Extending Europe’s REACH
R. David Whitby | TLT Worldwide January 2009
The problems and costs of complying with this complex regulation have prompted some to ask whether its deadlines should be extended.
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During the last two years, much has been written and talked about the new Registration, Evaluation and Authorization of Chemicals directive from the European Union. The aim of REACH is to increase the safe use of chemicals in all industries in Europe by very precisely managing their effects on health, safety and the environment.
All manufacturers of chemicals within Europe, as well as all importers of chemicals into Europe, now are subject to the EU regulations. Lubricants are covered in all forms, including base oils, synthetic fluids and additives, bulk and packaged finished oils and greases and prelubricated equipment such as factory-lubricated bearing sets.
REACH has four phases: preregistration, registration, evaluation and authorization. The new law was enforced on June 1, 2007, as manufacturers or importers of chemicals used in the EU were given 18 months to preregister substances already on the market. Any substances that were not preregistered by Nov. 30, 2008, were prohibited from being sold after Dec. 1, 2008, until their suppliers registered them.
The registration phase involves each manufacturer or importer compiling a dossier that lists the following:
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The identity of the manufacturer or importer
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The substance or mixture
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Manufacture or importation and its use
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Annual production volume
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Classification and labeling
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Guidance on its safe use, physical and chemical data
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Key health, safety and environmental information, hazard assessments, exposure assessments, risk characterization
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Exposure scenarios for manufacture and each identified use.
Once completed, the dossier on each chemical or mixture from each manufacturer or importer must be submitted to the European Chemicals Agency in Helsinki, Finland, for evaluation and authorization, using mandatory software for the submission. The ECA will determine whether and how each chemical or mixture can or cannot be used. Some chemicals might be authorized for some uses but not others. Authorizations are valid for three years, renewable upon resubmission of the dossier that includes any updated information.
Currently the registration process for chemicals or mixtures manufactured or imported in amounts greater than 1,000 tonnes per year must be completed by Nov. 30, 2010. Any chemical that is suspected or known to be hazardous must also be registered by that date. For chemicals manufactured or imported in smaller volumes, the time frames for registration are May 31, 2013 (100 to 1,000 tonnes), or May 31, 2018 (1 to 100 tonnes).
Last October some members of the UK Chemical Business Association, along with other European chemical companies, experienced difficulties with preregistering their chemicals via REACH-IT on the ECA Web site. A number of companies wrote to the European Commission requesting a six-week extension to the preregistration process—otherwise they might have to cease trading. At the time of writing, it was not known whether this extension had been granted.
While the aims of the REACH process are very laudable, it is quite clear that the whole process is enormously complex and can be quite costly. The process was not helped by the ECA, which was only formed in June 2007, and some of the guidelines for the process weren’t published until the beginning of 2008.
It appears the REACH process will prove much more difficult to achieve within the envisioned time frames that the EC, politicians, NGOs and environmental organizations had originally intended.
At a time of increasing financial difficulty for many companies, including those involved with chemicals, it is possible that the costs and complexities of REACH may prove too onerous.
With that said, perhaps the EU should rethink and extend the time frames and deadlines for implementing REACH.
David Whitby is chief executive of Pathmaster Marketing Ltd. in Surrey, England. You can reach him at pathmaster@dial.pipex.com.