Frequently asked questions

At Oxford Biosciences the standard Cosmetic Product Safety Report is £220, covering a single product of up to 20 ingredients. A single-ingredient product is £70, and a variation in essential oil or pigment that requires a full additional report is £40. Portfolio pricing applies to batches, from £875 for five products. All fees are exclusive of VAT. Timelines run from receipt of the full documentation set: standard turnaround is then typically 2 to 3 working days, with a 48-hour service at a 50 per cent premium and a 24-hour service at a 100 per cent premium where the complete set is supplied at the point of order.

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.

Article 10(2) of Regulation (EC) No 1223/2009 requires that the Part B safety assessment be carried out by a person holding a diploma in pharmacy, toxicology, medicine or a similar discipline. At Oxford Biosciences every assessment is conducted and signed by a Clinical Pharmacologist who holds an MSc from the University of Oxford. The assessor's credentials and approval form part of Part B and are the basis on which a competent authority evaluates the report.

A MoCRA Toxicological Risk Assessment is the safety substantiation the Modernization of Cosmetics Regulation Act 2022 requires a US responsible person to hold. Oxford Biosciences prepares it for £395, covering the federal requirement together with the state-level provisions that apply in California (Proposition 65, the Safe Cosmetics Act and the Toxic-Free Cosmetics Act), Washington, New York and Minnesota. It is prepared and signed by the same Clinical Pharmacologist who signs our EU and UK CPSRs, and can be produced in multiple languages.

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.

Not always. The evidence has to be proportionate to the claim. A quantified claim such as a percentage reduction in wrinkle depth needs instrumental measurement on a panel, while a softer appearance claim can often rest on expert grading or validated self-assessment.

A clinical efficacy study starts from £5,000 plus VAT for a 15-subject panel, £8,500 for 30 subjects and £14,500 for 60 subjects. The cost sits in the fixed study infrastructure rather than the per-subject rate, so it does not fall in proportion to panel size.

Plan for three to five months end to end. The timeline is driven by the in-use observation period, typically 8 to 12 weeks for wrinkle, pigmentation and brightening endpoints, with protocol design, ethics and recruitment before it and analysis and reporting after.

Cosmetic claims are regulated as statements of fact, not marketing copy. Article 20 of Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013 establish six Common Criteria that every claim must meet: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Evidence must exist before a claim is published and remain on file. Oxford Biosciences reviews claims per claim (£125, minimum five) and prepares formal Claims Substantiation Dossiers suitable for the Product Information File and for production to a competent authority or the Advertising Standards Authority.

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.

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.

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.

Selling cosmetics on Amazon UK carries the same legal requirements as any Great Britain sale: a valid Cosmetic Product Safety Report, a UK-established Responsible Person, SCPN notification to the Office for Product Safety and Standards, and compliant labelling, including the UK Responsible Person's details on the label since 1 January 2026. Marketplaces increasingly ask sellers to evidence this documentation. Oxford Biosciences provides the CPSR, acts as your UK Responsible Person, and manages the SCPN notification so your listings meet the requirement.

A UK Cosmetic Product Safety Report from Oxford Biosciences is £220 for a single product of up to 20 ingredients, the same report that serves the EU market under Annex I of Regulation (EC) No 1223/2009. A single-ingredient product is £70, variants are £40, and batch pricing applies from £875 for five products. Once the full documentation set is supplied, turnaround is typically 2 to 3 working days, with 48-hour and 24-hour expedited service available. All fees are exclusive of VAT.

To sell a cosmetic product in Great Britain you must appoint a UK Responsible Person established in the UK, who takes legal responsibility for compliance, holds the Product Information File, and notifies the product through the SCPN service to the Office for Product Safety and Standards. Since 1 January 2026 the UK Responsible Person's name and address must appear on the product label for goods placed on the GB market. Oxford Biosciences acts as UK Responsible Person through Oxford Biosciences Ltd, and as EU Responsible Person through our Irish-registered entity, under a single quality management system.

SCPN, the Submit Cosmetic Product Notification service, is the UK government system through which cosmetic products are notified before being placed on the Great Britain market. It replaced reliance on the EU's CPNP for GB after Brexit. Notification is made by the UK Responsible Person and is overseen by the Office for Product Safety and Standards (OPSS). A product should be notified only once it has been assessed as safe. Oxford Biosciences manages SCPN notification as part of its UK Responsible Person service.

No. Cosmetics do not carry CE or UKCA marks. Those conformity marks apply to other product groups such as electronics, toys, machinery, personal protective equipment and medical devices, not to cosmetics. In the EU a cosmetic demonstrates compliance through a Cosmetic Product Safety Report under Regulation (EC) No 1223/2009, notification on the CPNP, and an EU Responsible Person. In Great Britain it is the same evidence under the UK Cosmetics Regulation, notified through the SCPN with a UK-based Responsible Person. If a supplier or manufacturer tells you a cosmetic needs a CE or UKCA mark, they have confused cosmetics with a different product category. Oxford Biosciences prepares the safety report, notification and Responsible Person designation that actually establish cosmetic compliance.

Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment (£395), the Canadian Health Canada Cosmetic Notification (£395), the Australian AICIS Compliance Statement (£149), the New Zealand EPA Group Standard Compliance Statement (£179), and the ASEAN Cosmetic Directive Documentation Package (£249), with GCC and Latin American markets (Brazil, Mexico, Argentina and Chile) quoted on application. Where markets share an evidence base, a single Product Information File carries the jurisdiction-specific annexes rather than requiring a separate dossier for each.

Dual UK and EU Responsible Person designation is £299 per product in Year 1, reducing to £149 net of the £150 Regulatory Due Diligence credit applied to every new engagement, and £169 per product per year thereafter. A single jurisdiction, GB or EU only, is £199 in Year 1, £49 net of the credit, and £119 per year thereafter. Every new engagement is preceded by a Regulatory Due Diligence Review. All fees are exclusive of VAT.

Every cosmetic product placed on the EU or UK market must have a Responsible Person established within that jurisdiction. Under Articles 4 and 5 of Regulation (EC) No 1223/2009, the Responsible Person is the legal entity that holds the regulatory obligation for the product: it maintains the Product Information File, makes the CPNP or SCPN notification, oversees labelling, and handles cosmetovigilance and contact with the competent authority. It is not simply a postal address. Oxford Biosciences acts as Responsible Person in both the UK and the EU under a single quality management system.