1. Ministry of Agriculture and Rural Development CONTROL OF PLANT PROTECTION PRODUCTS ON MARKET IN ROMANIA Nicoleta Predescu, PhD., Chem. Eng. Central Laboratory for Phytosanitary Quarantine WARSAW, POLAND 13 th November 2008

2. AUTHORITIES OF THE CONTROL MARD NATIONAL PHYTOSANITARY AGENCY Compartment for registration of plant protection products Central Laboratory for Control of Pesticides Residue in Plants and Plant Products Country Phytosanitary Units- 42 Laboratory for Pesticide Quality Control within CLPQ Regional laboratories for pesticide quality control – (Arad, Bacau, Mures, Olt)

3. Objectives of the control concerning ppp: To prevent and forbid:  marketing and use of ppp which might be a risk to the people health, food safety, and environment; -ppp that are of inadequate quality or expired; -counterfeit ppp; -non-registered ppp.

4. Inspection Plan of ppp - number of economic operators authorized for marketing and /or use of ppp; - number of existent users in the country; - results of the inspections performed in previous year; The results of the inspections are periodically reported by the National Phytosanitary Agency to the Ministry of Agriculture and Rural Development.

5. In-force legislation (1) ■ Government Ordinance no. 4/1995 about manufacturing, marketing and use of the phytosanitary products for controlling diseases, pests and weeds in agriculture and forestry; ■ Ministerial Order no. 28/2001 regarding the organization and running of the fitosanitary police; ■ Government Decision no. 92/2003 which approves the methods to be applied when dangerous chemical products are classified, labelled and packed;

6.  (2) ■ Government Decision no. 1559/23.09.2004 regarding the registration procedure of plant protection products for placing on the market and use on Romanian territory. ■ Ministerial Order no. 1256/2005 for approving the methods for sampling the plants and plant products samples in view of performing the laboratory analyses for official determination of the residues level of pesticides; ■ Government Ordinance no. 41/2007 for placing of the plant protection products on the market, as well as for amending and repealing several regulatory acts in the phytosanitary field; ■ Ordonance no. 38/2007 concerning the import in Romania of plant protection products and samples, assistance and donations of plant protection products from third countries;

7. ■ Official Note no. 100043/12.01.2007 signed by the secretary of state regarding the monitoring program of the quality of plant protection products (pesticides) in 2007; ■Official Note no. 100042/12.01.2007 signed by the secretary of state concerning the control of plant protection products on sale and use; ■Official Note no. 126051/16.01.2008 signed by the secretary of state regarding the monitoring program of the quality of plant protection products (pesticides) in 2008;  Official Note no. 126085/23.01.2008 signed by the secretary of state concerning the control of plant protection products on sale and use in 2008; Procedures

8. Control System for ppp Control system for plant protection products in Romania is based on: -inspections regarding the sale and use of PPP; -quality control of PPP; -control of pesticides residues;

9. How the supervision runs The following aspects will be considered:  all legal decisions in use will be strictly observed;  the authorization of ppp;  label and package of ppp;  the storage conditions of ppp;  quality of plant protection products by sampling;

10. Documents check  the registration certificate;  authorization for marketing and/or use of T and T+class ppp;  service licence for ppp;  professional certificate for the staff employed in the commercialization of ppp;  professional certificate for the staff employed to use ppp of toxicity class T and T+ ppp;  quality, conformity and analysis certificate of ppp;

11. Inspection of label and package (1) The label has to be in Romanian and includes the following information: - commercial name of ppp; - name and address of the registration company; - number of registration certificate; - name and content of each active substance; -manufacture date; -batch number; -use doze (l, kg, t/ha);

12. Inspection of label and package (2) - specific phrases referring to the safety measures to be taken for the protection of people, animals and environment; - action mode; - formulation type; - utility type for which the plant protection product is registered; - instructions for use ; - expiry date; - information on first aid measures;

13. Control on marketing of ppp The following aspects will be checked : - authorization of economical agent for commercialization of ppp; - registration of ppp; - the guarantee period of ppp; - storage conditions for ppp; - the existence of separate places, properly labelled, locked, clean, made of lasting material, and well organized.

14. Control in use The following will be checked : - technical conditions of the equipment used for ppp application; - the existence of non-registered products; - the unauthorized use of T and T+ class ppp; - the use of product exclusively according to registration; - preserving of safety measures for the operator; - proper storage conditions for ppp; - possible cases of illegal marketing and use.

15. Control through sampling of ppp  sampling of ppp in order to prevent, guarantee the quality and detect the contaminants: - in national monitoring program of quality of plant protection products; - analysis of surface water, treatment solution; poisoned animals; soil – in order to obtain the evidences of illegal utilization; - samples of ppp with complains (no effect); - samples of ppp with suspect label, packing material;

16. The plant protection products monitoring has been set up in accordance with Article 17 of the Directive 91/414/EEC concerning the placing on the market of plant protection products. National monitoring program for the quality of plant protection products is elaborated by CLPQ in co-operation with MARD and approved by MARD; Sampling procedure is elaborated by CLPQ and approved by MARD; National monitoring program for the quality of ppp

17. Monitoring elements: The most important elements for control regarding conformity with authorization are: - content of active substance; - physical-chemical properties; Other activities: -the analysis in CLPQ of plant protection products samples, as a result of enforcement law, from: - ppp with problems - water system - crops - treatment solution - surface water - poisoned animals - soil

18. Monitoring quality of the Plant Protection Products

19. Total samples 247 224 samples compliance 90,68 % 17 samples non-compliance 6,88 % 6 samples counterfeit 2,42 % registration monitoring law enforcement Total samples analyzed in 2007 Total samples analysed in national monitoring program CLPQ- Bucharest County lab Arad County lab Bacau County lab Olt County lab Mures 613082117 Total 137 samples soil, seeds, water surface

20. Total samples 259 243 samples compliance 93,82 % 9 samples non-compliance 3,47 % 7 samples counterfeit 2,7 % registration monitoring law enforcement Total samples analyzed in 2008 (quarter I and II) Total samples analysed in national monitoring program CLPQ- Bucharest County lab Arad County lab Bacau County lab Olt County lab Mures 7121253322 Total 172 samples soil, seeds, water surface

21. Measurements for non-conformities ■ seizure of non-compliant products; ■ withdrawal from the market; ■ trace-back; ■ trace forward; ■ administrative sanctions and fines are issued to the producer;

22. THANK YOU FOR YOUR ATTENTION !