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It would be hard to miss this very newsworthy and obvious acronym published everywhere during the past several months, but unless you’re immersed in its impact on the European cosmetic industry, REACH may appear as yet another complex program with many unanswered questions. In fact, even the experts will agree that this enormous chemical initiative, while highly structured, still leaves many technical and economic uncertainties./
REACH is a comprehensive program for the registration, evaluation and authorization of chemicals, negotiated by the European Parliament and signed into law by the European Council of Ministers on December 18, 2006. The 800-page document, including annexes and supplemental guidances on implementation (ec.europa.eu/enterprise/reach/index_en.htm), will replace approximately 40 pieces of existing chemical legislation with a system intended to control and manage both new and existing chemicals throughout the supply chain. While finished cosmetic product safety and ingredient usage are already regulated and controlled via the 7th Amendment to the Cosmetic Directive (76/768/EEC), the REACH initiative addresses both the safety and long-term environmental impact of the ingredients used in cosmetics, as well as packaging.
REACH is based upon one principle: safety. It requires manufacturers, importers and downstream users to assure that chemical substances are inherently safe for consumer product use, occupational exposure and long-term environmental impact. It also admonishes the “no data, no market” rule and further imposes the “precautionary principal,” where additional data and definitive action are required when uncertainty is identified.
There are requirements to register all substances used in a product, evaluate the safety dossiers and the chemical substances, authorize the specific uses of very high concern substances and restrict usage of certain chemicals with documented safety concerns.
REACH goes into effect on June 1, 2007, with enforcement responsibility assigned to a new European Chemicals Agency (ECHA) to be established in Helsinki, Finland. There are extensive details yet to be addressed by the ECHA, so the forms, fees and basic refinements to many of the stated requirements of REACH must still be developed and published in the months ahead. Over the next 11 years, approximately 30,000 currently used chemical substances must be registered according to the established timetable.
REACH regulations have already had a broad effect on the industry because reporting requirements apply to all manufacturers in the EU, European importers and downstream users. The suppliers of chemical substances and those who use them to manufacture or blend products are subject to stringent reporting obligations when the annual average quantity of a single substance (based on a three year average) exceeds one metric ton for that manufacturer or importer. Other categories are scheduled for earlier registration, based upon higher tonnage and where greater safety concerns are warranted.