Specific Audit Report on the Controls in Germany of Pesticide Residues In

EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO)/2008-7852 - Final

GENERAL AUDIT

REPORT OF A SPECIFIC AUDIT CARRIED OUT IN GERMANY FROM 27/10/2008 TO 03/11/2008 IN ORDER TO EVALUATE THE CONTROLS OF PESTICIDE RESIDUES IN FOOD OF PLANT ORIGIN

PART B – SECTOR SPECIFIC ISSUES

Please note that factual errors in the draft report have been corrected. Clarifications provided by the Competent Authority are included in endnotes. TABLE OF CONTENTS

1. FINDINGS AND CONCLUSIONS ...... 5 1.1. LEGISLATION...... 5 1.2. CONTROLS FOR PESTICIDE RESIDUES ...... 5 1.2.1. National control programmes...... 5 1.2.2. Sampling ...... 7 1.2.3. Reporting ...... 8 1.2.4. Controls of pesticide residues in imported produce...... 9 1.3. CONTROLS OF ILLEGAL PESTICIDES ...... 10 1.4. LABORATORIES FOR PESTICIDE RESIDUE ANALYSIS ...... 11 1.5. RAPID ALERT SYSTEM FOR FOOD AND FEED...... 13 1.6. FOLLOW UP ON PREVIOUS MISSIONS ...... 14 2. RECOMMENDATIONS...... 15

ANNEX – LEGAL REFERENCES ...... 17

ANNEX – ENDNOTES ...... 19

2 Abbreviations and definitions used in this report

ADI Acceptable Daily Intake

ARfD Acute Reference Dose

AVV-RÜb General Administrative Provision on Framework Controls (Allgemeine Verwaltungsvorschrift Rahmen-Überwachung)

BfR Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung)

BIP Border Inspection Post

BMELV Federal Ministry for Food, Agriculture and Consumer Protection (Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz)

BVL Federal Agency for Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit)

CA Competent Authority ECD Electron Capture Detector EU European Union FIS-VL Consumer Protection and Food Safety Technical Information System (Fachinformationssystem Verbraucherschutz und Lebensmittelsicherheit) FBO Food Business Operator FNAO Food of Non – Animal Origin FPD Flame Photometric Detector FVO Food and Veterinary Office GC Gas Chromatograph GC-MS Gas Chromatograph – Mass Spectrometer GHP Good Hygiene Practice GMP Good Manufacturing Practice HACCP Hazard Analysis and Critical Control Points ISO International Organisation for Standardisation LAV Länder Working Group on Consumer Protection (Länderarbeitsgemeinschaft Verbraucherschutz)

LAV PQ Länder Working Group on Consumer Protection Expert Group Quality MQ Management LC Liquid Chromatograph LC-MS Liquid Chromatograph - Mass Spectrometer LC-TOF/MS Liquid Chromatograph Time-Of-Flight – Mass Spectrometer LFGB Food, Feed and Consumer Goods Code (Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch)

3 LHL Hessian Land Laboratory (Landesbetrieb Hessisches Landeslabor) LSGV Land Office for Health, Social Affairs and Consumer Protection (Saarland) (Landesamt für Gesundheit, Soziales und Verbraucherschutz) (SL) MANCP Multi-Annual National Control Plan

MJAGS Ministry of Justice, Labour, Health and Social Affairs (Ministerium für Justiz, Arbeit, Gesundheit und Soziales) - Saarland

MS Member State

MSD Mass Selective Detector

MRL Maximum Residue Level

NCP National Contact Point

NPD Nitrogen Phosphorous Detector

NRL National Reference Laboratory

PAH Polycyclic Aromatic Hydrocarbons

QMS Quality Management System RASFF Rapid Alert System for Food and Feed SOP Standard Operating Procedure TC Third Country TGSH Veterinary Border Inspection Post Hesse (Tierärztliche Grenzkontrollstelle Hessen) TLLV Thuringian Office for Food Safety and Consumer Protection (Thüringer Landesamt für Lebensmittelsicherheit und Verbraucherschutz) TMLNU Thuringian Ministry for Agriculture, Nature Conservation and Environment (Thüringer Ministerium für Landwirtschaft, Naturschutz und Umwelt) TMSFG Thuringian Ministry for Social Affairs, Family and Health (Thüringer Ministerium für Soziales, Familie und Gesundheit) UV-VIS Ultra Violet – Visible Spectroscopy

4 1. FINDINGS AND CONCLUSIONS

1.1. Legislation

The EC legislation within the scope of this mission is listed in the Annex.

