Reporting - 21CFR 80.21- Color Additive Certification

Color Certification Online User’s Guide
Office of Cosmetics and Colors (OCAC)

v 1.0 January 24, 2006
v 2.0 April 7, 2008

Adam Rixey
Applications Developer
Ali Jaffrey
Applications Developer
Raymond L. Decker
Director of Office of Cosmetics and Color

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About Color Certification Online ................................................................................... 1
Connecting to Color Certification Online....................................................................... 2
Color Certification Main Menu ...................................................................................... 3
1. Navigation Bar ........................................................................................................ 3
2. Company Information............................................................................................. 3
3. Folders..................................................................................................................... 3
4. Messages from OCAC HQ ..................................................................................... 4
5. Submit Color Additive Request .............................................................................. 4
6. FedEx Tracking Information................................................................................... 4
Updating Company Profile ............................................................................................. 5
Updating Online Preferences .......................................................................................... 6
Submitting Color Additives ............................................................................................ 7
Straight Color Additive............................................................................................... 7
Receipt ........................................................................................................................ 8
Lake Color Additive ................................................................................................... 9
Repack Color Additive ............................................................................................. 11
Queue and Pending Folders .......................................................................................... 12
Modifying a Color Request....................................................................................... 12
FedEx Tracking Information......................................................................................... 13

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About Color Certification Online
The Color Certification Online system is a new web interface that allows companies to
submit color additives requests to the Office of Cosmetics and Colors (OCAC) without
the need for paper forms. While a company must still mail the physical samples to the
FDA for analysis, advance knowledge of the incoming samples can help expedite the
testing process. It will also allow the companies to better track their color additives
through the certification process.
Note that this document is intended for the companies submitting color additive requests.
U.S. Agents representing foreign companies will have a different interface and set of
options available to them.

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Connecting to Color Certification Online
Open up your web browser and go to the following login screen at:
https://info1.cfsan.fda.gov/color
At the login screen, type in your user name and password. Select the agreement stating
that you understand that 18 U.S.C. 1001 code, and then select the Log In button.

Figure 1 - Color Certification Online Login Screen

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Color Certification Main Menu

Figure 2 – The Color Certification Online Main Menu

The main menu for the Color Certification Online program contains five key areas that
you need to be aware of.

1. Navigation Bar
The navigation bar along the top of the screen contains links that allow you to update
your company’s profile and your online preferences. There is also a link to send
feedback to the Office of Cosmetics and Colors (OCAC), as well as a button to log out of
the Color Certification Online system.
All other pages of Color Certification Online include a “Menu” link in the navigation bar.
Selecting that link will bring you back to this main menu.

2. Company Information
This box provides a brief snapshot of your current account balance with the OCAC. If
you have received any sample bottles from the OCAC, they will also be displayed here.
Below the box is a link to request more bottles.

3. Folders
These folders contain samples that you have submitted to the Color Certification Online
system. A folder may not appear if it does not have any contents. If the FDA is currently
analyzing a sample, it may temporarily not appear in any folders until our work is
completed.
The following folders are possible:
• In Queue
Samples in the queue are those that have been submitted online,
but not yet received by the FDA.

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•
•
•
•

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Pending
Pending samples have been received by the FDA, but have not yet
been analyzed.
Certified
Certified samples are those that have finished analysis and been
certified by the FDA.
Unaccepted Unaccepted samples are those that have not been accepted by the
U.S. Agent. (Foreign companies only)
Reports
Selecting the reports folder will let you download a report of your
company’s account and sample information.

4. Messages from OCAC HQ
Important notices from the Office of Cosmetics and Colors will be displayed here.

5. Submit Color Additive Request
Selecting one of these buttons will allow you to enter information for a new color
additive.

6. FedEx Tracking Information
This link allows you to enter in the FedEx tracking numbers for color sample packages
that you ship to the FDA.

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Updating Company Profile
Select the “Update Profile” link on the main menu to arrive at this screen. Here you can
update your contact information, email address, and password. Once finished making
changes, select the
Update button.

Figure 3 - Update Profile

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Updating Online Preferences
Select the “Update Preferences” link on the main menu to arrive at this screen. Here you
can change whether you prefer metric or imperial measurements. You can also set up
alerts so that you will be notified if your account balance or remaining bottles fall below
your desired values. When finished, select the
Update button.

Figure 4 - User Preferences

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Submitting Color Additives
On the main menu, select one of the three buttons to create a Straight, Lake, or Repack
color additive request. There are slight differences to each of the three types of color
additives, so we will start with the simplest of the three.

Straight Color Additive
Step 1: Enter Color Additive Information
The first step is to enter the basic color information. The following fields are required:
• Straight
The color additive.
• Batch #
Your company’s batch number.
• Weight
The batch weight. Enter in the units (pounds or kilograms) that
you specified when updating your preferences.
• Bottle Size Size of the bottle containing the sample you send to the FDA.
• Manufactured By Company that manufactured this color additive.
• Storage Method
How you are storing the color additive while it is pending
certification.
• Location
Where you are storing the color additive.
There is also an optional Notes field where you may enter any additional information that
you wish to include with your submission.

