Buyer questions · Comparisons
ISO 11930 versus USP <51> preservative challenge testing: what differs and which one does an export need?
Both inoculate five reference organisms and count over time; ISO 11930 is the cosmetics-specific standard accepted by EU CPSRs and ASEAN notifications; USP <51> comes from the US Pharmacopeia and is expected in the US and parts of the Americas. Pick by destination; one sample set can be evaluated against both.
1When it is required
A new formula, a change of preservative system, or a change of packaging each trigger a run; a fragrance-only change does not, a change in water activity or pH does.
2Acceptance basis
ISO 11930 grades A or B, with A sufficient on its own; USP <51> sets log-reduction targets per category and time point.
3What happens without it
No challenge data means no CPSR signature and a supplementary request in ASEAN; the practical risk is microbial growth in the field and a recall.
Follow-up questions
- Q:Are preservative-free formulas exempt?
- A:No: a self-preserving claim needs the challenge test as its only evidence.
- Q:How long does it take?
- A:ISO 11930 samples through day 28; allow 5–6 weeks including setup, run in parallel with accelerated stability.
Figures sourced from:质检体系 · 成品检验各国备案索引
Updated 2026-09-16
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