Turning Annex III Limits Into Correct Label Warnings

An ingredient can pass every concentration check you run and still leave your label incomplete, because the EU's restricted substances list does not only cap how much you can use, it often tells you what has to be printed on the pack because you used it at all.

Two separate obligations, one ingredient

Under Regulation (EC) No 1223/2009, restricted ingredients typically carry two kinds of conditions at once: a usage condition, like a maximum concentration or a product category limit, and a labeling condition, meaning specific wording that has to appear on the packaging when the ingredient is present. It is entirely possible to get the first one right and the second one wrong. Your formula is within the allowed concentration, your safety assessor has signed off, and your Cosmetic Product Safety Report reflects the correct usage. But if the printed warning text is missing, paraphrased, or buried somewhere a customer will not see before use, the label itself falls short of what the regulation requires.

Why this gets missed

Most small and mid-size makers build their formula first and their label copy last, often as a separate task handed to whoever designs packaging. If the person laying out the label was not the person who checked the restricted ingredient list, the precautionary wording can get lost in the handoff. Nobody decided to skip it. It just fell into a gap between formulation and design.

The fix is procedural: whatever document tracks your formula's restricted ingredients should also carry the exact required wording next to each one, so it travels with the formula file into the label brief rather than needing to be looked up again from scratch.

What this looks like in practice

Say your finished cosmetic contains a preservative or a UV filter that is permitted under the relevant restriction, but only within a specified concentration and only with a required caution statement about a specific pattern of use, for example a statement about avoiding contact with eyes or a note relevant to use around children. The wording is not something you draft yourself in spirit. It is prescribed by the entry, and it needs to appear on the label essentially as written, not as a paraphrase that captures the same general idea.

A short internal checklist for each restricted ingredient in a formula:

Check	Where it lives
Maximum concentration allowed	Your formula record and CPSR
Product category the limit applies to	The restriction entry
Any exclusions (not for use in X, not near Y)	The restriction entry
Exact required label wording, if any	The restriction entry, copied verbatim into your label brief
Where on the pack the wording will physically appear	Your packaging design file

The Product Information File is your paper trail

Your Product Information File and your Cosmetic Product Safety Report, both required before you can notify through CPNP and both maintained under the oversight of your Responsible Person established in the EU, should already document which restricted ingredients you used and at what concentration. Treat the label warning as a required output of that same documentation, not a separate task. If your PIF lists a restricted UV filter and its limit, your label brief should show, right next to it, the wording that limit requires. When those two things live in different files maintained by different people, this is where the gap opens up.

A practical habit for repeat formulas

If you reuse a base formula across several finished products, for example one preservative system across a whole skincare line, do the label wording lookup once and store it centrally, rather than re-deriving it for each SKU. Just make sure that whenever the formula changes, even slightly, someone rechecks whether the change altered the concentration enough to add, remove, or change a required warning. A minor reformulation that nudges a restricted ingredient's concentration is exactly the kind of change that can flip a label requirement without anyone noticing, since the change itself feels small.

Cosmetic Comply's ingredient screening flags restricted substances against the concentration you actually declare, which is a natural point to also surface any label wording tied to that entry, so it is sitting next to your formula record rather than waiting to be discovered during a packaging review.