{"product_id":"us-cosmetic-safety-substantiation-file-mocra","title":"US Cosmetic Safety Substantiation File (MoCRA)","description":"\u003cp\u003eMoCRA requires the responsible person to keep records showing adequate safety substantiation for each cosmetic sold in the US. FDA does not prescribe specific tests and does not require animal testing. We prepare a US safety substantiation file per product: £295 if we already hold your CPSR, or £650 standalone.\u003c\/p\u003e\u003ch2\u003eWhat is MoCRA safety substantiation?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eMoCRA\u003c\/strong\u003e added \u003cstrong\u003esection 608\u003c\/strong\u003e to the \u003cstrong\u003eFD\u0026amp;C Act\u003c\/strong\u003e: the \u003cstrong\u003eresponsible person\u003c\/strong\u003e must ensure, and keep records supporting, that each cosmetic has \u003cstrong\u003eadequate safety substantiation\u003c\/strong\u003e. That means tests, studies, research, analyses or other evidence that qualified experts accept as showing the product is safe under its labelled or customary conditions of use. FDA does not require specific tests or animal testing. A UK or EU \u003cstrong\u003eCPSR\u003c\/strong\u003e is often a strong starting point.\u003c\/p\u003e\u003ch3\u003eWhat's included in your safety substantiation file?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eEvidence review\u003c\/strong\u003e: Formula, ingredient safety data, test results and any existing CPSR\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS ingredient check\u003c\/strong\u003e: Ingredients checked against FDA-prohibited and restricted substances and colour additive rules\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSafety rationale\u003c\/strong\u003e: A written summary of why the product is safe under its labelled conditions of use\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulatory watch notes\u003c\/strong\u003e: Current status of fragrance allergen labelling, talc and PFAS for your product\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecord file\u003c\/strong\u003e: Organised for the responsible person to keep and provide if FDA asks\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this file for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with a UK or EU CPSR expanding to the US\u003c\/li\u003e\n\u003cli\u003eResponsible persons who need substantiation records for each product\u003c\/li\u003e\n\u003cli\u003eBrands using our US Responsible Person service\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this file not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaboratory testing.\u003c\/strong\u003e If evidence is missing, tests are arranged and paid for separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA approval.\u003c\/strong\u003e FDA does not approve cosmetics before sale, and this file is not submitted for approval.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC drug products.\u003c\/strong\u003e Sunscreens and other OTC drugs follow drug rules.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMore than one formula.\u003c\/strong\u003e Each formula needs its own file.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Cosmetic Safety Substantiation File work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eChoose your starting point\u003c\/strong\u003e: We hold your CPSR, or New.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your data\u003c\/strong\u003e: Full formula, supplier data, test results and labels.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview and write\u003c\/strong\u003e: We review the evidence and write the safety rationale.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFile delivered\u003c\/strong\u003e: You receive the file to keep with your MoCRA records.\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 608\u003c\/strong\u003e — adequate safety substantiation and records\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 604\u003c\/strong\u003e — definition of responsible person\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 73, 74, 81, 82\u003c\/strong\u003e — colour additives\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 700\u003c\/strong\u003e — prohibited and restricted cosmetic ingredients\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\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/us-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\u003c\/a\u003e, \u003ca href=\"\/nl\/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":"We hold your CPSR","offer_id":67824342270029,"sku":null,"price":295.0,"currency_code":"GBP","in_stock":true},{"title":"New (standalone)","offer_id":67824691642445,"sku":null,"price":650.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-cosmetic-safety-substantiation-file-mocra.webp?v=1793176386","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/us-cosmetic-safety-substantiation-file-mocra","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}