EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2014) /02/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN THE CZECH REPUBLIC FROM 10 TO 17 SEPTEMBER 2013 IN ORDER TO EVALUATE CONTROLS OF PESTICIDES In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

2 Executive Summary This report describes the outcome of a Food and Veterinary Office (FVO) audit in the Czech Republic, carried out from 10 to 17 September 2013, under the provisions of Regulation (EC) No 882/2004 on official food and feed controls and Regulation (EC) No 1107/2009. The objective of the audit was to evaluate the controls on pesticides. To a large extent, procedures are in place for the authorisation of Plant Protection Products (PPPs), which comply with the requirements as set out in EU legislation. A system is in place for official controls on the marketing and use of PPPs and comprehensive inspections take place at pesticide distributors and professional users covering all relevant issues. The actions taken with regard to training and certification of pesticide distributors and professional users, inspection of application equipment, handling, storage and safe disposal of packaging and remnants of PPPs and general knowledge on Integrated Pest Management (IPM) at user level are all positive aspects, which allow the sustainable use of PPPs in accordance with the provisions of Directive 2009/128/EC. Some deficiencies were identified, mainly relating to: the identification of all distributors and professional users of PPPs, risk based controls on the marketing, insufficient measures to identify and combat counterfeit and illegal pesticides and disproportionate and non-dissuasive sanctions. However, these would not appear to have a significant impact on the overall effectiveness and efficiency of official controls. The report makes a number of recommendations to the Competent Authorities (CAs), aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE LEGAL BASIS AND STANDARDS LEGAL BASIS STANDARDS BACKGROUND AUDIT SERIES COUNTRY PROFILE FINDINGS AND CONCLUSIONS RELEVANT NATIONAL LEGISLATION ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS DESIGNATION OF COMPETENT AUTHORITIES RESOURCES FOR PERFORMANCE CONTROLS AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTROLS ON THE MARKETING OF PLANT PROTECTION PRODUCTS CONTROLS ON THE USE OF PLANT PROTECTION PRODUCTS PRIORITISATION OF OFFICIAL CONTROLS PROCEDURES FOR PERFORMANCE AND REPORTING OF CONTROL ACTIVITIES CO-ORDINATION AND CO-OPERATION BETWEEN AND WITHIN COMPETENT AUTHORITIES ENFORCEMENT MEASURES OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...19 ANNEX 1 - LEGAL REFERENCES...21 ANNEX 2 STANDARDS QUOTED IN THE REPORT...23 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CIPAC CZK DG (SANCO) DPAEPPP(s) EU EUR FAO FVO IPM ISO LPIS MA ME MH MS(s) NAP NIPH Explanation Competent Authority(ies) Collaborative International Pesticides Analytical Council Czech Crowns Health and Consumers Directorate-General Department(s) for Pesticide Application Equipment and Plant Protection Products European Union Euros Food and Agriculture Organisation Food and Veterinary Office Integrated Pest Management International Organisation for Standardisation Land Parcel Identification System Ministry of Agriculture Ministry of Environment Ministry of Health Member State(s) National Action Plan National Institute for Public Health III

5 OM(s) PPP(s) PPPS PRCD RD(s) RSS SPA Official Measure(s) Plant Protection Product(s) Plant Protection Products Section Post-Registration Control Division Regional Department(s) Regional Subdivision Section State Phytosanitary Administration IV

6 1 INTRODUCTION The audit formed part of the Food and Veterinary Office's (FVO) planned programme. The audit took place from 10 to 17 September The team comprised three auditors from the FVO and one expert from a European Union (EU) Member State (MS). Representatives from the Central Competent Authority (CCA), the State Phytosanitary Administration (SPA), accompanied the FVO team for the duration of the audit. An opening meeting was held on 10 September 2013 with the CAs with representatives from the Plant Protection Products Section (PPPS), the Regional Subdivision Section (RSS) of the SPA and the Regional Departments (RDs) Brno and Prague. The opening meeting was also attended by representatives from the Ministry of Agriculture (MA), Ministry of Health (MH) and the Ministry of Environment (ME). At this meeting, the objectives of, and itinerary for, the audit were confirmed by the FVO team and the control systems were described by the authorities. 2 OBJECTIVES AND SCOPE The objectives of the audit were to evaluate the control systems in place for pesticides, in particular: the implementation of requirements for the authorisation of Plant Protection Products (PPPs) and official controls on the marketing and use of PPPs under Regulation (EC) No 1107/2009 and Directive 2009/128/EC; the implementation of requirements for official controls on the use of PPPs under Regulation (EC) No 882/2004; In terms of scope, the audit assessed the performance of CAs, as well as the organisation of the controls including the authorisation procedures, controls of the wholesalers and retailers of PPPs and controls of the growers. In pursuit of these objectives, the following sites were visited: Table 1: Audit visits and meetings Visits/meetings Comments Competent Authorities Central Regional Laboratories 1 2 PPPS and RSS of the SPA RDs Brno and Prague of the RSS / SPA Public 1 Central Formulation Laboratory Brno of the PPPS/SPA 1

