On the 1st of December 2008 at midnight, the European Chemical Agency (ECHA) closed the six-month REACH (Registration Evaluation and Authorisation of CHemicals) pre-registration period. European firms that make or import more than one tonne of a chemical substance per year, had to pre-register that chemical substance, if it is within a release agent on an article or within a preparation (mixture of chemical substances) , by that day. And there was a massive response: well over two million pre-registrations were submitted, covering more than 100,000 chemical substances. Ansell successfully pre-registered 28, after a time-consuming process of analytical dissection for all the gloves, condoms, gels, lubricants, etc. produced worldwide.

The pre-registration of chemicals is the key first component of REACH. Pre-registration is required to allow the company to take advantage of the "phase in" period , before formal registration is required. REACH is the EU's ambitious system for the Registration, Evaluation and Authorization of Chemicals, which came into force in June 2007.It was approved after years of studies and deliberations, started after a 1998 evaluation report of the European Commission had revealed the need for a new system. The former EU legislation framework on chemicals was a patchwork of different directives and regulations that did not really function properly. It made it difficult to determine the risks of many chemicals and took too long before measures were taken to ban chemicals with proven risks. In short: the former system hampered innovation and posed a hazard to both human health and the environment.
Industry responsibility
Of particular note in the new REACH system is the big responsibility that rests on the shoulders of the industry. The companies themselves have to know the risks of the chemicals they manufacture and/or use in the EU and manage them competently. REACH therefore stipulates that companies that import or manufacture over one tonne of a chemical compound per year have to register it in a central database. As this registration process is a very time-consuming, complex task for both industry and regulators, the registration of chemicals already on the market is to take place in three phases, spread over 11 years. To benefit from this phased process, REACH installed a pre-registration period, between 1st of June and 1st December 2008. Companies who failed to pre-register, can no longer manufacture or import their chemicals, unless they make immediate formal registrations.
28 Ansell chemicals
Ansell successfully completed the preregistration task. "We submitted information on all the substances we use in or on our articles , in quantities of over 1 tonne per year, which are designed for release or within preparations we produce" explained Phil Bates, Ansell Regulatory Affairs Director EMEA. "And although a full technical dossier is now required to complete the formal registrations , through the 'phase in' period, the first step itself was already quite challenging. It required breaking down all our products, from our gloves and condoms to gels and lubricants, manufactured throughout the world, into their constituent chemical substances. In the end, the 28 chemicals of which larger quantities are imported per year, were listed and posted on the REACH-IT portal over October and November." The next step, now, for the European Chemicals Agency (ECHA), is to publish all preregistered chemicals on its website, so that companies can identify potential registrants of the same substance and share data within the SIEF (Substance Information Exchange Forums) for each chemical substance. The majority of Ansell's chemicals will need full registration dossiers by 2018.
Substances of very high concern?
A second pillar of the REACH legislation where Ansell dutifully fulfilled its role is the notification of substances of very high concern (SVHC), i.e. chemicals with indications of impact on the environment and/or health. In October 2008, REACH published its first Candidate List with such SVHC chemicals. Companies now have the obligation to inform everyone involved in their supply chain if they use any of the Candidate List substances in concentrations over 0.1% w/w within their articles (eg gloves) or within preparations. Companies can continue to use these SVHCs up to October 2010 and then ,only if application is made to the ECHA for "Authorisation for continued use of the SVHC", can companies continue to use them after that date. To avoid this process, Ansell has recommended a program to replace the hazardous compounds with alternatives, if available. For more information on Ansell's policy in this matter, please refer to the Ansell website.