Cosmetics

Form 2512: Cosmetic Product Ingredient Statement

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 previously filed, or to let FDA know you are discontinuing a formulation.


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 voluntary filing of Form FDA 2512 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 provided in parentheses for your reference.

Note: The printed Forms FDA 2512 and 2512a (a continuation form) have been combined into Form FDA 2512 in the online VCRP system.


Instructions on 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 15 minutes of inactivity, so it will help to have all materials ready when you begin.

First, you will need to determine whether you are submitting an original CPIS,  amending or discontinuing an existing CPIS, or resubmitting a CPIS that was returned for action.

Type of submission:

Filing an Original Cosmetic Product Ingredient Statement

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 log into your account using this temporary password and create a new password. We recommend that you keep your new password in a safe place.

To file an original CPIS, select "Submit" in the top menu bar followed by "Submit Original Cosmetic Formulation Form FDA 2512."

Step 1: Enter Labeler Information

Labeler Type of Business (as listed on label)

Indicate whether the type of business of the company listed on the product label is a manufacturer, packer, distributor, or any combination of these types.

Labeler Name and Address (as listed on label)

Provide the labeler name and address by selecting “Add Labeler”, then--

  • Select a previously used labeler from the list provided, or
  • Select “Add New Labeler” to add a new labeler.

If adding a new labeler, enter the name and address of the company that is listed on the product label. For companies in the United States, include the street address, city, state, and ZIP Code. For companies outside the U.S., you may enter territorial subdivisions (such as province or prefecture) in the space for state. 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. Select "Add and Return to FORM FDA 2512."

Step 2: Provide Manufacturer/Contract Manufacturer Information

If you are filing the manufacturer/contract manufacturer information, select “Add Manufacturer”, then--

  • Select a manufacturer from the list of establishments you have entered previously on Form FDA 2511 – Registration of Cosmetic Product Establishment, or.
  • Select “Add Manufacturer Establishment” to complete Form FDA 2511 – Registration of Cosmetic Product Establishment. Refer to the instructions for filing Form FDA 2511, or.
  • Search for a registered manufacturer/contract manufacturer. To do this, you will need both the registration number and the establishment name.

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.

Next, select the type of manufacturer (manufacturer or contract manufacturer). The term manufacturer of a cosmetic product means the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product (21 CFR 700.3(k)). A contract manufacturer is a company that manufactures a product that is then marketed by a different company. An example is a firm that manufactures a shampoo that is marketed under various chain store brand names.

Step 3: Provide Packer Information

To provide packer information, select “Add Packer”, then--

  • Select a packer establishment from the list of establishments you have entered previously on Form FDA 2511 – Registration of Cosmetic Product Establishment, or
  • Select “Add Packer Establishment” to complete Form FDA 2511 – Registration of Cosmetic Product Establishment. Refer to the instructions for filing Form FDA 2511, or
  • Search for a registered packer. To do this, you will need both the registration number and the establishment name.

Step 4: Commercial Distribution

Indicate whether the product you are filing is in commercial distribution in the United States.

Note:

The term commercial distribution of a cosmetic product means annual gross sales in excess of $1,000 for that product (21 CFR 700.3(i)).

Step 5: Enter Product Information

From the drop-down lists, select the product category type followed by the product category code that best describes the formulation you are filing, then--

  • Enter the brand/specific product name under which the formulation is marketed,
  • Provide the product website, if it exists, to indicate where the product can be purchased in the United States, and
  • Attach product label images. To do this, select “Upload” or drag and drop files into the box that says, “Drop files here.”.

If applicable, select “Add Additional Brand/Specific Product Name” to submit additional brand names under which this formulation is marketed.

Step 6: 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 CAS/VCRP Code Number or Common, Usual, or Chemical Name, as described below:

  • CAS/VCRP Code Number: We strongly recommend that you use CAS/VCRP Code Numbers to identify your ingredients whenever you can. The system will automatically attempt to supply a CAS/VCRP Code Number for any ingredient names you enter.
  • Common, Usual, or Chemical Name. If you are unable to find a CAS/VCRP Code Number for an ingredient, you may use the common, usual, 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 CAS/VCRP Code Numbers or Common, Usual, or Chemical Names.
  • You can copy and paste a list of common, usual, or chemical names from an existing document. To do this, select "Show Enter multiple ingredients Tool," then indicate the delimiter between the ingredients (new line or semicolon). Next, copy your list of Common, Usual, or Chemical Names into the text box, then select "Add."

