Cosmetics and Consumer Products

Safety Assessment:

  • Preparation of a comprehensive Cosmetic Product Safety Report (CPSR) according to the EC Reg 1223/2009

  • Expert guidance on the final formula for both US and international marketplaces, ensuring that your products comply with all necessary regulations

  • Conduct preclinical toxicological profiling for ingredients

  • Recommendations on safe use-levels for raw materials and ingredients

  • Review fragrances and flavors to ensure safe use

  • Prop 65 compliance guidance

  • Impurities qualification

  • Expert guidance on NAMs, in silico tools, TTC approaches, QRA for dermal sensitization

  • Facilitate Seal of Recommendation or Acceptance:

Safety Testing:

  • Recommendations on appropriate clinical testing for products

  • Study placement and guidance on a variety of in vitro tox studies for various endpoints, such as:

    • Eye irritation

    • Skin Irritation

    • Skin Sensitization

    • Phototoxicity

    • Genotoxicity

    • Skin Absorption

Claims/Performance Testing:

  • Recommendations on the study need

  • Help finalize the study design

  • Collaborate with testing facilities

  • Study placement and monitoring

  • Reviewing and interpreting test results

Regulatory:

  • Serve as a Responsible Person, as defined in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), to:

    • List cosmetic products with the FDA

    • Ensure and maintain product-safety records

    • Report serious adverse events to the US FDA

  • Notify Health Canada > Cosmetic Notification Form (CNF)

  • Formulation review to ensure compliance with Reg (EC) No 1223/2009

  • Help facilitate CPNP notification

  • Facilitate compilation of Product Information File (PIF)

  • Formulation review to ensure compliance with the ASEAN Cosmetic Directive (ACD)

  • Artwork/label review

  • Recommendation on Cautionary Statements and Label Warning

  • Assist with a variety of regulatory compliance issues, including:

    • Addressing audit-associated queries

    • Providing guidance on international registration/notification requirements

    • Facilitating INCI registration

  • Facilitate meeting regulatory requirements of various countries such as European, China, Turkey, Indonesia, Singapore, Thailand, India, Saudi Arabia, Brazil, and more

Other:

  • We offer recommendations on the following to ensure the quality and safety of your products:

    • Packaging material requirements

    • Stability testing requirements

    • Micro-testing requirements

    • Product testing for contaminants (Heavy Metals, Nitrosamines, Benzene, 1,4 Dioxane, Ethylene Oxide, Acrylamide, and more )

Cosmetics-Safety-Assessment-Toxicological-Assessment

Frequently Asked Questions

  • A CPSR is mandatory under EU Regulation (EC) No 1223/2009. It assesses each ingredient, potential consumer exposure, and overall product safety before market launch. Without a CPSR, cosmetics cannot legally be sold in the EU, making it a cornerstone of market access and regulatory compliance.

  • Global compliance involves:

    ·         Formulation assessment

    ·         Banned/restricted substance compliance

    ·         Safety substantiation

    ·         Product notifications (e.g., EU CPNP, US FDA MoCRA, Health Canada)

    ·         Label/claim compliance

  • Global regulators are moving toward New Approach Methodologies (NAMs), Animal Testing Bans, Green Chemistry, and Stricter Claim Scrutiny. Proactive adaptation ensures long-term compliance and brand resilience.

  • It ensures formulations meet toxicological, microbiological, and stability standards required by regulators such as the FDA, EU authorities, and Health Canada. Robust safety substantiation protects consumers, supports claims, and shields brands from recalls or enforcement action.

  • SciQra delivers end-to-end safety and regulatory support, including CPSRs, PIF Compilation, Formulation and Packaging Safety, Label/Artwork Review, Claim Substantiation, and Global Market Notification (EU, US, Canada). We help brands launch products confidently across global markets.