Ingredient & Formula

Colorants and UV Filters: Why Positive Lists Matter

Updated 2026-09-01Regulatory review 2026-09-01
Cosmetic colorant and UV-filter positive-list review materials.

A positive-list review asks whether the precise substance and use conditions match the listed entry.

European UnionUnited StatesIngredients

Short Answer

Colorant and UV-filter review is a positive-list matching task. The exact substance identity, applicable list or regulation, product use and source version must all match before a result can support a formula decision.

Key Takeaways

  • Do not use a marketing name as the regulatory identity.
  • Keep colorant and UV-filter questions scoped to the market.
  • Record an explicit no-match or review-needed outcome.

Who This Applies To

This guide is for teams checking colorants or UV-filter ingredients for EU or U.S. cosmetic products. It is a workflow guide, not a universal list of permitted substances.

Regulatory Background

U.S. color-additive status is maintained in FDA official material, while EU cosmetic requirements are read through Regulation (EC) No 1223/2009 and its applicable annex structure. The same ingredient name does not automatically carry the same status across both systems. [11][20]

Key Requirements

The review should cite the official list or regulation entry, preserve its locator and show how the proposed product use corresponds to the listed scope or conditions. [11][20]

  • Normalize substance identity and identifiers.
  • Separate colorant, UV-filter and other functional roles.
  • Select market and product use before reading the entry.
  • Record exact list version and locator.
  • Escalate a mismatch instead of treating it as permission.

Step-by-Step List Review

Fix the formula version first. Resolve the ingredient identity, choose the jurisdiction and locate the official entry. Compare the proposed use with the entry, attach the citation and record whether the answer is matched, not matched or still uncertain.

Common Mistakes

  • Searching only by a trade name.
  • Assuming a colorant result answers a UV-filter question.
  • Treating a list match as permission for every product use.
  • Overwriting the source version after a later update.

Practical Checklist

  • Formula version is fixed.
  • Identity match is documented.
  • Market and product use are explicit.
  • List version and locator are stored.
  • No-match and uncertain outcomes remain visible.

How EasyComply Can Help

EasyComply can connect an ingredient search to the formula version, market and source locator used for the decision, making positive-list review reproducible for the next reviewer.

Relevant EasyComply services and RegWise tools

EasyComply provides regulatory services. RegWise provides the currently available EU ingredient search and formula review tools. Choose the route that matches your task.

Official Sources

#AuthorityDocumentLocatorPublished / EffectiveLink
1U.S. Food and Drug AdministrationColor Additive Status ListColor Additive Status List— / —Official source
2European Parliament and CouncilRegulation (EC) No 1223/2009 on cosmetic productsArticles 3–5, 8, 10–13, 19–20, 23 and applicable Annexes2026-05-01 / 2013-07-11Official source

Disclaimer

This article is for general information and does not constitute legal or regulatory advice. Check the official source and your product facts before making a market decision.

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