Abstract

Alarmingly, nine out of ten companies failed ECHA’s audit of 2010 dossiers submitted to satisfy the EU law on chemicals, also known as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). What’s wrong and what can we learn from this? Most of the issues relate to using alternatives to animal testing. Without a doubt, these areas are a challenge for everybody to interpret and apply – industry and regulators alike. WIL Research, a contract research organization that has been helping chemical companies file REACH dossiers since the law was first enforced, will show you how to successfully navigate five of the most challenging areas of the law so you can get REACH right the first time.

Compliance does not come easy with the European Union’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) law, which has been called one of the most complex chemical regulations in the world.

This 5-year-old legislative framework sets standards for production, import and use of substances. But it has another key objective, as well: It makes industry, not European authorities, responsible for assessing and managing the risks posed by chemicals and for providing appropriate safety information to the chemical’s end users.
Still, the EU council is closely involved in ensuring that information on the hazards and safe use of chemicals is available to everyone. REACH requires that the European Chemicals Agency, or ECHA, checks at least 5 percent of the registration dossiers per tonnage band to ensure compliance with legal requirements.
Alarmingly, a recent report has revealed that ECHA is finding errors in the vast majority of registrations. Of the dossiers that ECHA has checked for compliance, about 90 percent failed. The most common shortcomings include incorrect or ambiguous substance identification, the misuse of read-across (u ...