EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate F - and Veterinary Office

DG (SANCO)/7068/2004– MR final

FINAL REPORT OF A MISSION

CARRIED OUT IN GERMANY

FROM 28 JUNE TO 2 JULY 2004

IN ORDER TO

ASSESS THE CONTROL MEASURES IN PLACE FOR IMPORT CONTROLS ON PRODUCTS OF PLANT ORIGIN, AND IN PARTICULAR FOR THE ASSESSMENT OF , 3-MCPD CONTAMINATION, RESIDUES, SUDAN I-IV AND FOR THE MONITORING OF IRRADIATED FOODSTUFFS

AND TO

MONITOR COMPLIANCE WITH COMMISSION DECISIONS IMPOSING SPECIAL CONDITIONS ON THE IMPORT OF CERTAIN PRODUCTS CONCERNING AND CONCERNING THE PRESENCE OF SUDAN I-IV IN CERTAIN PRODUCTS

AND TO

FOLLOW UP ON MISSION SANCO/8592/2002

Please note that factual errors in the draft report, identified by the German Authorities, have been corrected in the text of this final report. Clarifications, provided by the German Authorities, are given as footnotes, in italics, to the relevant part of this final report. 17/01/05 - 43261

TABLE OF CONTENTS

1. INTRODUCTION...... 6

2. OBJECTIVES OF THE MISSION ...... 6

3. LEGAL BASIS AND SCOPE FOR THE MISSION ...... 7

4. BACKGROUND...... 7 4.1. Overview of previous missions regarding import controls...... 7 4.2. Background to present mission ...... 7 4.3. Public health information ...... 8 5. MAIN FINDINGS...... 8 5.1. General Observation...... 8 5.2. Legislation ...... 9 5.3. Competent Authorities in charge of the import control system ...... 9 5.3.1. Central Competent Authorities...... 9 5.3.2. The Länder Authorities...... 10 5.3.3. Other Authorities...... 11 5.4. Import Procedures...... 11 5.5. ...... 11 5.5.1. Sampling and Import Procedures ...... 11 5.5.2. Laboratory Performance...... 13 5.5.3. Control at visited premises ...... 14 5.6. 3-MCPD ...... 14 5.7. Sudan dyes...... 14 5.8. Pesticide residues controls...... 15 5.9. Irradiated foodstuffs...... 15 5.10. Rapid Alert System for Food and Feed ...... 15 5.11. Follow-up of action plan activities in response to mission report SANCO 8592/2002 ...... 16 6. CONCLUSIONS...... 19 6.1. Legislation ...... 19 6.2. Competent Authorities in charge of the import control system ...... 20 6.3. Import Control Procedures ...... 20 6.4. Mycotoxins...... 20 6.4.1. Sampling and Import Procedures ...... 20 6.4.2. Laboratory Performance...... 20 6.4.3. Action in the event of non-compliance ...... 20 2 6.4.4. Control at visited premises ...... 21 6.5. 3-MCPD ...... 21 6.6. Sudan dyes...... 21 6.7. Pesticide residues controls...... 21 6.8. Irradiated foodstuffs...... 21 6.9. RASFF Communications...... 21 6.10. Follow-up of report SANCO/8592/2002...... 21 7. CLOSING MEETING...... 22

8. RECOMMENDATIONS ...... 22 8.1. To the Competent Authorities of Germany...... 22 9. ADDENDUM...... 23

3

EXECUTIVE SUMMARY

The mission was carried out as part of a series of missions to major importing Member States to assess controls at import of products of plant origin and compliance with certain Commission Decisions. This was a follow-up mission to mission SANCO/8592/2002 due to the significance of the findings and recommendations on that mission.

The mission team visited the Federal Office of Consumer Protection and , the Federal Ministry of Consumer Protection, Food and Agriculture and the Ministry of Finance, two Länder, an official and a private control laboratory, a wholesaler importing spices and one office at the port (Bremenhaven). Representatives of the customs authorities were visited at the two Länder.

The structure and responsibilities of official food safety services have changed since the last FVO mission SANCO/8592/2002 at Federal level. Currently the competent authorities at Federal level are the Federal Ministry of Consumer Protection, Food and Agriculture (BMVEL), the Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Risk Assessment (BfR). At Länder level, the 16 Länder have the responsibility for the implementation of official control requirements in respect of foodstuffs.

In Germany, legal requirements for taking the sample for defence purposes are not as precisely defined as in Commission Directive 98/53/EC, and interpretation of the relevant German law differs in the two visited Länder. Sampling frequencies established in the relevant Commission Decisions are mostly met. In Bremen, the sampling procedure was not in compliance with the requirements set out in Commission Directive 98/53/EC.

Files kept in Bremen were insufficient to document adequate official controls and lacked documents as required in the relevant Commission Decisions (Annex I).

Regarding actions taken in response to the report of the mission SANCO/8592/2002 by the German authorities, while most of the recommendations have been satisfactorily addressed, controls at import point remain restricted to a very limited number of commodities and risks.

Regarding the notifications to the RASFF network, while improvements in the effectiveness of transmissions have been achieved, omissions in transmission were noted, in particular for certain goods analysed in private laboratories.

The report provides a number of recommendations to the German authorities to address the noted deficiencies.

