In Sweden, biostimulants and fertilisers are primarily regulated by EU Regulation (EU) 2019/1009, the European Fertiliser Regulation (EFR).

This regulation does not revoke national laws, so member states can impose additional requirements - and this certainly applies to Sweden as regards to Cadmium. You must ensure that biostimulants or fertilisers do not exceed the maximum of 100 mg Cd per kg P (phosphorus). This is stricter than EU levels and applies in Sweden to all fertilisers, including CE-marked.

For non-CE biostimulants placed on the market in Sweden under national law (instead of under the EFR), the following rules have to be observed:

Products containing animal materials (e.g. manure, bone meal and all other products considered animal by-products) must comply with EU rules on animal by-products (Regulation 1069/2009 and 142/2011) , and

Certain chemical ingredients are also regulated by the Swedish Chemicals Agency. It means that certain chemicals must not be used in biostimulants or fertilisers. There is a possibity to apply for an exemption with the Swedish Chemicals Agency (Kemikalieinspektionen). At the time of the updated (30 06 2025) the Restricted Substances Database was closed due to technical issues and until this issue is solved, users are referred to the European Chemicals Agency and/or to contact the KEMI's helddesk.

This chemical substance restriction is regulated through KIFS 2022:3, which lists lists substances exempted from Sweden’s bans on plant protection products. These substances are also likely not allowed in fertilisers/biostimulants that imply certain claims (to be checked on a case-by-case basis). If the chemical at stake is on the exemption list, it can typically be used.

Mutual Recogition (MR) is also possible and can be done if the product is the same as what it will be used for in Sweden (same function, formulation).

A dossier for the MR must be prepared and submitted to the Jordbruksverket, Kemikalieinspektionen or Livsmedelsverket, depending on the type of product (fertiliser, chemical or microbial biostimulant). Swedish authorities must accept the product unless they can justify a refusal based on public interest (e.g. environmental or health risks).

The timelines is about 20-30 days.

Last but not least, if you are importing or manufacturing more than 100 kg per year you will have to notify the Jordbruksverket (for product registration purposes).

Need help with your product for the Swedish market ?

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The sciBASICS Team