Enforcement 9/25: Labelling and analysis of biocidal products 2024

This report describes an enforcement project in which the Swedish Chemicals Agency has checked the labeling and conditions of biocidal products authorized under either the EU Biocides Regulation or national legislation.

In 2024, a project was carried out to check various legal requirements for biocidal products authorized under the Biocides Regulation or under national rules. In particular, the project verified that the labeling of the products was consistent with the information provided in the Summary of Product Characteristics (SPC) or the Decision. It also checked that the labels were not misleading and that the active substance in the products came from a supplier on the so-called Article 95 list.

The focus was on biocidal products within product types 14 (rodenticides), 18 (insecticides) and 19 (repellents and attractants). A total of 42 products authorized for the Swedish market by 29 registration holders, based both inside and outside Sweden, were examined. 18 products were authorized under our national rules and 24 products were authorized under EU rules. For 18 products, the active substance content was analyzed.

The results of the project showed that:

• There were no deficiencies regarding Article 95, i.e. the supplier of the active substance was found on the so-called Article 95 list.
• For two products, the chemical analysis showed that the concentration of active substance deviated from the approved concentration in the decision for the product.
• The majority of the products checked (69%) had some deficiency in the specific biocidal label. In most cases, these were minor deficiencies.
• The most common deficiencies in the specific biocidal product label were deficiencies in first aid information, deficiencies in the description of the area of use and failure to correctly indicate the active substance on the label.
• For 29% (12 products) of the products checked, deficiencies in CLP labeling were found. For 8 products, the deficiencies were assessed as major and would in most cases have led to a prosecution if the registration holder had been located in Sweden.
• For 10 products, the deficiencies were such that a prosecution report to the Swedish Police or Prosecution Authority would have been applicable if the registration holder had been located in Sweden.