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 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, 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.