Claritas Regulatory
Cosmetic regulation. Without the drama.
We help you sell cosmetic products in the European Union while staying fully compliant — without wasting time or making costly regulatory mistakes.
If “EU cosmetic regulation” sounds like endless paperwork, complex terminology and potential headaches, you’re in the right place.
Here, we speak clearly, focus on what matters, and make sure your products genuinely comply with European legislation.
No confusion. No hidden risks. No unpleasant surprises.
Services
What can we do for you?
Everything you need to comply with EU cosmetic regulation — without overcomplicating the process.
Initial Regulatory Audit
(The first step before preparing your PIF)
Before investing time and money in a full Product Information File, one question matters:
Is your product actually viable from a regulatory perspective?
This initial audit is a practical and focused review of your product so you understand exactly where you stand — and what needs to be done next.
What we review
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Formula (key ingredient restrictions and obvious compliance risks)
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Claims and marketing positioning
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Basic labeling requirements
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Viability for the EU market
What you receive
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A clear and structured report (no unnecessary legal jargon)
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What is compliant
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What needs correction
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Missing documentation
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An honest assessment of whether your product is market-ready
EU Cosmetic PIF Preparation and Maintenance
A PIF done right from the start (and properly maintained over time)
The Product Information File (PIF) is mandatory in order to place a cosmetic product on the European Union market in accordance with Regulation (EC) No 1223/2009.
But it is not just a document you “need to have.”
It is the technical backbone of your product.
And it must be properly built and properly maintained.
At Cláritas Regulatory, we do more than prepare your PIF.
We build a solid regulatory foundation so your brand can grow without unexpected setbacks.
PIF Preparation
Clear, coherent technical documentation — ready for inspection
We prepare the complete Product Information File in accordance with European legislation, structured and organized to be ready for review by the competent authorities at any time.
It includes:
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Cosmetic Product Safety Report (CPSR – Part A & B) prepared and signed by a qualified Safety Assessor
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Regulatory review of the formula and INCI list
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Verification of ingredient compliance and applicable restrictions
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Mandatory labeling compliance review
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Regulatory assessment of product claims
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Structured technical compilation designed for future updates
A PIF that does more than simply comply — it is internally consistent, well-documented and built to withstand regulatory scrutiny.
PIF Maintenance
Because regulation evolves — and your documentation must evolve with it
A PIF is not static.
New allergens may become declarable, ingredient classifications can change, and regulatory requirements are regularly updated.
We ensure your documentation remains compliant, so you do not have to monitor every regulatory amendment yourself.
This includes:
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Monitoring of relevant regulatory updates
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Documentation updates following labeling or technical changes
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Annual preventive review
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Basic support in case of authority inquiries or inspections
So you can focus on your product — while we take care of the regulatory side.
Start with a Technical Review
If you already have a formula or existing documentation, we will assess your current situation and define the most efficient path to full compliance from the very beginning.
Full Transparency
If your product requires reformulation, a new CPSR, or significant changes to packaging or manufacturing processes, these will be quoted separately — clearly and in advance.
👉 We always recommend starting with a regulatory audit to identify potential risks early and avoid costly surprises.
Tailored Regulatory Services
If you already have part of the regulatory work in place, I can support you exactly where you need it.
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Labeling and claims review
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Safety Data Sheets (SDS)
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Standard Operating Procedures (SOPs)
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CPNP notification
Clear services. Fixed pricing. No hidden clauses.
Not Just a Consultancy
Your Cosmetic Compliance Partner
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At Cláritas Regulatory, we focus exclusively on cosmetic Regulatory Affairs.
We know that dealing with regulation can feel confusing, slow — or
simply overwhelming.
That is why our approach is straightforward:
We speak your language.
We act quickly.
We handle the regulatory side, so you can focus on product
development, branding and sales.
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We specialize in EU, UK and US cosmetic regulation.
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We commit to every project as if it were our own.
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We value technical precision — and clear, direct communication.
The kind of stories we like to repeat
Natural cosmetics brand
The product was ready, but they were unsure how to proceed with EU notification.
We prepared the full PIF and reviewed the labeling. Today, the brand sells across Europe.
Artisan laboratory
They needed safety data sheets and labels. We resolved the issue in less than a week.