Allowed preservatives in EU cosmetics: Annex V of Regulation 1223/2009 explained

• Annex V of Regulation (EC) 1223/2009 is a positive list: only the preservatives it explicitly authorises may be used — as of June 2026, our database tracks around 58 entries.
• The logic is the inverse of Annex II: in Annex V, what is not listed is prohibited. Using an unlisted preservative is a direct infringement, even if the substance does not appear in Annex II.
• The most common compliance failures are the paraben dual-limit trap (individual + 0.8% combined), MIT in leave-on products, and the formaldehyde releaser labelling threshold that dropped 50-fold in 2022.

1. What is Annex V of Regulation 1223/2009?

Regulation (EC) 1223/2009 organises cosmetic ingredient restrictions into five Annexes, each with a distinct logic. Annex II prohibits. Annex III restricts with conditions. Annex V authorises.

Its official title makes this explicit: "LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS" — preservatives that are allowed. Unlike Annex II (a negative list of what is banned), Annex V is a positive list: only what appears on it may function as a preservative in a cosmetic product marketed in the EU.

Annex V shares this positive-list logic with Annex IV (colorants) and Annex VI (UV-filters), but not with Annex III (conditional restrictions). Understanding this distinction is the starting point for correct application of the Regulation.

For the full map of how the five Annexes relate to each other, the guide What is the CosIng database and how to use it covers the complete regulatory architecture.

2. What does Art. 14(1)(d) say?

Art. 14(1)(d) is the legal basis of Annex V. Its consolidated text (EUR-Lex, version 02009R1223-20250901) states:

"Without prejudice to Article 3, cosmetic products shall not contain any of the following: […] (d) preservatives — preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex."

The prohibition is dual: it covers preservatives not listed (first limb) and preservatives listed but used outside their conditions (second limb). Being in Annex V is not unconditional permission; it is permission conditional on meeting every column of the table.

3. The legal definition of preservative: Art. 2(1)(l)

Art. 2(1)(l) of the Regulation defines what counts as a preservative:

"'preservatives' means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product."

The qualifier "exclusively or mainly" draws an important boundary. An ingredient with a primary function other than preservation — solvent, keratolytic, fragrance component — may not be classified as a preservative even if it has antimicrobial activity. However, if it is used in the formulation with the primary purpose of preservation, declaring a different function to avoid Annex V limits constitutes non-compliance.

The most instructive case is Salicylic Acid: when functioning as a preservative, the 0.5% limit of Annex V applies; when functioning as a keratolytic or cosmetic active, the higher regime of Annex III applies (up to 2–3% depending on product type). The sibling post on restricted substances in Annex III explains this dual-listing mechanism in detail.

4. The positive-list principle: what is not listed is forbidden

This is the conceptual core of Annex V — and the source of many compliance failures in practice.

In Annex II the logic is prohibitive: the list names what cannot be used. Everything not listed is not specifically prohibited by that Annex (subject to the other Annexes and Art. 3).

In Annex V the logic is exclusively permissive: only the preservatives it lists are authorised. Any substance functioning as a preservative that is not on the list is excluded — not because it has been evaluated and rejected, but because it has not been authorised. The absence from the list IS the prohibition.

Practical consequence: if a formulation uses a novel preservative not yet evaluated by the SCCS, that preservative is banned in the EU — not because it is in Annex II, but because it is not in Annex V.

5. Verified preservative examples: reference table

The following table covers the Annex V preservatives with the greatest presence in European cosmetic formulations, with CAS numbers, current limits and principal conditions as verified against the regulatory database:

Phenoxyethanol (CAS 122-99-6) is the most widely used preservative in European cosmetics today, precisely because its Annex V profile is among the broadest: it applies to all product types without restrictions by body area or age group (subject to product-specific safety assessment).

6. Parabens: allowed versus banned

Parabens are the preservative group with the most complex Annex V regulation, because some are authorised and others are explicitly prohibited.

Parabens authorised by Annex V:

Combined cap rule: the Regulation sets a 0.8% combined cap for all parabens in a formulation, regardless of individual compliance. A blend of methylparaben at 0.4% and propylparaben at 0.4% breaches the 0.8% combined cap even though each individual paraben is within its own limit.

Parabens banned (Annex II): Regulation (EU) 358/2014 transferred five parabens to Annex II due to insufficient safety data:

• Isopropylparaben
• Isobutylparaben
• Phenylparaben
• Benzylparaben
• Pentylparaben

These five are not merely "unauthorised as preservatives" — they are explicitly banned in cosmetic products regardless of their declared function.

7. Salicylic acid as a preservative versus Annex III

Salicylic Acid (CAS 69-72-7) is the canonical example of a dual-listed ingredient: it appears in both Annex III (entry 98, as a restricted substance at up to 3% depending on use) and Annex V (entry 3, as a permitted preservative at 0.5%).

The rule is clear: the ingredient's declared function in the formulation determines which Annex governs. If the primary function is preservation, the 0.5% Annex V limit applies. If the primary function is keratolytic or cosmetic active, the Annex III regime applies (up to 2–3%).

