How to File
Printed Forms FDA 2512, 2512a and 2514
for the
Voluntary Cosmetic Registration Program
(VCRP)

The Office of Cosmetics and Colors has developed an on-line registration system, intended to make it easier to participate in the VCRP. You may still use paper forms, following these instructions. However, we currently are experiencing significant delays processing paper VCRP forms in a timely manner because of resource constraints. We strongly encourage you to participate in the VCRP using the online program. Thank you.

Welcome to the Voluntary Cosmetic Registration Program. These instructions are designed to guide you step by step through the registration process. Please read the instructions - both the introduction and the instructions for each individual form - completely before you attempt to fill out these forms.

Contents

1. Introduction: General Information on Filing Your VCRP Forms
   • Forms FDA 2512, 2512a and 2514: What each form is for
   • Cosmetic Product Ingredient Statement (CPIS) numbers: Use and restrictions
   • Who should file the forms, and when:
     • Who should file original Forms FDA 2512 and 2512a, and when
     • Who should file amended Forms FDA 2512 and 2512a, and when
     • Who should file discontinuance Form FDA 2514, and when
   • How to obtain forms
   • How to request confidentiality, and how FDA handles confidentiality requests
   • Special notes on preparing your forms
   • Mailing the completed forms
   • How FDA will acknowledge receipt and acceptance of your forms
2. How to File Original Forms FDA 2512 and 2512a
   • Form FDA 2512
   • Official Receipt
   • Form FDA 2512a
   • Final checklist for filing original Forms FDA 2512 and 2512a
3. How to File Amended Forms FDA 2512 and 2512a
   • Form FDA 2512 - Amendments to brand names
     • Changing brand names
     • Deleting brand names
     • Adding brand names
   • Official Receipt
   • Form FDA 2512a - Amendments to ingredients
     • Deleting ingredients
     • Adding ingredients
     • Final checklist for filing amended Forms FDA 2512 and 2512a
4. How to File Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product
   • Standard procedure - Using Form FDA 2514
   • Alternatives to filing Form FDA 2514
5. How to File Base Formulations on Forms FDA 2512 and 2512a
   • Definition of a "base formulation"
   • How to file a base formulation
   • How to file a base formulation as an ingredient in a cosmetic product

Reference Materials You Will Need

1. Cosmetic Product Category Codes
2. Sources for Cosmetic Ingredient Nomenclature
3. CAS and RD Numbers for Most Frequently Used Cosmetic Ingredients
4. Samples of Completed Forms
   • Sample 1A: (PDF) Original Form FDA 2512 completed by the manufacturer/packer/distributor on the label
   • Sample 1B: (PDF) ...with Original Form FDA 2512a
   • Sample 2A: (PDF) Original Form FDA 2512 completed by private labeler
   • Sample 3A: (PDF) Amended Form FDA 2512
   • Sample 3B: (PDF) ...with Amended Form FDA 2512a
   • Sample 4A: (PDF) Original "Base" Form FDA 2512
   • Sample 4B: (PDF) ...with Form FDA 2512a
   • Sample 5A: (PDF) Original Form FDA 2512 completed by private labeler
   • Sample 5B: (PDF) ...with Form FDA 2512a using "base formulation"
   • Sample 6A: (PDF) Original Form FDA 2514 completed by private labeler
   • Sample 6B: (PDF) Original Form FDA 2514 completed by private labeler

A. Introduction: General Information on Filing Your VCRP Forms

Please read the instructions - both these introductory notes and the instructions for each individual form - completely before you attempt to fill out these forms.

This introduction provides general information on using the following forms:
Forms FDA 2512 and 2512a - Cosmetic Product Ingredient Statement (CPIS), and
Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product

Forms FDA 2512, 2512a, and 2514: What each form is for

Forms FDA 2512 and 2512a go together. Use Form FDA 2512 for listing your brand names. Use Form FDA 2512a for listing specific ingredients.

Use Form FDA 2514 to notify FDA that you are discontinuing a formulation.

(You also may use the VCRP to register your establishment using Form FDA 2511. Instructions for filing Form FDA 2511 appear on the back of preprinted forms and accompany forms downloaded from the FDA Web site.)

Who should file original CPIS Forms FDA 2512 and 2512a, and when

Any firm, whether domestic or foreign, that manufactures or distributes cosmetics in the United States may file Forms FDA 2512 and 2512a. Additionally, a private labeler or packer of a cosmetic may file these forms.

You should file these forms within 60 days from the date of commercial distribution of the cosmetic product in the United States.

Who should file amendments to CPIS Forms FDA 2512 and 2512a, and when

Any firm, once having filed a CPIS form, is responsible for maintaining an accurate filing with FDA for that product.

Please notify FDA of changes in a brand name or ingredients within 60 days from an amended product's commercial distribution. Please submit other amendments within one year.

