Quick Answer
EU cosmetic ingredient compliance is checked against the current text of Regulation (EC) No 1223/2009, especially Article 14 and Annexes II–VI. Annex II lists prohibited substances; Annex III restricts certain uses; Annexes IV, V and VI govern colorants, preservatives and UV filters. A name appearing in CosIng is not an EU approval. Check identity, function, concentration, product type, warnings and effective dates for the exact finished formula.
For international brand owners, ingredient screening belongs before sample approval and again before commercial production. It is separate from the EU label-artwork review and from the finished-product safety assessment. The legal foundation is the current Regulation (EC) No 1223/2009; later amendments can change Annex entries and dates.
How the EU Annexes govern ingredients
The Annex number matters because it tells you which legal test to perform. A screening spreadsheet that merely says “EU allowed” or “EU banned” hides conditions that may determine compliance. Review each substance by identifiers such as CAS or EC number as well as its INCI name, and check the formulation purpose and category.
| Legal source | Screening question | Possible action |
|---|---|---|
| Annex II — prohibited substances | Is the identified substance prohibited for cosmetic products? | Do not intentionally formulate with it; investigate any trace issue under the narrow Article 17 conditions. |
| Annex III — restricted substances | Are product type, concentration, warnings and other conditions met? | Set formula and label controls for every applicable condition. |
| Annex IV — colorants | Is the colorant listed and used within its conditions and intended function? | Check shade, area of use and any restrictions. |
| Annex V — preservatives | Is the preservative permitted for the intended use and concentration? | Verify maximum level and restrictions in the final formula. |
| Annex VI — UV filters | Is the UV filter listed and used in accordance with its conditions? | Check concentration, product type and any warnings. |
Article 14 contains technical provisions for multifunctional ingredients and particular hair-colour cases; the table is a starting map, not the entire legal text. The general safety duty in Article 3 still applies even when no individual Annex limit is triggered.
Is an ingredient listed in CosIng automatically permitted?
No. The European Commission states that CosIng is an informational, non-legally binding database. An INCI entry or a historical record does not, by itself, authorize use. The operative legal position comes from the Cosmetics Regulation and its current Annexes, read with the ingredient’s identity and the intended use. CosIng helps locate names and references, but every result needs a legal cross-check.
A common error is to search a trade name, find a vaguely similar common name and assume the supplied raw material is equivalent. Ask the supplier for the complete composition, CAS/EC identifiers where relevant, impurities, concentration in the finished product and any changes to specifications. A blend can contain constituents with their own restrictions.
What about CMR substances and nanomaterials?
Article 15 addresses substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under the EU classification framework. Its prohibitions and tightly defined exceptions require a current, substance-specific legal review. Do not infer that a scientific opinion alone creates a market authorization; check whether and how the law has implemented the relevant outcome.
Article 16 has additional requirements for nanomaterials, including notification and safety-related conditions. If a supplier describes a material as “nano”, “micronized” or “ultrafine”, establish the actual legal characterization and supporting specifications. The ordinary non-nano version of a name does not settle the nano version’s status. Refer the issue to the qualified assessor and Responsible Person before finalizing a formula.
A defensible ingredient-screening workflow
- Freeze the intended product. Define leave-on or rinse-off use, body area, age group, function and target market.
- Identify the raw materials. Obtain full compositions and identifiers from suppliers, including fragrance constituents, colorants and preservatives.
- Calculate finished-product levels. Convert supplier blend percentages into actual concentrations of each regulated substance in the marketed formula.
- Check current legal text. Search Annex II first, then Annex III and the relevant positive lists in IV–VI. Record amendment and application dates.
- Apply every condition. Evaluate concentration, product type, use area, warnings and any specific restrictions. Do not review the maximum percentage in isolation.
- Escalate special cases. Assess CMR, nanomaterials, impurities and trace questions with qualified regulatory and safety specialists.
- Document the decision. Keep a source-linked screening log and transfer outcomes into the CPSR, PIF, formula specification and label review.
Which document proves the screen was done?
There is no single generic “EU ingredient certificate” that substitutes for a formula-specific assessment. A useful internal screening record identifies the product version, supplier and substance identifiers, actual finished-product level, applicable Annex entry and amendment, permitted use conditions, evidence reviewed, reviewer and date. It should flag unresolved supplier data instead of silently assuming a pass.
| Handoff point | Manufacturer or supplier | Brand / EU Responsible Person |
|---|---|---|
| Raw-material intake | Provide composition, specifications and changes; identify constituents and potential impurities. | Request missing data and define the intended EU product and markets. |
| Formula lock | Supply accurate quantitative formula and finished-product level calculations. | Commission regulatory screen and qualified safety assessment. |
| Change control | Notify substitutions, new supplier sources and altered concentrations. | Recheck Annex status, CPSR, PIF, label and notification before sale. |
| Market release | Retain traceable batch and quality records. | Approve the compliant marketed version and keep documentation accessible. |
For how the evidence reaches the safety assessor, use the CPSR document checklist. For the broader file and retention duties, see PIF documents. The Responsible Person remains legally accountable even when the OEM partner does the preliminary screen.
Do SCCS opinions change the law?
The EU Scientific Committee on Consumer Safety (SCCS) supplies scientific advice on ingredient risks. The Commission’s scientific-assessment overview describes that role. An SCCS opinion can be important evidence and may lead to later regulatory action, but it is not itself an Annex amendment. Separate “scientific conclusion”, “current legal rule” and “future proposal” in your compliance log.
Common formulation-screening mistakes
- Assuming every CosIng record is an approval.
- Checking an ingredient name but not its CAS identity, salt, derivative or blend constituents.
- Using the raw-material percentage rather than the constituent concentration in the finished product.
- Checking an Annex maximum but missing product-type restrictions or warning text.
- Copying a screen from a previous market or formula revision without checking effective dates.
- Treating a favorable SCCS opinion as proof that a legal restriction has already changed.
FAQ
Are all natural ingredients allowed in EU cosmetics?
No. “Natural” is not an exemption from prohibited-substance rules, restrictions or the general safety duty.
Can a restricted ingredient be used below its maximum percentage?
Possibly, but only if all conditions of the relevant Annex entry and the finished-product safety assessment are met. Concentration alone is not enough.
Does an INCI name in CosIng prove safety?
No. CosIng has no legal approval effect, and finished-product safety still requires assessment.
Who checks a private-label cosmetic formula for EU compliance?
The manufacturer and suppliers provide technical data; the brand and EU Responsible Person must arrange current legal screening and a qualified safety assessment.
What if the supplier changes the ingredient source?
Recheck identity, impurities, restrictions, safety evidence and affected documents before using the changed material in EU-market production.
Sources and review
- EUR-Lex: Regulation (EC) No 1223/2009, Articles 3, 14–17 and Annexes II–VI; review the current consolidated text.
- European Commission: CosIng ingredient database and legal-status notice.
- European Commission: Scientific and technical assessment / SCCS role.
Last reviewed: 26 September 2026. Editorial responsibility: MOOYAM technical content team, using the official EU sources above. This article is general information, not legal advice. Regulatory requirements may change. Brands should verify current requirements with the relevant authority or a qualified compliance professional before placing cosmetic products on the market.
MOOYAM provides OEM/ODM manufacturing and technical-documentation support for international cosmetic brands. If you need a controlled EU-market formulation handoff, contact our team with the intended product category, draft formula and target markets.