“Approximately 2.7 million pre-regis-
trations have been filed—roughly 13
times higher than originally
estimated by ECHA”
dossiers for them with ECHA.
Also by the same date, all chemicals over a one-ton
output, which are classified as being category one or two
CMRs—carcinogenic, mutagenic or toxic to reproduction—must be registered. In addition substances above
100-ton annual production, which are classed as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), will have to be
registered.
ECHA estimates that approximately 9,000 chemicals
will need to be registered by the end of November,
equivalent to between a third and a quarter of the total
to be registered under REACH. But they are the ones
requiring the most work in terms of gathering of safety
data because the higher the volume the more test data
is required by the legislation, while even more information is demanded for the safety profiles of CMRs, PBTs
and vPvBs.
“There is now a real possibility that because so much
needs to be done between now and the end of November
that a lot of companies will not be able to meet the deadline and will have to take their products off the market,”
said Jo Lloyd, technical director of ReachReady, a consultancy set up by the UK Chemical Industries Association
(CIA) to provide guidance on the legislation.
The major problem is that large numbers of SIEFS are
not working properly. Communication between the members, which can range from a few companies to several
thousand, is poor. There are also arguments within
SIEFs about how much individual members should pay
for test data, particularly when it is provided by another
SIEF member.
Companies within SIEFs have been slow to agree on
which one of them should be the lead registrant. This
position has the responsibility of drawing up the basic
registration dossier to which the individual members
will add their own specific data, such as information on
the use and application of the chemicals among their
customers.
ECHA was estimating at the beginning of the year that
approximately 2,000 SIEFs for substances due for regis-
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tration in 11 months had lead registrants, leaving 7,000
without someone organizing the creation of the basic
dossier. Earlier the agency had warned that the basic
dossiers should be completed by midsummer to leave
individual companies time to add information for their
individual registrations.