Who should file discontinuance Form FDA 2514, and when

A firm, once having filed a CPIS form, should notify FDA when the cosmetic formulation is no longer in commercial distribution.

You should notify FDA within 180 days after a product has been removed from commercial distribution.

How to obtain forms

You may obtain printed forms from your nearest FDA District Office or by contacting the Office of Cosmetics and Colors at (301) 436-1257. You also may download forms from the FDA Web site.

How to request confidentiality

Information voluntarily disclosed to FDA is available to the public unless:

1. The person submitting it -
   1. requests exemption from public disclosure and
   2. provides documentation showing that the information is a trade secret, or is commercial or financial information that is privileged or confidential, and
2. FDA accepts the information in confidence upon review of the submitted factual data.

If you consider the identity of an ingredient confidential, you must follow these steps:

• Attach to the submission, in triplicate, a statement of the factual and legal grounds supporting the request for confidentiality. Title 21 of the Code of Federal Regulations, Part 720.8 (21 CFR 720.8), Confidentiality of Statements, discusses how to prepare a Request for Confidentiality).
• Submit your forms for presubmission review for confidentiality.
• Request that FDA return your submission if your request for confidentiality is denied.
• Mark the appropriate block on Form FDA 2512a, as noted in the Form FDA 2512a instructions.

If you do not request confidentiality, the information becomes the property of FDA. For complete information on confidentiality of registration information, please refer to Title 21 of the Code of Federal Regulations, Part 720.8 (21 CFR 720.8).

Cosmetic Product Ingredient Statement (CPIS) Numbers - Use and restrictions

After receiving and accepting CPIS Forms FDA 2512 and 2512a for a product, FDA will assign the product a CPIS number. CPIS numbers are intended only for use in the VCRP. Assignment of a CPIS number does not in any way denote FDA approval of the firm or its product. Any representation in labeling, advertising, or trade literature that creates an impression of such official approval is considered misleading (21 CFR 720.9).

Special notes on preparing your forms

Type entries in CAPITAL LETTERS, starting at the extreme left of each space provided.

Use standard abbreviations whenever possible.

Omit all punctuation except in chemical names.

FDA does not expect the typing of forms to be perfect. You will note that several of the "Sample Submissions" contain "typing errors" that have simply been "XXXXed" or "----- ed" out. We have tried to leave room in each block for typing errors to be crossed out and retyped. If you find there is no room in a brand name block or ingredient block for the information to be corrected, "XXXX" out the block and use the next available block. Pen corrections are also acceptable if they are legible.

Sign and date the completed forms. FDA cannot accept unsigned forms and will return them unprocessed.

Mailing the completed forms

If your are using preprinted forms mailed to you by FDA, remove the REGISTRANT'S COPY from each completed form and retain it for your records. Do not separate the remaining two parts. If you have printed forms from FDA's Web site, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA.

Staple together Form FDA 2512 and one or more Forms FDA 2512a pertaining to the same CPIS; attach, where appropriate, the supporting statement for confidentiality; and send them to:

Voluntary Cosmetics Registration Program
HFS-125
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835

How FDA will acknowledge receipt and acceptance of your forms

FDA will acknowledge its receipt and acceptance of the forms you have filed by returning the OFFICIAL RECEIPT to you after FDA personnel have finished reviewing them. The OFFICIAL RECEIPT is located at the bottom of Form 2512. If you print forms from FDA's Web site, the receipt will print out as a page of Form 2512.

If your submission is complete, FDA will return the OFFICIAL RECEIPT to you marked COMPLETE, listing the Cosmetic Product Ingredient Statement Number (CPIS NO.) assigned to the submission.

If your submission is incomplete, FDA will return the forms to you, along with a request for the additional information needed to complete the submission. After FDA receives the requested information, FDA will send you the OFFICIAL RECEIPT marked COMPLETE, listing the CPIS NO.

B. How to File Original Forms FDA 2512 and 2512a

These instructions will guide you step by step through completing Forms FDA 2512 and 2512a for an original CPIS submission. Steps are numbered to match the numbers of each block on the form. Please read these instructions completely.

Form FDA 2512

• TYPE OF SUBMISSION

  Check the box marked "ORIGINAL" in the upper right corner if you are using the form for an original submission of a cosmetic product formulation.

• 01. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On label)

  Enter the firm name exactly as it appears on the label of the cosmetic formulation being filed.

• 02. KIND OF BUSINESS

  Indicate whether the firm listed in Block 01 manufactures, packages, and/or distributes the cosmetic product formulation. Please check all that apply.

• 03. NAME OF PARENT COMPANY (If any) (See Note)
• 04. COMPLETE MAILING ADDRESS (See Note)

  Please provide the complete mailing address of the firm listed in Block 01, including the street address and number, city, state, and domestic or foreign zip codes, as well as province/country for locations outside of the U.S.  Post Office boxes are acceptable.

