European Union · Cosmetics

Cosmetic Nanomaterials in the European Union

A practical guide to Cosmetic Nanomaterials for cosmetics sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Products containing nanomaterials need additional safety evidence and, in some markets, a separate notification; Online sellers listing cosmetics for buyers in the European Union

Authority

European Commission

Legal basis

Regulation (EC) 1223/2009 annexes

Local representative

A local responsible entity or authorised representative is required

Timeline

Before sale; notification review typically takes weeks

Cost

Official fees are usually low; testing and local representation add cost

If you do not comply

Recall, import block, fines, or marketplace delisting

Who needs this

Products containing nanomaterials need additional safety evidence and, in some markets, a separate notification
Online sellers listing cosmetics for buyers in the European Union

Documents you need

Nanomaterial safety assessment
Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Nanomaterial safety assessment
Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review

How to comply

Identify nanomaterials and check the extra notification duty
Confirm the product is legally a cosmetic in this market
Compile the product information file and safety assessment
Complete the local notification or registration step

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Cosmetic Nanomaterials — European Union
Product category: Cosmetics
Authority: European Commission
Legal basis: Regulation (EC) 1223/2009 annexes

Documents we already have:
  1. Nanomaterial safety assessment
  2. Product information file with a safety assessment
  3. GMP certificate for the manufacturing site
  4. Ingredient and labelling compliance review

Questions:
  1. Does our product fall under Cosmetic Nanomaterials in the European Union?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before sale; notification review typically takes weeks.

Official fees are usually low; testing and local representation add cost.

Common rejection reasons

Nanomaterial present but not disclosed in the dossier
Missing or incomplete product information file
Claims that are not supported by evidence
Label not in a required local language

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs Cosmetic Nanomaterials in the European Union?

Products containing nanomaterials need additional safety evidence and, in some markets, a separate notification Online sellers listing cosmetics for buyers in the European Union.

What documents are required for Cosmetic Nanomaterials?

Nanomaterial safety assessment; Product information file with a safety assessment; GMP certificate for the manufacturing site; and ingredient and labelling compliance review.

What is the first step for Cosmetic Nanomaterials?

Identify nanomaterials and check the extra notification duty. Before sale; notification review typically takes weeks.

How long does Cosmetic Nanomaterials take?

Before sale; notification review typically takes weeks.

How much does Cosmetic Nanomaterials cost?

Official fees are usually low; testing and local representation add cost.

What happens if I sell without it?

Recall, import block, fines, or marketplace delisting.

Who regulates Cosmetic Nanomaterials in the European Union?

European Commission.