Delhi · Bangalore · NABL Accredited

Cosmetic Preservative Efficacy and Microbiology

Cosmetic brands selling in India and exporting to regulated markets need both preservative efficacy data (ISO 11930) and general cosmetic microbiology results (ISO 17516) in their safety dossiers. A failed PET or a TAMC/TYMC out-of-spec finding stops a marketplace listing, blocks a CDSCO Form 39 cosmetic import, and triggers EU CPNP rejection. Auriga Research provides NABL-accredited cosmetic microbiology across both standards in a single integrated workflow.

Our scope covers PET challenge testing per ISO 11930, total aerobic microbial count (TAMC), total yeast and mould count (TYMC), and absence testing for E. coli, S. aureus, P. aeruginosa, and C. albicans per ISO 17516. USP 51 and EP 5.1.3 challenge protocols are quoted on request when pharma-equivalent testing is specifically required for quasi-drug filings or pharmacopoeial harmonisation. Water-based cosmetic formulations (micellar water, toners, sprays) receive a targeted microbial-limit panel because their preservation chemistry is structurally harder.

Backed by the Arbro Group's unbroken NABL ISO/IEC 17025:2017 accreditation since 2003 and integrated with cosmetics stability testing through the same group, PET and microbiology reports can be contextualised alongside shelf-life data on a single CoA. Our reports are accepted by CDSCO for cosmetic product registration and Form 39 import, by BIS for ISI and CRS mark applications, by Indian e-commerce marketplaces for listing approvals, and by EU CPNP submissions.

ISO 11930 PET 5 weeks | ISO 17516 microbial limits 5 to 7 days | Rapid screening 7 to 14 days

Six Test Types Across PET and Microbiology

Each card shows the regulatory standard, the test scope, and the indicative turnaround. PET (ISO 11930) and microbial limits (ISO 17516) carry equal weight; USP 51 and EP 5.1.3 are pharma-equivalent options on request.

ISO 11930

Preservative Efficacy Test (PET)

Cosmetic-default challenge testing. Inoculation with S. aureus, P. aeruginosa, E. coli, C. albicans, A. brasiliensis. Log-reduction measurements at days 7, 14, and 28. Indicative TAT 5 weeks (28-day challenge plus reporting).

USP 51

PET — Pharma-Equivalent (USP 51)

US Pharmacopoeia chapter 51 PET. Quoted on request when pharma-equivalent testing is required — quasi-drug filings, pharmacopoeial harmonisation, or buyer-specified protocols. Indicative TAT 5 weeks.

ISO 17516

Total Aerobic Microbial Count (TAMC)

Total aerobic microbial count per ISO 17516 product-category limits. Stricter limits for eye-area, under-three, and damaged-skin products. Indicative TAT 5 to 7 business days.

ISO 17516

Total Yeast and Mould Count (TYMC)

Total yeast and mould count per ISO 17516. Combined with TAMC for the general microbial-load dossier required for CDSCO Form 39, BIS, and EU CPNP submissions. Indicative TAT 5 to 7 business days.

ISO 17516

Absence of Specified Pathogens

Absence testing per ISO 17516 for E. coli, S. aureus, P. aeruginosa, and C. albicans. Mandatory for the cosmetic-microbiology safety dossier. Indicative TAT 5 to 7 business days.

Water-Based

Microbial Limits for Water-Based Products

Targeted microbial-limit panel for water-based cosmetic formulations including micellar water, toners, sprays, and aqueous serums where preservation is structurally harder. Indicative TAT 5 to 7 business days.

On USP 51 and EP 5.1.3: These are pharmaceutical preservative-efficacy standards. They are applied to cosmetics only when pharma-equivalent testing is specifically requested — for example, quasi-drug filings, pharmacopoeial harmonisation, or buyer-specified protocols. The default cosmetic PET protocol is ISO 11930.

How It Works

1

Get a Quote

Share your product type and whether you need PET (ISO 11930), microbial limits (ISO 17516), pharma-equivalent PET (USP 51 / EP 5.1.3), or the complete cosmetic microbiology dossier. Your dedicated SPOC will confirm scope, protocol, and the exact sample quantity required before you dispatch.

2

Send Your Sample

Dispatch product samples with a completed Test Request Form to the nearest Auriga lab (Delhi or Bangalore). Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Testing begins within 24 hours of registration.

3

Challenge / Limit Testing and QA Review

For PET, samples are inoculated with standardised microbial panels and incubated across the 28-day challenge window with log-reduction measurements at days 7, 14, and 28. For ISO 17516 limits, samples are plated for TAMC, TYMC, and tested for absence of specified pathogens. All results pass through internal QA review and microbiologist sign-off before the report is generated.

4

Receive Your NABL Report

Your NABL-accredited cosmetic microbiology report is delivered digitally within the committed turnaround time. Reports are accepted by CDSCO for cosmetic product registration and Form 39 import, by BIS for ISI / CRS mark applications, by EU CPNP submissions, and by Indian marketplaces. You can track sample status in real time through YLIMS at any point.

