- Annex VI of Regulation (EC) 1223/2009 is a positive list: only the UV filters it explicitly authorises may be used — as of June 2026, our database tracks 34 authorised entries.
- The legal basis is Art. 14(1)(e), and the UV-filter definition is in Art. 2(1)(n). Nano UV filters carry an additional [nano] labelling obligation under Art. 19(1)(g) and are prohibited in inhalation-risk spray products.
- Commission Recommendation 2006/647/EC sets the SPF categories (Low/Medium/High/Very high), the UVA ≥ 1/3 SPF rule, and the prohibited claims including "sunblock" and "100% protection".
1. What is Annex VI of Regulation 1223/2009?
Regulation (EC) 1223/2009 organises cosmetic ingredient restrictions into five Annexes, each with a distinct logic. Annex VI is a positive list of authorised UV filters: its official title is "LIST OF UV-FILTERS WHICH COSMETIC PRODUCTS MAY CONTAIN" — a list of what may be used, not of what is prohibited.
This logic is identical to Annex V (preservatives) and Annex IV (colorants): only what is listed is permitted. A UV filter not in Annex VI is prohibited in EU cosmetics, even if it is effective and marketed in other jurisdictions.
For the full picture of how all five Annexes relate to each other and to Regulation 1223/2009 overall, the guide What is the CosIng database and how to use it covers the complete regulatory architecture.
2. The definition: Art. 2(1)(n) of Regulation 1223/2009
Before determining which UV filter is permitted, the Regulation precisely defines what a UV filter is:
"'UV-filters' means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation."
Function is the operative criterion, not capability. An ingredient that happens to interact with UV radiation — a metallic pigment, a certain dye — is not a UV filter under the Regulation if its primary function is something else. Conversely, any ingredient whose primary function is photoprotection falls squarely under the Annex VI regime, regardless of any secondary properties it may have.
This has a direct formulation consequence: Titanium Dioxide (CAS 13463-67-7) can appear in Annex IV as a colorant (CI 77891) and in Annex VI as a UV filter. Which Annex governs depends on the function declared in the formulation.
3. Art. 14(1)(e): the positive-list prohibition
Art. 14(1)(e) is the legal basis of Annex VI. Its consolidated text states:
"Without prejudice to Article 3, cosmetic products shall not contain any of the following: […] (e) UV-filters — UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex."
The prohibition is dual: it covers UV filters not listed in Annex VI and UV filters listed but used outside their conditions. Being in Annex VI is not unconditional permission — it is permission conditional on meeting every column of the table (maximum concentration, product type, restrictions, labelling requirements).
This mirrors the structure of Art. 14(1)(d) for preservatives (Annex V), but applied to UV filters. Art. 14(1)(d) governs preservatives; Art. 14(1)(e) governs UV filters. Conflating the two article references is a basic compliance error.
4. Organic and inorganic UV filters: verified examples
Annex VI contains around 34 authorised entries as of June 2026. The following table covers the UV filters with the greatest presence in European cosmetic formulations, with verified CAS numbers, entry numbers, maximum concentrations and regulatory notes:
| Substance (INCI) | CAS | Entry | Max concentration | Notes |
|---|---|---|---|---|
| Benzophenone-3 (Oxybenzone) | 131-57-7 | 4 | 6% face/hands/lips; 2.2% body+sprays; 0.5% product protection only | Tiered by Reg. 2022/1176 (endocrine concern) |
| Homosalate | 118-56-9 | 3 | 7.34% face only (excl. propellant spray) | Cut from 10% by Reg. 2022/2195; full force 1 Jul 2025 |
| Octocrylene | 6197-30-4 | 10 | 10%; 9% propellant sprays | Reg. 2022/1176 |
| Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (Tinosorb S) | 187393-00-6 | 25 | 10% | Broad-spectrum UVA+UVB filter |
| Titanium Dioxide | 13463-67-7 | 27 | 25% | Inorganic filter; also listed as colorant CI 77891 in Annex IV |
| Titanium Dioxide [nano] | 13463-67-7 | 27a | 25% | No spray/inhalation; [nano] label mandatory; Reg. 2019/1857 |
| Zinc Oxide | 1314-13-2 | 30 | 25% | Inorganic (mineral) filter |
| Zinc Oxide [nano] | 1314-13-2 | 30a | 25% | No spray; [nano] label mandatory; Reg. 2016/621 |
| HAA299 (piperazine-based) | — | new | 10% | Added by Reg. 2022/2195; D50 ≥ 50 nm; no inhalation-risk products |
The full Annex VI list includes both UVB-absorbing and UVA-absorbing organic filters as well as broad-spectrum agents. The inorganic filters (TiO2, ZnO) are the only UV filters currently approved in nano form.
5. Nano UV filters: specific regulatory obligations
The use of UV filters in nano form introduces two additional regulatory layers that do not apply to conventional forms.
Labelling obligation — Art. 19(1)(g):
"All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word 'nano' in brackets."
If a formulation contains Titanium Dioxide [nano], the ingredient list must reflect this as such. Listing simply "Titanium Dioxide" when the form is nano constitutes a violation of Art. 19. This applies regardless of whether the nano form is subject to prior authorisation.
Spray/inhalation prohibition:
Titanium Dioxide [nano] (entry 27a) and Zinc Oxide [nano] (entry 30a) are expressly prohibited in products that may be inhaled. The reason is the inhalation toxicology of nanoparticles — their respiratory profile differs significantly from dermal application. This restriction was set by Regulations (EU) 2019/1857 (TiO2) and 2016/621 (ZnO) and remains in force.
HAA299 (added by Reg. 2022/2195) follows the same logic: only in non-dispersible form ≥ D50 50 nm and in products without inhalation exposure risk.
