Hoe Veiligheidslimieten voor Conserveermiddelen de Goedkeuring van CPSR in de EU Beïnvloeden (Updates 2025–2026)

Why preservative limits decide so many CPSR outcomes

When a Cosmetic Product Safety Report stalls, the trigger is often something small on paper: a preservative a tenth of a percent over its Annex V ceiling, a leave-on baby lotion using a paraben that is fine on adult skin but banned for the nappy area, or a perfectly legal level of phenoxyethanol with no challenge-test report behind it.

Preservatives exist because water-containing cosmetics are a growth medium. The EU does not leave the dose to brand preference. Regulation (EC) No 1223/2009 Annex V is a positive list. You pick from what is listed, you stay inside the maximum, and you honour every condition attached to that entry. The safety assessor then checks whether that legal use is also toxicologically and microbiologically sound for your product.

That second step is where people get surprised. "Within Annex V" is necessary. It is not a rubber stamp.

What Annex V actually controls

Annex V names the substances that may be used to preserve a cosmetic, with:

• a maximum concentration in the ready-for-use preparation;
• sometimes a product-type or body-part limit (rinse-off vs leave-on, oral care, eye area, and so on);
• sometimes an age or use restriction (the classic example is propylparaben and butylparaben in leave-on nappy-area products for children under three);
• sometimes a mandatory warning on the label.

If a substance is not on Annex V, you cannot use it as a preservative, full stop — including trendy "natural" antimicrobials that never made the list. CosIng and the consolidated Annex V table on ECHA are the day-to-day checks; EUR-Lex is the legal text when something is in dispute.

Useful reference points formulators ask about constantly:

• Phenoxyethanol — Annex V entry 29, max 1.0% in all cosmetic products. That ceiling did not move in 2025 or 2026.
• Methylparaben / ethylparaben — 0.4% for a single ester, 0.8% for mixtures of esters (with the separate rules for propyl/butyl).
• Propylparaben / butylparaben — max 0.14% for the sum of their individual concentrations; prohibited in leave-on products designed for the nappy area of children under three.
• Benzoic acid — 2.5% in rinse-off (except oral), 1.7% in oral care, 0.5% in leave-on — not a flat "0.5% rinse-off".
• Sorbic acid — 0.6%.
• o-Phenylphenol / Sodium o-Phenylphenate — see the 2026/78 update below.

For a broader walkthrough of how to pick a system, see our guide to cosmetic preservatives and Annex V.

Phenoxyethanol: what did and did not change in 2025–2026

Phenoxyethanol is still the workhorse preservative in a huge share of modern leave-on and rinse-off formulas. Brands moved toward it after the paraben scare of the 2000s. The Annex V number remains 1.0%.

What people misread as a "2025 ban" is usually one of three things:

• old national French advice on leave-on nappy-area labelling, which is not an EU Annex V prohibition and has been repealed;
• SCCS discussion of exposure in products for very young children — the Committee's opinion supports safety at 1.0%, but a careful assessor may still ask for age-specific Margin of Safety maths on an infant lotion;
• confusion with Omnibus CMR measures that banned other substances, not phenoxyethanol.

So if your CPSR is stuck on phenoxyethanol, it is rarely because Brussels lowered the percentage. It is usually missing PET data, an unsuitable pack, an infant-exposure story that was never calculated, or a declared 1.0% that packaging migration will not actually deliver by the end of shelf life.

Parabens: still usable, still easy to get wrong

Methyl- and ethylparaben remain widely used inside the 0.4% / 0.8% framework. Propyl- and butylparaben are the ones that trip dossiers. The combined 0.14% cap has been in force for years. The nappy-area leave-on ban for under-threes is the line assessors enforce without debate.

A leave-on baby lotion at 0.14% propylparaben is fine on the general concentration rule and still non-compliant if the product is designed for the nappy area. Fix the intended use on the label, or reformulate. Do not argue toxicology against a clear Annex V condition.

Isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben are already out of Annex V. If a supplier frame formulation still lists them, that is a sourcing problem, not a grey area.

