Introduction
Oral care products 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 cosmetic product safety report confirms your formulation and claims keep you correctly positioned as a cosmetic before it's placed on the market.
What Your CPSR Assesses
- Full ingredient toxicological review against Annex II, III and V (preservatives)
- Fluoride compound concentration check against the specific Annex III limits that apply to oral hygiene products
- Borderline-product review, flagging any ingredient or claim that risks reclassifying your product as a medicine
- Oral mucosa exposure and incidental-ingestion risk assessment, relevant given the product's intended use in the mouth
- Alcohol content review for mouthwash and breath spray formats, relevant to both safety and labelling
Who This Is For
Oral care products brands formulating toothpaste, mouthwash or breath spray, particularly those adding fluoride, active whitening agents or therapeutic-sounding claims.
Why Brands Choose Spectra Cosmetic Compliance
- Signed by a qualified Safety Assessor under Article 10(2), Regulation (EC) No 1223/2009 recognised across the UK and EU, applying SCCS methodology.
- Regulator-ready, or we revise it at no charge our compliance guarantee.
- PIF-ready your report slots directly into your product information file, no reformatting required.
- Clear 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).
- Trusted by cosmetic and fragrance brands across the UK, EU, US, Middle East and Asia.
Your CPSR Deliverables
Your completed cosmetic product safety report is supplied ready for inclusion in the PIF, to the Annex I specification, in two parts:
Part A — Cosmetic Product Safety Information
- Quantitative and qualitative formulation data
- Physico-chemical characteristics and stability over time
- Microbiological quality
- Impurities, traces and packaging material
- Exposure and toxicological profile of the ingredients
Part B — Cosmetic Product Safety Assessment
- The Safety Assessor's conclusion
- Margin of Safety calculations
- Conditions of use and labelling
- A signed compliance statement by a qualified assessor
Plus 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).
Legal Framework
- Article 3 and Annex I, Regulation (EC) No 1223/2009
- Schedule 34, Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/696)
- Annex III fluoride compound concentration limits for oral hygiene products
- MHRA borderline-products guidance, relevant where a claim or ingredient could shift classification from cosmetic to medicinal product
How It Works
- Share your formulation send your full INCI list with percentages, raw-material SDS and product label artwork.
- We screen every ingredient each ingredient is checked against the relevant UK/EU Annexes and current SCCS guidance.
- We complete the safety assessment a qualified Safety Assessor prepares and signs CPSR Parts A & B and builds your PIF-ready documentation.
- You receive your file your signed CPSR and supporting documentation are delivered within your chosen turnaround window.
- Delivery options: Standard (3-5 working days, included) | Fast (48 hours) | Priority (24 hours)