4 Abbreviations and Special Terms Used in the Report

BfR Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment) BMVEL Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft (Federal Ministry of Consumer Protection, Food and Agriculture) BVL Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (Federal Office of Consumer Protection and Food Safety) CEN European Committee for Standardization EU European Union FAPAS Food Analysis Performance Assessment Scheme FTE Full Time Equivalent FVO Food and Veterinary Office HACCP Hazard Analysis and Critical Control Point LMBG Lebensmittel- and Bedarfsgegenständegesetz (Foodstuffs and Commodities Act) LMTVet Lebensmittelüberwachungs-, Tierschutz- and Veterinärdienst des Landes Bremen (Food Control, Animal Protection and Veterinary Service of the Land of Bremen) LUA Landesuntersuchungsamt (State Laboratory for Chemistry, Hygiene and Veterinary Medicine) OTA Ochratoxin A RASFF Rapid Alert System for Food and Feed SOP Standard Operating Procedure TARIC Tariff Intégré de la Communauté (Integrated tariff of the Community) TEU Twenty Foot Equivalent Unit, or one small container, the shipping industry's standard unit of measurement 3-MCPD 3-Monochloro-1,2-propandiol

5 1. INTRODUCTION

The mission took place in Germany from 28th June to 2nd July 2004. The mission team comprised two inspectors from the Food and Veterinary Office (FVO) and one national expert.

The mission was undertaken as part of the FVO's planned mission programme, and in agreement with the central competent authority.

The inspection team was accompanied during the week by representatives from the central competent authority, the Federal Office of Consumer Protection and Food Safety (BVL) and representatives from the Central Tax Authority in Nürnberg. An opening meeting was held on the 28 June 2004 with representatives from the central competent authorities, the BVL and the Federal Ministry of Consumer Protection, Food and Agriculture (BMVEL), a representative of the Federal Ministry of Finances and representatives from both Länder (Hamburg and Bremen). At this opening meeting, the inspection team confirmed the objectives of, and itinerary for, the mission, and additional information required for the satisfactory completion of the mission was requested.

2. OBJECTIVES OF THE MISSION

The objectives of the mission were

• to assess the control measures for the controls on imported products of plant origin intended for free circulation within the European Union, in particular regarding mycotoxins, 3-MCPD contamination, pesticide residues, Sudan I-IV contamination and for the monitoring of irradiated foodstuffs.

• to monitor compliance with Commission Decisions imposing special conditions on the import of certain products concerning mycotoxin contamination and for the presence of Sudan I-IV in chilli and chilli products.

• in addition, to follow up on the previous mission SANCO/8592/2002 carried out from 19th to 21st February 2002 with similar objectives.

In pursuit of these objectives, the following visits were carried out in accordance with the itinerary agreed between the competent authorities and the FVO:

COMPETENT AUTHORITY VISITS Comments Competent authority Central 1 -Federal Office for Consumer Protection and Food Safety -Federal Ministry for Consumer Protection, Food and Agriculture -Federal Ministry of Finance Regional 1 Import point at Bremenhaven Port 2 Länder authorities in Hamburg and Bremen. LABORATORY VISITS Comments Private Laboratory 1 In Hamburg Public Laboratory 1 State Laboratory for Chemistry, Hygiene and Veterinary Medicine PREMISES VISITS Comments Processing Premises 1 Importer of spices, nuts and nut products in Bremen

6 3. LEGAL BASIS AND SCOPE FOR THE MISSION

The mission was carried out under the general provisions of Community legislation (the Treaty of the European Community and in particular Articles 10, 152, 153 and 211), and other provisions of Community legislation, specifically

– Council Directive 89/397/EEC1 of 14 June 1989 on the official control of foodstuffs,

– Council Directive 93/99/EEC2 of 29 October 1993 on additional measures concerning the official control of foodstuffs.

Other legislation within the scope of the mission is identified in mission report SANCO/9244/2003. In addition, the following Commission Decision was published after that mission report was finalised.

– Commission Decision 2004/92/EC3 of 21 January 2004 on emergency measures regarding chilli and chilli products, repealing Commission Decision 2003/460/EC4.

4. BACKGROUND

4.1. Overview of previous missions regarding import controls.

Detailed description of the background on previous missions regarding import controls can be found in the final report of the previous mission DG (SANCO)/8592/2002– MR final.

This report is part of a series of 14 missions to 11 Member States with similar objectives concerning assessment of controls over imports of products of plant origin. The reports of these missions are available on the DG Health and Consumer Protection Internet site

http://europa.eu.int/comm/food/fs/inspections/fnaoi/reports/contaminants/index_en.html

4.2. Background to present mission

There have been an increasing number of rapid alert (RASFF) messages circulated within the European Union related to products containing mycotoxins. In 2003 there have been over 500 RASFF messages for mycotoxins. In 2002 there were over 250 RASFF messages for mycotoxins, and in 2001 a total of 186. Implicated products included peanuts and peanut products, pistachios, hazelnuts, brazil nuts, almonds, dried fruits (figs, apricots), spices, coffee products and cereals. Most of these were products analysed at the point of import, and not at marketplace level.

In 2003, there had been over 80 alerts and additional information notifications pertaining to the finding of Sudan I-IV in a wide range of products.

As well as a general obligation for Member States to undertake random analysis of products, there are specific conditions imposed in Commission Decisions over products from certain third countries where the risk is considered greater. These specific

1 OJ L 186 of 30 June 1989 2 OJ L 290 of 24 November 1993 3 OJ L 27 of 30 January 2004 4 OJ L 154 of 21 June 2003 7 conditions relate to mycotoxin contamination. There is an additional Commission Decision imposing conditions over the import of chilli and chilli products following the presence of the unauthorised colourants Sudan I to IV.

