The Swedish Chemicals Agency can grant a derogation from the requirement to have a product authorisation for a plant protection product, either in an emergency situation or for research and development.
Derogation for an emergency situation
A derogation for an emergency situation can only be granted for the limited and controlled use of a plant protection product for a maximum of 120 days. To grant a derogation is an exceptional measure that can only be used in special cases when certain prerequisites are fulfilled.
One prerequisite for granting a derogation is that the product is needed because of a danger. As an applicant you must show that there is a danger and that the danger cannot be averted by any other reasonable means than by using a specific plant protection product. If the product is to be used on edible crops or fodder crops you must also provide data on residue levels.
When examining an application for a derogation the Swedish Chemicals Agency shall consider the following:
- The application must concern a specific case.
- There must be a danger.
- Granting a derogation must be necessary to avert the danger.
- There is no other reasonable way of averting the danger than by granting a derogation.
Normally a derogation for an emergency situation can only be granted once for the same purpose and product, or in special cases only a few times. Derogation for an emergency situation is a temporary solution to an acute problem. The possibility for the Swedish Chemicals Agency to grant more than one derogation is limited and should be avoided as far as possible. Repeated derogations tend to undermine the purpose of the legal requirement of authorisation for plant protection products.
There are other long-term solutions to frequently recurring problems. For example suppliers as well as other actors may apply for a mutual recognition or an extension of authorisation for minor uses (UPMA).
Not only the applicant but also others are allowed to use the product in similar situations to the one covered by the granted derogation.
A derogation can be granted for a plant protection product that does not have a product authorisation as well as for a crop or an area of use that is not included in the existing product authorisation.
Derogation for research and development
It is also possible to apply for exemption from the requirement to have product authorisation for a plant protection product to be used for experiments or tests for research or development purposes. The application must contain as much information as possible to facilitate the assessment of any effects on the health of humans and animals or the environment. The Swedish Chemicals Agency assesses the information and grants permits for experimental purposes in Sweden.
This permit may include rulings on limitations to the amounts that can be used and the areas that can be treated. The permit may also be linked to other conditions to prevent harmful effects on the health of humans and animals or an unacceptable negative impact on the environment. One example of this might be to prevent food and fodder that contain residue levels from entering the food chain.