1. Pre-registration
The first step of the REACH
process is pre-registration. Pre-registration will take place within a time
frame of 6 months which will start on June 1, 2008 and will end on December 1,
2008.
2. Substance Information Exchange Forums (SIEF)
All manufacturers and importers that pre-register the same substance will
automatically participate in
the SIEF for
that substance. One substance, one SIEF. A SIEF facilitates the exchange
of information and agreement on the classification and labeling of chemical
substances. All participants provide the SIEF with existing studies, react to
requests by others, identify possible needs for further studies and arrange to
carry them out.
If studies are available among participants, then they must agree on shared
costs. If the required studies are not available, the participants are to
agree on who will perform a required study and how the costs will be
distributed.
3. Registration
For the registration of a substance a volume-dependent set of data must be
provided in a dossier. Substances in higher volumes or with hazard potential
will have to meet additional information requirements. Manufacturers of the
same substance may form a formal consortium in order to work together to
create and submit a single dossier for that substance.
For substances above 10 ton per annum a chemical safety report (CSR) is
required, including a basic risk assessment which describes how a substance
should be handled for each intended use. This information will be transmitted
downstream, through the extended safety data sheet.
The IT format for the registration of these dossiers is
IUCLID5, an international standard for the reporting of (hazardous)
substances information.
4. Authorization
During the registration process, substance dossiers will be assessed for
completion, and some will receive additional attention with regard to the
information provided on hazards and risks. ECHA will provide a list of
candidate substances that they believe, on the basis of hazard potential,
require further authorization.
Further test work or risk evaluation may be required to satisfy ECHA and
Member States that these substances do not pose a risk to public or
environmental health. In some cases market bans may result, for example where
the hazard is deemed high and there is a technically feasible substitute.
Authorization involves the submission of a socioeconomic survey about the uses
of the substance, an overview of alternatives for each use and an explanation
as to why a specific substance can and should remain on the market for its
intended use. The list of candidate substances for authorization will be
compiled in 2009.
