Parabens: What the SCCS Concluded About Safety in Cosmetics
Parabens safety summary from SCCP/0873/05: SCCS conclusion, NOAEL, maximum concentration or conditions, and source-linked context.
Parabens is covered by SCCP/0873/05, an SCCS-family cosmetic safety opinion dated 2005-01-28. The opinion conclusion for this opinion is direct enough for a substance-specific summary: Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%).
Core Opinion Facts
- Opinion: SCCP/0873/05
- Opinion date: 2005-01-28
- Primary substance: Parabens
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 |
|---|---|---|---|
| general_chronic_toxicity_NOAEL | 1000 | mg/kg bw/day | rats, dogs, mice, subchronic and chronic toxicity |
| reproductive_NOAEL_methyl_paraben | 1000 | mg/kg bw/day | |
| reproductive_NOAEL_ethyl_paraben | 1000 | mg/kg bw/day | juvenile male rats, dietary administration; sex hormones and reproductive organs |
Maximum Concentration or Conditions
Conditions from the Opinion
Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%).; Therefore, it is the opinion of the SCCP that methyl and ethyl paraben can be safely used up to the maximum authorized concentration as actually established (0.4%).; It is the opinion of the SCCP that the available data do not enable a decisive response.
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 Parabens 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 Parabens should be treated as the substance hub, while SCCP/0873/05 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 SCCP/0873/05 actually assessed.
Review Notes
The conservative reading is to keep Parabens tied to this exact opinion. The opinion number, date, NOAEL table, and condition language all travel together. If a later formula review uses a different CAS identity, product type, or concentration basis, the source should be checked again rather than reusing this summary as a blanket answer.
This page is therefore an indexable safety summary, not a replacement for the committee text. It gives search readers the core SCCS facts for Parabens and keeps the source handle visible for audit.
Source
- SCCS opinion: SCCP/0873/05
- Source file: sccp_o_019.pdf
- Extraction JSON: Source documentation archived.