A biocidal product is defined in the Biocidal Products Regulation as any product or substance which is intended to destroy, control or prevent the effects of harmful organisms, or in any other way control harmful organisms, other than by means of physical or mechanical devices.
Biocidal products are all those pesticides that are not intended to protect plants or plant products. The biocidal products that act in a chemically or biologically way fall in the scope of the biocidal legislation. It can for example be disinfectants, a mosquito repellent, wood preservatives, rodenticides or antifouling paint for boats. Biocidal products that, on the other hand, act in a physical or mechanical way do not fall in the scope of the regulation for biocides. A mechanical mousetrap is an example of such a product.
Importing, manufacturing or selling?
If you want to import or sell a biocidal product in Sweden, the product must be authorised by a competent authority in the EU. As a rule in Sweden, the product must be authorised by the Swedish Chemicals Agency, but certain exemptions apply. Use our application guide to apply for the authorisation of a biocidal product.
In Sweden, the Swedish Chemicals Agency authorises biocidal products according to the provisions in the Environmental Code, the Pesticides Ordinance and the EU Biocidal Products Regulation. Regulations on the labelling and handling of chemical pesticides are contained in the Agency´s Pesticides Regulations KIFS 2008:3.
Apart from the specific regulations that apply for biocidal products, other rules are also valid for biocides. At this webpage, we have gathered the requirements in different legislations that might concern your product in parallel with the biocidal products regulations. (In Swedish) For example, companies manufacturing disinfectants must report to the Swedish Products Register. You can create an account and report your business activity to the Products Register via this webpage.
Contact us well in advance of the application
It is important that you contact us well in advance if the Swedish Chemicals Agency is to evaluate the complete documentation in the application, preferably one year before you submit the application. This is important in order for us to be able to give you the support you need before applying, but also for us to be able to plan our work in a good way.
According to the Biocidal Products Regulation, you are obliged to consult with us prior to an application, if Sweden is to be the reference Member State, that is, if the Swedish Chemicals Agency is the authority responsible for evaluating the complete documentation in your application.
We recommend that you book a meeting with relevant officers before submitting such an application, a so-called pre-submission meeting. During this meeting, we can discuss the process, the data requirements or other issues that are relevant to your application. Such a meeting is free of charge for applying companies.
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Requirements on knowledge and documentation
An important part of the authorisation process is to ensure that sufficient knowledge exists about the risks connected with the product, in order to be able to evaluate any unacceptable risks during normal use of the product. Evaluating the risks may prevent or minimise any breach of acceptable levels. The effects of the products are also evaluated in the authorisation process.
If you want to sell or in another way transfer a biocidal product you have to prove that you have or a person in the distribution chain has access to documentation on the active substance in the product. This requirement applies whether or not your product must be authorised. The requirement applies from 1 September 2015.