• 11. NAME OF MANUFACTURER/PACKER (Private Labeler)

  If the cosmetic product formulation being submitted is not manufactured by the firm listed in Block 01, you may list the name of the Private Label Manufacturer in Block 11.

  If the cosmetic product formulation is being submitted by the Private Label Manufacturer for the firm listed in Block 01, you must enter the filing Private Label Manufacturer in Block 11.

• 12. NAME OF PARENT COMPANY (If any) (See Note)

  If the firm listed in Block 11 is owned by another firm, please provide the name of this parent company.

• 13. COMPLETE MAILING ADDRESS (See Note)

  Please provide the complete mailing address of the firm listed in Block 11, including the street address and number, city, state, and domestic or foreign zip code, as well as province/country for locations outside of the U.S.  Post Office boxes are acceptable.

  NOTE: When you are filing two or more original submissions at the same time for the firm listed in Block 01, you need complete Blocks 03, 04, 12, and 13 on the first submission only. If you file more submissions in the future, follow the same procedure, completing these blocks for the first of any multiple submissions that you file at the same time.

• 14. IS THIS STATEMENT FILED BY COMPANY 01 OR COMPANY 11?

  If the submission is being filed by the company listed in Block 01, enter "0 1 " in the two spaces provided. If the submission is being filed by the company listed in Block 11, enter "1 1" in the two spaces provided.

• 15. PRODUCT CATEGORY CODE

  Select a single Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation.

• 16. BRAND NAME OF COSMETIC PRODUCT

  List the brand name(s) of the cosmetic product(s) sharing this cosmetic product formulation as they appear on the product label.

  Brand names submitted on the same Form FDA 2512 must belong to the company listed in Block 01, have the same Product Category Code, and have the same formulation.

  Shaded cosmetics -- meaning a line of products differing only in color additive composition, and whose Product Category Codes begin with "03," "07" or "08" -- may be filed as "(ALL SHADES)" rather than listing each shade separately.

  However, each shade of a line of hair colors (Product Category Codes beginning with "06") must be filed on separate submissions.

  If you are listing more than eight brand names, use a second Form FDA 2512.

• 17. TYPE OF ACTION

  Leave this block blank on original submissions.

• 18. DATE OF ACTION

  Leave this block blank on original submissions.

• 19. TYPE NAME AND TITLE OF AUTHORIZED INDIVIDUAL

  State the name and title of the person authorized by the filer to disclose the information to FDA.

• 20. TELEPHONE NO.

  Provide the telephone number, including the area code and any extension, of the authorized individual named in Block 19.

• 21. SIGNATURE AND DATE

  The authorized individual must sign and date Form FDA 2512. FDA cannot accept an unsigned submission.

  Page ____ of ____ pages

  Leave this item blank until all pages of your submission are ready to number.

Official Receipt

FDA will use the Official Receipt, located at the bottom of Form FDA 2512, to notify you that we have received your VCRP submission. If you print forms from FDA's Web site, the receipt will print out as a page of Form 2512.

Prepare the Official Receipt as follows:

BRAND NAME OF COSMETIC PRODUCT

Enter the brand name of the cosmetic product you are filing. If you are filing more than one cosmetic product, enter the first product brand name listed on Form FDA 2512.

Form FDA 2512a

TYPE OF SUBMISSION

Check the box marked "ORIGINAL" in the upper right corner of Form FDA 2512a if you are using this form for the original submission of a cosmetic product formulation.

1. COMMON, USUAL, OR CHEMICAL NAME

   The preferred listing in Block 1 is the COMMON or USUAL name for the ingredient. If none is available, list the CHEMICAL name. If a common, usual, or chemical name is not listed in any of the Sources for Cosmetic Ingredient Nomenclature, list the TRADE NAME of the material in Block 7 and the name of the supplier in Block 8.

   If an ingredient is a reaction product of two or more chemicals, list either the reaction product as a single ingredient, if you know it, or the reacting chemicals. For example:

   You may either list "SODIUM STEARATE," or list "SODIUM HYDROXIDE" and "STEARIC ACID" as separate ingredients.

   If an ingredient is a fragrance or flavor compound, list the compound as the common name "FRAGRANCE" or "FLAVOR."

   If you are listing more than ten ingredients, use a second Form FDA 2512a.

   If necessary, check the Sources for Cosmetic Ingredient Nomenclature to locate sources for names of cosmetic ingredients.

2. 9-DIGIT CAS NO.

   If you know the Chemical Abstract Service Number (CAS No.) or Recognized Disclosure Number (FDA-assigned RD No.), you may list it here. If you do not know the number, please check the list of CAS and RD Numbers for Most Frequently Used Cosmetic Ingredients.

