In June 2007, the Registration, Evaluation and Authorization of Chemicals (REACH) regulation became law. REACH requires companies to disclose to the European Chemicals Agency (ECHA), Helsinki, Finland, documentation regarding processing and content details for chemicals manufactured in or shipped to the European Union (EU). Replacing 40 existing pieces of legislation, REACH encompasses around 30,000 substances and will impact companies throughout the supply chain, including manufacturers, importers and downstream users.
REACH addresses three specific areas: registration of substances; compliance with safe-usage conditions following receipt of substance permits; and verification of proper usage of substances throughout the supply chain. To satisfy these requirements, a best-practices approach to REACH compliance focuses on:
- gathering and storing substance information and tracking revisions/changes to documents;
- registering and tracking proper usage of substances in the supply chain;
- tracking substance volume;
- supply-chain collaboration and information integration; and
- organizational alignment into substance information exchange forums (SIEFs) to control registration and testing activities and reduce registration costs.
The overall success of these steps depends on the structuring and positioning of information. Data management is key. Because of the extensive documentation involved, REACH requires a significant increase in information sharing, not only between individual companies and the ECHA but also among companies, their supply-chain partners and SIEF peers. To adequately account for the reactivity, flammability, usage content and other details of each chemical produced in or shipped to the EU, companies must devise solutions for sourcing and storing large volumes of data.
To satisfy the initial REACH phase-in deadline beginning November 2010 as well as other deadlines over the following eight years, companies must submit a technical dossier to the EU for each chemical produced or imported in excess of one tonne annually. Substances with volumes greater than10 tonnes per year require an additional chemical safety report. Further data regarding risk factors must be supplied for any chemical whose volume surpasses 100 and 1,000 tonnes per year. In general, the higher volatility of a substance, the more documentation is necessary. This accounts for the "Registration" element of REACH. (The "Evaluation" stage consists of the ECHA checking documents and clarifying impact on human and environmental safety.)
Inability to adequately handle the volume of data involved with registration will result in higher operational costs and redundant work. Also, without a solid collaboration tool, companies run the risk of delayed submissions. With such a vast amount of information to manage and prioritize, companies require a reliable system for identifying which substances must be registered and in what order. To do this, companies must know the location of their data and be able to attest to its accuracy.
Tackling The Data Issue
Automated documentation-management software provides an effective solution for handling the data. It creates centralized locations for data, which allows for the storage and integration of information in an organization's logistical processes. On an operational level, this software enables users to check in, check out, manage revisions and merge documents. For example, during the shipping and manufacturing processes, users can store and reference material safety data sheets (MSDS) and product formulations. On a wider level, automated solutions lay the foundation for a REACH-compliant streamlined enterprise.
Documents involved in REACH registration evolve dramatically as companies undergo the necessary testing and preparation activities. These efforts include definition of exposure scenarios, generation of predicted no-effect concentration and derived no-effect level, definition of risk-minimizing measurement, and preparation of chemical safety reports — just to name a few items on the pre-registration checklist. Automated solutions accommodate the dynamic nature of the submission process by tracking the changing status of documents (e.g., "draft," "submitted for review," "approved," etc.); this functionality also proves beneficial when collaborating with supply-chain partners and SIEFs.