Introduction to biocidal product regulations
Biocidal products are classed as pesticides and their use can pose risks to humans, animals and the environment. Therefore many biocidal products must be authorised before they can be sold or used in Sweden.
What is a biocidal product?
A biocidal product is a substance or mixture that has been designed to limit, destroy, neutralise or otherwise control the effects of a harmful organism in another way than by solely physical or mechanical efforts. All biocidal products comprise, contain or generate one or more active substances. The active substances provide the product with the desired biocidal characteristics. Ethanol is one example and is included in the biocidal product disinfectant.
The precise definition of a biocidal product can be found in Article 3.1 a of Regulation (EU) No. 528/2012 (EU biocidal product regulations)
There are 22 biocidal product types determined by the specific use of the product (for example, Product Type 14 – biocidal rodenticides).
Read more about product types External link.
Biocidal products must be authorised
The main regulation states that biocidal products must be authorised before they can be sold or used within EU. One requirement for product authorisation is that the active substance in the biocidal product must be approved. Therefore this requires two levels of authorisation – for both the active substances in the product and the biocidal product itself.
An examination of several active substances is ongoing as part of an EU-wide review programme. A transitional period will be in place for biocide regulations whilst the review programme is ongoing. During the transitional period, certain biocidal products are exempt from EU requirements. The member states may apply their own national rules to these biocidal products that contain active substances being evaluated in the EU Review Programme. Some member states have national authorisation requirements for biocidal products during the transitional period, whereas others do not. As a rule, Sweden has authorisation requirements for biocidal products, and exemptions for certain product types.
Read more about the exemptions in Chapter 3, 5 §, KIFS 2022:3. (In Swedish)
There are two authorisation levels in biocidal legislation:
- authorisation of active substance and
- authorisation of biocidal product.
Approval of active substances
The authorisation process for active substances is conducted at EU level. All EU member states are helped to evaluate the active substances in accordance with the EU Review Programme for active substances. It is called the work programme for the systematic examination of all existing active substances. Biocidal companies finance the examinations.
Read more about the Work Programme for Systematic Examinations in Delegated Regulation (EU) No. 1062/2014 External link.
The substances are evaluated for specific use, known as product types. Once the review is complete, a substance will either receive a decision for approval or non-approval. An approval decision may contain certain conditions for the use of the substance. One such condition may be that the substance may not be present in biocidal products intended for private use.