How to Read an EU Annex V Preservative Entry: A Technical Guide for Formulators

Annex V to Regulation (EC) No 1223/2009 is the positive list of preservatives allowed in EU cosmetic products. It is short compared with the other annexes — 54 entries, against 1,739 prohibited substances in Annex II, 373 restricted substances in Annex III, 154 colorants in Annex IV and 33 UV-filters in Annex VI — but it is also the annex most often misread, because its rules are split across several columns that do not all say the same kind of thing. This is a guide to reading one entry correctly, not a summary of what any single preservative is currently allowed to do.

Annex V is a positive list, not a permission slip

Article 2(1)(l) of Regulation 1223/2009 defines a preservative as a substance "exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product." Article 14(1) then closes the loop: a cosmetic product must not contain preservatives other than those listed in Annex V, and must not contain a listed preservative used outside the conditions that Annex V sets for it. Nothing is preserved unless it is on the list, and nothing on the list is unconditionally allowed.

The function test is the part readers skip. An Annex V entry governs a substance only when it is used as a preservative. If the same molecule is added for a different, primary function in the formulation, that use is not governed by Annex V — though it may still be covered by Annex II or III, or need its own justification in the product information file. Annex V does not certify a substance as safe in general. It authorizes one specific use, at one specific concentration, under specific conditions.

Because it is a positive list, silence is not permission. A preservative that is not on Annex V cannot be used as a preservative in an EU cosmetic product, regardless of how it is used elsewhere. And because entries are added, amended and occasionally withdrawn by later Commission regulations, an entry you read today is a snapshot of a moving list, not a permanent grant. An imported record on cosingchecker.com/annex/V/ is identity evidence for a substance's entry — its number, its identifiers, its currently recorded conditions — not proof that those conditions still hold unless you also check the entry's update date and the regulation that produced it.

The columns, and what each one actually restricts

Each Annex V entry carries the same structure, whether the underlying data comes from the original 2009 annex text or a later amending regulation:

• Reference number — the entry's position in the annex. Some numbers carry a letter suffix, such as "12 a", because a related substance was inserted next to an existing entry rather than appended at the end.
• Substance identification — chemical name, and CAS and EC numbers. A single entry can bundle several INCI names and several CAS/EC numbers under one chemical description, when the annex treats a group of related salts or esters as one restriction.
• Product type and/or field of application — restricts where the concentration limit applies (for example, rinse-off only, or a split between oral care and other leave-on products). When this field is empty, do not assume there is no product-type restriction: check the maximum-concentration column too, since some restrictions are worded there instead.
• Maximum concentration in the ready-for-use preparation — the ceiling for the finished product as sold, not for the raw material as purchased or for any intermediate mix.
• Other restrictions and conditions of use — exclusions, age limits, or cross-references to a related entry's combined ceiling.
• Wording of conditions of use and warnings — the mandatory label text, when the annex requires one. This is not sample phrasing; it is the wording the entry requires.

Of the 54 Annex V entries currently in the database, 17 carry a product-type restriction in that dedicated field, 12 carry mandatory warning wording, and 18 carry additional "other restrictions" text. The remaining entries look simple on the surface — a single percentage and nothing else — which is exactly why they get under-read: a plain entry is not a lenient one, it is one where the concentration cap is the only condition.

The "calculated as acid" convention

Several Annex V entries express their concentration limit "as acid" rather than as the weight of the salt actually used. Benzoic acid and sodium benzoate, entry 1, is a clear case: the annex sets 2.5% for rinse-off products, 1.7% for oral care and 0.5% for leave-on products, and all three figures are stated as the acid, not as whichever salt form is in the formulation. Sodium benzoate has a different molecular weight than benzoic acid, so a straight percentage-by-weight reading of the salt would not match the limit the annex actually sets.

The paraben entries make the same point with a combined ceiling. Entry 12 sets 0.4% as acid for a single ester (methylparaben, ethylparaben and their salts) and 0.8% as acid where esters are mixed. Entry 12 a, covering butylparaben and propylparaben and their salts, sets 0.14% as acid for the sum of those two, and separately caps the combined total of entries 12 and 12a — all esters and salts together — at 0.8% as acid, with the butyl/propyl share of that total not exceeding 0.14%. Reading entry 12 a on its own, without the cross-reference back to entry 12, understates the constraint on a formulation that uses both groups.

In the live data, 10 of the 54 Annex V entries use this acid-equivalent convention. A formulator working from the INCI declaration of a salt has to convert to the acid-equivalent basis before comparing against the limit; cosingchecker.com/concentration-calculator/ performs that conversion for entries recorded with an acid convention, so the comparison is against the same basis the annex uses.

Worked examples from current Annex V records

Phenoxyethanol — the plain case

Entry 29, CAS 122-99-6, sets a single limit: 1.0%, with no product-type split, no other restrictions and no mandatory warning recorded. There is nothing to misread here except the temptation to assume a one-line entry must be incomplete. It isn't; a single percentage with nothing else is a complete, binding entry.

