Today I have spoken with Dr. Knight concerning the substances that DKKK
propose to pre-register as phase-in substances.
We have considered DKKK's reasoning for these substances being classed
as Phase-in substances. I am afraid that we still have a strong concern
that these substances are actually new (i.e. non phase-in) substances.
Our concerns are based on analogy with a case we dealt with several
years ago. On this occasion the company in question manufactured an
inorganic pigment which is "made by high temperature calcination of
titanium oxide, zinc oxide and tin oxide in varying amounts are
homogeneously and ionically interdiffused to form a crystalline matrix".
I have attached a piece of correspondence from the UK CA concerning this
particular example. The conclusion was that the substance could not be
considered to be covered by EINECS entries for the individual metal
oxides. I think it is OK to share this CA opinion with DKKK as no
company specific information is disclosed.
Hence, it is quite clear to us that if a crystalline matrix is formed
then the separate EINECS entries for the individual oxides can not be
used. It is therefore critical to determine as soon as possible is this
is the case for the DKKK substances.
Alternatively, if there is no chemical reaction then the individual
EINECS numbers can certainly be used.
It is possible that the true situation is somewhere between the two
clear cases given above. In other words it could be that there is no
migration of metal into the crystal lattice but nevertheless a solid
mass is produced in which there are separate domains of the individual
oxides. This would be rather complicated to deal with but as you know
under REACH the decisions have to be made by industry so a practical
solution might be to consider the resultant compound as a preparation,
register the individual substances separately and then deal with the
unusual physical form of the preparation in the chemical safety report.
If it is confirmed that there is a crystalline matrix formed then the
situation is obviously a difficult one for the members of the consortia.
In theory the substances should not be manufactured or imported into
Europe until the REACH registrations are in place. However, it is widely
acknowledged that this type of situation will occur quite often upon the
implementation of REACH. Hence, it could reasonably be expected that
special arrangements will be made to allow supply to continue, providing
that an assurance is given that REACH registrations will be made as soon
as possible. This is a matter that would have to be decided by the
individual member state CA's, since enforcement of REACH is the
responsibility of the individual member states.
Impurity is defined in the "Guidance for identification....", page 11
(RIP 3.10). This definition includes the phrase "while it is present in
the final substance it was not intentionally added".
From this definition it is very clear to us that substances
intentionally added can not be considered to be impurities, regardless
of the percentage. Hence, we disagree with the Rhodia opinion.