Original Forms FDA 2512 and 2512a

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.