After EFSA’s 2021 conclusion on E171, the committee reviewed 84 titanium dioxide grades (44 pigmentary, 40 nano). It found that genotoxicity could not be excluded for almost all grades in oral cosmetic products, kept its earlier conclusions for dermally applied products unchanged, and noted that information on flexed or damaged skin was not available. Its summary of raw-material impurities gives maximum HCl-soluble levels of 1 mg/kg arsenic, 10 mg/kg lead, 2 mg/kg antimony, 1 mg/kg mercury and 1 mg/kg cadmium for pigmentary grades; cadmium was not provided for nano grades.
Key numbers
Table 3.1.5 (PDF p. 21), SCCS summary of maximum impurities:
| Impurity | Pigmentary grades | Nano grades |
|---|---|---|
| Water-soluble substances | ≤ 0.5% | <0.25% |
| Acid-soluble substances | ≤ 1.5% | <0.5% |
| Arsenic (HCl-soluble) | ≤ 1 mg/kg | <1ppm |
| Lead (HCl-soluble) | ≤ 10 mg/kg | <10ppm |
| Antimony (HCl-soluble) | ≤ 2 mg/kg | <2ppm |
| Mercury (HCl-soluble) | ≤ 1 mg/kg | <1ppm |
| Cadmium (HCl-soluble) | ≤ 1 mg/k g | not provided |
Annex B (PDF pp. 99-101) lists grade-by-grade profiles. Most rows print ceilings (≤ 10 or ≤ 5 mg/kg lead). Three rows print numbers: RM01 (pigmentary) lead 0.3 mg/kg, RM02 (pigmentary) lead 0.8 mg/kg, both with arsenic, antimony, mercury and cadmium < 0.1; RM81 (nano) lead 3, antimony 0.5, mercury 0.1 and arsenic < 1 mg/kg. The applicants state that trace metals from ilmenite, rutile or slag ores are “embedded in the lattice” of the pigment.
Methods (brief)
Arsenic, cadmium, lead and antimony are determined in a 0.5 N hydrochloric acid extract of 10 g of pigment boiled for 15 minutes (ETAAS for Cd and Pb, ICP-AES for Sb, hydride AAS for As). Mercury is determined by cold-vapour AAS after closed-vessel sulfuric and nitric acid digestion, although Table 3.1.5 labels mercury “HCl-soluble”. Secretariat contact: SANTE-SCCS@ec.europa.eu.
Evidence fitness
Supports the specification framework and the order of magnitude of HCl-extractable impurities in cosmetic titanium dioxide raw materials. Because the extraction is partial, these values are not total content and cannot be compared directly with total-digestion finished-product data. They describe raw materials, not finished sunscreens.
Limitations
Applicant data, mostly as ceilings. No zinc oxide data. Dermal conclusions are carried over from 2013/14 rather than re-evaluated.
Related evidence
- Opinion on Titanium Dioxide (nano form), COLIPA S 75 (SCCS/1516/13)
- Safety assessment of titanium dioxide (E171) as a food additive
- Baby Sunscreen, Mineral (ZnO + TiO2)
- Lead
Update history
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