   If you cannot find the CAS No. or RD No. for the ingredient, you may leave this block blank.

   List all numbers as 9-digit numbers. For example:

   List 99-76-3 as 000099763.
   Also list 99763 as 000099763.

3. TYPE OF ACTION

   Leave this block blank on original submissions.

4. DATE OF ACTION

   Leave this block blank on original submissions.

5. CONF

   If you consider the identity of an ingredient confidential, place an "X" in Block 05 and attach to the submission, in triplicate, a statement of the factual and legal grounds supporting the request for confidentiality. Title 21 CFR, Part 720.8 (21 CFR 720.8), Confidentiality of Statements, discusses how to prepare a Request for Confidentiality.

   Information voluntarily disclosed to FDA is available to the public unless:

   1. The person submitting it -
      1. requests exemption from public disclosure and
      2. provides documentation showing that the information is a trade secret, or is commercial or financial information that is privileged or confidential, and
   2. FDA accepts the information in confidence upon review of the submitted factual data.
6. BASE CPIS NO.

   If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the number here. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512a.

7. BASE NAME OR TRADE NAME MATERIAL

   If the common, usual, or chemical name in Block 1 is not listed in any of the accepted Sources for Cosmetic Ingredient Nomenclature, list the trade name as additional information.

   If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the base name as it appears on its Form FDA 2512 submission. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512a.

8. COMPANY NAME

   When you list a Base Name or Trade Name in Block 7, you must enter in Block 8 the name of the company supplying the ingredient.

Final Checklist for Filing Original Forms FDA 2512 and 2512a

Place your submission in order, with Form FDA 2512 placed before Form FDA 2512a. If you have used a second Form FDA 2512 or Form FDA 2512a, the second form should follow the first of the same type.

Count the total number of forms in the submission and complete the page numbering sequence at the bottom right of each form. The first page will be "Page 1 of X Pages" where X is the total number of forms in the submission. The next page will be "Page 2 of X pages," and so on.

Remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you have printed copies of forms posted on the Web, make two copies of each page you have filled out. Keep one copy for your own records. Mail the original and one copy to FDA.

Staple the entire submission together in page order. DO NOT use paper clips because the forms can become separated in the mail and will be returned unprocessed.

Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.

C. How to File Amended Forms FDA 2512 and 2512a

These instructions will guide you step by step through Forms FDA 2512 and 2512a to amend a Cosmetic Product Ingredient Statement (CPIS) submission.

If you are amending information found only on Form FDA 2512, you need only submit a Form FDA 2512. If you need to amend ingredient information, you must submit Forms FDA 2512 and 2512a.

Form FDA 2512

• TYPE OF SUBMISSION:

  Check the box marked "AMENDED" in the upper right corner if you are amending a CPIS.

• FDA CPIS NO. and FILING DATE:

  Enter the 7-digit CPIS number and Filing Date as found on the Official Receipt that you received as acknowledgment of filing your original submission.

• 01. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)

  Enter the firm name exactly as it appears on the label of the cosmetic formulation being filed.

• 02. KIND OF BUSINESS

  Leave this item blank unless you are amending this information.

  If you are amending this information, indicate whether the firm listed in Block 01 manufactures, packages, and/or distributes the cosmetic product formulation. Please check all items that apply.

• 03. NAME OF PARENT COMPANY (If any)

  Leave this item blank unless you are amending this information.

  If you are amending this information, please provide the name of the parent company if the firm listed in Block 01 is owned by another firm.

• 04. COMPLETE MAILING ADDRESS:

  Leave this item blank unless you are amending this information.

  If you are amending this information, please provide the complete mailing address of the firm listed in Block 01, including the street address and number, city, state, and domestic or foreign zip codes, as well as province/country for locations outside of the U.S.  Post Office boxes are acceptable.

• 11. NAME OF MANUFACTURER/PACKER (Private Labeler)

  If the cosmetic product formulation being submitted is not manufactured by the firm listed in Block 01, you may list the private label manufacturer's name in Block 11.

  If the cosmetic product formulation is being submitted by the private label manufacturer for the firm listed in Block 01, you must list the private label manufacturer in Block 11.

• 12. NAME OF PARENT COMPANY (If any)

  Leave this item blank unless you are amending this information.

  If you are amending this information, please provide the name of the parent company if the firm listed in Block 11 is owned by another firm.

• 13. COMPLETE MAILING ADDRESS:

  Leave this item blank unless you are amending this information.

  If you are amending this information, please provide the complete mailing address of the firm listed in Block 11, including the street address and number, city, state, domestic or foreign zip codes, and province/country for locations outside of the U.S.  Post Office boxes are acceptable.

• 14. IS THIS STATEMENT FILED BY COMPANY 01 OR COMPANY 11?

