Assessment of Substances in
Europe
The
REACH System (Registration, Evaluation, Authorisation
of Chemicals)
The draft legislation, which will replace over 40 existing directives
and regulations, will implement the proposals set out in the
Commission's February 2001 White Paper on the Strategy for a future
Chemicals policy (see IP/01/201). At its core is REACH: a single,
integrated system for the Registration, Evaluation, and Authorisation
of CHemicals. REACH will place a duty on companies which produce,
import and use chemicals to assess the risks arising from their use
requiring new test data to be generated in justified cases - and to
take the necessary measures to manage any risks they identify. This
will reverse the burden of proof from public authorities to industry
for putting safe chemicals on the market. Testing results have to be
shared to reduce any likely animal testing. Registration of
information on the properties, uses and safe use of chemical
substances will be an integral part of the new system. |
Scope of REACH
The exact registration requirements will vary depending on the volume in
which a substance is produced, and on the likelihood of exposure to humans
or the environment. A phased-in system lasting up to 11 years is foreseen.
Higher tonnage substances would require the most data, and would have to
be registered first; lower tonnage substances would require less data and
be registered later. The latter provisions will particularly reduce the
regulatory burden on small and medium sized enterprises.
Tighter controls will be introduced for the chemicals of highest concern.
Thus, certain types of substances s uch as carcinogens, mutagens and
reproductive toxicants (CMRs), persistent, bioaccumulative and toxic
substances (PBTs) and very persistent and very bioaccumulative substances
(vPvBs) will be subjected to an authorisation regime and would be
registered early. In certain cases also other substances, for example with
endocrine disruption effects, could be included on a case by case basis
within the authorisation system where it is shown that they give rise to
the same level of concern.
Each use of such substances will have to be authorised for a specific use.
Decisions would be based on a risk assessment and consideration of other
socio-economic factors. Others, such as polymers (chemicals used as raw
materials for plastics and detergents and a wide variety of other
products), and substances used as intermediates (chemicals used to make
other chemical substances or other products) will be subject to
substantially lighter registration requirements. In many cases, where
there is little risk of exposure, polymers and intermediates will be
exempted from registration.
The text of the proposals may be found at:
REACH
and
REACH-Whitepaper
The
Emission Scenario Documents published here are the result of
Research made by the INFU for the
Federal
Environmantal Agency. We would like to express our thanks
for the support given. |
According
to unified law, industrial chemicals in the European Union must be tested
and declared before they can be offered on the market in defined amounts
(Guideline 92/32/EWG of April 30th.1992 for the 7. change of the guideline
67/548/EWG; realized in German law in the new definition of the chemical
substance law of july 25th.1994). Old substances which were available on
the market before these declaration laws were passed are listed in the
European List of old substances EINECS. Since the declaration law of the
European Union was passed in 1993 (Declaration 793/93/EWG of march.
23th.1993 for the evaluation and control of environmental risks of old
chemical substances), these old substances are also tested and evaluated
according to a step by step process.
Within
the European union, the risk evaluation (meaning the evaluation in a
defined context) is done according to a defined process following
Guideline 93/67/EWG for new substances and declaration 1488/94/EWG for old
substances. The technical and scientific laws for the risk evaluation have
been summarized in a compendium of laws in the English language, the so
called Technical Guidance Document (TGD). The Federal Environmental Agency
has performed important preliminary work for this document and provided
qualified reasoning.
For the
evaluation of the environmental exposition, substance specific
concentrations (PEC-Values - Predicted Environmental Concentration) in the
various environmental compartments (water, sediment, ground and air) are
calculated. These PEC-Values are a basis for the risk evaluation of new
and old substances during normal industrial use according to the chemical
substance law and the old substance declaration of the EU.
Default
emission factors are listed for almost all possible emission types in the
appendix of the TGD, divided by industrial branch and use category. In
addition to this, chapter 7 of the TGD contains so called "Emission
Scenario Documents" for several industrial branches. These use a
technology specific method to calculate the emissions for certain
substances. Depending on the quality of the data and the plausibility,
values provided by the industry may be substituted for the default values
in the model calculations. This way specific, for example local data may
be taken into account.
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