Cosmetic Ingredient Annexes Explained (UK & EU Guide)

Whether an ingredient is allowed in a cosmetic and at what level is not a matter of opinion. It is set out in a series of legal lists known as the annexes to the cosmetic regulation. These annexes are the rulebook for what can and cannot go into a product, and understanding them is essential for any maker formulating for the UK or EU market. This guide explains what each annex does and how they fit together.

The annexes sit behind your CPSR: the safety assessor checks every ingredient against them. Knowing the basics yourself helps you formulate compliantly from the start rather than discovering a problem at assessment.

What are the cosmetic annexes?

The cosmetic regulation Regulation (EC) No 1223/2009, retained in UK law contains a set of technical annexes that list substances by how they may be used. Some annexes are negative lists (substances you cannot use), while others are positive lists (the only substances you may use for a given purpose, within stated limits). Together they define the chemical boundaries of a legal cosmetic, and they are updated regularly as scientific opinions evolve.

For a maker, the practical message is that you cannot simply put any ingredient into a cosmetic because it seems natural or is sold for cosmetic use. Each ingredient has to be checked against the relevant annex, and many carry concentration limits, conditions of use, or mandatory label warnings. The annexes are where those rules live.

Annex II prohibited substances

Annex II is the list of substances banned from cosmetics altogether. It is a very long list of thousands of entries, ranging from obvious toxins to specific chemicals found unsafe for cosmetic use. If a substance is on Annex II, it cannot be present in a cosmetic placed on the market there is no permitted level. This is the hard floor of cosmetic safety.

Most makers never intend to use Annex II substances, but they can appear unexpectedly as contaminants or as components of poorly documented raw materials. This is one reason ingredient traceability and good supplier documentation matter. We cover this list in detail in our guide to banned cosmetic ingredients.

Annex III restricted substances

Annex III lists substances that may be used, but only under restrictions typically a maximum concentration, limits on which product types they can appear in, conditions of use, and often mandatory warning wording for the label. Many everyday cosmetic ingredients sit here, allowed within carefully defined limits rather than banned or freely permitted.

Annex III is where a lot of real-world formulating decisions are made, because exceeding a limit or using a substance in the wrong product type makes the product non-compliant even though the ingredient is permitted in principle. Our guide to restricted cosmetic ingredients explains how these conditions work.

Annexes IV, V and VI the positive lists

Three annexes are positive lists meaning only the substances they contain may be used for that function, within the stated conditions. Annex IV lists permitted colourants, Annex V lists permitted preservatives, and Annex VI lists permitted UV filters. If you want to colour, preserve or add sun protection to a cosmetic, you must choose from these lists; a substance not on the relevant list cannot be used for that purpose, however effective it might be.

This positive list approach is stricter than a simple ban. It means the default is “not allowed unless listed” for these functions. We dig into two of the most important for makers in our guides to cosmetic preservatives and UV filters.

How the annexes work together

In practice, every ingredient in your formula is checked against the whole framework. Is it banned under Annex II? Is it restricted under Annex III, and if so are you within the limits and conditions? If it is a colourant, preservative or UV filter, is it on the relevant positive list and used within its conditions? Only when every ingredient clears these checks can the product be considered compliant on composition.

This is exactly the work a safety assessor does when preparing the CPSR, cross referencing your full formula against the current annexes. Because the lists change, an ingredient that was fine a few years ago may now be restricted or banned, which is why compliance is an ongoing matter rather than a one time check.

Nanomaterials and special cases

Some ingredients carry extra rules when used in nano form. A colourant, preservative or UV filter may be listed for normal use but require separate assessment or specific approval as a nanomaterial, and nano ingredients must be flagged on the label with “[nano]”. There are also CMR substances those classified as carcinogenic, mutagenic or toxic to reproduction which are generally prohibited, with only narrow derogations.

These special cases catch out makers who assume an ingredient's general listing covers every form and use. The safe approach is to check the exact entry, including any conditions attached to the specific grade or form you are using, rather than relying on the substance name alone.

How the UK and EU annexes can differ

Since Brexit, the UK and EU each maintain their own versions of these annexes. They started from the same point, but they are now updated independently, so a substance restricted or banned in one market may not yet have changed in the other. For most ingredients the two align, but divergence is growing as each authority issues its own updates.

For a brand selling in both markets, this means checking ingredients against both the UK and EU annexes rather than assuming they are identical. It is another reason that keeping compliance current a core duty of the Responsible Person matters as the rulebooks slowly drift apart.

How to check an ingredient yourself

You do not have to be a chemist to do a first-pass check on an ingredient. The authorities publish searchable databases of cosmetic ingredients and their regulatory status the European Commission's database for the EU, and OPSS resources for the UK where you can look up a substance and see whether it is banned, restricted, or a listed colourant, preservative or UV filter, along with any conditions. Getting into the habit of checking new ingredients before you buy or formulate with them saves expensive surprises later.

That said, a database lookup has limits. It tells you the headline status but not always how a condition applies to your specific product type, the form or grade you are using, or the interaction with the rest of your formula. It also will not catch a contaminant arriving inside a raw material. So a self-check is a useful filter, not a substitute for a proper safety assessment, which is where every ingredient is evaluated in the real context of your finished product.

The most reliable workflow is to vet ingredients against the databases as you design a formula, keep the supporting documentation for each one, and then have the complete formulation assessed for the CPSR. That way you rarely hit a nasty surprise at assessment, because the obvious problems have already been filtered out earlier.

What this means for your formula

• Check every ingredient against Annex II (banned).

• Confirm any Annex III restricted ingredient is within its limits and conditions.

• Use only listed colourants, preservatives and UV filters (Annexes IV, V, VI).

• Flag and check any nano ingredients separately.

• Re-check when lists change, and against both UK and EU annexes if you sell in both.

Frequently asked questions

What are the cosmetic ingredient annexes?

They are legal lists in the cosmetic regulation that control ingredients: Annex II (banned), Annex III (restricted), and Annexes IV, V and VI (positive lists of permitted colourants, preservatives and UV filters).

What is the difference between a banned and a restricted ingredient?

A banned ingredient (Annex II) cannot be present at all. A restricted ingredient (Annex III) may be used only within set limits, product types, conditions and label warnings.

What is a positive list?

A list where only the substances included may be used for that function. Colourants, preservatives and UV filters must come from Annexes IV, V and VI respectively anything not listed is not allowed for that purpose.

Do the UK and EU annexes match?

They started identical but are now updated separately, so they can diverge. Brands selling in both markets should check ingredients against both sets of annexes.

Who checks my ingredients against the annexes?

The safety assessor does this when preparing your CPSR, cross-referencing your full formula against the current annexes and conditions of use.

Can I check an ingredient's annex status myself?

Yes, as a first pass. The European Commission's database and OPSS resources let you look up a substance's status. It is a useful filter but not a substitute for a full safety assessment in the context of your finished product.

Do nano ingredients follow the same annex rules?

Not entirely. A substance listed for normal use may need separate assessment or specific approval in nano form, and nano ingredients must be flagged with '[nano]' on the label.

References: Regulation (EC) No 1223/2009, Annexes II–VI (EUR-Lex); UK Cosmetics Regulation as retained (legislation.gov.uk); OPSS and European Commission ingredient databases. General information only, not legal advice.