Prohibited cosmetic ingredients: what EU Annex II lists and how to verify them

• Annex II of Regulation (EC) 1223/2009 is the list of substances absolutely prohibited in EU cosmetics — as of June 2026, our database tracks 1,758 entries.
• The list grows continuously: the primary driver is the Art. 15 CMR mechanism (CLP classification → Omnibus Regulation), which has produced eight Omnibus Regulations to date.
• The prohibition is not absolute for unavoidable traces: Art. 17 permits non-intentional presence when it is technically unavoidable under GMP and the product remains safe — but there is no fixed numerical threshold, and the justification burden rests entirely with the Responsible Person.

1. What is Annex II of Regulation 1223/2009?

Regulation (EC) 1223/2009 is the EU legal framework for cosmetic products. It organises ingredient restrictions into five Annexes. Annex II is the most absolute of these: it contains the LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS — substances that cannot be present in any cosmetic placed on the EU market.

Unlike Annexes III, V, or VI — where a substance may be present under specific conditions — Annex II has no conditions of use. The substance is prohibited, full stop.

For the broader context of how the five Annexes fit together, the guide What is the CosIng database and how to use it covers the full regulatory architecture.

2. What does Art. 14(1)(a) say?

Art. 14(1)(a) is the legal pivot of the entire prohibition. Its consolidated text (EUR-Lex, version 02009R1223-20250901) states:

"Without prejudice to Article 3, cosmetic products shall not contain any of the following: (a) prohibited substances — prohibited substances listed in Annex II."

The cross-reference to Art. 3 matters: even if a substance does not appear in Annex II, the Responsible Person still has a duty to ensure the product is safe under the general safety standard of Art. 3. Annex II is the nominal list of known prohibitions, not the ceiling of the safety concept.

3. How many substances are listed as prohibited?

Our database, synchronised with CosIng, tracks 1,758 entries in Annex II as of June 2026. This figure incorporates the two most recent Omnibus Regulations:

• Omnibus VII — Reg. (EU) 2025/877 (OJ 13 May 2025, applicable from 1 September 2025): added 21 entries (refs 1731–1751).
• Omnibus VIII — Reg. (EU) 2026/78 (OJ 13 January 2026, applicable from 1 May 2026): added 15 entries (refs 1752–1766) and amended entries 1397–1399.

Sources predating Omnibus VII cite figures around 1,703 entries — those are stale snapshots. The list grows with each Omnibus cycle, so any figure without a reference date should be treated with caution.

Our CosIng database page reflects the current live count and allows you to browse or search the full list.

4. Examples of prohibited substances

The table below shows representative entries from Annex II, with their CAS number and the reason or pathway for prohibition:

Editorial note on Formaldehyde: it is common to see claims that Formaldehyde (CAS 50-00-0) is in Annex II. It is not. Formaldehyde is a restricted substance under Annex III (max 0.2% rinse-off, 0.1% leave-on). The Annex II substance is Formamide (CAS 75-12-7), a different organic compound.

5. How substances enter Annex II: the CMR-Omnibus mechanism

The primary growth engine of Annex II is the Art. 15 and Art. 31(1) mechanism of Regulation 1223/2009. There are two main pathways:

CMR pathway (Art. 15)

When ECHA classifies a substance as CMR (Carcinogenic, Mutagenic or Toxic for Reproduction) under the CLP Regulation (1272/2008), Art. 15 of the Cosmetics Regulation acts as the transposition mechanism:

• Categories 1A and 1B (known or presumed human effect): the substance is presumptively prohibited in cosmetics. The narrow exception pathway in Art. 15(2) requires the SCCS to evaluate the substance and confirm safety for a specific use, alongside three additional conditions — in practice, this route is rarely successful.
• Category 2 (suspected effect): Art. 15(2) allows an exception if the SCCS confirms safety for a specific cosmetic use.

