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Biocides are chemical and microbiological active substances or products designed to kill or control living organisms. Like plant protection products, they are governed under the Danish Chemicals Act and the Danish Pesticides Order. At the EU level, biocides are regulated by the Biocidal Products Directive, Directive 98/8/EC.
Biocides are divided into 23 different product types, for example disinfectants, preservatives (including wood preservatives and slimicides), pest control products (including rodenticides and insecticides) and antifouling products.
The person responsible for the import, placing on the market or use of biocides must also check whether the biocidal product is covered by the authorisation requirement and the regulations applying to the particular product prior to importing, selling or using the product.
Authorisation in accordance with the EU principles or with national principles under the transitional arrangements?
In principle, all biocidal products within all of the 23 product types specified in the Biocidal Products Directive require authorisation under the Directive.
Some products are temporarily exempted on the basis of the transitional arrangements.
Denmark has had a national authorisation system for many years for a number of biocides temporarily exempted under the Biocidal Products Directive. These include chemical substances and products intended to control:
- fungi attacking wood
- harmful organisms in timber and woodwork
- algae
- slime-forming organisms in pulp
- vermin that infest pets
- harmful organisms in textiles
- insects, such as cockroaches and ants
- water voles, moles, mice and rats, and
- certain repellant substances and products, for example mosquito repellants.
Such products require authorisation in Denmark irrespective of their active substances. Until their active substances have been included in Annex 1 to the Biocides Directive, these products will be subject to the transitional arrangements.
Products within the 'new' product types using existing active substances will, on the other hand, only require an authorisation (or become prohibited) after their active substances have been evaluated and found either suitable or unsuitable for inclusion in the positive lists of substances approved under the Biocidal Products Directive.
On the other hand authorisation is required for any product within any of the 23 product types listed in the Biocidal Products Directive using entirely new active substances (defined in the Directive as substances not placed on the EU market for biocidal products as at 14 May 2000).