{"title":"All Services","description":"\u003cp\u003eEvery cosmetic compliance service from Phoenix Cosmetic Safety in one place: CPSR safety assessments, Product Information Files, UK \u0026amp; EU Responsible Person, product notifications, safety data sheets, labelling reviews, stability testing, GPSR and US MoCRA compliance, and regulatory consulting.\u003c\/p\u003e","products":[{"product_id":"cpsr-for-fragrance-products","title":"CPSR Cosmetic Product Safety Reports for Fragrances and Perfumes","description":"\u003cp\u003eYes. Every perfume needs a \u003cstrong\u003efragrance CPSR\u003c\/strong\u003e (Cosmetic Product Safety Report) before it is sold in the UK or EU. Article 10 of \u003cstrong\u003eRegulation (EC) No 1223\/2009\u003c\/strong\u003e, and the same rule in the \u003cstrong\u003eUK Cosmetics Regulation\u003c\/strong\u003e, requires a safety assessment and CPSR for every cosmetic product, and eau de parfum, eau de toilette, body mist and solid perfume are all cosmetics.\u003c\/p\u003e\u003cp\u003eThis single-fragrance CPSR covers one scent. It combines a full toxicological assessment, a check against the current \u003cstrong\u003eIFRA Standards (51st Amendment)\u003c\/strong\u003e and a fragrance allergen review, so your formula is documented and ready for inspection. The IFRA Standards are the fragrance industry's self-regulatory safety standards rather than law, but Safety Assessors and retailers rely on them as evidence that a fragrance is safe. Launching several scents on the same base? Ask us about a Multiple Fragrances CPSR.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eIndependent and artisan perfumers launching a custom scent\u003c\/li\u003e\n\u003cli\u003ePrivate- and white-label makers creating a single fragrance\u003c\/li\u003e\n\u003cli\u003eNew and niche fragrance brands entering the UK or EU market\u003c\/li\u003e\n\u003cli\u003eSellers of an eau de parfum, eau de toilette or body mist\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR Part A — Cosmetic Product Safety Information\u003c\/strong\u003e – Composition (INCI, CAS\/EC numbers, concentrations), impurity screening, physico-chemical and exposure data\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR Part B — Cosmetic Product Safety Assessment\u003c\/strong\u003e – Toxicological evaluation, Margin of Safety, sensitisation and irritancy review, and a signed safety conclusion\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIFRA and allergen compliance report\u003c\/strong\u003e – A check against the IFRA Standards (51st Amendment) for your product category, plus Annex III allergens to declare\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePIF-ready documentation\u003c\/strong\u003e – Editable files ready for your Product Information File and your Responsible Person\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose the number of fragrance products and a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. Multi-product tiers are priced per bundle. Please send your fragrance supplier's IFRA certificate and allergen declaration with the formula.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"1 Fragrance Product \/ Standard Delivery (72 Hours)","offer_id":42151109918797,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"1 Fragrance Product \/ Fast Delivery (48 Hours)","offer_id":42151110574157,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true},{"title":"1 Fragrance Product \/ Priority Delivery (24 Hours)","offer_id":42151111229517,"sku":null,"price":125.0,"currency_code":"GBP","in_stock":true},{"title":"2 Fragrance Products \/ Standard Delivery (72 Hours)","offer_id":43807806586957,"sku":null,"price":146.0,"currency_code":"GBP","in_stock":true},{"title":"2 Fragrance Products \/ Fast Delivery (48 Hours)","offer_id":43807806619725,"sku":null,"price":196.0,"currency_code":"GBP","in_stock":true},{"title":"2 Fragrance Products \/ Priority Delivery (24 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The same rule applies in Great Britain under the GB version of the regulation, as amended by Schedule 34 to SI 2019\/696.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhich CPSR do I need?\u003c\/strong\u003e Choose this page when each product has its own formula, such as a cleanser, a serum and a shampoo: every product receives its own signed report, and the price per report falls as you add products. Choose the \u003ca href=\"\/products\/cosmetic-product-safety-reports-for-beauty-products-multiple-variant\"\u003emulti-variant CPSR\u003c\/a\u003e when the products are shades, scents or sizes of one base formula, and the \u003ca href=\"\/products\/all-in-one-compliance-documentations-cpsr-pif-sds-scpn\"\u003eAll-in-One bundle\u003c\/a\u003e when you also need the PIF, SDS and UK\/EU notification.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eIndie makers and small brands launching their first cosmetic product\u003c\/li\u003e\n\u003cli\u003eEstablished brands adding a new formula to a compliant range\u003c\/li\u003e\n\u003cli\u003eBrands launching several different products, each with its own formula\u003c\/li\u003e\n\u003cli\u003eSellers who need a CPSR to unblock an Amazon, Etsy or Shopify listing\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR Part A — Safety information\u003c\/strong\u003e – Composition, stability, microbiology, impurities, exposure and toxicology for your formula\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR Part B — Safety assessment\u003c\/strong\u003e – The assessor's conclusion, reasoning, label warnings and conditions of use\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQualified Safety Assessor sign-off\u003c\/strong\u003e – Signed by an assessor qualified as Article 10(2) requires\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDigital compliance certificate\u003c\/strong\u003e – A Phoenix certificate confirming the safety assessment is complete\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePIF integration guidance\u003c\/strong\u003e – Where the report sits in the Product Information File your Responsible Person keeps\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend the INCI list with percentages, raw-material SDS, test data and label artwork for each product.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose the number of products and a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. 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Report that covers several shades, tones, finishes, scents or sizes built on the same base formula. Article 10 of \u003cstrong\u003eRegulation (EC) No 1223\/2009\u003c\/strong\u003e, and the same rule in the \u003cstrong\u003eUK Cosmetics Regulation\u003c\/strong\u003e, requires a safety assessment and CPSR for every cosmetic before it is placed on the market. That does not always mean a separate report for every variant.\u003c\/p\u003e\u003cp\u003eThe European Commission's Annex I guidelines (\u003cstrong\u003eImplementing Decision 2013\/674\/EU\u003c\/strong\u003e) allow a combined product safety report for products in the same range where the only difference is the colouring agent and that difference has no impact on safety, such as lipstick or foundation shades. The grouping must be justified, so our Safety Assessor assesses each variant and records why it belongs in the report. A lipstick in twelve shades can then be covered by one consolidated CPSR instead of twelve separate reports.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands selling shade or scent ranges, like lipsticks and foundations\u003c\/li\u003e\n\u003cli\u003ePrivate-label manufacturers producing multi-variant collections\u003c\/li\u003e\n\u003cli\u003eResponsible Persons and importers handling high-volume product lines\u003c\/li\u003e\n\u003cli\u003eOnline sellers whose listings offer several shades, scents or sizes\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR Part A — Safety Information\u003c\/strong\u003e – Composition, stability, toxicology and exposure data for the base formula and every variant\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR Part B — Safety Assessment\u003c\/strong\u003e – A conclusion and Margin of Safety for each variant, signed by a qualified Safety Assessor\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eVariant Summary Sheet\u003c\/strong\u003e – Every shade, tone or scent in the range, listed with its own safety results\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSigned declaration of compliance\u003c\/strong\u003e – A formal statement of compliance covering the whole range\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePIF integration support and digital compliance certificate\u003c\/strong\u003e – PIF-ready output for your Responsible Person and enforcement authorities\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePick the number of variations (same base formula with a colour or essential-oil change) and a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. 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Like every cosmetic, a fragrance must have a PIF before it is placed on the market under \u003cstrong\u003eArticle 11 of Regulation (EC) No 1223\/2009\u003c\/strong\u003e and the \u003cstrong\u003eUK Cosmetics Regulation\u003c\/strong\u003e, and the Responsible Person keeps it for 10 years after the last batch.\u003c\/p\u003e\u003cp\u003eWhat sets a perfume Product Information File apart is the fragrance compound. A single perfume can contain dozens of aroma materials, so the file must show that each restricted material is within the \u003cstrong\u003eIFRA Standards\u003c\/strong\u003e for the product's category, and that every \u003cstrong\u003efragrance allergen\u003c\/strong\u003e above the labelling threshold is declared. We build those records in alongside the CPSR, GMP statement and claim evidence, one PIF per fragrance.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eIndependent perfumers launching a new scent\u003c\/li\u003e\n\u003cli\u003eBrands adding perfumes or body mists to their range\u003c\/li\u003e\n\u003cli\u003ePrivate-label makers documenting fragrances for clients\u003c\/li\u003e\n\u003cli\u003eResponsible Persons preparing a fragrance for inspection\u003c\/li\u003e\n\u003cli\u003eSellers documenting several fragrances in one order\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eIFRA conformity record\u003c\/strong\u003e – Your fragrance house's IFRA certificate filed, with your dose checked against your product's IFRA category limit\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAllergen summary and label check\u003c\/strong\u003e – Annex III fragrance allergens identified, quantified and checked against the ingredient list on the label\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eYour fragrance CPSR, filed and cross-checked\u003c\/strong\u003e – The signed Annex I Parts A and B report, matched to the formula, IFRA and allergen data\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormulation and ingredient data\u003c\/strong\u003e – Full INCI composition with concentrations, CAS and EC numbers and the IFRA product category\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRaw-material SDS\u003c\/strong\u003e – Supplier SDS for the fragrance compound, alcohol and other raw materials\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTesting, GMP and packaging records\u003c\/strong\u003e – Stability, bottle and spray compatibility, and ISO 22716 GMP evidence, in one structured file\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend the INCI list with concentrations, CAS\/EC numbers, the IFRA certificate or allergen breakdown, your CPSR, SDS and label artwork.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose the number of fragrance products and a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. The PIF must be kept available to UK and EU authorities for 10 years after the last batch is placed on the market.