EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

SPAIN

FROM 06 TO 13 MARCH 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.

DG(SANCO) 2013-6637 - MR FINAL

Ref. Ares(2013)2554557 - 02/07/2013

Executive SummaryThis report describes the outcome of a Food and Veterinary Office (FVO) audit in Spain, carried out between 6 to 13 March 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, and to follow-up on actions taken to address a number of recommendations from the previous audit in 2007.

An adequate and effective control system is in place for the marketing and use of plant protection products. Co-ordinated control plans, documented procedures, communication between authorities, training of staff and proportionate enforcement measures are in place. There is adequate co-operation to control illegal or counterfeit pesticides. The implementation of Directive 2009/128/EC on sustainable use of pesticides strengthens the controls. However, due to substantial delays in the review process, a high number of plant protection products on the market have not been authorised in accordance with the Uniform Principles specified in EU legislation. Despite the large number of pesticide residues investigated throughout the country, the pesticide residue controls are not sufficiently effective due to the limited analytical scope in the majority of the laboratories analysing official control samples, and as a consequence of the poor distribution and co-ordination of available resources across a large number of residue laboratories.The recommendations of the previous report regarding controls on the marketing and use of plant protection products have been adequately addressed, but the actions regarding residue laboratories have been insufficient. 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.

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Table of Contents 1 INTRODUCTION ........................................................................................................................1 2 OBJECTIVES AND SCOPE ...........................................................................................................1 3 LEGAL BASIS AND STANDARDS ..................................................................................................2

3.1 LEGAL BASIS ................................................................................................................................2 3.2 STANDARDS .................................................................................................................................2

4 BACKGROUND ..........................................................................................................................2 4.1 AUDIT SERIES ...........................................................................................................................2 4.2 COUNTRY PROFILE .........................................................................................................................3

5 FINDINGS AND CONCLUSIONS ...................................................................................................3 5.1 RELEVANT NATIONAL LEGISLATION ..................................................................................................3 5.2 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS ...........................................................4

5.2.1 DESIGNATION OF COMPETENT AUTHORITIES ................................................................................4 5.2.2 RESOURCES FOR PERFORMING CONTROLS ...................................................................................4 5.2.3 AUTHORISATION OF PLANT PROTECTION PRODUCTS ......................................................................5 5.2.4 CONTROLS ON THE MARKETING OF PLANT PROTECTION PRODUCTS .................................................6 5.2.5 CONTROLS ON THE USE OF PLANT PROTECTION PRODUCTS ...........................................................8 5.2.6 CONTROL PROGRAMMES FOR PESTICIDE RESIDUES .....................................................................10 5.2.7 PRIORITISATION OF OFFICIAL CONTROLS ...................................................................................11 5.2.8 PROCEDURES FOR PERFORMANCE AND REPORTING OF CONTROL ACTIVITIES ....................................12 5.2.9 CO-ORDINATION AND CO-OPERATION BETWEEN AND WITHIN COMPETENT AUTHORITIES ........................13 5.2.10 ENFORCEMENT MEASURES ...................................................................................................13

6 OVERALL CONCLUSION ..........................................................................................................14 7 CLOSING MEETING ................................................................................................................14 8 RECOMMENDATIONS ...............................................................................................................15ANNEX 1 - LEGAL REFERENCES .................................................................................................16ANNEX 2 – STANDARDS QUOTED IN THE REPORT ..........................................................................18

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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

AC Autonomous Community

AESAN Spanish Agency for Food Safety and Nutrition (Agencia Española de Seguridad Alimentaria y Nutrición)

CA(s) Competent Authority(ies)

CAG-AC Ministry of Agriculture (Consejería de Agricultura) of the Autonomous Community

CCA(s) Central Competent Authority(ies)

CIPAC Collaborative International Pesticides Analytical Council

CS-AC Ministry of Health (Consejería de Sanidad) of the Autonomous Community

DG (SANCO) Health and Consumers Directorate-General

EC European Community

ENAC Spanish Accreditation Body (Entidad Nacional de Acreditación)

EU European Union

FAO Food and Agriculture Organisation of the United Nations

FVO Food and Veterinary Office

GAP Good Agricultural Practice

GC-FID Gas Chromatograph coupled to Flame Ionisation Detector

GC-MS(/MS) Gas Chromatograph coupled to (Tandem) Mass Spectrometer

IPM Integrated Pest Management

III

ISO International Organisation for Standardisation

LC-DAD Liquid Chromatography coupled to Diode Array Detector

LC-MS(/MS) Liquid Chromatograph coupled to (Tandem) Mass Spectrometer

MAGRAMA Ministry of Agriculture, Food and the Environment (Ministerio de Agricultura, Alimentación y Medio Ambiente)

MRL Maximum Residue Level

MSSSI Ministry for Health, Social Services and Equality (Ministerio de Sanidad, Servicios Sociales e Igualdad)

MS(s) Member State(s)

NAP National Action Plan

NRL National Reference Laboratory

PPP(s) Plant Protection Product(s)

PT Proficiency Test

RD Royal Decree

SEPRONA Environmental Protection Service (Servicio de Protección de la Naturaleza)

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1 INTRODUCTION

The audit formed part of the Food and Veterinary Office's (FVO) planned programme.