Audit findings

The Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) is responsible for drafting legislation on food safety and transposing the EU legislation.

The mission team was informed that the legislation in the context of this mission at federal level is as follows:

¾ Regulation (EC) No 178/2002 is directly applicable; in addition requirements regarding sanctions for infringement are incorporated into the national legislation through the Food, Feed and Consumer Goods Code (LFGB) of September 2005.

¾ The provisions of Regulation (EC) No 882/2004 are directly applicable in Germany and have been adapted to the federal structure of Germany through the General Administrative Provision on Framework Controls (AVV-RÜb); legal powers of the competent authority (CA) to carry out official controls are additionally guaranteed by the provisions laid down in the LFGB.

¾ The AVV-RÜb, as last amended in June 2008, sets clear and detailed criteria on risk categorisation of food business operators (FBOs), inspection frequencies, as well as the general principles for official controls and the main requirements in respect to inspection performance and reporting.

¾ National legislation to implement Regulation (EC) No 852/2004 is in force.

¾ Regulation (EC) No 396/2005 is directly applicable in Germany. The Maximum Residue Levels Ordinance and the Feed Ordinance as last amended in August 2008 also apply in part, in particular as regards the provisions on penalties and fines.

¾ In addition, regulations and administrative instructions on official controls are in force in the two visited Länder – Thuringia and Saarland.

Conclusions

According to the information provided by the central CA, national legislation implementing the EC legislation in the context of this mission has been adopted. In addition, the two Länder visited by the mission team have specific legislation in this regard.

1.2. Controls for pesticide residues

1.2.1. National control programmes

Legal Basis

Article 26 of Regulation (EC) No 396/2005 requires Member States to carry out official controls on pesticide residues in order to enforce compliance with the Regulation. Article

5 27 requires Member States to take a sufficient number and range of samples to ensure that the results are representative of the market. Article 30 requires Member States to establish multi-annual control programmes for pesticide residues. It specifies the requirements of the control programme and requires Member States to participate in the Community control programme.

Audit findings

A multi-annual control programme for pesticide residues, as required by Article 30 of Regulation (EC) No 396/2005, has been drafted, but will only be in place from 2010.

In 2007, 4955 samples were taken for consumer basket monitoring; 1662 of them were from food of plant origin analysed for pesticide residues. Under project monitoring a further 1916 samples were taken in 2007, including 623 for pesticide residues in exotic fruits, green cabbage and table grapes. The total number of samples in 2007 reported by the German CA is around 17 000.

The manual on food monitoring for 2008 is aimed at assessing consumer exposure. The manual is very detailed and specifies the products to be sampled, minimum number of samples to be taken per Land, the analyses to be carried out and pesticides to be analysed. Additional instructions on sampling, sample preparation and methods of analysis to be used also form part of it. The coordinated Community monitoring programme for 2008 established by Recommendation (EC) No 2008/103 is taken into account and the designated official laboratories can analyse for most of the pesticides in the programme.

In accordance with the monitoring manual 4720 samples must be taken in 2008, as follows: 2810 under consumer basket monitoring and 2095 under project monitoring. The number of plant produce samples to be analysed for pesticide residues is 1355 for consumer basket monitoring and 180 for project monitoring. According to the monitoring manual for 2008, plants and plant products to be sampled for pesticide residues, include apple juice, pears, French beans, cucumbers, redcurrant, carrots, potatoes, mandarins, peppermint leaves (tea), rice, robust tea, spinach, gooseberries and onions. The number of analytes to be sought is around 130. The plant products and the analytes comply with the EU monitoring programme for 2008.

In the two Länder visited, official controls are mainly by inspection, sampling and analysis.

Sampling is performed in accordance with the annual and the quarterly sampling programmes established at Länder level.