4.3. Public health information

Detailed information on mycotoxins, their production and distribution on foodstuffs, associated health risks, limits established in the legislation, laboratory performance criteria and sampling procedures can be found in the final report of a previous mission DG (SANCO)/9244/2003– MR final.

Sudan I-IV are dyes unauthorised for food use, and suspected genotoxic . In May 2003 a first notification was received from France of the presence of Sudan I in imported chilli products indicating adulteration that could constitute a serious health risk. This resulted in a Commission Decision in June 2003 requiring all consignments of chilli to be received with an analytical certificate demonstrating the absence of Sudan I. This Commission Decision was repealed by a new Commission Decision in January 2004 extending the scope of the controls to Sudan I, II, III and IV in the view of analytical findings communicated to the RASFF.

5. MAIN FINDINGS

5.1. General Observation

Hamburg port, situated in the Northwest of Germany, is the second in container throughput in the EU and one of the world top ten, and thus, a large import point. Detailed information of Hamburg port and Free Port status is available in the final report of the previous mission DG (SANCO)/8592/2002– MR final. Hamburg is one of the main import points of pistachios in Europe.

Bremen is the second largest port in Germany and one of the most important in EU. However, figures show that the number of consignments of foodstuffs of plant origin is significantly lower than the number for Hamburg.

Container throughput (in TEU) for the main ports in the EU

2001 2002 2003

ROTTERDAM 6.096.142 6.506.311 7.106.778

HAMBURG 4.688.669 5.373.999 6.137.926

ANTWERP 4.218.176 4.777.151 5.445.437

FELIXSTOWE 2.800.000 2.684.000 2.700.000

BREMEN 2.972.882 3.031.587 3.190.707

(Source: Hamburg Port website)

8 5.2. Legislation

Legislation applicable within the scope of the mission as well as the different responsibilities in relation to it, is described in DG (SANCO)/8592/2002– MR final. Since the last mission, and in addition to EU legislation, Germany has approved some national rules, setting down maximum levels for certain contaminants in different foodstuffs, in particular for mycotoxins. All applicable legislation within the scope of this mission has been transposed. Relevant Commission Decisions have been published in the Federal Gazette. Under § 48 of the “Food and Commodities Act” (Lebensmittel und Bedarfsgegenständegesetz, LMBG) some foodstuffs must be tested for aflatoxins or other health hazards before clearance at points of import. This information is sent to the regional customs offices and a list of these goods is now also available in the customs internet website. At the time of the visit and within the scope of the mission, the goods in the list comprised peanuts from Argentina to be analysed for aflatoxins, Turkish paprika powder for aflatoxins and Turkish peppers for pesticide residues. Council Directive 98/53/EC was transposed by introducing a reference to the Directive in the LMBG. According to Annex I, Article 3.6, of the Directive, the replicate samples for enforcement, trade (defence) and referee purposes are to be taken from the homogenised laboratory sample, unless this conflicts with Member States' rules on sampling. National provisions in §42 of the LMBG require to leave behind part of the sample, or, if it is impossible or not possible without endangering the purpose of the investigation to divide the sample into homologous parts, a second piece of the same type and from the same manufacturer as that taken as the sample.

While the BMVEL and the Bremen Land authorities’ interpretation was that according to the applicable legislation two parallel identical samples are to be taken for purposes of enforcement, defence and reference, the Hamburg Land authorities and the instructions in the laboratory of Bremen stated that the defence sample shall be taken from the homogenised laboratory sample.

5.3. Competent Authorities in charge of the import control system

The structure and responsibilities of official food safety services at Federal level have changed since the previous FVO mission with the same objectives, mission DG (SANCO)/8592/2002.

The competent authorities at Federal level are the Federal Ministry of Consumer Protection, Food and Agriculture (BMVEL), the Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Risk Assessment (BfR), which was established as an independent federal body by Law in November 2002. Official control within the scope of this mission is implemented by the 16 Länder.

5.3.1. Central Competent Authorities

The BMVEL is the central competent authority in Germany in the field of food safety. The BVL is a co-ordination body and is responsible for administrative tasks related to

9 risk management5. It is also the National contact point for the RASFF. BVL coordinates the uniform implementation of food safety legislation in the Länder. The BfR is the central scientific institute in Germany carrying out risk assessment on safety of , substances and commodities.

In respect of foodstuffs, the authorities in the two Länder visited are responsible for enforcement policy, food controls and its administrative organisation.

5.3.2. The Länder Authorities

The structure of the two visited cities, which have the status of Land are as follows:

Hamburg

Until 18 of April 2004, the Authority responsible for official food monitoring was the Environment and Health Authority (Behörde für Umwelt and Gesundheit, BUG). With effect from 19.04.2004 this responsibility has passed to the Science and Health Authority (Behörde für Wissenschaft and Gesundheit, BWG). The team was informed that, in principle, regarding import controls on food of plant origin, the previous structure and competencies will not vary significantly.

The Health and Consumer Protection Office, via its Consumer Protection Division, covers all aspects broadly relating to consumer protection. Within it, the Food Safety Section of the Food Safety and Veterinary Health Division is the senior food monitoring authority in the Land of Hamburg.

