The Time Has Come for REACH

Solutions to chemical registrations in the EU

by Geoff Brooks

On June 1, 2007, the European Union began enforcing legislation known as REACH – the Registration, Evaluation and Authorization of CHemicals imported into or manufactured in the EU. The EU estimates that close to 30,000 companies will register more than 100,000 substances at a cost of about $3.1 billion. Once registered, chemicals will be fully assessed as to their health and environmental impact — and if deemed harmful, may require authorization and/or restriction.

REACH applies to:

• Chemical manufacturers within the EU and chemical importers into the EU
• Downstream users
• End-use sectors such as automotive and aerospace

The Regulation has three main elements: Registration, Evaluation, and Authorization and Restriction.

REACH requires all manufacturers/importers of chemicals in quantities of greater than one ton per year into the EU to register those chemicals with the European Chemicals Agency (ECHA). In the case of new chemicals, this will have to take place before manufacture/importation takes place, but in the case of existing chemicals (i.e., those that have been manufactured/imported within 15 years prior to the Regulation), companies will be required to pre-register the chemicals within 18 months of the regulation enactment (by Dec 31, 2008) so that they can continue manufacture/importation and use during a ‘phase-in’ period.

The task of registering existing chemicals will be arduous. In many instances, certain chemicals will require physical, chemical, toxicological, and environmental testing prior to submission, evaluation and authorization by the ECHA. Failure to register will mean that the chemicals cannot be manufactured in or imported into the European market.

Chemical companies are just now sorting out the registration process.

One of the first and most important questions for companies is: Are we going to pre-register/register a substance or not? This simple question can have a profound impact on the rest of their business. For instance, they may need to reshape product portfolios by eliminating substances from formulation/recipes or find less harmful alternatives.

To make an educated decision, a chemical manufacturer will need to develop or outsource the development of a single repository that can automatically gather and house data from disparate systems where it can be collated, analyzed and reported. This will allow the REACH coordinator to seamlessly cross-reference their products substance-by-substance to assess which chemicals are impacted by REACH. In addition, manufacturers will be able to see the impact substitution or elimination of certain chemicals will have on their formulations.

Chemical companies also have to go through the physical act of registering substances. The ECHA accepts information via a system called IUCLID 5. Every company (actually every ‘legal entity’ according to REACH) registering will need to submit data using this system. If the relevant data is gathered in a spreadsheet, it will then have to be re-entered manually into IUCLID 5; this process of re-entry is both prone to errors and time-intensive. A better alternative would be a software solution that directly transferred data into the IUCLID 5 database, eliminating the need for manual uploading.

The communication requirements of REACH ensure that not only manufacturers and importers, but also downstream users (DU) 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 material safety data sheets (SDS) supplied to them accurately reflects all 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.

No chemical company will be immune from the challenges associated with REACH registration. While the biggest manufacturers and importers may have the most resources for in-house development, they also have the largest and earliest obligations to register. Small manufacturers may have fewer burdens for REACH compliance, but have fewer or no internal development resources.

Time is running out. Building a solution internally — just to create a repository for REACH — can take as long as 15 months. The window for pre-registration is 18 months. So by the time chemical companies develop a solution that will tell them which chemicals to pre-register and register, the deadline will be upon them. If they want to meet these deadlines and comply with REACH, they should consider an outsourced REACH-specific IT solution. These can be rapidly implemented into the existing IT infrastructure and should have all the components necessary to meet the requirements of REACH, including a substance central database and a way to directly transfer this information into IUCLID 5. If chemical companies don’t act now, their ability to stay in the game will be out of reach.

Geoff Brooks is a chief software architect, The Wercs, Ltd. He can be contacted at info@thewercs.com.