Registration of a chemical

All companies in the European Economic Area (EEA = European Union + Norway + Iceland + Lichtenstein) that manufacture, import or use chemical substances in their activity, in a total quantity equal to or greater than one (1) tonne per year, whether these substances are on their own (such as a solvent or a metal), in a mixture (cleaning product containing this solvent, alloy) or contained in an article, such as a kitchen utensil. The chemical industry, manufacturing companies, crafts, all sectors are concerned.

More specifically, you must register if you :

• manufacture more than one tonne of substance per year: you produce a substance or extract it;
• are responsible for importing a substance into the EEA in a quantity of 1 tonne or more: you are responsible for the physical introduction of a substance into the EEA territory (as such, in a mixture or in an article).

Any legal entity outside the EU that wishes to comply with REACH on a voluntary basis.

If you manufacture or import less than one tonne of a substance per year, you do not have to register the substance.

Similarly, you do not have to register if you :

• distribute a substance: you store and place substances on the market, as such or in mixtures, on behalf of others;
• repackage: transfer substances or mixtures from one container to another, usually as part of a repackaging or rebranding exercise;
• formulate: you produce mixtures (e.g. paints, adhesives, detergents, diagnostic kits) which are usually supplied further downstream;
• are the end user: you use chemicals, but do not supply them further downstream.

REACh is the acronym for "Registration, Evaluation and Authorisation of Chemicals". This European regulation n°1906/2007 came into force on 1 June 2007, and applies across the board to provide a global framework for the activities of the European chemical industry. The aim of this regulation is to protect human health and the environment against the risks associated with chemical substances, and promotes the use of alternative methods (in vitro in particular) to assess the dangers of substances instead of resorting to animal testing.

Among the main provisions, registration (Title II) is built around the following 2 principles:

• no data, no market, with the burden of proof on industry
• one substance, one registration.