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.

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.

Global Markets

From £149

Cosmetic regulatory documentation for markets beyond the EU and UK: Canada, Australia, New Zealand, ASEAN, the GCC and Latin America, prepared from the same evidence base by the assessor who signs our CPSRs.

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.

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.

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.

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.

Border Detention

Expedited

Rapid resolution where a cosmetic shipment is detained at a port of entry for missing or deficient compliance documentation.

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.

Crisis Management

A single point of regulatory control when an incident, an enforcement action or an adverse finding threatens a product or a brand.

MSDS

From £195

Preparation of a Material Safety Data Sheet for a finished cosmetic product or an individual ingredient, in line with the applicable Annex II provisions of REACH and the Globally Harmonised System.

Notifications

Notification of cosmetic products to the EU Cosmetic Products Notification Portal and the Great Britain Submit Cosmetic Product Notifications service, with amendments and withdrawals managed within the regulated timeframes.

PIF Compilation

Compilation of the Article 11 Product Information File: the dossier a Responsible Person must hold for every cosmetic and produce to a competent authority on request.

Rapid Response

24 to 48 hours

Expedited regulatory support when a deadline, a detained shipment or an incident cannot wait for standard turnaround.

Recall Management

Support in managing a cosmetic product recall or withdrawal, from assessing the safety issue through authority notification to a documented corrective action plan.