EU cosmetic regulation annexes explained: what each one bans, restricts, and allows

• Regulation 1223/2009 organises cosmetic substances across six Annexes. Four of them hit your daily formulation and compliance work directly.
• Annex II: the blacklist — substances that cannot appear in any EU formula.
• Annex III: the orange list — allowed, but with strict conditions on concentration, product type, and mandatory label warnings.
• Annex V: permitted preservatives. Annex VI: permitted UV filters. Both are positive lists: if it is not on the list, you cannot use it.
• Knowing the difference between Annexes is not a theoretical exercise — it is what keeps your products on the shelf.

1. Six Annexes, four that matter every day

Regulation (EC) 1223/2009 on cosmetic products organises all relevant substances across six Annexes. Not all of them carry the same operational weight for a Regulatory Affairs team or a formulator. (If you still need context on what CosIng is and how the database works, that guide is the right starting point before diving into the Annexes.)

Annex I defines the content requirements for the Product Safety Report (CPSR): what sections it must contain, which parameters to assess, who signs it. It is a procedural framework, not a substance list. Annex IV covers authorised colorants for cosmetic use in the EU — only the listed ones may be used as colouring agents, with specific exceptions for oxidative hair dyes. The other four — II, III, V and VI — are the ones that need to be built into your daily workflow. They are substance lists with direct consequences for what you can and cannot formulate.

The shortcut to remember: Annex II says "never", Annex III says "yes, but carefully", Annexes V and VI say "only these, and only under these conditions".

2. Annex II — Prohibited substances (the blacklist)

Annex II lists substances that cannot be present in any cosmetic product placed on the EU market. There are no general exceptions: if a substance appears here, it is off the table. The list currently runs to around 1,700 entries (approximately 1,703 as of mid-2025) — check the current consolidated CosIng for the exact count, as it grows with each regulatory amendment.

How does a substance land in Annex II? The most common route is reclassification under the CLP Regulation (Classification, Labelling and Packaging, EC 1272/2008). When a substance is classified as CMR — carcinogenic, mutagenic or toxic for reproduction — in category 1A or 1B, the regulatory logic is straightforward: it cannot be in cosmetics. The Scientific Committee on Consumer Safety (SCCS) can also flag substances through other routes: dermal toxicology data, systemic absorption profiles, or endocrine disruption concerns.

Example 1: Hydroquinone

Hydroquinone is probably the most-cited case in Regulatory Affairs training. It has been used for decades as a skin-lightening agent. It has been prohibited as a general cosmetic ingredient in the EU since the early 2000s, due to its dermal toxicology and potential mutagenicity. A narrow exception for certain non-oxidative hair dye formulations existed for a period but was subsequently removed as well. The current exception is professional use in artificial nail systems (Annex III, entry 14, up to 0.02%). If your formula contains it at any concentration and no explicit current exception applies in Annex II, you cannot place it on the EU market. Always verify against the current consolidated text of the Regulation — the nuances matter, and they change.

Example 2: Certain parabens

Not all parabens are banned — this is one of the most persistent miscommunications in formulation circles. Methylparaben, ethylparaben, propylparaben and butylparaben remain permitted as preservatives in Annex V, entry 12 (with maximum concentrations and conditions). However, isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben were prohibited and moved to Annex II, primarily on the basis of endocrine disruption profiles. The distinction between permitted and banned parabens is exactly the kind of detail you need to verify against the current CosIng, not from memory.

Practical use for the RP: before any development or reformulation starts, the first check is not "does this ingredient work?" — it is "is this in Annex II?" It is the cheapest check in the process and the most expensive one to skip.

3. Annex III — Restricted substances (the orange list)

Annex III is the most dynamic of the six. It lists substances that can be used in cosmetics, but only within specific conditions of use defined in the list itself: maximum permitted concentration, product type, mandatory label warnings, and in some cases user restrictions (for example, products not intended for children below a certain age).

The structure of each entry matters: the identification column (name, CosIng reference number, CAS), the conditions column (product type, maximum concentration), the warnings column. Reading only the ingredient name without reading the conditions is a recurring mistake that generates non-conformances in audits.

Example 1: Salicylic acid

Salicylic acid sits in Annex III with different conditions depending on the product type. In general terms — verify the current consolidated text — maximum concentrations differ between rinse-off applications (such as shampoos) and leave-on products applied to skin, with additional restrictions for products intended for children under three years of age. The key point: it is not enough to know that salicylic acid is "allowed". You need to read for which product type and at which concentration. The conditions column in Annex III is as relevant as whether the ingredient appears on the list at all.

Example 2: Formaldehyde (methanal)

Formaldehyde is a textbook case of how a substance migrates between annexes as science evolves. Formaldehyde itself is now prohibited (Annex II) following its CMR classification. What remains relevant in practice are formaldehyde releasers (e.g. DMDM hydantoin, imidazolidinyl urea), permitted as preservatives in Annex V; any product where total released formaldehyde exceeds 0.001% (10 ppm) must carry the warning "releases formaldehyde" (Regulation (EU) 2022/1181). This mandatory statement is not optional or a best-practice recommendation — it is a labelling condition. A product that omits it is non-compliant at the labelling level regardless of how well the formula otherwise conforms.

Practical takeaway: Annex III is not a list of "safe ingredients". It is a list of "conditionally safe ingredients". The difference is that it forces you to read all three columns, not just the first one.

4. Annex IV — Authorised colorants (brief reference)

Annex IV lists the colorants — and in some cases, their lakes and salts — permitted for cosmetic use in the EU. This is a positive list: if a colorant does not appear in Annex IV, it cannot be used in an EU cosmetic product, regardless of its toxicological profile or its approval history in other markets. Specific exceptions exist for certain categories of oxidative and non-oxidative hair dye formulations, which follow their own conditions.

