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Sweden Cosmetic Product Registration

COSMETIC REGISTRATION IN SWEDEN

Regulatory Authority

Swedish Medical Products Agency (Lakemedelsverket)

Link for Regulatory Authority

https://www.lakemedelsverket.se/en

Local Regulation

European Union (EU) Cosmetics Regulation (EC) No 1223/2009

Who can Register?  

  • Responsible person 
  • Manufacturer 
  • Importer 
  • Distributer  

Data to be Communicated

Product Information File

  1.  When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
  2. The product information file shall contain the following information and data which shall be updated as necessary:
  • A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
  • The cosmetic product safety report referred to in Article 10(1);
  • A description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
  • Data on any animal testing performed by the manufacturer, his agents, or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

3. The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.

Notification

Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:

(a) The category of cosmetic product and its name or names, enabling its specific identification.

(b) The name and address of the responsible person where the product information file is made readily accessible.

(c) The country of origin in the case of import.

 (d) The Member State in which the cosmetic product is to be placed on the market.

 (e) The contact details of a physical person to contact in the case of necessity.

 (f)  The presence of substances in the form of nanomaterials and:

 (i)  Their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation.

 (ii) The reasonably foreseeable exposure conditions.

(g) The name and the Chemicals Abstract Service (CAS) or EC number of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008.

 (h) The frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties

Process

  • Prepare the Product Information File (PIF)
  • Appoint a Responsible Person
  • Notify the CPNP (Cosmetic Products Notification Portal)
  • Labelling and Language Requirements

Timeframe and Fees

The Swedish MPA charges an annual fee to those who are responsible for notifying cosmetic products to the Cosmetic Products Notification Portal (CPNP), i.e. the responsible person or distributor who translates the labelling of cosmetic products themselves.

    1. Administrative fee: SEK 4 000
    2. Fee per product in the range: SEK 600

Additional Information

  • The PIF is a compilation of technical documents that must accompany each cosmetic product before it may be sold in Europe. The responsible person must keep the file for at least 10 years after the last batch of a specified product was put on the market inside the European Union. It must be always available to European Competent Authorities. Appointing a Responsible Person early in the process, completing all the necessary testing and having PIF ready will speed up the process.   
  • Sweden has a ban on the sale of certain cosmetic products containing small plastic particles, known as microplastics. The purpose of this regulation is to restrict the release of plastic microplastics into our lakes and seas.

A certain part of the label must be in Swedish in accordance with the Swedish Cosmetics Regulation.

  • List of the parts of the label that must be in Swedish:
  • Nominal content
  • Reference to shelf-life.
  • Precautions for use
  • Function/purpose of the product.