Ref. Ares(2011)415390 - 13/04/2011

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO) 2011-6219 - MR FINAL

FINAL REPORT OF A MISSION

CARRIED OUT IN

GERMANY

FROM 26 TO 28 JANUARY 2011

IN ORDER TO REVIEW THE MEASURES TAKEN IN RESPONSE TO A RECENT CONTAMINATION OF FEED WITH DIOXINS

In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote. Executive Summary

This report describes the outcome of a fact-finding mission carried out by the Food and Veterinary Office in Germany from 26 to 28 January 2011. The overall objective of the mission was to review the measures taken by the German authorities in response to a recent contamination of feed and food with dioxins. In terms of scope, the mission concentrated on gathering information concerning the origin of the contamination and the risk management measures taken by the German authorities in response. The mission was also organised with a view to informing any decision on possible follow-up actions at European Union level aimed at avoiding similar incidents in the future. The report provides information about the contamination and the scale of the incident (including how it evolved as events unfolded and additional data became available) as well as about the risk management measures implemented along the different stages of the feed and food chain. These stages include: manufacturers of compound feed, in particular as regards the collection of information on the distribution of compound feed; farms, in particular as regards the process for their blocking and unblocking; and food of animal origin, in particular as regards the measures to ensure that it was not placed on the market. The report focuses on Niedersachsen, the federal State (Land) that has been most heavily affected by the contamination. The mission team holds the view that the German authorities took effective risk management measures in order to tackle the consequences of the contamination, notably in preventing the placing on the market of contaminated food. These measures involved significant resources and were implemented in a timely manner under pressure and changing circumstances.

I Table of Contents

1 INTRODUCTION ...... 1 2 OBJECTIVES OF THE MISSION ...... 1 3 LEGAL BASIS FOR THE MISSION ...... 1 4 FINDINGS ...... 2 4.1 THE INCIDENT ...... 2 4.1.1 FIRST NEWS ABOUT THE CONTAMINATION ...... 2 4.1.2 THE CHANGING SCALE OF THE CONTAMINATION AND ITS NATURE ...... 4 4.2 RISK MANAGEMENT MEASURES ...... 6 4.2.1 MANUFACTURERS OF COMPOUND FEED ...... 6 4.2.2 FARMS ...... 8 4.2.3 FOOD OF ANIMAL ORIGIN ...... 12 5 CLOSING MEETING ...... 15

II ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation BfR Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung) Federal Ministry of Food, Agriculture and Consumer Protection BMELV (Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz) Federal Office of Consumer Protection and Food Safety (Bundesamt für BVL Verbraucherschutz und Lebensmittelsicherheit) Farm distribution lists Lists of farms which had received potentially contaminated compound feed Feed mill Manufacturer of compound feed FVO Food and Veterinary Office HACCP Hazard analysis and critical control points Land/Länder Federal State(s) Landkries(e) District(s) The authority in charge of official controls in the feed area in Niedersachsen LAVES (Niedersächsisches Landesamt für Verbraucherschutz und Lebensmittelsicherheit) The authority in charge of official controls in the feed area in Schleswig-Holstein LSH (Landeslabor Schleswig-Holstein) Ministry of Agriculture in Niedersachsen (Niedersächsisches Ministerium für ML Ernährung, Landwirtschaft, Verbraucherschutz und Landesentwicklung) RASFF Rapid alert system for food and feed Samples of products used and of each batch of products manufactured or of each Retained samples specific portion of production which are retained by feed producers in order to ensure traceability PCBs Poly-chlorinated biphenyls The manufacturer of compound feed in Niedersachsen that first had access to the Triggering feed mill results of own-checks showing contamination of compound feed

III 1 INTRODUCTION

This mission took place in Germany from 26 to 28 January 2011 and was carried out by a team of three inspectors from the Food and Veterinary Office (FVO). The FVO team was accompanied during the whole mission by a representative from the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit – BVL) and by a representative from the Federal Ministry of Food, Agriculture and Consumer Protection (Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz – BMELV). An opening meeting was held on 26 January 2011 with the above representatives and with representatives from the competent authorities of Schleswig-Holstein. At this meeting, the FVO team confirmed the objectives of the mission and discussed its particular nature, including the applicable reporting procedures.