The Food Safety and Veterinary Health Division has a subsidiary service, the Border Service Veterinary Office, which is responsible for checking imports of all foods and arranges for sampling and analyses. Once the adequate tests have been carried out and expert opinions have been issued, the Institute for Hygiene and the Environment issues the certificate required by the customs authorities.

Bremen

Within Bremen’s Ministry for Labour, Women, Health, Youth and Social Affairs, Unit 32 of Department 3 (Health) has responsibility, amongst others, for all matters relating to food safety.

The Food Control, Animal Protection and Veterinary Service of the Land of Bremen (Lebensmittelüberwachungs-, Tierschutz- and Veterinärdienst des Landes Bremen, LMTVet) is responsible, as centralised inspectorate service, for all monitoring activities, including the controls at the border control posts.

The State Laboratory for Chemistry, Hygiene and Veterinary Medicine of the Land of Bremen (Landesuntersuchungsamt für Chemie, Hygiene and Veterinärmedizin Bremen, LUA) is the public laboratory for the Land of Bremen, competent for testing official samples.

5 In their response to the draft report, the German authorities clarified that “the responsibility of the Länder includes the follow-up of infringements”.

10 5.3.3. Other Authorities

The customs offices check whether the general import prerequisites are met. They request that consignments presented for clearance and needing further controls as defined in §48 of LMBG are notified to the food monitoring authority for its approval.

5.4. Import Procedures

Import procedures have not changed since last mission DG (SANCO)/8592/2002– MR final.

Both Länder charge fees on the consignments in order to cover the costs of import control activities.

In Hamburg, testing prior to importation of foods within the scope of the mission is conducted by the Hamburg Institute for Hygiene and the Environment and, mostly, by private accredited laboratories. Private laboratories analysing goods control under § 48 of LMBG are not obliged to communicate all the results to the official control bodies. Thus, non-compliant lots of these commodities are not notified to the competent authorities.

5.5. Mycotoxins

5.5.1. Sampling and Import Procedures

Some statistical information on the volumes of products affected by Commission Decisions imported into Germany via Hamburg and Bremen was provided.

Import controls on foods of plant origin in 2002 in Hamburg Origin /Product Pistachios Hazelnuts and Figs and Peanuts and products thereof products thereof products thereof

Iran Total 698 - - - (100% consignments 100% sampled sampling required) Turkey Total 3 Total 680 Total 514 - (10% consignments 1 sampled (33%) 159 sampled 88 sampled sampling required) (23%) (17%)

China - - - Total 604 (10% consignments 379 sampled (63%) sampling required)

In 2002, seven border rejections for Iranian pistachios were notified to the RASFF by Germany. For products coming from Turkey, there were 27 RASFF messages and none related to Chinese peanuts.

Import controls on foods of plant origin in 2003 in Hamburg Product/ Pistachios Hazelnuts and Figs and products Peanuts and Chilli Origin products thereof thereof products thereof

Iran Total 1 057 - - - - (100% consignments 100% sampling required) sampled Turkey Total 29 Total 532 Total 533 - - (10% consignments 9 sampled 50 sampled (9%) 28 sampled (5.3%)

11 sampling required) (31%)

China - - - Total 786 - (10% consignments 81 sampled sampling required) (10.3%) Other third countries - - - - Total 52 45 sampled (86.5%) In 2003, 265 border rejections for Iranian pistachios were notified to the RASFF by Germany. For products coming from Turkey, there were 43 RASFF messages and 1 message related to Chinese peanuts.

All analysis is undertaken to the lower limits for aflatoxins; no product has been presented in the visited Länder for sorting to the higher levels that are provided for in Commission Regulation (EC) 466/2001.

In Hamburg, goods covered by specific Commission Decisions are sampled by officials belonging to the competent authority. Tests are carried out at public or private laboratories. All non-compliant lots are notified to the competent authority and this information is adequately forwarded to the Commission services.

Goods not covered by Commission Decisions but with compulsory presentation for inspection under §48 of the LMBG are mostly sampled by private samplers authorised by the Hamburg Chamber of Commerce. These samples are analysed mainly at private laboratories. In this case, the competent authority only receives the results of lots that comply with levels set down in the legislation. Non-compliant lots may leave Hamburg for any other destination, including other Member States, without any further monitoring by the competent authority.

In Bremen, all goods are sampled by officials belonging to the LMVet. Samples are analysed by public laboratories and results forwarded in all cases to the competent authority.

Import controls on foods of plant origin in 2003 in Bremen as provided by the competent authorities.

Product Consignments Consignments Refused entry Refused entry 2002 2003 2002 2003 Hazelnuts and 26 6 none none products thereof 20 sampled (77%) 1 sampled (17%) Pistachios and 11 11 2 none products thereof 8 sampled (72%) 4 sampled (36%) Figs and 33 37 1 1 products thereof 21 sampled (64%) 8 sampled (22%) Chilli and chilli - 10 - 1 products

In 2004, up to the time of the mission, there had been 23 consignments of chilli products declared in Bremen, of which 5 (22%) had been tested for Sudan I-IV. In addition, 5 curry-powder products were declared. All consignments were compliant and were released for free circulation.

The mission team could not observe a sampling of a container in Bremen due to the lack of available consignments. However, the sampling procedure was described in detail,

12 equipment and tools were presented and the team examined a sample taken two days before the mission team’s arrival.

