Form FDA 2512 - the Cosmetic Product Ingredient Statement (CPIS) - is the way to file a cosmetic formulation with FDA. You also can use this form to amend a formulation you have submitted previously, or to let FDA know you are discontinuing a formulation.
- How to Complete Your Form FDA 2512
- Filing an Original CPIS
- Amending a CPIS
- Discontinuing a CPIS
- Transferring formulations
- Filing a Base Formulation
- Searching, Sorting, and Downloading Your Formulations
- Deleting Formulations
- Your Official Receipt
Please take a few minutes to read the following information and instructions for using the online VCRP system. This material is designed to familiarize you with Form FDA 2512 in order to make your participation in the online VCRP system as easy as possible. You may want to print out these instructions for easy reference when you are filling out your forms.
The VCRP is described in Title 21 of the Code of Federal Regulations, Part 720 (21 CFR Part 720). Wherever the information below is taken from a regulation that applies to the VCRP, the regulation is cited in parentheses for your reference.
How To Complete Your Form FDA 2512 - Cosmetic Product Ingredient Statement (CPIS):
The online VCRP system will request most or all of the following information, depending upon the answers you give. Being familiar with the information requested will streamline the process.
For security reasons, your login will "time out" after an hour of inactivity, so it will help to have all materials ready when you begin.
First, you will need to indicate whether you are submitting an original Form 2512 (CPIS), or amending or canceling an existing one.
Type of submission:
- Is this the first time you have filed Form FDA 2512 for this formulation? If so, see Filing an Original CPIS.
- If you are a contract manufacturer filing a base formulation, see Filing a Base Formulation.
- If you are submitting a change to a formulation you have submitted previously, see Amending a CPIS.
- If you are discontinuing a formulation - not just changing it - see Discontinuing a CPIS.
Filing an Original CPIS:
Before you file for the first time, you must set up an account. Go to "Request new account" and fill in the information as indicated. After you submit your account request, you will receive a temporary password by email. You should then login using this temporary password and create a new password. We recommend that you keep your new password in a safe place.
Step 1: Enter Label Information
Note: Please shorten this information if necessary to the maximum number of characters specified for each field.
Name of Business:
Enter the company name as it appears on the label (maximum 55 characters).
Name of Parent Company (if any):
If your company is owned by another company, enter the name of the parent company (55 characters). Otherwise, leave this space blank.
Label Name Address:
Enter the complete mailing address for your place of business. For establishments in the United States, include the street address (37 characters), city (25 characters), state, and ZIP Code. For establishments outside the U.S., enter the name of the country in the space provided. You may enter territorial subdivisions (such as province or prefecture) in the space for city or country, whichever is appropriate for addresses in your country. Postal codes for addresses outside the U.S. are optional. If you choose to include a postal code for an address outside the U.S., enter it in the ZIP / Postal Code field. This field can accommodate up to 12 characters.
Once you submit the information requested, you will receive a 5-digit Label Name Number by email. Use this number when you file in the future, instead of entering name and address information for each product.
Step 2: Provide Contract Manufacturer Information
A contract manufacturer is a company that manufactures and/or packs a product that is then marketed by a different company. An example is a firm that manufactures and/or packs a shampoo that is marketed under various chain store brand names.
If your firm is a contract manufacturer, you must enter this information. If your firm is not a contract manufacturer, entering information about a contract manufacturer is optional. When you have selected the option that applies to you, select "Next."
If you are filing contract manufacturer information, you can--
- Select from the VCRP's drop-down list of Label Name Numbers for contract manufacturers that you have used previously, or
- Select a new contract manufacturer number from this drop-down list, or
- If the contract manufacturer is not included in these lists, type in the name and address. For establishments in the United States, include the street address, city, state, and zip code. For establishments outside the U.S., enter the name of the country in the space provided. You may enter territorial subdivisions (such as province or prefecture) in the space for city or country, whichever is appropriate for addresses in your country.
When you have entered the information, select "Next."
Step 3: Business Type
Is your firm a manufacturer, a packer, or distributor of this product? Check off each box that applies for the formulation you are filing. For example, if your firm manufactures a number of cosmetics, but only packs and distributes this particular formulation, check "packer" and "distributor." Select "Next."
A manufacturer is the company that makes the product. This company may or may not be a contract manufacturer.
A packer is the company that packages the product. This company may or may not be a contract manufacturer.
A distributor is the company that sells the product to retailers. This company is never a contract manufacturer.
Step 4: Enter Product Information
Select the product category from the drop-down list that will appear on your screen. Next, scroll down and select the subcategory that best describes the formulation you are filing.
Enter the brand names (maximum 100 characters each) under which the formulation is marketed. After each brand name, select "Submit." When you have submitted all brand names under which you market this formulation, select "Next."
Step 5: Enter Ingredients
We encourage you to enter ingredients in descending order of predominance, the same as they are required to appear in the ingredient declarations on your product labels.
You can enter ingredients by 9-Digit Code or Ingredient Name, as described below:
- 9-Digit Codes: We strongly recommend that you use 9-Digit Codes to identify your ingredients whenever you can. The system will automatically attempt to supply a 9-Digit Code for any ingredient names you enter. Form FDA 2512 includes a link to FDA's 9-Digit Code Dictionary for easy reference.