7 On-Site-Visit Controls of growers Controls of wholesalers and retailers 2 2 One apple grower in Brno Region One vegetable grower in Prague Region One pesticide retailer in Brno Region One pesticide wholesaler in Prague Region 3 LEGAL BASIS AND STANDARDS 3.1 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular: Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. Article 68 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council. EU legal acts quoted in this report refer, where applicable, to the last amended version. Full references to the EU acts quoted in this report are given in Annex STANDARDS A list containing details of the applicable standard is provided in Annex 2. Reference to specific provisions of these texts is provided at the beginning of each section. 4 BACKGROUND 4.1 AUDIT SERIES This audit is part of a series of FVO audits in MSs of the EU on controls of pesticides. Prior to the current audit series, the FVO carried out three series of audits to MSs covering controls on the marketing and use of PPPs and pesticide residues. The general overview reports of the previous audit series can be found on the Health and Consumers Directorate-General (DG(SANCO)) internet site: During the previous audit series FVO teams identified that control systems vary considerably between MSs. The control system for pesticide residues was better developed than the control system for placing on the market and use of PPPs. Deficiencies in the planning and conducting of inspections for control on the marketing and use of PPPs were frequently identified. The operation of formulation laboratories to test PPPs was generally considered to be satisfactory. The planning and reporting of controls for pesticide residues in food of plant origin has improved significantly since the first audit series. Nevertheless, weaknesses were identified in particular regarding the assessment of self-control systems, the point of sampling, and enforcement measures taken in case of non-compliance. The main deficiencies found in pesticide residue laboratories 2

8 related to the lack of adequate equipment and implementation of quality control procedures. The CAs of the MSs subject to audit outlined in action plans how the recommendations would be addressed. These action plans are published on the DG(SANCO) internet site together with the reports. In the framework of a previous series, the FVO carried out an audit to the Czech Republic in The report DG(SANCO)/7628/2005 of this audit can be found at The overall conclusion of the audit report was that the control system for pesticide residues was well developed, but further improvement with regard to the range of analytes sought and the number of samples taken was necessary to increase effectiveness. The control system for marketing and use of PPPs needed to be strengthened, particularly in the areas of organisation, on-the-spot training and the scope, depth and number of inspections at both market and user level. Recommendations made in that report were adequately addressed by the Czech CAs. 4.2 COUNTRY PROFILE The FVO has published a country profile for the Czech Republic, which describes in summary the control systems for food and feed, animal health, animal welfare and plant health and gives an overview on the state of play of the implementation of recommendations of the previous FVO audit reports. The country profile can be found at: 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal Basis Article 291 of the Treaty on the Functioning of the EU establishes that MSs shall adopt all measures of national law necessary to implement legally binding Union acts. Findings Regulation (EC) No 1107/2009 The Regulation is directly applicable. At national level, Act No. 326/2004 on Phytosanitary Care, as amended by Act No 245/2011 and Act No 199/2012 (later on referred to as the Phytosanitary Act ), provides the legal framework for the authorisation of PPPs and official controls on the marketing and use of PPPs. Enforcement measures to be undertaken in the case of irregularities identified, including administrative sanctions and fines to be imposed, are also regulated by the Phytosanitary Act. Further legal provisions with regard to the marketing of PPPs are laid down in Decree No 32/2012 for Placing of PPPs on the Market, as amended by Decree No 326/2012. Directive 2009/128/EC The CAs stated that the Directive has been transposed into the national legislation. The main legal requirements with regard to the sustainable use of pesticides are set out in the Phytosanitary Act. In addition, further implementing legislation is in place, including: 3

9 Decree No 205/2012 on the General Principles of Integrated Pest Management (IPM); Decree No 206/2012 on the Professional Qualification for Handling of PPPs; Decree No 207/2012 on the Professional Equipment for Application of PPPs; Decree No 327/2012 on the Protection of Honeybees, Wildlife, Aquatic Organisms and Non- Target Organisms by Application of PPPs; Decree No 268/2009 on Technical Requirements for Buildings, as amended by the Decree No 20/2012. Further national legislation within the scope of the audit includes Act No 185/2001 on Waste, as amended by Act No 314/2006 (the Waste Act ), Act No 477/2001 on Packaging, as amended by Act No 94/2004 and Act No 66/2006 and Act No 350/2011 on Chemical Substances and Chemical Mixtures (the Chemical Act ). As required by Article 4 of Directive 2009/128/EC and based on the provisions laid down in Section 48(a) of the Phytosanitary Act, a National Action Plan (NAP) was adopted (document 87595/2012-MZE-17221) to reduce the use of pesticides in the Czech Republic. The NAP is to be up-dated every five years at the latest. Conclusions National legislation within the scope of the audit is in place and Directive 2009/128/EC has been transposed. 5.2 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS Designation of Competent Authorities Legal Requirements Articles 75(1) and (2) of Regulation (EC) No 1107/2009 require MSs to designate a CA or CAs to carry out the obligations laid down in this Regulation, and to inform the European Commission of the details concerning its CAs. Article 4(1) of Regulation (EC) No 882/2004 requires MSs to designate the CAs responsible for official controls. Article 5 of Regulation (EC) No 882/2004 sets out the scope of possible delegation to control bodies, the criteria for delegation, and the minimum criteria which must be met by control bodies. Findings The overall description of the CAs is in the country profile (DG(SANCO)/ Final) valid as of July The CAs confirmed that there have been no changes in the meantime. The main CA responsible for activities within the scope of the audit is the SPA, which reports to the MA. Two sections of the SPA are of relevance to this audit: the PPPS and the RSS. The main responsibilities of the PPPS Central Office cover: 4