2 OBJECTIVES OF THE MISSION

The objective of the mission was to review the measures taken by the German authorities in response to a recent contamination of feed and food with dioxins. In terms of scope, the mission concentrated on gathering information concerning the origin of the incident and its subsequent developments, as well as on the management of the consequences of the contamination by the German authorities. The mission was also organised with a view to informing any decision on possible follow-up actions at European Union level aimed at avoiding similar incidents in the future. The table below lists the meetings held and sites visited in order to achieve the above objective.

MEETINGS/VISITS COMMENTS Central 2 Opening and closing meetings

COMPETENT Regional 2 Meetings with the State authorities in Schleswig-Holstein and Niedersachsen AUTHORITIES Meetings with the authorities in the districts of Vechta and Verden Local 2 (Niedersachsen) and discussions held in the course of visits to sites

SITES (ALL OF THEM IN NIEDERSACHSEN) The triggering feed mill (the one that first had access to the results of own- Manufacturers of 2 checks showing contamination of compound feed) and the feed mill located compound feed next to the pig farm mentioned below One poultry/pig farm that has been recently unblocked and the pig farm Farms 2 where animals whose meat was sent to two Member States had been fed, and which was still blocked at the time of the mission

3 LEGAL BASIS FOR THE MISSION

The mission was carried out in agreement with the German competent authorities. A full list of the legal instruments referred to in this report is provided in the Annex and refers, where applicable, to the last amended version.

1 4 FINDINGS

4.1 THE INCIDENT

4.1.1 First news about the contamination

A fat processor 1 located in Schleswig-Holstein purchased, between the beginning of November and mid December 2010, several consignments of mixed fatty acids (know as type 5359) for the purpose of producing fat. This fat processor produced both feed fat and fat for industrial uses in separate lines; however, at least in this particular case, they had subcontracted the production of feed fat (and, consequently, the use of most of the afore-mentioned mixed fatty acids type 5359) to another fat processor located in Niedersachsen. This information was unknown to the competent authorities until 27 December 2010 (see section 4.1.2). The above mixed fatty acids type 5359 had been purchased via a Dutch trader that handled both fat for the production of feed and fat for industrial uses. The Dutch trader had bought the fatty acids from a biodiesel plant, from which the material was delivered directly to the fat processor in Niedersachsen. The fat processor in Niedersachsen subsequently used these fatty acids for the production of feed fat which was directly dispatched therefrom to several manufacturers of compound feed (hereafter, feed mills) as vegetable fatty acids. On 21 December 2010 a feed mill located in Niedersachsen (hereafter, the triggering feed mill) was contacted by phone by the accredited laboratory responsible for the analysis for dioxins in the framework of the feed mill's own-checks. The triggering feed mill was informed that two samples of compound feed for laying hens had been found to have a contamination with dioxins above the maximum permitted levels 2; the same day, the triggering feed mill contacted the authority in charge of official controls in the feed area in Niedersachsen (Niedersächsisches Landesamt für Verbraucherschutz und Lebensmittelsicherheit – LAVES), and a meeting was scheduled for the following day. On 22 December 2010, the the triggering feed mill received from the laboratory written confirmation of the analytical result. On 22 December 2010 the triggering feed mill contacted the suppliers of the raw materials used for production of the concerned compound feed; the fat processor in Schleswig-Holstein declared that there was no problem with their fat. On 23 December 2010, the fat processor in Schleswig-Holstein phoned back the triggering feed mill to notify that they had just learned that mixed fatty acids that had been used for the production of feed fat were contaminated with dioxins (123 ng/kg 3). The fat processor in Schleswig-Holstein declared not to be aware of the level of contamination of the feed fat. On 23 December 2010 the fat processor in Schleswig-Holstein phoned Landeslabor Schleswig- Holstein (LSH), the authority in charge of official controls in the feed area in that Land (federal State), to notify that they had received an analytical result that showed contamination with dioxins beyond the maximum permitted levels 2 in a batch of mixed fatty acids used for the production of feed fat. LSH requested that written information be provided concerning the results of the analysis as well as the list of deliveries of the fat (see section 4.1.2). Observations: • The contract between the biodiesel plant and the Dutch trader identified the concerned products as “Mixed fatty acids from cooking oils – not intended for food or feed purposes”. The contract

1 For the sake of simplifying the narrative (and avoiding the repeated used of the term business operator), the various businesses are referred to by function throughout the report. 2 As set out in Annex I to Directive 2002/32/EC of the European Parliament and of the Council. 3 Concentrations of dioxins are always expressed in ng/kg (or pg/g fat) WHO-PCDD/F-TEQ.

