{"product_id":"mocra-small-business-exemption-check","title":"MoCRA Small Business Exemption Check","description":"\u003cp\u003eMoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for certain products such as eye-area, injected or long-lasting products. We check your sales and product range against section 612 and confirm the current threshold at order. £295.\u003c\/p\u003e\u003ch2\u003eWhat is the MoCRA small business exemption?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eFD\u0026amp;C Act section 612\u003c\/strong\u003e, added by \u003cstrong\u003eMoCRA\u003c\/strong\u003e, exempts certain small businesses from \u003cstrong\u003efacility registration\u003c\/strong\u003e and \u003cstrong\u003eproduct listing\u003c\/strong\u003e, and from some GMP requirements. It is based on \u003cstrong\u003eaverage annual gross sales in the US\u003c\/strong\u003e over the previous three years, with a threshold adjusted for inflation, which we \u003cstrong\u003econfirm at order\u003c\/strong\u003e. The exemption does \u003cstrong\u003enot\u003c\/strong\u003e apply to products that contact the eye, are injected, are for internal use, or alter appearance for more than 24 hours. Small businesses must still report serious adverse events, label correctly and keep safety substantiation records.\u003c\/p\u003e\u003ch3\u003eWhat's included in your exemption check?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eSales test\u003c\/strong\u003e: Your average annual US gross sales over three years compared with the current threshold\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct test\u003c\/strong\u003e: Each product checked against the categories that are never exempt\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDuties that still apply\u003c\/strong\u003e: Adverse event reporting, labelling and safety substantiation\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWritten conclusion\u003c\/strong\u003e: Whether you appear exempt from registration and listing\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this check for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eSmall and new brands starting to sell in the US\u003c\/li\u003e\n\u003cli\u003eBrands unsure whether they must register and list\u003c\/li\u003e\n\u003cli\u003eBrands whose US sales are growing\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this check not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLegal advice.\u003c\/strong\u003e This is a regulatory assessment, not a legal opinion.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration or listing.\u003c\/strong\u003e Available separately if you are not exempt.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eVerification of your accounts.\u003c\/strong\u003e We rely on the sales figures you provide.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Small Business Exemption Check work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: US sales for the last three years and your product list.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCheck\u003c\/strong\u003e: We apply the sales and product tests.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive a written conclusion and the duties that still apply.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 612\u003c\/strong\u003e — small business exemptions and excluded products\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605\u003c\/strong\u003e — adverse event reporting still applies\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 608\u003c\/strong\u003e — safety substantiation still applies\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Modernization of Cosmetics Regulation Act of 2022 (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra)\u003c\/li\u003e\n\u003cli\u003e[Registration and Listing of Cosmetic Product Facilities and Products (FDA)](https:\/\/www.fda.gov\/cosmetics\/registration-listing-cosmetic-product-facilities-and-products)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/fr\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/fr\/products\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/mocra-product-listing-volume-plans\"\u003eMoCRA Product Listing — Volume Plans\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":67824342663245,"sku":null,"price":295.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-small-business-exemption-check.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/mocra-small-business-exemption-check","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}