Regulatory Compliance Calculator
INCI listing and regulatory limits by market (EU, US, Asia).
About this calculator
This calculator checks one active ingredient at a time against four major market caps and layers pH rules where they apply. Ingredient Type selects a row from a six-entry limits table covering salicylic acid, retinol, AHA or glycolic, phenoxyethanol, hydroquinone, and niacinamide, each with US, EU, China, and Japan maximums where negative one means banned in cosmetics (lines 34-43). For every market, compliance is true when your Concentration is at or below that market's cap and false when the cap is a ban or your level exceeds it (lines 47-55). Markets Compliant counts how many of the four individual flags pass (line 64). Product pH is evaluated separately: when the ingredient row defines a minimum pH and the product is leave-on, pH Compliant requires Product pH to meet that floor -- 3.0 for salicylic acid, 3.5 for AHA (lines 58-61).
Ingredient Weight in Batch is batch size times concentration divided by one hundred (line 67). Strictest Limit filters out banned entries and takes the minimum of the remaining caps (lines 70-71). Global Max reports that minimum only when all four markets have numeric limits; otherwise it returns negative one (line 74). Safety Assessment Level starts at zero, rises to one when concentration exceeds half the strictest cap, and jumps to two when concentration exceeds eighty percent of that cap or pH fails (lines 78-80).
Inputs
Results
Markets compliant (of 4)
4
How to Use This Calculator
- Select the ingredient (Salicylic Acid, Retinol, AHA/Glycolic, Phenoxyethanol, Hydroquinone, or Niacinamide) you want to check.
- Enter its concentration, your product's pH, and whether it is a leave-on product.
- Enter the batch size in grams to calculate the ingredient's weight in the batch.
- Review the compliance checklist -- flagged items require regulatory attention.
- Use the output to prioritize safety assessments, CPNP notifications, or FDA filings.
How the result changes with Concentration (%)
| Concentration (%) | Markets compliant (of 4) |
|---|---|
| 1 | 4 |
| 1.5 | 4 |
| 3 | 0 |
| 5 | 0 |
What each input means
- Ingredient
- The restricted ingredient to check against market limits.
- Concentration (%)
- Your ingredient concentration as a percentage of the formulation.
- Product pH
- Product pH. Important for AHA and salicylic acid compliance (pH >= 3.5 required).
- Leave-on product? (0/1)
- 1 = leave-on (serum, cream), 0 = rinse-off (cleanser, shampoo). Affects pH requirements.
- Batch size (g)
- Batch weight for calculating ingredient mass.
What each result means
- Markets compliant (of 4)
- Number of major markets (US, EU, China, Japan) where your concentration is allowed.
- US/FDA compliant? (1=yes)
- Whether the concentration is within FDA limits for the US market.
- EU compliant? (1=yes)
- Whether the concentration is within EU Cosmetics Regulation limits.
- China compliant? (1=yes)
- Whether the concentration is within NMPA limits for China.
- Japan compliant? (1=yes)
- Whether the concentration is within PMDA limits for Japan.
- pH compliant? (1=yes)
- Whether the product pH meets requirements for this ingredient (if applicable).
- Strictest limit (%)
- The lowest maximum concentration across all markets. -1 if banned in any market.
- Ingredient weight (g)
- Grams of the ingredient in your batch.
- Safety assessment level
- 0 = minimal documentation, 1 = standard safety report, 2 = full toxicology review needed.
How this is calculated
Worked example, using the default values
- Identify Input Parameters4 parametersIngredient (1-6) = 1, Concentration (%) = 2, Product pH = 5.5, Leave-on product? (0/1) = 1 = 5 input(s) provided
- Calculate Markets compliantMarkets compliant4 = 4
- Calculate US/FDA compliant?1 = 1
- Calculate EU compliant?1 = 1
Engine last updated . Checked against 4 independently-derived tests — how we verify calculators. Built by Paul Gunder, a software engineer, not a licensed financial, medical, or legal professional.
Frequently Asked Questions
Does Batch Size change whether my formula passes in each market?
No. Every market flag compares your Concentration percentage directly against that market's cap from the ingredient table (lines 47-55). Batch Size appears only in Ingredient Weight in Batch, which converts the same percentage into grams for the batch you entered (line 67). A larger batch adds more grams of the ingredient but does not move compliance thresholds.
When does Product pH affect my results beyond the pH Compliant flag?
pH is checked only for ingredients whose table row defines a minimum and only when Leave-on Product is set to yes (lines 58-61). A failing pH pushes Safety Assessment Level to two even if concentration is below every market cap (line 80). Rinse-off products skip the pH floor entirely, so Product pH does not influence pH Compliant for them.
Why might Global Max show negative one even when some markets allow my ingredient?
Global Max returns the strictest numeric limit only when all four markets have non-negative caps (line 74). If any market entry is negative one -- meaning a cosmetic ban -- that ingredient cannot achieve four-market numeric compliance and Global Max reports negative one instead of a blended percentage, even though individual market flags may still show passes where sales are allowed.
How does Safety Assessment Level escalate as concentration rises?
The level begins at zero, moves to one when Concentration exceeds half of the strictest allowed cap among non-banned markets (line 79), and reaches two when Concentration exceeds eighty percent of that same cap or when pH Compliant fails (line 80). That means approaching a regulatory ceiling triggers heavier documentation requirements before you actually exceed the limit.
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