Turnaround Time

Panel Standard TAT Express
PET per ISO 11930 (28-day challenge plus reporting) ~5 weeks On request
PET per USP 51 or EP 5.1.3 (pharma-equivalent) ~5 weeks On request
TAMC + TYMC per ISO 17516 5 to 7 business days Available
Absence of specified pathogens per ISO 17516 5 to 7 business days Available
Water-based product microbial limits (micellar, toner, spray) 5 to 7 business days Available
Rapid microbial screening (ATP bioluminescence) 7 to 14 days Available

Who Needs Cosmetic PET and Microbiology

  • D2C skincare founders needing microbiology clearance before listing on Amazon, Flipkart, Nykaa, or Myntra and entering retail distribution.
  • Private label manufacturers verifying preservative systems before scale-up and contract handoff to retail or marketplace partners.
  • CDMO clients requiring microbiology results as part of the integrated stability and safety dossier for product development.
  • Exporters to EU and US markets requiring ISO 11930 PET results for Cosmetic Product Notification Portal (CPNP) safety reports under EU Regulation 1223/2009.
  • Brands reformulating to remove or change preservatives — paraben-free, formaldehyde-donor-free, or natural-preservative pivots — needing fresh PET data on the new formulation.
  • Water-based product brands (micellar water, toners, sprays, hydrosols) where preservation is structurally harder and microbial limits need close monitoring.
  • Brands launching for under-three, eye-area, or damaged-skin product categories where ISO 17516 imposes stricter TAMC and TYMC limits.
  • Brands contesting a CDSCO finding, BIS non-conformance, or marketplace microbiology challenge — full re-test under NABL chain of custody.

Why Auriga for PET and Cosmetic Microbiology

ISO 11930 + ISO 17516 in Scope

Both PET (ISO 11930) and cosmetic microbiology limits (ISO 17516) in NABL ISO/IEC 17025:2017 scope at Delhi and Bangalore. No additional lab needed for multi-standard compliance dossiers.

Pharma-Equivalent PET on Request

USP 51 and EP 5.1.3 challenge testing quoted on request for quasi-drug filings, pharmacopoeial harmonisation, or buyer-specified pharma-equivalent protocols.

Integrated with Stability Testing

PET sits inside the cosmetic stability dossier. Through the same Arbro Group, PET data can be contextualised alongside shelf-life and physical stability results on a single integrated report.

NABL Accepted by CDSCO and EU CPNP

NABL-accredited results accepted by CDSCO for cosmetic product registration and Form 39 import, by EU CPNP for safety report submissions, by BIS for ISI / CRS, and by Indian marketplaces.

Water-Based Product Expertise

Targeted microbial-limit panels for micellar water, toners, sprays, and aqueous serums where preservation chemistry is structurally harder and standard panels may not surface contamination risk.

Arbro Group Heritage Since 2003

Two decades of unbroken NABL ISO/IEC 17025 conformity. Arbro Lab since 1990, Auriga Research since 2007 — the audit trail CDSCO, BIS, EU CPNP, and international buyers look for.

Frequently Asked Questions

What is the difference between ISO 11930 and ISO 17516?
ISO 11930 governs the preservative efficacy test (PET) — the challenge-testing protocol that confirms a product's preservative system can control microbial growth across shelf life. ISO 17516 governs general microbial limits for finished cosmetic products — total aerobic microbial count (TAMC), total yeast and mould count (TYMC), and absence of specified pathogens. A complete cosmetic microbiology dossier typically requires both standards: ISO 11930 for the preservation system, ISO 17516 for the in-spec finished product.
What is a preservative efficacy test (PET)?
A preservative efficacy test, also called challenge testing, evaluates whether a cosmetic formulation can adequately control microbial growth throughout its shelf life. The product is inoculated with specified concentrations of bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli), yeast (Candida albicans), and mould (Aspergillus brasiliensis). Microbial counts are measured at defined intervals (7, 14, 28 days) to assess the log reduction achieved by the preservative system.
When are USP 51 and EP 5.1.3 used instead of ISO 11930?
USP 51 (United States Pharmacopeia chapter 51) and EP 5.1.3 (European Pharmacopoeia 5.1.3) are pharmaceutical preservative-efficacy standards. They are applied to cosmetics only when pharma-equivalent testing is specifically requested — for example, when a cosmetic is being filed under a quasi-drug or pharma-bridging route, or when a buyer requires harmonised pharmacopoeial criteria. The default cosmetic PET protocol is ISO 11930; USP 51 and EP 5.1.3 are quoted on request.
What organisms does ISO 17516 require absence testing for?
ISO 17516 requires absence testing for four specified pathogens in cosmetic products: Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans. The standard also sets TAMC and TYMC limits depending on the product category — for example, products intended for use around the eye area, children under three, or on damaged skin carry stricter total-count limits than general-use cosmetic products.
How long does PET and cosmetic microbiology testing take?
Standard PET per ISO 11930 takes 28 days for the inoculation phase plus 5 to 7 days for reporting, totalling approximately 5 weeks. Microbial limit testing (TAMC, TYMC, pathogen absence) per ISO 17516 takes 5 to 7 business days. Rapid PET screening using ATP bioluminescence provides preliminary results in 7 to 14 days. Express service is available for marketplace listing deadlines.
Are Auriga PET and microbiology reports accepted by CDSCO and EU importers?
Yes. Auriga PET and cosmetic microbiology reports are NABL-accredited under ISO/IEC 17025:2017. They are accepted by CDSCO for cosmetic product registration and Form 39 import submissions, by BIS for ISI and CRS mark applications, by EU importers for Cosmetic Product Notification Portal (CPNP) safety reports under EU Regulation 1223/2009, and by Indian marketplaces for cosmetic product listing approvals.

Get Your PET and Cosmetic Microbiology Quote

NABL-accredited PET per ISO 11930 and microbial limits per ISO 17516 at Delhi and Bangalore. USP 51 and EP 5.1.3 pharma-equivalent on request. Integrated with stability testing through the same group.

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