Registration in the National Database of Sweden

Renee van der Weij - 28 May 2024 - /

If you place products on the Swedish market, the importer may require the product to be registered in the national database. How does this process work, what does it cost, and who is obligated to carry out this registration? We will briefly explain this below.

Which products need to be registered?

The Swedish national database is called KEMI. If you produce or import chemicals in Sweden, it could be that these must be reported to KEMI. If you exceed the limit of 100 kg per year, you must also register these products with KEMI, including the quantity produced/imported.

Notifiable chemicals are chemicals listed with a customs tariff number in Appendix 1 of the Chemical Products and Biotechnical Organisms Ordinance (Swedish).

Registration must be carried out if the following conditions apply:

  • You are a professional producer or importer of chemical products in Sweden.
  • The products are packaged in your name, repackaged, or change trade names.
  • You produce or import notifiable pesticides.

Who must register the products?

The obligation to register products lies with the Swedish producer or importer. In Sweden, it is mandatory to report all hazardous ingredients, regardless of concentration, and non-hazardous ingredients present at more than 5% in your mixture.

This composition information is more extensive than the information required by REACH in section 3.2 of a Safety Data Sheet (SDS). This means that an importer in Sweden will effectively request the composition from the non-Swedish producer to comply with the Swedish registration obligation.

Fortunately, there is an option for a non-Swedish producer to register their product through a so-called ‘Product-in-Product’ (PiP) registration. The Swedish importer can then register the chemical product using an A-number (assigned upon registration).

When a PiP registration is carried out, the importer cannot see the product's composition, but it is known to the competent authority (KEMI). This allows you to protect your product's composition if you, as a non-Swedish producer, want to sell a product to a Swedish customer.

Additional costs for registering products

For a non-Swedish company performing a PiP registration, there are no extra costs. However, for a Swedish producer/importer, there are costs associated with the registration if the total quantity of notifiable products exceeds 1000 kg per year. These costs consist of two parts:

  • Registration costs of SEK 600 per product per year, with a maximum of SEK 70,000 per year.
  • 'Quantity costs' of SEK 12 per ton of product per year, with a maximum of SEK 70,000 per year.

How can we be of service?

In addition to preparing a Safety Data Sheet (SDS) in compliance with EU and Swedish legislation we can perform a PCN registration via the ECHA's PCN portal, furthermore we can carry out a PiP registration as a non-Swedish company. This allows you to provide an A-number to your Swedish customers. This A-number can then be used to register a product without having to disclose its composition.

Please let us know if you have any other questions regarding the product notification in Sweden. Contact us via email or call us +31 (0) 85 009 2200.

Source:  as of 27-5-2024