For the
European flexible packaging industry, REACH arguably is the
most significant legislative development of the past two
decades. Standing for Registration, Evaluation and Authorization
of Chemicals, REACH obliges packaging manufacturers, importers
and end-users to show that chemical substances they manufacture,
import and use won’t harm human health or
the environment.
Though the legislation hasn’t been finalized, shrewd
companies are assessing its likely impact on processes, products
and supply chain partners. It’s an urgent
mission: the EU hopes to implement REACH in Spring, 2007.
Evaluating 30,000 Chemical Substances
As currently legislated, REACH will replace the varied
chemical safety regulations that European countries currently
administer and will govern all chemicals produced in amounts
over one ton. Some 30,000 substances must be assessed under
the new rules, and the EU believes that in the first 11
years of REACH, its new chemicals agency will receive about
80,000 dossiers from companies registering chemical substances.
Some substances, such as polymers, are exempt from the
registration process.
When the law takes effect, its application will be gradual in most cases:
within three years, companies must register substances
that are imported or manufactured in amounts more than
1,000 tons yearly, and all substances that are classified carcinogenic, mutagenic
and reprotoxic (CMT) and persistent, bioaccumulative and toxic (PBT).
within six years, companies must register substances imported or manufactured in amounts between 100 and 1,000
tons
within 11 years, companies must register substances imported or manufactured between one and 100 tons.
The first practical hurdle, however, is pre-registration:
REACH requires companies importing or manufacturing
substances covered by the law to pre-register those substances
within 12 to 18 months after the legislation takes effect.
Draft legislation does not list which chemicals are affected;
companies may consult the European Inventory of Existing
Chemical Substances for more information. Each company
must assess which chemicals it manufactures or imports
at amounts above one ton.
Opinions Differ on the Effect of REACH
How will REACH affect the thousands of companies that
depend on regulated chemicals? KPMG, a global consulting
firm who weighed in on the flexible packaging segment,
predicts that price increases due to REACH won’t
hurt competitiveness, and that few high-volume substances
are at risk of withdrawal. Downstream users can breathe
a sigh of relief, since they most likely won’t experience
withdrawal of chemicals important to their businesses.
Some others, however, predict negative impacts on
innovation, pricing, competition, chemical availability
and chemical formulations. “It’s difficult
to say exactly what the actual effect will be,” says
Andrea Sitia, product stewardship manager for Rohm
and Haas Adhesives and Sealants in Europe. “However,
we expect that it will impact the number of substances
authorized for use in Europe. This is particularly
true for concerned — CMR and PBT — substances.
We think REACH increases the likelihood that they will
be phased out.”
Rohm and Haas Prepares for Compliance
Rohm and Haas is preparing thoroughly for implementation.
The company maintains a dedicated REACH team, composed
of members such as toxicologists and product integrity
and regulatory specialists, that tracks developments daily. “We
conducted an in-depth evaluation of how many substances
we use, import or manufacture in Europe that might be affected
by REACH,” Sitia
explains.
The company recommends that its customers educate
themselves soon. “In particular, understand final
end-use applications for those products containing
concerned substances,” Sitia cautions. “The
EU will authorize those substances only for specific
end-uses in which risks are controlled, where the benefits
outweigh the risks, and when no substitutes exist.”
Customers also must prepare and plan for the costs
associated with implementation and with supplying data
such as use and safe handling methods. Many studies
have assessed the expected economic impact of REACH
across the entire European chemical industry over the
first 11 years. Most estimate total compliance costs
between two and four billion Euros, but the most alarming
studies see costs as high as seven billion.
Leveraging the Advantages REACH Offers
Experts also find that REACH may confer significant
advantages such as easier and more effective risk
management, better access to facts about chemical properties
and more meaningful communication with the public and government
as information becomes available and legislative processes
become more transparent. The law also encourages data sharing,
recommends that companies use already existing data
and requires that producers and importers share chemical
information along the supply chain.
As the REACH era approaches, customers can begin
planning and benefiting by working closely with Rohm
and Haas now, Sitia concludes.
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