In addition to sampling, premises (mainly big farms or storage facilities) are inspected in order to check the traceability and auto-control systems in place for pesticide residues. In Thuringia some 130 controls were performed in 2007. In Saarland the number of inspections was reported to be 10 – 15 for the period 2006 – 2008. The food inspectors there explained that this type of control is mainly performed as a follow-up when an MRL has been exceeded. The CA of the two Länder stressed that the number reported refers to cross-compliance checks. The CA in the two Länder also stated that further inspections are carried out as part of the general audits of FBOs when traceability and auto-control systems for pesticide residues are also checked.

6 Conclusions

A multi-annual national control programme for pesticide residues, as required by Article 30 of Regulation (EC) No 396/2005, is not in place.

Risk-based controls for pesticide residues in fresh fruits and vegetables are included in the manual on food monitoring drawn up by the BVL. The manual is aimed at assessing consumer exposure. It contains very detailed information as requested by Article 30 (1) of Regulation (EC) No 396/2005.

In addition, comprehensive annual and quarterly sampling programmes for pesticide residues are in place in both of the Länder visited Thuringia and Saarland.

The number of inspections to check the traceability and auto-control systems in place for pesticide residues is low.

1.2.2. Sampling

Legal Basis

Commission Directive 2002/63/EC establishes methods of sampling for the official control of pesticide residues.

Article 11(7) of Regulation (EC) No 882/2004 requires that samples must be handled and labelled in such a way as to guarantee their legal and analytical validity.

Audit findings

A framework SOP on sampling has been developed by the Länder Working Group on Consumer Protection Expert Group Quality Management (LAV PQ MQ) and is also available in the FIS - VL system. The CA in the Länder develop their own SOPs following the same structure. SOPs on sampling were available in the two Länder visited as well as in Hesse, where the Border Inspection Post (BIP) Frankfurt Airport is located. In addition SOPs on sampling have been developed at local level in all district offices of Thuringia, as required by the quality management system (QMS).

In the Land of Thuringia, Gotha district the mission team observed a sampling procedure for sweet peppers produced in Spain and supplied to the wholesaler whose premises were visited by the mission team. The sampling inspector had available during the inspection copies of the national legislation, the weekly sampling programme and the company file. The requirements laid down in the national legislation and the Thuringian Regulation on Official Controls were followed. The requirements for random sampling were adhered to by the sampling officer. The lot number was identified and the requirements on the weight and number of units required by legislation were fully complied with. The sample was correctly sealed. The CA explained that the sampling record is registered in the database first, and the sample is numbered then automatically by the system. In Gotha district the sample is normally delivered to the laboratory by the sampling officer on the same day. The CAs from the other districts usually deliver the samples by courier.

A general SOP on sampling has been developed as part of the QMS by the local authorities in Gotha. Specific requirements concerning the sampling of fresh fruit and vegetables are laid down in both the national and the Thuringian legislation and are annexed to the quarterly sampling reports, but they basically refer to the sample weight number of units required. 7 During the visit of the mission team to the laboratory in Bad Langensalza (Thuringia) the laboratory staff rejected a sample which did not meet the minimum requirements in respect of the number of units.

Sampling of okra imported from Ghana was demonstrated at the BIP – Frankfurt Airport. Two SOPs on sampling are available in the Hessian Land Laboratory (LHL): one on non- regulated food of plant origin and another on food of plant origin regulated by specific Commission Decisions or included in the "Draft Commission Regulation establishing a list of feed and food of non-animal origin that is, on the basis of known or emerging risk, to be subject to an increased level of official controls before to be imported into the Community as foreseen in Article 15(5) of Regulation (EC) No 882/2004". Commission Directive 2002/63/EC is listed in both of the SOPs as the main document to be followed for pesticide residues. The sampling inspector followed strictly the requirements set out in the SOP and, in Commission Directive 2002/63/EC respectively. A standard sampling record was filled in by the officer; the sample was correctly sealed and identified by a unique bar code. The sampling officer explained that for better traceability the same bar code is always attached to each of the four sampling records. The samples are usually taken to the LHL in Kassel on the same day. Sampling is also registered in the BALVI iP system.

Sampling records are drawn up in a standardised form in Thuringia, Saarland and at Frankfurt Airport. The original is handed to the owner of the sample, two copies accompany the sample to the laboratory, and another is left with the inspector.

