The Rupp Report: To REACH, Or Not To Reach

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) has been one of
the prominent and influencing issues in the chemical world for many years. It is a European Union
regulation – 2006/1907, passed Dec. 18, 2006.

REACH covers the production and use of chemical substances. Its 849 pages took seven years to
pass. It has been described as the most complex legislation in the European Union’s history, and
the most important in 20 years. It is the strictest law to date regulating chemical substances and
will impact industries throughout the world.

Since coming into force in June 2007, REACH requires all chemicals of one metric ton or more
in volume that are manufactured in or imported into the European Union each year to be tested for
health and safety and to be registered with a new central European authority – the European
Chemicals Agency (ECA), Helsinki, Finland. REACH encourages manufacturers and importers of such
chemicals to preregister them during the six-month preregistration period from June 1, 2008, to
Dec. 1, 2008. This will allow companies much more time before they have to test and fully register
the chemicals.

Classification And Labeling

Classification and labeling involves an evaluation of the hazard of a substance or
preparation in accordance with Directive 67/548/EEC (substances) and 1999/45/EC (preparations) and
a communication of that hazard via the label. This evaluation must be made for any substance or
preparation manufactured within or imported into the European Union and placed on the market and
results in classification of the substance/preparation as dangerous for one or several end-points
concerning physical-chemical properties, health or environmental effects.

Risk Management

Classification and labeling is therefore a useful tool for the risk management of chemicals.
All marketed substances and preparations must be classified and labeled, irrespective of the
quantity placed on the market. The labeling is the first and often the only chemical hazard
information that reaches the user. In addition, the classification has a large number of downstream
consequences within the EU legislation. The classification and labeling work area provides
technical and scientific support to member state authorities and commission services (mainly DG
Environment – Chemicals) concerning the hazard classification and labeling of pesticides, biocides,
and new and existing chemicals.

Human Health Or The Environment

REACH also applies to all chemicals that are considered of very high concern to human health
or the environment. These are called SVHC (substances of very high concern). Their use in products
– articles, in REACH terminology – is regulated if they are in concentrations greater than 0.1
percent by weight of article or if they are intended to be released from the article, such as ink
in a pen. The most hazardous chemicals only can be used if authorized by the ECA. REACH applies to
all chemicals imported into or produced in the EU, in contrast to the US Toxic Substances Control
Act, which only applies to chemicals newly coming into use.

Who Is Responsible?

The ECA will manage the technical, scientific and administrative aspects of the REACH system.
ECA is also responsible for the Technical Committee on Classification and Labeling of Dangerous
Substances. The group discusses classification and labeling of substances of special concern, which
are then proposed for entry to the list of harmonized classifications of substances, which is
legally binding.

The published list of substances with a harmonized classification and labeling at present
contains approximately 2,700 existing and 1,100 new substance entries – covering approximately
8,000 substances in total. If a dangerous substance not yet listed is put on the market – as such
or contained in a preparation – manufacturers, importers and distributors have to self-classify
that substance.

Next Steps

The current classification and labeling directives will be replaced in the coming years by a
Regulation that implements the United Nations Globally Harmonized System (GHS). The aim of the
proposed regulation is to enable a judgment on a substance or mixture (preparation) with respect to
its hazardous properties and to provide a hazardous chemical with pertinent hazard labeling and
information on safety measures.

As with the current legislation, the proposed Regulation is intended to be primarily a
self-classification system for enterprises. It stipulates that after entry into force, the deadline
for substance reclassification is Nov. 30, 2010; and for mixtures, May 31, 2015. The current
directives on classification, labeling and packaging, i.e. Council Directive 67/48/EEC and
Directive 1999/45/EC, will be repealed on June 1, 2015.

May 6, 2008