FAQ · Light on Regulations
Your compliance questions, answered.
Everything you need to know about cosmetic and chemical compliance with Lexora — from safety reports and lab testing to PCN, UFI codes and SDS.
Getting started
General
We provide complete regulatory solutions for market entry. Our core services include preparing the Cosmetic Product Safety Report (CPSR), Product Information File (PIF) assembly and review, EU Responsible Person (RP) representation, mandatory CPNP Notifications, and Cosmetic Label Reviews.
We offer flexible solutions depending on your stage of compliance. You can select individual, standalone services (like a single CPSR or a Label Review). Alternatively, our Cosmetic Service Packages and Chemical Service Packages are comprehensive bundles designed to take a product from zero to fully market-ready. Bundles combine all necessary safety assessments, lab test coordination, and legal reporting into one streamlined process, saving you time and administrative effort.
Our pricing policy is built on absolute transparency. All service fees are clearly listed on our website, meaning you will never encounter surprise fees or hidden costs. Because we provide this upfront, standardized pricing to all companies universally, we do not offer flexible discounts on standard orders. However, for manufacturers with exceptionally large product portfolios, our expert team provides dedicated operational support to streamline the submission process.
We manage the complexity for you through a simple 3-step process:
- Select & Order: Choose your required service directly through our website.
- Document Collection: We securely gather your required files (INCI lists, MSDS, existing test reports). If testing is needed, we coordinate sample shipments.
- Completion & Delivery: Our experts finalize your compliance documentation (such as CPSR, CPNP Report etc.) and digitally deliver your finalized reports.
Through our accredited laboratory partners, we coordinate all necessary physical, microbiological, and safety testing. This typically includes Stability and Compatibility Testing, Certificate of Analysis (Product Specification Testing), Microbiological Testing, Challenge Testing (Preservative Efficacy), and Heavy Metal Testing.
Not necessarily. The required tests depend entirely on the specific formulation and physical state of your product. For example, anhydrous (water-free) formulas often do not require Challenge Testing (Preservative Efficacy). Our Safety Assessors evaluate your unique product to determine exactly which tests are legally mandated, ensuring you do not pay for unnecessary analysis.
Cosmetics
Cosmetic Product Compliance
Absolutely. Under EU Regulation 1223/2009, any cosmetic product placed on the European market must have a designated Responsible Person established within the EU. We act as your official legal representative, holding your PIF and serving as the primary contact for EU regulatory authorities.
Yes, this is particularly common for color cosmetics (makeup). If the base formulation is identical and the only variation is the colorant ingredients, these products can generally be grouped within the same shade group. This allows for a combined PIF and CPSR, making the process highly efficient.
No. As long as the cosmetic formulation itself remains completely unchanged, selling the exact same product in multiple sizes (e.g., a 50ml jar and a 100ml jar) does not require an additional CPSR.
Our safety assessments are strictly data-driven. We calculate a precise Margin of Safety (MoS) for each ingredient utilizing the latest toxicological data, including POD and NOAEL values from reputable databases like ECHA and CIR. This scientific reasoning ensures every component is legally substantiated and safe for human health.
Our safety assessments are exclusively conducted by highly qualified experts who meet strict EU requirements. Our principal Safety Assessor holds a university degree with full EU equivalence, possesses a specialized certification in Cosmetic Product Safety Assessment from Vrije Universiteit Brussel (VUB), and is an officially EU-recognized Toxicologist. This high level of qualification ensures your CPSR is completely legally valid and accepted across all European member states.
Yes. Beyond standard INCI and warning label reviews, we provide illustrative graphic design guidance for mandatory environmental labeling (such as Triman and CONAI). We ensure your packaging artwork meets strict guidelines — for instance, implementing the Triman logo as a minimalist technical pictogram without unauthorized inner text or symbols, and correctly classifying accessories which are exempt from packaging waste categories.
The timeline depends heavily on the specific product and whether laboratory testing is required. If all necessary documentation (formulations, MSDS, existing test reports) is fully available, a standard CPSR can be finalized within 2-3 weeks. If new stability or challenge testing is needed, the timeline will align with the mandatory laboratory testing periods.
Chemicals
Chemical Product Compliance
Chemical compliance requires a different regulatory pathway than cosmetics. We provide comprehensive services under the CLP Regulation, including the preparation of Safety Data Sheets (SDS), mandatory Poison Centre Notifications (PCN), CLP Label preparation and review, and UFI Code generation for mixtures placed on the EU market.
If your chemical mixture is classified as hazardous due to health or physical effects under the CLP Regulation, a PCN is legally mandatory before placing the product on the EU market. We handle the complete PCN dossier compilation and submission through the ECHA portal on your behalf.
A UFI (Unique Formula Identifier) is a 16-character code required for hazardous mixtures sold in the EU. Once we generate this code through your Poison Centre Notification (PCN), it must be printed or affixed clearly and permanently on your product's label, typically near the hazard pictograms and safety information. We guide you through the exact placement rules during our label review service.
An SDS is not a static document. It must be updated immediately whenever new hazard information becomes available, when your formulation changes, or when new regulatory requirements (such as updated REACH annexes or new CLP classifications) come into force. We provide ongoing SDS authoring and review services to ensure your documents never fall out of compliance.
No. An SDS provided by a non-EU supplier is rarely compliant with strict European standards. To legally place a chemical product on the EU market, the SDS must specifically comply with the EU REACH Regulation (Annex II) and the CLP Regulation. A compliant EU SDS must include EU-specific occupational exposure limits, correct CLP hazard classifications, and explicitly list an EU-based legal entity (such as the EU importer). We can evaluate your supplier's original SDS and re-author it to ensure it strictly meets all European legal requirements.
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