Business Solutions
Contract Manufacturing
Regulatory support for contract manufacturers and the brands that use them: cosmetic GMP under ISO 22716, the split of duties between manufacturer and Responsible Person, per-formula CPSRs and PIF compilation.
Contract manufacturers make the products that other brands sell. The recurring question is where the manufacturer’s responsibility ends and the brand’s begins, and the answer matters for good manufacturing practice, for the Product Information File and for who signs the safety report.
Good manufacturing practice and ISO 22716
Cosmetics must be manufactured in accordance with good manufacturing practice. ISO 22716 is the recognised GMP standard for cosmetics, and compliance with it gives the presumption of conformity. The Product Information File has to contain a description of the manufacturing method together with a statement of GMP compliance, so the manufacturer’s processes are part of the regulatory record for every product made, not a separate operational matter.
Manufacturer or Responsible Person
The two roles are distinct and are usually held by different parties. The contract manufacturer supplies the formula, the manufacturing method, the GMP statement and the stability and quality data. The Responsible Person, normally the brand or a party it appoints, holds the CPSR, the PIF and the notification and carries the legal duty for the product on the market. A manufacturer is not automatically the Responsible Person, and a brand cannot assume its manufacturer has taken that role unless it has been agreed in writing. Each distinct formula needs its own CPSR.
Supporting manufacturers and their brand customers
We work on both sides of this relationship. For manufacturers, we prepare CPSRs per formula and variant, compile the Product Information File from the manufacturing data, and run stability, preservative-efficacy and analytical testing through our on-site laboratories. We can also act as the Responsible Person for the manufacturer’s brand customers, so a manufacturer can offer its clients a compliant route to market as part of its service.
How we help
We provide the safety assessments, PIF compilation and testing a contract manufacturer’s output needs, and we make the division of responsibility between manufacturer, brand and Responsible Person explicit, so that no product reaches the market with a gap where each party assumed another had it covered.
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 →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.
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 cosmetic GMP and ISO 22716?
In the EU and UK, cosmetic good manufacturing practice is the set of production, quality-control and documentation standards a cosmetic must be made to. ISO 22716 is the recognised GMP standard for cosmetics, and compliance gives a presumption of conformity. A GMP statement and manufacturing method form part of the Product Information File.
Is the contract manufacturer the Responsible Person?
In the EU and UK, usually not: the manufacturer supplies the formula, manufacturing method, GMP statement and quality data; the Responsible Person, normally the brand or an appointed party, holds the CPSR, PIF and notification and carries the legal duty. A manufacturer is the RP only if it has expressly agreed to be.
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.