Registration of plant protection products (PPP)
An applicant who wants to trade in PPP requests for the registration by himself or through a representative in each individual Member State where he plans to trade in PPP.
The competent authority decides on the registration of PPP on the basis of the consent of the authority competent for chemicals.
The request must include the following information:
- list of the foreseen use in each zone and Member States where the applicant lodged or intends to lodge a request;
- a proposal which Member State should assess the request for the respective zone. In the case of the request for the use in greenhouses, treatment after the harvesting, treatment of empty warehouses and treatment of seeds, only one Member state is proposed to assess the application taking into account all suitable zones,
- copies of all registrations already issued for this respective PPP in the Member State; and
- if appropriate, the copies of all resolutions of Member States assessing the equivalence.
Upon submitting a request, the applicant may demand that some information and some parts of documentation remain confidential and physically separates this information.
An application for the registration must be drawn up in the Slovenian language, whereas the documentation attached to the application may be in the Slovenian, English or German language or exceptionally also in other official language of the European Union, if the competent authority consents.
- For the PPP in question, complete documentation and the summary of each item from the regulation on the data required for PPP
- For each active substance, safener or synergist in PPP, complete documentation and the summary of each item from the regulation on the data required for the active substance, safener or synergist
- For each experiment or study which includes vertebrate, the justification of measures taken to prevent animal testing, and duplication of experiments and studies on vertebrates
- Reasons why the submitted reports on experiments and studies are required for initial registration or changes in the conditions for registration
- If appropriate, copy of request for maximum residue levels referred to in Article 7 of Regulation (EC) No 396/2005 or justification why the data has not been included
- Assessment of all data submitted in accordance with Article 8(1) of Regulation (EC) No 1107/2009
- Draft label
- Applicants send a complete file or its summary to other Member States at their request
- Applicants also submit a complete list of studies submitted in accordance with Article 8(2) of Regulation (EC) No 1107/2009, and a list of reports on experiments and studies which require data protection in accordance with Article 59 of Regulation (EC) No
- At the request of a Member State, applicant provides samples of PPP and analytical standards of their components
- Judicial remedy: Appeal
- Competent authority: Ministry of Agriculture, Forestry and Food
- Plant Protection Products Act
- REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
- Decree on the implementation of Regulations (EC) on placing plant protection products on the market
- NATIONAL REQUIREMENTS FOR REGISTRATION OF PLANT PROTECTION PRODUCTS (PPPs) IN SLOVENIA FOR: EFFICACY, TOXICOLOGY WITH EXPOSURE ASSESSMENT, FATE AND BEHAVIOUR IN THE ENVIRONMENT and ECOTOXICOLOGY