Biocidal Products

As a principle rule all biocidal products have to be authorised before they can be placed on the market or used in Sweden. The Biocidal Products Regulation (EU) No 528/2012 includes 22 product types instead of the 23 previously included in the Biocidals Products Directive. Irrespective of the need for an authorisation of the product or not, the active substance has to be in the work programme for systematic examination of all existing substances (Regulation (EU) No 1062/2014). For further information, please visit the Swedish Chemical Agency’s website.

We can serve as your external resource in regulatory issues.

AdvocoTox offers support in all parts of the application process, as described below:

• Active substances

  • Application for authorisation of active substances according to the Biocidal Products Regulation (EU) No 528/2012

• Biocidal products

  • Preparation of national applications for authorisation or registration of biocidal products to authorities in Sweden, Finland, Denmark and Norway
  • Preparation of different kinds of applications for authorisation of biocidal products according to the Biocidal Products Regulation (EU) No 528/2012:
    • National authorisation
    • Union authorisation
    • Mutual recognitions
    • Simplified authorisation procedure
    • etc.

which include i.e. information gathering, Safety Data Sheets, labels, exposure scenarios and risk assessments, reviewing applications, propose plan for testing, preparation of application documents, preparation of dossiers in IUCLID, compilation of dossiers in R4BP.

We also assist in the preparation of supplementary documentation for applications under evaluation, if the authority has demanded such.

• Assist in the investigation of borderline problems (e.g., certain topical medications or cosmetic products vs. biocidal products).

• We can help companies meet new regulatory requirements for biocide treated articles; for example check that the article contains active substances that are allowed in the EU and that the articles are properly labelled. Examples of articles that may contain biocides are paint, clothing, electronics and building materials.

• Ecotoxicological testing and investigations of pollutants
• Chemical analyses
• Microbiological testing
• In vitro testing

Barbro Ingemarsson
+4670 315 09 58
barbro.ingemarsson@advocotox.se