Conclusions

SOPs on sampling are available in the two Länder visited and at the BIP Frankfurt Airport.

The sampling officers in Thuringia and at Frankfurt Airport follow the requirements set out in Commission Directive 2002/63/EC.

1.2.3. Reporting

Legal Basis

Article 30(3) of Regulation (EC) No 396/2005 requires Member States to publish, on an annual basis, all results of national residue monitoring on the Internet. Article 31 of the Regulation requires Member States to submit the results of official controls on pesticide residues to the Commission, the European Food Safety Authority, and the other Member States.

Audit findings

The results of official controls on pesticide residues are communicated by the Länder to BVL and then by BVL through the BMELV to the EU. The results are also published in the national annual reports and the reports produced by the Länder.

The laboratories visited comply with the SANCO Guidelines No 2007/3131 on method validation and quality control procedures for pesticide residues analysis in food and feed regarding measurement uncertainty. In deciding on non-compliance, the CA apply the default value of 50-% specified in the SANCO Guideline 2007/3131.

Conclusions 8 In line with Regulation (EC) No 396/2005, the results of official controls on pesticide residues are communicated by the Länder to BVL and then by BVL through BMELV to the EU

In deciding on non-compliance, the CA of Thuringia and Saarland apply the default value of 50-% as specified in the SANCO Guideline 2007/3131.

1.2.4. Controls of pesticide residues in imported produce

Legal Basis

Article 11 of Regulation (EC) No 178/2002 requires that food and feed imported into the Community shall comply with the relevant requirements of food law. Article 15 of Regulation (EC) No 882/2004 establishes that the CA shall carry out regular official controls on food and feed of non-animal origin imported into the EU. Article 16(3) of the Regulation requires Member States to ensure that the equipment and methodology are adequate for measuring the limit values laid down under Community or national legislation. Article 24 of the Regulation requires that the CA and the customs services shall cooperate closely for the organisation of the official controls.

Audit findings

The BIP at Frankfurt Airport was visited by the mission team, where a project on import controls for food of non-animal origin (FNAO) was launched in April 2007. The CA of Hesse stated that a detailed annual control programme is not in place, because it is not possible to foresee what commodities and what quantities will be imported during the year. The number of samples to be taken per year in Hesse as a whole is around 1000. In the period April-December 2007, a total of 514 samples were taken at the BIP and tested for pesticide residues. The number of samples for pesticide residues from 1 January to 28 October 2008 is 438, or 10 samples per week on average.

A well organised risk-based sampling is performed during the year, in particular for pesticide residues. Data on previous cases of non-compliances and RASFF notifications are taken into account. A list of risk commodities, countries and suppliers is drawn up for internal use by the sampling inspectors and is up-dated on an ongoing basis.

Food of plant origin is divided into three risk categories. Category 1 includes food of plant origin regulated by EC Decisions, and customs officials have to inform the staff of the Veterinary Border Inspection Post Hesse (TGSH) prior to customs clearance. Categories 2 and 3 include non-regulated food of plant origin, and prior warning by the customs is not required. Fresh fruit and vegetables are considered as category 3. For imports of plant produce, TGSH mainly rely on the import notifications which are submitted by the importers on a voluntary base prior to import. An official letter to importers was sent in August 2008 to provide them with information about the risk categorisation and the procedure on import controls for pesticide residues. The CA stated that after this letter was sent out the number of import notifications went down.

Following any case of non-compliance, the next consignment of the same type of goods, from the same country of origin and from the same supplier is sampled and may only be released when the laboratory report has been submitted and no MRL exceedances have been identified. The laboratory analysis must be performed in a laboratory accredited to

9 ISO 17025. This plant produce will be subject to an increased level of official controls until three consecutive negative results have been reported.

The number of MRL exceedances for 2007 (from April to December) was 53. RASFF notifications were created for 12 of them (22.6 % of non-compliances). In 2008 (from January to October) the number of non-compliant samples has been 58, of which 17 (29.2 % of samples exceeding MRL values) were notified through the RASFF.

The CA explained that if non-compliance is detected, the import must be rejected or the consignment must be destroyed in accordance with Article 19 of Regulation 882/2004.

The Hessian CA stated that they work in close and effective co-operation with the Customs Office.

