CE.way Regulatory Consultants Ltd.

★★★★★ 4.9 / 5
• 81 reviews

CE.way offers comprehensive regulatory and testing solutions for cosmetic products, ensuring market access in the EU and UK. They provide expert guidance on compliance, safety assessments, and product testing.

CE.way Regulatory Consultants Ltd. specializes in helping businesses bring cosmetic products to market efficiently, with a strong focus on EU and UK regulations. They offer a full suite of services including regulatory consulting, product information file (PIF) preparation and review, CPNP/SCPN notifications, and acting as the EU and/or UK Responsible Person (RP). Their testing capabilities are extensive, covering crucial areas like stability and compatibility testing, preservative efficacy testing (challenge tests), and comprehensive microbiology testing to ensure product safety and compliance with standards such as ISO 29621 and ISO 11930. CE.way also provides expert cosmetics safety assessments (CPSR), a mandatory requirement for placing products on the EU/UK market. They meticulously evaluate product formulas, raw material safety, packaging compatibility, and microbiological data to guarantee consumer safety. With their in-house lab facilities and deep regulatory knowledge, CE.way acts as a trusted partner for navigating the complexities of cosmetic product compliance.

About

**Who they are**
CE.way Regulatory Consultants Ltd. provides comprehensive regulatory and testing solutions to ensure cosmetic products can be placed on the EU and UK markets. They offer expert guidance on compliance, safety assessments, and product testing.

**Expertise & scope**
* **EU & UK Cosmetics Regulations:** Assistance with fulfilling all regulatory requirements for market access in both regions.
* **Product Information File (PIF) Preparation & Review:** Support in creating and reviewing essential documentation.
* **Cosmetic Product Safety Assessment (CPSR):** Conducting safety assessments performed by qualified persons, forming part of the PIF.
* **Stability & Compatibility Testing:** Evaluating product stability under various conditions, assigning shelf life and period after opening.
* **Preservative Efficacy Testing (PET) / Challenge Testing:** Assessing the effectiveness of preservative systems against microbial contamination according to ISO 11930:2019 or USP 51.
* **Microbiological Testing:** Testing for common microbiological specifications to ensure product safety and compliance with EU regulations, including Total aerobic plate count (ISO 21149:2017), Yeast & mould count (ISO 16212:2017), and specific pathogen testing (e.g., Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Escherichia coli).
* **Safety Data Sheet (SDS) Preparation:** Creating SDS documents for substances or mixtures classified as hazardous or meeting PBT/vPvB criteria.
* **Patch Testing:** Recommending and performing patch tests to determine potential skin irritation, contributing to product safety claims.

**Reputation / proof points**
* Adherence to international standards such as ISO 29621, ISO 11930:2019, ISO 21149:2017, ISO 16212:2017, ISO 22718:2016, ISO 22717:2016, ISO 18416:2015, ISO 21150:2015.
* Expertise in EU Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.

Additional information

CE.way offers flexible service packages, allowing clients to order individual services or choose comprehensive packages tailored to their needs. They emphasize the importance of a complete Product Information File (PIF), which includes the cosmetic product formula, raw material toxicological profiles, and physical/chemical specifications. For safety assessments, a qualified person must conduct the evaluation before market placement. While patch testing is not mandatory under EU or UK regulations, CE.way recommends it as an additional measure to prove product safety and support dermatological claims. They can assist with various types of testing, including stability, challenge, and microbiological analyses, all crucial for demonstrating compliance and consumer safety.

Key Highlights

  • Provides comprehensive regulatory and testing solutions for cosmetic products targeting the EU and UK markets. Source
    “CE.way cosmetics regulatory services that help you fulfil all of the regulatory requirements posed by the EU and UK cosmetics regulations and consequently enable you to place your products on the EU and UK market.”
  • Offers expert services including Product Information File (PIF) preparation and review, and Cosmetic Product Safety Assessments (CPSR). Source
    “Product information file (PIF) preparation Product information file (PIF) review”
  • Conducts critical safety tests such as stability, compatibility, and challenge (preservative efficacy) tests. Source
    “The cosmetic product stability and compatibility test is required by EU Cosmetics Regulation 1223/2009 and the UK Schedule 34...”
  • Performs essential microbiological testing according to international standards like ISO 21149:2017 and ISO 16212:2017. Source
    “Total aerobic plate count (ISO 21149:2017) Yeast & mould count (ISO 16212:2017)”

Certifications & Trust Signals

  • Adheres to EU Cosmetics Regulation 1223/2009 and UK Schedule 34. Source
    “The cosmetic product stability and compatibility test is required by EU Cosmetics Regulation 1223/2009 and the UK Schedule 34...”
  • Utilizes international standards for testing, including ISO 11930:2019 for challenge tests. Source
    “CE.way checks the preservation system's effectiveness using the international cosmetics challenge test standard ISO 11930:2019...”

Buyer Snapshot

Best for
  • Cosmetic brands seeking EU and UK market access
  • Companies needing assistance with regulatory documentation (PIF, CPSR)
  • Manufacturers requiring product safety and compliance testing
How engagement typically works
  • Project-based service delivery
  • Customizable service packages
  • Direct expert consultation
Typical deliverables
  • Product Information File (PIF)
  • Cosmetic Product Safety Report (CPSR)
  • Stability test reports
  • Microbiological test reports
  • Safety Data Sheets (SDS)
  • Patch test reports
Good to know
  • Best when clients have a clear understanding of their product formula and intended markets.
  • Requires client cooperation for providing product samples and detailed information.

Pricing

Model: Custom pricing
HQ: United States, EU
Languages: English
Timezones: EST
Claim status: Listed

Services & Capabilities

EU+UK Cosmetics Compliance

Jurisdictions: EU, UK
Countries: EU, UK
Industries: Medical Devices, Pharmaceuticals, Biotech
Onboarding time: 7–21 days
Pricing model: Custom pricing
Supports CPNP: No
Supports PIF: No
Product Categories: Oral care, Make-up and Decorative Cosmetics
Label Review Included: Yes
Supports CPSR: Yes
Supports Claims Substantiation: Yes
Supports Ukcosmetics Rp: Yes
Can Provide Local Address On Label: No
Turnaround SLA: Custom
Supports Regulatory Consulting: Yes
Supports Formula Compliance Checks: Yes

Additional cosmetics_rp Details

Supports CPNP
false
Supports PIF
true
Supports CPSR
true
Markets Covered
EU+UK
Can Provide Local Address On Label
false
Label Review Included
false
Onboarding Steps
Clients can order services individually or choose a package. Contact CE.way for a quote.
Supports Regulatory Consulting
true
Supports Formula Compliance Checks
true
Supports Testing Coordination Management
true
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