewable under condition)
  • Substances used in products covered by specific end use legislation, such as medicinal products, foodstuffs