2 between the Dutch trader and the fat processor in Schleswig-Holstein identified the products as “Technical mixed fatty acids type 5359”. • According to LSH, the fat processor in Schleswig-Holstein was registered as a feed business 4 in 2006; in 2007 it was subject to a registration check, and a further inspection concerning equipment and facilities was also carried out. Two official inspections in the area of feed were carried out in 2008 (and five samples of fat were analysed, with satisfactory results). One official inspection was carried out in 2009, which focused mainly on record keeping and traceability requirements; three samples of fat were analysed for dioxins and the results were satisfactory. One official inspection was carried out in July 2010, in the framework of which one sample was analysed for dioxins, with satisfactory result. No major shortcomings had been found by the above official inspections. • LSH was aware (prior to December 2010) that the fat processor in Niedersachsen was working for the fat processor in Schleswig-Holstein, but only as storage premises and transporter. The fat processor in Niedersachsen was not registered as producer of feed fat 4, but only as a transporter of feed, and also as transporter of animal by-products and food since 2007. The fat processor in Niedersachsen was inspected by the authorities responsible for feed safety at the end of December 2010 (see section 4.1.2.2) for the first time since the entry into force of Regulation (EC) No 183/2005. • At the time of the mission, LSH was not in a position to comment on the hazard analysis and critical control points (HACCP) programme of the fat processor in Schleswig-Holstein as all the establishment's records had been seized by the public prosecution authorities. In the framework of the registration check carried out in 2007, the existence of a HACCP programme had been verified. However, LSH had never checked the appropriatness of the HACCP programme (e.g. whether it catered or not for the subcontracting of production and the potential risks stemming from the use of products of technical origin for the production of feed fat). They pointed out that this is meant to be a requirement which is part of the private quality schemes of the establishment (QS and GMP+), and that the fact that the business was certified under those provided sufficient guarantees that the HACCP programme was satisfactory. • LSH could not see legal grounds for prohibiting the use of technical fatty acids in the production of feed unless it is explicitly mentioned that these are not to be used for this purpose. In their view, some establishments, notably food businesses, are reluctant to label their products as feed and so frequently do not make the distinction between products intended for technical use or for use in feed, preferring instead a neutral term product description without any indication of intended use. LAVES declared that the use of technical products in the production of feed would be acceptable for them only if there is satisfactory evidence that the products meet all relevant feed safety criteria, laying the burden of proof in this regard on the user of the material. • A fat processor in another Land had bought three consignments of the same mixed fatty acids from the Dutch trader. According to information provided by the competent authorities in that Land: this establishment produces fat for feed and for technical uses in separate lines; an inspection carried out on 21 January 2011 confirmed that these fatty acids had been used in the technical line for the production of fat for the steel industry; the establishment had been inspected regularly in recent years, and samples had been analysed; the last inspection (and analysis of samples) was carried out in January 2011; no non-compliance has been found since 2004. • The triggering feed mill had taken the two samples of compound feed on 24 November 2010 as part of their obligations stemming from the GMP+ quality assurance scheme, which envisaged

4 In accordance with Regulation (EC) No 183/2005 of the European Parliament and of the Council.

3 for this feed mill the analysis for dioxins of seven samples of compound feed each year; previous analysis had not revealed any contamination with dioxins. The triggering feed mill declared that the turn-around time for obtaining the result of the analysis was within the usual range (three-four weeks). • On 22 December 2010 the competent authorities from Niedersachsen considered whether it was appropriate or not to issue a notification concerning the contamination of animal feed with dioxins via the rapid alert system for food and feed (RASFF). They decided against, on the basis of the limited scale of the incident, as it appeared to them at this stage.

