- Annex III of Regulation (EC) 1223/2009 is NOT a list of permitted ingredients: it is a list of substances that cosmetics must not contain EXCEPT under specific conditions — as of June 2026, our database tracks 381 entries.
- The table uses sub-entries a/b/c to assign different limits per product type: Hydrogen Peroxide (CAS 7722-84-1) reaches 12% in hair products but only 0.1% in oral care.
- Dual-listing is real: Salicylic Acid appears in Annex III as a restricted substance and in Annex V as a permitted preservative, with different limits for each function.
1. What is Annex III of Regulation 1223/2009?
Regulation (EC) 1223/2009 is the EU legal framework for cosmetics. It organises ingredient restrictions into five Annexes. If Annex II is the list of the absolutely prohibited, Annex III is something different — and often misunderstood.
Annex III is not a list of permissions. Its official title states this precisely: "LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN". The governing word is "except": the substance is still presumptively problematic; what Annex III provides is a regulated pathway under which it may be used, if and only if the specific conditions are met.
For the full context 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)(b) say?
Art. 14(1)(b) is the legal basis of Annex III. Its consolidated text (EUR-Lex, version 02009R1223-20250901) states:
"Without prejudice to Article 3, cosmetic products shall not contain any of the following: […] (b) restricted substances — restricted substances which are not used in accordance with the restrictions laid down in Annex III."
The cross-reference to Art. 3 is important: even if a formulation meets every Annex III condition, the Responsible Person still has a duty to ensure the product is safe under the general safety standard of Art. 3. Annex III sets necessary conditions, not sufficient ones.
3. Structure of the Annex III table
The Annex III table has six columns that the Responsible Person must understand in order to apply it correctly:
| Column | Content |
|---|---|
| Ref. No. | Entry reference number |
| Substance identification | Chemical/INN name, CosIng glossary name, CAS, EC number (EINECS/ELINCS) |
| Product type / body parts | Type of cosmetic and body area to which the restriction applies |
| Maximum concentration | Percentage limit in the ready-for-use preparation |
| Other restrictions | Additional conditions: age restrictions, professional-use only, etc. |
| Warning wording | Mandatory text that must appear on the label when the substance is present |
The "product type / body parts" column is what generates sub-entries. When the same substance has different restrictions for different uses, the table splits it into sub-entries a, b, c… each with its own concentration limit and its own conditions.
4. The sub-entry phenomenon: Hydrogen Peroxide as a teaching example
Hydrogen Peroxide (entry 12, CAS 7722-84-1) is the textbook case for understanding sub-entries. The same molecule receives six different regulatory regimes in Annex III:
| Sub-entry | Product type | Maximum concentration | Special conditions |
|---|---|---|---|
| a | Hair products | 12% | — |
| b | Skin products | 4% | — |
| c | Nail hardening products | 2% | — |
| d | Oral hygiene products | 0.1% | — |
| e | Tooth whitening (0.1%–6%) | Up to 6% | Dispensed by dentists only; prohibited under 18; first use in dental surgery |
| f | Eyelash products (professional) | 2% | Professional use only |
Mandatory warning text in all cases: "Contains hydrogen peroxide. Avoid contact with eyes. Rinse immediately if contact occurs."
This structure has direct implications for formulation decisions. A tooth-whitening product at 3% is legal if dispensed by a dentist — and non-compliant if sold to consumers directly. The concentration alone does not answer the compliance question; the entire sub-entry must be read.
5. Dual-listing: Salicylic Acid in Annex III and Annex V
Salicylic Acid (CAS 69-72-7) is the most-cited example of dual-listing: it appears in both Annex III and Annex V of the Regulation.
In Annex III (entry 98), it is a restricted substance with the following limits:
- Maximum 3.0% in rinse-off hair products
- Maximum 2.0% in other uses
- Not for children under 3 years of age; not for oral products; not for spray/nebuliser applications
- Source: SCCS/O/268
In Annex V (entry 3), it is a permitted preservative at a maximum of 0.5%.
In practice, the declared function of the ingredient in the formulation determines which Annex governs. If salicylic acid is acting as a preservative, the 0.5% limit from Annex V applies. If it is acting as a keratolytic or cosmetic active, the higher Annex III limits (up to 2%–3% depending on use) apply. Declaring the wrong function to exploit the higher limit is a direct path to non-compliance.
For the full picture of how Annex V governs preservatives including salicylic acid, the sibling post Allowed preservatives in cosmetics — Annex V covers the preservative regime in detail.
6. Recent amendments: 2023/1545, 2024/996, and 2025/877
Annex III is one of the most active Annexes of the Regulation. These are the three most significant modifications of recent years:
Reg. (EU) 2023/1545 — Expanded fragrance allergens (entries 327–371)
Reg. (EU) 2023/1545 was the most extensive revision of the fragrance allergen block of Annex III in decades. It expanded the list from 24 to around 80 substances (45 new entries) and established new mandatory labelling thresholds: 0.001% for leave-on products and 0.01% for rinse-off products.