Conclusions

The CA of Hesse carry out well organised and risk based regular official controls on food and feed of non-animal origin imported into the EU through the BIP at Frankfurt Airport, as required by Article 15 of Regulation (EC) No 882/2004.

Due to the fact that there is no legal obligation for the importers to submit an import notification for non-regulated food of plant origin, it is not possible for the CA to ensure a systematic sampling in accordance with the risk assessment.

Laboratory reports must be submitted for consignments considered to be a risk (included in the list) to be released. Laboratory reports are accepted by the CA only if analyses have been performed in a laboratory accredited to ISO 17025.

1.3. Controls of illegal pesticides

Legal Basis

Article 17 of Directive 91/414/EEC requires Member States to officially check the use of plant protection products to see whether they comply with the requirements of the Directive and in particular with the requirements of the authorisation and information on the label.

Audit findings

According to the provisions laid down in the Plant Protection Act (last amended in March 2008) non-authorized pesticides, which contain banned active substances1, have to be disposed of. Safe disposal procedures have to be accordance with the provisions of the Recycling and Waste Act. A national plant protection control programme is co-ordinated by BVL at central level, covering all Länder. Checks for non-authorized pesticides and non-authorized uses are performed as part of the official controls on marketing and use by the Thuringian Agricultural Institute (TLL) and the Agricultural Offices in Thuringia, and by the Plant Protection Service in Saarland. Targeted controls of illegal pesticides were performed on berry fruits in the period 2005 – 2006. In the period 2007 – 2009 these targeted inspections are focused on vegetables. Annual reports on the control activities and results are published on the websites of the CA involved. The number of inspections performed and the results are reported by the Länder to the BVL. This information is also included in the annual reports and published on the websites of BVL and the CA of the Länder. BVL is responsible for summarising the results and submitting the data to the EU. 10 In the event of infringements follow-up visits are performed and administrative measures, sanctions or fines are imposed.

In addition a bilateral agreement between the Thuringian Ministry for Social Affairs, Family and Health (TMSFG) and the Thuringian Ministry for Agriculture, Nature Conservation and Environment (TMLNU) has been signed for mutual information exchange and cooperation for the enforcement of the Plant Protection Act and monitoring of compliance with maximum residue levels for pesticides in or on foods.

Conclusions

A national plant protection control programme is in place. BVL is responsible for summarising the results and submitting the data to the other Member States (MSs) and the EU as laid down in Article 17 of Directive 91/414/EEC.

1.4. Laboratories for pesticide residue analysis

Legal Basis

Article 12 of Regulation (EC) No 882/2004 requires that competent authorities designate only laboratories that operate and are assessed and accredited in accordance with the standards EN ISO/IEC 17025, EN 45002 und EN 45003. Article 33 of the Regulation requires MS to designate National Reference Laboratories (NRL) for each Community reference laboratory, and specifies tasks for the NRL. Regulation (EC) No 2076/2005 allows competent authorities to designate a non accredited laboratory until the end of 2009, provided it has initiated and is pursuing the accreditation procedure and provides satisfactory guarantees that quality control schemes for the analyses it conducts for the purpose of official controls are in place.

Article 28 of Regulation (EC) No 396/2005 requires that the methods of analysis of pesticide residues shall comply with the criteria set out in the relevant provisions of Community law relating to official controls for food and feed, and that all laboratories analysing samples for the official controls on pesticide residues participate in the Community proficiency tests for pesticide residues organised by the Commission.

Audit findings

General overview According to information provided by the German CA there is a network of 23 laboratories designated as official laboratories for pesticide residue analysis of FNAO. All laboratories within the network are accredited to ISO 17025.

The BVL was designated as NRL for pesticide residues analysis in 2006. The laboratory is accredited for chemical analyses with open scope by the designated accreditation body (AKS) in accordance with ISO 17025. It is also the NRL for residues of veterinary drugs, heavy metals and PAHs. No pesticide residue analysis for FNAO had been carried out before designation as the NRL for pesticide residues. The NRL does not carry out routine analysis. Analysing routine samples for the official controls on pesticide residues is beyond the field of responsibility of the BVL laboratory.

