{"product_id":"mocra-cosmetic-facility-registration-with-fda","title":"MoCRA Cosmetic Facility Registration with FDA","description":"\u003cp\u003eUnder MoCRA, every facility that manufactures or processes cosmetics for US distribution must register with the FDA and renew every two years. We prepare and submit your registration through FDA's Cosmetics Direct portal. There is no FDA fee. Foreign facilities also need a US agent. FDA issues no certificate. £795 per facility.\u003c\/p\u003e\u003ch2\u003eWhat is MoCRA facility registration?\u003c\/h2\u003e\u003cp\u003eThe \u003cstrong\u003eModernization of Cosmetics Regulation Act of 2022 (MoCRA)\u003c\/strong\u003e added \u003cstrong\u003esection 607\u003c\/strong\u003e to the US Federal Food, Drug, and Cosmetic Act. It requires each facility that \u003cstrong\u003emanufactures or processes cosmetics\u003c\/strong\u003e for US distribution to register with the \u003cstrong\u003eFDA\u003c\/strong\u003e through \u003cstrong\u003eCosmetics Direct\u003c\/strong\u003e and to \u003cstrong\u003erenew the registration every two years\u003c\/strong\u003e. Facilities outside the US must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e. There is no government fee. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.\u003c\/p\u003e\u003ch3\u003eWhat's included in your facility registration?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eEligibility check\u003c\/strong\u003e: Whether your site manufactures or processes cosmetics and must register\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration preparation\u003c\/strong\u003e: Facility name, address, FEI number, contacts, product categories and brands\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCosmetics Direct submission\u003c\/strong\u003e: Submitted through FDA's portal on your behalf\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent check\u003c\/strong\u003e: Confirms the US agent named for a foreign facility\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecord of submission\u003c\/strong\u003e: The registration number once FDA issues it, and your renewal date\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this facility registration for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eOwners or operators of cosmetic manufacturing or processing facilities outside the US\u003c\/li\u003e\n\u003cli\u003eUK and EU contract manufacturers supplying US brands\u003c\/li\u003e\n\u003cli\u003eBrands that own their own production site\u003c\/li\u003e\n\u003cli\u003eUS facilities that have not yet registered\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this facility registration not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eA US agent.\u003c\/strong\u003e Foreign facilities must name one; Phoenix Safety Consultants LLC can act as your US agent as a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct listings.\u003c\/strong\u003e Each cosmetic product is listed separately by the responsible person.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA registration certificate.\u003c\/strong\u003e FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA guaranteed date.\u003c\/strong\u003e FDA processing time varies and is outside our control, so we do not guarantee a date.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Cosmetic Facility Registration with FDA work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: Facility name and address, owner or operator, FEI or DUNS number if you have one, product categories, brands and US agent details.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCheck and prepare\u003c\/strong\u003e: We check what is needed and prepare the registration.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit through Cosmetics Direct once your information is complete.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send the registration number when FDA issues it and note your two-year renewal date.\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 607(a)\u003c\/strong\u003e — facilities that manufacture or process cosmetics for US distribution must register\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(a)(3)\u003c\/strong\u003e — registrations are renewed every two years\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(b)\u003c\/strong\u003e — foreign facility registrations include a US agent\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 612\u003c\/strong\u003e — some small businesses are exempt, but not for certain product types\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNo FDA fee\u003c\/strong\u003e — no government fee applies to registration\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=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/us-agent-for-cosmetic-facilities-12-months\"\u003eUS Agent for Cosmetic Facilities (12 Months)\u003c\/a\u003e, \u003ca href=\"\/products\/mocra-facility-registration-us-agent-first-year\"\u003eMoCRA Facility Registration + US Agent (First Year)\u003c\/a\u003e, \u003ca href=\"\/products\/mocra-product-listing-volume-plans\"\u003eMoCRA Product Listing — Volume Plans\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":67824338337869,"sku":null,"price":795.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-cosmetic-facility-registration-with-fda.webp?v=1793176384","url":"https:\/\/phoenixcosmeticsafety.com\/products\/mocra-cosmetic-facility-registration-with-fda","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}