4.1.2 The changing scale of the contamination and its nature

4.1.2.1 Schleswig-Holstein

On 27 December 2010 the fat processor in Schleswig-Holstein submitted to LSH some of the requested information, which revealed that seven feed mills had received contaminated fat; the feed mills were located in other Länder, especially in Niedersachsen. The fat processor in Schleswig- Holstein declared that the contamination had been caused by a human error whereby fatty acids intended for use in the paper industry were accidentally used for the production of feed fat in the fat processor in Niedersachsen. Other Länder were informed by phone and e-mail about the incident and the first RASFF message was drafted and submitted to BVL, which issued it the following day. On 29 December 2010 LSH inspected the fat processor in Schleswig-Holstein, and they found out that the operator had already detected (in the framework of their own-checks) that the maximum permitted levels for dioxins 2 had been exceeded on three occasions (in March, June and October 2010); the levels ranged from 1.14 to 1.64 ng/kg. At this establishment, LSH blocked all stocks containing mixed fatty acids type 5359 and similar mixed fatty acids that were not clearly labelled as feed or food and took samples for analysis. On 2 January 2011 LSH carried out another inspection at the fat processor in Schleswig-Holstein and this revealed that the incident was not the consequence of a one-off human error, but that there were several cases where mixed fatty acids type 5359 had been used for the production of feed fat. Consequently, it was assumed that other batches of feed fat that had been put on the market were also potentially contaminated. The potentially contaminated fat had been dispatched to 25 feed mills in Germany, whose compound feed had been dispatched to nearly 5,000 farms. LSH took all retained samples 5 of incoming consignments of fatty acids received from 11 November to 15 December 2010 (the delivery period of mixed fatty acids type 5359), and the corresponding outgoing products, for analysis. Observations: • LSH received the results concerning the contamination of the fatty acids during the first week of January 2011. • According to LSH, the set of documents received on 27 December 2010 contained a first list of deliveries of feed fat to feed mills (which was subsequently revealed to be incomplete) but without identifying the batches; from these documents, the authorities became aware, for the first time, that the production of the feed fat had taken place in Niedersachsen and not in Schleswig-Holstein.

5 I.e. samples of products used and of each batch of products manufactured or of each specific portion of production which are retained by feed producers in order to ensure traceability, as laid down by Annex II to Regulation (EC) No 183/2005, point 3 of the section concerning quality control.

4 • According to LSH, the inspection carried out in the fat processor in Schleswig-Holstein on 2 January 2011 revealed the existence of seven other consignments of mixed fatty acids type 5359. On 5 January 2011 LSH learned about another consignment, following the seizure by the police at this establishment of a laboratory logbook with comprehensive information. LSH noted that another consignment (the ninth one) had been delivered directly to the fat processor in Schleswig-Holstein for the production of fat for the paper industry.

4.1.2.2 Niedersachsen

On 23 December 2010 LAVES collected at the the triggering feed mill the lists of farms which had received potentially contaminated compound feed (hereafter, farm distribution lists) and crisis management measures were undertaken; 22 farms were affected (see section 4.2). On 27 December 2010 the competent authorities inspected the fat processor in Niedersachsen and the operations effectively carried out therein were established (see section 4.1.2.1). Another inspection was carried out the following day, where samples were taken and documents inspected. On 29 December 2010 another inspection was organised, which was a joint inspection involving the food surveillance authority, LAVES and the Landkreis (district) authorities. LAVES noted that retained samples and delivery lists for the manufactured feed fat were not kept at the fat processor in Niedersachsen; LSH confirmed that delivery lists and retained samples were only in the hands of the fat processor in Schleswig-Holstein (retained sampled were sent by courier to Schleswig- Holstein on a weekly basis). LAVES did not find any documentation concerning the production of feed fat at the fat processor in Niedersachsen. The same day, LAVES blocked all tanks containing feed products (there was no feed fat at the establishment) and the transport of feed was also prohibited. On 30 December 2010 LAVES had already checked the (at that moment) seven affected feed mills, whereby it has been found that no compound feed had been distributed outside Niedersachsen. However, on 3 January 2011 the authorities from Schleswig-Holstein notified other Länder about the distribution of potentially contaminated fat to more feed mills (located mostly in Niedersachsen); this resulted in the need to implement risk management measures in a substantial number of new farms. On 12 January 2011 LAVES carried out an on-the-spot inspection to a feed mill (see section 4.2.1). This inspection was triggered by the detection by LAVES of a mismatch between the feed fat and the produced compound feed (the amount of feed fat purchased from the fat processor in Schleswig- Holstein was significantly higher than the amount of fat that would have been used for the compound feed that this feed mill had declared as produced). The inspection found out that this feed mill had submitted incomplete farm distribution lists, which did not include the deliveries of compound feed to some farms. LAVES compiled the real farm distribution lists. On 12 January 2011 LAVES also learnt that a laboratory analysing retained samples of feed fat for another feed mill (see section 4.2.1) had accidentally mixed up two samples and, as a consequence, the analytical results that had been originally provided reflected a level of contamination lower than the real one; therefore, the contamination with dioxins of the concerned compound feed had to be re-assessed (see section 4.2.2). The above-mentioned episodes of 12 January 2011 had an impact in the scale of the incident, since they resulted in the drafting of more farm distribution lists (and in the need to re-evaluate pre- existing ones). Approximately 1,000 farms had to be blocked (these were either new farms or farms that had been unblocked on the basis of erroneous information).

