Swedish Medical Products Agency (Lakemedelsverket)
Link for RA:
Regulation (EC) N° 1223/2009
Who can register :
- Responsible person
Data to be communicated :
Product Information File:
- A description of the cosmetic product which enables the product information file to be 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 practices are referred to in Article 8
- Proof of the stated claim for the cosmetic product, where justified by the type of effect of the cosmetic product
- Data on any animal research conducted by the manufacturer, his agents, or suppliers connected with the development or safety evaluation of the cosmetic product or its constituents.
- The category of cosmetic product and its name or names, enabling its specific identification
- The name and address of the responsible person where the product information file is made readily accessible
- The country of origin in the case of import
- The Member State where the cosmetic product is to be placed on the market
- The contact details of a physical person who have to be contacted in the case of necessity
- The presence of substances in the form of nanomaterials and:
- Their identification includes the IUPAC name and other descriptors that are specified in point 2 of the Preamble to Annexes II to VI
- The reasonably foreseeable exposure conditions
- The name and the 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
- The frame formulation allows for prompt and appropriate medical treatment in the event of difficulties.
- A compliance check of the cosmetic formula
- A redaction of a Product Information File (PIF) and a Cosmetic Product Safety Report (CPSR)
- A CPNP number (Cosmetic Product Notification Portal)
- A Responsible Person based in the European Union territory
- Completing all the necessary Safety Tests
Timeframe and fees:
The Swedish MPA charges an annual fee to those 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.
- Administrative fee: SEK 4000
- Fee per product in the range: SEK 600
The hourly rate is a fee that the Swedish MPA charges the party acting as distributor and who is not obliged to notify their cosmetic products to the CPNP. The hourly rate is charged after performing market surveillance of the time spent processing the case. The fee is SEK 750 for each hour or part thereof.
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 available to European Competent Authorities at all times. Appointing a Responsible Person early on in the process, completing all the necessary testing and having PIF ready will speed up the process.