Pre-launch testing checklist: stability, compatibility, PET, safety and claims

Q: How long does cosmetic product testing take?

PET runs 28 days and an HRIPT about six weeks [2] [10] . Stability sets the pace: accelerated tests run for months, and real-time testing continues to the end of shelf life [1] .

Premalatha

Claims & Testing3 Nov 20268 min read

Pre-launch testing checklist: stability, compatibility, PET, safety and claims

Cosmetic product testing is where a formula proves it is stable, safe and honest about what it claims. This checklist sets out which tests each product type needs by market, how each test works, what counts as a pass, and which claim each result allows.

By Dr. Premalatha, Ph.D., Life Science, Regulatory Consultant, Cosmetic Science Lab

Key references: EU 1223/2009, 655/2013, MoCRACovers: 5 test gates, pass criteria, timingFor: R&D, QA and brand owners

Testing Claims support Product development

A cosmetic microbiology lab with a biosafety cabinet and incubators

Cosmetic product testing at a glance

Five gates: Stability, packaging compatibility, preservative efficacy (PET), safety, claims
Market rules: EU 1223/2009 and 655/2013; US MoCRA; Canada heavy-metal guidance
Longest lead time: Stability: accelerated for months, real-time to end of shelf life
Pass rule for pet: ISO 11930 criterion A: bacteria down 3 log by day 7
Common mistake: Testing in glass instead of the final pack
Continues to: Safety assessment (EU CPSR guide)

Quick answer

Cosmetic product testing before launch covers five gates: stability, packaging compatibility, preservative efficacy (PET), safety and claims substantiation. Every product needs the first four in some form; claims testing depends on what the label says.
Test the final formula in the final pack; stability guidance asks for the marketed packaging material [1].
A PET passes ISO 11930 criterion A when bacteria fall by at least 3 log and Candida albicans by 1 log by day 7 [2].
EU products need a signed safety report before launch [3]; US products need adequate safety substantiation under MoCRA [4].
Every claim needs evidence that matches its exact wording [5].

Take-home message for formulators

Freeze the formula and pack before testing; a late change usually means repeating stability and PET.
Run PET on the final pack, and again after stability storage if the preservative system is marginal.
Use analytical chemistry, such as liquid chromatography, to confirm actives hold over shelf life.

Take-home message for brand owners

Testing time, not cost, usually sets the launch date: plan stability first.
Write claims before booking studies; the wording decides the panel and method.
One extra market can add tests (heavy metals, SPF, local rules).

01The cosmetic product testing matrix

Which tests are must-have depends on product type and market. Use this matrix as the starting checklist, then let the safety assessor confirm it.

**Table 1.** Test matrix by product type (CSL recommendation; "Must" is our advice, not a legal list). Anhydrous or high-alcohol products may replace PET with an ISO 29621 risk assessment [2][11]. HRIPT panels are adult volunteers, never infants. "Must" for heavy metals reflects pigments, clays and mineral filters; eye-area and baby products carry stricter microbial limits.
Test	Leave-on skin care	Rinse-off	Eye area & baby	Colour cosmetics	Sunscreen
Stability (accelerated + real-time)	Must	Must	Must	Must	Must
Packaging compatibility	Must	Must	Must	Must	Must
PET (ISO 11930)	Must	Must	Must	Must	Must
Microbial limits (ISO 17516)	Must	Must	Must	Must	Must
Heavy metals	Nice	Nice	Nice	Must	Must
HRIPT (sensitisation)	If claimed	Nice	Must	Nice	Nice
SPF and broad spectrum	If claimed	–	If claimed	If claimed	Must
Efficacy claims studies	If claimed	If claimed	If claimed	If claimed	If claimed
Safety assessment (EU CPSR / US substantiation)	Must	Must	Must	Must	Must

**Table 2.** Market rules that change the checklist. For other markets, ask our global regulatory team.
Market	Must-have before launch
European Union	A Cosmetic Product Safety Report signed by a qualified safety assessor, built on stability, microbiology, impurity and packaging data [3] (see the EU CPSR guide). Claims must meet common criteria [5].
United States	Adequate safety substantiation from tests, studies or analyses under MoCRA [4]. Sunscreens are OTC drugs: "Broad Spectrum" needs a critical wavelength of at least 370 nm [8].
Canada	Heavy metals within Health Canada guidance limits [7].