10 Co-ordination Division: the authorisation of PPPs, co-ordination of the evaluation work, drafting authorisation reports, granting of authorisation certificates, keeping an electronic register of the PPPs authorised for placing on the market in the Czech Republic, granting permits for parallel trade of PPPs and additional administrative tasks; Risks and Efficacy Division: evaluation of dossiers for the purposes of PPP authorisation with regard to their biological efficacy, fate and behaviour and eco-toxicology and certification of testing stations under the Good Experimental Practice; Post-Registration Control Division (PRCD): providing methodological support to inspectors by drafting written instructions; planning of official controls on the marketing and use of PPPs, which also includes sampling of PPPs for the purposes of quality controls of pesticides; reporting of results from official controls; further investigation of non-compliant cases; undertaking enforcement measures at authorisation holders, imposing sanctions and / or fines where the irregularities found are related to the chemical composition of PPPs; collection of data on the sale and use of PPPs, keeping and up-dating of the list of certified testing stations approved for checks of application equipment; Formulation laboratory: quality controls of pesticides by formulation analysis. Within the scope of the audit, staff members from the RSS Central Office, through its Methodology and Management Unit, are involved in further investigation and imposing fines in cases where administrative measures have been proposed and launched by inspectors from the RDs. In addition, the RSS at central level is involved in drafting, co-ordinating and implementing annual training programmes for SPA s own staff. The RSS has seven RDs and 72 local offices throughout the country. The local offices are directly subordinated to the RDs. Each RD is further divided into two specialised Departments, one of which, the Department for Pesticide Application Equipment and Plant Protection Products (DPAEPPP), is directly relevant to this audit. This Department is responsible for the performance of official control on the marketing and use of PPPs by carrying out on-the-spot inspections at pesticide distributors and professional users. The FVO team was informed that no tasks are delegated to control bodies. Conclusions CAs within the scope of the audit have been designated and their responsibilities are clearly defined. There is no delegation of tasks in the meaning of Article 5 of Regulation (EC) No 882/ Resources for Performance Controls Legal Requirements Article 75(3) of Regulation (EC) No 1107/2009 requires MSs to ensure that CAs have a sufficient number of suitably qualified and experienced staff to carry out their obligations efficiently and effectively. Article 4 of Regulation (EC) No 882/2004 requires the CAs to ensure that they have access to a sufficient number of suitably qualified and experienced staff; and that they have appropriate and properly maintained facilities and equipment. Article 6 requires CAs to ensure that staff receive appropriate training, and are kept up-to-date in their competencies. 5

11 Findings There are 57 staff at the PPPS, including the Head of the PPPS and staff from all three Divisions listed under chapter Designation of Competent Authorities, 35 of which are dealing with expert evaluations for the authorisation of PPP. There are 24 experts at the National Institute for Public Health (NIPH) under the MH are involved in evaluations for the purposes of PPP authorisation. Their responsibilities related to the authorisation of PPPs are regulated by the Phytosanitary Act. A total of 22 staff are allocated to the PRCD, of whom ten staff members work for the formulation laboratory and nine perform inspection related activities. A total of 189 staff work at the RSS. For the control activities within the scope of the audit, a total staff of 54 inspectors are allocated to the seven DPAEPPPs at regional level. These are mainly involved in official controls on the marketing and use of PPPs. The RD Brno, visited by the audit team, covers two regions and 11 districts. In the second region visited, the RD Prague covers the Central Bohemia Region, the capital city of Prague and 13 districts. A background in either agriculture or plant health is required for all SPA staff. The newly appointed staff must undergo an initial training covering administrative procedures, legislation in place and official control related issues. Regular training is organised for SPA staff based on an annual training programme. Topics to be covered are identified based on assessment of training needs and proposals from staff members at central and regional level. Ad-hoc training sessions and meetings are also organised when considered necessary, e.g. in cases of new legislation entering into force and specific problems arising from or identified during the routine work. In addition, staff members may also attend appropriate external training sessions. SPA staff met during the audit confirmed their participation in training and this was supported by documentary evidence. Staff members met during the audit had an adequate background in the area of their competences and had all the necessary knowledge to perform their tasks. Conclusions Suitably qualified and experienced staff are available for the authorisation of PPPs and official controls on the marketing and use of PPPs, which is in line with the requirements of Article 75(3) of Regulation (EC) No 1107/2009 and Article 4 of Regulation (EC) No 882/2004. In accordance with Article 6 of Regulation (EC) No 882/2004, staff members receive appropriate training and are kept up-to-date in their competencies Authorisation of Plant Protection Products Legal Requirements Article 29 of Regulation (EC) No 1107/2009 requires that a PPP shall only be authorised if it complies with specified requirements. The required contents of the authorisation are specified in Article 31. Article 57 requires that an updated electronic register must be publicly available. Articles of Regulation (EC) No 1107/2009 lay down the requirements and procedures for mutual recognition of authorisations between MSs. Article 53 of the Regulation provides for the authorisation of PPPs for limited and controlled use in emergency situations. 6