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"1 Fragrance Product \/ Standard Delivery (72 Hours)","offer_id":42153554182221,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"1 Fragrance Product \/ Fast Delivery (48 Hours)","offer_id":42153554313293,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true},{"title":"1 Fragrance Product \/ Priority Delivery (24 Hours)","offer_id":42153554444365,"sku":null,"price":125.0,"currency_code":"GBP","in_stock":true},{"title":"2 Fragrance Products \/ Standard Delivery (72 Hours)","offer_id":43809827356749,"sku":null,"price":146.0,"currency_code":"GBP","in_stock":true},{"title":"2 Fragrance Products \/ Fast Delivery (48 Hours)","offer_id":43809827389517,"sku":null,"price":196.0,"currency_code":"GBP","in_stock":true},{"title":"2 Fragrance Products \/ Priority Delivery (24 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Person must keep for every cosmetic product placed on the market. It is required by \u003cstrong\u003eArticle 11 of Regulation (EC) No 1223\/2009\u003c\/strong\u003e in the EU and by the same article of the \u003cstrong\u003eUK Cosmetics Regulation\u003c\/strong\u003e in Great Britain, and it must exist before the product goes on sale.\u003c\/p\u003e\u003cp\u003eThe PIF is the first document an enforcement officer asks to see: in Great Britain, the \u003cstrong\u003eOffice for Product Safety and Standards (OPSS)\u003c\/strong\u003e and local Trading Standards; in the EU, the competent authority of the member state where the file is kept. This page prepares one cosmetic PIF for each product that has its own formula. Order several products together and the price per file falls.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands launching one or more separate cosmetic products\u003c\/li\u003e\n\u003cli\u003eUK importers placing individual cosmetic items on the GB market\u003c\/li\u003e\n\u003cli\u003eResponsible Persons preparing an OPSS or EU inspection file\u003c\/li\u003e\n\u003cli\u003ePrivate-label and contract manufacturers supplying single products\u003c\/li\u003e\n\u003cli\u003eSellers needing files for several different formulas in one order\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct description\u003c\/strong\u003e – Name, product type, function and application site, so the file is clearly attributed to your product\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eYour CPSR, filed and cross-checked\u003c\/strong\u003e – The signed Annex I Parts A and B safety report, checked against the formula, label and PIF data\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eManufacturing method and GMP statement\u003c\/strong\u003e – How the product is made, with your manufacturer's ISO 22716 Good Manufacturing Practice evidence\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClaim and animal-testing records\u003c\/strong\u003e – Evidence for the effects you claim, plus the animal-testing data Article 11 requires\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel verification checklist\u003c\/strong\u003e – Responsible Person, INCI list, warnings, nominal content and batch code checked against Article 19\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStructured digital PIF\u003c\/strong\u003e – One PDF with organised folders, ready for your Responsible Person and for inspection\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend the full formula with INCI percentages, your CPSR, raw-material SDS, label artwork and any test reports you hold.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose the number of products and a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. 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Great Britain applies the same duty through UK REACH and GB CLP. 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Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). 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Under REACH, an SDS is legally required mainly for hazardous substances and mixtures, and finished cosmetics are outside the SDS duty altogether. Even so, marketplaces, retailers and freight forwarders in the UK and EU regularly ask for one before they list or ship a product.\u003c\/p\u003e\u003cp\u003eWe assess your composition against the CLP and GB CLP criteria, then document the conclusion in the 16-section REACH Annex II format, or as a shorter 'not classified' statement where that is what the requester accepts.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK and EU cosmetic brands asked for an SDS by a marketplace\u003c\/li\u003e\n\u003cli\u003eBrands supplying retailers that require an SDS at onboarding\u003c\/li\u003e\n\u003cli\u003eExporters whose freight forwarder wants proof of non-hazardous status\u003c\/li\u003e\n\u003cli\u003eSuppliers checking whether EUH210 belongs on a non-classified mixture\u003c\/li\u003e\n\u003cli\u003eMakers of water-based and other low-risk formulations\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eCLP \/ GB CLP assessment\u003c\/strong\u003e – Your composition checked against every hazard class, plus REACH Article 31(3) triggers\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e16-section non-hazardous SDS\u003c\/strong\u003e – In the EU REACH Annex II format or the GB UK REACH format\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e'Not classified' statement or exemption letter\u003c\/strong\u003e – A shorter document, where your marketplace or buyer accepts one\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTransport status\u003c\/strong\u003e – Section 14 confirming whether ADR, IMDG or IATA rules apply\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNext-step guidance\u003c\/strong\u003e – If the product is classified, we point you to the hazardous SDS and, for the EU, PCN requirements\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eOr send your full composition with percentages, any supplier SDSs, packaging details and the UK or EU buyer that asked.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per product SDS. Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153565913165,"sku":null,"price":45.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153565945933,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153565978701,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Safety_Data_Sheet_for_NON_HAZMAT_UK_EU.webp?v=1789900235"},{"product_id":"safety-data-sheets-for-non-hazmat-products","title":"Safety Data Sheets for NON HAZMAT Products (USA, CA and AU)","description":"\u003cp\u003eA non-hazardous SDS for the USA, Canada and Australia is a safety data sheet for a product that does not meet the GHS criteria for any health, physical or environmental hazard. Workplace chemical laws in all three countries require an SDS only for hazardous chemicals, yet marketplaces, retailers and freight forwarders routinely ask for one before they list or ship a lotion, cream, serum or other everyday product.\u003c\/p\u003e\u003cp\u003eWe assess your composition against the GHS criteria and the dangerous goods rules, then document the result: a 16-section SDS stating that the product is not classified, with the basis for that conclusion, or a shorter non-hazmat exemption letter where that is what your buyer accepts. If the assessment shows the product is hazardous, we tell you and point you to the right hazardous SDS.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eSkincare and cosmetic brands selling in the USA, Canada or Australia\u003c\/li\u003e\n\u003cli\u003eSellers asked for an SDS or exemption sheet before a listing goes live\u003c\/li\u003e\n\u003cli\u003eBrands asked for an SDS by a US, Canadian or Australian retailer\u003c\/li\u003e\n\u003cli\u003eExporters whose freight forwarder wants proof of non-hazmat status\u003c\/li\u003e\n\u003cli\u003eMakers of water-based and other low-risk formulations\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eGHS assessment\u003c\/strong\u003e – Your composition checked against every GHS health, physical and environmental hazard class\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e16-section non-hazardous SDS\u003c\/strong\u003e – In the US, Canadian or Australian format, stating 'not classified' with the basis\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTransport status\u003c\/strong\u003e – Section 14 confirming whether the product is regulated as dangerous goods\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNon-hazmat exemption letter\u003c\/strong\u003e – A shorter confirmation, where your marketplace or buyer accepts one\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eOr send your full composition with percentages, any supplier SDSs, packaging details and who has asked for the SDS.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per product SDS. Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153566371917,"sku":null,"price":45.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153566404685,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153566437453,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Safety_Data_Sheet_for_NON_HAZMAT_USA_AU_CA.webp?v=1789900276"},{"product_id":"safety-data-sheets-for-amazon-uk-products","title":"Safety Data Sheets for Amazon UK Products","description":"\u003cp\u003eAn Amazon UK SDS is a safety data sheet written to Great Britain's chemical rules — UK REACH and GB CLP — for upload in Seller Central once Amazon.co.uk opens a dangerous goods (hazmat) review on an ASIN. Until a usable document is on file, the listing can stay inactive and FBA inbound stock can be held.\u003c\/p\u003e\u003cp\u003eSince 1 January 2021, Great Britain has run its own versions of REACH and CLP, with the Health and Safety Executive (HSE) acting as the Agency for both. A sheet written for the EU, or an OSHA sheet from a US supplier, may carry classifications and supplier details that do not reflect the GB position. We write a GB-specific SDS from your formula so it matches both the law and your Amazon.co.uk listing.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eSellers whose Amazon.co.uk listing is inactive pending hazmat review\u003c\/li\u003e\n\u003cli\u003eFBA sellers with UK inbound shipments on hold for a hazmat check\u003c\/li\u003e\n\u003cli\u003eBrands holding only an EU, US or supplier SDS for a GB listing\u003c\/li\u003e\n\u003cli\u003ePerfume, aerosol, nail and essential oil brands launching on Amazon UK\u003c\/li\u003e\n\u003cli\u003eImporters and private-label sellers placing products on the GB market\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eGB CLP hazard classification\u003c\/strong\u003e – GB CLP hazard classes with matching hazard (H) and precautionary (P) phrases, pictograms and signal word\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e16-section SDS to UK REACH Annex II\u003c\/strong\u003e – Written in English, with the GB supplier and emergency contact details you give us\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 14 transport entry\u003c\/strong\u003e – UN number, class and packing group where the product is regulated for transport, or a 'not regulated' statement\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUpload-ready PDF for Seller Central\u003c\/strong\u003e – Trade name and brand matched to your Amazon.co.uk detail page\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDocumented non-hazardous outcome\u003c\/strong\u003e – If the formula meets no GB CLP hazard criteria, the SDS records that conclusion for Amazon's reviewers\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eList every ingredient with its percentage, attach supplier SDSs and give the Amazon.co.uk ASINs that were flagged.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per product SDS. Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. Amazon makes its own classification decision; we revise the SDS free if a point is raised about the sheet itself.