  If the submission is being filed by the company listed in Block 01, enter "01" in the two spaces provided. If the submission is being filed by the company listed in Block 11, enter "11" in the two spaces provided.

• 15. PRODUCT CATEGORY CODE

  Leave this item blank unless you are amending this information.

  If you are amending this information, select a single Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation.

• 16. BRAND NAME OF COSMETIC PRODUCT, 17. TYPE OF ACTION, and 18. DATE OF ACTION

  Use Block 16 to identify brand names and Blocks 17 and 18 to note how and when brand names have changed.

  If you are not amending brand names:

  • List in Block 16 the brand name of a cosmetic product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being amended.
  • Skip to Block 19.

  Please read the following general instructions before amending, deleting, or adding brand names:

  • List the brand name(s) of the Cosmetic Product(s) sharing this cosmetic product formulation as they appear on the product label.
  • Brand names submitted on the same Form FDA 2512 must belong to the company listed in Block 01, have the same Product Category Code, and have identical formulations.
  • Shaded cosmetics - meaning a line of products differing only in color additive composition and and whose Product Category Codes begin with "03," "07," or "08" - may be filed as "(ALL SHADES)" rather than listing each shade separately.
  • However, each shade of a line of hair colors (Product Category Codes beginning with "06") must be filed on separate submissions.

  Changing brand names:

  • List, starting in the space for BRAND NO. 01, the old brand name of the cosmetic product to be changed, as it appeared when filed. Under TYPE OF ACTION enter "DELETE" and under DATE OF ACTION enter the date on which the brand name was changed.
  • List, in the space for the next BRAND NO., the new brand name of the cosmetic product. Under TYPE OF ACTION enter "ADD" and under DATE OF ACTION enter the date the brand name was changed.
  • If you are submitting changes to other brand names for the same formulation, list them on subsequent BRAND NO. lines.
  • If you are listing more than eight brand names, use a second Form FDA 2512.

  Deleting brand names:

  • Starting in the first available BRAND NO. space, list the Brand Name of the Cosmetic Product to be deleted, as it appeared when filed. Under TYPE OF ACTION enter "DELETE" and under DATE OF ACTION enter the date on which the brand name was deleted.
  • Enter further deletions of other brand names for the same formulation on subsequent BRAND NO. lines.
  • If you are listing more than eight brand names, use a second Form FDA 2512.
  • List the brand name(s) of the cosmetic product(s) sharing this cosmetic product formulation as they appear on the product label.

  NOTE: Do not confuse deleting a brand name with discontinuing a product formulation. You may file an amended Form FDA 2512 to delete one or more brand names from a product formulation on file with FDA. If the formulation is no longer in commercial distribution, file a Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product, not an amendment deleting the product brand name.

  Adding brand names:

  • Starting in the first available BRAND NO. space, list the Brand Name of the Cosmetic Product to be added, as it appeared when filed. Under TYPE OF ACTION enter "ADD" and under DATE OF ACTION enter the date on which the brand name was deleted.
  • Enter further additions of other brand names for the same formulation on subsequent BRAND NO. lines.
• 19. TYPE NAME AND TITLE OF AUTHORIZED INDIVIDUAL

  State the name and title of the person authorized by the filer to disclose the information to FDA.

• 20. TELEPHONE NO.

  Provide the telephone number, including the area code and any extension, of the authorized individual.

• 21. SIGNATURE AND DATE

  The authorized individual must sign and date Form FDA 2512. FDA cannot accept an unsigned submission.

  Page ____ of ____ pages

  Leave this item blank until the complete submission is ready to number.

Official Receipt

FDA will use the Official Receipt, located at the bottom of Form FDA 2512, to notify you that we have received your VCRP submission. If you print forms from FDA's Web site, the receipt will print out as a page of Form 2512.

Prepare the Official Receipt as follows:

BRAND NAME OF COSMETIC PRODUCT

Enter the brand name of the cosmetic product that you are changing, deleting, or adding to your cosmetic filing. If you are filing more than one cosmetic product, enter the first product brand name listed on Form FDA 2512. If you are not amending brand names, enter the brand name listed on the Official Receipt submitted with the original submission.

Amendments to Ingredients

Use Form FDA 2512a to file amendments to ingredients. If you are NOT amending ingredients, you do not need to file a Form FDA 2512a.

TYPE OF SUBMISSION:

Check the box marked "AMENDED" in the upper right corner.

FDA CPIS NO. and FILING DATE: Enter the same 7-digit CPIS number and filing date as entered on Form FDA 2512.

Deleting Ingredients

• Starting in the first available INGRED NO., list the ingredient to be deleted from the formulation as it appeared when filed. Under TYPE OF ACTION enter "DELETE" and under DATE OF ACTION enter the date the ingredient was deleted.
• If you are deleting other ingredients from the formulation, continue on subsequent INGRED NO. lines.
• If you are deleting more than ten ingredients, use a second Form FDA 2512a.