The sampling is undertaken in the Border Inspection Post in the harbour.. The sampling tools (short metal sampling spears) were not adequate to ensure that samples are taken at various points in a sack or to sample certain type of goods (such as figs or Brazil nuts). .

While in Hamburg the replicate sample for defence purposes was taken from the slurry, in Bremen two parallel samples of the same characteristics are taken, one for the initial test in the official laboratory and a second replicate sample to allow the importer to initiate an appeal against the decision taken by the competent authorities. The laboratory standard operational procedure (SOP) states that samples for this purpose are to be taken from the slurry.

Information forwarded by the BMVEL regarding this issue6 stated that, in Germany, the procedure for taking a counter-sample for the duty holder (sample for defence purposes) is governed by §42 of the LMBG. This sets out the requirement to leave behind part of the sample, or, if it is impossible or not possible without endangering the purpose of the investigation to divide the sample into homologous parts, a second piece of the same type and from the same manufacturer as that taken as the sample. Samples left behind are to be officially sealed. The §42 LMBG procedure for taking of a counter-sample applies to all supervisory measures necessary to enforce the rules on dealing in products within the meaning of the LMBG, and hence also to import controls.

Files regarding lots imported in Bremen were not complete. In most of the cases, records did not contain documents essential to adequately carry out the official controls and files did not contain official documents provided by the authorities of the country of origin, as required in the Annex I of the relevant Commission Decisions.

5.5.2. Laboratory Performance Hamburg The private laboratory visited in Hamburg was previously located in Bremen and was moved at the beginning of 2004. It analyses a large number of samples for aflatoxins in the context of import controls. It has only recently started operations. The accreditation of the previous laboratory in Bremen was reconfirmed by the German accreditation body in April 2004 for the premises in Hamburg. Incoming samples are delivered in transparent bags.

In the new facilities the milling process was changed to slurry mixing with newly bought equipment. There are no available tests on homogenisation, validation data, SOP for the milling process and description of the slurry process.

The analysis is performed according to a written procedure different from the one listed in the annex of the accreditation certificate. The first method contained no validation data. The limit of determination was given as 0.2 µg/kg and the limit of detection as 0.1 µg/kg for all four aflatoxins. In the second method, validation data are only given for B1 and the sum of aflatoxins in four different commodities. Standard and control samples are added in the analytical process, but this is not described in the SOP.

6 In their response to the draft report, the German authorities clarified that “Hamburg and Bremen do not agree to this legal interpretation by the BMVEL”.

13 Proficiency test samples regarding the determination of aflatoxins in nuts were analysed by this procedure showing some deviation from the expected results.

Bremen In Bremen, since 2003 all analyses relating to statutory import controls have been performed by the LUA Bremen or outsourced to other State testing institutes in neighbouring Länder.

This laboratory is accredited since May 1999 for the relevant methods and had undergone the last re-accreditation visit in May 2004. The laboratory of LUA Bremen is well equipped for aflatoxin analysis. The SOP for routine aflatoxin analysis is in use since July 7th 1999. It includes instructions for control and spiked samples to be inserted in the routine sequence. It was extensively validated, by evaluating the results of daily routine measurements on a control sample as well as on proficiency tests. Two different international proficiency tests were applied, both with good results. A separate validated SOP is present for the homogenisation procedure when applying slurry mixing. It mentions that samples for analysis, trade (defence) and referee purposes are to be taken from the slurry. Action in the event of non-compliance

The products contaminated with mycotoxins are rejected at import point and always sent to third countries or re-exported to the country of origin. The destruction of contaminated lots is not seen as an appropriate alternative by the Land competent authorities. The team was informed that, in the opinion of the Land authorities, there is no legal basis for that action unless it is specified in the relevant Commission Decision.

According to information forwarded by the BMVEL, destruction of batches of goods, rejected at import point, that are liable to be harmful to health is subject to the law of the Länder.

Lots failing to comply with the lower levels set down in the legislation are rejected and have not been presented for subsequent sorting to the higher levels as provided by Commission Regulation (EC) 466/2001.

5.5.3. Control at visited premises

The mission team was taken to the premises of an importer of packed spices. This visit was not relevant for the objectives of the mission.

5.6. 3-MCPD

Soy sauce was controlled at import point under §48 of LMBG for one year from April 2002. Currently there are no controls at import point of this type of goods.

5.7. Sudan dyes

The German authorities have carried out extensive analysis of samples for the presence of Sudan I to IV at import point, including different commodities. Sampling is performed by the Border Service Veterinary Office in accordance with the method prescribed in § 35 of the LMBG.

14 At import point, only one lot has been found to contain Sudan dyes and it was destroyed according to the instructions in the relevant Commission Decision.

5.8. Pesticide residues controls

Since July 2003, there is a statutory obligation under §48 of the LMBG to present imports of peppers (fresh or frozen) originating from Turkey for inspection. The BMVEL informed that this action has led to a dramatic reduction of pepper imports from Turkey. In 2003, only one consignment was declared to the Bremen border inspection post and released after it was found compliant. No consignments of Turkish peppers were declared to the border inspection post in Hamburg. No data were available about analytical results of further samples taken under the § 48 action in other regions of Germany.

There has been no further sampling for pesticide residue analysis of imported fresh fruit, vegetables and grains at import point in 2003.

5.9. Irradiated foodstuffs

The border inspection posts in the visited Länder have not inspected or sampled foodstuffs of plant origin for possible unauthorised treatment with ionising radiation.