The NRL for pesticide residues fulfils the tasks described in Article 33 (2) of Regulation (EC) No 882/2004. The establishment of scientific and technical expertise is in progress and the NRL cannot yet provide sufficient assistance to designated laboratories and CA2. Seventeen staff members are involved in the different NRLs, with some overlap of staff 11 responsibilities for the different tasks. Two staff members are specialised in pesticide residue analyses for FNAO.

In addition to the NRL within BVL the mission team also visited the designated laboratories for pesticide residue analyses in Bad Langensalza (Thuringia) and Saarbrücken (Saarland).

Analysis Good facilities are available in the NRL: the equipment comprises LC-MS/MS, LC- TOF, a GC-MS and a high resolution GC-MS.

Both laboratories visited in Thuringia and Saarland are equipped with qualified staff, good facilities in new buildings, LC-MS/MS, GC-MS/MS and GC-MSD. In addition three GCs with ECD, NPD and FPD detectors and a UV-VIS Photometer are available in Bad Langensalza (Thuringia). In both laboratories the method to be used for GC-MS/MS is currently being developed; in Bad Langensalza the GS-MSD is currently used only for confirmation purposes. In Saarland the available equipment (LC-MS/MS) is used not only for pesticide residues, but also for other applications such as veterinary drugs.

Quality control procedures The NRL has validated the ChemElut method (EN 15637) for LC-MS/MS with 31 pesticides. Validation of the QuEChERS method (EN 15662) for GC-MS is in progress. The NRL has participated in recent proficiency tests with a limited scope and mostly satisfactory results3.

The laboratories in Bad Langensalza and Saarbrücken use two multi-methods, the ChemElut for LC-MS/MS and the S 19 (EN 12393) for GC analyses. The maximum scope is around 240 active substances. In addition, a photometric method is in use for detecting dithiocarbamates, and a GC-ECD method for detecting bromides in Bad Langensalza. These methods were also used in Saarbrücken laboratory until 2006, but are not used anymore because of lack of staff. In 2007, some 400 samples were analysed for pesticide residues in Bad Langensalza and 275 in Saarbrücken.

In both official laboratories visited (in Thuringia and Saarland) validation of both multi- residue methods is in progress. The mission team noted that validation data are not complete for representative matrices and all analytes in the scope of the methods. For quality control during routine analysis the laboratories partially follow the SANCO Guidelines 2007/3131. Confirmation of all findings and re-extraction is done, when MRL exceedances have been identified. Both laboratories regularly participate in proficiency tests with mostly good results, and corrective action is taken where necessary.

Standardised forms are in place for the laboratory reports. The scientists 1.75 full-time equivalents in Bad Langensalza (Thuringia) and 0.8 in Saarbrücken.(Saarland) are responsible for drawing up the laboratory reports, with information about methods of analyses, a summary of positive quantified pesticides, the national legal basis on MRLs and a toxicological evaluation including an intake assessment. Non-detected pesticides are not stated in the report. All analyses are sent to the BVL and registered in the database FIS - VL.

In both Thuringia and Saarland laboratory reports are sent back to the food inspectors if an MRL exceedance has been found out. The sampling officers at Frankfurt Airport stated that they are always provided with copies of the laboratory reports. The CA in the two Länder stated that the time from the sample reception to the delivery of the

12 analytical results varies between 3 and 4 weeks. In cases of suspicion or complaints this period may be reduced to 1 week. However, the documented cases of non-compliance submitted to the mission team by the CA of Thuringia and Saarland demonstrate a delay in the submission of the laboratory report, of one and around two months respectively for the two reported cases of non-compliances in Thuringia. For both of the reported MRL exceedances in Saarland this period was more than 3 months.

Conclusions

A NRL is designated, as required by Article 33(1) of Regulation (EC) No 882/2004.

In accordance with the requirements laid down in Article 12 (1) and (2) of Regulation (EC) No 882/2004, there is a network of 23 laboratories designated as official laboratories for pesticide residue analysis of FNAO, and all laboratories within the network are accredited to ISO 17025.

Both official laboratories visited in Thuringia and Saarland have qualified staff and good facilities in new buildings; a broad analytical screen is in place, and equipment available allows further broadening of the scope. Analytical performance could be improved by targeted trainings and by using more efficiently the potential of the resources in the laboratories.

