Cosmetics & Personal Care

Cosmetics & Personal Care

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:

  • Skin Cancer Foundation

  • National Eczema Association

  • Canadian Dermatology Association

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 )

Frequently Asked Questions