{"product_id":"mocra-essentials-annual-package","title":"MoCRA Essentials Annual Package","description":"\u003cp\u003eMoCRA Essentials is a 12-month package for non-US cosmetic brands. It covers FDA facility registration and renewal management, Phoenix Safety Consultants LLC as US agent, up to 10 product listings with annual updates, one US label and claims review and regulatory alerts, with a 5-business-day response time. FDA issues no certificate. £2,950 a year.\u003c\/p\u003e\u003ch2\u003eWhat does MoCRA require of a non-US cosmetic brand?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eMoCRA\u003c\/strong\u003e requires facility \u003cstrong\u003eregistration\u003c\/strong\u003e (FD\u0026amp;C Act section 607(a)), a \u003cstrong\u003eUS agent\u003c\/strong\u003e for foreign facilities (607(b)) and \u003cstrong\u003eproduct listing\u003c\/strong\u003e with annual updates (607(c)). \u003cstrong\u003eMoCRA Essentials\u003c\/strong\u003e handles these for 12 months through \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e, plus a US label review and regulatory alerts, with work reviewed by \u003cstrong\u003eSyed Muhammad Shamuel Shees, US Regulatory Lead\u003c\/strong\u003e. There is no FDA fee for cosmetic registration or listing.\u003c\/p\u003e\u003ch3\u003eWhat's included in your MoCRA bundle?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFacility registration\u003c\/strong\u003e: Prepared, submitted and renewal managed\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent\u003c\/strong\u003e: Phoenix Safety Consultants LLC named in your registration for 12 months\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct listings\u003c\/strong\u003e: Up to 10 products listed, with annual updates\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel and claims review\u003c\/strong\u003e: One US label reviewed against FDA, FPLA and MoCRA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulatory alerts\u003c\/strong\u003e: Updates on MoCRA rules that affect your products\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponse time\u003c\/strong\u003e: Replies within 5 business days\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this bundle for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eNon-US cosmetic brands with up to 10 US products\u003c\/li\u003e\n\u003cli\u003eAmazon US sellers needing MoCRA compliance\u003c\/li\u003e\n\u003cli\u003eBrands that want one annual fee\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this bundle not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponsible person service.\u003c\/strong\u003e Included in the Professional package.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAdverse event reporting.\u003c\/strong\u003e Included in Professional, or available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSafety substantiation files.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMore than 10 listings or 1 label review.\u003c\/strong\u003e Charged separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA guaranteed FDA date or certificate.\u003c\/strong\u003e FDA processing time varies and is outside our control, so we do not guarantee a date. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Essentials Annual Package work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eOnboarding\u003c\/strong\u003e: Send your facility, product and label details.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: You sign the 12-month package and US agent agreement.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We register your facility and list your products.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThrough the year\u003c\/strong\u003e: Label review, alerts, listing updates and renewal tracking.\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\u003c\/strong\u003e — registration, US agent and product listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 604 and 609\u003c\/strong\u003e — responsible person and label contact\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605 and 608\u003c\/strong\u003e — adverse events and safety substantiation\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-professional-annual-package\"\u003eMoCRA Professional Annual Package\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/mocra-enterprise-annual-package\"\u003eMoCRA Enterprise Annual Package\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/mocra-facility-registration-us-agent-first-year\"\u003eMoCRA Facility Registration + US Agent (First Year)\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":67824343220301,"sku":null,"price":2950.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-essentials-annual-package.webp?v=1793176384","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/mocra-essentials-annual-package","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}