
Denmark
Summary of Danish current national requirements for PPP dossiers
- DK does not automatically require a vertebrate study on acute inhalation toxicity when the product is sprayed.
- DK does not accept EUROPOEM II or German Guidance (Martin et al) as second tier for bystander and resident risk assessment.
- DK requires risk assessment for toddlers/small children for uses on recreational lawns in public areas but not for golf courses.
- In DK, recreational resident exposure assessment also applies to products intended for use on private lawns.
- DK does not accept the use of re-entry times as a refinement for risk assessment of recreational residence.
- DK does not accept the EU definition of non-relevance of metabolites. Denmark generally considers all metabolites as relevant, but in some cases, and after evaluation by DEPA
- Bridging studies are required for similar products.
- Field trials must cover danish conditions.
Residue studies must cover Danish conditions
DT50 soil < 180 days for active substance and some metabolites – otherwise no approval.
Please consult the Danish Framework for Assessment of Plant Protection Products for details about the persistence cut-off (specific persistency assessment)
Specific groundwater modelling - including all metabolites
The following requirements should be included in the core assessment:
Makro Danish scen. or PELMO Hamburg + specific input and output values
All metabolites that are not inherently non-relevant needs to be covered by the assessment.
For uses in open greenhouses the half-life in soil measured in standard tests (representative for Danish agricultural soil) must be below 60 days (DT50 < 60 days) for active substances and their metabolites.
Danish Environmental Protection Agency’s supplementary framework for the environment for plant protection product uses in open greenhouses.
Please consult the Danish supplementary framework for Plant Protection Product uses in open greenhouses.
Birds and mammals
Higher tier guidance on risk assessment for birds and mammals
Danish refinement options for: FS, PD, PT, RUD, DT50 and interception
Ecotoxicology - Aquatic organisms
Specific aquatic risk assessment
Specific assessment princples for mesocosm studies (check in version 1.7 Nov 2019 guidance)
Risk assessment for open greenhouses
Specific assessment for uses in open greenhouses
(see updated guidance)
Need help with a PPP dossier for Denmark?
Feel free to contact us!

Biostimulants
legislation
Scientific regulatory
affairs
Regulatory support for
biostimulants
Biostimulants legislation | Regulatory support for biostimulants | email me >