12 Findings Authorisation of PPPs is the responsibility of the PPPS. Procedures, backed by a dedicated data base, are in place for the authorisation. Authorisation certificates are granted by SPA. The PPPS is also the CA in charge of keeping the electronic register of PPPs authorised for placing on the market and use in the Czech Republic. This register is publicly available and is up-dated on a daily basis, as required. In addition, an off-line version of the register is in place which could be used by SPA staff during inspections at pesticide distributors and professional users in case there is no Internet access. This off-line version is up-dated once a month. Up to 2011, the SPA issued a hard copy of the register annually. Currently, a paper version exists, which is printed each January by a private association using the on-line register as the main source of information. The electronic register provides detailed information on: the brand name; active substance contained; authorisation number; date of authorisation and expiry date; sell-out period; biological function; authorisation holder; authorised uses (crop/targeted pest combinations); pre-harvest intervals; risk- and safety-phrases; any existing risk mitigation; etc. It also has a search function to identify PPPs: per crop or group of crops; targeted pests; active substances contained; biological function; intended method of application (e.g. seed treatment); area of use (on plots in or close to surface waters). For PPPs authorised and / or re-registered after the entry into force of Regulation (EC) No 1107/2009, approved labels also appear as pdf-files in the register. The audit team checked several active substances (abamectin, nicosulfuron, dimethoate) authorised in the Czech Republic with regard to EU deadlines fixed for re-registration at MS level and found them compliant. Based on information in the electronic register, the audit team noted that there are PPPs still authorised for placing on the market containing the active substance flusilazole for which authorisations had to be withdrawn in April At the time of the audit, there were 22 such PPPs authorised in the Czech Republic containing this active substance. For ten PPPs, authorisations had already been withdrawn (for one, in April, two in June and seven in August). However, for the remaining twelve, which came from parallel trade, permits were still valid at the time of the audit. PPPS staff explained that, according to administrative procedures in place, withdrawal of parallel trade permits could only be launched once the authorisation of the reference PPP is withdrawn, which is not fully in line with EU requirements. At the time of the audit, there were 769 PPPs authorised for placing on the market and use in the country, of which 84 were for professional use and 675 for non-professional use. As at 13 June 2013, the authorised PPPs contained 264 approved active substances in total. In addition, 891 permits were issued for placing on the market of PPPs from parallel trade, of which 20 were authorised for professional use. In addition, there were 543 parallel trade permits for own use. Mutual recognition of authorisations generally follows EU requirements in terms of procedure and deadlines. From the entry into force of Regulation (EC) No 1107/2009 on 14 June 2011 until 13 June 2013, 40 applications were submitted for mutual recognition of authorisations mainly from neighbouring countries (Austria and Germany) and some from Poland, Hungary, the United Kingdom, the Netherlands and Belgium. Representatives of the PPPS explained that, in order to facilitate the evaluation, they usually require applicants to submit a full dossier so as to allow PPPS, if needed, to perform a full peer-review. It was explained that such a peer-review could lead to possible delays. One case of mutual recognition was demonstrated in which there was a delay of 20 days in granting the authorisation certificate. So far, there have been no rejections. In the same period, seven requests were submitted for the authorisation of PPPs to be used in 7