The audit took place from 6 to 13 March 2013. The team comprised two auditors from the FVO and one expert from a European Union (EU) Member State (MS).

Representatives from the central competent authority (CCA) accompanied the FVO team for the duration of the audit. An opening meeting was held on 6 March 2013 with the CCAs, the Ministry of Agriculture, Food and the Environment (MAGRAMA), the Ministry of Health, Social Services and Equality (MSSSI) and the Spanish Agency for Food Safety and Nutrition (AESAN). 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 of the use of PPPs at growers under Regulation (EC) No 882/2004;

• to follow-up recommendations of report Health and Consumers Directorate-General DG(SANCO)/2007-7179 of 2007, and to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the report have been implemented and enforced by the CA.

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, controls of the growers, and follow-up of recommendations regarding the laboratories for pesticide residues.

In pursuit of these objectives, the following sites were visited:

Table 1: Mission visits and meetings

Visits/meetings No. Comments

Competent Authorities

Central

Regional

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3

MAGRAMA, MSSSI and AESAN

Ministries of Agriculture (CAG-AC), and Health (CS-AC) of the Autonomous Communities (ACs)

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Environmental Protection Service (SEPRONA)

Laboratories

Public 2 Agri-Food Reference Laboratory (Laboratorio Arbitral Agroalimentario) (performs formulation analysis) and Almería laboratory of the CS-AC (performs pesticide residue analysis)

On-Site-Visits

Controls of growers

Controls of retailers of PPPs

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2

Visits to a tomato grower in Almería province of the Andalusia AC and to a pepper grower in the Murcia AC

Visits to retailers of PPPs in Almería and Murcia

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 1.

3.2 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 Member States (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 marketing and use of PPPs and pesticide residues. The general overview reports of the former audit series can be found on the DG(SANCO) internet site:

http://ec.europa.eu/food/fvo/specialreports/index_en.htm

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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, and deficiencies in the planning and conducting of inspections for control on the marketing and use of PPPs were frequently identified.

The planning and reporting of controls for pesticide residues in food of plant origin has improved significantly since the first audit series. 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 related to the lack of adequate equipment and implementation of quality control procedures.

The CAs of the MS subject to audit outlined in action plans how the recommendations would be addressed. These action plans are also published on the DG(SANCO) internet site together with the reports.

In the framework of the last series, the FVO carried out a audit to Spain in 2007. The report DG(SANCO)/2007-7179 of this audit can be found at http://ec.europa.eu/food/fvo/ir_search_en.cfm. The overall conclusion of the audit report was that the control system in place for pesticide residues in foodstuffs of plant origin was developing but further progress was required, particularly in the areas of co-ordination, co-operation and performance of controls, the communication of results, assessment of consumer risk and in the laboratories.

4.2 COUNTRY PROFILE

The FVO has published a country profile for Spain, 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 mission reports The country profile can be found at:

http://ec.europa.eu/food/fvo/country_profiles_en.cfm

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.

FindingsRegulation (EC) No 1107/2009 is applicable without transposition. A “standardised written work procedure for processing the registration dossiers requested under mutual recognition pursuant to Article 40 of Regulation (EC) No 1107/2009” has been drafted. As regards the zonal evaluation of PPPs, the CA stated that the administrative procedure followed is in line with Articles 28 to 39 of Regulation (EC) No 1107/2009.

Directive 2009/128/EC was transposed into Spanish legislation by Royal Decree (RD) 1311/2012 of 14 September 2012 establishing the framework for action to achieve the sustainable use of PPPs.

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The framework of inspection and calibration of pesticide application equipment is established by RD 1702/2011. Both the Directive and RD 1311/2012 require MSs to adopt a National Action Plan (NAP). The Spanish NAP was adopted on 11 December 2012 in the Sectoral Conference for Agriculture and Rural Development and notified to the European Commission on 14 December 2012.

ConclusionsAdequate legislation to enforce controls within the scope of the audit is in place.

5.2 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS

5.2.1 Designation of Competent Authorities

Legal RequirementsArticles 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.

FindingsThe CAs stated that there have been no substantial changes since the last update of the country profile (see section 4.2).

ConclusionsThe CAs are designated as described in the country profile.