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153566502989,"sku":null,"price":45.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153566535757,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153566568525,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Safety_Data_Sheet_for_Amazon_UK_Region.webp?v=1789900308"},{"product_id":"safety-data-sheets-for-amazon-ca-products","title":"Safety Data Sheets for Amazon CA Products","description":"\u003cp\u003eAn Amazon Canada SDS is a Canadian safety data sheet built around WHMIS — Canada's Workplace Hazardous Materials Information System, set out in the Hazardous Products Act and the Hazardous Products Regulations (SOR\/2015-17) — for upload when Amazon.ca places a product in dangerous goods (hazmat) review. Health Canada administers these supplier rules.\u003c\/p\u003e\u003cp\u003eTwo requirements set a Canadian sheet apart from a US one. Every information element must be in both English and French, and Section 1 must identify the Canadian manufacturer or Canadian importer rather than a foreign supplier. An English-only OSHA sheet from your Amazon.com listing meets neither, so we prepare a WHMIS version for Amazon.ca.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eSellers with an Amazon.ca listing inactive pending hazmat review\u003c\/li\u003e\n\u003cli\u003eUS sellers adding Amazon.ca with an English-only OSHA sheet\u003c\/li\u003e\n\u003cli\u003eUK and EU brands entering Canada through a Canadian importer\u003c\/li\u003e\n\u003cli\u003eFBA sellers with shipments to Canadian fulfilment centres on hold\u003c\/li\u003e\n\u003cli\u003eSellers whose SDS predates the December 2022 HPR amendments\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eWHMIS hazard classification\u003c\/strong\u003e – WHMIS hazard classes and categories, with the label elements required by the Hazardous Products Regulations as amended in 2022\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEnglish and French text\u003c\/strong\u003e – One bilingual sheet, or two matching unilingual versions supplied together\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSchedule 1 section layout\u003c\/strong\u003e – The 16 headings and information elements required by Schedule 1 to the HPR\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInitial supplier identifier\u003c\/strong\u003e – Section 1 completed with the Canadian manufacturer or importer you name\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePDF matched to Amazon.ca\u003c\/strong\u003e – Product name and brand aligned with your Amazon.ca detail page, ready to upload\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eProvide the formula, supplier SDSs, the Amazon.ca ASINs and your Canadian importer's name, address and phone number.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per product SDS. Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. Amazon makes its own classification decision; we revise the SDS free if a point is raised about the sheet itself.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153566863437,"sku":null,"price":45.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153566896205,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153566928973,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Safety_Data_Sheet_for_Amazon_Canada_Region.webp?v=1789900525"},{"product_id":"scpn-product-notification-for-single-variant","title":"UK SCPN Product Notification for UK Cosmetic Products","description":"\u003cp\u003eAn \u003cstrong\u003eSCPN notification\u003c\/strong\u003e is the pre-market notification of a cosmetic product on \u003cstrong\u003eSubmit Cosmetic Product Notifications (SCPN)\u003c\/strong\u003e, the UK government service run by the \u003cstrong\u003eOffice for Product Safety and Standards (OPSS)\u003c\/strong\u003e. Under \u003cstrong\u003eArticle 13 of Regulation (EC) No 1223\/2009\u003c\/strong\u003e as it applies in Great Britain, the Responsible Person must notify the Secretary of State electronically before a cosmetic is placed on the GB market. SCPN replaced the EU's CPNP for the GB market from 1 January 2021.\u003c\/p\u003e\u003cp\u003eAn SCPN notification is not a product approval: the Responsible Person stays legally responsible for the product's safety. The notification gives enforcement authorities the information they need for market surveillance, and the Secretary of State shares it with the UK National Poisons Information Service so doctors can treat poisoning cases. SCPN covers England, Scotland and Wales; Northern Ireland follows the EU rules and uses the CPNP.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK brand owners launching a new cosmetic product\u003c\/li\u003e\n\u003cli\u003eImporters bringing EU or non-UK cosmetics into Great Britain\u003c\/li\u003e\n\u003cli\u003eResponsible Persons managing notifications for several brands\u003c\/li\u003e\n\u003cli\u003ePrivate-label and white-label companies launching a single SKU\u003c\/li\u003e\n\u003cli\u003eBrands relisting a product after a reformulation or rebrand\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePre-submission data check\u003c\/strong\u003e – Product name, category, formulation and Responsible Person details checked against your CPSR and PIF\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel and packaging upload\u003c\/strong\u003e – Your original labelling and, where legible, a packaging photograph prepared as Article 13 requires\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSCPN submission\u003c\/strong\u003e – The notification completed and submitted on SCPN for your UK Responsible Person\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmission confirmation\u003c\/strong\u003e – Evidence of the notification and its date for your Responsible Person and PIF records\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHelp with authority queries\u003c\/strong\u003e – Support with any information gaps or questions about the notification\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend your product name, INCI list with percentages, Responsible Person details, label artwork and a packaging photograph.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per product notification. Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. A UK Responsible Person must be in place first; we can act as that person under our UK RP service.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153567387725,"sku":null,"price":35.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153567420493,"sku":null,"price":45.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153567453261,"sku":null,"price":55.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/UK_SCPN_Notifications_for_Cosmetic_Products.webp?v=1789901156"},{"product_id":"toxicological-risk-assessment-for-fragrances","title":"Toxicological Risk Assessment (TRA) for Fragrances","description":"\u003cp\u003eA \u003cstrong\u003efragrance toxicological risk assessment\u003c\/strong\u003e is a scientific evaluation of the aroma chemicals, essential oils and natural extracts in a perfume or fragrance compound, showing that each is safe at the level and in the way consumers use it. Fragrance materials carry risks that most other ingredients do not: skin sensitisation, declarable allergens and materials restricted by the IFRA Standards.\u003c\/p\u003e\u003cp\u003eThe assessment supplies the toxicology that a perfume's cosmetic product safety report (CPSR) must contain under Article 10 and Annex I of Regulation (EC) No 1223\/2009 and its GB version. It is not a substitute for that report. Unlike a general ingredient TRA, it treats sensitisation as the primary endpoint and checks every component against IFRA limits and the Annex III allergen list.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003ePerfume and eau de parfum brands preparing a fragrance CPSR\u003c\/li\u003e\n\u003cli\u003eBody mist and hair mist launches\u003c\/li\u003e\n\u003cli\u003eBrands buying fragrance oils from a fragrance house\u003c\/li\u003e\n\u003cli\u003eBrands moving a fragrance into a new IFRA product category\u003c\/li\u003e\n\u003cli\u003eNot for launch on its own: a perfume on sale needs a full CPSR\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eSigned component-level summary\u003c\/strong\u003e – Every fragrance material analysed, signed by a qualified Safety Assessor\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSensitisation assessment\u003c\/strong\u003e – Skin sensitisation risk for each sensitising material at your dose and product type\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIFRA conformity check\u003c\/strong\u003e – Restricted materials checked against the IFRA limit for your product category\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAllergen summary\u003c\/strong\u003e – Declarable Annex III fragrance allergens identified and quantified in the finished product\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMargin of Safety table\u003c\/strong\u003e – NOAEL, SED and MoS for components with systemic toxicity data\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR-ready format\u003c\/strong\u003e – Laid out to slot into Part A of your fragrance CPSR\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eTell us about the product and upload the fragrance documents listed below.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153590947917,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153590980685,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153591013453,"sku":null,"price":150.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Toxicological_Risk_Assessment_for_Fragrance_Products_TRA.webp?v=1789901286"},{"product_id":"toxicological-risk-assessment-for-beauty-products","title":"Toxicological Risk Assessment (TRA) for Beauty Products","description":"\u003cp\u003eA \u003cstrong\u003etoxicological risk assessment for cosmetics\u003c\/strong\u003e (TRA) is the scientific evaluation of whether each ingredient in a product is safe at the concentration used and in the way consumers are exposed to it. It identifies each ingredient's hazards, estimates how much reaches the body, and compares the two using the Margin of Safety.\u003c\/p\u003e\u003cp\u003eA TRA is one part of the cosmetic product safety report (CPSR), not a substitute for it. Annex I of Regulation (EC) No 1223\/2009, in both its EU and GB versions, requires the CPSR to cover exposure to the product and its substances and the toxicological profile of each substance, including the Margin of Safety. The TRA supplies exactly that evidence, which the safety assessor then relies on for the Part B conclusion.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands checking a draft formula before ordering the full CPSR\u003c\/li\u003e\n\u003cli\u003eFormulators testing whether a higher ingredient level is still safe\u003c\/li\u003e\n\u003cli\u003eSkincare, haircare and make-up brands selling in the UK or EU\u003c\/li\u003e\n\u003cli\u003eNot for launch on its own: a product on sale needs a full CPSR\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eSigned toxicological summary report\u003c\/strong\u003e – Every ingredient analysed and the report signed by a qualified Safety Assessor\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMargin of Safety table\u003c\/strong\u003e – NOAEL, Systemic Exposure Dose (SED) and MoS set out for each relevant ingredient\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eExposure assessment\u003c\/strong\u003e – Exposure modelled for your product category, application area, frequency and leave-on or rinse-off use\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormulation safety conclusion\u003c\/strong\u003e – A consolidated judgement on whether the formula is toxicologically safe for its intended use\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR-ready format\u003c\/strong\u003e – Laid out to match the exposure and toxicology sections of CPSR Part A\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eGive us your product details and upload your formula and raw-material data.