Restricted Cosmetic Ingredients: Annex III Explained

Many useful cosmetic ingredients are neither freely allowed nor banned they sit in between, permitted only under restrictions. These are listed in Annex III of the cosmetic regulation, with limits on how much you can use, which products they can go in, and what warnings the label must carry. This guide explains how Annex III works and why staying within its conditions is essential.

Annex III is part of the framework covered in our pillar guide to cosmetic ingredient annexes. Here we focus on restricted substances.

What is Annex III?

Annex III lists substances that cosmetics must not contain except subject to the restrictions laid down. In other words, these ingredients are allowed, but only within strict boundaries. Each entry specifies the conditions: a maximum concentration, the product types it may be used in, who it may be marketed to, and frequently the exact wording of warnings or conditions of use that must appear on the label.

This makes Annex III the busiest annex for everyday formulating. A great many common ingredients across preservbuffers, actives, certain fragrance components, and more are permitted on Annex III terms. The ingredient itself is fine; the question is always whether you are using it within its specific limits.

How restrictions work

A typical Annex III entry sets a maximum concentration for the substance in the finished product, and may set different limits for different product types. For example, a substance might be allowed at one level in a rinse off product but a lower level in a leave-on one, reflecting the greater exposure when a product stays on the skin. Some entries restrict an ingredient to particular categories entirely, or prohibit it in products for a certain group such as young children.

Going over the maximum, or using a restricted ingredient in a product type where it is not allowed, makes the product non compliant even though the ingredient is perfectly legal in principle. This is why knowing the exact percentage of each ingredient in your formula matters so much: you cannot confirm you are within an Annex III limit without it.

Mandatory warnings and conditions of use

Many Annex III entries come with mandatory label wording specific warnings or conditions of use that must appear verbatim on the product. These are not optional or paraphrasable; the regulation states the text, and it must be reproduced accurately. Common examples include cautions tied to certain ingredients, instructions to avoid contact with the eyes, or warnings relevant to particular product types.

This is one of the main reasons your labelling must follow your safety assessment rather than precede it. The assessor identifies which restricted ingredients are present and what warnings their entries require, and those then have to be built into the label. Printing packaging before this check risks omitting a legally required warning.

Leave-on versus rinse-off limits

A recurring theme in Annex III is the distinction between leave-on and rinse-off products. Because a leave on product such as a lotion or serum stays on the skin and continues to be absorbed, exposure is far higher than for a rinse-off product such as a wash or shampoo that is quickly removed. Restricted ingredients therefore often carry stricter limits for leave-on use.

For a maker, this means you cannot assume an ingredient level that is fine in one product will be fine in another. The same ingredient at the same percentage might be compliant in a body wash but exceed the limit in a body butter. Each product has to be checked against the limit for its own category.

Why restrictions change over time

Annex III is one of the most frequently updated parts of the regulation. As new scientific opinions are published, the authorities adjust limits, add conditions, or move substances between annexes sometimes tightening a concentration, sometimes restricting an ingredient that was previously unrestricted. The expansion of fragrance allergen labelling is one recent example that touched this area, which we cover in our allergen labelling guide.

Because the limits move, an established formula can quietly drift out of compliance without any change to the product itself. Keeping up with these updates and updating formulations and labels accordingly is part of the ongoing compliance the Responsible Person is accountable for. Since Brexit, the UK and EU update Annex III separately, so the limits can differ between markets.

A worked example of how a restriction applies

Picture a single restricted ingredient with an Annex III entry that allows it up to a certain maximum in rinse-off products, a lower maximum in leave-on products, and not at all in products intended for young children and that requires a specific warning on the label. A maker putting this ingredient into a shower gel checks the rinse-off limit, stays below it, and adds the required warning: compliant. The same maker putting it into a leave on body lotion must use the lower limit instead, and adding it to a baby product would not be permitted at all.

This illustrates why a restricted ingredient cannot be assessed in the abstract. The very same substance, at the very same percentage, can be fine in one product and non-compliant in another simply because of the product type. Every use has to be checked against the specific conditions of the entry, in the context of the specific product.

It also shows why “it's a permitted ingredient” is never the end of the question. Permitted under what conditions, in what product, at what level, with what warning? Those details are the actual rule, and getting them right is the difference between a compliant product and a recall risk.

Staying within Annex III

• Know the exact concentration of every ingredient in each product.

• Check each restricted ingredient's maximum level and permitted product types.

• Apply the correct leave-on or rinse-off limit.

• Reproduce any mandatory warning wording exactly on the label.

• Re-check when limits change, and against both UK and EU entries.

• Have it all verified in your CPSR.

Frequently asked questions

What are restricted cosmetic ingredients?

Substances listed in Annex III that may be used only within set conditions a maximum concentration, permitted product types, and often mandatory label warnings. They are allowed, but only within those limits.

What happens if I exceed an Annex III limit?

The product becomes non compliant, even though the ingredient is legal in principle. Using a restricted ingredient above its limit or in a disallowed product type is a compliance failure.

Why do leave-on and rinse-off products have different limits?

Leave-on products stay on the skin and are absorbed more, so exposure is higher. Restricted ingredients often carry stricter limits for leave on use than rinse-off.

Do I have to use the exact warning wording?

Yes. Where an Annex III entry specifies warning text or conditions of use, that wording must appear on the label exactly as set out in the regulation.

Do Annex III limits change?

Frequently. Limits and conditions are updated as scientific opinions evolve, and the UK and EU now update separately, so an established formula can drift out of compliance and should be re-checked.

Can the same ingredient be fine in one product and not another?

Yes. A restricted ingredient at the same percentage can be compliant in a rinse-off product but exceed the limit in a leave-on one, or be disallowed in products for young children. Each use is checked against the entry's conditions.

Where do I find the warning wording for a restricted ingredient?

In the substance's Annex III entry, which states the exact conditions of use and warning text. The safety assessment identifies which apply to your product so they can be put on the label.

References: Regulation (EC) No 1223/2009, Annex III (EUR-Lex); UK Cosmetics Regulation as retained; SCCS opinions; OPSS guidance. General information only, not legal advice.