5.2.2 Resources for Performing Controls

Legal RequirementsArticle 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.

FindingsWithin the central CA, there are five experts working for the authorisation of PPPs. Assistance is provided by a further 20 experts under the control of a public enterprise. Two central CA staff coordinate the surveillance programmes for the marketing and use of PPPs, and 131 staff work at AC level.

Staff are trained by various authorised official training bodies. The inspectors met by the FVO team in Murcia had received comprehensive training on issues on plant health and pesticide controls in April 2010. This training course was organised by the regional training centre for the public administration. Inspectors of SEPRONA performing pesticide controls in Andalusia were trained in

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three courses during 2012 by the staff of the regional CAG-AC.

ConclusionsSuitably qualified staff were available and the staff met by the FVO team have received appropriate training.

5.2.3 Authorisation of Plant Protection Products

Legal RequirementsArticle 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 40 - 42 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.

FindingsOn 30 January 2013, there were 2 343 PPPs authorised, containing 338 active substances. The active substances are all included in Regulation (EC) No 540/2011. There has been a delay in the re-evaluation of PPPs in accordance with the Uniform Principles, as required in the Commission Directives approving the individual substances. MAGRAMA stated that at the time of the audit 1 493 PPPs were awaiting authorisation under these requirements. The audit team evaluated an authorisation file for a PPP containing phenmedipham. According to Commission Directive 2004/58/EC, evaluation and re-authorisation should have taken place by 28 February 2009, but the product was not re-authorised until 27 September 2012. Applications of PPPs containing the toxic (T) substance pirimicarb were recorded as treatments by the growers met. PPPs containing this substance were due for evaluation and re-authorisation on 31 January 2011 (Commission Directive 2006/39/EC). The CA stated that authorisations for 16 PPPs containing this active substance were withdrawn, and the one remaining product is currently being re-evaluated and the authorisation has been temporarily prolonged. Similarly, products containing the very toxic (T+) active substance oxamyl were due for re-evaluation by 30 July 2010 (Commission Directive 2006/16/EC), but the two products authorised continue being evaluated and marketed under temporary authorisations.

The MAGRAMA stated that since July 2012, an action plan with different measures is in place to reduce the backlog. A state-owned company is now involved in the assessment of applications. As a result, around 340 applications have been processed since July 2012.

An electronic register of authorised PPPs is available on the website of MAGRAMA. The CA stated that it is updated whenever changes are made:

http://www.magrama.gob.es/es/agricultura/temas/medios-de-produccion/productos-fitosanitarios/ fitos.asp

Until 7 March 2013, the CA has received 152 applications for mutual recognition, of which 33 have been approved. The remainder were at different stages of evaluation.

In 2011 there were 52 applications for emergency authorisation under Article 53 of Regulation (EC) No 1107/2009, 23 of which were granted. In 2012, there were 82 applications for emergency authorisation and 40 were granted. The CA stated that some of these authorisations related to the extension of authorised uses to minor crops. The authorisations also included active substances, which are not approved in the EU, as specified under Regulation (EC) No 540/2011. In the case of 1,3- dichloropropene, the emergency authorisation was granted both in 2011 and 2012. However,

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the CA stated that repeated applications are usually a criterion for non-approval. A PPP containing the non-approved substance dichlorvos was authorised for use in traps, which was stated to be a requirement from the USA authorities for the export of citrus.

The audit team checked labels of PPPs at the retailers for PPPs visited, and no discrepancies with the requirements of Regulation (EC) No 547/2011 were found.

ConclusionsThe delay of re-authorising PPPs in accordance with the Uniform Principles means that a high number of PPPs on the market are not authorised in accordance with the requirements specified in EU legislation. Although measures have been taken to speed-up the evaluation, it will take several years to process the pending applications. Procedures for mutual recognition and for emergency authorisation are in place and follow the requirements of Regulation (EC) No 1107/2009.

The labels of PPPs checked by the audit team followed the requirements of Regulation (EC) No 547/2011.

5.2.4 Controls on the Marketing of Plant Protection Products

Legal RequirementsArticle 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 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 2013.

Article 6 of Directive 2009/128/EC lays down that, by 26 November 2015, the sales 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 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.

FindingsAccording to data from MAGRAMA, there are 122 manufacturers, 2 377 distributors and 3 628 sellers of PPPs registered in Spain.

Official Controls are the responsibility of the ACs. The regional authorities differ between the ACs, but they are usually the Plant Health Services of the regional CAG-AC, and in some ACs, the regional CS-AC and SEPRONA are also involved.

Training and certification of distributors, retailers and re-packers of PPPs is a requirement of RD 1311/2012, and all ACs must have introduced these certification systems by 26 November 2015. Some ACs are already implementing this measure, including the regions of Andalusia and Murcia visited by the audit team.

