European Union · Cosmetics

EU Cosmetic Annex Restrictions

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

Who needs it

Brands and importers placing cosmetics on the market in the European Union; 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

Brands and importers placing cosmetics on the market in the European Union
Online sellers listing cosmetics for buyers in the European Union

Documents you need

Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review
Local notification, registration, or acknowledgement

Compliance checklist

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

Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review
Local notification, registration, or acknowledgement

How to comply

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
Check labels, warnings, and claims against local rules

Brief for your lab or agent

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

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

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

Questions:
  1. Does our product fall under EU Cosmetic Annex Restrictions 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

Missing or incomplete product information file
Claims that are not supported by evidence
Label not in a required local language
Manufacturer GMP certificate missing or expired

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 EU Cosmetic Annex Restrictions in the European Union?

Brands and importers placing cosmetics on the market in the European Union. Online sellers listing cosmetics for buyers in the European Union. The importer of record normally holds the evidence.

What documents do I need for EU Cosmetic Annex Restrictions?

Product information file with a safety assessment; GMP certificate for the manufacturing site; Ingredient and labelling compliance review; and local notification, registration, or acknowledgement.

What is the first step for EU Cosmetic Annex Restrictions?

Confirm the product is legally a cosmetic in this market, then compile the product information file and safety assessment. Before sale; notification review typically takes weeks.

How long does EU Cosmetic Annex Restrictions take?

Before sale; notification review typically takes weeks.

How much does EU Cosmetic Annex Restrictions 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 EU Cosmetic Annex Restrictions in the European Union?

European Commission.