At market level, 55 samples of foodstuffs of plant origin, originating in third countries were analysed in Hamburg, in 2002 and 2003, for unauthorised irradiation treatment. No evidence of irradiation treatment was found in any of them.

5.10. Rapid Alert System for Food and Feed

The national contact point for the Commission RASFF System is the Unit 104 of the BVL. This body sends relevant alerts to the competent authority in the Länder electronically. The Länder in turn are responsible for communicating these alerts to the districts and depending offices within their regions.

In relation to risk assessment of goods found to be non-compliant, a set of administrative rules has been drafted by the Federal authorities, in co-operation with the Länder. These rules are not yet finalised and were not in use in the visited Länder. These rules will include harmonised procedures for initial risk assessment by the Länder.

All rejections of products covered by Commission Decisions are notified to the relevant central services and forwarded to the RASFF.

In Hamburg, and in relation to measures taken according to § 48 of LMBG, non- compliant goods analysed in private laboratories are not notified to the RASFF since this information is not available to the competent authorities. There is no standardised procedure for the risk assessment of non-compliant lots sampled at market level and no designated body carrying it out.

In Bremen, all non-compliant lots inspected at import point are notified to the RASFF.

Samples taken at market level found to be non-compliant are assessed at the relevant Land unit. There is a written procedure to evaluate non-compliant lots of samples taken at market level in order to notify them to the RASFF. This procedure is based on a draft working document of the Commission services.

15 5.11. Follow-up of action plan activities in response to mission report SANCO 8592/2002

The table below summarises the recommendations in report SANCO/8592/2002, the responses included in the action plans and findings in the present mission related to the implementation of the proposed actions.

RECOMMENDATION CA RESPONSE COMMENTS TO CA (1) The Competent The focus of controls on non-animal Acceptable action although not yet Authority should take products is at the marketing level. implemented. measures to ensure that However, at the moment a list of This group has met three times and import controls on higher-risk foods is being prepared, will produce a list of higher-risk foodstuffs of plant origin which in future should make it foods, which should allow carrying are reviewed and possible to carry out risk-oriented out risk-oriented import controls on strengthened, import controls on foods of plant foods of plant origin, as foreseen in particularly where non- origin. This will shift the emphasis the new Feed and Food Control compliance is suspected, of controls away from the marketing Regulation (EC) No 882/20047. in order to attain a level level. The Federal Ministry for However, controls at import point of official controls at the Consumer Protection, Food and remain currently restricted to a very appropriate stage which Agriculture has set up a joint limited number of commodities. will prevent risks to working group (federal and Länder They do not include irradiated public health within the authorities) in cooperation with the foodstuffs of plant origin, pesticide meaning of Council customs authorities for this purpose. residues (except for Turkish Directive 89/397/EEC. peppers) or mycotoxins in Consignments foodstuffs others than those in list monitoring should under § 48 of LMBG and increase and the commission decisions. Competent Authority in Since April 2003 onwards, they do charge of food of plant not longer include soy sauce for 3- origin should be MCPD. involved in carrying out checks regularly. Given the considerable information existing on recurrent contaminant findings, the controls should cover a broader variety of products of plant origin. (2) Implementation of At the moment, European Acceptable Commission Decisions Commission decisions do not have The BMVEL has reviewed its should not be delayed. direct legal effect in Germany. They internal administrative procedures must first be published in the federal for publishing Commission gazette and do not apply until one Decisions. The Food Importation day after publication. Ordinance was amended in 2003 to The German government will allow for a faster publication of the

