The Cosmetics industry encompasses a number of personal care products used every day by men, women and children throughout the world. Including products for skin care, hair care, nail care, makeup, fragrances and shampoo.

The EU Regulation n. 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products placed on the EU market. It strengthens the safety requirements for cosmetic products, the safety assessor qualifications and non-animal testing; pointing out attention on quality, safety, efficacy and labelling requirements.

ToxHub Consulting, with its European Registered Toxicologists (ERT) and Cosmetologist, will assist your company to meet its goals by offering you a complete set of solutions ranging from the cosmetic formula design and development to the Product Information File preparation. Our scientific and regulatory experts can help you to become a trusted and valued cosmetic ingredient supplier. We can assist you to be competitive and to avoid any issue in advance and to effectively and efficiently meet the requirements of the EU Regulation.

Our team of experienced toxicology and risk assessment specialists provide creative, science-based solutions to support the cosmetic and consumer product industries’ ongoing and new business initiatives.

Our cosmetic consulting services performed by a Safety Assessor qualified according to Regulation (EC) No 1223/2009, include:

  • Toxicological characterization of new cosmetic ingredients in line with EU guidance and legislation and Scientific Committee on Consumer Safety (SCCS) guidance and in any case useful for meeting regulatory requirements worldwide;
  • Project plan to develop a new cosmetic ingredient with non-animal alternative method selection (in silico and in vitro) complying with the restrictions on animal testing placed under Regulation (EC) No 1223/2009;
  • In silico assessment (QSAR modelling, analogue identifications and read across justification) of toxicological endpoints for new cosmetic ingredients using commercial tools such as Lhasa and Leadscope. The ICH M7 approach will be followed for the evaluation of genotoxicity potential. Other endpoints (e.g. skin sensibilization) will be evaluated following a step-by-step approach (services provided by partners);
  • Guidance-compliant screening for endocrine disrupting properties;
  • Feasibility and safety screening of new technologies including botanicals and nanomaterials;
  • Selection and monitoring of the most suitable experimental in vitro assays for safety and efficacy evaluation for both new cosmetic ingredients and cosmetic formulations;
  • Document-based review to ensure that all ingredients used in the cosmetic product meet the restriction and limitation of the regulatory agencies;
  • Hypoallergenic claim evaluation according to the technical document on cosmetic claims;
  • Preparation of cosmetic ingredient dossiers;
  • Development of Product Information Files (PIF):
    • Part A – Cosmetic Product Safety Information
    • Part B – Cosmetic Product Safety Assessment
  • Notification via CPNP (Cosmetic Product Notification Portal);
  • Due diligence evaluation of new business ventures;
  • Customized external training on the EU Regulation (EC) No 1223/2009.