Product Categories
Sun Protection
Compliance for sunscreens: approved UV filters, SPF and UVA testing to the relevant ISO standards, and the fact that sunscreens are cosmetics in the EU and UK but OTC drugs in the US.
Sun protection is the most test-dependent category we handle, and one where the regulatory classification changes entirely depending on the market.
Filters and performance testing
UV filters must appear in Annex VI of Regulation (EC) No 1223/2009, and a declared SPF has to be substantiated by testing. The historic reference method is the in vivo determination on a volunteer panel, ISO 24444:2019. In December 2024 ISO published two alternatives that reduce or remove human exposure: the fully in vitro Double-Plate Method, ISO 23675:2024, for static SPF on emulsions and alcoholic one-phase formulations, and the hybrid diffuse reflectance method, ISO 23698:2024, which characterises SPF, UVA-PF and critical wavelength together. UVA protection factor and critical wavelength are determined in vitro under ISO 24443:2021. EU and UK guidance also requires UVA protection of at least a third of the labelled SPF, signalled by the UVA-in-a-circle symbol, alongside a minimum critical wavelength. We select the method that fits the formulation, since the in vitro Double-Plate Method does not apply to powders, compressed products or sticks, arrange the testing in our laboratories, and integrate the result into the safety report.
A cosmetic here, a drug there
In the EU and UK a sunscreen is a cosmetic. In the United States it is an over-the-counter drug regulated by the FDA, which changes the entire compliance pathway. We make that distinction explicit and prepare for each market on its own terms.
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 →FDA MoCRA
From £395
US market entry under MoCRA: a MoCRA-compliant Toxicological Risk Assessment with the state-level provisions for California, Washington, New York and Minnesota, prepared by the same assessor who signs our EU and UK CPSRs.
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 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.
What is MoCRA?
MoCRA, the Modernization of Cosmetics Regulation Act 2022, is the first comprehensive federal cosmetics law in the United States. It amended the Federal Food, Drug, and Cosmetic Act to require registration of manufacturing facilities with the FDA, product listing, adequate substantiation of product safety, adverse event recordkeeping and reporting, and a named responsible person. Oxford Biosciences prepares the MoCRA-compliant Toxicological Risk Assessment that substantiates safety, with the relevant US state provisions addressed alongside it.