The NAP under Directive 2009/128/EC lays down that all retailers, distributors and re-packers of PPPs must be inspected within five years. In Almería, the CA plan to annually inspect 20 % of

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registered retailers and distributors of PPPs, in accordance with the regional plan for Andalusia. The retailer visited for the demonstration of an inspection by the CA had last been controlled in 2003, and the CA explained that the frequency of inspections has been increased from 10 % to 20 % through the NAP.

Manufacturers of PPPs are included in the control plan, and the documented procedures seen in Murcia include the control of documented transactions, training and certification of staff, and sampling for formulation analysis.

The audit team witnessed inspections of two distributors in the Andalusia and Murcia regions. The inspections were performed by two staff, and unannounced. The inspectors checked the certification of the staff, the conditions of storage, and selected four to six PPPs for detailed label checks. For the label check, details of the authorisation were downloaded from the MAGRAMA website. The inspectors checked the transaction records and invoices. In Almería these were cross-checked against the available stocks of one selected PPP. Inspectors checked the documentation that toxic and very toxic products are only sold to producers holding certification. The inspectors also sample PPPs for formulation analyses. In Almería, no instructions were given on which products to sample, and the inspectors stated they would take random samples.

Targeted controls of illegal and counterfeit pesticides are performed in co-operation with SEPRONA, which form part of the Civil Guard (Guardia Civil), a military-status police force with comprehensive powers. The CAG-AC in Almería stated that they are in regular contact with manufacturers, and have followed up on suspected fraud.

According to the annual national report for 2011, which has been submitted to the European Commission, a total of 182 formulation samples were analysed in Spain, with 14 non-compliances regarding the concentration of the active substance. Analyses are carried out in five laboratories, and cover mostly the identity and content of the active substance. However, the audit team evaluated the documentation of a case in Andalusia, where the CA had received a complaint letter about the contamination of a PPP with another active substance. A screening analysis of the PPP confirmed the contamination of the product with two other active substances.

The Agri-Food Reference Laboratory (Laboratorio Arbitral Agroalimentario) visited by the audit team is responsible for pesticide formulation analyses, together with four laboratories in the ACs. There is bilateral communication between the laboratories on an informal basis. The laboratory stated that the Spanish reports submitted to the Collaborative International Pesticides Analytical Council (CIPAC) do not include data from all five laboratories.

The laboratory has adequate facilities, and was well organised, with good traceability of samples and excellent documentation of results, method validation and instrument records. The laboratory has four types of methods under accreditation by the Spanish accreditation body ENAC, with a flexible scope: liquid chromatography with diode array detector (LC-DAD), gas chromatography with flame ionisation detector (GC-FID), density by electronic densimetry, and determination of dithiocarbamates by iodometric titration. Further physical-chemical methods are performed when requested: suspensibility, pH, and wettability. Two trained analysts undertake the determination of the active ingredient content using CIPAC methods.

In 2011 the laboratory analysed 65 official samples of formulated products, and 80 samples in 2012. There was documented evidence for the validation of 160 active substances by LC-DAD, and 27 active substances by GC-FID. The laboratory participated in proficiency tests organised by three different organisations and achieved satisfactory results. The laboratory has also received “information samples” to conduct follow up investigations regarding complaints about composition of the formulated products on the market. The laboratory demonstrated the capability to carry out such investigations.

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The analytical reports did not include a statement on compliance nor reference to FAO specifications for pesticides. These are internationally agreed criteria for compliance. Instead of the FAO specification, the report specified the analytical uncertainty estimated by the Agri-Food Reference Laboratory as is required for accredited laboratories by standard EN ISO/IEC 17025. In one case observed by the audit team, this was misleading for the AC in Castilla-La Mancha, who took the decision on compliance.

ConclusionsComprehensive controls on the marketing of PPPs take place as laid down in Article 68 of Regulation (EC) No 1107/2009. The controls include checks on the requirements regarding training and certification of PPP distributors, handling and storage of PPPs and treatment of packages and remnants of PPPs, which are laid down in Articles 5 and 13 of Directive 2009/128/EC. The controls also include checks that records are kept by producers and distributors of PPPs, as laid down by Article 67(1) of Regulation (EC) No 1107/2009. Targeted controls are in place to combat illegal or counterfeit pesticides.

There is a sampling programme for formulation analysis, with adequate capabilities and knowledge in the laboratory visited. There were a few weaknesses regarding co-ordination of laboratories analysing formulations, and guidance for interpretation of results regarding compliance. No specific requirements for these points are laid down in EU legislation.

5.2.5 Controls on the Use of Plant Protection Products

Legal RequirementsArticle 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 2014. 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 2013.

