Navigating the complexities of international fragrance and cosmetic regulations to ensure your product is legal, safe, and ready for retail.

Our Compliance Expertise: Global Standards

  • IFRA Standards: Mandatory compliance with the latest IFRA (International Fragrance Association) amendments for all fragrance oils, ensuring safe concentration levels based on product category (e.g., perfume vs. candle).

  • Allergen Reporting: Providing detailed Allergen Lists (根据欧盟 EU 1223/2009 要求) for proper labeling.

  • European Union (EU): Expertise in REACH (化学品注册、评估、授权和限制) and the Cosmetic Products Regulation (CPR, EC 1223/2009), including required documentation for CPNP (Cosmetic Products Notification Portal) filing.

  • United States (US): Ensuring compliance with the FDA (Food and Drug Administration) regulations, including required labeling formats and adherence to MoCRA (Modernization of Cosmetics Regulation Act of 2022).

  • MSDS/SDS: Providing complete and accurate Safety Data Sheets (SDS) for all finished products, formatted according to global standards (e.g., GHS format).

  • Certificates of Analysis (COA): Issuing Certificates of Analysis for every batch to verify purity and specifications.

  • Sourcing Gate: All raw materials must pass an internal IFRA/REACH screening before R&D.

  • Formulation Review: Regulatory specialists review the proposed formula (including concentration levels) against the target market’s specific restrictions.

  • Stability & Safety Testing: Products undergo safety assessments to confirm stability and compatibility.

  • Final Dossier Creation: We compile the required technical documentation (PIF – Product Information File for EU clients).

  • Liability: Clearly state your role in compliance and your quality control guarantees.

  • Audit Readiness: Our facility and documentation are prepared for any necessary external audits by clients or regulatory bodies.

Statement: Discuss your target market and let our regulatory team outline the necessary compliance steps for your project.

F.A.Q.

Regulatory Compliance FAQ

A: The single most important standard is IFRA (International Fragrance Association) compliance. IFRA sets the global safety standards for fragrance ingredients. Every formula we create or duplicate is guaranteed to meet the latest IFRA amendments for the specific product application (e.g., a candle requires a much lower concentration than a room spray). This is the foundation of product safety globally.

A: We provide all the necessary technical documentation required for CPNP filing (part of the Product Information File – PIF), including ingredient breakdowns and safety assessments. However, the final legal responsibility for filing the notification on the CPNP portal rests with the designated Responsible Person (RP) established by the brand in the EU. We work closely with your designated RP to ensure the information transfer is seamless.

A: Our compliance strategy includes:

  1. Ingredient Vetting: Ensuring all ingredients are permissible under US law.

  2. Facility Registration: We maintain current Facility Registration with the FDA.

  3. Labeling Review: We ensure the ingredient lists and warnings meet the format required by the MoCRA legislation.

A: We have dedicated regulatory staff monitoring IFRA and EU/US updates in real-time. If a change affects your active formula:

  1. Immediate Notification: We immediately notify the client of the required change.

  2. Rapid Re-Formulation: Our R&D team provides a compliant replacement formulation that maintains the original scent profile as closely as possible, typically within 1-2 weeks.

A: Liability is shared based on the issue:

  • Manufacturing/Formulation Errors: If the non-compliance stems from our formulation (e.g., using a non-compliant IFRA ingredient) or production process, we assume liability for the manufacturing error.

  • Labeling/Marketing Errors: If the non-compliance is due to incorrect marketing claims, incorrect labeling (e.g., missing mandatory warnings), or failure to appoint an EU Responsible Person, the Client (Brand Owner/Responsible Person) typically holds the liability. Our contracts clearly define the scope of our quality and compliance guarantee.

A: Yes. We provide a complete Safety Data Sheet (SDS) for every finished product. This document is essential for safe handling, emergency response, and is legally required for logistics and customs clearance (especially for flammable goods). Our SDS documents are formatted to meet current international standards (e.g., GHS format).

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Email: koohancom@gmail.com.