5 Observations: • Both feed mills visited by the mission team were aware that the fat sold by the fat processor in Schleswig-Holstein was produced by the fat processor in Niedersachsen. In both cases, the feed mills were under the assumption that the fat processor in Schleswig-Holstein took full responsibility over the fat. According to the triggering feed mill, they had developed a certain degree of trust towards the fat processor in Schleswig-Holstein with which they have been satisfactorily working for more than 20 years. The other feed mill visited had worked for a few years with the fat processor in Schleswig-Holstein and relied on the GMP+ and QS certification of the fat processor; this feed mill requested a confirmation of the certification of its suppliers every year, and held the view that it was out of question that a certified establishment could not be working within the rules of the quality schemes. • LAVES noted that they created a telephone information line for citizens on 4 January 2011; at the peak of the incident, this telephone line had to be continuously manned by three people.

4.1.2.3 Profile of the contamination

The analytical results of mixed fatty acids at the fat processor in Schleswig-Holstein showed a pattern of contamination which concerned, almost exclusively, dioxins, i.e. there was very little contamination with poly-chlorinated biphenyls (PCBs). Subsequent analytical results confirmed this contamination profile. As a result, the German authorities focused their analytical efforts on the analysis of dioxins (and not on PCBs). Observations: • The German competent authorities noted that no new synthesis of dioxins is expected in the biodiesel process, therefore, the causes behind the contamination of four batches of mixed fatty acids with four specific dioxin-congeners to a level of up to 145 ng/kg remain to be found. They also pointed out that the relevant legislation concerning chemical processes was satisfactorily complied with by the concerned biodiesel plant.

4.2 RISK MANAGEMENT MEASURES

4.2.1 Manufacturers of compound feed

By 30 December 2010 LAVES had collected on-the-spot the farm distribution lists at the (by then) seven affected feed mills. On 4 January 2011 LAVES requested that the (now 20) affected feed mills (see section 4.1.2.2) submit to them the farm distribution lists. Given that the latter farm distribution lists had been produced by the feed mills, LAVES subjected them to a plausibility check in order to establish if they made sense; this resulted in the discovery that wrong data had been provided by one feed mill, which was subsequently inspected (see section 4.1.2). Aside from the afore-mentioned feed mill, LAVES inspected three other randomly chosen feed mills in order to carry out a check on their farm distribution lists (i.e. they were compared with traceability checks carried out by LAVES on-the-spot); moreover, checks on the farm distribution lists were also carried out on 12 farms. These checks showed that (with the exception of the afore- mentioned case) the information submitted by the feed mills was accurate. Observations: • On 22 December 2010 the triggering feed mill decided, in agreement with LAVES, to suspend the production and delivery of compound feed for laying hens. On 23 December 2010, the feed

6 mill contacted all the laying hens farmers that had received contaminated compound feed, and asked them to block the delivery of eggs and to submit samples for analyses of dioxins. • The other feed mill visited by the mission team was informed by LAVES about a possible contamination of the feed fat on 27 December 2010; LAVES advised to stop using the fat. This feed mill phoned the same day to the fat processor in Schleswig-Holstein, which declared that although there had been a contamination incident this feed mill was not affected. Because of increasing concerns about the feed fat, this feed mill stopped using it on 29 December 2010. On 31 December 2010 this feed mill received a fax from the fat processor in Schleswig-Holstein informing that a contamination of 36.5 ng/kg in the fat sold to them had been detected; the following week LAVES confirmed the contamination. In September 2010 this feed mill had analysed for dioxins a sample of compound feed (in the framework of their own-checks) with favourable results. • LAVES noted that the affected feed mills were requested to inform urgently their clients about the incident and to recall any contaminated feed from the market, which would remain blocked. At the farms visited, the mission team confirmed that information on the incident had been received from the feed mills and that all compound feed had been already consumed. • LAVES noted that, aside from the official analyses, the affected feed mills also wanted to analyse privately their retained samples of feed fat and compound feed. LAVES agreed to this, on the condition of receiving the results of the analyses. The results of the analyses requested by these feed mills were also used for the implementation of risk management measures at farm level (see section 4.2.2). • LAVES noted that the reliability of the samples analysed at the request of feed mills (i.e. the confirmation that the feed mills had requested the analysis of samples from the affected fat or compound feed and not from other products) was ensured by comparison of their analytical results with the estimations that could be made with the analytical results of retained samples of fat that had been seized at the fat processor in Schleswig-Holstein 6 and/or with the analytical results of official samples of fat taken at feed mills. In this sense, LAVES noted that, in many cases there were batches of fat for which two analytical results were available, which facilitated ascertaining the reliability of the results of the analyses requested by the feed mills 7. • At the time of the mission, LAVES noted that 115 samples of fat had been analysed (22 officially and 93 by the feed mills), out of which 53 (three official and 50 fed mill samples, respectively) showed a dioxin content above the maximum permitted levels 2. • At the time of the mission, LAVES noted that 81 samples of compound feed had been analysed (five officially and 76 by feed mills), none of which showed a dioxin content above the maximum permitted levels 2 (aside from the two original ones – see section 5.1.1). LAVES confirmed that the analysis of compound feed had been undertaken with a view to providing further assurances about the estimation of the contamination levels, which was mostly extrapolated from the analytical results of feed fat (see section 4.2.2). • The mission team noted that from the information provided by the authorities from Hamburg, Nordrhein-Westfalen, and Saxon-Anhahlt, it was clear that in those Länder the risk management measures in feed mills were comparable to those implemented at Niedersachsen. The only

