Regulatory affairs & PIF

Mandatory testing, safety assessment, Product Information File and CPNP notification. We turn a complex obligation into calm compliance, for a product you can sell with complete peace of mind.

  • Regulation 1223/2009
  • Complete PIF
  • CPNP notification
  • Safety assessment
Checking and measuring a formula at the laboratory
01Your challenge

The framework to comply with

Placing a cosmetic on the European market commits a Responsible Person and requires a complete safety file. One mistake and you face a product recall or a block on sales. Our job is to make sure your product is beyond reproach, on paper as on the skin.

  • You are placing a product on the European market
  • You have a formula but not the file
  • You import and need to be compliant
  • You want to secure your claims
02Our answer

The whole regulatory chain, end to end

At the lab in Marans
  1. 01

    Mandatory testing

    Management of stability, compatibility, challenge testing and the trials required for safety.

  2. 02

    Toxicological assessment

    Safety assessment of the finished product by the qualified experts it requires.

  3. 03

    PIF & CPNP

    Compilation of the Product Information File and notification on the European CPNP portal.

  4. 04

    Claims & labelling

    Review of claims, labelling and communication to keep you on solid ground.

Regulation feels intimidating because it is poorly explained. Our job is to make it simple and get you compliant, with no blind spots.
Julien B., co-founder
03How it works

The steps to compliance

File audit

Diagnosis

We review your formula, your existing tests and what is missing.

Testing & safety

Depends on the product

We manage the regulatory testing and the safety assessment of the product.

PIF

Complete file

We compile the Product Information File in line with Regulation 1223/2009.

Notification

Market launch

CPNP notification and claims validation: you are ready to sell.

04What is included

What the service covers

  • Supervision of all regulatory testing
  • Stability and packaging compatibility testing
  • Toxicological assessment of the finished product
  • Compilation of the PIF (Regulation 1223/2009)
  • Notification on the CPNP portal
  • Review of product claims
  • Labelling verification
  • Regulatory watch
Your file: your questions

Which framework applies?

Regulation (EC) No 1223/2009 - the European market.

What is the key deliverable?

A complete PIF + the CPNP notification.

For which products?

New product, existing formula or import.

Every file depends on the product and its history. Send us your formula and we will tell you exactly what is needed.

Get my quote
05Why us

Our approach to regulatory work

20 yearsof cosmetics expertise
A to Za single point of contact
1223/2009the European regulation, applied to the letter
PIF + CPNPcomplete file and notification included
06Your questions

Frequently asked questions

What is the PIF?

The Product Information File gathers all the safety information for a cosmetic product. It is mandatory and must be kept available for the authorities for every product placed on the market.

What is CPNP notification?

It is the declaration of your product on the European portal before it is placed on the market. We handle it for you.

Can you manage compliance for a formula I provide?

Yes. We audit your formula and your tests, fill in whatever is missing and compile the file.

Do you help validate marketing claims?

Yes. We review your claims and your labelling so they are both compelling and defensible from a regulatory standpoint.

Do you work on imported products?

Yes, as soon as the product is placed on the European market and needs a compliant file.

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