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MoCRA FAQ (Frequently Asked Questions and Answers)


MoCRA FAQ

With the upcoming MoCRA effect date, numerous cosmetic companies are seeking clarification on MoCRA compliance.


To provide further clarification, we are sharing the MoCRA Frequently Asked Questions and Answers taken from the FDA's final guidance on MoCRA compliance, which is titled "Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, Appendix B, Frequently Asked Questions and Answers."


Q1. Do owners and operators of facilities that only manufacture or process cosmetic ingredients need to register their facilities? Does a responsible person need to submit a product listing for cosmetic ingredients?


A. No, at this time, FDA only expects non-exempt facilities to register if they manufacture or process the final formulation of cosmetic ingredients (including a final formulation that includes a single ingredient). This includes final formulations that have not yet been packaged. FDA only expects non-exempt responsible persons to list cosmetic products that are marketed for users (e.g., consumers or professional use).


Q2. Can a consultant be a “responsible person” under section 607 of the FD&C Act?


A. A consultant can only be a responsible person if they meet the definition of “responsible person” in section 604(4) of the FD&C Act. A “responsible person” as defined in section 604(4) of the FD&C Act, means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.


Q3. Can a company located outside of the U.S. be the “responsible person”?


A. “Responsible person,” as defined in section 604(4) of the FD&C Act, means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. A company located outside of the U.S. could be a “responsible person” so long as they are the manufacturer, packer, or distributor of the cosmetic product. However, we note that, under section 609(a) of the FD&C Act, each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may be a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product. We recommend that firms consider when selecting electronic contact information, such as an email address or a website (whether foreign or domestic), how they can best respond to these reports and meet maintenance, inspection, and reporting requirements under section 605 of the FD&C Act.


Q4. Is the brand name the same as the product name?


A. No. FDA does not consider the brand name and product name to be the same.The product name is generally considered the statement of identity, as required under 21 CFR 701.11. The statement of identity provides information about the type or kind of cosmetic product in the package to help the consumer understand the functional use of the product. The brand name is the distinguishing name used by a company to identify a commercial product on the product label. The brand name may be proprietary and/or registered as a trademark.


Q5. What are examples of products whose manufacture does not qualify the responsible person or facility for the small business exemptions under section 612 of the FD&C Act?


A. Section 612 of the FD&C Act provides exemptions to certain small businesses from the requirements of sections 606 (Good Manufacturing Practice) and 607 (Registration and Product Listing).


However, such exemptions from the requirements of sections 606 and 607 of the FD&C Act do not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products listed in section 612(b) of the FD&C Act:

(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.

(2) Cosmetic products that are injected.

(3) Cosmetic products that are intended for internal use.

(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.


Q6. What are examples of products that regularly come into contact with the mucus membrane of the eye?


A. While there may be certain exceptions, an eye makeup remover, a liquid or mucosal eyeliner, or a false eyelash adhesive may regularly come into contact with the mucous membrane of the eye under conditions of use that are customary or usual, such that they would not qualify the small business exemption (see section 612(b)(1) of the FD&C Act). However, facial cleaners, moisturizers, and serums generally would not be expected to regularly come into contact with the mucous membrane of the eye under conditions of use that are customary or usual.


Q7. What are examples of products that are intended to alter appearance for more than 24 hours?


A. Examples of cosmetic products that are intended to alter the appearance for more than 24 hours and removal by the consumer is not part of such conditions of use that are customary or usual, as described in section 612(b)(4) of the FD&C Act, may include certain nail polishes, some hair products, some eyebrow dyes, and certain leave-on skin preparations. To determine if a product falls under section 612(b)(4) of the FD&C Act one should consider product labeling, including directions for use, as well as the uses of the product that are not indicated in the labeling but are customary or usual.


Q8. If a facility engages in the manufacturing or processing of cosmetic products listed in section 612(b) of the FD&C Act, does the facility need to include information required under section 607(b)(2)(D) and (E) for only the cosmetic products listed in section 612(b), or for all of the cosmetic products manufactured or processed by the facility?