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153591078989,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153591111757,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153591144525,"sku":null,"price":150.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Toxicological_Risk_Assessment_for_Beauty_Products_TRA.webp?v=1789901409"},{"product_id":"cpnp-product-notification-for-single-variant","title":"EU CPNP Product Notifications for EU Cosmetic Products","description":"\u003cp\u003eA \u003cstrong\u003eCPNP notification\u003c\/strong\u003e is the pre-market notification of a cosmetic on the \u003cstrong\u003eCosmetic Products Notification Portal (CPNP)\u003c\/strong\u003e, the European Commission's free online notification system. \u003cstrong\u003eArticle 13 of Regulation (EC) No 1223\/2009\u003c\/strong\u003e requires the Responsible Person to submit it electronically before the product is placed on the EU market. The Commission makes the data available to national competent authorities for market surveillance and to poison centres for medical treatment.\u003c\/p\u003e\u003cp\u003eA notification is not a product approval. The EU has no pre-market authorisation for cosmetics, and safety remains the Responsible Person's legal duty. One CPNP notification covers the whole EU single market, and the portal is also used for EEA countries and for products placed on the Northern Ireland market. Selling in Great Britain too? You also need a separate \u003ca href=\"\/products\/scpn-product-notification-for-single-variant\"\u003eUK SCPN notification\u003c\/a\u003e.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands launching a single cosmetic product in the EU\u003c\/li\u003e\n\u003cli\u003eUK and other non-EU brands that already have an EU Responsible Person\u003c\/li\u003e\n\u003cli\u003eBrands supplying Northern Ireland, which also uses the CPNP\u003c\/li\u003e\n\u003cli\u003eEU Responsible Persons who want a notification handled for them\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePre-submission document review\u003c\/strong\u003e – Your CPSR, PIF, label artwork and packaging photo checked against Annex I and Annexes II–VI\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFull CPNP portal entry\u003c\/strong\u003e – Category, name, Responsible Person, country of origin, frame formulation or composition, nanomaterials and CMRs\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel and packaging upload\u003c\/strong\u003e – Your original labelling and a photograph of the packaging, as Article 13(2) requires\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPNP notification reference number\u003c\/strong\u003e – Confirmation that your product has been notified on the portal\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCompliance summary\u003c\/strong\u003e – A record of the notification for your files and your retailers\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend your CPSR, PIF, label artwork, a packaging photo and your EU Responsible Person's details.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per product notification. Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. Your EU Responsible Person must be in place first; we can act as that person under our EU RP service.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153591373901,"sku":null,"price":35.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153591406669,"sku":null,"price":45.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153591439437,"sku":null,"price":55.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/EU_CPNP_Notifications_for_Cosmetic_Products.webp?v=1789901887"},{"product_id":"label-design-for-beauty-products","title":"Fragrance and Cosmetic Products Labelling \u0026 Packaging Design","description":"\u003cp\u003eCompliant cosmetic label design is the creation of new label artwork that meets Article 19 of Regulation (EC) No 1223\/2009 in the EU and Northern Ireland, and the UK Cosmetics Regulation in Great Britain, while presenting your brand the way you want. A cosmetic label is a legal document as well as a sales tool, and the Responsible Person is accountable for every particular on it.\u003c\/p\u003e\u003cp\u003eOur designers and regulatory specialists work from your verified formula, CPSR and Responsible Person data, so compliance is built in from the first draft rather than fixed after print. Already have finished artwork that only needs checking? Use our \u003ca href=\"\/products\/label-and-packaging-review\"\u003eLabel \u0026amp; Packaging Review\u003c\/a\u003e instead.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands launching a first skincare, haircare or fragrance product\u003c\/li\u003e\n\u003cli\u003eBrands with a finished formula but no label artwork yet\u003c\/li\u003e\n\u003cli\u003eSmall containers that need a peel-off label, tag or leaflet\u003c\/li\u003e\n\u003cli\u003eBrands selling into the EU that need multilingual labels\u003c\/li\u003e\n\u003cli\u003eBrands rebranding or adding new shades, scents or sizes\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrint-ready artwork\u003c\/strong\u003e – Label files in AI, PDF and PNG formats, ready for your printer\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eArticle 19 compliance checklist\u003c\/strong\u003e – Each mandatory particular confirmed for the UK, the EU or both\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eVerification certificate\u003c\/strong\u003e – Confirms the artwork matches your Responsible Person and PIF data\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePackaging materials guidance\u003c\/strong\u003e – Advice on label stock and finishes that stay legible through use\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eWe confirm your container, label size and markets (UK, EU or both) and collect your brand assets, formula, Responsible Person and claims data.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a turnaround: Standard (7 days), Fast (4 days) or Priority (2 days). The turnaround starts once we have your brand assets, the final text and the INCI list. We confirm the number of revision rounds and the file formats when we start the brief.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (7 Days)","offer_id":42153613754445,"sku":null,"price":55.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (4 Days)","offer_id":42153613787213,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (2 Days)","offer_id":42153613819981,"sku":null,"price":105.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Fragrance_and_Cosmetic_Products_Labelling_Packaging_Design.webp?v=1789928738"},{"product_id":"label-and-packaging-review","title":"Cosmetic Products Labelling \u0026 Packaging Review","description":"\u003cp\u003eA cosmetic label compliance review is an independent audit of label and packaging artwork you already have, checked against Article 19 of Regulation (EC) No 1223\/2009 in the EU and Northern Ireland, and against the same article of the UK Cosmetics Regulation in Great Britain. Article 19 sets out the particulars every cosmetic container and outer pack must show, in indelible, easily legible and visible lettering.\u003c\/p\u003e\u003cp\u003eThe review is for existing artwork: we audit it and tell you exactly what to fix. If you have no artwork yet and need it created from scratch, use our \u003ca href=\"\/products\/label-design-for-beauty-products\"\u003eLabel \u0026amp; Packaging Design\u003c\/a\u003e service instead.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with finished artwork that has not yet gone to print\u003c\/li\u003e\n\u003cli\u003eImporters checking Responsible Person and country-of-origin details\u003c\/li\u003e\n\u003cli\u003eSellers moving from the UK into the EU, or from the EU into the UK\u003c\/li\u003e\n\u003cli\u003eBrands preparing for an OPSS or Trading Standards enquiry\u003c\/li\u003e\n\u003cli\u003eAnyone unsure whether a label already on sale meets the rules\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel Compliance Report\u003c\/strong\u003e – The status of every Article 19 particular and packaging check on your artwork\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCorrective action list\u003c\/strong\u003e – What to change, element by element, before the label goes to print\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLegal reference for each finding\u003c\/strong\u003e – The article, annex or standard behind every issue we raise\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClaims and symbols check\u003c\/strong\u003e – Claims tested against Article 20; PAO and other symbols verified\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUK and EU market check\u003c\/strong\u003e – Language, Responsible Person and origin details checked for each market\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003ePrices are per label (one SKU). Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153614082125,"sku":null,"price":55.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153614114893,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153614147661,"sku":null,"price":95.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Cosmetic_Products_Labelling_Packaging_Review.webp?v=1789902031"},{"product_id":"product-formulation-review","title":"Cosmetic Product Formulation Review","description":"\u003cp\u003eA cosmetic formulation review is an early-stage diagnostic check of a draft or existing formula. It tests whether every ingredient is permitted, used within its legal limit and suitable for the intended product type, and it tells you what to change before you commission a Cosmetic Product Safety Report (CPSR).\u003c\/p\u003e\u003cp\u003eThe ingredient rules sit in Regulation (EC) No 1223\/2009, which applies in the EU and, as amended for Great Britain, in GB. Its annexes list prohibited substances (Annex II), restricted substances (Annex III) and the only colourants, preservatives and UV filters allowed (Annexes IV–VI). \u003cstrong\u003eReview or validation?\u003c\/strong\u003e Choose a review while the formula can still change; if your formula is finished and you need a documented pass before the CPSR, choose \u003ca href=\"\/products\/product-formulation-validation\"\u003eformulation compliance validation\u003c\/a\u003e instead.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with a draft formula not yet sent for a CPSR\u003c\/li\u003e\n\u003cli\u003eBrands changing an existing formula, ingredient or supplier\u003c\/li\u003e\n\u003cli\u003ePrivate-label producers checking a manufacturer's formula\u003c\/li\u003e\n\u003cli\u003eFormulators and laboratories wanting an independent compliance check\u003c\/li\u003e\n\u003cli\u003eResponsible Persons who need ingredient data before a CPSR\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eIngredient compliance summary\u003c\/strong\u003e – INCI name, CAS\/EC number, function, permitted limit and UK\/EU status for each ingredient\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAnnex II–VI cross-reference table\u003c\/strong\u003e – Every prohibited or restricted entry that affects your formula, with its conditions and maximum concentration\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecommendations report\u003c\/strong\u003e – Each problem explained, with the concentration change, substitution or label warning that fixes it\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAllergen and IFRA summary\u003c\/strong\u003e – For fragranced products: allergens above the labelling threshold and IFRA category limits\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR-ready ingredient data file\u003c\/strong\u003e – Your ingredient data structured for Part A of the CPSR once the fixes are made\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend your formula with INCI names and exact percentages, any fragrance composition, and the product type and intended use.