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Sep 23 2008 12:00AM | Permalink | Email this | Comments (3) |
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REACH is a European Union (EU) regulation governing the registration, evaluation, authorization (and restriction) of chemicals.
Some 300 pages long, with hundreds of pages of guidance notes, REACH is one of the most complex regulations to come out of the EU. From a list of more than 100,000 chemicals used in Europe, only 3% of the 30,000 most popular chemicals in use have been fully tested. There is still no data for 21% of them and inadequate data on a further 65%. At the same time, the number of incidents of allergies, asthma, certain types of cancer, and reproductive disorders, including low sperm counts, are on the increase in Europe. One percent of all diseases are attributed to chemicals.
REACH requires the registration of these popular chemicals, as well as all new ones, along with the adequate safety and risk assessment data. Substances considered of very high concern (SVHC) may need to be authorized at significant cost. Dates for registration vary over some 10 years through to 2018, with chemicals of highest use and the greatest concern, under review as a matter of priority.
If United States-based companies intend to export in to the EU, they will require either a distributor, or "only representative," to register their products as appropriate, depending on tonnage. Such a representative will probably need to be a chemicals professional. A period of pre-registration will end in December, and if US companies have not pre-registered their substances, they will not be able to export into Europe until they have fully registered with all the appropriate safety data -- a process that could take several months.
Registration is dependent on the tonnage imported into the EU, but can vary from around $2,000 to more than $40,000. Authorization costs of use of SVHC can be even more significant, more than $70,000. These prohibitive costs may well have an impact on US companies looking to import goods from the EU. As a result of these costs, certain substances may be phased out by EU manufacturers.
At the very least, US companies are likely to find that products and raw materials purchased from the EU will become more expensive, as EU companies comply with the REACH regulations.
US companies with operations in the EU are likely to be affected by REACH regulations that require EU importers, manufacturers, producers, and downstream users to comply with a variety of procedures including, in some cases, registration of substances, where certain weight thresholds are met.
US companies with EU operations should now be looking into their potential obligations. For example, does their EU operation use substances imported from outside the EU, and are there substances in products they import from outside the EU that are intended to be released, or any that are likely to be categorized as substances of very high concern? If so, these factors could trigger various burdensome registration and notification obligations.
On the benefits side, once REACH is fully implemented around year 2010, research estimates that there will be 4,500 fewer cases of cancer and 90,000 fewer allergies every year in Europe. Now offset that against the European Commission's estimation of implementation costs to industry of between $4 billion and $10 billion.
Worth it or not, what do you think? Voice your thoughts below.
About the author
As director of legislation and environmental affairs, Gary Nevison is Newark's and Farnell's spokesperson and customer interface on legislation that affects the electronics industry, such as the ROHS (all variations around the world), REACH, EuP, and WEEE directives. For more on Gary, click here.