13 emergency situations under Article 53 of Regulation (EC) No 1107/2009. Six PPPs contained active substances approved in the EU. One PPP contained an active substance not approved in the EU (flocoumafen). However, it was approved under the Biocides Regulation and was authorised in the Czech Republic as a biocide. There were no cases of applications being rejected. Conclusions Procedures are in place for the authorisation of PPPs which comply with the requirements set out in the EU legislation with one exception: procedures for the withdrawal of parallel trade permits are not fully in line with the requirements of Article 52(6) of Regulation (EC) No 1107/ Controls on the Marketing of Plant Protection Products Legal Requirements Article 28 of Regulation (EC) No 1107/2009 lays down that a PPP shall not be placed on the market unless it has been authorised in the MS concerned. Article 29 of Regulation (EC) No 1107/2009 sets out the requirements for the authorisation for placing PPPs on the market. Article 5 of Directive 2009/128/EC requires MSs to ensure that all distributors of PPPs have access to appropriate training by bodies designated by the CAs. Certification systems have to be established by 26 November Article 6 of Directive 2009/128/EC lays down that, by 26 November 2015, the sale of PPPs to professional users shall be restricted to persons holding a certificate. Article 67(1) of Regulation (EC) No 1107/2009 requires that producers, suppliers, distributors, importers and exporters of PPPs shall keep records for at least 5 years. Article 68 requires MSs to carry out official controls in order to enforce compliance with this Regulation. Article 13 of Directive 2009/128/EC requires MSs to adopt the necessary measures to ensure that handling and storage of pesticides and handling, recovery or disposal of their packaging and remnants do not endanger human health or the environment. Findings Pesticide distributors in the Czech Republic are not registered. The information provided by the SPA on the number of pesticide distributors was stated to be only an estimate based on information gathered during inspections at growers on the basis of invoices and delivery notes from their suppliers and also based on inspections at PPP distributors with local knowledge in all seven regions. According to the information provided, the total number of distributors is about 970, as follows: 212 authorisation holders, who also operate as wholesalers and/or retailers, manufacturers and re-packaging facilities, and 758 premises for sale of PPPs, covering both retailers and wholesalers. According to data provided by both RDs visited, there are about 144 pesticide distributors in Brno Region and 136 (of which 23 wholesalers and 113 retailers) in Prague Region. An annual control programme is in place for official controls on the marketing and use of PPPs, which is drafted by the PRCD. With regard to controls on the marketing of PPPs, the programme only indicates the number of inspections per inspector for the relevant year; for 2013, this number 8

14 was fixed at four inspections per individual inspector. Premises to be visited are selected by the inspectors in the regions based mainly on the size of businesses, date of previous inspection, work load and previous history. No specific requirements are in place with regard to the frequency of official controls at pesticide distributors. According to data provided by the SPA, 347 inspections were performed in 2012 at 280 distributors (out of 970). Of those, 57 were follow-up inspections. In the same year, 42 inspections were carried out at pesticide retailers in Brno Region and 33 in Prague Region. Regarding the quality control of pesticides, the annual programme identifies the PPPs to be sampled, as well as the active substances contained and the authorisation holder. The audit team noted that PPPs from parallel imports are the main focus, as well as PPPs found to be noncomplaint in previous years. In 2012, 53 samples were taken for analysis and irregularities were identified in 11 cases. Planned inspections cover all relevant legal requirements, as detailed in the standard check-lists. In the case of follow-up inspections the scope is limited to the problems found during the planned inspections. Both planned and follow-inspections are performed with prior warning. Two routine inspections were observed by the audit team in both regions visited, one at a pesticide retailer and one at a wholesaler. As routine inspections at pesticide distributors might take from half a day up to three days (depending on the size of the premises and the range of PPPs in stock), the audit team could only partly observe both inspections. Reports from these inspections were provided to the audit team after they had been completed. Inspections are performed by either one or two inspectors, depending on the individual region s practice. Both inspections covered the same scope, including: documentary checks (professional qualification certificates, inventory list); checks on the storage facilities and display area, where applicable; all PPPs in stock at the time of inspection were checked for date of manufacturing, expiry date, authorisation number, batch number, labelling in Czech language; inspectors took notes and checked PPPs in stock against the inventory provided by the distributors; in the storage and display area only the basic conditions of storage were checked (floors, spillages, separate storage of PPPs per function, separate storage of expired and / or non-authorised PPPs). detailed labelling checks; these are usually performed on two or three randomly selected PPPs from among the more recently approved PPPs, where the entire content of the label is cross-checked against the electronic register of PPPs (either on-line at the time of the inspection or later in the office); an example of such a check was witnessed by the audit team and did not give rise to any particular comments. Record-keeping Legal requirements are in place for pesticide distributors to keep records on sales for a period of five years. These records include full details of PPPs delivered to clients, e.g. quantities, batch number, expiry date, certificates of clients professional qualifications, etc. Distributors visited by the audit team complied with this requirement. Training and Certification of Pesticide Distributors A system has been in place for training and certification of pesticide distributors and professional users since According to information provided by the CAs, the Phytosanitary Act, as last 9