SANCO Guidelines 3131/2007 are only partly followed in the NRL and in the two laboratories visited. The lack of validation in the official laboratories for all substances in the analytical scope is not in compliance with the requirements of ISO 17025 and Article 12(2) of Regulation (EC) No 882/2004. The time between reception of samples and delivery of the laboratory report varies between 1 and 3 months. In the event of non-compliance this period is too long to allow effective follow-up measures. Optimising the number of scientific laboratory staff will enable laboratory reports to be finalised quicker and follow-up activities undertaken more efficiently.

1.5. Rapid Alert System for Food and Feed

Legal Basis

Article 50 of Regulation (EC) No 178/2002 requires Member States to immediately notify any information relating to the existence of a serious direct or indirect risk to human health deriving from food to the Commission under the rapid alert system. Article 35 of Regulation (EC) No 396/2005 lays down that Articles 53 and 54 of Regulation (EC) No 178/2002 on emergency measures shall apply where pesticide residues or MRLs covered by this Regulation may endanger human or animal health requiring immediate action.

Audit findings

The BVL (Unit 104) is designated as the national contact point (NCP) within the EU RASFF. General administrative rules for the RASFF implementation have been in force since 01 January 2006, applicable in all Länder. Responsibilities, criteria and procedures for RASFF notifications are set out in the legal document.

In the event of non-compliant samples, the scientists from the official laboratories perform a risk assessment, which forms part of the laboratory report. According to the

13 national legal provisions, if the acute reference dose (ARfD) or the acceptable daily intake (ADI) (where ARfD is not fixed) has been exceeded, the plant products are considered a risk for the consumer. In these cases the laboratory reports are forwarded to the senior CA of the Länder (the ministries responsible). The ministries then communicate the information to the NCP, and BVL informs the EU RASFF.

CA in the Länder of Thuringia and Saarland stated that if the MRL exceedances identified are close to the limit values a risk assessment is additionally performed by the BfR.

The mission team checked some RASFF files and found that the period from finalising laboratory reports and identifying a risk for the consumers respectively to notifying a non-compliant FNAO in RASFF takes between 6 and 20 days. In two recent cases this period was around 40 days.

Conclusions

In line with Article 50 of Regulation (EC) No 178/2002, responsibilities are clearly defined and procedures for RASFF notifications are laid down in the German national legislation. An adequate communication network has been established for exchanging information between the NCP and the Länder. However, the delay in notifying a non- compliant FNAO in RASFF could lead to insufficient follow-up.

1.6. Follow up on previous missions

Legal Basis

Article 45(5)(a) of Regulation (EC) No 882/2004 requires Member States to take appropriate follow-up action in the light of the recommendations resulting from Community controls.

Audit findings

In the report of the last mission on pesticide controls in Germany in 2004, 10 recommendations were made. One of these has not yet been addressed:

Recommendations of Follow-up in DG(SANCO)/7070/2004 DG(SANCO)/2008-7852

14 Recommendations of Follow-up in DG(SANCO)/7070/2004 DG(SANCO)/2008-7852 1. The competent authorities Fulfilled. should ensure that the analytical uncertainty, established using The analytical uncertainty is taken into account analytical quality control data for the decision on non-compliance in of the laboratory, is taken into accordance with SANCO Guidelines account in the estimation of 2007/3131 in the Länder visited, Thuringia, consumer risk, in accordance Saarland and Hessen. The CA stated that this with Commission Directive concept has been introduced in all official 2002/63. laboratories since October 2007.

Furthermore, the analytical In progress screens should include all metabolites included in the According to data provided in both official harmonised EU residue laboratories visited (in Thuringia and definitions Saarland) the number of analytes sought has been increased since the last mission, however metabolites included in the harmonised EU residue definitions are still not fully included in the analytical screen4.

Conclusions

The analytical uncertainty is taken into account in the estimation of consumer risk according to SANCO Guidelines 2007/3131 in the official laboratories in Thuringia, Saarland and Hesse.

Metabolites included in the harmonised EU residue definitions are not yet fully included in the analytical screen.

2. RECOMMENDATIONS

The Competent Authority of Germany is recommended to:

1 Ensure that a multi-annual national control programme for pesticide residues is established as required by Article 30 of Regulation (EC) No 396/2005.

