Cosmetic Ingredient Annexes II to VI Explained
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Quick Answer
Annexes II to VI of the Cosmetics Regulation are the ingredient rulebook. Annex II lists substances that are prohibited. Annex III lists substances allowed only within stated limits and conditions. Annexes IV, V and VI are positive lists: the only colourants, preservatives and UV filters you may use, under their listed conditions. Article 14 of the Regulation makes all five binding, and your safety assessor must confirm every ingredient complies before the product is sold.
The Rule Behind the Annexes
The legal source is Chapter IV of the Regulation. Article 14 says a cosmetic product must not contain prohibited substances listed in Annex II, restricted substances not used according to the restrictions in Annex III, or colourants, preservatives and UV filters other than those listed in Annexes IV, V and VI. The EU text is on EUR-Lex. Think of it as five gates every ingredient must pass, and the gate depends on what the ingredient does in the formula.
The Five Annexes at a Glance
| Annex | What it lists | What it means for your formula |
|---|---|---|
| II | Prohibited substances | Must not be intentionally used |
| III | Restricted substances | Allowed only within the listed limits and conditions |
| IV | Permitted colourants | Colourants must be on the list and used as specified |
| V | Permitted preservatives | Preservatives must be on the list and used as specified |
| VI | Permitted UV filters | UV filters must be on the list and used as specified |
The Irish regulator, the HPRA, publishes a clear overview of restricted and prohibited ingredients that matches this summary and explains where to find the lists.
Positive Lists vs Negative Lists
This distinction trips up many new brands. Annexes II and III are negative lists: they name what is banned or limited, and anything not named is not automatically approved. Annexes IV, V and VI are positive lists: if a colourant, preservative or UV filter is not on the list, you cannot use it, however natural or popular it is. That is why a "natural preservative" that is not in Annex V cannot simply be added because it sounds gentle. If you want to understand how a preservation system is proven to work once it is allowed, read our guide to stability and preservative challenge testing.
Three Related Rules in the Same Chapter
How to Check Your Formula, Step by Step
- Start from the full INCI list and the quantitative formula, including fragrance and colour.
- Assign each ingredient a function: preservative, colourant, UV filter or other.
- Check Annex II for every ingredient, including impurities and constituents of mixtures.
- Check Annex III for limits, product-type restrictions, maximum concentrations and required warnings.
- Check Annexes IV, V and VI for the function-specific ingredients, using the listed conditions.
- Check classifications for CMR status under Article 15, using supplier SDS data.
- Record the result in the safety report and carry any required warnings to the label.
Tools help, but they are not proof. The HPRA notes that the Commission's CosIng database is useful for information on ingredients in Annexes II to VI, yet it is "not considered 100% accurate", that an ingredient appearing in it does not mean it is approved, and that a suitably qualified safety assessor must confirm every ingredient complies with the annexes as amended. Treat CosIng as a starting point and the legal text as the authority.
The Annexes Change: Build In a Review
The annexes are amended regularly as new scientific opinions arrive, and the HPRA recommends checking amendments on the Commission's legislation page and signing up for update alerts. Because each market maintains and amends its own version, check the version that applies where you sell, and review your formulas whenever your assessor, supplier or regulator flags a change. A product that was compliant at launch can become non-compliant when an annex is amended, which is one more reason to keep the file under change control. See our guide to keeping a PIF up to date.
Where This Fits in Your Safety Report
Annex compliance is not a separate document. It sits inside the safety assessment. Annex I requires the report to cover the composition, toxicological profile of each substance and exposure, and your assessor draws on the ingredient annexes when forming the conclusion. For how the two halves of the report work, read our guide to CPSR Part A vs Part B, and for choosing the right professional, our guide to choosing a safety assessor. Chemical hazard classifications that sit outside cosmetics law are covered in our article on SVHC and restricted substances.
Common Mistakes
Mistake #1 — Assuming "natural" means permitted. A colourant, preservative or UV filter must be on its positive list, regardless of origin.
Mistake #2 — Using an old copy of the annexes. The lists are amended, so work from the current version for your market.
Mistake #3 — Relying only on a database. CosIng is a helpful tool, not legal proof of approval.
Mistake #4 — Forgetting restrictions that need label warnings. Annex III conditions can require specific wording on the pack.
Practical Checklist
- Give each ingredient a function and check it against the right annex.
- Check for prohibited substances, including constituents and impurities.
- Confirm Annex III limits, product-type conditions and warnings.
- Verify every colourant, preservative and UV filter is on its positive list.
- Check CMR status and any nanomaterial notification duties.
- Let a qualified safety assessor confirm compliance with the current annexes.
- Set a review date and sign up for regulatory update alerts.
Frequently Asked Questions
What is the difference between Annex II and Annex III?
Annex II lists substances that are prohibited in cosmetic products. Annex III lists substances that are allowed only if they meet stated restrictions and conditions, such as maximum concentrations, product types or warnings.
Can I use a preservative that is not listed in Annex V?
No. Article 14 prohibits preservatives other than those listed in Annex V. If an ingredient is not on the list for that function, it cannot be used as a preservative in a cosmetic product.
Is a substance safe if it appears in CosIng?
Not necessarily. Appearing in the database does not mean an ingredient is approved for use, and the database is not considered fully accurate. Always check the legal text and have a qualified safety assessor confirm compliance.
What about trace amounts of a banned substance?
Article 17 tolerates unavoidable traces arising from impurities, manufacturing, storage or packaging migration, provided the product remains safe under Article 3. Your safety assessor should consider such traces in the report.
Final Word
The annexes are the part of cosmetics law that touches your formula directly. Knowing which gate each ingredient has to pass, and checking against the current text rather than a half-remembered list, prevents the most avoidable compliance failures. Check early, record the result, and keep an eye on updates.
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Sources
- Regulation (EC) No 1223/2009, Chapter IV — Restrictions for certain substances, Articles 14 to 17 (as it applies in the UK) — legislation.gov.uk
- European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products — eur-lex.europa.eu
- HPRA, Restricted and prohibited ingredients in cosmetic products — hpra.ie
- Regulation (EC) No 1223/2009, Annex I — Cosmetic product safety report — legislation.gov.uk
- Related guides on this site: CPSR Part A vs Part B, Choosing a safety assessor, SVHC and restricted substances
This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.