Plant protection product registration and control in lithuania (l.taluntyte)


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Plant protection product registration and control in lithuania (l.taluntyte)

  1. 1. STATE PLANT SERVICE UNDER THE MINISTRY OF AGRICULTURE Ozo str. 4 A, LT- 08200 Vilnius, Lithuania Tel. / faksas: 85 2 7302 3 3 , Mail:, Web: http//
  2. 2. <ul><li>Plant Protection Product registration and control in Lithuania </li></ul><ul><ul><li>dr. Loreta Taluntyte </li></ul></ul><ul><ul><li>Deputy Director </li></ul></ul>2011-06-07/08, Vilnius
  3. 3. <ul><li>State Plant Service under the Ministry of Agriculture was established on the 1st of July in 2010, when three State Services were reorganized and merged together : </li></ul><ul><ul><li>State Plant Protection Service, </li></ul></ul><ul><ul><li>State Seed and Grain Service under the Ministry of Agriculture , </li></ul></ul><ul><ul><li>State Plant Varieties Testing Center. </li></ul></ul>
  4. 4. <ul><li>Further reorganization has been made on the 1st of March 2011 , when 7 Plant Variety Testing Stations were integrated under Service administration. </li></ul><ul><li>After all structural changes, more </li></ul><ul><li>efficient and streamlined </li></ul><ul><li>management of State institutions </li></ul><ul><li>is made and “one-way gate” </li></ul><ul><li>principle in practice is being </li></ul><ul><li>implemented. </li></ul>
  5. 5. <ul><li>Service develops and implements State policy </li></ul><ul><li>in the fields of: </li></ul><ul><ul><li>plant health, </li></ul></ul><ul><ul><li>quality of plant propagating material and plant products (i.e. grain), </li></ul></ul><ul><ul><li>plant varieties registration and granting the legal protection for plant varieties, </li></ul></ul><ul><ul><li>plant protection products registration and control, </li></ul></ul><ul><ul><li>control of the use of fertilizers . </li></ul></ul>
  6. 6. Division of Plans Preparation and Control Department of General Affairs Division of Economy Division of Document Management Kai š iadorys Plant Variety Testing Division Kaunas Plant Variety Testing Division Pasvalys Plant Variety Testing Division Plungė Plant Variety Testing Division Šilutė Plant Variety Testing Division Utena Plant Variety Testing Division Vilnius Plant Variety Testing Division Plant Production Quality Diagnostic Division
  8. 8. Plant protection products authorisation division <ul><li>Evaluation and authorisation, re-registration of plant protection products in Lithuania, </li></ul><ul><li>Evaluation and preparation of Draft assessment reports concerning inclusion of active substance in Annex I of directive 91/414/EEC, </li></ul><ul><li>Evaluation of parallel trade applications, </li></ul><ul><li>Evaluation of emergency applications for 120 days, </li></ul><ul><li>Evaluation of applications for scientific trials. </li></ul>
  9. 9. Plant protection products authorisation division <ul><li>Head of division </li></ul><ul><li>Deputy head - administrative and general issues </li></ul><ul><li>Specialists for the assessment of: </li></ul><ul><ul><li>- identity, physical and – chemical properties and analytical methods 1 </li></ul></ul><ul><ul><li>t oxicology 2 </li></ul></ul><ul><ul><li>r esidues 1 </li></ul></ul><ul><ul><li>ecotoxicology 2 </li></ul></ul><ul><ul><li>fate and behaviour 2 </li></ul></ul><ul><ul><li>biological efficacy 1 </li></ul></ul>
  10. 10. Plant protection products authorisation
  11. 11. Legal acts (1) <ul><li>Law on plant protection </li></ul><ul><li>Law on chemical substances and preparations </li></ul><ul><li>Regulations for authorisation of plant protection products which contain active substances included in the List of active substances and new active substances </li></ul><ul><li>Requirements for the dossier to be submitted for the active substance and requirements for the dossier to be submitted for authorisation on plant protection products </li></ul>
  12. 12. Legal acts (2) <ul><li>List of active substances, which may be contained in plant protection products </li></ul><ul><li>U niform principles for the evaluation and decision-making of plant protection products </li></ul><ul><li>Procedure for the Classification and Labeling of Dangerous Substances and Preparations </li></ul><ul><li>S pecific risk and safety phrases for plant protection products </li></ul><ul><li>P rocedure for the evaluation of information on active substances, the drawing up of a draft assessment reports and its submission to the European Commission </li></ul>
  13. 13. Legal acts (3) <ul><li>Consulting Commission and its Regulation </li></ul><ul><li>L ist of minor crops and minor users </li></ul><ul><li>Governmental resolution on the approval of the state charges for the registration, re-registration, amendment on use, extension for minor crops </li></ul><ul><li>Regulations for trade of parallel plant protection products </li></ul><ul><li>Regulation s for good experimental practice </li></ul>
  14. 14. Plant protection products authorisation <ul><li>Advisory Committee </li></ul><ul><li>Scientists (Vilnius University, Institute of Ecology, Institute of Hygiene, Institute of Agriculture, Institute of Horticulture); </li></ul><ul><li>Experts from relevant Ministries (Ministry of Health, Environmental Protection Agency, State Plant Service under Ministry of Agriculture, State Forest Service). </li></ul>
