REACH (Registration, Evaluation and Authorization of Chemicals) is the EC1907/2006 Regulation, which entered into force on June 1st 2007 and replaces all previous legislation on authorization of chemicals in the EU. In fact it creates a single system for both “existing” and “new” chemicals manufactured in or imported into the EU in quantities greater than 1 tonne/year. Although REACH is a European program, it impacts manufacturers worldwide.

According to REACH requirements, industry has the responsibility to ensure that the chemicals it manufactures, imports and puts on the market in the EU do not adversely affect human health or the environment. It requires manufacturers and importers of chemicals into the European Union (EU) to submit hazard, use, and risk data for all substances.

Registration will be mandatory before a new chemical can be marketed and to keep an existing chemical on the market. The extent of the information required for each chemical by REACH will depend on the volume of the chemical produced or imported. Chemicals classified as carcinogens, mutagens, reproductive toxins (CMR 1 and 2 category), persistent, bio-accumulative, toxic (PBT), very persistent, and very bioaccumulative (vPvB) under REACH will be banned entirely if the manufacturer cannot demonstrate that risks associated with the chemical can be controlled.

The REACH program will require the sharing of information and joint applications by multiple manufacturers. Sharing of animal data is mandatory. Downstream users of the chemicals will be required to do their own Chemical Safety Assessment (CSA) or secure data from suppliers.

The registration dossier contains information on the properties, uses and on the classification of a substance as well as guidance on safe use. Information requirements are mainly based on volume and comprise data regarding physicochemical, toxicological and eco-toxicological properties. For substances with annual volumes of more than 10 tons, a Chemical Safety Report containing a Chemical Safety Assessment is required. Moreover, to avoid toxicological test duplication and to reduce costs for industry, registrants are required to jointly submit information on the hazardous properties of the substance and its classification, and can, if they agree, jointly submit the chemical safety report.