{"product_id":"mocra-facility-registration-us-agent-first-year","title":"MoCRA Facility Registration + US Agent (First Year)","description":"\u003cp\u003eForeign cosmetic facilities must register with the FDA under MoCRA and name a US agent. This package covers both: we prepare and submit your registration through Cosmetics Direct, and Phoenix Safety Consultants LLC acts as your US agent for the first 12 months. There is no FDA fee and FDA issues no certificate. £1,095 for the first year.\u003c\/p\u003e\u003ch2\u003eWhy register and appoint a US agent together?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eMoCRA\u003c\/strong\u003e requires each facility that manufactures or processes cosmetics for the US to \u003cstrong\u003eregister with FDA\u003c\/strong\u003e under \u003cstrong\u003eFD\u0026amp;C Act section 607\u003c\/strong\u003e, and a foreign facility's registration must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e. Doing both together means the registration is submitted once, with the agent already in place. \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e acts as your US agent. There is no government fee.\u003c\/p\u003e\u003ch3\u003eWhat's included in your registration and US agent package?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFacility registration\u003c\/strong\u003e: Prepared and submitted through Cosmetics Direct\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent for 12 months\u003c\/strong\u003e: Phoenix Safety Consultants LLC named as your US agent\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA communications\u003c\/strong\u003e: Received and forwarded to you promptly\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgent agreement\u003c\/strong\u003e: Responsibilities set out in writing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRenewal reminders\u003c\/strong\u003e: US agent renewal each year and registration renewal every two years\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this package for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK, EU and other non-US facilities that manufacture or process cosmetics for the US\u003c\/li\u003e\n\u003cli\u003eBrands with their own production site entering the US\u003c\/li\u003e\n\u003cli\u003eContract manufacturers supplying US brands\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this package not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponsible person duties.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct listings.\u003c\/strong\u003e Each 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 Facility Registration + US Agent work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: Facility, owner or operator, product categories and brands.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: You sign the US agent agreement.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit the registration naming Phoenix Safety Consultants LLC as US agent.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send the registration number when FDA issues it.\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 — facility registration and biennial renewal\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(b)\u003c\/strong\u003e — US agent for foreign facilities\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNo FDA fee\u003c\/strong\u003e for 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=\"\/nl\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/nl\/products\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/us-agent-for-cosmetic-facilities-12-months\"\u003eUS Agent for Cosmetic Facilities (12 Months)\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/mocra-essentials-annual-package\"\u003eMoCRA Essentials Annual Package\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":67824341549133,"sku":null,"price":1095.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-facility-registration-us-agent-first-year.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/mocra-facility-registration-us-agent-first-year","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}