Sweden · Cosmetics

Cosmetic Responsible Person in Sweden

A practical guide to Cosmetic Responsible Person for cosmetics sold in Sweden: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

A named entity in the market must accept legal responsibility for the product and hold the product information file; Online sellers listing cosmetics for buyers in Sweden

Authority

Swedish Medical Products Agency

Legal basis

EU Regulation 1223/2009

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

A named entity in the market must accept legal responsibility for the product and hold the product information file
Online sellers listing cosmetics for buyers in Sweden

Documents you need

Signed responsible person mandate
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.

Signed responsible person mandate
Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review

How to comply

Appoint the responsible entity and record it on the label
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 Responsible Person — Sweden
Product category: Cosmetics
Authority: Swedish Medical Products Agency
Legal basis: EU Regulation 1223/2009

Documents we already have:
  1. Signed responsible person mandate
  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 Responsible Person in Sweden?
  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

No local responsible entity named on the product
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 Responsible Person in Sweden?

A named entity in the market must accept legal responsibility for the product and hold the product information file Online sellers listing cosmetics for buyers in Sweden.

What documents are required for Cosmetic Responsible Person?

Signed responsible person mandate; 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 Responsible Person?

Appoint the responsible entity and record it on the label. Before sale; notification review typically takes weeks.

How long does Cosmetic Responsible Person take?

Before sale; notification review typically takes weeks.

How much does Cosmetic Responsible Person 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 Responsible Person in Sweden?

Swedish Medical Products Agency.