Home Cosmetic Science Talk Formulating I manufacture my products at home, how does MoCRA affect me?

  • I manufacture my products at home, how does MoCRA affect me?

    Posted by CzarXavier on May 15, 2024 at 7:43 pm

    I read that we are now required to register our facility, but since my facility is my home do I just register my home or is that no longer legal and will I have to find a lab to manufacture my product for me? Sorry if this has been asked before, I searched the forum but couldn’t find anything.

    • This discussion was modified 3 days, 20 hours ago by  CzarXavier.
    MarkBroussard replied 1 day, 8 hours ago 4 Members · 4 Replies
  • 4 Replies
  • mikethair

    Member
    May 15, 2024 at 8:03 pm

    And exactly where are you located? This makes a difference……different countries have different compliance regulations.

    • CzarXavier

      Member
      May 15, 2024 at 8:20 pm

      I’m in the USA, out of Arizona

  • PhilGeis

    Member
    May 16, 2024 at 6:17 am

    You can find info for small companies on the net - e.g. https://www.modernsoapmaking.com/blog/understanding-the-2022-united-states-cosmetic-regulation-changes-with-mocra

    To your immediate question

    small businesses are fully exempt from facility registration and product listing submission if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make any of the following:

    • cosmetics that come in contact with mucus membranes of the eye
    • cosmetics that are injected
    • cosmetics that are intended for internal use
    • cosmetics that intend to alter the appearance for more than 24 hours

  • MarkBroussard

    Member
    May 18, 2024 at 7:01 am

    @CzarXavier

    As @PhilGeis pointed out, you are probably Small Business Exempt. Your situation is exactly why FDA created the Small Business Exemption … they did not want to have a registry of home-based businesses in FDA Direct, but they could have created a separate SBE Directory.

    You are subject to all other mandates of MoCRA even if SBE. Your products must have Safety Substantiation dossiers - Preservative Challenge Test Results (Passing) + Cosmetic Ingredient Safety Reports (essentially a toxicology profile of each ingredient in your formula). You do not need to conduct Skin Patch Testing if you have a robust CISR. You also must comply with Serious Adverse Event/Adverse Event Reporting & Recordkeeping.

    Reach out to me if you need help with MoCRA compliance.

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