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153615491149,"sku":null,"price":50.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153615523917,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153615556685,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Cosmetic_Product_Formulation_Review.webp?v=1789902277"},{"product_id":"product-formulation-validation","title":"Cosmetic Formulation Compliance Validation","description":"\u003cp\u003eFormulation compliance validation is the final compliance sign-off of a finished cosmetic formula, carried out just before the Cosmetic Product Safety Report (CPSR). It confirms that each ingredient, concentration and intended use meets the ingredient rules of Regulation (EC) No 1223\/2009 in the EU and Great Britain, and records the result in a validation report.\u003c\/p\u003e\u003cp\u003eThe report gives your safety assessor checked data for Part A of the CPSR (composition, stability, microbiological quality and exposure) and gives the Responsible Person a record for the Product Information File (PIF). \u003cstrong\u003eValidation or review?\u003c\/strong\u003e Choose validation when the formula is final; if it may still change or you suspect problems, start with a \u003ca href=\"\/products\/product-formulation-review\"\u003ecosmetic formulation review\u003c\/a\u003e, which recommends fixes.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with a finished formula ready for its CPSR\u003c\/li\u003e\n\u003cli\u003eManufacturers signing off a formula before production\u003c\/li\u003e\n\u003cli\u003ePrivate-label producers validating a supplier's formula\u003c\/li\u003e\n\u003cli\u003eImporters checking a formula made outside the UK or EU\u003c\/li\u003e\n\u003cli\u003eResponsible Persons compiling the Product Information File\u003c\/li\u003e\n\u003cli\u003eCosmetic chemists wanting independent sign-off before toxicology\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormulation validation report\u003c\/strong\u003e – Ingredient-by-ingredient record of identity, function, concentration and compliance status\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eValidation outcome\u003c\/strong\u003e – A clear pass, or a list of non-conformities to close before the CPSR\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAnnex II–VI validation\u003c\/strong\u003e – Prohibited, restricted, colourant, preservative and UV-filter limits confirmed for your product type\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eToxicological summary\u003c\/strong\u003e – SCCS opinions and NOAEL data noted so your safety assessor can calculate the Margin of Safety\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFragrance-allergen validation\u003c\/strong\u003e – IFRA certificate and Annex III allergen thresholds confirmed against your label list\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFinished-product data review\u003c\/strong\u003e – Your pH, stability and challenge-test results checked against the intended use\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend your final formula (INCI names and exact percentages), the product type and intended use, and any supporting data you hold.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":42153615622221,"sku":null,"price":55.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":42153615654989,"sku":null,"price":75.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":42153615687757,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/Cosmetic_Formulation_Compliance_Validation.webp?v=1789902325"},{"product_id":"product-validation-for-restricted-ingredients","title":"Restricted Ingredients Compliance \u0026 Validation","description":"\u003cp\u003eA \u003cstrong\u003erestricted ingredients check\u003c\/strong\u003e is a focused review of named ingredients in a cosmetic formula against the UK and EU lists of banned and restricted substances. It confirms that each ingredient is not prohibited under \u003cstrong\u003eAnnex II of Regulation (EC) No 1223\/2009\u003c\/strong\u003e, and that any ingredient listed in \u003cstrong\u003eAnnex III\u003c\/strong\u003e, or any colourant, preservative or UV filter in \u003cstrong\u003eAnnexes IV–VI\u003c\/strong\u003e, is used within its maximum concentration, in a permitted product type and with the required warnings. \u003cstrong\u003eArticle 14\u003c\/strong\u003e makes these restrictions binding in the EU and, under the GB version of the regulation, in Great Britain.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhich service do I need?\u003c\/strong\u003e Choose this check when your concern is a few named ingredients. If you want the whole formula screened and fixed while it can still change, choose a \u003ca href=\"\/products\/product-formulation-review\"\u003ecosmetic formulation review\u003c\/a\u003e; if your formula is finished and needs a documented final pass before the CPSR, choose \u003ca href=\"\/products\/product-formulation-validation\"\u003eformulation compliance validation\u003c\/a\u003e.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eFormulators checking a specific ingredient or concentration\u003c\/li\u003e\n\u003cli\u003eBrands with a preservative, colourant or UV filter close to its limit\u003c\/li\u003e\n\u003cli\u003eBrands importing a third-party formula who want a quick legality check\u003c\/li\u003e\n\u003cli\u003eSellers answering a retailer or marketplace query about a substance\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eRestricted-ingredient validation table\u003c\/strong\u003e – Each ingredient checked, with its annex reference, limit, conditions of use and status\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNotes on flagged substances\u003c\/strong\u003e – What is wrong and what would bring each flagged ingredient within its limit\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGB and EU comparison\u003c\/strong\u003e – Any difference between the Great Britain and EU annex entries for the ingredients checked\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR-ready summary\u003c\/strong\u003e – A short summary of the ingredients reviewed, ready to pass to your Safety Assessor\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSend your INCI list with percentages, the product type, how it is used and which ingredients concern you.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). 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After checkout we email you a booking link to choose a time. If you need longer, see our Brand Launch or Enterprise consultations, which offer 60 to 240 minutes.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":42153616769101,"sku":null,"price":100.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/30-Minute_Expert_Consultation_for_EU_UK_and_USA_Regulations.webp?v=1789902418"},{"product_id":"brand-startup-consultation","title":"Cosmetic \u0026 Fragrance Brand Launch Consultation","description":"\u003cp\u003eA cosmetic brand launch consultation is a guided planning session for founders that sets out, in order, everything a new cosmetic or fragrance brand must have in place before its first product is sold in the UK, EU or US. It answers the question most founders start with: how do I start a cosmetic brand legally, and what do I need to do first?\u003c\/p\u003e\u003cp\u003eWe combine toxicology, cosmetic chemistry and regulatory knowledge to turn the rules into a practical launch plan: which documents you need, who must sign them, what your label must say and which notification portal applies. The aim is a compliance system your team understands and can keep running after launch.\u003c\/p\u003e\u003ch3\u003eWho it's for\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eFounders launching their first skincare, haircare or cosmetic brand\u003c\/li\u003e\n\u003cli\u003eFragrance developers preparing a compliant first collection\u003c\/li\u003e\n\u003cli\u003ePrivate-label brands putting their name on a stock formula\u003c\/li\u003e\n\u003cli\u003eIndie makers moving from craft fairs to retail or online\u003c\/li\u003e\n\u003cli\u003eUK start-ups planning their first EU or US sales\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eYour launch roadmap\u003c\/strong\u003e – The five stages from classification to notification, in order, for your products and markets\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCPSR roadmap\u003c\/strong\u003e – What your safety assessor will need from you and when to commission the report\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePIF setup guidance and templates\u003c\/strong\u003e – How to structure your Product Information File, with start-up templates\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel feedback\u003c\/strong\u003e – Comments on your artwork, INCI list and mandatory statements against Article 19\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTesting recommendations\u003c\/strong\u003e – Which stability, microbiological, challenge and tolerance tests your products are likely to need\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNotification checklist\u003c\/strong\u003e – What you need ready for CPNP (EU) or SCPN (GB) notification\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat we need from you\u003c\/h3\u003e\u003cp\u003eSelect 30, 60, 120 or 240 minutes above, depending on how much of your launch you want to cover.\u003c\/p\u003e\u003ch3\u003eTurnaround and price\u003c\/h3\u003e\u003cp\u003eChoose a session length: 30, 60, 120 or 240 minutes. 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A manufacturer based outside the EU, including in Great Britain, the US or elsewhere, must designate an EU-established person by written mandate. Phoenix acts as your EU Responsible Person across CPNP notification, PIF management, label checks and post-market surveillance. Selling in Great Britain too? 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Without it, the ASIN can stay blocked from sale or kept out of fulfilment centres in that country.\u003c\/p\u003e\u003cp\u003eWhat sets the EU apart is language. REACH requires the SDS in an official language of each member state where the product is placed on the market, unless that country provides otherwise. 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Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. 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Choose a turnaround: Standard (72 hours), Fast (48 hours) or Priority (24 hours). The turnaround starts once we have your complete formula and supporting documents; only the delivery speed changes the price. 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The turnaround starts once we have complete information; FDA processing then follows on its own timeline.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Standard Delivery (72 Hours)","offer_id":43230347165773,"sku":null,"price":185.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (48 Hours)","offer_id":43230347198541,"sku":null,"price":225.0,"currency_code":"GBP","in_stock":true},{"title":"Priority Delivery (24 Hours)","offer_id":43230347231309,"sku":null,"price":280.0,"currency_code":"GBP","in_stock":true}]},{"product_id":"eu-gpsr-compliance-sanitary-pads-tampons-menstrual-products","title":"EU GPSR Compliance for Menstrual \u0026 Intimate Hygiene Products","description":"\u003cdiv style=\"border: 2px solid #E8622C; background: #FDEDE4; padding: 16px 20px; margin: 16px 0;\"\u003e\n\u003cp style=\"margin: 0 0 6px; font-weight: bold; letter-spacing: 1px; text-transform: uppercase; font-size: 12px; color: #e8622c;\"\u003eQuick answer\u003c\/p\u003e\n\u003cp style=\"margin: 0; font-size: 16px; color: #1b2a41; line-height: 1.5;\"\u003eMost menstrual and intimate hygiene products are consumer products under the EU General Product Safety Regulation (EU) 2023\/988, which requires an internal risk analysis, technical documentation and traceability labelling. Some products, such as certain menstrual cups or products with medical claims, may be classed as medical devices, and some countries add their own rules. We prepare the GPSR risk assessment and technical documentation and review your labels and listings. £350 per product.