I have added the comments in the paragraphs below to your product
ModelDough, and the comments are in reference to submitted reports that we
received in mid December of 2015 and also the status of products and costs
estimates.
These test data appear to have been submitted in support of a question from
NARA Factory concerning the review status of products Dough-Nara,
Clay-Nara, and Modeling Dough and the basis of the cost estimates provided
by DukeTox. The products Dough-Nara and Clay-Nara are made for Crayola,
and the product ModelDough is apparently only for Nara Factory.
The submitted test reports are for soluble metals (1 report of 8 soluble
metals), 1 EN71 report for 24 colors, and phthalate data; the EN71 report
appears to be for product Clay-Nara since 24 colors are reported rather
than the 16 colors for product(s) ModelDough/Dough-Nara; With the exception
of the EN71 report these reports are for testing that is not required in
the review, and the EN71 is only needed if an EU review is being requested.
The EN71 testing has already been completed by Crayola in their product
Claynar (the test report submitted by Nara Factory appears to use alternate
color names but contains 24 colors as does the Crayola product Claynar)
The product Clay-Nara has all product testing completed and was reviewed by
one of the supervisory toxicologists on 9-30-2015 so it is not clear why
you would not have been updated. The Crayola product Claynar has already
received an EU TRA because all testing had been completed.
There is still outstanding testing that needs to be completed for
product(s) ModelDough/Dough-Nara. Crayola often provides all the required
testing for their products even when the product is being supplied by a
third party. You may want to coordinate testing objectives with Crayola to
avoid unnecessary testing or duplication of your efforts/testing costs.
I am not sure I am free to discuss the formula for the toxicology review
estimates that are provided to ACMI companies. You have mentioned the
estimate of $1,035 for Clay-Nara and $1,935 for product Dough. Dough-Nara
has 36 ingredients and Clay-nara has 18 ingredients so from a toxicological
perspective there is more to be reviewed in Dough-Nara than Clay-Nara. A
factor in the estimate may also include how much toxicological information
we already have in the Duke Tox database with regard to the ingredients in
the formula.
Sorry I cannot say more about the cost estimates but hopefully one of the
supervisory toxicologists or Caroline will add more information if it is
allowed.
Thanks for your cooperation.
Regards,
Paul