- Common or Chemical Name. If you are unable to find a 9-Digit Code for an ingredient, you may use the common or chemical name.
Time Saver Tips!
- The system will compile a drop-down list of ingredients you have entered. You can select ingredients from this list for future submissions, without having to type in 9-Digit Codes or ingredient names.
- You can copy and paste a list of ingredients from an existing document, if the list is formatted with one ingredient per line. To do this, select "Enter multiple ingredients." Copy your list, select "Enter multiple ingredients," and paste the list in the "multiple ingredients" box.
- You can enter ingredients by locating them in FDA's 9-Digit Code Dictionary and selecting the 9-Digit Code for each ingredient. The ingredient will be added to your CPIS automatically.
- You can use the dictionary to search for synonyms, using either complete or partial names to perform your search.
After entering each ingredient, select "Submit."
If an ingredient you have entered is flagged as "unresolved," that means the system does not recognize the ingredient name or number that you have entered. Please check to see if it is spelled correctly, or if our dictionary lists the ingredient under a different Ingredient Name or 9-Digit Code. If you cannot resolve an ingredient entry, FDA staff will locate its 9-Digit Code or assign a new one. However, this will delay processing of your Form FDA 2512.
You can edit or delete submitted ingredient information by selecting the appropriate icon to the left of the 9-Digit Code. When you select the "edit" icon, the system will give you the opportunity to
- retype the ingredient,
- select "See potential corrections" to view a list of similar ingredients names, or
- check the name and number in the 9-Digit Code Dictionary.
Changing the order of ingredients
To change the order of the ingredients you have entered so that they reflect the actual order of predominance in the formulation, select "Change Order" and renumber the ingredients as appropriate.
After you have finished entering all the ingredients in this formulation, select "Next."
Step 6: Base CPIS: Base CPIS Number. Contract Manufacturers Only!
If your product contains a base formulation and you have filed the base formulation with the VCRP, you can save time by entering the CPIS Number for that base formulation instead of listing its ingredients individually. Base CPIS Numbers may be used only by the company that filed them. Refer to the instructions for filing a base formulation.
Step 7: Confirm Formulation
You will see all the information you have entered. If you need to make a correction, use the "Previous" button to return to the screen where you entered the incorrect information. Make any needed corrections and return to Step 7.
When you are certain that all the information is correct, select "Submit Formulation."
Amending a CPIS
Login to the online VCRP system as usual, selecting Form FDA 2512. Select the formulation you wish to amend. Select amend, and type in any necessary changes. Check your work for accuracy. Your CPIS will automatically be amended as you enter your changes.
Discontinuing a CPIS:
Login to the online VCRP system as usual, selecting Form FDA 2512. Next, select either active or amended formulations. Select the one you wish to discontinue and select "Discontinue."
Transferring formulations that you have filed previously on paper forms to your new online VCRP account:
Login to the online VCRP system as usual, selecting Form FDA 2512. Then select "Transfer My Formulations." Fill in the required information. Print out the report and attach it to your company letterhead, or print it directly onto your letterhead. Send it to the address indicated on the screen so that FDA can process your request.
Filing a Base Formulation:
Login to the online VCRP system as usual, selecting Form FDA 2512. Next, under "Submit New Formulation," select "Base Formulation."
Step 1: Enter your company information, the same as you would in Step 1, above, for any cosmetic formulation.
Step 2: Enter contract manufacturer information. If you already have a 5-digit contract manufacturer Label Name Number, you can (A) select it from a drop-down list of previously entered Label Name Numbers. You also can (B) type it in or select from FDA's list of contract manufacturers. If you do not already have a contract manufacturer Label Name Number, select (C) and enter the requested information.
Step 3: Enter product information, the same as you would in Step 4 of a regular cosmetic formulation.
Step 4: Enter the ingredients contained in your Base Formulation, the same as you would enter ingredients for any cosmetic formulation.
Step 5: Check the information for accuracy. Make corrections as needed.
Searching, Sorting, and Downloading Your Formulations
Several features of the VCRP system allow you to manage your formulations in the VCRP database:
You can search for your formulations that have been accepted into the VCRP by the label name, product category, ingredient, or brand name. To use this feature, open your "Active" folder and enter the search criteria in the boxes. Select "filter" and your products that match the selected criteria will be listed.
You can sort your formulations by CPIS Number, Product Category, or Filing Date by clicking any of these headings at the top of your list.
You can download your products to a spreadsheet by selecting "Excel Download." This will allow easy transfer of your data to your own computer.
You can delete from your "Rejected" folder any formulations that have never been accepted and that you don't intend to resubmit. To do this, open your "Rejected" folder. Open the formulation you want to delete and select the Delete button.
Your Official Receipt
In order to access a CPIS for purposes of viewing, amending, or discontinuing the formulation, you will need to read and acknowledge the official receipt for that CPIS. To do this, login to the VCRP online system as usual, selecting FDA Form 2512. Next, select "Obtain receipts for formulations you have filed." You will see a screen listing all formulations to be activated. When you select a formulation from this list, you can view and acknowledge the receipt for that formulation. We recommend that you print a copy for your records.