Seat cushions. Paints. Perfumes. Cosmetics.
Computer housing. What do these products have in common? They
all release chemical substances into the environment, so exporters
of the products to Europe must comply with new demanding European
regulations known as REACH, short for "Registration, Evaluation
and Authorization, and Restriction of Chemicals."
Some 30,000 chemical substances are covered by REACH, which will
be phased in starting this June. Rosemary Gallant, deputy senior
commercial officer at the U.S. Mission to the EU, called REACH
"the world's most ambitious law on public health and environmental
protection and one of the most complex texts in the history of
the EU." The new regulations comprise some 1,000 pages of legal
text and technical annexes, including some that have yet to be
finalized. "The devil is in the details, and some details are
not yet decided," Gallant said.
Unlike some other regulations, the rules of REACH are based on
the substance used in each product, not its end use. For example,
an ordinary garment exported to Europe would not be subject to
REACH, but garments treated with pesticides for use while hiking
in the woods would be covered. So would mattresses made with polyurethane,
an environmentally risky chemical.
Who needs to register? Not the manufacturer who uses these substances,
but his EU importer and Europe-based downstream users and third-party
representatives. Phase-in periods of REACH will range from three
to 11 years, depending on the substance. U.S. manufacturers and
their importers in Europe will be able to benefit from an extended
deadline if they pre-register their substances with the European
Chemicals Agency in Helsinki, Finland, by Nov. 30, 2008.
The good news is that products already registered under other
European regulations, such as foods, pharmaceuticals, biocides
and pesticides, will not need to be registered again through REACH.
Also exempt are low-risk substances such as water and oxygen;
minerals, ores or concentrates; and polymers.
The bad news is that REACH will impose significant costs. Technical
dossiers outlining the health and environmental risks will be
required whenever shipments of that substance to Europe amount
to more than one metric ton a year. Even more demanding chemical
safety reports will be required for substances shipped to the
EU in quantities of more than 10 metric tons annually. During
the pre-registration period, some companies will have to test
their substances for safety on vertebrate animals. Failure to
register a covered substance could halt all trade in that substance.
"If you don't register your chemicals, they cannot be exported
to Europe," Gallant said. Substances categorized by the REACH
rules as of "very high concern" will need to meet even more stringent
requirements, beyond registration with the European Chemicals
Agency. These substances will need official authorization from
the ECA or they will be banned outright from entering the EU.
Gallant said, "The ECA wants companies to prove that they have
looked at safer alternatives, and prove that they cannot substitute
for those substances," if such is the case. Importers and downstream
users will be encouraged to share data about each risky substance
in order to eliminate duplication of their efforts.
Many details of REACH remain murky. For example, will the "importer"
be defined as the person who makes an entry to European customs,
or the person who moves the goods into Europe? Because of the
complexities of the new rules, international law firms with a
presence in Europe will play an essential role in guiding U.S.
exporters through the shoals of REACH.
"Law firms have a leg up in understanding the regulations, and
they will be some of the winners," said Michael J. Ford, vice
president, regulatory compliance and quality, at BDP
International, a third-party logistics provider. Although 3PLs
will eventually feel some indirect impact from REACH, law firms
will play the crucial role at the front end of the process, long
before REACH has an impact on the operations of transportation
and logistics.
To adjust to REACH, 3PLs eventually will need to develop procedures
for deciding what happens to any shipment that winds up being
detained in Europe because of insufficient or incorrect documentation.
Ford noted that by the time a shipment enters Europe, U.S. exporters
have incurred a considerable cost, so 3PLs will have to answer
such questions as, "Do we send it back? Do we send it somewhere
else? Do we move it into a warehouse and move it later?" Some
small-scale exporters to Europe may be tempted to ignore REACH,
and hope that their noncompliant shipments pass through entry
points in Europe below the radar screen.
Given its breadth and complexity, it's not surprising that the
U.S. Department of Commerce will be educating the trade community
about REACH for months to come. "They are concerned to see that
REACH does not become a trade barrier," Ford said. Sooner or later,
exporters to Europe will find that they can ignore REACH only
at their own risk.