6 In their response to the draft report, the competent authorities noted that during loading at the fat processor in Niedersachsen two retained samples of fat were taken from each delivery; one sample was dispatched to the receiving feed mill and the other one was stored at the fat processor in Schleswig-Holstein. 7 In their response to the draft report, the competent authorities noted that all samples of fat that had been taken at the fat processor in Niedersachsen were tested. Moreover, the results of dioxin testing of the fat samples from the feed mills had to be introduced by them in an ad hoc table created by LAVES. This enabled LAVES to compare both results.

7 difference is that in the former Länder, given that the number of affected feed mills was much lower, the farm distribution lists had been collected by the competent authorities on-the-spot.

4.2.2 Farms

On 23 December 2010, the (then) affected Landkreise in Niedersachsen were informed by the Ministry of Agriculture in Niedersachsen (Niedersächsisches Ministerium für Ernährung, Landwirtschaft, Verbraucherschutz und Landesentwicklung – ML) about the need to block farms that had received potentially contaminated feed; other Landkreise authorities were informed as soon as more news about the contamination emerged. Thereafter, farms that had received potentially contaminated feed were urgently blocked by the Landkreise authorities and any remaining feed was recalled. LAVES noted that the Landkreise authorities had to examine nearly 44,000 deliveries of compound feed in order to establish which farms had to be blocked; during the first week of January 2011, approximately 4,500 farms were blocked. Most of the farms were located in the territory of the Landkreis Vechta (Niedersachsen). For the purpose of taking a decision on whether to block a given farm or not, LAVES developed a traffic light system. The system was based on whether the dioxin content in the compound feed that the farms had received was estimated to be above or below 0.5 ng/kg (which is the relevant action threshold for dioxins 8). The dioxin content in the compound feed was estimated multiplying the dioxin content in the fat by its incorporation rate; for instance, compound feed with 2.3% of fat known to contain 48.9 ng/kg yields an estimate of 1.12 ng/kg (= 48.9 × 0.023). In the absence of knowledge about the dioxin content of the fat, the worst case scenario was used, i.e. a dioxin content of 61.7 ng/kg 9, which automatically resulted in an estimated dioxin content well above the afore-mentioned threshold (the incorporation rate of fat in compound feed varied between 2 and 10%). The system granting farms either a green, red or amber light, operated as follows: – Green light (dioxin content below 0.5 ng/kg): feed and food products are considered safe and the farm is not blocked (or it is unblocked); – Red light (dioxin content above 0.5 ng/kg): feed and food products are not considered safe and the farm is blocked (or it remains blocked); – Amber light (dioxin content unknown – worst case scenario used): feed and food products are not considered safe and the farm is blocked (or it remains blocked). Amber light farms were moved to either green or red light states on the basis of the analytical results on the dioxin content in fat. Red light farms are meant to remain blocked until the safety of food of animal origin originating at those farms is ensured by means of analytical results (see section 4.2.4). Once farms had been blocked, the implementation of the above traffic light system resulted in the need to re-evaluate on a daily basis the farms that could be safely unblocked (or those that had to be newly blocked or blocked again on the basis of the information emerging on 12 January 2011 – see section 4.1.2.2). ML noted that in Germany it is a legal requirement that there have to be “reasonable grounds” for killing animals; culling farmed animals only because they had been fed contaminated feed has not been deemed sufficient justification and such practice would be a criminal offence.

