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