6. Recent regulatory changes: three key amendments
Annex VI has undergone significant changes in recent years that directly affect formulations that were compliant four or five years ago.
Reg. (EU) 2022/1176 (July 2022) — Benzophenone-3 and Octocrylene:
Regulation 2022/1176 introduced tiered limits for Benzophenone-3 (CAS 131-57-7) following the SCCS endocrine-concern assessment:
- 6% in products for face, hands and lips
- 2.2% in body products (including body sprays)
- 0.5% when used only to protect the cosmetic product (not for consumer photoprotection)
The previous limit was a single 6% cap. Body sunscreen formulations using benzophenone-3 at 4–5% had to be reformulated.
Reg. (EU) 2022/2195 (November 2022) — Homosalate and HAA299:
- Homosalate (CAS 118-56-9) was cut from 10% to 7.34% and restricted to face products (excluding propellant sprays). Full application from 1 July 2025.
- HAA299 was added as a new entry: max 10%, non-dispersible form only (D50 ≥ 50 nm), no products with inhalation-exposure risk.
Reg. (EU) 2024/996 — Removal of 4-MBC:
4-Methylbenzylidene Camphor (4-MBC, CAS 36861-47-9) was removed from Annex VI entirely. The SCCS concluded it is an endocrine disruptor (thyroid and oestrogenic effects) for which no safe use concentration can be determined in cosmetics. The implementation timeline:
- 1 May 2025: prohibition on placing new 4-MBC-containing products on the market
- 1 May 2026: mandatory withdrawal of existing 4-MBC-containing products from the market
Any sunscreen or cosmetic with photoprotective function that still contained 4-MBC and was placed on the market after 1 May 2025 is directly non-compliant. Products on shelves after 1 May 2026 are also non-compliant.
For context on how ingredients transition out of Annex VI into Annex II, the guide on prohibited ingredients in Annex II explains that pathway.
7. SPF and Commission Recommendation 2006/647/EC
Commission Recommendation 2006/647/EC does not amend Annex VI — it neither adds nor removes UV filters. Its scope is consumer communication about the level of protection that sunscreen products offer.
Recommended SPF categories:
| Category | SPF values | Minimum recommended label |
|---|---|---|
| Low | 6 and 10 | "Low" |
| Medium | 15, 20 and 25 | "Medium" |
| High | 30 and 50 | "High" |
| Very high | 50+ | "Very high" |
UVA protection rule:
To use a recommended SPF category on the label, the product's UVA protection factor must be at least 1/3 of its SPF (persistent pigment darkening method, PPD), and critical wavelength must be ≥ 370 nm. A product with SPF 50 and inadequate UVA protection cannot legally use the "High" category claim under this framework.
The UVA circle logo:
The circular UVA logo is a voluntary industry symbol managed by Cosmetics Europe — it is NOT part of the Recommendation 2006/647/EC text. Its use indicates the product meets the UVA ≥ 1/3 criterion, but the logo is not a legal requirement.
Prohibited claims (explicitly flagged in the Recommendation):
- "100% protection"
- "sunblock" / "total protection"
- "all day prevention" / "no need to re-apply"
Mandatory warnings for sun protection products:
The Recommendation specifies that sunscreen products should carry warnings including:
- "Do not stay too long in the sun, even while using a sunscreen product"
- "Keep babies and young children out of direct sunlight"
- "Over-exposure to the sun is a serious health threat"
These warnings are aligned with broader EU labelling requirements for cosmetics and are reinforced by national consumer protection frameworks across Member States.
8. How to verify the current state of Annex VI
Two resources in our database address this with up-to-date regulatory data:
CosIng database — /en/cosing-database: covers all authorised UV filters with CAS numbers, maximum concentrations, use conditions and product-type restrictions. Updated to reflect the 2022/1176 and 2022/2195 amendments and the 4-MBC removal under 2024/996. Particularly useful for the tiered Benzophenone-3 limits, which differ by application area.
Search by INCI or CAS: query any ingredient to see every Annex in which it appears and the applicable conditions in each. Essential for dual-function ingredients like Titanium Dioxide, which appears in both Annex IV (colorant) and Annex VI (UV filter).
The other Annexes that complete the regulatory picture: Annex II (prohibited ingredients), Annex III (restricted substances), and Annex V (allowed preservatives).
9. Frequently asked questions
How does EU law define a UV-filter? Art. 2(1)(n) defines UV-filters as "substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation". Function is the operative criterion — capacity alone does not make an ingredient a UV filter under the Regulation.
How many UV filters are authorised in the EU? Around 34 entries as of June 2026. Some sources still cite "29" — that count is stale and must not be used. The list changes with each amending Regulation.
What is the difference between organic and inorganic UV filters? Organic filters absorb UV and convert it to heat. Inorganic filters (TiO2, ZnO) reflect and scatter light. Both must be in Annex VI. Inorganic nano forms carry additional spray restrictions and mandatory [nano] labelling under Art. 19(1)(g).
What does [nano] in the ingredient list mean? Art. 19(1)(g) requires the name to be followed by "nano" in brackets when the ingredient is present as a nanomaterial. "Titanium Dioxide [nano]" and "Zinc Oxide [nano]" are the forms required in the INCI list. Omitting "[nano]" when the nano form is used is a labelling violation.
Is the UVA circle logo a legal requirement? No. It is a voluntary industry symbol managed by Cosmetics Europe, indicating the product meets the UVA ≥ 1/3 SPF criterion from Recommendation 2006/647/EC. Using or omitting it carries no legal sanction under the Cosmetics Regulation itself.
Why was 4-MBC removed from Annex VI? The SCCS found it to be an endocrine disruptor with no determinable safe use concentration. Regulation 2024/996 removed it entirely: no new products from 1 May 2025, and full market withdrawal required by 1 May 2026.
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