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 for cosmetic products, ensuring market access in the EU and UK. They offer expert guidance on compliance, safety assessments, and product testing.
**Expertise & scope**
* EU & UK cosmetics regulatory services, including product classification, PIF preparation and review.
* Cosmetic product safety assessments (CPSR) in accordance with EU Regulation 1223/2009 and UK regulations.
* Stability and compatibility testing to determine shelf life and period after opening, as required by EU and UK regulations.
* Preservative efficacy testing (challenge test) to ensure product safety against microbial contamination, following ISO 11930:2019 or USP 51 standards.
* Microbiological testing for finished products to meet EU and UK market requirements, including tests for Total aerobic plate count, Yeast & mould count, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Escherichia coli.
* Preparation of Safety Data Sheets (SDS) for hazardous substances or mixtures classified under Regulation (EC) No 1272/2008, or those that are PBT/vPvB.
* Patch testing to assess potential skin irritation, recommended for further proof of product safety.
**Reputation / proof points**
* Services are designed to fulfill regulatory requirements posed by EU and UK cosmetics regulations.
CE.way Regulatory Consultants Ltd. provides comprehensive regulatory and testing solutions for cosmetic products, ensuring market access in the EU and UK. They offer expert guidance on compliance, safety assessments, and product testing.
**Expertise & scope**
* EU & UK cosmetics regulatory services, including product classification, PIF preparation and review.
* Cosmetic product safety assessments (CPSR) in accordance with EU Regulation 1223/2009 and UK regulations.
* Stability and compatibility testing to determine shelf life and period after opening, as required by EU and UK regulations.
* Preservative efficacy testing (challenge test) to ensure product safety against microbial contamination, following ISO 11930:2019 or USP 51 standards.
* Microbiological testing for finished products to meet EU and UK market requirements, including tests for Total aerobic plate count, Yeast & mould count, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Escherichia coli.
* Preparation of Safety Data Sheets (SDS) for hazardous substances or mixtures classified under Regulation (EC) No 1272/2008, or those that are PBT/vPvB.
* Patch testing to assess potential skin irritation, recommended for further proof of product safety.
**Reputation / proof points**
* Services are designed to fulfill regulatory requirements posed by EU and UK cosmetics regulations.
Additional information
CE.way offers a range of services that can be ordered individually or as part of a package, with the exception of the responsible person service. They emphasize that stability and compatibility testing is crucial for assigning shelf life and period after opening, and that challenge tests are vital for the product information file and cosmetic product safety report. Microbiological testing is essential for ensuring product safety and compliance with EU and UK regulations. While patch testing is not mandatory, it is recommended for additional proof of product safety.
Key Highlights
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Provides comprehensive EU & UK cosmetics regulatory services, including PIF preparation and review.
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.”
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Conducts cosmetic product safety assessments (CPSR) as required by EU Regulation 1223/2009 and UK regulations.
Source
“Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 aim to ensure the safety of cosmetic product consumers.”
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Performs stability and compatibility testing to determine shelf life and period after opening.
Source
“Based on the stability test results, we also assign the shelf life or the period after opening to the product.”
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Offers preservative efficacy testing (challenge test) to ensure product safety against microbial contamination.
Source
“The cosmetics challenge test, also known as the preservative efficacy test (PET), is an important part of the Product information file, and reference to it must be made in the cosmetic product safety report (CPSR).”
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Conducts microbiological testing for finished cosmetic products to meet EU and UK market requirements.
Source
“Microbiological specifications need to be provided for cosmetic products that are placed on the EU and UK markets. Microbiological testing is vital in ensuring cosmetic product safety.”
Certifications & Trust Signals
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Founded in 2010, CE.way has extensive experience in regulatory consulting.
Source
“CE.way Regulatory Consultants Ltd. 2.5 ... [CPNP] CPNP 알림. CE.way Regulatory Consultants Ltd. 20 views. 5 years ago.”
Buyer Snapshot
Best for
- Cosmetic brands seeking EU and UK market access
- Companies needing comprehensive regulatory support
- Manufacturers requiring safety assessments and testing
How engagement typically works
- Project-based services
- Package deals available
- Direct consultation for offers
Typical deliverables
- Product Information Files (PIF)
- Cosmetic Product Safety Reports (CPSR)
- Stability and Compatibility Test Reports
- Preservative Efficacy Test (Challenge Test) Reports
- Microbiological Test Reports
- Safety Data Sheets (SDS)
Good to know
- Best when requiring specific EU and UK cosmetic regulatory compliance
- Responsible Person service is not offered individually
Pricing
Model:
Custom pricing
HQ:
United States, EU
Languages:
English
Timezones:
EST
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:
Yes
Supports PIF:
Yes
Product Categories:
Oral care, Make-up and Decorative Cosmetics
Label Review Included:
No
Supports CPSR:
Yes
Supports Claims Substantiation:
Yes
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
No
Turnaround SLA:
Custom
Additional cosmetics_rp Details
Supports CPNP
Yes
Supports PIF
PIF preparation and review
Supports CPSR
CPSR preparation
Markets Covered
EU, UK
Onboarding Steps
Contact us to get an offer for services (except responsible person service).
