1. State Plant Health and Seed Inspection Service The system of supervision of plant protection products marketing in Poland Autors: Tadeusz Kłos Katarzyna Prugar The Main Inspectorate of Plant Protection and Seed Inspection 27 September, 2007

2. Overview  Legal provisions on marketing of plant protection products  Scope of activities of SPHSIS  The system of supervision of plant protection products marketing  Results of inspections  Summary State Plant Health and Seed Inspection Service

3. Provisions regulating the market of plant protection products Act of 18 December 2003 on plant protection (OJ 2004, no 11, item 94, as amended) regulates the registration, marketing and application of plant protection products and transposes the provisions of Council Directive 91/414/EEC of 15 July 1991 on marketing of plant protection products to the Polish law. Act of 30 March 2007 amending the act on plant protection (OJ no 80, item 541) introduced changes to the plant protection act related to registration and supervision over marketing of plant protection products defining – inter alia – principles for granting authorisations for parallel imports

4.  SPHSIS is a national authority competent for supervision of plant protection, seed production, evaluation and marketing and marketing and application of plant protection products.  The tasks performed by SPHSIS aim at reduction of threats posed by harmful organisms, production of seed material fully compliant with quality and health requirements and elimination of threats resulting from marketing and application of plant protection products State Plant Health and Seed Inspection Service

5. Basic indicators  According to administrative division of the country Poland is composed of 16 voivodships and 379 poviats  There are 16 voivodship inpectorates incorporating 269 field units and 12 border divisions.  SPHSIS’s staff – 2 300 employes  The number od staff involved in tasks related to supervision of marketing and use of plant protection products is 553, of whom 414 inspectors perform direct inspections of ppp marketing voivodeship inspectorate

6. Structure of State Plant Health and Seed Inspection Service

7. Primary objectives of supervision over plant protection products:  preventing of introduction in to the market products, which have not been comprehensively tested or which do not meet requirements set out in the registration procedures, e.g. products unregistered, expired, of inadequate quality;  elimination of premises inadequate for marketing or storage of plant protection products;  not allowing, persons who do not have appropriate qualifications, to trade the plant protection products;  elimination of forbidden ways of trading, e.g. in local markets or mobile trade.

8.  registration of entrepreneurs re-packaging or selling plant protection products (5 275) and locations of these businesses (6148);  performing inspections (8000 - 11 000 each year);  performing official control of quality of plant protection products (300-400 ppp samples each year);  approving entities for delivering trainings on marketing and packaging of plant protection products and supervision of these trainings (235) Primary tasks of supervision over plant protection products:

9. The points of sale plant protection products wholesale- 337 retail sale - 5795

10. The market of plant protection products  Registration of products is within the competence of the Minister of Agriculture and Rural Development.  Authorisations for plant protection products are granted through a decision.  There are 773 plant protection products registered currently.  Current register of plant protection products is available at http://www.minrol.gov.pl The number of authorised plant protection products dropped by 200, from 973 to 773 in the period 2004- 2007

11. Act of 18 December 2003 on plant protection  marketing and use of plant protection products, which have been approved by the Minister of Agriculture and Rural Development (article 37), including the ppp authorised for parallel import;  production, storage and moving of unregistered in Poland plant protection products, provided they are intended for use in another Member State, if they are approved for marketing in this State. These products may not be used in the territory of Poland (article 37, paragraph 4, item 1 and 2)  marketing only plant protection products which are in original, hermetically sealed packages ( article 62 paragraph 1) Current provisions on marketing of plant protection product in the terrritory of the Republic of Poland allow for:

12. The Inspection checks locations where plant protection products are re-packaged, wholesale businesses, warehouses, retailers, markets and other locations where plant protection products are or may be sold. During an inspection conditions of storage, ppp range, qualifications of staff and sales documentation are checked. Plant protection products are checked for:  approval for marketing;  original packaging;  condition of packaging;  compliance of label/instructions with MARD’s authorisation;  expiry date;  quality. Inspections of plant protection products marketing locations

13. Infringement of the Act on plant protection results in:  imposing a fine,  issuing, by voivodship inspector, a decision on withdrawing a ppp from the market at owner’s cost or banning ppp application,  issuing, by voivodship inspector, a decision on sanction payment. Sanction payment article 108 paragraf 1 of the Act on plant protection 1.An entity selling plant protection products not approved for marketing shall be subject to a sanction payment equal to 200% of the value of plant protection products sold and is obliged to withdraw these products from the market at own expense. 2.An entity selling or packaging plant protection products without registering shall pay a sanction payment of 2 270 PLN; Act of 18 December 2003 on plant protection