15 amended by Act No 199/2012 and Decree No 206/2012 on the Professional Qualification for Handling of PPPs, fully transposed the requirements of Directive 2009/128/EC with regard to training and certification. Following the entry into force of the above-mentioned legislation, three grades of professional qualification have been introduced. Grade III certification is required for training providers, advisors and pesticide distributors. Grade II is a requirement for professional users of PPPs and Grade I certificates are granted to auxiliary staff who handle pesticides, under the supervision of Grade II or Grade III certification holders. It is also a legal requirement that at least one Grade III certification holder be available at pesticide distributors to provide advice at the time of purchase. In order to obtain a Grade II or Grade III certificate, which is issued by the RD of the RSS, applicants have to either undergo an initial training or to have an appropriate third level or postgraduate qualification in the area of plant protection. Grade I applicants must complete an initial training and certificates are issued by the training providers. All types of certificates are valid for a period of five years and renewal could be obtained only if additional training has been completed. Legal requirements are in place for certificates to be withdrawn when considered necessary. However, there have been no cases of withdrawals so far, according to the CAs. Training providers must be approved by the MA. In order to get approval, they must have one staff member holding at least a Grade III certificate and have proper facilities and equipment. The content of training courses is to be approved by RDs of the RSS, in co-operation with the MA. Training providers are subject to supervision. At the time of the audit, there were 55 training providers. The list of training providers, as well as information about forthcoming training sessions is to be found on eagri website. In accordance with the national legal requirements laid down in the Phytosanitary Act, as amended, distributors are obliged to sell PPPs for professional use only to entities ensuring that the products will be handled by Grade II or III certificate holders. At both pesticide distributors visited by the audit team, it was confirmed that PPPs for professional use are only sold to operators who have an adequate qualification. Evidence of such certification was seen by the audit team. Handling, storage and safe disposal of packaging and remnants of plant protection products Handling, storage, transport and disposal of empty packages and remnants of PPPs are the responsibility of the pesticide distributors and professional users, as appropriate. Separate storage facilities for used packaging, pending disposal, were observed by the audit team at the entities visited. The operators visited had measures in place to respect the legal requirements for handling, storage and safe disposal. For collection and safe disposal of pesticides, they used services provided by approved companies and corresponding documentary evidence was seen by the audit team. A list of approved companies is kept by the MA and it is publicly available. Formulation laboratory The formulation laboratory is the only official laboratory for quality control of PPPs in the Czech Republic. In the formulation laboratory, most of the samples analysed are official samples under the annual control programme. In addition, samples are analysed for the purposes of PPP authorisation. The scope of analysis of official samples covers the identity and content of active substances, relevant impurities and physical-chemical properties in order to check compliance with the Food and Agriculture Organisation (FAO) specifications. In the case of suspicion, the scope is extended. Moreover, based on information submitted with regard to the use of non-authorised PPPs, the analytical scope is extended in order to check the product concerned against the documentation provided in the pre-authorisation stage and to compare the composition of the PPP in order to prove that neither co-formulants nor relevant impurities are present, which had not been assessed with 10

16 regard to public health risks prior to granting the authorisation. In May 2008, the laboratory was accredited to ISO by the Czech Accreditation Institute and re-accredited in The current accreditation certificate is valid until 24 March The scope of accreditation covers 15 different methods and techniques for physical, chemical and technical testing of formulations and other PPPs. The laboratory regularly participates in Proficiency Tests for active substance of PPPs and relevant impurities organized by the Association of American Pesticide Control Officials and for physical-chemical properties of PPPs and active substances organised by the Federal Agency for the Safety of the Food Chain in Belgium. In addition, the formulation laboratory takes part in international collaborative tests organized by the Collaborative International Pesticides Analytical Council (CIPAC) and the English Speaking Pesticide Advisory Council. Analytical methods used in the laboratory are either accredited or validated and they are usually methods listed in FAO Specifications, in accordance with operational procedures described in the CIPAC Handbooks 1A-N, or methods of manufacturers, which are submitted as part of dossiers for the purposes of authorisation. The audit team visited the laboratory and noted that the premises, equipment and qualified staff allow for physical-chemical properties, active substances, relevant impurities and co-formulants to be analysed. Information was provided by the CAs where illegal pesticides were identified as result of quality controls under the national control programme. Documentary evidence was provided for some joint actions undertaken in co-operation with Customs authorities. In these cases, communication also took place between Czech CAs and CAs of other MSs. However, these were individual cases where efforts were made to identify counterfeit or illegal pesticides. There is neither a systematic approach nor a strategy in place to address these issues by more targeted controls or further in-depth investigation following individual irregularities identified. Conclusions A system for training and certification of pesticide distributors is in place, as required by Article 5 of Directive 2009/128/EC. Pesticide distributors are required to keep records on sales for a period of 5 years, as laid down in Article 67 of Regulation (EC) No 1107/2009. Although a system is in place for official controls on the marketing of PPPs, the lack of register of pesticide distributors does not ensure that all wholesalers and retailers are subject to official controls under Article 68 of Regulation (EC) No 1107/2009. Therefore, sufficient guarantees could not be provided that all PPPs placed on the market in the Czech Republic fully comply with the requirements of Article 28 of Regulation (EC) No 1107/2009. The current frequency of controls and risk criteria applied in the planning stage may exclude some distributors from official controls. A better use of existing laboratory capacity and an adequate frequency of controls at pesticide distributors could increase the possibility for illegal and counterfeit pesticides to be detected. Measures were applied by the pesticide distributors visited for handling, storage, transportation and safe disposal of packaging and remnants of PPPs, as required by Article 13 of Directive 2009/128/EC. 11

