Business Solutions
Contract Manufacturing Compliance
The regulatory layer for brands that manufacture through a third party: who holds the obligations, GMP under ISO 22716, and formulation support to bring a product within a target market's rules.
When a brand manufactures through a contract manufacturer, the regulatory responsibilities do not transfer to the factory. They stay with the brand placing the product on the market, and the documentation has to reflect that.
Where the obligations sit
The contract manufacturer is expected to operate to Good Manufacturing Practice under ISO 22716, the standard Article 8 of the Regulation treats as the benchmark, and to supply the formulation, raw-material and batch data that the Product Information File depends on. But the safety report, the Article 13 notification and the Responsible Person remain the brand’s responsibility, not the factory’s. We prepare the safety assessment from the manufacturer’s data, confirm the testing where gaps exist through our own laboratories, and act as Responsible Person so the brand carries its obligations properly rather than assuming the factory has covered them.
Formulation support
Where a product needs adjusting to sit within a target market’s restrictions, our in-house formulation team provides reformulation review, so the compliance work and the bench work stay joined up. Our role here is the science and the regulatory layer around contract-manufactured products, working alongside your manufacturer.
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 →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 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.
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.