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.

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FindingsA national register for operators and producers involved in plant protection is under development by MAGRAMA. It is planned that the register will include all operators making up the value chain for PPPs from the manufacturers to the professional users of such products. In future a national centralised electronic register of transactions in PPPs is to be launched.

National guidelines regarding integrated pest management of the main crops cultivated in Spain are under development by MAGRAMA. The CA in Andalusia and Murcia developed integrated production schemes for the main crops grown in the region. The CA stated that some 5 000 growers operate under this scheme in the Almeria province of Andalusia and 80-90% of farmers are certified by private schemes.

The framework of the training system of professional users of PPPs is established by RD 1311/2012 and is planned to be fully implemented by the end of 2013. It is also planned that the certification system for professional users is fully operational by 2015. In both regions visited, training sessions are organised for professional users registered by the official training service of the regional agricultural administration or by approved training providers. A training certificate is granted for a period of ten years in Andalusia, and five years in Murcia. The system is planned to be updated to ensure that users receive additional training as required by Article 5.1 of Directive 2009/128/EC.

The framework of inspection and calibration of pesticide application equipment is established by RD 1702/2011. In Andalusia and Murcia, pesticide application equipment must be registered. The system for calibration and inspection has not been implemented yet.

In Almería, there are some 13 000 growers producing greenhouse vegetables, mainly tomatoes, peppers and cucumbers. The average cultivated area is around two hectares. In Murcia, there are another 13 000 growers registered.

The national surveillance programme for use of PPPs is prepared annually by MAGRAMA, based on RD 1311/2012. The 2013 programme requires that 5-10% of companies providing services of PPP treatment and at least 1% of agricultural holdings are to be inspected. ACs prepare their own control plans, taking into account the national programme. They report their control results annually to MAGRAMA.

In the Autonomous Community of Andalusia, the Plant Health Plan is prepared annually by the CAG-AC, and includes controls of use of PPPs. The programme is implemented in collaboration with the SEPRONA. Annually, 10% of operators providing services of PPP treatment and the larger growers are inspected randomly. The CA indicated that 1-2 % of growers are inspected annually. Controls carried out in Andalusia by SEPRONA are targeted to the time of pesticide applications, and 23 samples were taken from the tank of the spraying equipment in 2012. Inspections by SEPRONA are unannounced. Controls also include samples taken for pesticide residues analysis before marketing, in order to check that the pesticide residues are in accordance with the authorised uses of the PPPs. A total of 915 samples were taken in Andalusia under the national programme, and another 708 samples under the regional plan. In Murcia, there were 183 and 215 inspections carried out on use of PPPs in 2011 and in 2012, respectively. A total of 188 and 195 samples were taken before marketing in 2011 and 2012.

The audit team observed an inspection of a tomato grower in Almería. He was a member of a cooperative and his produce was certified by a number of private schemes. The inspector checked the records of PPP usage, the grower’s licence to use PPPs and whether the grower has access to collection points to dispose of empty packaging of PPPs. In the pesticide store, the inspector checked whether the PPPs on stocks were authorised and also checked the availability of personal

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protective equipment. A sample of tomatoes was taken for residues analysis to check whether the farmer applies PPPs in accordance with the authorised use.

The audit team also observed an inspection at a greenhouse grower of sweet peppers in Murcia. The visit was announced in writing, seven days in advance. Article 3.2 of Regulation (EC) No 882/2004 requires that official controls shall be carried out without prior warning, except in cases where prior notification of the feed or food business operator is necessary. The inspection had the same scope as in Andalusia. In addition, the general condition of the pesticide application equipment was checked, and whether it is officially registered.

ConclusionsAn adequate control system is in place regarding the use of PPPs, in line with Article 68 of Regulation (EC) No 1107/2009. The notification of growers in Murcia seven days prior to inspections is not in line with Article 3.2 of Regulation (EC) No 882/2004. Substantial progress has been made to ensure that requirements of Directive 2009/18/EC are implemented before the deadlines laid down in the Directive.

5.2.6 Control Programmes for Pesticide Residues

Legal RequirementsArticle 12 of Regulation (EC) No 882/2004 requires that CAs only designate laboratories that operate and are assessed and accredited in accordance with standards EN ISO/IEC 17025 and EN ISO/IEC 17011. Article 28 of Regulation (EC) No 396/2005 lays down requirements for the methods of analysis and quality control procedures for pesticide residue analysis.

Guidance Document (SANCO/12495/2011) on Method Validation and Quality Control Procedures for pesticide residues analysis in food and feed was also taken into account for this audit.