Application deadlines:
- 31 July 2026: new products placed on the market
- 31 July 2028: products already on the market
The full scope of this Regulation — which substances are added, what the thresholds mean in practice, and how fragrance systems are affected — is analysed in the dedicated guide: EU Regulation 2023/1545 — Fragrance allergens.
Reg. (EU) 2024/996 — New entries 373–378
Published on 3 April 2024, Reg. (EU) 2024/996 added six new entries to Annex III, driven primarily by endocrine disruption concerns and cumulative exposure assessments:
| Entry | Substance | Key limit |
|---|---|---|
| 373 | Genistein | 0.007% |
| 374 | Daidzein | 0.02% |
| 375 | Kojic Acid | 1% (face and hands) |
| 376 | Retinol / Retinyl Acetate / Retinyl Palmitate | 0.05% RE body lotion / 0.3% RE others |
| 377 | Alpha-Arbutin | 2% face / 0.5% body |
| 378 | Arbutin | 7% face cream |
Entry 376 (the Vitamin A group) warrants particular attention: it introduces maximum concentrations expressed in retinol equivalents (RE) and requires the mandatory warning text "Contains Vitamin A. Consider your daily intake before use". Application dates are 1 November 2025 for new formulations and 1 May 2027 for existing ones. Reference CAS numbers: Retinol 68-26-8, Retinyl Acetate 127-47-9, Retinyl Palmitate 79-81-2.
Reg. (EU) 2025/877 — Deletion of entry 311
Published 12 May 2025, applicable from 1 September 2025, Reg. (EU) 2025/877 deleted entry 311 from Annex III: Trimethylbenzoyl Diphenylphosphine Oxide (CAS 75980-60-8), a UV photoinitiator. The reason: reclassification as CMR 1B under the CLP Regulation, which triggered Art. 15 of Regulation 1223/2009 and moved the substance to Annex II (new entry 1731).
This is the CMR mechanism operating as an exit route from Annex III: when a restricted substance receives a sufficiently serious CMR classification, the conditional restriction regime is no longer applicable and the substance moves to an absolute prohibition. The sibling post Prohibited cosmetic ingredients — Annex II explains how this mechanism works in detail.
7. How to check whether a substance meets Annex III limits
The CosIng database provides three complementary tools for this:
Annex III page: the full list of all 381 entries (as of June 2026), with all sub-entries, maximum concentrations by product type, additional restrictions, and required warning texts. This count can vary slightly between regulatory versions: Reg. 2025/877 deleted entry 311, so sources referencing an earlier version may cite 382 entries.
Search tool: search by INCI name, CAS number, or entry reference to see every Annex in which the substance appears and the applicable conditions in each. Particularly useful for dual-listed substances like salicylic acid.
Annex V cross-reference: for substances that appear in both Annex III and Annex V, comparing the conditions in each is the starting point for determining which regime governs based on the ingredient's declared function.
The other Annexes that complete the regulatory picture are Annex II (prohibited substances), Annex V (allowed preservatives), and Annex VI (UV filters).
8. Frequently asked questions
What is the difference between Annex II and Annex III? Annex II lists absolutely prohibited substances. Annex III lists substances that cosmetics must not contain EXCEPT when the restrictions are met: product type, maximum concentration, additional conditions, and mandatory warning text. An Annex III entry is a conditional permit, not a safety endorsement.
Why does the same ingredient appear with multiple limits? Because Annex III uses sub-entries (a, b, c…) for different uses. Hydrogen Peroxide (CAS 7722-84-1, entry 12) reaches 12% in hair products but only 0.1% in oral products.
What is the dual-listing of salicylic acid? Salicylic Acid (CAS 69-72-7) appears in Annex III (entry 98) at up to 3% in rinse-off hair products and 2% elsewhere, and in Annex V (entry 3) as a preservative at 0.5%. The ingredient's declared function determines which limit applies.
What did Regulation 2025/877 do to Annex III? It deleted entry 311 (Trimethylbenzoyl Diphenylphosphine Oxide, CAS 75980-60-8), reclassified as CMR 1B and moved to Annex II from 1 September 2025.
Are the fragrance allergens from Regulation 2023/1545 in Annex III? Yes. Entries 327–371 cover the expanded allergens, with labelling thresholds of 0.001% (leave-on) and 0.01% (rinse-off). Deadlines: 31 July 2026 (new products) and 31 July 2028 (existing products).
How do I check Annex III compliance for a substance? Search our CosIng database by INCI name or CAS number to see the full entry, all sub-entries, and required conditions. You can also compare conditions across Annexes to handle dual-listed substances.
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