New Safe Harbor Level for Breathable Titanium Dioxide in California

California has updated the permissible exposure levels for respirable titanium dioxide under Proposition 65. These limits determine when a brand must include the familiar warning about exposure to potentially carcinogenic substances.

A key point: this update does not affect pigmented titanium dioxide used in creams, lotions, sunscreens, compact makeup, or emulsion products. The change focuses solely on particles that can be inhaled, commonly found in loose powders, aerosols, or mists.

Table of contents

• A) New Safe Harbor levels (permanent)

• B) Impact on cosmetics: who does it really affect?

• C) What should brands do to comply?

New Safe Harbor Level for Breathable Titanium Dioxide in California

A) New Safe Harbor levels (permanent)

California has set two daily exposure thresholds:

• Fine particles (≤10 µm): 440 µg/day

• Ultrafine particles (≤0.8 µm): 44 µg/day

Below these values, a Proposition 65 warning is not required. If they are exceeded, the warning must appear on the label, on the website, and on any sales material or media where the product is marketed.

B) Impact on cosmetics: who does it really affect?

Formats with a higher probability of generating inhalant exposure

• Loose powder

• Sprays, mists and aerosols

• Atomized or nebulizable products

Formats that are normally out of reach

• Compact makeup (not loose)

• Creams, gels, lotions and any emulsion

• Products that do not generate suspended particles

In general, if the product does not release dust or mist into the air during use, respirable exposure is minimal.

C) What should brands do to comply?

1. Identify the form of titanium dioxide

   Confirm whether it is breathable or if it is integrated into a non-inhalable matrix.

2. Assess the actual risk of inhalation

   It depends on both the particle size and the format and method of use.

3. Store internal documentation

   Proposition 65 does not require prior registration, but it does require the ability to demonstrate compliance in the event of inspections or enforcement actions.

4. Update labeling only when necessary

   The warning should only be applied if the estimated exposure exceeds the Safe Harbor Level.

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