The practical process: ECHA updates the CLP Regulation via a Delegated Regulation → the Commission issues an Omnibus Regulation formally adding the substance to Annex II. Omnibus VII and VIII resulted from Delegated Regulations (EU) 2024/197 and 2024/2564 respectively.

SCCS pathway (Art. 31(1))

The Scientific Committee on Consumer Safety (SCCS) can evaluate a substance at the Commission's request. An unfavourable opinion empowers the Commission to amend the Annexes under Art. 31(1).

Cross-Annex movement example

The case of Trimethylbenzoyl Diphenylphosphine Oxide (CAS 75980-60-8) illustrates the dynamic: it was a restricted substance in Annex III (entry 311). Reg. (EU) 2025/877 reclassified it as CMR 1B and moved it to Annex II (new entry 1731), applicable from 1 September 2025.

The detailed mechanics of how CLP classifications feed cosmetic prohibitions are covered in the guide CMR substances in cosmetics. The sibling post on Annex III — restricted substances explains when a substance can remain on the market under conditions, before or instead of landing in Annex II.

6. What does "prohibited" mean in practice? (Art. 17 — unavoidable traces)

The Annex II prohibition does not mean that any detectable trace automatically constitutes non-compliance. Art. 17 of Regulation 1223/2009 establishes a technical tolerance:

"The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3."

Key points:

1. There is no fixed numerical threshold. The assessment is qualitative: is it technically unavoidable? Is the quantity small? Does the product remain safe?
2. The justification burden rests entirely with the Responsible Person, who documents the assessment in the Product Safety Report (PSR).
3. "In conformity with Article 3" is the final standard: the product must be safe when used under normal or reasonably foreseeable conditions of use.

This margin is relevant for formulations with complex natural raw materials (extracts, essential oils) where cross-contamination with prohibited substances may be difficult to eliminate entirely. The distinction from intentional use is both technical (GMP + documentation) and one of intent.

7. How to verify whether an ingredient is in Annex II

The most direct route is our CosIng database, which covers the full Annex II list updated through the latest Omnibus regulations. You can search by INCI name, CAS number, or entry reference.

The four Annexes covering substances that may be used under specific conditions — Annex III (restricted substances), Annex V (preservatives), and Annex VI (UV filters) — regulate what can still be used and under what terms. The pillar guide explaining the full architecture of the Annexes is What is the CosIng database and how to use it.

8. Frequently asked questions

What is Annex II of Regulation 1223/2009? Annex II is the "LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS" — the list of substances that cannot be present in any cosmetic placed on the EU market. Its legal basis is Art. 14(1)(a) of Regulation (EC) 1223/2009. As of June 2026, our database tracks 1,758 entries.

Why does Annex II keep growing? Mainly through the CMR mechanism: when ECHA classifies a substance as carcinogenic, mutagenic or toxic for reproduction (categories 1A, 1B or 2) under the CLP Regulation, Art. 15 of the Cosmetics Regulation presumes it prohibited. The Commission formalises the prohibition in Annex II via an Omnibus Regulation. Substances can also enter through an unfavourable SCCS opinion under Art. 31(1).

Does "prohibited" mean any detectable trace is illegal? Not necessarily. Art. 17 of Regulation 1223/2009 allows the non-intentional presence of a small quantity of a prohibited substance when it is technically unavoidable under GMP and the product remains safe under Art. 3. There is no fixed numerical threshold — the justification rests with the Responsible Person.

Is formaldehyde in Annex II? No. Formaldehyde (CAS 50-00-0) is a restricted substance in Annex III. The Annex II substance is Formamide (CAS 75-12-7), entry 744 — a different compound.

Is hydroquinone completely prohibited? For most uses, yes: Hydroquinone (CAS 123-31-9) appears in Annex II (entry 1339). A narrow exception in Annex III (entry 14) allows its use by professionals in artificial nail systems at up to 0.02%.

How do I check whether an ingredient I use is in Annex II? Check directly at our CosIng database, which covers all Annex II entries updated through the latest Omnibus regulations. Search by INCI name or CAS number.