02Methods, panels, duration and pass criteria

**Table 3.** Methods, panels, duration and pass criteria for each pre-launch test.
Test	Method	Panel or samples	Duration	Pass criteria
Stability	Accelerated at 37–45 °C, cycling, freeze-thaw, light; real-time storage [1]; actives assayed by liquid chromatography	Final pack, smallest size, several orientations [1]	Months; no fixed duration is prescribed [1]	No meaningful change in appearance, odour, pH, viscosity, weight or active content (see why a lotion separates at 40 °C)
Packaging compatibility	Product stored in the final pack against a glass control [1]	Each pack type [1]	Alongside stability	No adsorption, migration, corrosion or barrier loss [1]
PET	ISO 11930: five organisms incl. Candida albicans; counts at day 0 (inoculum), 7, 14 and 28 [2]	Each formula	28 days [2]	Criterion A: bacteria ≥3 log and yeast ≥1 log by day 7; mould ≥1 log by day 28; no regrowth [2]
Microbiology	ISO 17516 limits [6]	Typically each batch under GMP	About a week	≤1,000 CFU/g; ≤100 CFU/g for eye area, mucous membranes and under-3s; no E. coli, P. aeruginosa, S. aureus or C. albicans [6]
Heavy metals	Analytical chemistry (e.g. ICP-MS) on product or raw materials	Each formula	Days	Canada: lead 10, arsenic 3, cadmium 3, mercury 1, antimony 5 ppm [7]
SPF and broad spectrum	In vivo SPF (ISO 24444 in the EU; 21 CFR 201.327(i) in the US); in vitro UVA-PF and critical wavelength [8]	At least 10 valid subjects for SPF [8]	Weeks	US: critical wavelength ≥370 nm [8]; EU: UVA-PF at least one-third of SPF and critical wavelength ≥370 nm [9]
HRIPT	3-week induction, 2-week rest, challenge read at 24–72 h, 96 h if needed [10]	50–200 subjects; 100+ recommended [10]	About 6 weeks [10]	No sensitisation reactions at challenge

Decision chart: ISO 11930 challenge test or ISO 29621 risk assessment — **Figure 1.** Does the product need a PET? Water-based products are challenged; low-risk anhydrous products are risk-assessed [2][11].

03Which claim each result allows

Start from the claim wording and work back to the study. Under EU common criteria, evidence must match what the claim actually says [5].

**Table 4.** Which claim each result allows. Our claims and clinical support team matches study design to wording.
Result	Claim it can support	What it does not support on its own
Stability and compatibility pass	Shelf life and period-after-opening; "stable formula"	Any efficacy claim
PET criterion A	In-use microbial safety in the stated pack	"Preservative-free" or microbiome-friendly claims
HRIPT, no reactions	"Tested for skin sensitisation"; supports "dermatologically tested" with dermatologist oversight	"Hypoallergenic" without formula-level evidence
Heavy metals within limits	Factual "tested for heavy metals"	"Free from" a metal
SPF and UVA tests	"SPF 30"; "Broad Spectrum" (US) [8]; EU UVA claim (UVA-PF ≥1/3 SPF) [9]; the circled UVA logo follows the Cosmetics Europe recommendation	Water-resistance (needs its own test after 40 or 80 minutes of immersion) [8]
Instrumental or consumer product tester study	The specific benefit tested, e.g. "hydrates for 24 hours"	A broader benefit than the study measured [5]

04Cost and time drivers

Prices vary by lab and scope, but the same factors drive both cost and time:

Number of SKUs and pack variants: each pack type needs its own compatibility data [1].
Formula changes after testing starts: stability and PET restart from day zero.
Panel size and recruitment: sensitive-skin, eye-area or ethnic-specific panels take longer to fill.
Markets: sunscreens for the US need drug-standard testing; Canada adds heavy-metal checks.
Real-time stability length: a 30-month shelf life needs data that supports it.
Analytical scope: lab testing on advanced instruments, such as ICP-MS for metals or liquid chromatography for actives, adds time per method.