When you stack several parabens, the assessor looks at the mixture as well as each line. Cumulative exposure is part of a proper Part B argument, not an optional extra.

Commission Regulation (EU) 2025/877 — Omnibus VII, not an Annex V rewrite

Reg (EU) 2025/877 applies from 1 September 2025. It implements CMR classifications by adding substances to Annex II (prohibited) and, where needed, deleting old restricted-use permissions. The headline cosmetic example is Trimethylbenzoyl Diphenylphosphine Oxide (TPO), previously allowed in professional artificial nail systems under Annex III entry 311 — that permission is gone, and there is no sell-through for making TPO products available after the application date.

For preservative work, the practical lesson is process, not a new phenoxyethanol number: when CLP classifies a substance as CMR and no Article 15 derogation is granted, the Omnibus regulation moves it onto Annex II on the same timeline as the classification. Screen your INCI list against the latest Omnibus. Do not wait for a customer complaint.

Commission Regulation (EU) 2026/78 — the Annex V change that does matter

Reg (EU) 2026/78 (Omnibus VIII) applies from 1 May 2026. Alongside further CMR Annex II entries, it replaces Annex V entry 7 for o-Phenylphenol and Sodium o-Phenylphenate:

• rinse-off: max 0.2% (as phenol);
• leave-on: max 0.15% (as phenol);
• when both are used, the combined concentration (as phenol) must stay inside those caps;
• not for oral products;
• not for applications that may expose the end user's lungs by inhalation;
• label warning: Avoid contact with eyes.

If your preservation system uses these actives, update the formula sheet, the label and the CPSR before the application date. If you do not use them, you still want the Omnibus on your watch list because the CMR half of the regulation can remove unrelated ingredients you do use.

PET / ISO 11930: the evidence Annex V numbers cannot replace

You can sit comfortably inside every Annex V ceiling and still fail the microbiological half of the assessment. For water-containing products, assessors expect a challenge test — typically ISO 11930 — on the finished formula in representative packaging. The report goes in CPSR Part A; Part B then says whether that evidence supports the safety conclusion.

Typical organisms and pass criteria are defined in the standard. What matters for your project plan is timing: run PET while you can still change the system. A fail after artwork is locked is an expensive fail.

Re-test when you change preservative level, pH, water activity, key actives or the primary pack. A pass on version 1 is not a pass on version 2. More detail sits in our challenge test / preservative efficacy guide.

Stability, packaging and the concentration you think you have

Assessors also ask whether the preservative is still there at the end of shelf life. Phenoxyethanol can migrate into some polyolefin packs. pH drift can switch off acid preservatives. Proteins, clays and certain oils can bind actives. Chelating agents such as disodium EDTA are not preservatives, but they often make a borderline system pass PET by reducing metal-driven inactivation.

Build the formula's pH around the preservative chemistry you chose. Do not pick a system and then force an incompatible pH because a brief said "skin-neutral".

Four submission scenarios we see repeatedly

1. Over the limit. Formula at 1.2% phenoxyethanol. Flagged immediately. Reformulate. Weeks lost.

2. Within limits, no PET. 0.8% phenoxyethanol, clean INCI — and no ISO 11930 report. CPSR on hold until the lab work arrives.

3. Wrong category / age use. Leave-on under-three lotion with propylparaben aimed at the nappy area. Concentration looks fine; Annex V condition does not. Relabel intended use or reformulate.

4. Clean submission. Current Annex V entries respected, PET passed in final pack, stability and impurity data filed, infant or eye exposure justified where relevant. Assessor can finish Part B without a scavenger hunt.

If you are assembling the dossier from scratch, use the CPSR Part A document checklist. For Margin of Safety mechanics, see the Margin of Safety explained. For under-three design constraints, see CPSR for baby and children's cosmetics.

Building a preservation system that clears CPSR first time

1. Start from current Annex V — not from a 2019 formula spreadsheet and not from a blog list of "clean" actives.
2. Match pH and chelation to the chemistry you chose.
3. Challenge-test early in the real pack.
4. Document impurities and supplier specs the assessor will ask for anyway.
5. Screen Omnibus updates (2025/877, 2026/78 and whatever follows) before each launch and each significant reformulation.
6. Re-open the CPSR when limits, PET or intended use change — Great Britain follows the same logic under retained 1223/2009 with its own amendment track, so UK-only ranges need the OPSS lens too.

