Project-based service

EU Cosmetics Market-Entry Package (CPSR + CPNP + PIF)

The complete EU market-entry compliance bundle for cosmetics: formula and label review, safety assessment (CPSR), Product Information File (PIF), and CPNP notification in one engagement, with testing coordinated as needed.

Core regulation(EC) No 1223/2009

Core deliverablesCPSR + PIF + CPNP

Timeline4-8 weeks

PrerequisiteEU-based Responsible Person

On this page

What this service is

The core EU cosmetics law is Regulation (EC) No 1223/2009: before a cosmetic product is placed on the EU market, an EU-based Responsible Person must be designated, a safety assessment must produce the Cosmetic Product Safety Report (CPSR), a Product Information File (PIF) must be established, and the product must be notified through the CPNP portal.

The CPSR must be signed by a duly qualified safety assessor; the PIF is kept by the Responsible Person and updated continuously; only after CPNP notification may the product be sold in the EU.

Regulation (EC) No 1223/2009Article 11 (PIF)Annex I (CPSR)Article 13 (CPNP)ISO 22716 (GMP)

Who needs it

Brands or manufacturers exporting cosmetics to the EU for the first time

Brands already selling in the EU with incomplete or outdated CPSR/PIF files

Companies changing their EU Responsible Person and rebuilding their file

Prerequisites and sequence

Final formula & packaging→Designate EU Responsible Person→EU Cosmetics Package

Final formula and packaging: the assessment is based on the final formula, and changes require re-assessment
An EU-based Responsible Person designated (appointment can be arranged with our help)
Manufacturing under GMP (ISO 22716), which the Responsible Person and assessor will verify

Who holds regulatory responsibility

The EU-based Responsible Person holds the primary legal responsibility for compliance. The brand provides authentic and complete formula and testing data; the safety assessment is signed independently by a qualified assessor; we organize the process and coordinate all parties.

Materials we need from you

Complete formula (ingredient concentrations with INCI names)

Raw material specifications and existing test reports (microbial, heavy metals, stability, challenge test, if any)

Packaging and label artwork (including claims)

Manufacturer information and GMP evidence (e.g. ISO 22716)

Packaging compatibility data (if any)

Process

01
Formula and ingredient compliance review (restricted/prohibited substances, colorant lists)
02
Label and claims review (Responsible Person details, ingredient list, warnings)
03
Identify testing gaps and coordinate labs (stability, microbial, challenge, compatibility as needed)
04
Qualified assessor issues the CPSR
05
Compile the Product Information File (PIF)
06
Notify the product through CPNP
07
Deliver the full file with ongoing-update obligations explained

Deliverables

Cosmetic Product Safety Report (CPSR, signed by a qualified assessor)

Product Information File (PIF)

CPNP notification confirmation

Formula and label review report with action points

Testing coordination records (if arranged)

Timeline

Typically 4-8 weeks with complete materials; additional lab testing extends the timeline per lab schedules. Mid-project formula or packaging changes reset parts of the work, so start after finalization.

Scope

What we provide

Formula and ingredient review against restricted/prohibited lists
Label and claims review
CPSR organization and report delivery
PIF compilation
CPNP notification
Testing gap assessment and lab coordination
Responsible Person appointment assistance

What is not included

Laboratory testing fees (quoted per project)
Responsible Person annual service fee (available separately)
Clinical substantiation of product claims
Non-EU market compliance (the UK requires separate notification — see the UK package)

What usually follows

U.S. MoCRA Facility Registration UK Cosmetics Package

Common pitfalls

Starting the assessment before the formula is finalThe CPSR is based on the final formula. Changing even one ingredient concentration after the assessment can invalidate the safety conclusion, doubling time and cost.

Claims crossing into drug territoryClaims like treating, anti-acne, or hair growth can reclassify the product as a medicine or borderline product in the EU — a completely different pathway. Claims must be contained within cosmetic boundaries at the label review stage.

Treating CPNP notification as an approvalCPNP is a notification, not an approval — completing it does not mean the EU endorses product safety. Responsibility always sits with the Responsible Person, and the CPSR and PIF are the real compliance evidence.

Building the PIF and never updating itThe PIF must be kept for ten years and updated continuously. Failing to produce an updated file during an inspection is equivalent to having no compliance documentation.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Can we notify through CPNP without an EU company?

Yes, but you must designate an EU-based Responsible Person who carries the legal responsibility; the notification is made under their name. We can assist with the appointment.

Can we write the CPSR ourselves?

The regulation requires the CPSR to be signed by a safety assessor with prescribed qualifications (pharmacy, toxicology, or a related discipline). You can prepare the data, but the report must be completed by a qualified assessor.

Is the PIF finished once compiled?

No. The PIF must be updated continuously: formula changes, new safety information, and post-market adverse reaction records all go into the file, kept by the Responsible Person for ten years after the last batch is placed on the market.

Does this cover the UK market?

No. After Brexit the UK requires separate SCPN notification and a UK Responsible Person. The file structure is similar but independent — see the UK Cosmetics Package if you sell in both markets.

Related services

UK Cosmetics PackageThe complete UK market-entry compliance bundle for cosmetics: formula and label review, UK safety assessment (UK CPSR), Product Information File (PIF), and SCPN notification in one engagement, with testing coordinated as needed.MoCRA Facility RegistrationMoCRA requires facilities that manufacture or process cosmetics for the U.S. market to register with FDA and renew every two years. Foreign facilities must also designate a U.S. agent. We prepare the filing, submit it, and track renewals.Cosmetic Label ReviewA clause-by-clause review of your existing label against FDA cosmetic labeling rules: claims wording, ingredient declaration, mandatory statements, type size and layout. You receive an action-point list and a suggested corrected draft, reducing misbranding risk.

Disclaimer

This is a compliance organization and filing assistance service; the CPSR is signed by an independent qualified assessor. This page is general information, not legal advice.