Registration – No data, no market
REACH requires each manufacturer and/or importer (importing from outside the EU) of substances at 1 tonne or more per year, and each producer/importer of articles (containing substances intended to be released) to submit a registration dossier to the European Chemicals Agency (ECHA). So, if a company manufactures a substance in the EU, or imports a substance into the EU from a non-EU country at greater than 1 tonne per annum, then that company potentially has registration duties. The registration dossier must be submitted to ECHA via a specific IT system, known as REACH IT. A standard set of data will be required to be submitted for each substance – the amount of information to be submitted will depend on the tonnage of the substance placed on the market. The information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled.
If a manufacturer or importer does not register the substances he manufactures or imports, then there will be no data available and so he will not be able to manufacture or import them legally.
Exemptions from registration
Some substances are exempt from registration requirements. This can be the case for example for substances covered by other legislation (such as those used in medical products), or for substances for which sufficient information is known so that they are considered to cause minimal risk because of their intrinsic properties. All exemptions are indicated in Article 2 of the REACH Regulation.
In addition to exemptions, active substances for use in plant protection or biocidal products, as well as substances already notified under Directive 67/548/EEC, are considered as already registered under REACH.