17 5.2.5 Controls on the Use of Plant Protection Products Legal Requirements Article 4(1) of Regulation (EC) No 852/2004, and Annex I, Part A.III of the same Regulation, require that food business operators (FBOs) producing or harvesting plant products are to keep records on any use of PPPs. Article 55 of Regulation (EC) No 1107/2009 requires that the use of PPPs shall comply with the general principles of Integrated Pest Management (IPM), as referred to in Article 14 of Annex III to Directive 2009/128/EC, which shall apply at the latest by 1 January Article 14(5) of the Directive specifies that MSs shall establish appropriate incentives to encourage professional users to implement crop or sector-specific guidelines for IPM on a voluntary basis. Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users keep, for at least 3 years, records of the PPPs they use. Article 55 specifies that PPPs shall be used, inter alia, in compliance with the authorised conditions specified on the labels. Article 68 of Regulation (EC) No 1107/2009 requires MSs to carry out official controls in order to enforce compliance with this Regulation. Article 5 of Directive 2009/128/EC requires MSs to ensure that all professional users have access to appropriate training by bodies designated by the CAs. Certification systems have to be established by 26 November Article 8 of Directive 2009/128/EC requires MSs to ensure that pesticide application equipment in professional use is subject to inspections at regular intervals. By 26 November 2016, all equipment shall have been inspected at least once. Article 13 of Directive 2009/128/EC requires MSs to adopt the necessary measure to ensure that handling and storage of pesticides and handling, recovery or disposal of their packaging and remnants do not endanger human health or the environment. Article 8(5) of Directive 2009/128/EC requires professional users to conduct regular calibrations and technical checks of the pesticide application equipment. Findings Official controls on the use of PPPs are performed in accordance with the annual national control programme mentioned under Chapter Controls on the marketing of Plant Protection Products. There are four types of inspections, as follows: cross-compliance, delegated, national and other controls (cases of complaints, suspicion, reported spray drifts, or bee mortality, etc.). Since 2009, the SPA has been designated as the CA in charge of monitoring the cross-compliance checks, in particular, aspects related the use of PPPs, at growers receiving subsidies under agri-environmental measures. Since 2011, the SPA has been the CA in charge of cross-compliance checks at growers, applying for direct payments. At the same time, the SPA was delegated to perform inspections on behalf of the State Agricultural Intervention Fund at growers who receive subsidies under the Rural Development Fund (integrated production of fruit, wine grapes and vegetables) and special aid (potatoes for the production of starch and hops). For the purposes of cross-compliance checks, the SPA prepares the list of growers to be inspected based on risk analysis. With regard to delegated controls, the State Agricultural Intervention Fund provides the list of operators. This information is then entered into the SPA electronic database during the year, indicating growers to be visited and the date of inspection. Based on the location of the premises/plots, an automatic is generated a few days before the inspections and it is sent 12

18 to the head of the relevant RD, who further allocates these specific inspections to individual inspectors. For national controls, individual growers to be visited are indicated by the PRCD for each individual region. Usually, operators to be inspected are chosen among those who are entitled to either direct payments or subsidies under agri-environmental measures. In these cases, scheduling of inspections is up to the regional inspectors, based on the work load, the size of businesses to be inspected, etc. There are some differences between these types of controls with regard to aspects to be covered. However, aspects related to the application of PPPs are common to all and cover the following: documentary checks (certificates for professional qualification, certificates for check of application equipment, records on the application of PPPs, inventory lists and invoices/delivery notes for PPPs); storage facilities (PPPs in stock and general conditions of storage, covering the same issues as described in the Chapter Controls on the marketing of Plant Protection Products); and application equipment (stickers of the approved testing stations, visual check of general condition, nozzles, visible leakages, and cross-check against additional information from the certificates such as the unique manufacturing number of the equipment). Compliance with any restrictions and specific provisions with regard to PPP application in water protection areas are also checked. For this purpose, SPA inspectors use data available in the national Land Parcel Identification System (LPIS), to which they have direct access. LPIS data are also used for cross-check of records on the application of PPPs. With regard to checks of records on the application of PPPs, different time periods are covered as follows: the current year in the case of cross-compliance; three years for national controls; and the entire period for which the subsidies are allocated in the case of delegated controls. Both planned and follow-up inspections at professional users are always announced at least 48 hours in advance, the only exception being where controls are performed following a complaint, suspicion or special request by the central CA. According to the requirements laid down in Act No 552/1991 on State Controls, all types of inspections performed by CAs in the Czech Republic are to be announced at least 48 hours in advance, unless there is urgency or potential danger to the health of humans, animals, plants or the environment. However, in all cases demonstrated in one of the regions visited, inspections were announced five to ten days in advance. A national register of all growers is not maintained and no reliable information is available on the total number of growers in the Czech Republic. According to data in the annual national control programmes for 2012 and 2013, the total number of growers registered with the relevant paying agencies is , but this excludes growers who may not be in receipt of subsidies. In 2012, inspections were performed at operators, as follows: national controls (890 of which were planned controls), 418 cross-compliance controls and 645 delegated controls. Two inspections at growers were observed by the audit team. The operator visited in the Brno Region, had 171,5 ha of orchards (apples, peaches, nectarines, plums and apricots), 9 ha of vineyards and ha of field crops (wheat, maize, barley, peas and oilseed rape). The second operator visited in the Prague Region was a vegetable grower who had total plots of 300 ha, 190 ha of which were allocated for vegetables (early potatoes, cabbage, carrots, and other leafy vegetables) and the rest for field crops grown for the purposes of crop rotation. Both growers visited hold Grade II certificates and were certified under private schemes. They had a system in place for own controls of pesticide residues and analyses were performed in accredited laboratories. The operators 13

