CPSR Validity: EU, Great Britain, Switzerland and the USA

What does CPSR validity mean in the EU?

In the EU, the Responsible Person must ensure a safety assessment and a CPSR set up under Annex I before a cosmetic is placed on the EU market (Article 10(1)).

The CPSR has Part A, the safety information, and Part B, the safety assessment. Part B is carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent (Article 10(2)). The CPSR then sits in the Product Information File, which the Responsible Person keeps for ten years after the last batch is placed on the market (Article 11).

Only a cosmetic with a Responsible Person designated within the EU may be placed on the EU market (Article 4(1)). Eldris prepares the signed CPSR (Part A and Part B) and the PIF for one formula, 5–10 working days after it receives your complete documents. The Responsible Person and the EU notification are separate lines, and the notification is made to the Commission before the product is placed on the market (Article 13(1)).

What does Great Britain require?

Great Britain has its own rules: a cosmetic may not be placed on the market there unless there is a Responsible Person established in the UK.

That person notifies the product electronically before placing it on the market, through the SCPN service. The rules come from Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which changes how Regulation 1223/2009 applies in Great Britain.

Item	EU	Great Britain
Responsible Person	Designated within the EU (Article 4(1))	Established in the UK, with a UK established address
Notification	To the Commission before placing on the market (Article 13(1))	Through the SCPN service before placing on the market
Safety documents	CPSR under Annex I, kept in the PIF (Articles 10 and 11)	PIF in English that includes the product safety report

Whether a CPSR made for the EU is accepted as that product safety report is not stated here. The GOV.UK guidance sets out what a Responsible Person in Great Britain must do.

What about Northern Ireland, Switzerland and the USA?

The GOV.UK guidance for Great Britain does not cover Northern Ireland, where the Responsible Person must be established in Northern Ireland or the EU.

This guide says no more about Northern Ireland than that rule. Switzerland and the USA are not part of the EU or Great Britain, and each has its own rules for cosmetics, which this guide does not describe. It states nothing on whether a CPSR is accepted in either country, and nothing in it is advice on those countries. The rules quoted on this page are those of Regulation (EC) No 1223/2009 and Schedule 34 only.

A seller who ships there reads those countries' rules separately, and the same goes for any other country outside the EU and Great Britain. Before placing a product on the market in Switzerland or the USA, check that country's own rules. Eldris offers the Responsible Person role for the EU and, as a separate appointment, for Great Britain, and this guide covers those two markets only.

What does Eldris do for the EU and for Great Britain?

For the EU, Eldris prepares the signed CPSR (Part A and Part B) and the PIF for one formula. For Great Britain, Eldris can be your UK Responsible Person as a separate appointment.

The UK appointment is at the same market fee as the EU one, covered by the same monthly plan. Neither the UK Responsible Person nor the UK notification is in the formula fee, and the EU notification is a separate line as well. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing.

The pricing page shows the per-formula fee, the EU notification fee and the Responsible Person's per-market fee and monthly plan. The per-formula fee stays the same whatever the number of ingredients. Eldris's CPSR and notification service delivers the CPSR and PIF 5–10 working days after complete documents. If the safety assessor needs more from you, the question appears in your portal, and the 5–10 working days start again from the day you answer. The clock restarts; it never pauses.

How should a seller with several markets plan the documents?

List each market you plan to enter, then treat each market's rules as separate.

For the EU, that means a Responsible Person, a CPSR, a PIF and a notification before the product is placed on the market. For Great Britain, it means a UK Responsible Person, a UK notification before the product is placed on the market there and a PIF in English that includes the product safety report.

With Eldris, a product placed on the market in both the EU and Great Britain has two Responsible Person appointments, one for each market, covered by one monthly plan. For any other country, check that country's own rules. The guide to the UK Responsible Person and SCPN covers Great Britain in more detail. The FAQ page also gives the short answer on where a CPSR applies. You pay first, then upload your documents in your Eldris portal, and Eldris tells you what is still missing.

Frequently asked questions

Is an EU CPSR accepted in Great Britain?

This guide cannot say. Great Britain asks the Responsible Person to keep a PIF in English that includes the product safety report. Whether a CPSR made for the EU is accepted as that report is not stated here. A UK Responsible Person is a separate appointment.

Does Great Britain use the CPNP?

In Great Britain the Responsible Person notifies the product electronically before placing it on the market, through the SCPN service. The EU notification goes to the Commission through the CPNP, its free online notification system for the Regulation. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing.

Where must a UK Responsible Person be based?

A Responsible Person in Great Britain needs a UK established address. A cosmetic may not be placed on the market in Great Britain unless there is a Responsible Person established in the UK (Schedule 34). Eldris can be your UK Responsible Person as a separate appointment.

Does the PIF have to be in English for Great Britain?

Yes. In Great Britain the Responsible Person keeps a PIF in English, which includes the product safety report. In the EU, the PIF holds, among other things, the CPSR, the manufacturing method and a good manufacturing practice statement (Article 11(2)).

Is the UK Responsible Person included in the formula fee?

No. The UK Responsible Person and the UK notification are not in the formula fee. Eldris can be your UK Responsible Person as a separate appointment at the same market fee. The formula fee includes the signed CPSR (Part A and Part B), the PIF, the Article 19 label review and the INCI ingredient list for one formula.

Is anything monthly?

The cosmetics fees are paid once, with no monthly fee for this service. Only the Responsible Person service runs on a monthly plan, and one plan covers the EU and UK appointments. You can cancel it at any time, effective at the end of the billing period.

Does this guide cover Switzerland and the USA?

No. Switzerland and the USA have their own rules, and this guide does not describe them or say whether a CPSR is accepted there. For Northern Ireland, the GOV.UK guidance notes that the Responsible Person must be established in Northern Ireland or the EU.