Can you apply for a derogation from a product authorisation?
Content:
The Swedish Chemicals Agency can in some cases decide on a derogation from the requirement for product authorisation. Here you can read more about the circumstances under which this is allowed.
Which prerequisites apply for a derogation depends on whether or not the product’s active substances are being evaluated in the EU Review Programme for active substances.
The rules in the EU Biocidal Products Regulation apply in those cases where the biocidal product contains
- only active substances which are approved according to the Biocidal Products Regulation
- an active substance which is a so-called new active substance
- an active substance which is not being evaluated by the EU and/or where EU decision has been taken on non-approval.
The Swedish rules apply in those cases where the product contains
- only active substances which are being evaluated in the Review Programme
- a combination of active substances which are being evaluated and those which are approved according to the Biocidal Products Regulation.
You can find the rules for biocides here.
A derogation to prevent danger
We can only issue a derogation for biocidal products that are regulated by the Biocidal Products Regulation if this is essential for avoiding danger to humans and animals or the environment, and if the danger cannot be managed in any other way than with pesticides. This applies for a maximum of 180 days.
A derogation can also be issued for biocidal products that are governed by Swedish rules in cases such as avoiding danger to public health and the environment.
The derogation is always a time-limited exemption from the requirement for authorisation and may not be used to replace an authorisation. A derogation can be applied for by anyone who is able to show that there are overriding reasons for such an exemption.
You can find application forms and guidance documents here
Derogation for research and development
Biocidal products and active substances may be used for research and development without approval on condition that they are used according to the regulations in Article 56 of the Biocidal Products Regulation and that they fulfil the prerequisites described above.
If this trial could mean release of emissions into the environment, such use must be reported in advance to the Swedish Chemicals Agency.
Report in advance through R4BP at ECHA's website
External link.
For biocidal products that are regulated by Swedish rules you shall report the trial in advance to the Swedish Chemicals Agency. Use the application form for exemption for a biocidal product.