Responsible Person Services
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.
- Designation as both UK and EU Responsible Person under one engagement and one quality management system
- SCPN (GB) and CPNP (EU) notification, Product Information File maintenance, and labelling oversight
- Cosmetovigilance and direct interface with the competent authority on your behalf
- Dual UK and EU from £299 in Year 1 (£149 net of the £150 Regulatory Due Diligence credit), then £169 per product per year
- Single jurisdiction from £199 in Year 1 (£49 net of the credit), then £119 per year
Every cosmetic product placed on the EU or UK market must have a Responsible Person established within that jurisdiction. The Responsible Person is not a postal address. It is the legal entity that holds the regulatory obligation for the product, and it is the entity a competent authority approaches first when a question arises.
Oxford Biosciences acts as Responsible Person in both jurisdictions: in the United Kingdom through Oxford Biosciences Ltd, and in the European Union through our company registered in the Republic of Ireland. Both entities operate under a single quality management system, served by the same qualified safety assessor team and in-house laboratory team that prepare the underlying CPSRs.
What the role involves
The obligation extends well beyond designation. Articles 4 and 5 of Regulation (EC) No 1223/2009 establish the appointment and duties of the Responsible Person; Article 11 the Product Information File; Article 13 the CPNP notification; Article 19 labelling; Article 23 cosmetovigilance; and Articles 25 and 26 the enforcement powers of the competent authorities. In Great Britain the parallel framework is set by the Cosmetic Products Enforcement Regulations 2013, with notification made through the Submit Cosmetic Product Notification (SCPN) service to the Office for Product Safety and Standards. In Ireland, S.I. No. 440 of 2013 transposes the Regulation, and the HPRA Guide to Cosmetic Products for Responsible Persons (ADV-G0010-7) sets out the competent authority’s expectations.
In practice that means we hold and maintain the Product Information File electronically and make it available to the competent authority within the regulated timeframes; we make and keep current the CPNP and SCPN notifications, synchronising formulation, labelling and product images between the file and the notifications; and we receive, assess and report undesirable and serious undesirable effects in accordance with Article 23 and the EU serious undesirable effects reporting guidelines.
Engagement and fees
Each new product is preceded by a Regulatory Due Diligence Review by a qualified safety assessor, which establishes whether the existing documentation supports a CPSR and PIF and what further work is required. A credit of £150 from that review is applied against the first year of any subsequent Responsible Person engagement.
Dual UK and EU designation is £299 per product in Year 1, reducing to £149 net of the credit, and £169 per product per year from Year 2. A single jurisdiction, GB or EU only, is £199 in Year 1, £49 net of the credit, and £119 per year thereafter. Senior representation of the brand to a competent authority, distributor or marketplace is available at £300 per hour. All fees are exclusive of VAT.
Frequently asked questions
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 much do Responsible Person services cost?
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.
What is SCPN?
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.