2 Ensure that any information relating to MRLs or pesticide residues in FNAO considered as a serious direct or indirect risk to human health is immediately notified to the Commission under the RASFF as required by Article 50(2) of Regulation (EC) No 178/2002.

15 3 Consider SANCO Guidelines No 2007/3131 on method validation and quality control procedures for pesticide residues analysis in food and feed to be fully followed.

4 Ensure that analytical methods used in the designated official laboratories are validated in order to comply with the requirements of ISO 17025 and Article 12(2) of Regulation (EC) 882/2004.

16 ANNEX – LEGAL REFERENCES

Reference number Full title Publication details

Directive 91/414/EEC Council Directive 91/414/EEC of 15 July 1991 OJ L 230, concerning the placing of plant protection 19/08/1991, p. 0001 - products on the market. 0032

Regulation (EC) No Regulation (EC) No 178/2002 of the European OJ L 31, 01/02/2002, 178/2002 Parliament and of the Council of 28 January 2002 p.0001 - 0024 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

Directive 2002/63/EC Commission Directive 2002/63/EC of 11 July OJ L 187, 2002 establishing Community methods of 16/07/2002, p. 0030 - sampling for the official control of pesticide 0043 residues in and on products of plant and animal origin and repealing Directive 79/700/EEC. Regulation (EC) No Regulation (EC) No 852/2004 of the European OJ L 139, 852/2004 Parliament and of the Council of 29 April 2004 30/04/2004; on the hygiene of foodstuffs. Corrected and re- published in OJ L 226, 25/06/2004 p. 0003 - 0021

Regulation (EC) No Regulation (EC) No 882/2004 of the European OJ L 165, 882/2004 Parliament and of the Council of 29 April 2004 30/04/2004. on official controls performed to ensure the Corrected and re- verification of compliance with feed and food published in OJ L law, animal health and animal welfare rules. 191, 28/05/2004 p. 0001 - 0052

Regulation (EC) No Regulation (EC) No 396/2005 of the European OJ L 70, 16/03/05, p. 396/2005 Parliament and of the Council of 23 February 0001 - 0016 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. Commission Regulation Commission Regulation (EC) No 2076/2005 of 5 OJ L 338, (EC) No 2076/2005 December 2005 laying down transitional 22/12/2005, arrangements for the implementation of p. 0083 - 0088 Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004. Directive 2006/125/EC Commission Directive 2006/125/EC of 5 OJ L 339, December 2006 on processed cereal-based foods 05/12/2006, p. 0016 - and baby foods for infants and young children. 35 Directive 2006/141/EC Commission Directive 2006/141/EC of 22 OJ L 401, December 2006 on infant formulae and follow-on 30/12/2006, p. 0001- formulae and amending Directive 1999/21/EC. 0033

17 Recommendation Commission Recommendation 2008/103/EC of 4 OJ L 36, 04/02/2008, 2008/103/EC February 2008 concerning a coordinated p. 0007 - 0015 Community monitoring programme for 2008 to ensure compliance with maximum residue levels of pesticide residues in and on cereals and certain other products of plant origin and national monitoring programmes for 2006.

18 ANNEX – ENDNOTES

1 In their response to the draft report the Competent Authority noted that the disposal obligation refers to plant protection products containing active substances which are banned under the Plant Protection Application Ordinance or not included in Annex I to Directive 91/414/EEC. 2 In their response to the draft report the Competent Authority noted that since 2007 the NRL has been organising twice-yearly meetings of experts to discuss the implementation of validation projects, as well as an annual conference at which information is conveyed to the designated laboratories. On these occasions there have been no complaints from the official laboratories about any lack of support from the NRL. On 30 March 2009 the NRL is organising a workshop on the Quechers method for 30 participants from the laboratories. 3 In their response to the draft report the Competent Authority noted that the remaining restrictions to the scope of tests on food of plant origin are explained by the fact that the NRL, prior to designation, carried out tests only on food of animal origin. The scope of tests is being extended continuously. 4 In their response to the draft report the Competent Authority noted that the analytical screen is being extended continuously, also to include metabolites, insofar as the reference substances are commercially available.