Impact of REACH on US exporters of manufactured goods to the EU –
EU regulations are more stringent and more numerous than US regulations, and US manufacturers who don’t consider themselves chemical companies will find themselves widely affected by REACH. Dr. Louis Wyness of TSG Europe, a UK-based regulatory services consultancy, explains.
With trepidation from industry a new chemical regulation in the European Union (EU) called REACH (Regulation (EC) No 1907/2006) was published late in 2006. The Regulation which comes into force on 01 June 2007 will have a major impact on chemical and associated industries worldwide which manufacture and/or import chemicals, preparations and articles to the EU.
Before REACH the EU legislative framework for chemicals was fragmented with different rules for new and existing chemical substances and the requirements were generally considered by government to be inadequate for protecting human and environmental health. REACH brings together all existing EU legislation and is arguably the most comprehensive and far-reaching system of chemical regulation worldwide.
Basic elements of REACH
In brief, the basic elements of REACH are Registration (by industry), Evaluation (by a new Chemical Agency), Authorisation (and possible restriction) of Chemicals. The extent of the obligations placed on industry varies depending on the chemical tonnage manufactured in, or exported to, Europe and on the hazard properties of the chemical substance. Substances alone, in preparations or in articles are affected.
There are many exemptions from many or all of the provisions of REACH. Some substances being structurally simple and benign are exempted (and listed in the Annexes to the Regulation). Other chemicals or preparations already regulated are exempt from certain provisions such as those in medicinal products or in foods. Keep reading →