ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. We have a reputation for applying sound science in all that we do, for leading-edge thinking, and for tailoring our approach to meet the specific needs of our clients, whether a rapid response or a comprehensive analysis is needed.
Ensuring the safety of cosmetics and personal care products requires knowledge not only of standard and next-generation approaches in safety and risk assessment but also of the ever-evolving regulatory requirements associated with development, testing, and compliance. As many companies move toward the use of natural ingredients such as botanicals, new complexities are introduced in ingredient and product safety assessments. Moreover, evaluations must accommodate heterogeneous data from emerging technologies, address a wide array of toxicological endpoints, and be conducted according to rigorous standards—hence the need for strategic, multidisciplinary, systematic approaches to the evaluation of safety for these personal care products. We have relevant experience and capabilities in the following areas:
Modernization of Cosmetics and Regulation Act (MoCRA)
- Compliance
- Safety substantiation
- Adverse-event reporting and record keeping
- Fragrance allergens
- Talc-containing cosmetics
- Good Manufacturing Practices
- PFAS in cosmetics
Ingredient and Raw Material Safety Assessment
- Templates and standard operating procedures: development and review
- Screening-level or comprehensive assessment
- Assessment strategy development for a variety of ingredient types, including polymers, botanicals, proteins
- Literature searches using in vivo, in vitro, and/or in silico data
- Landscape and data gap assessment
- Identification of restricted ingredients
- Hazard evaluation (systemic, site-of-contact, sensitization, phototoxicity)
- Endocrine disruption assessment
- Ecological safety and environmental impact evaluation
- Application of approaches for next-generation risk assessment
- Exposure assessment (dermal, systemic [inhalation, oral])
- Determination of dermal sensitization threshold and points of departure
- Risk assessment (margins of exposure and safety, toxicological threshold of concern [TTC])
- Conditions-of-use recommendations
- California Proposition 65 evaluations
Product Safety Assessment
- Template and standard operating procedure development and/or review
- Final formula assessment
- Clinical testing design strategy development and evaluation
- Product information files
- Cosmetoviligance
Non-Animal Testing Methods
- Design and interpretation of animal-free testing strategies
- Placement and monitoring of studies
- Curation and interpretation of high-throughput screening data
- Facilitation of new-approach methods (NAMs) for skin sensitization and other endpoints
- QSAR, read-across, and other in silico models (OECD, QSAR Toolbox, VEGA-QSAR, ToxTree, USEPA EPI Suite, Lhasa Ltd., Derek Nexus, and Leadscope Model Applie)
- Development and application of weight-of-evidence safety justifications
- Support associated claims (e.g., leaping bunny, cruelty free, vegan)
Product Sustainability
- Biodegradability claims
- Verified assessors
- Ecoscoring methods
- Chemical Alternatives Assessment
- Assessment of post-consumer recycled plastics in a variety of contexts
Botanicals
- Novel ingredient assessment of botanically derived ingredients, including proteins, waxes, and fibers
- Characterization of plant extract preparations, including essential oils, various extraction methods, etc.
- Hazard assessment, data gap identification, and prioritized recommendations
- History of human-use justification
- Structural screening of unknown compounds or contaminants
- Quantitative risk assessment (including TTC)
Regulatory/Authoritative Frameworks
- Provide scientific guidance on global regulatory issues
- Development of strategies to mitigate business impact from regulatory restrictions
- Familiarity with:
- Scientific Committee on Consumer Safety (SCCS)
- Food and Drug Administration (FDA) (e.g., MoCRA, Sunscreen Drug Products for over-the-counter human use; sunscreen drug products developed under an NDA; generally recognized as safe and effective [GRASE])
- European Commission Cosmetics Directive
- United Nations Globally Harmonized System (GHS)
- Classification, Labeling, and Packaging (CLP) of substances and mixtures
- Cosmetic Ingredient Review (CIR)
- International Fragrance Association (IFRA) and Research Institute for Fragrance Materials (RIFM)