thumbnail image
Biostimulants legislation - regulatory support for biostimulants
Biostimulants legislation - regulatory support for biostimulants
  • HOME
  • BIOSTIMULANTS LEGISLATION
  • (BIO)PESTICIDES
  • CLASSIFICATION (CLP)
  • TRAININGS & GUIDES
  • CHEMICAL TESTING
  • SCIBASICS
  • CONTACT
  • FAQ
  • …  
    • HOME
    • BIOSTIMULANTS LEGISLATION
    • (BIO)PESTICIDES
    • CLASSIFICATION (CLP)
    • TRAININGS & GUIDES
    • CHEMICAL TESTING
    • SCIBASICS
    • CONTACT
    • FAQ
    Biostimulants legislation - regulatory support for biostimulants
    Biostimulants legislation - regulatory support for biostimulants
    • HOME
    • BIOSTIMULANTS LEGISLATION
    • (BIO)PESTICIDES
    • CLASSIFICATION (CLP)
    • TRAININGS & GUIDES
    • CHEMICAL TESTING
    • SCIBASICS
    • CONTACT
    • FAQ
    • …  
      • HOME
      • BIOSTIMULANTS LEGISLATION
      • (BIO)PESTICIDES
      • CLASSIFICATION (CLP)
      • TRAININGS & GUIDES
      • CHEMICAL TESTING
      • SCIBASICS
      • CONTACT
      • FAQ
      Biostimulants legislation - regulatory support for biostimulants
      • Denmark

        Summary of Danish current national requirements for PPP dossiers

        broken image
        • 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
        broken image
        • Bridging studies are required for similar products.
        • Field trials must cover danish conditions.
        broken image

        Residue studies must cover Danish conditions

        broken image

        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.

        broken image

        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!

        Contact
      broken image

      Biostimulants

      legislation

      Scientific regulatory

      affairs

      Regulatory support for

      biostimulants

      Biostimulants legislation | Regulatory support for biostimulants | email me >

      Terms & Conditions
      Privacy Policy
      Powered By
        Store
      Cookie Use
      We use cookies to ensure a smooth browsing experience. By continuing we assume you accept the use of cookies.
      Learn More