UK/EU Cosmetic Compliance Service: CPSR & PIF Preparation
Launch Your Cosmetic Product Legally in the UK & EU
AED 80.00
π Launch Your Cosmetic Product Legally in the UK & EU
Access the lucrative European market confidently. We provide end-to-end preparation, review, and authorization of the mandatory regulatory documentation required under Regulation (EC) No 1223/2009 (EU) and the UK Cosmetics Regulation.
π‘ Key Selling Points
Guaranteed Market Access: Complete regulatory files prepared for immediate EU CPNP and UK SCPN notification.
Qualified Safety Assessor: The mandatory Cosmetic Product Safety Report (CPSR) is signed by a European-certified Toxicologist.
PIF Compilation: We compile and verify all 5 critical sections of your Product Information File (PIF).
Reduced Time-to-Market: Avoid costly regulatory delays and product recall risks with our streamlined, expert-led process.
π Comprehensive Service Breakdown
Our service is dedicated to creating the two core documents essential for legal trade: the CPSR and the PIF.
1. Cosmetic Product Safety Report (CPSR)
The CPSR is the scientific proof that your finished product is safe for human use under normal and reasonably foreseeable conditions. It is the most critical component of the PIF.
Part A: Safety Information: We compile and verify all technical data, including:
Quantitative and Qualitative Composition (Full INCI list with % concentrations).
Physico-Chemical Characteristics and Stability Data.
Microbiological Quality and Preservative Efficacy Testing (PET).
Impurity/Trace Substance Data and Packaging Compatibility.
Toxicological Profiles for every ingredient.
Part B: Safety Assessment: This is the signed expert opinion, covering:
Risk Characterization and Margin of Safety (MoS) Calculation.
Final Conclusion on Product Safety.
Mandatory Warnings and Instructions for Use to be included on the label.
2. Product Information File (PIF) Compilation
The PIF is the comprehensive dossier containing all administrative, technical, and regulatory data related to the product. It must be held by the Responsible Person (RP) for 10 years after the last batch is placed on the market.
We organize and verify the five mandatory sections of your PIF:
PIF Section | Description | Our Deliverable |
|---|---|---|
I. Product Description | Name, function, and description of use. | Detailed Product Profile Sheet. |
II. CPSR | The complete 2-part safety assessment. | Final CPSR, signed by a Qualified Assessor. |
III. Manufacturing Compliance | Proof of adherence to Good Manufacturing Practices (GMP). | Verification of ISO 22716 compliance documentation. |
IV. Proof of Effect | Scientific evidence supporting any claims (e.g., "24-hour hydration"). | Claim substantiation review and summary of supporting data. |
V. Animal Testing Statement | Declaration of compliance with the EU/UK animal testing ban. | Official, Signed Non-Animal Testing Declaration. |
π― Who Needs This Service?
Manufacturers: Brands producing cosmetics for the EU or UK market.
Importers/Distributors: Businesses bringing non-EU/UK manufactured products into the region.
Responsible Persons (RP): RPs who need a complete, validated PIF to fulfill their regulatory duties.
πΌ Available Packages & Deliverables
Choose the package that aligns with your market strategy.
Package Tier | Focus | Includes |
|---|---|---|
Starter (CPSR Only) | Single, low-risk product entry. | Full CPSR (Part A & B) signed by Assessor. |
Professional (PIF Ready) | Comprehensive documentation and filing support. | CPSR, Full PIF Compilation (Sections I-V), and Label/Claim Review. |
Enterprise (Dual Market) | Compliance for complex formulations or multiple markets. | Professional Package + Support for both EU CPNP and UK SCPN notifications + two minor formula revisions. |
β Frequently Asked Questions (FAQ)
Q: Who is the Responsible Person (RP)? A: The RP is the entity (manufacturer, importer, or third party) established within the UK (for the UK market) or the EU (for the EU market) who is legally accountable for the product's safety and PIF maintenance. We can help you understand this role.
Q: What materials do I need to provide? A: You must supply a full percentage breakdown of your formula (INCI list), Safety Data Sheets (SDSs) for all raw materials, Stability Test Results, and Preservative Efficacy Test (PET) results.
Q: Is the UK regulation different from the EU regulation? A: Post-Brexit, the UK maintains its own regulation, which is currently very similar to the EU's (EC) No 1223/2009. We prepare documents to meet both standards simultaneously, ensuring seamless compliance across both markets.