Adding Ingredients

DO NOT list the entire formulation as filed originally. Instead, starting in the first available INGRED NO., list the ingredient(s) to be added to the formulation, as follows:

1. COMMON, USUAL, OR CHEMICAL NAME

   The preferred listing in Block 1 is the common or usual name for the ingredient. If none is available, you may list the chemical name. If a common, usual, or chemical name is not available, you may enter the TRADE NAME of the material in Block 7.

   If necessary, check Sources for Cosmetic Ingredient Nomenclature for names of cosmetic ingredients.

   If an ingredient is a reaction product of two or more chemicals, either list the reaction product as a single ingredient, if known, or list the reacting chemicals. Example: You may either list "SODIUM STEARATE," or list "SODIUM HYDROXIDE" and "STEARIC ACID" as separate ingredients.

   If an ingredient is an undisclosed proprietary fragrance or flavor compound, purchased from an outside supplier, list the compound as the common name "FRAGRANCE" or "FLAVOR."

   If you are listing more than ten ingredients, use a second Form FDA 2512a.

2. 9-DIGIT CAS NO.

   If you know the Chemical Abstract Service Number (CAS No.) or Recognized Disclosure Number (FDA-assigned RD No.), you may list it here. If you do not know the number, please check the list of CAS and RD Numbers for Most Frequently Used Cosmetic Ingredients.

   If you cannot find the CAS No., you may leave the item blank.

   List all CAS Numbers as 9-digit numbers.

   For example:

   List 99-76-3 as 000099763.
   Also list 99763 as 000099763.

3. TYPE OF ACTION

   Enter "ADD".

4. DATE OF ACTION

   Enter the date when the ingredient was added to the formulation.

5. CONF

   If your firm considers the identity of an ingredient confidential, place an "X" in Block 05 and attach to the submission, in triplicate, a statement of the factual and legal grounds supporting the request for confidentiality. Title 21 CFR, Part 720.8 (CFR 21 720.8), Confidentiality of Statements, discusses preparation of a Request for Confidentiality.

   Information voluntarily disclosed to FDA is available to the public unless:

   1. The person submitting it -
      1. requests exemption from public disclosure and
      2. provides documentation showing that the information is a trade secret, or is commercial or financial information that is privileged or confidential, and
   2. FDA accepts the information in confidence upon review of the submitted factual data.
6. BASE CPIS NO.

   If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the number here. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512A.

7. BASE NAME OR TRADE NAME MATERIAL

   If the common, usual, or chemical name entered in Block 1 is not listed in any of the accepted Sources for Ingredient Nomenclature, you may list the trade name as additional information.

   If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the base name as it appears on its Form FDA 2512 submission. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512a.

8. COMPANY NAME

   When a Base Name or Trade Name is provided in Block 7, enter the name of the company supplying the ingredient.

Final Checklist for Filing Amended Forms FDA 2512 and 2512a

Place the submission in order, with Form FDA 2512 placed before Form FDA 2512a. If you have used a second Form FDA 2512 or Form FDA 2512a, the second form should follow the first of the same type.

Count the total number of forms in the submission and complete the page numbering sequence at the bottom right of each form. The first page will be "Page 1 of X Pages" where X is the total number of forms in the submission. The next page will be Page 2, and so on.

If you are using preprinted forms mailed to you by FDA, remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you are using forms printed from FDA's Web page, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA.

Staple the entire submission together in page order. DO NOT use paper clips, because the forms can become separated in the mail and will be returned unprocessed.

Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.

D. How to File Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product

Standard Procedure - Use of Form FDA 2514

NOTE: Submission of Form FDA 2514 will discontinue an entire Cosmetic Product Ingredient Statement (CPIS). All Brand Names reported under this CPIS Number will be discontinued. If more than one cosmetic product has been filed under the CPIS and you wish to delete one or more of the Brand Names, but not all of them, file an amended Form FDA 2512 deleting those cosmetic products that are no longer manufactured.

1. FDA CPIS NO.

   Enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of filing your original submission.

2. FILING DATE

   Enter the Filing Date as found on the Official Receipt that you received as acknowledgment of filing your original submission.

3. DISCONTINUANCE DATE

   Enter the date when the formulation was removed from commercial distribution.

4. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)

   Enter the firm name exactly as it appeared on the label of the cosmetic formulation being discontinued.

5. BRAND NAME OF COSMETIC PRODUCT

   List any Brand Name of a Cosmetic Product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being discontinued.

6. COMMENTS (If any)

   Any comments concerning the discontinuance may be stated in Block 6.