Declaring the wrong function to exploit the higher Annex III limit when the ingredient is acting as a preservative is a direct path to non-compliance. The full guide on Annex III explains this dual-listing mechanism and its compliance implications in detail.

8. Formaldehyde releasers and the 2022 threshold change

Several Annex V preservatives do not release formaldehyde directly, but do so gradually in the formulation over time. These are the formaldehyde releasers:

Regulation (EU) 2022/1181 introduced a critical change to the mandatory labelling threshold for products that release formaldehyde: it dropped from 0.05% (500 ppm) to 0.001% (10 ppm) of released formaldehyde, triggering the mandatory label "releases formaldehyde". This 50-fold reduction was driven by a 2021 SCCS opinion finding that 500 ppm did not adequately protect sensitised consumers.

Application calendar for Regulation 2022/1181:

• 31 July 2024: mandatory for products placed on the market
• 31 July 2026: mandatory for products already on the market (sell-through)

Any formulation containing releasers at concentrations that exceed 0.001% released formaldehyde and has not updated its labelling has been non-compliant since July 2024.

9. The most recent amendment: Regulation (EU) 2026/78

The most recent amendment to Annex V at the time of publishing this guide is Regulation (EU) 2026/78 (Official Journal, 13 January 2026), applicable from 1 May 2026.

It amends entry 7 of Annex V, which covers o-Phenylphenol (CAS 90-43-7) and its sodium salt (Sodium o-Phenylphenate):

• New limits: 0.2% in rinse-off products / 0.15% in leave-on products
• Prohibited uses: products with inhalation-exposure risk (aerosols); oral hygiene products
• Mandatory warning: "Avoid contact with eyes"
• Technical basis: Delegated Regulation (EU) 2024/2564 (CLP ATP)

Any formulation that contained o-Phenylphenol before 1 May 2026 and has not been reviewed against these new conditions may currently be non-compliant.

10. The 6 most common compliance traps

Experience in formulation verification reveals six recurring traps in the application of Annex V:

1. Dual-function ingredient (wrong declared function): Benzoic Acid, Benzyl Alcohol, and Salicylic Acid all have antimicrobial activity but also other recognised functions. Declaring a non-preservative function to avoid Annex V limits is non-compliance.

2. Rinse-off-only preservatives used in leave-on products: MIT, the MCI/MIT 3:1 mixture, Phenoxyisopropanol (ref 43), and Benzylhemiformal (ref 55) are only authorised in rinse-off products. Their presence in any leave-on product at any concentration is a direct infringement.

3. "As acid" calculation for salts: The limits for Benzoic Acid, Sorbic Acid, and parabens are calculated as acid equivalents. Using the salt concentration without converting underestimates the actual active content.

4. Combined paraben cap breached: Meeting each individual paraben limit (0.4% / 0.14%) does not guarantee compliance with the 0.8% combined cap when multiple parabens are blended.

5. Age restrictions overlooked: Propylparaben and Butylparaben are prohibited in leave-on products applied to the nappy area of children under 3 years. IPBC is prohibited in products for children under 3. Triclocarban is prohibited for children under 6.

6. Outdated formaldehyde releaser threshold: Many formulations that were within the old 500 ppm threshold now exceed the new 10 ppm threshold and require labelling updates since July 2024.

11. How to verify the current state of Annex V

Two resources in our database address this with up-to-date regulatory data:

CosIng database — /en/cosing-database: covers all authorised preservatives, with CAS numbers, maximum concentrations, use conditions and product-type restrictions. Updated to include the 2026/78 amendment and all recent Annex V changes.

Search tool: query by INCI name or CAS number to see every Annex in which a substance appears and the applicable conditions in each. Particularly useful for dual-listed ingredients like Salicylic Acid.

The other Annexes that complete the regulatory picture: Annex II (prohibited ingredients), Annex III (restricted substances), and Annex VI (UV filters).

12. Frequently asked questions

How does EU law define a preservative? Art. 2(1)(l) defines preservatives as "substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product". The declared function determines whether Annex V limits apply or those of another Annex.

What does it mean for Annex V to be a positive list? Only the preservatives explicitly listed in Annex V are authorised. Any preservative not on the list is prohibited by default, even if it does not appear in Annex II.

How many preservatives are authorised in the EU? Around 58 as of June 2026. The exact count varies between 57 and 60 depending on the consolidated version consulted.

Which parabens are allowed and which are banned? Allowed: Methylparaben, Ethylparaben, Propylparaben, Butylparaben. Banned (Annex II): Isopropylparaben, Isobutylparaben, Phenylparaben, Benzylparaben, Pentylparaben.

What is the combined paraben cap trap? Annex V sets individual limits (0.4% or 0.14%) and a combined cap of 0.8% for all parabens summed. A blend of parabens can respect each individual limit and still breach the combined cap.

Why is MIT a compliance risk? Since 2017 it is banned in leave-on products at any concentration. Only permitted at 0.0015% in rinse-off. Any leave-on product containing MIT is directly non-compliant.