3/3/2008
REACHing for help on IT
Specialty Chemicals January/February
The task of pre-registering and registering new and existing chemicals under the REACH regulations is arduous. In many instances, certain chemicals require physical, chemical, toxicological, and environmental testing prior to submission, evaluation and authorisation by the European Chemicals Agency (ECHA). Failure to pre-register means that the chemicals cannot be manufactured in or imported into the European market.
Some companies have created specific in-house IT database tools and applications to manage the pre-registration and registration process. However, this process can be costly and time-consuming, and the tools usually have less functionality than those developed by a regulatory compliance company with extensive REACH expertise.
With a looming pre-registration deadline, in-house alternatives are becoming less feasible. In this situation, the attraction of outsourced REACH software tools which can integrate into existing ERP systems, inventory and sales modules and other IT systems is obvious. In this arena, The Wercs offers the REACH 1 2 3 modules.
Currently, many companies are climbing the first rung of the REACH ladder - identifying which substances need to be pre-registered or registered. This basic question can have a profound business impact. For instance, product portfolios may need to be reshaped to accommodate eliminated substances from formulations and recipes or safe alternatives must be found to replace harmful chemicals.
To make an educated decision, a chemical manufacturer needs a tool that automatically gathers and houses data from disparate systems where it can be collated, analysed and reported. The Wercs WercsSIMS (Substance Information Management System) module can help with this part of the pre-registration process.
WercsSIMS cross-references a company's products with a database that holds the substance information of their suppliers to assess which chemicals will be impacted by REACH. In addition, manufacturers will be able to see the impact certain chemicals will have on their formulations.
Once the decision to pre-register or register a substance has been made, the pertinent chemical information must be submitted to the ECHA. This information includes, for example, the international chemical name, common or trade names, the EINECS number, the CAS name and number and extensive physicochemical, toxicological and ecotoxicological information.
The ECHA accepts information through an IT system called IUCLID 5, via which every 'legal entity' (as defined by REACH) registering substances will be required to submit data. There are approximately 9,000 data elements that comprise the maximum number of fields that a substance can contain. This data may originate in multiple applications across the enterprise and must be collated and approved before it can be submitted.
In addition, multiple companies may be registering the same chemical. In these cases, the companies are bundled into a Substance Information Exchange Forum (SIEF). Participation in a SIEF requires the sharing of data, workload and costs related to all aspects of getting the registration completed. IUCLID 5 also serves as the tool for exchanging data among SIEF partners.
The relevant chemical data, if it is in a spreadsheet, has to be re-entered manually into IUCLID 5. This process of re-entry is both time-intensive and prone to human error. A better alternative is a software system that directly transfers data into the IUCLID 5 database, eliminating the need for manual uploading.
WercsSIMS plugs into the IUCLID 5 database through its REACHConnect module. This connection eliminates the need for manually uploading data and allows the data to be controlled and transferred between IUCLID 5, the Chemical Safety Report and extended Safety Data Sheet (SDS) without significant rework. REACHConnect can also coordinate the phrase data of IUCLID 5 with The Wercs phrase library.
The communication requirements of REACH guarantee that not only manufacturers and importers, but also downstream users and distributors have the information they need to use the chemicals safely. Downstream users will also need to communicate effectively with their manufacturers to ensure that the SDS supplied to them accurately reflects all of their uses.
Having a robust system in place for manufacturers to manage the large volumes of comments from their customers will be critical for effective REACH compliance. WercsDownstream manages this step of the process. This portal allows end-users to check if the risk management measures included in the extended SDS are relevant to their conditions of use. It also allows them to communicate new product uses back to the supplier.
Figure 1 shows how REACH 1 2 3 modules would fit into a company s IT environment. The boxes in the centre define the range of systems that exist in many enterprises, from large ERP systems to more specialised systems such as Customer Relationship Management. The REACHConnect module connects WercsSIMS directly to IUCLID 5 and streamlines the pre-registration and registration process.
For companies that do not already have an in-house system to meet pre-regulation deadlines and specifications, an outsourced REACH-specific IT system is the logical answer. Software tools like REACH 1 2 3 can be rapidly implemented into the existing IT infrastructure and should have all the components necessary to meet the requirements of REACH, including a central substance database and a way to directly transfer this information into IUCLID 5.
If chemical companies do not act soon to find an IT solution to help them comply with REACH legislation, their ability to tap into one of the largest markets in the world will quickly be out of reach.