Related reading on the Phoenix blog

• Cosmetic preservatives explained: Annex V
• The cosmetic challenge test (preservative efficacy) explained
• How to prepare for a CPSR: documents for Part A
• The Margin of Safety in cosmetic toxicology
• CPSR for baby and children's cosmetics
• CPSR example: what a finished report looks like
• All regulatory compliance articles

Phoenix services mentioned in this article

• Cosmetic Product Safety Report, single variant
• Product Information File service
• All-in-one CPSR, PIF, SDS and UK/EU notification
• Expert regulatory consultation
• Contact Phoenix

Official sources

• Regulation (EC) No 1223/2009
• European Commission CosIng
• ECHA Annex V preservatives list
• Scientific Committee on Consumer Safety (SCCS)
• Commission Regulation (EU) 2025/877
• Commission Regulation (EU) 2026/78
• ISO 11930
• OPSS: making cosmetic products available in Great Britain

Disclaimer: This article is general information, not legal advice. Annexes to Regulation (EC) No 1223/2009 and related Commission regulations change. Product decisions depend on your exact formula, intended use, pack and market (EU and/or Great Britain). Have the product reviewed by a qualified safety assessor before placing it on the market.

Myths we hear

• Commission Regulation (EU) 2025/877 rewrote Annex V preservative limits. 2025/877 is Omnibus VII — it adds CMR substances to Annex II and removes TPO's old Annex III permission. Annex V was not the target.
• Phenoxyethanol is banned in nappy-area products for children under three across the EU. Annex V still allows phenoxyethanol at up to 1.0% in all cosmetics. A French national labelling measure on leave-on nappy-area use was repealed. Assessors may still demand age-specific justification; that is not the same as an Annex V ban.
• If every preservative is within its Annex V number, the CPSR will pass. Limits are necessary, not sufficient. The assessor still needs challenge-test evidence, stability, impurity data, correct product-category restrictions and a coherent toxicological argument (including Margin of Safety where relevant).
• Natural or "preservative-free" antimicrobials sit outside Annex V. If you rely on a substance to preserve the product, it must be an Annex V preservative used within its entry. Unlisted plant extracts do not become legal preservatives by marketing language.
• Transition periods always let you sell through old stock after a ban. Omnibus CMR measures often apply with no sell-through (2025/877 is an example). Read the application date in each regulation; do not assume a grace period.

What to do this week

1. Screen every intentional preservative against the current Annex V entry (CosIng / EUR-Lex) for max %, product type, body part and age restrictions before you freeze the formula.
2. Confirm propylparaben and butylparaben stay within the 0.14% combined cap and are absent from leave-on nappy-area products for under-threes.
3. Run ISO 11930 (or equivalent) PET on the finished formula in representative packaging; file the report in CPSR Part A.
4. Check pH, chelators, proteins/clays/oils and pack material for interactions that could weaken preservation between filling and end of shelf life.
5. Track Omnibus updates: 2025/877 (Annex II CMRs from 1 Sep 2025) and 2026/78 (Annex V entry 7 o-Phenylphenol rules from 1 May 2026); update the CPSR when an entry you use changes.
6. Re-challenge and re-assess after material formula, preservative, pH or packaging changes — do not recycle an old PET for a new variant.

Frequently asked questions

Official sources and legislation

• Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
• European Commission CosIng ingredient database
• ECHA: EU allowed preservatives (Annex V consolidated)
• Scientific Committee on Consumer Safety (SCCS)
• Commission Regulation (EU) 2025/877 (Omnibus VII — CMR / Annex II)
• Commission Regulation (EU) 2026/78 (Omnibus VIII — incl. Annex V entry 7)
• ISO 11930 — Evaluation of the antimicrobial protection of a cosmetic product
• Regulation (EC) No 1223/2009 as retained in Great Britain
• OPSS: Making cosmetic products available to consumers in Great Britain