{"product_id":"cpsr-for-oral-care-including-toothpaste-mouthwash-breath-spray","title":"CPSR for Oral Care Products (Including Toothpaste, mouthwash, breath spray)","description":"\u003ch2 dir=\"ltr\"\u003eIntroduction\u003c\/h2\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003eOral care products\u003c\/strong\u003e sit close to a regulatory boundary most other cosmetics don't face: the line between a cosmetic and a medicinal product. Fluoride toothpaste, in particular, is regulated as a cosmetic in the UK and EU, but only within defined fluoride concentration limits above certain thresholds, or with therapeutic claims attached, a product can be reclassified as a medicine. Your \u003cstrong\u003ecosmetic product safety report\u003c\/strong\u003e confirms your formulation and claims keep you correctly positioned as a cosmetic before it's placed \u003cstrong\u003eon the market\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 dir=\"ltr\"\u003eWhat Your CPSR Assesses\u003c\/h2\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003eFull ingredient toxicological review against Annex II, III and V (preservatives)\u003c\/li\u003e\n\u003cli\u003eFluoride compound concentration check against the specific Annex III limits that apply to oral hygiene products\u003c\/li\u003e\n\u003cli\u003eBorderline-product review, flagging any ingredient or claim that risks reclassifying your product as a medicine\u003c\/li\u003e\n\u003cli\u003eOral mucosa exposure and incidental-ingestion risk assessment, relevant given the product's intended use in the mouth\u003c\/li\u003e\n\u003cli\u003eAlcohol content review for mouthwash and breath spray formats, relevant to both safety and labelling\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 dir=\"ltr\"\u003eWho This Is For\u003c\/h2\u003e\n\u003cp dir=\"ltr\"\u003e\u003cstrong\u003eOral care products\u003c\/strong\u003e brands formulating toothpaste, mouthwash or breath spray, particularly those adding fluoride, active whitening agents or therapeutic-sounding claims.\u003c\/p\u003e\n\u003ch2 dir=\"ltr\"\u003eWhy Brands Choose Spectra Cosmetic Compliance\u003c\/h2\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003eSigned by a qualified Safety Assessor under Article 10(2), Regulation (EC) No 1223\/2009 recognised across the UK and EU, applying SCCS methodology.\u003c\/li\u003e\n\u003cli\u003eRegulator-ready, or we revise it at no charge our compliance guarantee.\u003c\/li\u003e\n\u003cli\u003ePIF-ready your report slots directly into your \u003cstrong\u003eproduct information file\u003c\/strong\u003e, no reformatting required.\u003c\/li\u003e\n\u003cli\u003eClear turnaround options standard delivery in 3-5 working days, with 48-hour and 24-hour priority options available. (Subjected to the 100% provision of documents).\u003c\/li\u003e\n\u003cli\u003eTrusted by cosmetic and fragrance brands across the UK, EU, US, Middle East and Asia.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 dir=\"ltr\"\u003eYour CPSR Deliverables\u003c\/h2\u003e\n\u003cp dir=\"ltr\"\u003eYour completed \u003cstrong\u003ecosmetic product safety report\u003c\/strong\u003e is supplied ready for inclusion in the PIF, to the Annex I specification, in two parts:\u003c\/p\u003e\n\u003ch3 dir=\"ltr\"\u003ePart A — Cosmetic Product Safety Information\u003c\/h3\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003eQuantitative and qualitative formulation data\u003c\/li\u003e\n\u003cli\u003ePhysico-chemical characteristics and stability over time\u003c\/li\u003e\n\u003cli\u003eMicrobiological quality\u003c\/li\u003e\n\u003cli\u003eImpurities, traces and packaging material\u003c\/li\u003e\n\u003cli\u003eExposure and toxicological profile of the ingredients\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 dir=\"ltr\"\u003ePart B — Cosmetic Product Safety Assessment\u003c\/h3\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003eThe \u003cstrong\u003eSafety Assessor's\u003c\/strong\u003e conclusion\u003c\/li\u003e\n\u003cli\u003eMargin of Safety calculations\u003c\/li\u003e\n\u003cli\u003eConditions of use and labelling\u003c\/li\u003e\n\u003cli\u003eA signed compliance statement by a qualified assessor\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp dir=\"ltr\"\u003ePlus a digital compliance certificate confirming your product meets UK\/EU cosmetic safety law. A Safety Data Sheet (SDS) of finished product provided alongside your CPSR as complimentary support (SDS of finished product is FREE with CPSR order).\u003c\/p\u003e\n\u003ch2 dir=\"ltr\"\u003eLegal Framework\u003c\/h2\u003e\n\u003cul dir=\"ltr\"\u003e\n\u003cli\u003eArticle 3 and Annex I, Regulation (EC) No 1223\/2009\u003c\/li\u003e\n\u003cli\u003eSchedule 34, Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019\/696)\u003c\/li\u003e\n\u003cli\u003eAnnex III fluoride compound concentration limits for oral hygiene products\u003c\/li\u003e\n\u003cli\u003eMHRA borderline-products guidance, relevant where a claim or ingredient could shift classification from cosmetic to medicinal product\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 dir=\"ltr\"\u003eHow It Works\u003c\/h2\u003e\n\u003col dir=\"ltr\"\u003e\n\u003cli\u003eShare your formulation send your full INCI list with percentages, raw-material SDS and product label artwork.\u003c\/li\u003e\n\u003cli\u003eWe screen every ingredient each ingredient is checked against the relevant UK\/EU Annexes and current SCCS guidance.\u003c\/li\u003e\n\u003cli\u003eWe complete the \u003cstrong\u003esafety assessment\u003c\/strong\u003e a qualified Safety Assessor prepares and signs CPSR Parts A \u0026amp; B and builds your PIF-ready documentation.\u003c\/li\u003e\n\u003cli\u003eYou receive your file your signed CPSR and supporting documentation are delivered within your chosen turnaround window.\u003c\/li\u003e\n\u003cli\u003eDelivery options: Standard (3-5 working days, included) | Fast (48 hours) | Priority (24 hours)\u003c\/li\u003e\n\u003c\/ol\u003e","brand":"Spectra Cosmetic Compliance","offers":[{"title":"Standard Delivery (5 Business Days)","offer_id":53244544352565,"sku":null,"price":84.0,"currency_code":"GBP","in_stock":true},{"title":"Fast Delivery (3 Business Days)","offer_id":53244544385333,"sku":null,"price":105.0,"currency_code":"GBP","in_stock":true},{"title":"Express Delivery (48 Hours) 🚀","offer_id":53244544418101,"sku":null,"price":126.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1010\/2456\/3509\/files\/spectra-cpsr-oral-care-cosmetics-compliance.webp?v=1787938473","url":"https:\/\/spectracomply.com\/de\/products\/cpsr-for-oral-care-including-toothpaste-mouthwash-breath-spray","provider":" Spectra Cosmetic Compliance","version":"1.0","type":"link"}