7. TYPED NAME AND TITLE OF AUTHORIZED INDIVIDUAL

   State the name and title of the person authorized by the filer to disclose the information to FDA. Provide the telephone number, including the area code and any extension, of the authorized individual.

8. SIGNATURE AND DATE

   The authorized individual must sign and date Form FDA 2514. FDA can not accept an unsigned submission.

   If you are using preprinted forms mailed to you by FDA, remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you have printed your form FDA 2514 from FDA's Web site, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA. FDA will not send an Official Receipt or acknowledgment for submission of a discontinuance.

   Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.

Alternatives to Filing Form FDA 2514

There are three other ways to discontinue a listing in the VCRP:

• A participant may request, in writing, a complete computer listing of all products currently on file with FDA under the VCRP. The participant may then cross out all product formulations no longer in commercial distribution, sign and date the listing, and return the listing to FDA for updating of the participant's records.
• A participant may submit, in writing, a listing of product formulations no longer in commercial distribution, along with their CPIS numbers, to FDA for updating to discontinued status.
• Use Form FDA 2512 as follows:

TYPE OF SUBMISSION: Check the box marked "DISC" in the upper right corner of Form FDA 2512 to discontinue a submission of a cosmetic product formulation.

FDA CPIS NO.

Enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of filing your original submission.

FILING DATE

Enter the Filing Date as found on the Official Receipt received as acknowledgment of filing your original submission.

1. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)

Enter the firm name exactly as it appeared on the label of the cosmetic formulation being discontinued.

16. BRAND NAME OF COSMETIC PRODUCT

List in the space for BRAND NO. 01 any Brand Name of a Cosmetic Product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being discontinued.

Enter in the space for BRAND NO. 02, "AND ALL OTHER PRODUCTS LISTED UNDER THIS CPIS NUMBER".

17. TYPE OF ACTION

Enter "DISC".

18. DATE OF ACTION

Enter date formulation was removed from commercial distribution.

19. TYPE NAME AND TITLE OF AUTHORIZED INDIVIDUAL

State the name and title of the person authorized by the filer to disclose the information to FDA.

20. TELEPHONE NO.

Provide the authorized individual's telephone number, including the area code and any extension.

21. SIGNATURE AND DATE

The authorized individual must sign and date Form FDA 2514. FDA cannot accept an unsigned submission.

E. How to File Base Formulations on Forms FDA 2512 and 2512a

Definition of a "Base Formulation"

A base formulation is a partial or complete cosmetic formulation shared by two or more cosmetic products manufactured by a private label manufacturer. Private label manufacturers may greatly facilitate the filing of cosmetic products for their clients by filing their base formulations using Forms FDA 2512 and 2512a. The private label manufacturers then list a base formulation as a single ingredient when filing cosmetic product formulations for their clients.

Base formulations are used to facilitate multiple filings by private label manufacturers and will not be accepted by FDA unless accompanied by three or more cosmetic product ingredient statement submissions using them.

How to File a Base Formulation

A base formulation is prepared and filed in exactly the same manner as any other cosmetic filing except the following four items:

A. TYPE OF SUBMISSION:

Check the boxes marked "Original" and "Base" in the upper right corner on Form FDA 2512.

B. 01. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)

Enter the private label manufacturer's firm name.

C. 15. PRODUCT CATEGORY CODE

Select the Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation that the base formulation will be used in.

D. 16. BRAND NAME OF COSMETIC PRODUCT

List in the space for Brand No. 01 the base formulation name chosen by the Private Label Manufacturer for this base formulation. You may list only one base formulation on a base formulation submission.

How to File a Base Formulation as an Ingredient in a Cosmetic Product Using Forms FDA 2512 and 2512a

Form FDA 2512

Prepare and file the Form FDA 2512 in exactly the same manner as any other cosmetic filing.

Form FDA 2512a

Because the base formulation comprises most or all of the ingredients of the finished cosmetic product being filed, it should be entered in INGRED NO. 01.

6. BASE CPIS NO.

When you are filing the first three or more cosmetic product formulations with the original base formulation, leave the BASE CPIS NO. blank since the number has yet to be assigned. Use a heavy clip or rubber band to secure the cosmetic product formulations to the base formulation.

With later cosmetic product formulations enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of your base formulation filing.

7. BASE NAME

Enter the base formulation name as filed.

8. COMPANY NAME

Enter the name of private label manufacturer.

If there are any other ingredients that have been added to the base formulation that are unique to the product, such as color, fragrance, or flavor they should be listed starting in INGRED NO. 02.

Cosmetic Product Category Codes

Return to instructions

Use this list to determine the Product Category Code that you enter in Block 15 of Form FDA 2512. Each Product Category Code consists of a two-digit number, which indicates the general category, and a letter, which indicates the specific type of product. For example, to find the Product Category Code for a baby shampoo, note that "Baby Products" are category "01." Baby shampoos are listed in this category as item "A." Therefore, the Product Category Code for a baby shampoo is "01A."

