Annex III Restricted Ingredients and Their Use Limits

If you're eyeing the EU market, Annex III of Regulation (EC) No 1223/2009 is one of the first documents you should sit down with, before you finalize a formula, not after. Annex III isn't a ban list. It's a "yes, but" list, substances the EU allows in cosmetics only within specific concentration ceilings, only in certain product types, or only alongside required warning text on the label.

How Annex III differs from a straightforward prohibited list

A prohibited list is simple: the substance can't be in the product, period. Annex III is more like a set of conditions attached to permission. A given entry might say a preservative is allowed up to a stated percentage in leave-on products but a different, often lower, percentage in products intended for children under a certain age, or it might require specific wording on the label warning about a known sensitivity. This is why simply checking "is this ingredient banned" against a mental list isn't enough for EU formulating. You have to check the specific conditions attached to it.

What each Annex III entry typically specifies

When you look up a restricted substance, expect to find several pieces of information tied to it:

• The maximum authorized concentration, sometimes as a flat percentage, sometimes split by product category (rinse-off versus leave-on, or general use versus specific applications like oral care).
• Product type or population restrictions, for example a substance permitted in adult products but restricted or prohibited in products marketed for children.
• Required warning statements, wording that must appear on the label if the substance is used, so the concentration limit and the labeling requirement travel together.
• Purity or specification requirements, since some entries only permit a substance if it meets a stated purity standard, relevant for botanical extracts and certain colorants.

A simplified illustration of the format

Annex III entries follow a structured format with columns for substance, restrictions, and wording conditions. A simplified version of how that reads:

Column	What it tells you
Substance identity	The named restricted ingredient
Product type / body part	Where the restriction applies (rinse-off, leave-on, oral, etc.)
Maximum concentration	The ceiling allowed in the finished product
Other restrictions	Age limits, purity specs, or combination rules with other ingredients
Conditions of use and warnings	Label text required if the substance is present

The exact substances, numeric limits, and current wording change as the EU updates the annex, so treat any specific number you find in an older source as something to reconfirm against the current official annex text before you rely on it in a Product Information File.

Where this connects to your CPSR

Your Cosmetic Product Safety Report, signed by a qualified safety assessor, is where Annex III compliance actually gets checked and documented for your specific formula. The assessor isn't just confirming an ingredient appears on the permitted list, they're confirming your concentration falls within the stated limit for your specific product type, and that any required warning language is planned for your label copy before you notify through CPNP. This is one of the clearest reasons the EU requires a Responsible Person established in the EU and a safety assessor's sign-off rather than a simple self-notification, the restrictions are conditional enough that they benefit from expert review.

Practical steps if you're formulating for both Canada and the EU

Many makers building for multiple markets end up with formulas that pass comfortably in one market and need adjustment for another, since Canada's Hotlist, the EU's Annex III, and other regional lists don't mirror each other substance for substance or limit for limit. A colorant fine at one concentration for Canada might carry a lower Annex III ceiling, or vice versa. Build your formula around the more conservative limit across your target markets if you want a single formula to travel well, or plan on maintaining a market-specific variant if the ingredient is doing real work in your product and you don't want to compromise it.

Keep your Annex III research documented alongside your formula sheet, noting which entry you checked and when, since annex updates happen periodically and a limit you confirmed a year ago is worth reverifying before a reformulation or a new market launch. Cosmetic Comply's Canada notification tooling is live today, with US, EU, and Australia support on the way, and the same ingredient-mapping approach, INCI names, CAS numbers, and concentration screening, will carry over as those markets come online, which is worth knowing if you're planning your compliance workflow with more than one country in mind.