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  • MoCRA - Product Registration Requirements

    Posted by MarkBroussard on August 31, 2023 at 8:47 am

    MoCRA: FDA Requirements For Product Registration

    The FDA has released its Draft Guidance To Industry on the requirements for FDA Facility and Product Registration:

    Go here for info on Facility Registration: https://lnkd.in/eabit9pj

    Here’s the information that is MANDATORY to be submitted in your cosmetic product listing:

    (1) The Facility Registration Number of each facility where the cosmetic product is manufactured or processed. If you are using a contract manufacturer, the facility registration number is your contract manufacturer’s FDA Establishment Identifier (FEI) number;

    (2) The name and contact number of the Responsible Person and the name for the cosmetic product, as such name appears on the label;

    (3) The applicable cosmetic category or categories for the cosmetic product; The FDA has a list of 17 different categories of cosmetic products and specific types of products within each category. For example: Category (14) Skin care preparations (creams, lotions, powder, and sprays) (f) Moisturizing

    (4) A list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name (INCI), or by the common or usual name of the ingredient;

    (5) The product listing number, if any previously assigned; You won’t have a previously assigned product listing number since this is a new requirement and listings in the Voluntary (VCRP) will not be carried over into the new Mandatory system

    (6) Type of submission (initial, update to content (annual), abbreviated renewal). Obviously, this will be an initial listing.

    If you have a product that has multiple SKUs that have an identical base formulation and differ only with respect to color, fragrance, flavors or different sizes, then a single listing submission for a cosmetic product is all that is required. So, a Shampoo that has 3 different scents and is offered in 4oz or 8oz sizes only needs to be listed once.

    FDA also requests that the following additional OPTIONAL information be submitted in your product listing:

    - Parent company name (if applicable);
    - Type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
    - Image of the label;
    - Link to your webpage for the product;
    - Whether the cosmetic product is for professional use only;
    - Responsible person DUNS Number (Dun & Bradstreet) for address listed on product label
    - Unique Ingredient Identifiers (UNIIs). This is an FDA identifier number for cosmetic ingredients
    - Additional contact information for individuals associated with the listing.

    If you need assistance with MoCRA compliance, contact Bloom Cosmetic Test Lab ( https://lnkd.in/eV6pp5sJ ) for our MoCRA Compliance Officer service.

    MarkBroussard replied 7 months, 3 weeks ago 1 Member · 0 Replies
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