is based on the idea that industry itself
is best placed to ensure that the chemicals
it manufactures and puts on the market in
the EU do not adversely affect human health
or the environment.
requires that industry has certain knowledge
of the properties of its substances and
manages potential risks. Authorities should
focus their resources on ensuring industry
are meeting their obligations and taking
action on substances of very high concern
or where there is a need for Community action.
creates a single system for both ¡§existing¡¨
and ¡§new¡¨ substances; substances are now
described as non-phase-in substances (i.e.
those not produced or marketed prior to
the entry into force of REACH) and phase-in
substances (those substances listed in the
basic elements are described below:
All substances are covered by the REACH
Regulation unless they are explicitly exempted
from its scope.
Registration requires manufacturers and
importers of chemicals to obtain relevant
information on their substances and to use
that data to manage them safely.
To reduce testing on vertebrate animals,
data sharing is required for studies on
such animals. For other tests, data sharing
is required on request by other registrants.
Better information on hazards and risks
and how to manage them safely will be passed
down and up the supply chain.
Downstream users are brought into the system.
Evaluation is undertaken by the Agency for
testing proposals made by industry or to
check compliance with the registration requirements.
The Agency co-ordinates substance evaluation
by the authorities to investigate chemicals
with perceived risks. This assessment may
be used later to prepare proposals for restrictions
Substances with properties of very high
concern will be made subject to authorization;
the Agency will publish a list containing
such candidate substances. Applicants will
have to demonstrate that risks associated
with uses of these substances are adequately
controlled or that the socio-economic benefits
of their use outweigh the risks. Applicants
must also analyze whether there are safer
suitable alternative substances or technologies.
If there are, they must prepare substitution
plans, if not, they should provide information
on research and development activities,
if appropriate. The Commission may amend
or withdraw any authorization on review
if suitable substitutes become available.
The restrictions provide a procedure to
regulate that the manufacture, placing on
the market or use of certain dangerous substances
shall be either subject to conditions or
prohibited. Thus, restrictions act as a
safety net to manage Community wide risks
that are otherwise not adequately controlled.
The European Chemicals Agency (ECHA) will
manage the technical, scientific and administrative
aspects of the REACH system at Community
level, aiming to ensure that the legislation
can be properly implemented and has credibility
with all stakeholders.
A classification and labelling inventory
of dangerous substances will help promote
agreement within industry on the classification
of a substance. For some substances of high
concern there may be a Community wide harmonization
of classification by the authorities.
Rules on the access to information combine
a system of publicly available information
over the internet, the current system of
requests for access to information and REACH-specific
rules on the protection of confidential