Cosmetic Compliance in European Union

Full EU cosmetic compliance under Regulation (EC) No 1223/2009: the Annex I CPSR, EU Responsible Person, CPNP notification, labelling and claims. Held on your behalf through our Irish-registered entity.

Regulatory framework

Regulator
European Commission and national competent authorities
Primary regulation
Regulation (EC) No 1223/2009
Notification
CPNP (Cosmetic Products Notification Portal)
Region
Europe

Cosmetic products placed on the European Union market are governed by Regulation (EC) No 1223/2009, the single instrument that sets the legal threshold for safety, documentation, notification and labelling across all member states. Before a product is placed on the market, four things must be in place: a Cosmetic Product Safety Report under Annex I, a complete Product Information File, a notification through the CPNP, and an EU Responsible Person established within the Union.

What the Regulation requires

The safety assessment itself is Annex I, in two parts (Part A, the safety information; Part B, the assessor’s reasoned conclusion), elaborated by Commission Implementing Decision 2013/674/EU. Articles 4 and 5 establish the Responsible Person; Article 11 the Product Information File; Article 13 the CPNP notification; Article 19 the mandatory label particulars; and Article 20, with Commission Regulation (EU) No 655/2013, the rules on claims.

The substance annexes are revised regularly. Commission Regulation (EU) 2026/909, the second Omnibus act, entered into force in May 2026 and tightened restrictions on fragrance allergens, the UV filter DHHB, certain hair dyes and aluminium, with most provisions applying from 2027. A safety assessment is only as current as the annexes it was written against.

How Oxford Biosciences supports EU market entry

We prepare the CPSR, hold and maintain the Product Information File, make and keep current the CPNP notification, and act as your EU Responsible Person through our company registered in the Republic of Ireland, under the same quality management system as our UK operation. The standard CPSR is Β£220; EU Responsible Person designation is available within our dual UK and EU engagement.

Our services for European Union

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CPSR

From Β£70 Β· 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.

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Responsible Person

From Β£149 Β· 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.

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Labelling

From Β£195 Β· 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 Β£195; per-claim review from Β£125; substantiation dossiers from Β£1,495.

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Testing

From Β£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.

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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 must appear on a cosmetic label?

Article 19 of Regulation (EC) No 1223/2009 sets out the mandatory particulars: the Responsible Person's name and address, the nominal content, the date of minimum durability or the period-after-opening (PAO) symbol, precautions for use, the batch number, the product function, and the list of ingredients in INCI nomenclature. In Great Britain the same requirements apply through the Cosmetic Products Enforcement Regulations 2013, and since 1 January 2026 the UK Responsible Person's details must appear on the label of products sold in GB. Oxford Biosciences reviews packaging artwork against these requirements for Β£195.

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