EU & UK Market Entry: Ingredients & Restrictions
The EU takes a positive-list approach: prohibited substances are named, restricted substances carry use conditions, and colourants, preservatives and UV filters are permitted only from defined lists. The annexes to Regulation (EC) No 1223/2009 are the operative text.
At a glance
- Prohibited
- One annex names substances that may not be used at all
- Restricted
- Another annex sets concentration, area and warning conditions
- Positive lists
- Colourants, preservatives and UV filters from their own lists
- Special cases
- CMR substances and nanomaterials carry additional controls
What the market requires
Prohibited and restricted annexes
Prohibited substances are listed in one annex, while restricted ones appear in another with the conditions that make them permissible: concentration, application area, product type and required label warnings.
Positive lists
Colourants, preservatives and UV filters may only be used from the annexes listing permitted substances, each with its own conditions. An ingredient that performs well is not usable unless it appears on the relevant list.
What the safety assessment screens for
CMR status and nanomaterial presence are additional screening questions, and trace impurities matter too, because the assessment covers the material as supplied rather than as merely named.
What this means for your brief
Screen the formula against the annexes while it is still a draft. Most EU assessment findings are concentration or application-site issues rather than prohibited ingredients, which makes them cheap to fix early and expensive to fix after stability work.
What we provide
- Formula documentation identifying restricted ingredients with concentrations and annex references
- Raw material specifications that support the assessor's review, including impurity information
- Reformulation support when an ingredient needs substituting for a destination market
Capabilities above are limited to what is verifiable: GMPC and ISO 22716 certification audited by third parties, cosmetics production licence 粤妆20250206, and FDA MoCRA facility registration. See certifications.
Market questions
Can I use a US-approved ingredient in the EU?
Not on that basis alone. The EU works from its own positive and negative lists, so a US position on a substance does not determine the EU position.
Are nanoscale ingredients treated differently?
Yes. Some insoluble or biopersistent nanoscale ingredients carry a separate notification obligation in addition to the product notification, and the safety information required differs.
More on Europe & UK market entry
Regulatory requirements change. Confirm the current position for your product with your local adviser or appointed representative before you place artwork or place an order. See also certifications and compliance and the sourcing glossary.
Sourcing for Europe & UK?
Send your product brief with the destination market — quotation and formula recommendations within 24 hours.
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