8 As set out in Annex II to Directive 2002/32/EC. 9 In the RASFF messages, the maximum content of dioxins detected in fat is reported to be 62.7 ng/kg. The German authorities presented the spread sheet with the analytical results to the mission team where it appears as 61.7 ng/kg.

8 Observations: • According to the authorities from the Landkreis Vechta: • At the beginning of the incident (only seven feed mills affected at that moment), 31 laying hens farms had to be blocked, and they were visited by officials in most cases. • Subsequently, during the first week of January 2011 they received the first set of farm distribution lists (20 feed mills affected at that moment, and approximately 10,000 deliveries of compound feed); the concerned farms (360) were blocked within 48 hours. Given that the amount of information that had to be processed surpassed the normally available resources, the Landkreis had to allocate up to 18 staff members to three task forces: one for analysing the farm distribution lists, another for notifying the 360 farms of their blockage in writing (the notification was sent by fax), and a third one for contacting by telephone these 360 farms in order to make sure that they had received the written notification. • On 14 January 2011 new farm distribution lists were received (this was due to the episodes of 12 January 2011 – see section 4.1.2.2) which contained almost the same number of deliveries of compound feed. Again, this information was processed within 48 hours (i.e. during the following weekend – 15 and 16 January 2011) and 364 farms were blocked in the same way. • Notifications for the blockage sent to farms also included instructions to report back to the Landkreis authorities and provide the following information: i) confirmation of data concerning the farm (registration and number of animals); ii) a template to be used for indicating the movement of animals in and out the farm; iii) a form for reporting the details concerning the deliveries of compound feed (type, amount and dates); iv) a copy of the blueprint of the farm for the purpose of identifying the precise location of the silos or buildings used for the storage of compound feed; and v) an indication about the location where samples of feed could be taken. Examples of these notifications were examined by the mission team, which found the same information on the poultry/pig farm visited. • The requested information was timely provided by farms: e.g. during the second wave of notifications 80% and 97% of farms had responded by 16 and 17 January 2011, respectively; the remaining (14) farms were contacted on 18 January 2011 and a response was immediately received. • Notifications for the release of farms were also sent in writing and included the relevant analytical results and a statutory document authorising the unblocking of the farm. The mission team found this information on the poultry/pig farm visited. • Since the beginning of the incident, the crisis unit that has been handling it in the Landkreis has been working from 8:00 am to 10:00 pm during the weekends, and longer on weekdays. • The poultry/pig farm visited was notified by the Landkreis about the need to block the poultry part of the farm (in particular to stop the delivery of eggs) by phone on 3 January 2011 and by fax on 4 January 2011 (also blocking the pig part of the farm). The farmer provided the necessary information to the Landkreis on 5 January 2011. The farmer decided subsequently to submit samples of eggs and pig meat for analysis (see section 4.2.3). On 10 January 2011 the farm received an unblocking notification from the Landkreis on the basis that the feed was not contaminated. However, on 14 and 15 January 2011, the poultry and pig parts of the farm were blocked again (this was due to the episodes of 12 January 2011 – see section 4.1.2.2). The farm was unblocked later on based on the result of the analyses that had been requested by the farmer (25 and 26 January 2011 for the pig and poultry parts of the farm, respectively).