Return to instructions

Sources for Cosmetic Ingredient Nomenclature

1. CTFA Cosmetic Ingredient Dictionary

The Cosmetic, Toiletry and Fragrance Association, Inc.
1101 17th Street, N.W.
Washington, DC 20036

If a monograph lists both a "generic" CAS No. and an RD No., report the RD No. in Block 2 of the Form FDA 2512a.

If neither a CAS NO. nor a RD No. is listed, report the CTFA Adopted Name in Block 1 as the Common, Usual, or Chemical Name, and provide the Trade Name and Supplier in Blocks 7 and 8 on the Form FDA 2512a.

2. United States Pharmacopeia/National Formulary

United States Pharmacopoeial Convention, Inc.
12601 Twinbrook Parkway
Rockville, MD 20852

3. USAN and the USP Dictionary of Drug Names

United States Pharmacopoeial Convention, Inc.
12601 Twinbrook Parkway
Rockville, MD 20852

4. Merck Index

Merck & Co., Inc.
Rahway, NJ 07065

5. FDA VCRP Cosmetic Ingredient Listing

A limited supply of the ingredient listings is available upon request from the Cosmetics Registration Section. However, FDA recommends using the following list of CAS and RD Numbers For Most Frequently Used Cosmetic Ingredients.

CAS and RD Numbers for Most Frequently Used Cosmetic Ingredients

000077894   Acetyl Triethyl Citrate	039236469   Imidazolidinyl Urea
061788496   Acetylated Lanolin Alcohol	001332372   Iron Oxides
977021796   Alcohol Denatured 39C	000067630   Isopropyl Alcohol
977021810   Alcohol, Denatured 40	063393931   Isopropyl Lanolate
000097596   Allantoin	000110270   Isopropyl Myristate
000123308   Aminophenol, P-	000142916   Isopropyl Palmitate
001336216   Ammonium Hydroxide	001332587   Kaolin
000050817   Ascorbic Acid	008020846   Lanolin
008006404   Beeswax, White	008027336   Lanolin Alcohols
008012893   Beeswax, Yellow	070321630   Lanolin Oil
025013165   BHA (Butylated Hydroxyanisole)	008006540   Lanolin, Anhydrous
000128370   BHT (Butylated Hydroxytoluene)	008002435   Lecithin
007787599   Bismuth Oxychloride	001327431   Magnesium Aluminum Silicate
000123864   Butyl Acetate	000546930   Magnesium Carbonate
000094268   Butylparaben	000099763   Methylparaben
000076222   Camphor	012001262   Mica
008006448   Candelilla Wax	063231607   Microcrystalline Wax
009007163   Carbomer-934	008012951   Mineral Oil, Heavy
008015869   Carnauba Wax	977000137   Mineral Oil, Light
008001794   Castor Oil	000112801   Oleic Acid
009004324   Cellulose Gum	000143282   Oleyl Alcohol
008001750   Ceresin	012198935   Ozokerite
036653824   Cetyl Alcohol	008002742   Paraffin
000540103   Cetyl Palmitate	008027325   Petrolatum, White
012001999   Chromium Hydroxide Green	008009038   Petrolatum, Yellow
000077929   Citric Acid	000106503   Phenylenediamine, P-
004403901   DC Green #5	007664382   Phosphoric Acid
000633965   DC Orange #4	009005645   Polysorbate 20
977011678   DC Red #6-Barium Lake	009005678   Polysorbate 60
977011689   DC Red #7-Calcium Lake	009003398   Povidone
015086949   DC Red #21	000057556   Propylene Gylcol
003567666   DC Red #33	000094133   Propylparaben
977058755   DC Yellow #5-Aluminum Lake	004080313   Quaternium-15
008004920   DC Yellow #10	000108463   Resorcinol
000084742   Dibutyl Phthalate	007647145   Sodium chloride
009006659   Dimethicone	000151213   Sodium Lauryl Sulfate
000141786   Ethyl Acetate	008007430   Sorbitan Sesquioleate
003844459   FDC Blue #1	000111013   Squalane
004548532   FDC Red #4	000057114   Stearic Acid
001934210   FDC Yellow #5	000112925   Stearyl Alcohol
002783940   FDC Yellow #6	014807966   Talc
014038438   Ferric Ferrocyanide	013463677   Titanium Dioxide
001309371   Ferric Oxide	000102716   Triethanolamine
008006073   Formaldehyde Solution (Formalin)	057455375   Ultramarine Blue
000056815   Glycerin	007732185   Water
031566311   Glyceryl Monostearate	001314132   Zinc Oxide
009004620   Hydroxyethylcellulose	000557051   Zinc Stearate

*All Numbers starting with 977 are RD numbers.