FindingsIn the report from the previous FVO audit DG(SANCO)/2007-7179, recommendations were made to the CAs to ensure that all designated laboratories comply with Article 12 of Regulation (EC) No 882/2004, and to consider substantially increasing the range of validated analytical methods for detection of pesticide residues and metabolites being sought.The CA stated that a database was being developed to optimise resources of 12 pesticide residues laboratories within the responsibility of MSSSI. In addition, 19 laboratories in the agricultural service portfolio and nine private laboratories perform official pesticide residue analysis. Twenty one of the laboratories are equipped with LC-MS and GC-MS instruments. Very few of the laboratories conduct analysis using Single Residue Methods and not all of the laboratories participated in the EU PT (Proficiency Test) scheme, which is a requirement under Regulation (EC) No 396/2005. In 2011 only three of the laboratories (in addition to the National Reference Laboratory (NRL)) achieved an A rating, awarded to laboratories which successfully analysed 90% of the pesticides present in the proficiency test material. The NRLs provided evidence of regular meetings with the other laboratories in the network and the fact that issues with laboratory PT performance were discussed.

Information provided for a list of 23 of the laboratories that undertake analysis for official pesticide residues control showed that 20 were accredited, but typically with a restricted analytical scope which does not meet the requirements of Regulation (EC) No 1274/2011. The throughput of samples and scope of the methods varied across the laboratory network. In 2012 two laboratories analysed one sample whilst one laboratory located in Valencia analysed more than 600 for pesticide

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residues. With the exception of the laboratory in Valencia, the laboratories with the largest scope (greater than 200 pesticides), analysed low numbers of official control samples. According to the report drafted by the European Food Safety Agency for 2010, a total of 560 residues were sought in the different laboratories in Spain.

The Murcia CS-AC provided information for the two laboratories designated for pesticide residue control in the AC. One laboratory under the control of the CS-AC was accredited by ENAC, but not for pesticide residues analyses. In 2010 the laboratory analysed eight samples (cereals and baby foods) for pesticide residues. The second laboratory, of the CAG-AC, has a method scope of 355 pesticides, of which 208 were not accredited. The laboratory is equipped with LC-MS/MS, GC-MS/MS and LC-Time-of-flight MS. The laboratory is not able to analyse 34 of the pesticides required by Regulation (EC) No 1274/2011. In 2012 the laboratory analysed 22 official control samples only. The laboratories have contact with the NRL.

The audit team visited the Almería laboratory of the CS-AC. The laboratory had three trained analysts/technicians working on pesticide residues analyses, and was equipped with LC-MS/MS and GC-MS/MS. The instruments were adequate for the analytical requirements.

The samples are analysed using common Multi Residue Methods using GC-MS/MS and LC-MS/MS, but no Single Residue Methods (including dithiocarbamates) are undertaken.

All of the analyses are conducted in accordance with the EU “Sanco Method Validation and Quality Control Procedures for Pesticide Residue Analysis in Food and Feed” (Document N° SANCO/12495/2011). The laboratory is accredited (ENAC) for the analysis of approximately 95 pesticides by LC-MS/MS and approximately 90 pesticides by GC-MS/MS in a number of fruit and vegetables with high water content. Approximately 88 compounds required by Regulation (EC) No 1274/2011 are not included in the scope of the method. Similarly, 20 pesticides on sale at a local PPP retailer were also outside of the scope.

In 2011 the trained operator of the LC-MS/MS system retired, and the accreditation and analysis of official control samples was suspended. From 2011 – 2013, the staff were re-organised and trained, and the accreditation was re-instated by ENAC on 1 March 2013. The laboratory expected to analyse 140-150 official control samples during 2013. The laboratory staff have received invitations from the NRL, but did not attend the meeting in 2012.

ConclusionsA large number of laboratories have been designated for official analyses. Although the total number of pesticides sought in the different laboratories is high, the individual laboratories do not meet the analytical scope required by EU legislation and have not achieved full accreditation, as the resources are too dispersed for efficient and effective control.

The laboratory visited in Almería is well organised, with trained competent analysts, but has insufficient resources to increase the scope of the methods, which does not meet the requirements of EU legislation. Due to the limited resources of this laboratory a breakdown of equipment or the loss of a staff member mean that analyses are interrupted.

The three related recommendations of the previous report have been partially addressed.

5.2.7 Prioritisation of Official Controls

Legal RequirementsArticle 3(1) 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

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(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.

FindingsThe various programmes to check the marketing and use of PPPs are based on risk. The frequency of inspections takes into account previous non-compliances. In Andalusia there was a special programme to control the use of PPPs in the production of strawberries, olives and vegetables under cover, where non-compliances had been identified previously. In Murcia, a special control programme was performed targeted on the possible illegal use of ethephon in pepper. This action was instigated in response to the inclusion of ethephon notifications in the EU Rapid Alert System for Food and Feed, which was communicated through the CS-AC.

