Opinion on Titanium Dioxide (nano form), COLIPA S 75 (SCCS/1516/13)

The committee concluded that nano titanium dioxide with the listed characteristics, at up to 25 % in sunscreens, is not expected to pose a risk after application on healthy, intact or sunburnt skin, and it did not recommend spray applications. On purity, the applicant only claimed conformity with USP and FDA specifications. SCCS recorded that analytical data on purity and impurities were not submitted and asked for mercury, cadmium, lead, arsenic and antimony contents and for the contact allergens chromium, cobalt and nickel.

Key numbers

Claimed specifications (PDF p. 8): USP 35, TiO2 99.0 to 100.5 %, water-soluble ≤ 0.25 %, acid-soluble ≤ 0.5 %, arsenic ≤ 1 ppm, loss on ignition ≤ 13 %; FDA, lead (HCl-soluble) ≤ 10 ppm, antimony (HCl-soluble) ≤ 2 ppm, mercury ≤ 1 ppm. Materials were tested uncoated.
SCCS comments (PDF p. 9): “Analytical data on purity and impurities were not submitted”; the applicant said the materials contain no heavy metals “beyond the generally accepted limits” under USP-31, which SCCS asked to be quantified.
One material, S75-N, is doped with 1000 ppm iron (PDF p. 16).
Conclusion (PDF p. 103): up to 25 % for materials of mainly rutile form or rutile with up to 5 % anatase, purity ≥ 99 % or impurities shown safe; not for sprays.

Methods (brief)

Committee review of the submission and open literature. Secretariat contact: SANCO-C2-SCCS@ec.europa.eu.

Evidence fitness

Supports the EU conclusion for dermal use and the fact that the assessment rested on claimed, not measured, impurity ceilings. The ceilings match 21 CFR 73.575 for lead, antimony and mercury. The opinion does not provide measured metal content of any titanium dioxide material.

Limitations

The 2024 SCCS advice notes that data on flexed or damaged skin were not available to this opinion. No infant-specific assessment.

Update history

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