Rules and regulations
REACH
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is a European Union Regulation of 18 December 2006.
REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.
Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years.
It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force in June 2007, with a phased implementation over the next decade.
A separate regulation – the CLP Regulation (for "Classification, Labeling, Packaging") – implements the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive. It came into force on January 20, 2009, and will be fully implemented by 2015.
When REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one ton or more per year to register these substances with a new European Chemicals Agency (ECHA) in Helsinki, Finland. Because REACH applies to some substances that are contained in objects ('articles' in REACH terminology), any company importing goods into Europe could be affected.
The European Chemicals Agency has set three major deadlines for registration of chemicals. In general these are determined by tonnage manufactured or imported, with 1,000 tons p.a. being required to be registered by December 1, 2010; 100 tons p.a. by June 1, 2013; and 1 ton p.a. by June 1, 2018.
In addition, chemicals of higher concern or toxicity also have to meet the 2010 deadline.
About 143,000 chemical substances marketed in the European Union were pre-registered by the December 1, 2008 deadline.
Supply of substances to the European market, which have not been pre-registered or registered is illegal (known in REACH as "no data, no market").
REACH also addresses the continued use of chemical substances of very high concern (SVHC) because of their potential negative impacts on human health and/or the environment.
As of June 1, 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one ton per year and the SVHC is present at more than 0.1% of the mass of the object.
Some uses of SVHCs may be subject to prior authorization from the European Chemicals Agency, and applicants for authorization will have to include plans to replace the use of the SVHC with a safer alternative (or, if no safer alternative exists, the applicant must work to find one) - known as 'substitution'.
REACH applies to all chemicals imported into or produced in the EU. The European Chemicals Agency will manage the technical, scientific and administrative aspects of the REACH system.
Under certain circumstances the performance of a Chemical Safety Assessment (CSA) is mandatory and a Chemical Safety Report (CSR) assuring the safe use of the substance has to be submitted with the dossier. Dossier submission is done using the web-based software REACH-IT.