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European Registrations

Pyrethrum Support in Europe

MGK supports registrations of finished products for plant protection and biocides in Europe by the submission of dossiers for both the Directive 91/414 EC as well as the Directive 98/8 EC Biocides.  In strict compliance with European, US EPA and worldwide regulatory requirements, MGK prepares and maintains acute and chronic toxicological, ecotoxicological, environmental fate and physical-chemical data packages on our active substance, pyrethrins.  The dossier for plant protection products was assembled and submitted to the required Member State and this dossier included a broad base of studies and data on all aspects of pyrethrins. When evaluating applications and granting authorizations on end use formulations, the Member States will make use of the data that was submitted for the inclusion of the active substance in Annex I, as well as the result of the evaluation of those data.

In addition to the existing studies, MGK continues to invest in pyrethrins by expanding the existing database with residue studies on growing crops, efficacy studies on a wide variety of crops and insects and additional environmental fate studies.  These studies will be used to support the Annex III dossiers on the end use formulations.

In addition to the agricultural products, pyrethrin is used in a wide variety of consumer/domestic products which fall under the Biocides Directive.  The dossiers for the biocidal uses were submitted and reviewed by the designated Member State and will soon be listed on Annex I for PT 18 and PT 19 products under the Biocides Directive.  PT 18 products are insecticides, acaracides and products to control other arthropods; PT 19 products are repellents and attractants.  As with the plant protection products dossier, the biocides dossier includes the data necessary to assess the risks to human health and the environment (including any risks from physico-chemical properties and possible unacceptable effects) and the efficacy in accordance with the Directive 98/8/EC for the use of pyrethrins as a product type 18. This assessment included an evaluation of data submitted on one product formulation with pyrethrins necessary to evaluate the risk of use of the active substance.