“Mineral” sunscreens rely on titanium dioxide, zinc oxide or both, and brands love them for their gentle image. The rules around them are more detailed than many founders expect. This guide to the titanium dioxide cosmetics regulation covers how mineral UV filters are controlled in the EU, what changes when the particles are nano, why sprays and loose powders get extra attention, and what you should test and document before launch. It is general information, not legal advice. Titanium dioxide and zinc oxide are permitted as UV filters in the EU within set conditions, but nano forms, inhalation risk and the exact specification of your material decide what you can do, and the rules are still moving.
Contents
- The short answer
- How does Annex VI control UV filters?
- What is different about nano titanium dioxide and zinc oxide?
- Labelling and notification of nanomaterials
- Why are sprays and powders singled out?
- Which products are affected?
- Formulation and stability issues with mineral filters
- Which tests does a mineral sunscreen need?
- Claims to handle with care
- Pre-launch checklist
- Frequently asked questions
- Key takeaways
The short answer
Under Regulation (EC) No 1223/2009, UV filters are allowed only if they are on the list in Annex VI, with conditions. Titanium dioxide and zinc oxide are both listed, with separate entries for the nano forms, and nano titanium dioxide has to meet a detailed specification. For both minerals the restrictions exclude applications that may expose the user’s lungs to the particles by inhalation. Titanium dioxide powders are also subject to a separate restriction in Annex III from 2021. Because this area has seen legal changes, always read the current consolidated text and discuss your product type with your safety assessor.
How does Annex VI control UV filters?
Annex VI of the Cosmetics Regulation is a positive list. A substance may only be used as a UV filter in a cosmetic if it appears there, within the stated maximum concentration and with any conditions of use. The same material used for another purpose, for example titanium dioxide as a white pigment (colourant CI 77891), is governed by a different annex, so the purpose of the ingredient matters. For both minerals the entries set a maximum concentration in the ready-to-use product, but meeting it is only the start of compliance.
Read also Nanomaterials Cosmetics Regulation: Rules and Notification
What is different about nano titanium dioxide and zinc oxide?
The Regulation defines a nanomaterial as an insoluble or biopersistent, intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale of 1 to 100 nanometres. Mineral filters can be made as nano or non-nano grades, and they are not interchangeable:
- Nano zinc oxide was authorised as a UV filter after a positive scientific opinion, with a maximum concentration and the lung exposure exclusion.
- Nano titanium dioxide has its own Annex VI entry with a detailed specification covering purity, crystal form, particle size and shape, allowed coatings and limited photocatalytic activity, and it must be photostable in the final formula.
- Non-nano grades have separate entries and are treated differently for labelling.
Your supplier’s documents must show that the grade you buy fits the entry you rely on. A generic “titanium dioxide” certificate is not enough.
Labelling and notification of nanomaterials
Ingredients present as nanomaterials must be shown in the ingredient list with the word “nano” in brackets after the name. Nanomaterials that are not covered by the colourant, preservative or UV filter annexes generally have to be notified to the Commission six months before being placed on the market, whereas nano UV filters listed in Annex VI follow their own route. Check with your safety assessor how your formula is treated, and keep the nano status of every grade in your file. Applying the label correctly is also part of your CPSR review.
Why are sprays and powders singled out?
Safety assessment of these minerals is mainly based on skin application. Inhaled fine particles are a different exposure route, which is why the Annex VI entries for the nano forms, and for the oxides in general, exclude uses that may lead to lung exposure. In 2021 the EU also added a specific restriction in Annex III for titanium dioxide in powder form containing a share of small particles (aerodynamic diameter of 10 micrometres or less), after the substance was classified under chemicals law for carcinogenicity by inhalation. The restriction allows loose face powders and hair aerosol sprays only under set conditions and bars other uses that may expose the lungs. A later Court of Justice ruling in 2025 upheld the annulment of that classification. We are not aware of how, or when, the cosmetics rule will change as a result, so check the current annexes before you launch a spray or a loose powder with titanium dioxide.
Read also Salicylic Acid in Cosmetics: EU Limits and Safe Use
Which products are affected?
- Sunscreen sprays and mists: the inhalation exclusion is directly relevant.
- Loose mineral powders and powder foundations: the powder restriction can apply even when the oxide is only a colourant.
- Dry shampoos and hair sprays with titanium dioxide: aerosol uses are specifically covered.
- Creams, lotions, sticks and pressed powders: lower inhalation exposure, but still need the correct grade and a safety assessment.
When in doubt, ask your assessor whether your pump spray or powder format counts as an application that may lead to lung exposure.
Formulation and stability issues with mineral filters
- Dispersion: particles agglomerate and settle if not dispersed and stabilised well, which hurts both appearance and protection.
- Coatings: they influence compatibility with oils and water, white cast and photostability.
- Interactions: reactive titanium dioxide can degrade other ingredients, one reason the nano entry limits photocatalytic activity.
- Emulsion stability: high filter loads thicken the formula and can destabilise it.
A stability and compatibility test in the final packaging shows whether colour, viscosity, separation and packaging hold up over the shelf life.
Which tests does a mineral sunscreen need?
Sun protection claims fall under Commission Recommendation 2006/647/EC on the efficacy of sunscreen products and claims made, and SPF and UVA protection are measured by specialised methods that are separate from the tests described here. Around these, a mineral sunscreen typically needs:
- A challenge test and a microbiological specifications test for water-containing formulas.
- A patch test if you plan claims for sensitive skin, children or “dermatologically tested”.
- A CPSR that covers the filter grade, nano status, use format and the SPF evidence.
Read also Retinol EU Regulation: Limits, Dates and Safety
Claims to handle with care
Claims must meet the common criteria of Regulation (EU) 655/2013. For mineral sunscreens:
- “Mineral” or “physical filter” claims must match the actual filter system. A formula mixing mineral and organic filters is not purely mineral.
- “Non-nano” needs supplier evidence for every batch.
- “Reef safe” or “ocean friendly” are not defined terms, so they need strong evidence and are best avoided.
- “Total protection” or “sunblock” wording is not accepted for sunscreens.
Pre-launch checklist
- Record the exact grade, nano status and specification from the supplier.
- Check the Annex VI entry and the conditions that apply to that grade.
- Decide the product format and ask your assessor about inhalation.
- Label nano ingredients correctly and complete any notification needed.
- Run stability, challenge and microbiological tests in the final packaging.
- Have SPF and UVA evidence ready before you state any protection level.
Frequently asked questions
Is titanium dioxide banned in cosmetics?
No. It is permitted as a UV filter and colourant within conditions, with specific restrictions for nano forms and inhalable powders and sprays.
Is zinc oxide treated the same way?
Both are listed UV filters with a maximum concentration and a lung exposure exclusion. The detailed specifications differ.
Do I have to label nano ingredients?
Yes. Ingredients in nano form must be followed by the word “nano” in brackets in the ingredient list.
Key takeaways
- Mineral UV filters must follow Annex VI, and nano grades have their own conditions.
- Sprays and loose powders need extra attention because of inhalation exposure.
- Check supplier documents against the exact grade and label nano ingredients.
- Back up stability, preservation and safety with tests and a signed CPSR.