For choosing cosmetic lab testing methods by stage, see choosing testing methods at each stage.

05The pre-launch sequence, step by step

Lock the formula and final pack.
Freeze the formula and packaging before testing; any later change restarts stability and PET.
Start stability and compatibility.
Run accelerated, cycling and real-time stability in the final pack, with a glass control.
Run preservative efficacy (ISO 11930).
Challenge water-based products with five organisms over 28 days; risk-assess anhydrous ones under ISO 29621.
Check microbiology and impurities.
Test against ISO 17516 limits and screen heavy metals by analytical chemistry.
Run safety and claims studies.
HRIPT, SPF and efficacy studies matched to the exact claim wording.
Sign off the safety assessment.
EU: CPSR by a qualified safety assessor. US: MoCRA safety substantiation on file.

Typical pre-launch cosmetic product testing sequence in weeks — **Figure 2.** A typical pre-launch sequence (illustrative). Durations vary by product, lab and market.

New to launching? Start with New brand? Start here and How we work (brief to shelf).

Planning your pre-launch testing?

Our Safety & stability testing team builds the test plan from your formula, pack, markets and claims, then runs it to sign-off.

Request a testing plan Talk to our testing team

06Questions readers ask

What testing does a cosmetic product need before launch?

Every product needs stability, packaging compatibility, microbiological quality and a safety assessment. Water-based products also need a preservative efficacy test (ISO 11930). Claims testing depends on what the label says.

How long does cosmetic product testing take?

PET runs 28 days and an HRIPT about six weeks [2][10]. Stability sets the pace: accelerated tests run for months, and real-time testing continues to the end of shelf life [1].

Is cosmetic lab testing required by law?

The EU requires a signed safety assessment and the US requires adequate safety substantiation [3][4]. Neither lists every test, so the data you generate has to support that assessment.

Do anhydrous products need a challenge test?

Not always. Products classed as low microbiological risk under ISO 29621, such as many anhydrous or high-alcohol formulas, can be covered by a documented risk assessment instead [2][11].

07References

Colipa (now Cosmetics Europe), CTFA. Guidelines on stability testing of cosmetic products. Brussels: Colipa; March 2004. cosmeticseurope.eu
ISO 11930:2019. Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product. Geneva: International Organization for Standardization; 2019. iso.org. See also our ISO 11930 guide.
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, Article 10 and Annex I. Off J Eur Union. 2009;L342:59–209. eur-lex.europa.eu
Safety substantiation, 21 U.S.C. § 364d (2022), added by the Modernization of Cosmetics Regulation Act. law.cornell.edu
Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Off J Eur Union. 11 Jul 2013;L190:31–34. eur-lex.europa.eu
ISO 17516:2014. Cosmetics — Microbiology — Microbiological limits. Geneva: International Organization for Standardization; 2014 (second edition due late 2026). standards.iteh.ai
Health Canada. Guidance on heavy metal impurities in cosmetics. Ottawa: Health Canada; 2012 (modified 2017). canada.ca
US Food and Drug Administration. Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule. Fed Regist. 2011;76(117):35620–65 (21 CFR 201.327(j)). govinfo.gov
Commission Recommendation 2006/647/EC on the efficacy of sunscreen products and the claims made relating thereto. Off J Eur Union. 2006;L265:39–43. eur-lex.europa.eu
Eurofins CRL. Human repeated insult patch test (HRIPT): study design. eurofinsus.com
ISO 29621:2017. Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products. Geneva: International Organization for Standardization; 2017. iso.org

CSL

Dr. PremalathaPh.D., Life Science, Regulatory Consultant, Cosmetic Science Lab · Last reviewed 3 Nov 2026Safety & stability testing

Update log

3 Nov 2026Published by Cosmetic Science Lab

This article is general technical information, not legal, regulatory or medical advice. Confirm requirements for your product and market before launch.