{"product_id":"us-responsible-person-for-cosmetics-12-months","title":"US Responsible Person for Cosmetics (12 Months)","description":"\u003cp\u003eUnder MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Safety Consultants LLC can take this role for 12 months, after reviewing your products, and handles product listing duties with you. Serious adverse events must be reported to FDA within 15 business days. £1,950 per year.\u003c\/p\u003e\u003ch2\u003eWhat is a US responsible person for cosmetics?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eMoCRA\u003c\/strong\u003e, the \u003cstrong\u003eresponsible person\u003c\/strong\u003e is the manufacturer, packer or distributor of a cosmetic whose name appears on the label (\u003cstrong\u003eFD\u0026amp;C Act section 604\u003c\/strong\u003e). The label must include a \u003cstrong\u003edomestic US address, phone number or electronic contact\u003c\/strong\u003e for adverse event reports. The responsible person must \u003cstrong\u003elist products\u003c\/strong\u003e with FDA, report \u003cstrong\u003eserious adverse events within 15 business days\u003c\/strong\u003e, keep \u003cstrong\u003erecords for 6 years\u003c\/strong\u003e (3 for small businesses) and hold \u003cstrong\u003esafety substantiation\u003c\/strong\u003e records. \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e can take this role.\u003c\/p\u003e\u003ch3\u003eWhat's included in your responsible person service?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct review\u003c\/strong\u003e: Your products, labels and safety information reviewed before we accept the role\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS label details\u003c\/strong\u003e: Phoenix Safety Consultants LLC's name and US contact for your labels\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct listing role\u003c\/strong\u003e: Listings submitted in the responsible person's name\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAdverse event intake\u003c\/strong\u003e: Reports received at our US contact and passed to you\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWritten agreement\u003c\/strong\u003e: Duties, data you supply and how either side can end the arrangement\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eNon-US cosmetic brands with no US company of their own\u003c\/li\u003e\n\u003cli\u003eBrands selling on Amazon US and other US marketplaces\u003c\/li\u003e\n\u003cli\u003eBrands that need a US address on the label\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eSerious adverse event reports.\u003c\/strong\u003e Investigating and filing reports is our separate Adverse Event Reporting Service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSafety substantiation.\u003c\/strong\u003e The records showing your products are safe are a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProducts sold with drug claims.\u003c\/strong\u003e We may decline products whose claims make them drugs.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eLegal advice.\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Responsible Person for Cosmetics work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your products\u003c\/strong\u003e: Labels, formulas, CPSR or other safety data, and where you sell.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview\u003c\/strong\u003e: We review the products and confirm whether we can act as responsible person.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: You sign the responsible person agreement and update your labels.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCover starts\u003c\/strong\u003e: Our US contact appears on your labels for 12 months.\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 604\u003c\/strong\u003e — definition of responsible person\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605\u003c\/strong\u003e — serious adverse event reporting within 15 business days and record keeping\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(c)\u003c\/strong\u003e — product listing by the responsible person\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 608\u003c\/strong\u003e — safety substantiation records\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 609\u003c\/strong\u003e — label must include domestic contact information\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-serious-adverse-event-reporting-service\"\u003eMoCRA Serious Adverse Event Reporting Service\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/us-cosmetic-safety-substantiation-file-mocra\"\u003eUS Cosmetic Safety Substantiation File (MoCRA)\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/mocra-professional-annual-package\"\u003eMoCRA Professional 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":67824341909581,"sku":null,"price":1950.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-responsible-person-for-cosmetics-12-months.webp?v=1793176386","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/us-responsible-person-for-cosmetics-12-months","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}