Methylparaben: What the SCCS Concluded About Safety in Cosmetics
Methylparaben safety summary from SCCS/1652/23: SCCS conclusion, NOAEL, maximum concentration or conditions, and source-linked context.
Methylparaben is covered by SCCS/1652/23, an SCCS-family cosmetic safety opinion dated 2023-12-14. The opinion conclusion for this opinion is direct enough for a substance-specific summary: On the basis of the safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Methylparaben as a preservative in cosmetic products at concentrations of up to 0.4% (expressed as acid) is safe.
Core Opinion Facts
- Opinion: SCCS/1652/23
- Opinion date: 2023-12-14
- Primary substance: Methylparaben
- CAS: 99-76-3
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 |
|---|---|---|---|
| NOAEL repeated dose oral 28-day | 1000 | mg/kg bw/day | Wistar rat, oral gavage, 28 days + 14 days recovery |
| NOAEL repeated dose oral 90-day (OECD TG 408) | 1000 | mg/kg bw/day | Rat, Wistar Crl:WI(Han), oral gavage, 90 days + 28 days recovery |
| NOAEL combined repeated dose / reproductive screen (OECD TG 422) | 1000 | mg/kg bw/day | Rat, Wistar Crl:WI(Han), oral gavage, OECD TG 422 (GLP) |
Maximum Concentration or Conditions
Conditions from the Opinion
On the basis of the safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Methylparaben as a preservative in cosmetic products at concentrations of up to 0.4% (expressed as acid) is safe.
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 Methylparaben 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 Methylparaben should be treated as the substance hub, while SCCS/1652/23 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/1652/23 actually assessed.
Source
- SCCS opinion: SCCS/1652/23
- Source file: sccs_o_276.pdf
- Extraction JSON: SCCS Scientific Opinions