7 OJ L 165 , 30 of April 2004

16 shortly table a proposal to amend relevant Commission Decisions. §6a of the Food Importation Ordinance, so that Commission decisions can be implemented more rapidly. (3) The procedure to An “official list” of measures Acceptable. update and communicate relating to imports does not exist at Currently, the Nürnberg Regional goods to be imported either national or EU level. Finance Office draws up, on behalf that are submitted to Commission decisions apply directly of the Federal Ministry of Finance, certain requirements once they have been published in the a list of the goods which are according to specific federal gazette. Additional measures required to be presented for circulars under Article relating to imports are adopted in inspection according to § 48 of the 48 of LMBG should be individual cases and prescribed by LMBG and has posted this list on clearly established. the Federal Ministry of Finance in the Internet. It will be also available specific circulars addressed to the to all customs services through the customs offices. These circulars are Ministry’s Intranet. This list is also normally published in the updated when necessary. Besides, Finance Ministry’s gazette (VSF-N) the customs authorities are faxed as information for importers. decrees of any new compulsory goods presentation instructions issued pursuant to § 48 of LMBG and of import measures based on EC legislation. (4) Customs decisions In accordance with Article 50 of Partly acceptable since it does not taken on a rejected Regulation (EC) No 178/2002 a address notifications of some non- consignment should be notification system has been in place compliant lots. notified to other border since 21 February 2002, which also Rejected consignments of goods posts to avoid different covers border inspection posts. covered by Commission Decisions treatment. Hamburg has been forwarding are duly notified to the RASFF. details of all rejected consignments However, in Hamburg, results of via the Commission’s rapid alert the private analysis of commodities system since November 2002. included in § 48 of LMBG are not forwarded to the competent authorities in cases of non- compliance. Thus, these non- compliant lots are not notified to the RASFF. (5) The Competent On 1 December 2001 the German Acceptable Authority should take customs service started to introduce The ATLAS system is now fully measures to ensure that the IT-supported clearing system operational, and the competent accurate data regarding ATLAS as the successor to the food monitoring authority is consignments of food previous systems, which did not notified by Customs of commodities are cover the whole country. All of consignments of these types of available to the Germany’s customs offices will be goods awaiting Customs clearance. Authority in charge of equipped with ATLAS by July However, the risk profiles have not import controls. 2003. ATLAS will automatically yet been fed into the system. draw customs officials’ attention to Consequently, the customs service product-related risks. Risk analyses does not have yet available this with corresponding risk profiles will information when working with be fed into the system. However, as ATLAS. yet there are only very few of these 17 in the food and veterinary legislation Information related to rejected field. Consequently, the working consignments is not forwarded to group mentioned in (1) will help the other customs points and the customs service to develop a risk dossier remains with the acting analysis in the field of “prohibitions customs point. and restrictions”, which also covers food controls. (6) The Competent The incorrect tariff number for Acceptable Authorities should peanuts which was apparently The system currently in place ensure that declarations mentioned inadvertently during the provides automatically with the concerning imported inspection was immediately appropriate TARIC code for each peanuts are under the corrected in the course of the commodity. appropriate TARIC meeting. Community legal acts are codes. binding on the customs offices as they stand, as soon as they have been published in the federal gazette. The customs offices are working, with computer support, on an electronic customs tariff from which the correct code for peanuts can be taken. Independently of this, co-ordination with the Federal Finance Ministry (responsible for customs matters) with regard to customs tariff codes for non-animal products is to be improved, so that potential problems can be avoided through uniform practice. (7) The Competent The performance of private Partly acceptable since it does not Authority should accredited laboratories is ensured by address the private sampling supervise private regular participation in comparative assessment issue. sampling to ensure the laboratory studies and is monitored All sampling of goods covered by enforcement of by the competent supervisory Commission Decisions has been legislative provisions. authority. In connection with EU- officially conducted or officially The Competent wide import control measures, all supervised and all test results Authority should take sampling has so far been undertaken produced in private accredited measures to ensure that and monitored officially. Pursuant to laboratories are forwarded to the the results of tests the reporting requirements imposed control authority. carried out in private by the Commission in November laboratories are notified 2002 in conjunction with EU-wide However, for commodities to the competent official import control measures, Hamburg included in § 48 of LMBG, private body. Laboratory has since then applied a written sampling has not been assessed performance should be order to the effect that all relevant and results of the private analysis assessed to evaluate the test results obtained at private are not forwarded to the competent impact of rejection rate accredited laboratories must be authorities in cases of non- differences. forwarded to the supervisory compliance. Thus, these non- authority. compliant lots are not notified to the RASFF. In the case of Hamburg, the

18 laboratory performance of the private laboratory visited was assessed through a visit carried out in May 2004 by experts belonging to the Institute for Hygiene and the Environment. (8) The Competent See remarks concerning (4). See remarks concerning (4). Authority should take measures to ensure that all rejected consignments are promptly notified to the RASFF. (9) The Competent On the basis of the applicable Partly acceptable since it does not Authority should take legislation, Hamburg has fully address monitoring of some non- the necessary measures ensured that no consignments compliant lots. in the event of non- subject to import control measures While for commodities controlled compliance to ensure enter the internal market either under Commission Decisions are that contaminated goods without being tested or if any limit adequately monitored, the controls within the scope of the values are exceeded. In addition, on goods under § 48 of LMBG as mission are not monitoring takes place at the currently carried out in Hamburg forwarded to other EU appropriate marketing stages in do not fully guarantee that non- destinations. accordance with Directive compliant lots are adequately 89/397/EEC (which, however, was supervised as to ensure that they not covered by the inspection visit to are not forwarded to other EU Hamburg). destinations. (10) Import controls on In order to implement this Not acceptable. foodstuffs potentially recommendation, legislation is No measure has been taken at exposed to ionising needed which does not exist at either import point in respect of this radiation should include national or EU level. This global recommendation. foodstuffs of plant requirement thus contravenes origin. Directive 89/397/EEC, which makes In the FVO’s point of view, it is provision for surveillance not just as the most appropriate point to an import control measure, but also ensure that irradiated food includes each appropriate marketing originating in non-approved stage. establishments in third countries enters the EU.

6. CONCLUSIONS 6.1. Legislation

All relevant legislation is transposed and in force.

Interpretation of legal provisions transposing Council Directive 98/53/EC regarding sampling requirements for aflatoxins differs between the visited competent authorities.

19 6.2. Competent Authorities in charge of the import control system

Apart from the Customs authority who carries out the clearance of the consignments at the border, the competent authorities in charge of controls on foodstuffs at import level are the 16 Länder. They have the responsibility for the implementation of all official control requirements in this respect.

6.3. Import Control Procedures

Customs clearance only takes place after the approval of the relevant Competent Authority. There is a written procedure in both Länder for this purpose.

6.4. Mycotoxins

6.4.1. Sampling and Import Procedures

Interpretation of legal basis laying down procedures to take the replicate sample for defence purposes (as defined in Commission Directive 98/53/EC) differ in the two visited Länder. Consequently, the procedures themselves were different in the two visited Länder

In Hamburg, private sampling is still neither assessed nor supervised and results of the private analysis of commodities included in § 48 of LMBG are not forwarded to the competent authorities in cases of non-compliance.