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003ch2\u003eWhat is GPSR compliance for menstrual and intimate hygiene products?\u003c\/h2\u003e\n\u003cp\u003eMost sanitary pads, liners, tampons and period underwear sold in the EU or Northern Ireland are consumer products under the General Product Safety Regulation (EU) 2023\/988. Manufacturers must carry out an internal risk analysis, keep technical documentation for 10 years and label products so they can be traced. Some products, such as certain menstrual cups or products with medical claims, may be regulated as medical devices, and some countries have specific national rules for menstrual products. 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We confirm the delivery date when we have your documents; the documentation is delivered by email for you to keep on file.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":50528598818893,"sku":null,"price":330.0,"currency_code":"GBP","in_stock":true}]},{"product_id":"stability-testing-for-cosmetic-compliance","title":"Stability Testing for EU and UK Cosmetic Compliance","description":"\u003cp\u003eStability testing shows that your cosmetic stays safe and keeps its intended quality in its final packaging over its shelf life. 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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"},{"product_id":"mocra-cosmetic-facility-registration-renewal","title":"MoCRA Cosmetic Facility Registration Renewal","description":"\u003cp\u003eMoCRA requires cosmetic facility registrations to be renewed with the FDA every two years. We check your existing registration in Cosmetics Direct, update any changed details, such as products, brands or your US agent, and submit the renewal. There is no FDA fee and FDA issues no certificate. £450 per facility.\u003c\/p\u003e\u003ch2\u003eWhat is MoCRA registration renewal?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003esection 607(a)(3)\u003c\/strong\u003e of the \u003cstrong\u003eFD\u0026amp;C Act\u003c\/strong\u003e, added by \u003cstrong\u003eMoCRA\u003c\/strong\u003e, a cosmetic facility registration must be \u003cstrong\u003erenewed every two years\u003c\/strong\u003e. Cosmetics Direct now shows a registration status and renewal date for each facility. Renewal is a chance to correct details such as categories, brands and the \u003cstrong\u003eUS agent\u003c\/strong\u003e for foreign facilities. There is no government fee.\u003c\/p\u003e\u003ch3\u003eWhat's included in your registration renewal?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration review\u003c\/strong\u003e: Your current Cosmetics Direct record checked against your current details\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUpdates\u003c\/strong\u003e: Changed addresses, contacts, categories, brands or US agent entered\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRenewal submission\u003c\/strong\u003e: Submitted through Cosmetics Direct\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNext renewal date\u003c\/strong\u003e: Recorded and sent to you\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this renewal for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eFacilities that registered under MoCRA two years ago\u003c\/li\u003e\n\u003cli\u003eFacilities that registered elsewhere and want us to manage renewals\u003c\/li\u003e\n\u003cli\u003eFacilities whose details or US agent have changed\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this renewal not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eA first-time registration.\u003c\/strong\u003e New facilities need our MoCRA Facility Registration service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent services.\u003c\/strong\u003e Available separately from Phoenix Safety Consultants LLC.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct listing updates.\u003c\/strong\u003e Annual listing updates are separate.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA certificate or a guaranteed date.\u003c\/strong\u003e FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval. 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 Renewal work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: Your registration number and Cosmetics Direct access, or permission to act for you, plus any changes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview\u003c\/strong\u003e: We compare your record with your current details.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit the renewal with any updates.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send confirmation and your next 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)(3)\u003c\/strong\u003e — biennial renewal of facility registration\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(a)(4)\u003c\/strong\u003e — updates within 60 days of changes\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(b)\u003c\/strong\u003e — US agent for foreign facilities\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\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\u003c\/a\u003e, \u003ca href=\"\/products\/us-agent-for-cosmetic-facilities-12-months\"\u003eUS Agent for Cosmetic Facilities (12 Months)\u003c\/a\u003e, \u003ca href=\"\/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":67824341188685,"sku":null,"price":450.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-cosmetic-facility-registration-renewal.webp?v=1793176384"},{"product_id":"us-agent-for-cosmetic-facilities-12-months","title":"US Agent for Cosmetic Facilities (12 Months)","description":"\u003cp\u003eMoCRA requires every cosmetic facility outside the US to name a US agent in its FDA registration. Phoenix Safety Consultants LLC acts as your US agent for 12 months, is named in Cosmetics Direct, and receives and passes on FDA communications. The agent role does not make us your responsible person. £695 per facility per year.\u003c\/p\u003e\u003ch2\u003eWhat is a US agent for a cosmetic facility?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eMoCRA\u003c\/strong\u003e and \u003cstrong\u003eFD\u0026amp;C Act section 607(b)\u003c\/strong\u003e, a cosmetic facility outside the US must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e in its FDA registration. The US agent must live or have a place of business in the US and acts as a point of contact between \u003cstrong\u003eFDA\u003c\/strong\u003e and the foreign facility. \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e provides this service. The US agent is different from the \u003cstrong\u003eresponsible person\u003c\/strong\u003e, whose name appears on the label.\u003c\/p\u003e\u003ch3\u003eWhat's included in your US agent service?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent designation\u003c\/strong\u003e: Phoenix Safety Consultants LLC named as US agent in your facility registration\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA communications\u003c\/strong\u003e: Receipt of FDA contact and prompt forwarding to you\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration entry\u003c\/strong\u003e: Agent details entered or updated in Cosmetics Direct\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgent agreement\u003c\/strong\u003e: A written agreement setting out both sides' responsibilities\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e12 months of cover\u003c\/strong\u003e: Renewable each year\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this US agent service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK, EU and other non-US cosmetic manufacturers and processors\u003c\/li\u003e\n\u003cli\u003eContract manufacturers supplying US brands\u003c\/li\u003e\n\u003cli\u003eFacilities registering under MoCRA for the first time\u003c\/li\u003e\n\u003cli\u003eFacilities replacing an existing US agent\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this US agent service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponsible person duties.\u003c\/strong\u003e Being US agent does not make us the responsible person on your label; that is a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFacility registration.\u003c\/strong\u003e Available separately or in our Registration + US Agent package.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eProduct listings or adverse event reporting.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLegal representation.\u003c\/strong\u003e The agent is a point of contact for FDA, not your lawyer.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Agent for Cosmetic Facilities work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eOrder and send details\u003c\/strong\u003e: Facility details and your registration number, if you have one.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: We send the US agent agreement to sign.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDesignation\u003c\/strong\u003e: We enter Phoenix Safety Consultants LLC as your US agent in Cosmetics Direct.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCover starts\u003c\/strong\u003e: We forward any FDA communications to you 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 607(b)\u003c\/strong\u003e — foreign facility registrations must include a US agent\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(a)\u003c\/strong\u003e — facility registration and biennial renewal\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 604\u003c\/strong\u003e — the responsible person is a separate role\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\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\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\/us-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\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":67824341319757,"sku":null,"price":695.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-agent-for-cosmetic-facilities-12-months.webp?v=1793176386"},{"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=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\u003c\/a\u003e, \u003ca href=\"\/products\/us-agent-for-cosmetic-facilities-12-months\"\u003eUS Agent for Cosmetic Facilities (12 Months)\u003c\/a\u003e, \u003ca href=\"\/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"},{"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=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/mocra-serious-adverse-event-reporting-service\"\u003eMoCRA Serious Adverse Event Reporting Service\u003c\/a\u003e, \u003ca href=\"\/products\/us-cosmetic-safety-substantiation-file-mocra\"\u003eUS Cosmetic Safety Substantiation File (MoCRA)\u003c\/a\u003e, \u003ca href=\"\/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"},{"product_id":"mocra-serious-adverse-event-reporting-service","title":"MoCRA Serious Adverse Event Reporting Service","description":"\u003cp\u003eUnder MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 years. Our managed annual plan covers intake, triage and record keeping, from £2,250 a year for 1–10 products. Each serious event report on MedWatch Form 3500A is £450.\u003c\/p\u003e\u003ch2\u003eWhat is MoCRA adverse event reporting?