Product Categories
Oral & Dental Care
Compliance for toothpaste and mouthwash: fluoride limits and labelling under Annex III, and the borderline with medicinal and medical-device claims.
Oral care products are cosmetics, but they sit unusually close to the medicinal boundary, and fluoride is where the rules bite.
Fluoride
Fluoride compounds are restricted under Annex III of Regulation (EC) No 1223/2009. Toothpaste may contain fluoride up to a maximum of 0.15 per cent (1500 ppm) as fluorine, and any toothpaste containing more than 0.1 per cent must carry the prescribed statement advising on use by children under six. We confirm the level and set the mandatory labelling precisely. Methyl salicylate, common in toothpastes and mouthwashes, was separately restricted by Commission Regulation (EU) 2023/1545, with detailed limits by product type (toothpaste up to 2.52 per cent) and a prohibition in products for children under six, except toothpaste.
The medicinal and device borderline
Claims matter here more than almost anywhere. Wording around treating gum disease, remineralisation or sensitivity can push a product across the line into a medicinal product or a medical device, each with a heavier approval route. We assess the formula and the claims together so the product stays within the cosmetic category it is sold in, and flag where a claim would not.
Relevant services
CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →Testing
From £75
Stability, microbiology, photoprotection and analytical testing carried out in our three in-house laboratories. Analytical work is not contracted out; results pass directly to the assessor preparing your CPSR.
Learn more →Labelling
From £195 · from receipt of artwork
Independent review of packaging artwork against Article 19, and of product claims against the six Common Criteria of Regulation (EU) 655/2013. Label review £195; per-claim review from £125; substantiation dossiers from £1,495.
Learn more →Frequently asked questions
What is a CPSR?
A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.
What must appear on a cosmetic label?
Article 19 of Regulation (EC) No 1223/2009 sets out the mandatory particulars: the Responsible Person's name and address, the nominal content, the date of minimum durability or the period-after-opening (PAO) symbol, precautions for use, the batch number, the product function, and the list of ingredients in INCI nomenclature. In Great Britain the same requirements apply through the Cosmetic Products Enforcement Regulations 2013, and since 1 January 2026 the UK Responsible Person's details must appear on the label of products sold in GB. Oxford Biosciences reviews packaging artwork against these requirements for £195.
What testing does Oxford Biosciences provide?
Oxford Biosciences operates three in-house laboratories supporting Annex I, sections 3 to 5 of Regulation (EC) No 1223/2009. Services include microbiology (Preservative Efficacy Test to ISO 11930, Microbial Content Test to ISO 17516:2014), real-time and accelerated stability and packaging compatibility, photoprotection testing (in vitro and in vivo SPF and UVA-PF under the current ISO series), and analytical work including heavy metals by ICP-MS, antioxidant capacity by the DPPH assay, and GC/MS constituent analysis of essential oils, hydrolats and perfumes. Analytical work is not contracted out.