In Bremen, the sampling procedure described resulted in an aggregate sample of adequate size but a fully representative distribution of incremental samples is not achieved and tools and equipment for the sampling were not adequate. The sampling procedure did not comply with Council Directive 98/53/EC.

Files kept in Bremen were incomplete and insufficient to document adequate official supervision at import point and lacking documents required in the relevant Commission Decisions.

Compliance with the established frequencies of controls established in Commission Decisions regarding import of Turkish hazelnuts, dried figs and mixtures was generally met, with some minor deviations.

6.4.2. Laboratory Performance

The private laboratory in Hamburg is accredited for aflatoxins analysis. The performance of the laboratory appears to be acceptable although the method is not fully validated and proficiency tests results showed room for improvement.

The LUA Laboratory in Bremen is accredited for relevant methods and its performance was found to be acceptable. Sampling preparation equipment meets the specifications to prepare the sample in accordance with requirements in Directive 98/53/EEC.

6.4.3. Action in the event of non-compliance

Non-complying lots at import point are returned to the country of origin or a third country. Destruction of lots contaminated with aflatoxins does not take place, irrespective

20 of the levels detected. Destruction is only carried out in consignments of products containing Sudan I-IV as the Commission Decision specifically imposes this action.

Rejected products have not been presented in Hamburg or Bremen for subsequent sorting to the elevated levels of aflatoxins allowed in Council Regulation (EC) 466/2001.

6.4.4. Control at visited premises

The inspection carried out in the company visited was not relevant for the objectives of the mission.

6.5. 3-MCPD

While evidence of adequate controls on 3-MCPD contamination in soy sauce was shown from April 2002 to April 2003 under § 48 of LMBG, currently there are no longer controls at import point of this type of goods.

6.6. Sudan dyes

At import point, monitoring of products for Sudan I to IV contamination covers a wide range of products and a high number of samples. Official controls activities are seen as adequate.

6.7. Pesticide residues controls

Regarding pesticide residues, there are no controls over fresh products of plant origin exerted at import point, except for peppers originating from Turkey. No regular sampling for pesticide residue analysis is carried out at this point.

The Bremen LUA laboratory is very well equipped for pesticide residues analysis, and accredited to ISO 17025. It analyses for a limited number of and metabolites.

6.8. Irradiated foodstuffs

There are no regular controls on foodstuffs of plant origin at import points in Germany for these purposes. At market level, samples of these products originating in third countries were analysed in 2002 and 2003 for unauthorised irradiation treatment and no evidence of irradiation treatment was found in any of them.

6.9. RASFF Communications

Dissemination of information from central services to local services is seen as adequate. Import rejections of products covered by Commission Decisions are notified to the Commission Services but, in Hamburg, privately analysed lots of commodities included in § 48 of LMBG and found to be non-compliant are not notified to the competent authorities. Thus, these non-compliant lots are not notified to the RASFF.

There is no harmonised procedure in place for risk assessment and, in Hamburg, no designated body was carrying it out effectively.

6.10. Follow-up of report SANCO/8592/2002

Corrective actions signalled in the action plan have been fully or mostly implemented in respect of recommendations 2, 3, 4, 5, 6 and 8. While most of the ten recommendations

21 have been satisfactorily addressed, there are some actions that have not yet been implemented and one recommendation that has not been addressed at all.

7. CLOSING MEETING

A closing meeting was held on the 2nd July with representatives of the Competent Authorities. The mission team presented the main observations and initial conclusions of the mission. The representatives of the Competent Authority accepted the initial conclusions presented during that meeting with some minor observations. Further information was requested regarding the laboratories and legislative provisions affecting sampling procedures and destruction of non-compliant lots.

8. RECOMMENDATIONS

8.1. To the Competent Authorities of Germany

Further to recommendations made in the report SANCO/8592/2002, the Competent Authorities of Germany should address the conclusions stated above in section 6, in order to improve the official control system of imported foodstuffs, and in particular:

(1) Ensure that the procedure to take the replicate sample for enforcement, defence and reference purposes is in compliance with the relevant legal provisions and that this procedure is harmonised through all Länder.

(2) Ensure that all sampling procedures at import point are carried out in accordance with Council Directive 98/53/EC.

(3) Take measures to ensure that accurate data regarding consignments of food commodities are available to the Authority in charge of import controls.

(4) Consider to take measures that the results of tests carried out in private laboratories are duly notified to the competent official body in Hamburg.

(5) Proceed with the actions initiated to widen, increase and strengthen import controls on foodstuffs of plant origin, in order to attain a level of official controls at the appropriate stage which will prevent risks to public health within the meaning of Council Directive 89/397/EEC.

(6) Consider to include foodstuffs of plant origin in import controls on foodstuffs potentially exposed to ionising radiation .

Written assurances should be forwarded to the European Commission with regard to the above recommendations within two months of receipt of the final translated mission report. The Competent Authority should provide detailed information on the actions that will be taken and propose deadlines by which these actions will be completed.

22 9. ADDENDUM

Regarding the recommendations made in the draft report, initial comments were provided in relation to actions that have been or will be taken. With regard to recommendation (2), Bremen stated that they will check and rectify any non- compliances with Directive 98/53/EC. They informed that missing equipment will be purchased. With regard to recommendation (3), Bremen stated that completeness of documentation is ensured by a checklist. The relevant services have been instructed to ensure completeness of documentation.

23