  15. 15. Authori s ed plant protection products in Lithuania <ul><li>For professional use: F or amateur use: </li></ul><ul><li>Total, including 261 Total, including 37 </li></ul><ul><li>Herbicides 117 Herbicides 2 1 </li></ul><ul><li>Insecticides 20 Insecticides 6 </li></ul><ul><li>Fungicides 80 Fungicides 10 </li></ul><ul><li>PPP for seed treatment 22 </li></ul><ul><li>Plant growth regulators 8 </li></ul><ul><li>Plant growth inhibitors 2 </li></ul><ul><li>Fumigants 6 </li></ul><ul><li>Others 6 </li></ul>
  17. 17. Organization of PPP s post-registration control: <ul><li>State Plant Service is the national authority responsible for the authorization and control of plant protection products (PPPs) in Lithuania. </li></ul><ul><li>Plant Protection Products Control Division (Division) of SPSMA is responsible for the control of PPPs placing on the market, storage, packaging and labelling, marketing and use. </li></ul><ul><li>2 7 regional specialists (inspectors) carry out post registration control of PPPs in accordance to comply with the provisions of the legal acts and report directly to the administration of the Division. </li></ul>
  18. 18. There are 2 7 regional inspectors responsible for control of plant protection products in the Country
  19. 19. <ul><li>Administration of Plant Protection Products Control Division is responsible for: </li></ul><ul><li>Preparation, adoption and replacement of the National and EU Legal acts. </li></ul><ul><li>Organising, administration and control of implementation of PPP post – registration control. </li></ul><ul><li>Planning of measures for improvement of PPPs control system. </li></ul><ul><li>Preparing inspection guidelines, protocol forms and providing technical advice on conducting inspections. </li></ul><ul><li>Analyses of inspection results. </li></ul><ul><li>Evaluating the quality of inspections, including inspection of check lists. </li></ul><ul><li>Training of regional inspection staff. </li></ul><ul><li>Organising and control of testing of sprayers in use, etc. </li></ul>
  20. 20. Administration, planning and control measures (1) <ul><li>The activities of regional inspection staff are coordinated by the Administration of the Division. </li></ul><ul><li>Setting of the Annual control activities plan (according to the analyses of the inspection activities from last year and available funds). </li></ul><ul><li>On base of the Annual control activities plan set by the Administration of the Division, - regional inspectors develop a very detailed individual Annual inspection plans. </li></ul><ul><li>Once a year regional inspection staff give a overall report to Administration about the inspection activities implemented. </li></ul><ul><li>Inspection reports are analyzed and filed. </li></ul>
  21. 21. Inspections <ul><li>Planned inspections : on PPPs marketing, packaging - labelling, storage and use are implemented according to the Annual control activities plan set by order of the Director of SPSMA. </li></ul><ul><li>Unplanned inspections : are implemented according to complaints, information received or the secondary visits when the infringements were found during planned inspections (the found faults must be corrected and revised). </li></ul><ul><li>Inspector after carrying out inspection on PPPs marketing, packaging – labelling, use or storage fills out a special forms of a Check list. </li></ul><ul><li>Annual control activities plan also include the task for Inspectors: to take number of PPPs samples and delivering them to the competent Laboratory for the quality testing. </li></ul>
  22. 22. <ul><li> Activities of PPPs control inspectors (1) </li></ul><ul><li>Carry out the control of trade, packaging – labelling, storage and use of plant protection products: </li></ul><ul><li>- Control on sale (trade, storage, records keeping). </li></ul><ul><li>- Control on packaging and labelling. </li></ul><ul><li>- Control on use at user level (use, storage, records journal). </li></ul><ul><li>- Control of the records on use and trade of plant protection products. </li></ul><ul><li>- Control documents to prove the legality of purchase of plant protection products (users and marketing chain). </li></ul><ul><li>- Sampling of plant protection products for inspection of their quality (delivering them to the Laboratory) . </li></ul>
  23. 23. <ul><li>Activities of PPPs control inspectors (2) </li></ul><ul><li>Control of certification (testing) of plant protection sprayers. </li></ul><ul><li>Participation in training of users and traders of plant protection products according to approved programs. </li></ul><ul><li>Laying administrative penalties for legal and natural persons for the violation of legal acts on trade, packaging – labelling, storage and use of PPPs. </li></ul><ul><li>Suspension or prohibition to use and trade of plant protection products in case of violations of the requirements laid down in relevant legislation. </li></ul><ul><li>Collection of statistics on sale of PPPs and reporting. </li></ul>
  24. 24. Control of use, storage, packaging - labelling and sale of plant protection products in 20 10 (violators in units) Inspections Violators Use of plant protection products 797 202 Marketing of plant protection products 544 123 Packaging and labeling 259 74 Storage of plant protection products 410 96 Total 2010 495
  25. 25. Inspections carried out and violators identified in 2 010 797 544 259 410 2010 123 74 96 495 202 0 500 1000 1500 2000 2500 3000 Use Marketing Packaging and labelling Storage Total Inspections Violators
  26. 26. The quantities of PPP s sold to users (farmers) in tons of AS (Dynamics by years : 200 8 – 20 10 )