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eMoCRA\u003c\/strong\u003e added \u003cstrong\u003esection 605\u003c\/strong\u003e to the \u003cstrong\u003eFD\u0026amp;C Act\u003c\/strong\u003e. The \u003cstrong\u003eresponsible person\u003c\/strong\u003e for a cosmetic must report any \u003cstrong\u003eserious adverse event\u003c\/strong\u003e associated with its use in the US to \u003cstrong\u003eFDA\u003c\/strong\u003e within \u003cstrong\u003e15 business days\u003c\/strong\u003e of receiving the report, usually on \u003cstrong\u003eMedWatch Form 3500A\u003c\/strong\u003e, and send any new medical information received within one year. Adverse event records must be kept for \u003cstrong\u003e6 years\u003c\/strong\u003e, or 3 years for small businesses. Small businesses are not exempt from this duty.\u003c\/p\u003e\u003ch3\u003eWhat's included in your adverse event service?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntake\u003c\/strong\u003e: Reports received at our US contact and logged\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTriage\u003c\/strong\u003e: Each report assessed against the MoCRA definition of a serious adverse event\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA report\u003c\/strong\u003e: Serious events reported on MedWatch Form 3500A within 15 business days (per-event fee)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFollow-up\u003c\/strong\u003e: New medical information received within a year sent to FDA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecords\u003c\/strong\u003e: Adverse event records kept for 6 years\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands whose responsible person needs an adverse event process\u003c\/li\u003e\n\u003cli\u003eBrands using our US Responsible Person service\u003c\/li\u003e\n\u003cli\u003eUS brands without in-house regulatory staff\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eMedical advice or treatment.\u003c\/strong\u003e We do not advise consumers medically.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct recalls.\u003c\/strong\u003e Handled separately with you.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eLegal defence of claims.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSerious event reports on the annual plan alone.\u003c\/strong\u003e Each FDA report is charged per event.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Serious Adverse Event Reporting Service work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSet up\u003c\/strong\u003e: We agree the intake contact and the information you must send us.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntake\u003c\/strong\u003e: Reports are logged and triaged.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: If an event is serious, we prepare and file the MedWatch report within 15 business days.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecords\u003c\/strong\u003e: All reports are kept for 6 years.\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 605(a)\u003c\/strong\u003e — definition of serious adverse event\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605(b)\u003c\/strong\u003e — report to FDA within 15 business days; new information within 1 year\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605(e)\u003c\/strong\u003e — records kept for 6 years (3 for small businesses)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 612\u003c\/strong\u003e — the small business exemption does not cover adverse event reporting\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-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\u003c\/a\u003e, \u003ca href=\"\/products\/us-cosmetic-safety-substantiation-file-mocra\"\u003eUS Cosmetic Safety Substantiation File (MoCRA)\u003c\/a\u003e, \u003ca href=\"\/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":"Annual plan, 1–10 products","offer_id":67824691478605,"sku":null,"price":2250.0,"currency_code":"GBP","in_stock":true},{"title":"Annual plan, 11–25 products","offer_id":67824691511373,"sku":null,"price":2950.0,"currency_code":"GBP","in_stock":true},{"title":"Annual plan, 26–50 products","offer_id":67824691544141,"sku":null,"price":3950.0,"currency_code":"GBP","in_stock":true},{"title":"Annual plan, 51–100 products","offer_id":67824691576909,"sku":null,"price":4950.0,"currency_code":"GBP","in_stock":true},{"title":"Per serious event report","offer_id":67824342073421,"sku":null,"price":450.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-serious-adverse-event-reporting-service.webp?v=1793176385"},{"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=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\u003c\/a\u003e, \u003ca href=\"\/products\/us-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\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":"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"},{"product_id":"us-cosmetic-label-review-mocra-fda","title":"US Cosmetic Label Review (MoCRA \u0026 FDA)","description":"\u003cp\u003eUS cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event reports. We review the identity statement, net quantity, ingredient list, responsible person details, warnings and claims, and flag any drug claims. £595 per product.\u003c\/p\u003e\u003ch2\u003eWhat does a US cosmetic label need?\u003c\/h2\u003e\u003cp\u003eUS cosmetic labels are governed by \u003cstrong\u003eFDA's cosmetic labelling regulations (21 CFR Part 701 and 740)\u003c\/strong\u003e, the \u003cstrong\u003eFair Packaging and Labeling Act (FPLA)\u003c\/strong\u003e and \u003cstrong\u003eMoCRA\u003c\/strong\u003e. They need a \u003cstrong\u003estatement of identity\u003c\/strong\u003e, \u003cstrong\u003enet quantity\u003c\/strong\u003e in US units, an \u003cstrong\u003eingredient declaration\u003c\/strong\u003e in the required order, the \u003cstrong\u003ename and place of business\u003c\/strong\u003e of the manufacturer, packer or distributor, and, under MoCRA section 609, a \u003cstrong\u003edomestic US contact\u003c\/strong\u003e for adverse event reports. Claims that a product treats or prevents disease, or affects the body's structure or function, may make it a \u003cstrong\u003edrug\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in your label review?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrincipal display panel\u003c\/strong\u003e: Statement of identity and net quantity in US units\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIngredient declaration\u003c\/strong\u003e: Order and naming checked against 21 CFR 701.3\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMoCRA contact\u003c\/strong\u003e: Responsible person name and US contact for adverse event reports\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWarnings\u003c\/strong\u003e: Required warning statements for your product type\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClaims review\u003c\/strong\u003e: Claims that could make the product a drug flagged\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this label review for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK and EU brands adapting labels for the US\u003c\/li\u003e\n\u003cli\u003eAmazon US sellers asked to fix labelling\u003c\/li\u003e\n\u003cli\u003eBrands launching new US products\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this label review not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel design.\u003c\/strong\u003e We review and mark up; artwork changes are yours or a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC drug labels.\u003c\/strong\u003e Sunscreens and other OTC drugs need a Drug Facts review.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eState-law labelling.\u003c\/strong\u003e Some states have their own rules; we flag known issues but do not do a full state review.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSeveral products.\u003c\/strong\u003e Each product label is reviewed separately.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Cosmetic Label Review work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your label\u003c\/strong\u003e: Artwork or photos of every panel, with the formula.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview\u003c\/strong\u003e: We check each element against FDA, FPLA and MoCRA rules.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive a marked-up report with required changes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecheck\u003c\/strong\u003e: One recheck of the revised label is included.\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\u003e21 CFR Part 701\u003c\/strong\u003e — cosmetic labelling, including ingredient declaration (701.3)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 740\u003c\/strong\u003e — cosmetic warning statements\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFair Packaging and Labeling Act\u003c\/strong\u003e — identity and net quantity\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 609\u003c\/strong\u003e — MoCRA label contact for adverse events\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 201(g)\u003c\/strong\u003e — drug definition and claims\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Cosmetics Labeling Guide (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide)\u003c\/li\u003e\n\u003cli\u003e[MoCRA (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra)\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-cosmetic-safety-substantiation-file-mocra\"\u003eUS Cosmetic Safety Substantiation File (MoCRA)\u003c\/a\u003e, \u003ca href=\"\/products\/mocra-product-listing-volume-plans\"\u003eMoCRA Product Listing — Volume Plans\u003c\/a\u003e, \u003ca href=\"\/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":67824342597709,"sku":null,"price":595.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-cosmetic-label-review-mocra-fda.webp?v=1793176386"},{"product_id":"mocra-small-business-exemption-check","title":"MoCRA Small Business Exemption Check","description":"\u003cp\u003eMoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for certain products such as eye-area, injected or long-lasting products. We check your sales and product range against section 612 and confirm the current threshold at order. £295.\u003c\/p\u003e\u003ch2\u003eWhat is the MoCRA small business exemption?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eFD\u0026amp;C Act section 612\u003c\/strong\u003e, added by \u003cstrong\u003eMoCRA\u003c\/strong\u003e, exempts certain small businesses from \u003cstrong\u003efacility registration\u003c\/strong\u003e and \u003cstrong\u003eproduct listing\u003c\/strong\u003e, and from some GMP requirements. It is based on \u003cstrong\u003eaverage annual gross sales in the US\u003c\/strong\u003e over the previous three years, with a threshold adjusted for inflation, which we \u003cstrong\u003econfirm at order\u003c\/strong\u003e. The exemption does \u003cstrong\u003enot\u003c\/strong\u003e apply to products that contact the eye, are injected, are for internal use, or alter appearance for more than 24 hours. Small businesses must still report serious adverse events, label correctly and keep safety substantiation records.\u003c\/p\u003e\u003ch3\u003eWhat's included in your exemption check?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eSales test\u003c\/strong\u003e: Your average annual US gross sales over three years compared with the current threshold\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct test\u003c\/strong\u003e: Each product checked against the categories that are never exempt\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDuties that still apply\u003c\/strong\u003e: Adverse event reporting, labelling and safety substantiation\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWritten conclusion\u003c\/strong\u003e: Whether you appear exempt from registration and listing\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this check for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eSmall and new brands starting to sell in the US\u003c\/li\u003e\n\u003cli\u003eBrands unsure whether they must register and list\u003c\/li\u003e\n\u003cli\u003eBrands whose US sales are growing\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this check not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLegal advice.