Business Solutions
Brand Acquisition Due Diligence
Regulatory due diligence for buying or investing in a cosmetic brand: a product-by-product audit of CPSRs, Responsible Persons, PIFs, notifications, claims and ingredient exposure, delivered as a report the deal can be priced against.
When buying or investing in a cosmetic brand, the regulatory state of the portfolio is a material risk that financial and legal due diligence rarely covers properly. A range that looks healthy commercially can carry liabilities that only surface after completion: recalls, forced reformulation, lost market access, or a Responsible Person arrangement that does not survive the change of ownership.
What we examine
We audit the portfolio product by product. Are the Cosmetic Product Safety Reports valid and signed by a suitably qualified assessor, or are they thin, expired or self-certified. Are Responsible Persons genuinely in place for each market, and will those arrangements transfer on a change of control or have to be re-established. Are the Product Information Files complete and retained for the required ten years. Are the notifications through SCPN and CPNP current and in the right entity’s name. Are the marketing claims substantiated, or is the brand’s positioning resting on claims it cannot evidence. Do the labels comply in each market sold. Are there open adverse events, complaints or recalls. And, increasingly important, what is the portfolio’s exposure to recent and forthcoming ingredient changes, because a substance newly restricted under an EU Omnibus act or a UK statutory instrument is a reformulation liability sitting inside the range.
The report
We deliver a regulatory due-diligence report written for a buyer or investor: a product-by-product compliance status, the risks identified and quantified, and a remediation plan with indicative cost and timing. That lets the regulatory position be priced into the deal and used in negotiation, rather than discovered afterwards.
Post-completion
Where a transaction proceeds, we carry out the remediation we identified: transferring or re-establishing Responsible Person roles, re-notifying products in the acquirer’s name, refreshing safety reports, and closing the gaps the audit found, so the acquired portfolio is brought to a clean compliance footing under its new owner.
How we help
We give an acquirer or investor an independent, expert read of what they are actually buying in regulatory terms, and then the means to fix it, so a cosmetic brand acquisition is made with the compliance risk understood and costed rather than inherited blind.
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 →Responsible Person
From £149 · per product, per year
Oxford Biosciences acts as your Responsible Person in the UK and the EU under a single quality management system, holding the regulatory obligation: PIF maintenance, SCPN and CPNP notification, labelling oversight, and cosmetovigilance.
Learn more →Claims Testing
From £5,000 · 3 to 5 months
Clinical efficacy studies that generate the measured evidence a cosmetic claim needs, to a standard a regulator or a broadcaster will accept. For anti-ageing, brightening and other performance claims.
Learn more →Cosmetovigilance
Receipt, assessment and reporting of undesirable and serious undesirable effects under Article 23, with direct interface to the competent authority on the brand's behalf.
Learn more →Frequently asked questions
What does regulatory due diligence on a cosmetic brand cover?
In the EU and UK, a product-by-product audit of whether the CPSRs are valid and properly signed, Responsible Persons are in place and transferable, PIFs complete, notifications current, claims substantiated and labels compliant, plus the portfolio's exposure to recent and forthcoming ingredient bans, delivered as a costed report.
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.
Who is qualified to sign a CPSR?
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.
What is a Responsible Person?
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.
How are cosmetic claims regulated?
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.