19 stated that regular calibrations and technical checks of the pesticide application equipment are performed on an annual basis, before the start of the growing season. In both regions, inspections were performed following a uniform approach and covering the scope described above. Record-keeping Legal requirements are in place for professional users to keep records on the application of PPPs for a period of three years. The national legislation in place, in particular Section 9a of Decree No 32/2012, lays down the requirements on the minimum information to be recorded, as follows: identification and size of the plot (for all individual parcels, in accordance with the LPIS); trade name of the PPP; crop; targeted pest; application rate; area treated in ha and date of application. Both growers visited kept records in accordance with the national legal requirements and their records also contained additional data on the application, such as: method of application; the unique number of the application equipment; total quantity of PPP(s) used; water quantity; plant variety; staff member who performed the application. IPM According to provisions laid down in Decree No 205/2012, professional users are obliged to apply the general IPM principles as from 1 January IPM Guidelines have been developed by SPA for the main groups of crops, including orchards, vineyards and field crops. These are in the final stage of approval and they will be published soon on the SPA web-site. CAs stated that they plan to develop further crop specific IPM guidelines from They also plan to provide additional training to professional users on IPM related issues. Both growers visited were IPM registered. Evidence was provided during the visits on the application of alternative, non-chemical methods and application of PPPs based on data from pest monitoring. Training and Certification of Professional Users Professional users have access to training and a system was introduced for training and certification in The Phytosanitary Act, as last amended by Act No 199/2012, and Decree No 206/2012 require for a Grade II certificate to be held by professional users. Grade I certificates are a requirement for auxiliary staff who apply pesticides, under the supervision of Grade II or Grade III certification holders. One Grade II certification holder at least should be available at professional users. More details with regard to training and certification are to be found under Chapter Controls on the marketing of Plant Protection Products. Application Equipment Legal requirements for the control of application equipment have been in place since 1997 in the Czech Republic. Currently, the legal requirements to be complied with are stipulated in Decree No 207/2012, under which a regular check of machinery is to be carried out every five years. Technical checks are to be performed by testing stations approved by the SPA. At the time of the audit, the CA confirmed that there were 49 testing stations and a list of these is to be found on the SPA web-site. Handling, storage and safe disposal of packaging and remnants of plant protection products Handling, storage, transport and disposal of empty packages and remnants of PPPs are described in more detail in Chapter Controls on the marketing of Plant Protection Products. 14

20 Conclusions Requirements are in place for growers to keep records on the application of PPPs for a period of three years as provided for in Article 4(1) of Regulation (EC) No 852/2004 and Article 67 of Regulation (EC) No 1107/2009. Evidence of record keeping was seen at the growers visited during the audit. Legal requirements are in place for professional users to apply general IPM principles as from 1 January 2014, which is in compliance with the EU requirements and deadlines fixed in Article 55 of Regulation (EC) No 1107/2009, as referred to in Article 14 of Annex III to Directive 2009/128/EC. A system is in place for official controls on the use of PPP which is in accordance with Article 68 of Regulation (EC) No 1107/2009 and comprehensive inspections take place at growers covering all relevant issues with regard to the use of PPPs. A system for training and certification of professional users is in place, which is in line with Article 5 of Directive 2009/128/EC. Measures are taken at professional users for handling, storage and safe disposal of packaging and remnants of PPPs and for regular calibrations and technical checks of the pesticide application equipment, as laid down in Article 13 and Article 8(5) of Directive 2009/128/EC. Inspections at growers are limited to growers who receive subsidies, which does not provide sufficient guarantees that PPPs are used in compliance with the conditions of use specified on the labels, as required by Article 55 of Regulation (EC) No 1107/2009, given, in particular, that there are other non-identified users. Inspections at professional users are performed with prior warning, which is not in line with the provisions laid down in Article 3(2) of Regulation (EC) No 882/ Prioritisation of Official Controls Legal Requirements Article 3 of Regulation (EC) No 882/2004 requires that official controls are carried out regularly, on a risk basis and with appropriate frequency, taking account of (a) identified risks; (b) the FBOs past record as regards compliance; (c) the reliability of any own checks that have already been carried out; and (d) any information that might indicate non-compliance. Findings Planning of official controls within the scope of the audit is within the responsibilities of the PRCD. With regard to inspections at professional users, in particular, these are planned on the basis of data provided by the relevant paying agencies. Inspections at growers are risk based and individual growers / agricultural businesses to be inspected are selected taking into account information available on the total number of growers registered for receiving EU subsidies, as well as information on water protection zones on the territory of the operators, previous non-compliances and dates of previous inspections. The general rule for cross-compliance controls is to cover 1 % of the total number of growers entitled to subsidies. Based on this risk analysis, lists of operators to be visited are prepared indicating the individual growers to be visited by each one of the RSS RDs. 15