Methylisothiazolinone — the restriction hidden in the wrong column

Entry 57, CAS 2682-20-4, sets the limit as "0,0015% Rinse-off products" inside the maximum-concentration field itself, with the dedicated product-type field left empty. Read the product-type column alone and you would miss that this preservative is rinse-off-only. The related mixture entry, 39 (methylchloroisothiazolinone and methylisothiazolinone, 3:1), does the opposite: it records "Rinse-off" in the product-type field and states the 0.0015% mixture ratio separately in the concentration field. Two adjacent, chemically related entries encode the same kind of restriction in different columns — the only safe habit is to read both fields together, every time.

Salicylic acid and its salts — one entry, two sets of rules

Entry 3, updated under Regulation (EU) 2019/1966, sets 0.5% as acid for salicylic acid and 0.5% as acid for its salts, then attaches different warnings and different other-restrictions text to each half of the entry. Salicylic acid itself is not to be used in products for children under three, not to be used in oral products, and not to be used in applications that could expose the end user's lungs by inhalation; the corresponding label warning is restricted to products that might be used on children under three. The salts carry their own, narrower age restriction, with an exception for shampoos. Treating this as one undifferentiated limit — instead of two parallel sets of conditions bundled into a single entry number — drops half of what the entry actually requires.

Butylparaben and propylparaben — a warning tied to a use, not to the substance generally

Entry 12 a also carries a warning limited to one context: leave-on products designed for children under three years of age must state "Do not use on the nappy area," and the corresponding other-restrictions text repeats that the substances are not to be used in leave-on products applied to the nappy area of children under three. Outside that specific product and age context, the warning does not apply — the entry is conditional on the use case, not a blanket label requirement for every product containing these parabens.

A rule that lives in the preamble, not in any entry's own row

Not every Annex V condition sits inside an entry's own columns. The annex's introductory text carries a standing rule for formaldehyde-releasing preservatives: since Commission Regulation (EU) 2022/1181, a product must carry the warning "releases formaldehyde" once the concentration of free formaldehyde released by the preservative exceeds 0.001% in the finished product — a large reduction from the previous 0.05% threshold. Placing non-compliant products on the market was prohibited from 31 July 2024, and making them available was prohibited from 31 July 2026, so any current formulation using a formaldehyde-releasing preservative from the annex needs to be checked against this preamble rule, not just against that preservative's own concentration cell. Reading only the numbered row and skipping the preamble is exactly how a condition like this gets missed.

Common reading mistakes

• Treating an empty product-type or other-restrictions field as "no restriction," instead of checking whether the same restriction is worded inside the maximum-concentration text.
• Applying a concentration limit to the raw weight of a salt instead of converting to the acid-equivalent basis the entry actually specifies.
• Reading one entry number in isolation and missing that a related, separately numbered entry imposes a combined ceiling across both.
• Treating mandatory warning wording as suggested phrasing rather than the label text the entry requires.
• Treating the existence of an Annex V entry as proof a substance is generally safe, or permitted for a different, non-preservative function in the same formulation.
• Relying on a remembered concentration limit without checking the entry's update date and originating regulation, since Annex V is amended by separate Commission acts over time.
• Skipping the annex's preamble text, which carries standing conditions — like the formaldehyde-release warning threshold — that are not repeated inside each affected entry's own row.

Checking a specific entry

cosingchecker.com/annex/V/ lists the current Annex V entries as imported from the consolidated regulation, each with its own update date and originating regulation. cosingchecker.com/checker/ screens an INCI or CAS list against the annexes, including Annex V, to flag which ingredients carry a preservative entry and which conditions are attached to it. cosingchecker.com/concentration-calculator/ converts a salt's declared percentage to the acid-equivalent basis used by entries like benzoic acid/sodium benzoate and the paraben group, so a formulation can be checked against the same basis the annex states rather than against raw label weight.

Sources

• Regulation (EC) No 1223/2009, Article 2 (Definitions) — https://www.legislation.gov.uk/eur/2009/1223/article/2
• Regulation (EC) No 1223/2009, Article 14 (Restrictions for substances listed in the Annexes) — https://www.legislation.gov.uk/eur/2009/1223/article/14
• Regulation (EC) No 1223/2009, Annex V (List of preservatives allowed in cosmetic products) — https://www.legislation.gov.uk/eur/2009/1223/annex/V
• EUR-Lex, consolidated text 02009R1223 — https://eur-lex.europa.eu/eli/reg/2009/1223/2024-04-24/eng
• Biorius, "Decrease of the threshold for the warning 'releases formaldehyde'" (Regulation (EU) 2022/1181) — https://biorius.com/cosmetic-news/decrease-of-the-threshold-for-the-warning-releases-formaldehyde/
• cosingchecker.com API, live Annex statistics — https://cosingchecker.com/api/v1/stats/
• cosingchecker.com API, live Annex V entries — https://cosingchecker.com/api/v1/entries/?annex=V&per_page=100