FORMULA SUBMISSIONS
UPDATED 5/14/07
The most important thing to remember when submitting a product formulation to the Duke OEM Toxicology Program for evaluation is to provide as much information as possible. Be sure to include the following information with your submission for evaluation of a new product:
1. The complete formulation of the product, including the concentration of each ingredient. Provide the trade name, chemical name, and the CAS/Colour Index or DCMA number. This information can be submitted on the "Formulation Information" and "Color Specific Information" sheets ( which follow), as a matrix or by electronic submission. The "formulation information" sheet and overview of your product and should include all ingredients in your base formula with ranges (percentage) and should be a summary of all ingredients used in the product. The "color specific information" sheet should include a detailed breakdown of pigments, dyes, stains, frits, etc. used in each color. The base formula does not have to be repeated on these sheets. A separate color specific information sheet should be completed for each unique color. If you have several suppliers for a particular ingredient, list them all.
Alternately you can submit a matrix or database printout for your product line. This matrix should identify all of the colors in your product line on one axis and all of the ingredients (and alternates) on the other axis with percent weight loadings for each ingredient specified for each color.
2. Identify all sizes of your product and product category. Separate product categories (such as different mediums) should not be submitted as part of the same formula. For information on categories, please feel free to contact the Duke Staff at 919-286-5744.
3. Submit a Material Safety Data Sheet (MSDS) for each ingredient, unless already supplied to Duke or it is contained in the ACMI Windows Database Management software.
4. A list of suppliers and their contact information (contact person, address, telephone and fax numbers) for each ingredient.
5. Any instructions or labels for the product including instruction sheets or manuals, web sites, current labels or art work for proposed labels.
6. A sample of the actual product and its packaging (if available).
7. Include a list of colors and any color-specific codes that appear on the packaged product. This information may be used in the future if there are any user concerns that require specific color identification.
8. Identify all of your trade names for this product line. If you have different color names for each trade name, they should be identified in your product submission as alternate color names. Also a provide separate list of these unique color names under each trade name. If you supply your product for repackaging or distribution by a third party under their trade name, their name should be appended to the trade name.
9. If you are submitting a formula change, name change or new color, please be sure to mark it as such on your formula submission sheet or matrix. Also, be sure to include a hard copy of the latest formulation printout we have sent you with your changes highlighted. Whether you are adding something, deleting something or changing something in a formulation, it is imperative that we see the change/addition/deletion highlighted. It is also very important that you enclose a cover letter explaining what you are requesting.
10. For substitutions or new alternate ingredients which are at the same loading, list the original ingredient and product lines that are affected by name and our assigned product number as well as new alternate ingredients.
11. Specify if the submission should be expedited. An expedited submission will be evaluated by our staff within 3 working days of receipt and returned to you. There is a 25% surcharge for such evaluations. The normal turnaround time is a maximum of 3 weeks from submission.
When submitting a new product or a formula change, if you have additional questions, please don't hesitate to contact our offices where our professional toxicology staff will be more than happy to assist you.
The approval process often requires testing the product or ingredients for expected contaminants. Prior to requiring additional testing, a "worst case" analysis is done where the expected contaminant level is set at 100% of the loading of an ingredient. If at this level no labeling is required, then no additional testing will be required.
DUKE OEM TOXICOLOGY PROGRAM
FORMULATION INFORMATION SHEET
TRADE SECRET INFORMATION
MFG.#
COMPANY NAME
PRODUCT #
PRODUCT CATEGORY
_________
__________________________
______________
__________________________
BRAND NAME
ALTERNATE BRAND NAME
ALTERNATE BRAND NAME(2)
__________________________
_________________________________
________________________________________
PRODUCT SIZES
# OF COLORS
LAST APPROVED
SUBMITTED BY (LAST, FIRST NAME)
DATE SUBMITTED
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PLEASE CHECK ONE:
_______NEW PRODUCT
________NEW COLOR
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NAME CHANGE
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FORMULA CHANGE
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FORMULA REVIEW
FORMULATION INFORMATION- ENTER THE FORMULATION INFORMATION FOR EACH INGREDIENT.
INCLUDE ONE ENTRY FOR EACH PIGMENT/DYE WITH HIGH/LOW RANGE ON THIS FORM.
FILL OUT ONE OF MORE COLOR SPECIFIC FORMS FOR EACH PIGMENT/DYE.
TRADE NAME
CHEMICAL NAME
CAS/CI OR DCMA#
LOW
HIGH
ALT
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DUKE OEM TOXICOLOGY PROGRAM
COLOR SPECIFIC INFORMATION SHEET
CONFIDIENTIAL!!!
TRADE SECRET INFORMATION
COLOR SPECIFIC FORMULATION- USE ONE OR MORE FORMS FOR EACH PIGMENT/DYE
TRADE NAME
CHEMICAL NAME
CASE/CI OR DCMA#
COLOR # AND COLOR NAME
%LOADING
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CLICK HERE TO DOWNLOAD FORMULATION SUBMISSION FORMS
DUKE
STAFF 
DUKE
MED CTR. ACMI
WIMA
POISINDEX
WINDOWS
SYSTEM
Questions? (919)286-5744 E:mail: rourk003@mc.duke.edu
© 2007 Duke University Medical Center
P.O. Box 3834 DUMC, Durham, N.C. 27710 USA
