Margin of Safety Calculator
Calculate MoS and SED for cosmetic ingredients using SCCS methodology. 15 product categories with default exposure values.
SCCS/1647/22 CompliantSCCS default: 50% if no in vitro data available
SCCS default: 60 kg
SED Calculation Breakdown
MoS Calculation
Maximum Safe Concentration
Parameters Used
Look up ingredient safety data in our database of 30,000+ cosmetic ingredients
Search Ingredient DatabaseWhat is the Margin of Safety (MoS)?
The Margin of Safety (MoS) is a fundamental safety metric required in every EU Cosmetic Product Safety Report (CPSR) under Regulation EC 1223/2009. It quantifies how far below the toxic dose an ingredient's actual exposure is.
Where:
- NOAEL = No Observable Adverse Effect Level (mg/kg bw/day) — the highest dose in animal studies showing no adverse effects
- SED = Systemic Exposure Dosage (mg/kg bw/day) — how much of the ingredient enters the body through normal cosmetic use
Safety threshold: MoS must be ≥ 100 to be considered safe. This 100x factor accounts for 10x interspecies variability (animal → human) and 10x intraspecies variability (between humans).
How SED is Calculated
| Variable | Description |
|---|---|
| C | Concentration of ingredient in product (%) |
| DA | Dermal absorption (%). Default 50% per SCCS; 100% for oral products |
| Amount | Daily amount of product applied (mg/day, from SCCS Table 3) |
| Retention | 1.0 for leave-on; 0.01 for rinse-off products |
| BW | Body weight (default 60 kg) |
SCCS Default Product Category Values
Source: SCCS Notes of Guidance (SCCS/1647/22), Table 3
| Category | Amount (mg/day) | Retention | Type |
|---|---|---|---|
| Body Lotion | 7,820 | 1.0 | Leave-on |
| Face Cream | 800 | 1.0 | Leave-on |
| Hand Cream | 1,700 | 1.0 | Leave-on |
| Lipstick | 57 | 1.0 | Oral |
| Toothpaste | 138 | 1.0 | Oral |
| Mouthwash | 1,000 | 1.0 | Oral |
| Deodorant | 500 | 1.0 | Leave-on |
| Eye Cream | 160 | 1.0 | Leave-on |
| Shampoo | 10,460 | 0.01 | Rinse-off |
| Shower Gel | 16,350 | 0.01 | Rinse-off |
| Conditioner | 14,000 | 0.01 | Rinse-off |
| Hand Soap | 800 | 0.01 | Rinse-off |
| Hair Styling | 3,920 | 1.0 | Leave-on |
| Sunscreen | 18,000 | 1.0 | Leave-on |
| Foundation / Makeup | 510 | 1.0 | Leave-on |
How to Find NOAEL Values
The NOAEL is typically derived from 90-day repeated-dose oral toxicity studies. Key sources:
SCCS Opinions
Scientific Committee on Consumer Safety publishes ingredient-specific opinions with NOAEL values. Search at ec.europa.eu/health/scientific_committees
CIR (Cosmetic Ingredient Review)
US-based expert panel reviews. Available at cir-safety.org. Often includes NOAEL data from toxicological studies.
ECHA REACH Dossiers
European Chemicals Agency REACH registration dossiers contain repeated-dose toxicity data. Search at echa.europa.eu
EFSA Scientific Opinions
European Food Safety Authority for ingredients also used in food. Available at efsa.europa.eu
Dermal Absorption Guidelines
Default 50%: When no in vitro or in vivo dermal absorption data is available, the SCCS recommends using 50% as a conservative default.
100% (oral route): For products with oral exposure (lipstick, toothpaste, mouthwash), 100% absorption is assumed since the ingredient is ingested.
In vitro studies: If validated in vitro percutaneous absorption data is available (OECD TG 428), the mean + 2 standard deviations of the absorbed amount should be used.
100% for small molecules: For substances with molecular weight below 100 Da, 100% absorption may be warranted.
References
- SCCS (Scientific Committee on Consumer Safety). Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 12th Revision. SCCS/1647/22. European Commission, 2023.
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. Official Journal of the European Union, 2009.
- OECD Test Guideline 428: Skin Absorption: In Vitro Method. OECD Guidelines for the Testing of Chemicals, 2004.