Water-soluble zinc salts (used in oral hygiene products - Submission II): What the SCCS Concluded About Safety in Cosmetics
Water-soluble zinc salts (used in oral hygiene products - Submission II) safety summary from SCCS/1657/23: SCCS conclusion, NOAEL, maximum concentration o.
Water-soluble zinc salts (used in oral hygiene products - Submission II) is covered by SCCS/1657/23, an SCCS-family cosmetic safety opinion dated 2023-10-26. The opinion conclusion for this opinion is direct enough for a substance-specific summary: The SCCS has calculated aggregate exposure to water-soluble zinc salts via toothpaste at the concentrations of 1% and from diet, and concluded that the use of zinc in toothpaste is safe per se except for children under the age of 1 year because the intake exceeds the upper limit level.
Core Opinion Facts
- Opinion: SCCS/1657/23
- Opinion date: 2023-10-26
- Primary substance: Water-soluble zinc salts (used in oral hygiene products - Submission II)
NOAEL Values Cited in the Opinion
The no-observed-adverse-effect data below is shown only from the SCCS source fields for this opinion. It is not a calculated margin-of-safety output.
| Endpoint | Value | Unit | Study context |
|---|---|---|---|
| systemic_NOAEL_adults | 50 | mg/day | human, oral, repeated-dose (short-term supplementation studies) |
| oral_NOAEL_copper_status | 0.43 | mg/kg bw/day | human, oral, repeated-dose supplementation studies |
| tolerable_upper_intake_level_adult | 25 | mg/day | human, oral, chronic (reference UL) |
Maximum Concentration or Conditions
| Use condition | Value | Unit |
|---|---|---|
| Toothpaste (adults and children ≥1 year) | 1.0 | % |
| Toothpaste (children 6 months to 1 year) | 0.72 | % |
| Mouthwash (age >6 years; not recommended ≤5 years) | 0.1 | % |
Conditions from the Opinion
Toothpaste: max 1% Zn for ages ≥1 year, max 0.72% Zn for ages 6 months to 1 year. Mouthwash: max 0.1% Zn for ages >6 years (not recommended for ages ≤5 years).
How to Read This Safety Conclusion
The key point for formulators is the match between the named ingredient, the cited NOAEL, and the SCCS conclusion. A NOAEL is a study point of departure, not a standalone permission to use Water-soluble zinc salts (used in oral hygiene products - Submission II) at any level. The SCCS conclusion and any concentration or product-type conditions remain the controlling context for cosmetic use.
The source also matters because SCCS opinions can be ingredient-specific. The internal ingredient page for Water-soluble zinc salts (used in oral hygiene products - Submission II) should be treated as the substance hub, while SCCS/1657/23 is the opinion-level page for the committee record.
Practical Formulation Takeaway
For a formula review, start with the identity check: confirm the INCI name, CAS number, and opinion reference align with the material in the formula. Then compare the intended product type against the SCCS concentration or condition language above. If the formulation uses a different exposure route, product category, or concentration basis, the SCCS conclusion should not be stretched beyond what SCCS/1657/23 actually assessed.
Source
- SCCS opinion: SCCS/1657/23
- Source file: sccs_o_279.pdf
- Extraction JSON: SCCS Scientific Opinions