Specialised Products
Intimate Care
Safety assessment for intimate hygiene products, where mucous-membrane exposure, pH and the borderline with medical devices and medicines shape the work.
Intimate care products demand a more cautious assessment than general body care, because of where they are used and how easily a claim can move them out of the cosmetic category.
Mucous-membrane exposure
Products applied to or near mucous membranes fall into the strictest microbiological category under ISO 17516, and pH, osmolality and preservative selection all carry more weight than they would in a body wash. The safety assessment treats the exposure route directly, and preservative efficacy is confirmed to ISO 11930 against the tighter limits.
The medicine and device borderline
Claims are where intimate care gets caught out. A product that claims to treat thrush, infection or a medical condition is no longer a cosmetic, and an intimate lubricant is generally a medical device rather than a cosmetic at all. We assess the formula and the intended claims together and tell you, before launch, which regulatory category the product actually belongs in.
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 →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 is a Preservative Efficacy Test (challenge test)?
A Preservative Efficacy Test, also called a challenge test, demonstrates that a product's preservative system controls microbial growth across its life. Oxford Biosciences performs it to ISO 11930 for £165: the product is inoculated with the five specified challenge organisms (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus brasiliensis), and viable counts are enumerated over a 28-day window against the Criterion A or B log-reduction thresholds. Typical turnaround is six weeks, reflecting the protocol duration plus enumeration and reporting.
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.