Banned Cosmetic Ingredients in the EU: How Annex II Keeps Growing

The list of banned cosmetic ingredients in the EU is not a fixed document you can print once and file away. Annex II of Regulation (EC) 1223/2009 already runs to more than 1,600 entries, and it grows several times a year through amending acts that most brand owners never see until a formula they have been selling for three years is suddenly illegal.

That is the part small brands underestimate. A ban is rarely a surprise to the regulators, because it usually follows a hazard classification or a published scientific opinion that has been in progress for two years. It is a surprise to the brand, because nobody was watching. This guide explains how a substance gets onto Annex II, how the transition dates work, which recent bans have caught brands out, and how to check a formula before it becomes a recall.

How a substance ends up on Annex II

Two mechanisms feed the prohibited list, and they behave very differently.

The automatic CMR route

Article 15 of the Cosmetic Regulation says that substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) in category 1A, 1B or 2 under the CLP Regulation are prohibited in cosmetic products. The ban is close to automatic. Once ECHA and the Member States agree a harmonised classification and it is published in an Adaptation to Technical Progress (ATP) of CLP, the Commission adds the substance to Annex II in the next omnibus regulation.

There is an exemption procedure for category 2 substances, and in rare cases for category 1A and 1B, but it requires an SCCS opinion confirming safety for the specific cosmetic use, plus evidence that no alternative exists. In practice, exemptions are rare and industry has to request them well in advance.

The SCCS opinion route

The second route runs through the Scientific Committee on Consumer Safety. The Commission asks the SCCS whether a substance is safe at the levels used. The opinion may conclude that it is safe below a certain concentration, in which case the substance goes into Annex III with a limit, or that it cannot be considered safe, in which case it goes into Annex II. This is the route that produced the vitamin A limits, the arbutin limits and the restrictions on lash serum ingredients.

The omnibus rhythm and why formulas expire

CMR bans arrive in batches. Each batch is an amending regulation, informally called an omnibus, that adds every newly classified CMR substance to Annex II at once. The rhythm is roughly annual, which gives you a predictable window: when a CLP ATP is published, anything on it that is in your formula has about a year of life left.

The TPO ban is the clearest recent example of how this plays out commercially. A photoinitiator that had been in gel polish for years was reclassified as a reproductive toxicant, and the cosmetic ban followed. Brands that were monitoring reformulated in advance. Brands that were not found out from their distributors, or from a customs hold.

Placing on the market versus making available

Every amending regulation carries two dates, and confusing them is expensive.

• Placing on the market is the first supply of a product to the EU market by the Responsible Person. After this date you cannot bring new non-compliant stock into the EU.
• Making available on the market is any subsequent supply, including a retailer selling from a shelf. After this date, non-compliant stock must be withdrawn everywhere, including from third party retailers and marketplaces.

The gap between the two is typically six to eighteen months, and it exists so that goods already in the distribution chain can sell through. Some bans have no sell-through period at all, which happens where the SCCS has flagged an acute concern. Read the transitional article of the amending regulation rather than assuming.

The bans that catch brands out most often

Some categories generate far more compliance problems than others.

Fragrance components

Lilial is the textbook case. It was a workhorse floral note used across hundreds of fragrance compounds, and its prohibition forced perfumers to rebuild accords rather than swap one line in a formula. Because you usually buy fragrance as a compound rather than as individual materials, you cannot check this yourself. You need a current IFRA certificate and an allergen declaration from your fragrance house, dated after the amendment. Our guide to fragrance allergen labelling covers the declaration side in detail.

Preservatives

The preservative list in Annex V has narrowed steadily. Methylisothiazolinone is prohibited in leave-on products and capped at 15 ppm in rinse-off. Formaldehyde itself is prohibited, while releasers remain permitted with a warning triggered at a very low threshold. Every tightening pushes formulators towards the same short list of remaining options, which is why preservation problems increasingly show up at the safety assessment stage.

Colourants and nail chemistry

Nail products carry a high concentration of reactive chemistry, so they attract regulatory attention. TPO is the recent example, but the same pattern applies to monomers, photoinitiators and solvents. If you sell gel systems, treat every CLP ATP as directly relevant to your catalogue and read our note on nail polish and nail care compliance.

Botanicals with a hidden constituent

An extract is not one substance. A botanical can contain a constituent that is separately prohibited or restricted, and the annex entry applies to the constituent regardless of how it arrives in the formula. Tagetes extracts, certain citrus oils containing furocoumarins and comfrey preparations are all examples where the extract is permitted only within limits set on a constituent. Ask suppliers for a constituent breakdown, not just a trade name.

How to check a formula properly

A defensible check has four steps, and it is worth writing them down as a procedure.

1. Get a full quantitative formula including the composition of every compound raw material. Trade names hide constituents, and an assessor cannot screen what they cannot see.
2. Screen each INCI name against Annexes II, III, IV, V and VI in their current consolidated form. CosIng is convenient for a first pass, but the consolidated text on EUR-Lex is the legal reference.
3. Check impurities and technically unavoidable traces separately. A prohibited substance present as an unavoidable trace can be acceptable under Article 17 if the product remains safe, but you have to document the argument rather than ignore it.
4. Re-screen when the annexes change, not only when the formula changes. This is the step everyone skips, and it is the reason legacy products fail inspections.

If your formula clears the annexes, the concentrations still have to survive the safety assessment. Being permitted is not the same as being safe at your use level, which is the job of the margin of safety calculation in your CPSR.

Bringing it all together

Annex II is a moving target by design. The system is built so that a hazard classification agreed in one part of EU chemicals law flows automatically into cosmetics, which means your formula can change legal status without anyone contacting you. The brands that never get caught are not the ones with the most cautious formulas, they are the ones with a habit of re-checking.

Two practical habits cover most of the risk. Screen every new formula against the annexes before you commission a safety assessment, and re-screen your existing catalogue once a year against the amendments published since. Both are small tasks compared with recalling stock from a marketplace.

Lexora screens formulas against Annexes II to VI and flags substances heading towards restriction before they are banned. Start with a cosmetic formula screening, or keep the whole catalogue under review with regulatory monitoring and consultancy.