For formulators working with decorative colour lines or hair colouration, Annex IV is as routine as Annex III. For most other categories, the check is simply confirming that the chosen colorant has a reference number on the list.

5. Annex V — Permitted preservatives (positive list)

Annex V defines the only preservatives that may be used as preservatives in cosmetics placed on the EU market. The "as preservatives" qualifier matters: a substance can appear in Annex III for a different permitted function, but if its role in the formula is preservation, Annex V governs.

Like Annex VI, the logic is a positive list: if the preservative is not here, it cannot serve that purpose. Each entry includes maximum concentration, the product types in which it is permitted (all products, or rinse-off only, or not for use near mucous membranes) and, in some entries, mandatory label warnings.

Example 1: Phenoxyethanol

Phenoxyethanol is arguably the most widely used preservative in contemporary European cosmetic formulation. The SCCS assessed it across multiple opinions and confirmed safety at up to 1% for consumers of all ages, including the nappy area. It sits in Annex V (entry 29) at a 1% maximum with no nappy-area restriction in the EU text — a French national requirement on the nappy area was struck down by the EU Court of Justice. The detail rows in each Annex V entry — including end-user restrictions — carry as much weight as the maximum concentration figure.

Example 2: MIT (methylisothiazolinone)

MIT was for years a standard preservative in leave-on cosmetics. Accumulated data on skin sensitisation — a wave of contact dermatitis cases documented across Europe — led the SCCS to conclude that no safe concentration existed for leave-on use. The outcome: MIT can no longer be used in leave-on products. It is permitted only in rinse-off products, at a maximum concentration significantly lower than historical usage levels. This is the kind of Annex V change a company can miss entirely without an active regulatory monitoring process. The ingredient was not removed from the Annex — its permitted use category was fundamentally restricted.

Operational tip: Annex V maximum concentrations get revised. Do not assume the maximum you used two years ago is still current. Verify against the current consolidated text, particularly for preservatives with a history of SCCS scrutiny.

6. Annex VI — Permitted UV filters (positive list)

Annex VI works the same way as Annex V, but for UV filters: only the listed substances may be used as UV protection filters in EU cosmetics. If a UV filter is not in Annex VI, it cannot serve that function, even if it has approvals in other major markets — FDA, ANVISA, PMDA. Market-by-market divergence here is significant and well-documented.

The EU UV filter list is relatively short compared to Annexes II and III, but its implications are substantial. The suncare industry has been awaiting decisions on newer filters — some already approved in Asia or North America — that have not yet been incorporated into Annex VI through an amending Commission Regulation. For suncare formulators, this means working with the available list and not adopting more advanced filters used globally until a formal EU amendment is published.

Example: Octocrylene

Octocrylene is an organic UV filter in Annex VI with maximum concentrations differentiated by product type. It has been under SCCS scrutiny since studies published from around 2021 documented its degradation into benzophenone (a substance with endocrine disruption concerns) in stored cosmetic products. The SCCS has issued opinions on the matter. At the time of writing, Octocrylene remains in Annex VI, but the conditions around it continue to evolve. It is precisely the kind of ingredient that requires active monitoring of OJEU publications and SCCS opinions. Verify current status before making any formulation decisions based on this paragraph.

A specific note on titanium dioxide: it is a physical UV filter in Annex VI, but conditions of use exclude applications that may generate inhalation (sprays, powders), particularly in nanoparticulate form, where additional information requirements apply at the label level.

7. How Regulatory Affairs manages this in practice

Four operational Annexes, around 1,700 prohibited substances in Annex II, dozens of dynamic entries in Annex III, positive lists for preservatives and UV filters. The operational challenge is not understanding the framework — that is the easy part — it is keeping it current without running a parallel full-time project.

The minimum process any company with active EU formulas should have in place:

1. Ingredient-to-Annex mapping: every ingredient in your portfolio needs an assigned Annex (or a confirmed absence from all Annexes, which implies no specific 1223/2009 restriction). This map is the foundation of any regulatory impact assessment when an Amendment drops.

2. Pre-reformulation verification: before introducing a new ingredient or changing an existing concentration, verify current status in CosIng and in the consolidated text of the Regulation. Do not rely on a previous audit's snapshot as your reference.

3. Active OJEU monitoring: the Annexes are amended through Commission Regulations published in the Official Journal of the EU. Without a monitoring system, you find out weeks or months later. An Annex III change can affect formulas already on the market — and the sell-through period for existing stock has a time limit from the date of application of the change.

BD-API's CosIng database has every ingredient cross-referenced to its Annex and current status, with automatic alerts when an OJEU publication affects an entry. For teams with active EU portfolios, that eliminates manual lookup and returns time for what actually adds value: analysis, not data retrieval. Explore the ingredient search at /en/cosing-database.

And if what you need is to interpret the tables themselves — what each column means, how to read a limit, which warning is mandatory — we wrote a column-by-column guide to reading the annexes, with a real entry worked through cell by cell.

8. Closing thought

The Annexes of Regulation 1223/2009 are not just another item in the technical file. They are the line between legal market access and a market withdrawal. A formulator who does not immediately know which list to check for a given ingredient can learn that — it is not a complex framework. A development process that does not make that verification a mandatory gate before any formulation advance is a systemic risk.

The good news is that the structure is stable in its logic — blacklists, conditional lists, positive lists — even as the content of those lists shifts. Understanding the structure is step one. Having a system to catch the changes is step two.