Figure 5 - Color Additive Information

The Manufactured By, Storage Method, and Location fields will each remember the
values that you enter, to make future submissions easier. The first time you enter a
submission, you will need to type in the value.
The next time you enter a submission, you will be able to select your previous choice
from a pull-down menu. To create a new value, select the first option from the pull-down
menu, such as “New Location”. A text box will appear and allow you to enter in the new
information. When finished, select the
Update button. If you have

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accidentally chosen an incorrect value, you can select the
make the pull-down menu reappear.

Change button to

Figure 6 - Location Pull-Down Menu

When you have filled out all the required fields for the color additive, select the
Next button.
Step 2: Verification
Straight color additives do not require any additional information, so you arrive at a page
Previous button to make any
to verify that all data is accurate. Select the
Submit Request button to
changes to your information, or select the
send the request to the Office of Cosmetics and Colors.

Figure 7 - Step 2: Verification

Receipt
Once a request has been submitted, you will be presented with a receipt that you may
print out for your records. If you wish to submit another color additive request of the
same type, select the
Add More button. You will be taken back to Step 1 of a
new entry. As a time-saving measure, all information other than the Batch # and Weight
will be exactly the same as the request that you just completed.

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Lake Color Additive
Step 1: Initial Information
Lakes start out the same as entering a straight. You must enter the same basic
information about the color additive, where it is stored, etc. The only changes are that the
list of color additives is now made up of lakes instead of straights, and there is a new
header at the top of the screen to show your position in the process.

Figure 8 - Lake Header

Step 2: Included Samples
The second step is to add one or more samples included in the lake. Some lakes, such as
all approved for use in foods, require a certified FDA Lot # to be used in the new lake.
Others will accept either a Lot # or the name of the color. Depending upon the color
additive that you have selected in Step 1, you will see one of two different forms.

Figure 9 - Certified FDA Lot # Required

To enter a certified FDA Lot #, type the value into the text box. Then type in the weight
and select the
Add button to enter the sample.

Figure 10 - Certified FDA Lot # or Color Name Allowed

To enter a certified FDA Lot # or Color Name, first select the button next to the
appropriate label (Lot # or Name). Then type in the value and weight, and then select
the
Add button to enter the sample.
Once you enter a color, the screen will refresh to show a list of colors added to this
Edit button next to a color to alter
sample. If you make a mistake, you can select the
Delete button to remove that color.
it or the

Figure 11 - Added Color List

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Color Certification Online User’s Guide
When ready, select the
process.

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Next button to continue on to the next stage of the

Step 3: Precipitant and Substratum
The third step allows you to enter the precipitant and substratum used in creating the lake.
Select the values from the pull-down menus, enter the weight of the substratum, and then
select the
Add Substratum button. Note that depending upon the color
chosen in Step 1, you may be able to add more than one substratum; however, you can
only have one precipitant.

Figure 12 - Precipitant and Substratum

When finished, select the

Next button.

Step 4: Confirmation
This is just like the confirmation screen used when creating a straight color additive, only
it now displays the included samples, precipitant, and substratum information. To make
any changes, select the
Previous button to go back in the process. (As a
shortcut, you my also select a completed step in the header to jump directly to that page;
for instance, selecting “Step 1: Initital Information” will take you back to the beginning.)
When you are ready to submit the data to the FDA, select the
Request button.

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Submit

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Repack Color Additive
Repacked color additives are handled similarly to lakes, only there are now three steps
instead of four.

Figure 13 - Repack Header

Step 1: Initial Information
This first step is exactly the same as when submitting straights and lakes.
Step 2: Included Samples
The second step behaves the same as Step 2 for lakes; however, with repacks you must
always supply a certified FDA Lot #. The total weight of repacked samples must also
match up with the weight that you specified in Step 1.
Step 3: Confirmation
When you are ready to submit the data to the FDA, select the
Request button.

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Submit

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Queue and Pending Folders
Selecting the In Queue or Pending folders on the main menu will allow you to view
your samples sent to the FDA. While neither folder contains samples that have been
analyzed, there is one very important distinction to make: items in the queue can still be
edited, while those that are pending cannot be edited. If you submit a color additive
request and then realize that you made a mistake, you can still go in and change it so long
as it is still in the queue1.
To view either the queue or pending color requests, select their folder from the main
menu. If there are a large number of records, you will be able to filter by Batch # and/or
Color Additive.

Figure 14 - Color Requests in the Queue

Modifying a Color Request
To modify a color request, click on its Batch # in the queue. You will be taken back to
Step 1 for that particular color type (straight, lake, or repack). Go through the steps as
you normally would and make any necessary changes, and then re-submit on the
confirmation page to update the sample request.

1

Note that foreign companies must make any changes before their U.S. Agent accepts the sample request;
once the Agent accepts responsibility for a sample, even if that sample is still in the queue, it may no longer
be modified.

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FedEx Tracking Information

Figure 15 - FedEx Shipment Information

Select the FedEx Tracking Information link on the front page to enter information
about your shipments to the FDA. There you can enter in your tracking numbers and the
date sent. You do not need to specify which color samples are in each package.
If you have not yet received the FedEx account number, please contact Ray Decker at
(301) 436-1148.

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