Biocidal products requiring authorisation but not yet authorised may neither be sold nor used. Products in a development stage containing new compositions or active substances may, however, be tested experimentally with a permit from the Danish EPA.
Is there a risk of the substance being released into the environment?
The permit for experimental testing from the Danish Environmental Protection Agency is necessary if there is a potential risk of the substance being released into the environment.
For laboratory testing a permit is not required.
However, a specification for all relevant information relating to the experiment must be drawn up in writing and kept for inspection. If research or development is related to process the written specification must also be sent to the Danish EPA before testing commences.
For scientific research and development, the written specification must be stored and must be submitted to the Danish EPA on demand.
- The written specification must always contain information about:
- The identity of the product or active substance
- Labelling data
- The quantities delivered
- Names and addresses of those persons receiving the product or active substance
- All available data on possible effects on human or animal health or on the environment.
Studies outside a laboratory
If the studies are not to take place exclusively in a laboratory, a risk is posed of the product escaping into the environment, and a permit from the Danish Environmental Protection Agency must therefore be obtained before testing can commence.
The application for a permit must be submitted to the Danish EPA before the experiment is commenced and must contain information on the following:
- The composition of the product and the acute toxicity of its active substance(s)
- For microbiological products: the ability of the active “substance(s)” to cause disease (the pathogenicity of the active substance) in mammals, and in particular in humans, and the natural occurrence and extent of the relevant microorganisms in Denmark
- Other information that may elucidate possible effects on human and animal health or on the environment
- The area of use of the product
- The conditions under which the testing is to take place, including specifying what measures will be taken to counter any potential risk to health and the environment
- Name and address of the person in charge of the tests
- Name and address of the person or persons receiving the product for testing.
Application can be sent electronically to the Danish EPA at firstname.lastname@example.org.
For any further questions about experimental testing please contact the Danish EPA at email@example.com .