"Unresolved" Ingredients:

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 Common, Usual, or Chemical Name or CAS/VCRP Code Number. If you cannot resolve an ingredient entry, FDA staff will locate its CAS/VCRP Code Number or assign a new one.

You can change the order of ingredients or delete ingredients by selecting “Edit Ingredient Statement.” The system will then give you the opportunity to:

  • Change the order of the ingredients you have entered so that they reflect the actual order of predominance in the formulation. To do this, select the ingredient number to the left of the CAS/VCRP Code Number, then change the ingredient number as appropriate from the drop-down menu.
  • Delete an ingredient. To do this, select the “delete icon” next to the ingredient you wish to remove from your CPIS.

Step 7: Who is Filing This Statement

Is your firm a manufacturer, a packer, a distributor, or retailer 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."

Note:

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 fills or labels product containers. 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.

A retailer is a firm that sells cosmetics directly to consumers.

Step 8: Authorized Individual Name

Select an authorized individual name from the drop-down menu. If you are a staff member or consultant participating in VCRP on behalf of a company, then select your name in the alternative authorized individual name field.

Additional alternative authorized individuals can be added to your account by selecting “Add New Alternative Authorized Individual” from the main menu.

Step 9: Submit Formulation

When you have finished, you may select “Close” if you do not wish to save this data, or you may select “Save Draft” if you wish to save your progress and continue with your filing at a later time. If the information is correct and you wish to submit this filing, select "Submit and Return to Previous Page." You will receive an e-mail indicating that you have successfully submitted Form FDA 2512 for our review.

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Amending a Cosmetic Product Ingredient Statement

Log into your account and view the "Cosmetic Formulation (Form FDA 2512)" section on the main menu. Next, select the "Brand(s)" of the formulation you wish to amend.

You will see the information currently on file for that formulation. Select "Amend Form" from the upper right-hand corner. Carefully review the information and type in any necessary changes. Check your work for accuracy, then select "Resubmit and Previous Page."

Discontinuing a Cosmetic Product Ingredient Statement

Log into your account and view the "Cosmetic Formulation (Form FDA 2512)" section on the main menu. Next, select the "Brand(s)" of the formulation you want to discontinue.

You will see the information currently on file for that cosmetic formulation. Make sure that you have selected the correct formulation to be discontinued. To discontinue the cosmetic formulation, select "Discontinue This Form" from the upper left-hand corner.

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Resubmitting a Cosmetic Product Ingredient Statement that was Returned for Action

If your CPIS was returned for action, that means FDA has a follow-up question about the information on the Form FDA 2512 that you have submitted. To view the follow-up question and resubmit your cosmetic formulation, read the instructions for Reviewing a CPIS, then view the message in the comment section at the bottom of your Form FDA 2512.

To respond to the comment, or make changes to the information you have submitted, select "Resubmit Form" from the upper right-hand corner. Check your information for accuracy, then select "Resubmit and Return to Previous page."

Reviewing a Cosmetic Product Ingredient Statement

Log into your account and view the "Cosmetic Formulation (Form FDA 2512)" section on the main menu. You will see a list of your cosmetic formulations currently filed, or submitted for filing, in the VCRP. Next, select the "Brand(s)" of the formulation you want to review.

You will see the information currently on file for that cosmetic formulation. You may review the information on this page, make amendments, or discontinue the cosmetic formulation if necessary.

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Transferring formulations that you have filed previously on paper forms to your new online VCRP account

Send an email to VCRP@fda.gov with your CPIS number(s), brand/specific product name(s), and the name of the new online VCRP account, so that we can process your request.

Deleting a Cosmetic Product Ingredient Statement

You can delete formulations that have never been assigned a CPIS number. To do this, open the formulation you want to delete and select "Delete this Form."

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Page Last Updated: 09/20/2018
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