\u003c\/strong\u003e This is a regulatory assessment, not a legal opinion.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration or listing.\u003c\/strong\u003e Available separately if you are not exempt.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eVerification of your accounts.\u003c\/strong\u003e We rely on the sales figures you provide.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Small Business Exemption Check work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: US sales for the last three years and your product list.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCheck\u003c\/strong\u003e: We apply the sales and product tests.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive a written conclusion and the duties that still apply.\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 612\u003c\/strong\u003e — small business exemptions and excluded products\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605\u003c\/strong\u003e — adverse event reporting still applies\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 608\u003c\/strong\u003e — safety substantiation still applies\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\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\u003c\/a\u003e, \u003ca href=\"\/products\/mocra-product-listing-volume-plans\"\u003eMoCRA Product Listing — Volume Plans\u003c\/a\u003e, \u003ca href=\"\/products\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\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":67824342663245,"sku":null,"price":295.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-small-business-exemption-check.webp?v=1793176385"},{"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=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/mocra-professional-annual-package\"\u003eMoCRA Professional Annual Package\u003c\/a\u003e, \u003ca href=\"\/products\/mocra-enterprise-annual-package\"\u003eMoCRA Enterprise Annual Package\u003c\/a\u003e, \u003ca href=\"\/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"},{"product_id":"otc-drug-establishment-registration-labeler-code-fda","title":"OTC Drug Establishment Registration + Labeler Code (FDA)","description":"\u003cp\u003eSunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them must register with FDA and obtain a labeler code before listing products. We prepare and submit both as SPL files through FDA's electronic system. FDA fees and laboratory testing are extra. £1,450.\u003c\/p\u003e\u003ch2\u003eWhat is OTC drug establishment registration?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eFD\u0026amp;C Act section 510\u003c\/strong\u003e and \u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e, establishments that manufacture, repack or relabel \u003cstrong\u003edrugs\u003c\/strong\u003e for the US must \u003cstrong\u003eregister with FDA\u003c\/strong\u003e and \u003cstrong\u003elist\u003c\/strong\u003e each drug. Many personal-care products are \u003cstrong\u003eOTC monograph drugs\u003c\/strong\u003e: \u003cstrong\u003esunscreens\u003c\/strong\u003e, \u003cstrong\u003eacne treatments\u003c\/strong\u003e with benzoyl peroxide or salicylic acid, \u003cstrong\u003eantiperspirants\u003c\/strong\u003e and \u003cstrong\u003eanti-dandruff\u003c\/strong\u003e products. Registration is made in \u003cstrong\u003eStructured Product Labeling (SPL)\u003c\/strong\u003e format, and a \u003cstrong\u003elabeler code\u003c\/strong\u003e is needed before NDC listing. Foreign establishments must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in your establishment registration?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct check\u003c\/strong\u003e: Confirms your products are OTC drugs and the relevant monograph\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabeler code request\u003c\/strong\u003e: Prepared and submitted as an SPL file\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEstablishment registration\u003c\/strong\u003e: Prepared and submitted as an SPL file\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent check\u003c\/strong\u003e: Confirms the US agent for a foreign establishment\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAnnual renewal date\u003c\/strong\u003e: Registration renewed each year, 1 October to 31 December\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eManufacturers of sunscreen, acne, antiperspirant and anti-dandruff products\u003c\/li\u003e\n\u003cli\u003eUK and EU brands making SPF products for the US\u003c\/li\u003e\n\u003cli\u003eAmazon US sellers asked for drug registration\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaboratory testing.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included. SPF and other monograph tests are arranged separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA fees.\u003c\/strong\u003e Any FDA OMUFA facility fee is extra and passed through at cost; the current amount is confirmed at order.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct (NDC) listings.\u003c\/strong\u003e Available separately per SKU.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA US agent.\u003c\/strong\u003e Foreign establishments need one; available on request.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA approval.\u003c\/strong\u003e 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 OTC Drug Establishment Registration + Labeler Code work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: Establishment, products, formulas and DUNS number.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCheck\u003c\/strong\u003e: We confirm the products are OTC monograph drugs.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit the labeler code request and the establishment registration.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send your labeler code and registration confirmation. FDA processing time varies and is outside our control, so we do not guarantee a 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 510\u003c\/strong\u003e — drug establishment registration and listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e — registration, listing and NDC rules\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 505G\u003c\/strong\u003e — OTC monograph drugs\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 744M\u003c\/strong\u003e — OTC monograph drug user fees (OMUFA)\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Drug Registration and Listing System (FDA)](https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/electronic-drug-registration-and-listing-system-edrls)\u003c\/li\u003e\n\u003cli\u003e[OTC Monograph Drug User Fee Program (FDA)](https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/over-counter-monograph-drug-user-fee-program-omufa)\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\/otc-drug-listing-with-fda-ndc-per-sku\"\u003eOTC Drug Listing with FDA (NDC), per SKU\u003c\/a\u003e, \u003ca href=\"\/products\/otc-drug-facts-label-review-monograph-conformity\"\u003eOTC Drug Facts Label Review (Monograph Conformity)\u003c\/a\u003e, \u003ca href=\"\/products\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\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":67824343351373,"sku":null,"price":1450.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/otc-drug-establishment-registration-labeler-code-fda.webp?v=1793176385"},{"product_id":"otc-drug-listing-with-fda-ndc-per-sku","title":"OTC Drug Listing with FDA (NDC), per SKU","description":"\u003cp\u003eEach OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug listing SPL with your labeler code, product code and package codes, including the Drug Facts label, and submit it. Your establishment must already be registered. Testing is excluded. £395 per SKU.\u003c\/p\u003e\u003ch2\u003eWhat is OTC drug listing?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e, each \u003cstrong\u003edrug\u003c\/strong\u003e in US commercial distribution must be \u003cstrong\u003elisted\u003c\/strong\u003e with FDA, and each product and pack receives a \u003cstrong\u003eNational Drug Code (NDC)\u003c\/strong\u003e. For \u003cstrong\u003eOTC monograph drugs\u003c\/strong\u003e like \u003cstrong\u003esunscreens\u003c\/strong\u003e and \u003cstrong\u003eacne treatments\u003c\/strong\u003e, the listing names the active ingredients, the monograph and the \u003cstrong\u003eDrug Facts label\u003c\/strong\u003e. Listings are updated each June and December when information changes.\u003c\/p\u003e\u003ch3\u003eWhat's included in your drug listing?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eNDC assignment\u003c\/strong\u003e: Product and package codes built on your labeler code\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eListing SPL\u003c\/strong\u003e: Active ingredients, dosage form, route and monograph\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel upload\u003c\/strong\u003e: Drug Facts label and packaging included in the SPL\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmission\u003c\/strong\u003e: Through FDA's electronic system\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this listing for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with a registered OTC drug establishment\u003c\/li\u003e\n\u003cli\u003eSellers of sunscreen, acne, antiperspirant and anti-dandruff products\u003c\/li\u003e\n\u003cli\u003eBrands adding new SKUs or pack sizes\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this listing not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaboratory testing.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEstablishment registration and labeler code.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDrug Facts label review.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA fees.\u003c\/strong\u003e Any FDA OMUFA facility fee is extra and passed through at cost; the current amount is confirmed at order.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does OTC Drug Listing with FDA work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your product\u003c\/strong\u003e: Formula, labels and pack sizes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrepare\u003c\/strong\u003e: We assign codes and build the listing SPL.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit the listing.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send your NDCs. FDA processing time varies and is outside our control, so we do not guarantee a 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 510(j)\u003c\/strong\u003e — drug listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e — listing and NDC format\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR 201.66\u003c\/strong\u003e — Drug Facts labelling\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Drug Registration and Listing System (FDA)](https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/electronic-drug-registration-and-listing-system-edrls)\u003c\/li\u003e\n\u003cli\u003e[OTC Monograph Drug User Fee Program (FDA)](https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/over-counter-monograph-drug-user-fee-program-omufa)\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\/otc-drug-establishment-registration-labeler-code-fda\"\u003eOTC Drug Establishment Registration + Labeler Code (FDA)\u003c\/a\u003e, \u003ca href=\"\/products\/otc-drug-facts-label-review-monograph-conformity\"\u003eOTC Drug Facts Label Review (Monograph Conformity)\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":67824343515213,"sku":null,"price":395.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/otc-drug-listing-with-fda-ndc-per-sku.webp?v=1793176385"}],"url":"https:\/\/phoenixcosmeticsafety.com\/collections\/all-services.oembed?page=3","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}