14. 2004 r.2005 r.2006r. Inspections 8372698710918 Recommendations 4866222044 Fines 502944 Decisions on sanction payment 182123 Decisions on withdrawal of ppp from the market 605886 Nailed by SPHSIS cases of introducting falsified or not genuine ppp 333 Total quantity of ppp withdrawn from the market 17,7 t24,64,2 t - on the grounds of selling unapproved ppp including marketing falsified or not genuine ppp introducting on the market on the basis of forged authorization of the MARD 16,65 t 16,35 t 19 t 18,7 t 0,60 t 0,55 t - on the grounds of exceeding expire date 0,8 t1,9 t2,7 t - on the grounds of inadequate quality 0,02 t3,6 t0,87 t - on the grounds another reasons 0,23 t0,10 t0,03 t Results of plant protection products inpections

15. The information on falsified, not genuine plant protection products, apart from cases which are discovered directly by the SPHSIS, comes from following sources:  manufacturers and importers of original plant protection products;  agricultural producers;  institutes testing quality of ppp. Identification of falsifications is based on:  external appearance of packaging;  information on packaging – on label/instructions for use;  chemical analysis of product’s composition. Ways in which packaging is modified:  different shape and size of packaging;  different material of which packaging has been made;  different way and location of product’s labelling (production date, lot number). Falsification of plant protection products

16. Official control of plant protection products quality This is a statutory task of SPHSIS, fulfilling the requirements set out in Article 17 of Directive 91/414/EEC and has the nature of independent, post- registration control of ppp The results of official control of ppp are used for:  evaluation of approved plant protection products;  protetecting products‘ users from negative results of decreased quality of ppp,  identification of not genuine, falsified plant protection products in the market;  elimination of plant protection products, which pose a threat to human or animal health, or to the environment. Authorities involved in the task:  SPHSIS – responsible for developing annual ppp control plan and sampling plant protection products in sale outlets in the whole of the country,  research institutes – responsible for testing the samples submitted by the SPHSIS

17. Appropriation of rights resulting from authorization issued for marketing ppp Primary reason for withdrawal of all ppp in 2004 was selling unapproved ppp (93.86%), and in particular illegal marketing on the basis of forged authorization of the MARD. In 2004 the SPHSIS  querried a herbicide called BINGO 360 SL, marketed on the basis of the authorization of the Minister of Agriculture and Rural Development no 27/2003. The Ministry of Agriculture and Rural Devlopment confirmed, that a authorization with this number has not been issued. 15,98 t of this product were withdrawn from the market.

18. Appropriation of rights resulting from licence issued for marketing ppp Example: In 2004  t he Inspection querried a product called ALPHACYPER 100 EC, marketed on the basis of the authorization of the MARD no 21/2003. The Min i stry of Agriculture and Rural Devlopment confirmed, that a authorization  with this number has been issued fot another ppp called ECOPART 020 SC. 431 litres of this product were withdrawn from the market. Forgeries of this kind are reported to the police and prosecutor’s office, who take action on the basis of the provisions of code of offences.

19. In 2005 the primary reason for withdrawing products from the market was sale of unapproved ppp (77,31%), in particular the Inspection querried herbicide called ISOPROTURON marketed on the basis of rights resulting from an autorisation issued for another ppp called KOYOTE 500 S.C. 18,7 t of this product were withdrawn from the market. Appropriation of rights resulting from licence issued for marketing ppp

20.  In the first half of 2007 the SPHSIS did not find cases of ppp forgeries. Does this mean the market situation had improved?  Many ppp are forged very well. In many cases genuinuess of the product can only be confirmed after comparison with a genuine product or specialised quality tests Is the detectability of this problem adequate and does it show the real scale of the problem? Conclusions

21. Since the borders were opened in 2004 the SPHSIS finds more and more cases of unnaproved products entering the market, as well as single cases of forging plant protection products. This situations resulted in necessity of taking comprehensive preventive measures including:  increasing the number of annual inspections in locations where plant protection products are sold, in particular wholesale businesses, as well and inspections of ppp purchase and sales documentation;  improving the flow of information on forged plant protection products within the Inspection;  increasing legal sanctions in this respect, i.e. introduction of sanction payment for marketing unapproved plant protection products;  improving cooperation with other national authorities (prosecutor’s office, police, Road Transport Inspection) in relation to detection and prosecution of such offences;  organization and participation in information and educational activities aiming at raising awareness of threats related to this phenomenon. Summary

22. State Plant Health and Seed Inspection Service  Through performing statutory tasks actively works towards reduction of marketing of unapproved and forged plant protection products  It is the task of the Inspection to provide help to farmers, distibutors and and the Police in determining whether a given product or packaging are forged. Within the framework of ofiicial quality control it may order testing the composition of suspected products.  Permanent supervision of points of sale of ppp’s products ensures credibility of these entities.

23. State Plant Health and Seed Inspection Service Thank you for your attention!