Registration, Evaluation, Authorization of Chemicals

Today’s active laws and directives, Registration, Evaluation, Authorization of Chemicals (REACH) and Reduction of Hazardous Substances (RoHS) among them, are government-sanctioned. If your company should fail or refuse to comply with them, the penalties will be immediate. Frequently, they will be extremely harsh, too, as the record shows.

For example, when a number of Apple’s products did not comply with environmental regulations, many countries in the EU were forced to stop purchasing them, resulting in heavy losses of revenue on both sides of the value chain. The same thing happened when Palm, Inc. failed to comply. One of their major products is no longer available to the European market.

1. Ascertain which REACH requirements will affect your products, customers, and suppliers

2. Implement structures to guarantee executive responsibility and accountability

3. Create a fund to handle your compliance response

4. Decide which products you intend to pre-register well before the June 2008 deadline

5. Define your research and development efforts to accord with REACH so that you can transition to alternate substances should any products be threatened by blacklisting

One good thing about the preregistration process is that you are not required to provide every piece of data about your substances for long-term registration. To begin, you only need the name of the substance, its chemical abstract and European inventory numbers, and range of production volume. Each chemical product or substance will be given one registration number under REACH.

Registration is not the only process involved in complying with REACH, however. For example, those companies that produce or deal in common bleach, which is used in products as diverse as paper, makeup, and cleaning supplies, must also provide their customers with appropriate compliance documentation, conduct testing based on foreseeable use-case scenarios, and share resulting information with others in the industry so that they, too, can conduct testing.

American companies under the impression that they will not be affected by this law because it derives from EU legislation are sorely mistaken. If you are one of them, you would do well to adjust your attitude immediately. In fact, REACH should assume the status of a critical business matter that will affect the operations of your company, your vendors, and your customers across whole enterprises.

REACH is so important that Robert Matthews, a REACH authority and partner in the Washington-based law firm McKenna, Long & Aldridge, has recommended that industry executives “elevate REACH compliance from the environment, health, and safety departments in [their] firms to the level of a business development-unit reporting directly to the company president.” Recently, Dupont assigned top-level executives to manage REACH compliance and processes — an indication of how serious and important this issue is to businesses today.

Until its final enactment on June 1, 2007, REACH (EC 1907/2006) was a matter not only of serious legislative debate, but also on the receiving end of bitter condemnation. And though it may still be grounds for all sorts of feelings, good and bad, the fact is that its regulations will force businesses around the world to make some excruciating decisions about tens of thousands of substances by June 2008, because that is the date of the first regulatory deadline set to affect existing chemical products. REACH, whose provisions will be phased-in over 11 years, now replaces 40 existing pieces of legislation in the European Union (EU). Companies can find explanations of REACH in the guidance documents, on the EU’s REACH web site (see Figure 12-1) and a number of help desks are available for consultation. The European Commission is slated to conduct a series of reviews of REACH Annexes until December 2008 (Annexes I, IV, V, XI, XIII).

What REACH says

The TSCA (which hasn’t been amended since its enactment over 30 years ago) is to REACH what a speck of dust is to the sun. The difference between them — to say nothing of both the immediate and long-term consequences of the latter — is enormous. Remember our discussion on the difference between substances and materials? Well, this is where those differences come into play even as they are obliterated. Forget materials. REACH forces companies to comply on the level of substances — an enormous task compared to complying with the TSCA.

The current registration process, in which you must register every product you make with the European Chemicals Agency (ECA), covers nearly 30,000 substances. Of these, 2,500 are likely to be hazardous to human health or the environment and will have to undergo continued testing to show that they can be used safely. Over the next dozen years, however, as many as 100,000 existing substances will be subject to REACH evaluation, authorization, and, in many cases, restriction. Ultimately, the ECA estimates that a total of 150,000 to 200,000 substances will be registered, though some authorities put that number much higher, going so far as to suggest that there will be half a million applications for approval.