A. The exemptions in section 612 of the FD&C Act apply to responsible persons and owners and operators of facilities that meet the definition of a small business in section 612(a). Thus, a facility is required to include information required under section 607(b)(2)(D) and (E) for all of the cosmetic products manufactured or processed by the facility if a facility manufactures or processes any of the following cosmetic products:

(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.

(2) Cosmetic products that are injected.

(3) Cosmetic products that are intended for internal use.

(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.


Q9. Where can I submit documentation that my business meets the small business exemption in order to receive an exemption certificate from FDA?


A. FDA is not generally asking companies to submit this information nor does FDA provide small business exemption certificates for cosmetic product facilities or responsible persons.


Q10. Does an importer need to register and/or list under 607 of the FD&C Act?


A. If an importer meets the definition of a facility and/or a responsible person in section 604 of the FD&C Act, and does not meet any exemption, then they must comply with any applicable registration or listing requirements. Otherwise, the importer is not required to register or list.


Q11. Does a laboratory that only performs testing on cosmetic products used for research and development need to register?


A. No. If a laboratory tests cosmetic products that are solely for use in research, development, or evaluation, and that are not offered for retail sale, it does not need to register because it is an establishment that is not included in the definition of facility in section III.B. above (see section 604(3)(B)(vii) of the FD&C Act).


Q12. Does a laboratory that performs cosmetic product batch release testing need to register?


A. Yes. Cosmetic product batch release testing is part of manufacturing and processing. Laboratories conducting this testing are considered facilities subject to the registration requirements.


Q13. My company owns 2 buildings with 2 addresses, and 1 of the buildings is for storage only. Do we need to register the building used only for storage?


A. No. An establishment that solely performs storage (holding) with respect to cosmetic products is not required to register under section 607 of the FD&C Act.


Q14. If a contract manufacturer of cosmetic products is located outside of the United States are they required to be registered with the FDA under section 607 of the FD&C Act? Is there an exemption from registration if the contract manufacturer follows ISO22716?


A. If a contract manufacturer manufactures or processes cosmetic product(s) distributed in the United States, then the contract manufacturing facility must be registered with the FDA, even if the contract manufacturer is located outside of the United States. More information, including on exemptions, are described in section III above. There is not an exemption from registration for following ISO22716.


Q15. Do hair coloring preparations (including hair dyes) need to be listed?


A. Yes. Hair coloring preparations, including hair dyes, are cosmetic products and therefore need to be listed, unless an exemption applies.


Q16. Do hairbrushes and wigs need to be listed?


A. No. We do not expect hairbrushes and wigs to be listed.


Q17. My cosmetic products don’t fit into any of the product categories provided in Appendix A. Therefore, what product category and code should be used?


A. We recommend that you select the product category and code in Appendix A (above) that match most closely and use the “other” category and code if another category and code does not appear to fit. Keep in mind that products intended for use in the eye area should be entered into an eye area product category. FDA intends to periodically update the product categories and codes. Any proposed update to the product categories and codes FDA intends to publish as draft guidance on our website, with a notice in the Federal Register announcing that the draft guidance document is available. After providing an opportunity for public comment on the draft guidance, FDA will: (A) Review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate; (B) Publish a notice in the Federal Register announcing that the guidance document is available; (C) Post the guidance document on the Internet and make it available in hard copy; and (D) Implement the guidance document.


Q18. What is the receipt date for registrations and listings submitted via paper form?


A. When FDA receives a paper submission, the submission is assigned a receipt date. The receipt date for a paper submission is the date on which the submission is deemed to have arrived at FDA. A paper submission is deemed to have arrived at FDA on the date on which it arrived physically at the appropriate receiving unit, while open for business, for the FDA unit that will review the submission. If paper registration and listing forms are mailed, we recommend using a method that includes tracking. FDA encourages electronic submission of registration and listing for cosmetic product facilities and products.


Q19. The cosmetic establishment registration is to be renewed biennially. Does this mean the biennial renewal has to be done every two years from the date of initial registration?


A. Yes, a cosmetic product facility needs to renew its registration every two years from the date of initial registration.



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