In Almería and Murcia there were a high number of growers of food certified to private Good Agricultural Practice (GAP) standards, and the large volumes of data from the private certification schemes were not evaluated and taken into account by the CA for the frequency of inspections, in contravention to Article 3(1)(c) of Regulation (EC) No 882/2004.

ConclusionsControls are carried out based on risk, and take into account the risk factors specified in Article 3(1) of Regulation (EC) No 882/2004, except Article 3(1)(c).

5.2.8 Procedures for Performance and Reporting of Control Activities

Legal RequirementsArticle 8 of Regulation (EC) No 882/2004 requires that CAs carry out their official controls in accordance with documented procedures, containing information and instructions for staff performing official controls.

Article 9 of the above Regulation requires CAs to draw up reports on the official controls carried out, including a description of the purpose of official controls, the methods applied, the results obtained and any action to be taken by the business operator concerned.

Article 68 of Regulation (EC) No 1107/2009 requires MSs to transmit to the Commission a report on the scope and the results of controls to enforce compliance with this Regulation within six months of the end of the year.

FindingsIn the report from the previous FVO audit DG(SANCO)/2007-7179, recommendations were made to the CAs to ensure the introduction of co-ordinated and comprehensive inspection and enforcement procedures for controlling the marketing and use of plant protection products.Report templates in the form of check-lists were available for all inspections on the marketing and use of pesticide witnessed by the audit team in Murcia and Andalusia. In addition, more details on how inspections were conducted could be taken from documented procedures. In Andalusia these documents had been finalised in respect of the controls conducted by SEPRONA and the remainder of the documented procedures had been drawn up and were awaiting approval. The procedures included the control items specified in the national surveillance programme. The national implementation of the provisions laid down in Directive 2009/128/EC has led to further co-ordinated and comprehensive procedures. The enforcement procedures evaluated by the audit team

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in Almería and Murcia were based on the provisions laid down in Act 30/1992 of 26 November 1992 and Act 43/2002 of 20 November 2002 (see section 5.2.10).

Reports are drawn up following all inspections. Annual national reports on controls on the marketing and use of PPPs have been sent to the European Commission, in line with Article 68 of Regulation (EC) No 1107/2009.

ConclusionsThe CAs have implemented documented procedures and provisions for reporting in line with EU legislation. The related recommendations of the previous report have been addressed.

5.2.9 Co-ordination and co-operation between and within Competent Authorities

Legal RequirementsArticle 4(3) of Regulation (EC) No 882/2004 provides for efficient and effective co-ordination between CAs.

Article 4(5) of Regulation (EC) No 882/2004 requires that, when, within a CA, more than one unit is competent to carry out official controls, efficient and effective co-ordination and co-operation shall be ensured between the different units.

FindingsA number of examples for adequate co-operation between and within competent authorities have been observed by the audit team. The regional authorities for Agriculture and SEPRONA in Murcia and Almería were co-operating intensively (see sections 5.2.4 and 5.2.5). The regional CAG-AC and CS-AC in Murcia co-operated in the follow-up of illegal uses of ethephon (see section 5.2.7). In Almería and Murcia, the CAG-ACs had regular communication with the authorities performing cross-compliance checks. The CAG-AC Murcia have also informed authorities of another region about non-compliances detected in produce from that region. However, in Murcia the audit team observed an inspection of a grower who had previously been inspected on integrated production by the regional service on Rural Development, with a similar scope. There was no exchange of information between the services, except in case of non-compliances.

ConclusionsThere was overall efficient and effective co-ordination and co-operation between and within competent authorities for controls on the marketing and use of PPPs.

5.2.10 Enforcement Measures

Legal RequirementsArticle 72 of Regulation (EC) No 1197/2009 states that MSs shall lay down the rules on penalties applicable to infringements and ensure that they are implemented. The penalties shall be effective, proportionate and dissuasive.

Article 54 of Regulation (EC) No 882/2004 requires a CA which identifies a non-compliance to take appropriate action to ensure that the operator remedies the situation.

Article 55 of Regulation (EC) No 882/2004 states that MSs shall lay down the rules on sanctions applicable to infringements of feed and food law and other EU provisions relating to the protection of animal health and welfare and shall take all measures necessary to ensure that they are

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implemented. The sanctions provided for must be effective, proportionate and dissuasive.

FindingsRegarding non-compliances for the authorisation of PPPs, the ACs or SEPRONA send inspection records to MAGRAMA, and where relevant authorisations have been revoked, after hearing the interested party, within a deadline of ten days, pursuant to Act 30/1992 of 26 November 1992 on the legal regime for the public administrative authorities and the common administrative procedure.

