Change the preservative, add 28 days of challenge testing
The shortest line on an ingredient list moves the schedule the most. Swap or remove a preservative and it is not only the label that changes: EN ISO 11930 runs for 28 days from the start again, and in the EU a preservative-free claim is judged on function, not on list membership.
Swapping a preservative is never just a label edit. EN ISO 11930, the efficacy test the EU accepts, runs five strains over 28 days and takes four to five weeks with lab scheduling, and any change to the formula restarts it. The EU list of permitted preservatives (Annex V) holds around 60 entries while Korea's runs past 150, so one formula lands differently in each market.
The shortest line moves the schedule the most
On an ingredient list the preservative sits near the end and rarely runs past two lines. Touch that line, though, and the label, the cost and the ship date all move together. EN ISO 11930:2019+A1:2022, the efficacy method the EU accepts, is only finished after 28 days, and with strain preparation and reporting a lab usually asks for four to five weeks.
The word buyers tend to miss is *again*. Remove a preservative or change its level and the previous certificate no longer describes the formula, so the test starts over. A variant that differs only in fragrance or color is a different product microbiologically, which means those 28 days attach once per SKU as the range grows.
Five strains are used: three bacteria plus a yeast and a mold. Counts are taken at 7, 14 and 28 days, and Criterion A is what you aim for. Criterion B is a lower bar accepted only when packaging or conditions of use are argued separately; it is not handed out by product category.
Off the list does not mean not a preservative
Preservative-free formulas usually lean on multifunctionals such as 1,2-hexanediol, caprylyl glycol and ethylhexylglycerin. None of these appear on the EU list of permitted preservatives, so on the ingredient list they read as humectants or skin conditioning agents.
That is where the claim parts company with the chemistry. The EU has no legal definition of preservative-free; claims are assessed instead against the common criteria in Regulation (EU) No 655/2013 and the Commission's technical document. If microbiological protection actually rests on the multifunctional, the claim can be challenged regardless of Annex V status. Coming off the list and earning the claim are two different exercises.
Cost moves the same way. Multifunctionals go in at higher percentages than conventional preservatives when they are doing preservation work, and one rarely covers both bacteria and fungi, so two or three are layered. A lighter-looking label often means a heavier dose and more testing.
Limits come from a different table in each market
Common preservatives and their EU limits are below. Korea works from its own notice (Annex 2 of the Regulation on Safety Standards for Cosmetics), so a formula bound for more than one market has to clear both tables ingredient by ingredient.
| Ingredient | EU Annex V limit | Condition |
|---|---|---|
| Phenoxyethanol | 1.0% | Restricted, nappy area, under 3 |
| Benzyl alcohol | 1.0% | Also a regulated fragrance allergen |
| Chlorphenesin | 0.3% | — |
| Dehydroacetic acid and sodium salt | 0.6% (as acid) | — |
| Sorbic acid / potassium sorbate | 0.6% (as acid) | Works in an acidic range |
| Benzoic acid / sodium benzoate | 0.5% (as acid) | 2.5% in rinse-off |
| Methylparaben | 0.4% single, 0.8% mixtures | Propyl + butyl capped at 0.14% |
| Methylisothiazolinone | 0.0015% | Rinse-off only |
The lists differ in size as well. EU Annex V held roughly 60 entries as of August 2026, while Korea's preservative list runs past 150, and the United States operates no positive list for preservatives at all — the responsible person answers for safety instead. A formula that raised no question in the US can stop at a single ingredient in the EU, and one long used in Korea can be absent from the EU list entirely.
One deadline has already gone by
Preservatives that slowly release formaldehyde, such as DMDM hydantoin or imidazolidinyl urea, are not banned. What changed is the warning: Regulation (EU) 2022/1181 lowered the threshold for the "releases formaldehyde" statement from 0.05% (500 ppm) to 0.001% (10 ppm). A fifty-fold drop means most working concentrations now trigger the wording.
The dates have passed. Products made to the old rule could be placed on the EU market until 31 July 2024 and made available until 31 July 2026. If the artwork you are sending a European buyer today carries one of these ingredients without that statement, it comes back.
Decide these alongside the formula
A preservation system is never chosen on its own. Benzoic and sorbic acid types only perform in an acidic range, so the target pH has to be fixed first, and a pump behaves differently from an open jar, which changes how much protection the product needs to show.
Counting backwards helps. Subtract four to five weeks from the ship date and you have the day the formula must be locked, with stability and packaging compatibility sitting ahead of that. Worth writing into the quotation: a "just change the preservative" request after sample approval brings the whole 28 days back.
In short
- Changing a preservative restarts EN ISO 11930 from the beginning — 28 days of measurement, four to five weeks with lab scheduling.
- Multifunctionals like 1,2-hexanediol are absent from EU Annex V, but a preservative-free claim is judged on function rather than on list membership.
- The EU list holds about 60 entries, Korea's over 150, and the US has none. One formula rarely covers all three.
- The warning threshold for formaldehyde releasers is 10 ppm, and the sell-through for old-rule products ended on 31 July 2026.
- Fix pH and packaging before choosing the system, and set the formula lock date four to five weeks before shipping.
See which ingredients are moving right now in today's ingredient signal, and work through category price bands and cost structure in the product planner.
*Sources: Safic-Alcan, Preservatives in Cosmetics — EU Regulatory Guide (Annex V) (accessed 24 October 2026 — about 60 Annex V entries, phenoxyethanol 1.0%, benzyl alcohol 1.0%, chlorphenesin 0.3%, dehydroacetic acid 0.6%, parabens 0.4%/0.8%/0.14%, EN ISO 11930:2019+A1:2022, Criteria A and B, preservative-free claims and Regulation 655/2013) / CosIng Checker, Annex V Permitted Cosmetic Preservatives (sorbic acid 0.6%, benzoic acid 0.5% and 2.5%, methylisothiazolinone 0.0015% rinse-off) / Microbe Investigations, ISO 11930 Preservative Efficacy Test (five strains, counts at 7, 14 and 28 days, 4–5 weeks) / ChemLinked, EU Lowers the Labelling Threshold for Formaldehyde Releasers (0.05% to 0.001%, 31 July 2024 and 31 July 2026) / ChemRadar GlobalCosIng, Korea — List of Preservatives Allowed in Cosmetic Products (153 entries) / Korea Easy Law, Standards for Use of Cosmetic Ingredients (Annex 1 and Annex 2, negative list system)*
Using preservatives in a Korean private label formula
If you want preservatives in your own product, a Korean private label (OEM/ODM) partner can start from a tested base instead of a blank page. We check the grade, the dose that can legally be claimed in your market and the cost per unit before the first sample, so the label and the formula agree.
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Questions people ask
A changed formula means a new efficacy test. EN ISO 11930 measures at 28 days, and with strain preparation and reporting you should budget four to five weeks. Leave that out of the production plan and the shipping date slips.
Not being on the list is not the same as earning the claim. The EU assesses claims under the common criteria in Regulation 655/2013, so if microbiological protection rests on that ingredient the claim can be challenged whatever its Annex V status.
1.0% in the finished product under EU Annex V, with a restriction for nappy-area products for children under three. Korea regulates through its own notice, so each ingredient has to be checked against both.
They are not banned, but the warning threshold dropped from 0.05% to 0.001%. The last day products made to the old rule could be made available on the EU market was 31 July 2026, which has passed.
Most systems use two or three. Coverage against bacteria and fungi differs, and benzoic and sorbic acid types only work in an acidic range, so pH and packaging have to be settled alongside.