The penalty procedures for marketing and use of PPPs are implemented by the ACs, who have the authority to impose penalties, in accordance with Chapter II of Act 43/2002 of 20 November 2002 on plant health.

A sanction of Euro 300 – 3 000 was proposed for a contamination of a PPP with undeclared small concentrations of two other active substances. In addition, the authorisation of the PPP was withdrawn. The case was not concluded at the time of the audit. A sanction of Euro 500 was applied for an unauthorised use of an authorised PPP in cucumbers, and a sanction of Euro 300 was applied for the use of PPPs without a valid user certificate. In a case of a retailer selling authorised PPPs without certification, a fine of Euro 3 001 was applied and the business activity was prohibited.

ConclusionsIn case of non-compliance, the CAs have taken appropriate action to ensure that the operator remedies the situation. The sanctions provided for were effective, proportionate and dissuasive.

6 OVERALL CONCLUSION

An adequate and effective control system is in place for the marketing and use of PPPs. Co-ordinated control plans, documented procedures, communication between authorities, training of staff and proportionate enforcement measures are in place. There is adequate co-operation to control illegal or counterfeit pesticides. The implementation of Directive 2009/128/EC on sustainable use of pesticides strengthens the controls. However, due to substantial delays in the review process a high number of PPPs on the market have not been authorised in accordance with the Uniform Principles specified in EU legislation. Despite the large number of pesticide residues investigated throughout the country, the pesticide residue controls are not sufficiently effective due to the limited analytical scope in the majority of the laboratories analysing official control samples, and as a consequence of the poor distribution and co-ordination of available resources across a large number of residue laboratories.

The recommendations of the previous report regarding controls on the marketing and use of PPPs have been adequately addressed, but the actions regarding residue laboratories have been insufficient.

7 CLOSING MEETING

A closing meeting was held on 13 March 2013 with representatives of the central CAs. At this meeting, the FVO team presented the main findings and preliminary conclusions of the audit. The CAs provided initial comments and clarifications.

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8 RECOMMENDATIONS

The CAs are invited to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below, within twenty five working days of receipt of this audit report. The CA should:

N°. Recommendation

1. Ensure the re-evaluation and authorisation of PPPs containing approved active substances, in accordance with the Uniform Principles, and within the deadlines specified in the Commission Directives approving the individual substances (inter alia Commission Directive 2006/39/EC and Commission Directive 2006/16/EC).

2. Ensure that grower inspections in Murcia are unannounced, or that the prior notification is reduced in line with Article 3.2 of Regulation (EC) No 882/2004.

3. Improve the co-ordination of pesticide residue analyses, in order to ensure the effective use of laboratory resources, in line with Article 4.3 of Regulation (EC) No 882/2004.

4. Ensure that all designated laboratories comply with Article 12 of Regulation (EC) No 882/2004.

5. Increase the range of validated analytical methods for pesticide residues to cover the substances of EU Proficiency Tests and the EU control programme for pesticide residues under Article 29 of Regulation (EC) No 396/2005.

6. Ensure that the reliability of auto-controls is taken into account for official controls of growers, in line with Article 3(1)(c) of Regulation (EC) No 882/2004.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=2013-6637

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ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Horizontal Legislation

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Legislation on Plant Protection Products

Reg. 1107/2009 OJ L 309, 24.11.2009, p. 1-50

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

Dir. 2009/128/EC OJ L 309, 24.11.2009, p. 71-86

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides

Reg. 540/2011 OJ L 153, 11/06/2011, p.0001-0186

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

Reg. 547/2011 OJ L 155, 11/06/2011, p.0176-0205

Commission Regulation (EU) No 547/2011 of 08 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products

Legislation on Pesticide Residues

Reg. 396/2005 OJ L 70, 16.3.2005, p. 1-16

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

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Legal Reference Official Journal Title

Reg. 1274/2011 OJ L 325, 08/12/2011, p.0024-0043

Commission Implementing Regulation (EU) No 1274/2011 of 7 December 2011 concerning a coordinated multiannual control programme of the Union for 2012, 2013 and 2014 to ensure compliance with maximum residue levels of pesticide residues and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin

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ANNEX 2 – STANDARDS QUOTED IN THE REPORT

Reference number

Full title Publication details

SANCO/12495/2011

Method Validation and Quality Control Procedures for Pesticide Residues Analysis in Food and Feed

http://www.eurl-pesticides.eu/docs/public/tmplt_article.asp?CntID=727&LabID=100&Lang=EN

FAO Pesticide Storage and Stock Control Manual

http://www.fao.org/docrep/V8966E/V8966E00.htm

FAO Specifications for Pesticides http://www.fao.org/agriculture/crops/core-themes/theme/pests/jmps/en/