9 • According to the authorities from the Landkreis Verden, on 3 January 2011 they received information about the need to block a number of farms; these farms were blocked orally the following day. The need to block more farms became known during the following days; a maximum of 13 farms had to be blocked. The Landkreis authorities visited most of these farms (there was no need to visit others since they kept less than three animals) and has maintained continuous contact with the affected farmers. Subsequently, many of these farms were unblocked following the traffic light system. At the time of the mission, only five (pig) farms remained blocked. • According to the authorities from the Landkreis Verden, on 12 January 2011 they started to make arrangements for the culling of some animals that had received contaminated feed; at that moment, the first doubts arose on whether there were legitimate grounds in order to justify the culling or not. The following day the Landkreis was officially informed by ML that there were no legitimate grounds in order to justify the culling. The Landkreis authorities noted that the housing of pigs was creating a serious animal welfare situation and that they had actively looked at other alternatives without success (e.g. using the meat to feed zoo animals, transferring the animals to shelters or using them for research purposes). The Landkreis authorities also noted that they had been criticised both by animal rights groups (for considering the culling of the animals) and by consumers' organisations (for keeping the animals on the farms, because they would grow and thus the contamination be diluted). • The German authorities confirmed that the above described traffic light system has been used by all affected Länder. ML presented documentary evidence that the system had been discussed and agreed by all Länder on 8 January 2011. • LAVES confirmed that where the real dioxin content of compound feed was known (because it had been analysed), this knowledge was used for the traffic light system. The mission team notes that the analyses of compound feed served mostly to confirm the estimates made from the level of contamination of the fat. • The analytical results of compound feed show relatively low levels of contamination 10. The mission team notes that this is coherent, since: a) where the estimated contamination of compound feed with dioxins exceeded the maximum permitted levels 2, it made no sense to analyse the compound feed; and b) it was much more cost effective to analyse fat, since a single analytical result would clarify the situation of several batches of compound feed that had been produced with the fat. • An action threshold is the content that has to trigger an investigation to identify the sources of undesirable substances, which is lower than the maximum permitted level (i.e. the level above which undesirable substances should not be tolerated) of 0.75 ng/kg for dioxins in compound feed 2. LAVES noted that the analytical focus on dioxins (thus not paying much attention to PCBs) was decided on the basis of the profile of the contamination (see section 4.1.3) and that the use of the action threshold 8 for the traffic light system was decided in agreement with the operators. • LAVES confirmed that, theoretically, it was possible for a red light farm to analyse privately the concerned compound feed in order to establish if its dioxin contamination was below 0.75 ng/kg but this did not happen. • LAVES noted that, if an analytical result of compound feed had shown a level of contamination above the action threshold 8 but below the maximum permitted level, the farms would not have been blocked and their product could have been placed on the market. The mission team notes that this is purely theoretical as such a result has not been obtained.

10 For further details, see Annexes 3b and 3bb of the RASFF message on this incident.

10 • Given the constant flow of analytical results (with its impact on the unblocking or confirmation of blocking of farms), on 12 January 2011 ML took the decision to request that the Lankreise inform LAVES on a daily basis about the status of the concerned farms. The mission team notes that this information was used for ensuring that pigs from blocked farms were not slaughtered (see section 4.2.3). • The mission team noted that from the information provided by the authorities from Hamburg, Nordrhein-Westfalen, and Saxon-Anhahlt, it was clear that in those Länder the risk management measures in farms were quite comparable to those implemented in Niedersachsen. The only difference is that in the former Länder the affected farms were blocked on-the-spot by officials in many cases, given that the number of these farms was much lower.

4.2.2.1 Extended risk categorisation

LAVES explained that the immediate blockage of farms was an essential measure in light of the precautionary principle, whereby it was assumed that animals that had received contaminated feed would yield contaminated food. However, it is not sustainable keeping the farms blocked indefinitely, since this creates animal welfare problems. Moreover: a) the current blockage of farms is not scientifically justified in all cases (given the knowledge about the extent and severity of the contamination), b) there is a limited capacity for analysing samples, and therefore, this needs to be prioritised, and c) the intake of contaminated feed has completely ceased. In light of the above, LAVES developed an extended risk categorisation, that has been envisaged for the future unblocking of farms, whereby an estimate is made of the extent to which animals of different species or production types are contaminated. The estimate takes account of: a) the amount and duration of the exposure to dioxins via feed, b) the analytical results obtained in blocked farms, and c) the scientific knowledge about the toxico-kinetics of dioxins in the animal body (residues and excretion). The estimate is underpinned by the fact that, while there is no elimination of dioxins from contaminated tissues, dioxins are excreted where animals mobilise fat (notably in milk and eggs production), and there is a reduction in the absolute content of dioxins where there is an increase in the fat tissue (due to growth). Following this rationale, the approach used would be as shown below. The blocking can be lifted for farms (or part thereof) of: – sows (that is their piglets can be released); however, sows' meat can be placed on the market only after a favourable analytical result; – piglets, provided that the animals are subsequently fattened until they reach the normal slaughtering weight (no less than 110 kg) and they are not placed on the market otherwise; – fattening pigs which were less than 60 kg at the end of the exposure and are fattened until they reach at least 110 kg; – breeding poultry (that is their progeny can be released); however, meat from the parent animals can be placed on the market only after a favourable analytical result. The blocking cannot be lifted, and it continues until favourable analytical results are obtained, for farms (or part thereof) of: – fattening turkeys; – laying hens and their eggs; – fattening pigs which have reached the slaughter weight;

11 – suckling and underweight pigs. In parallel, three monitoring programmes for different animals are envisaged (with a budget of 100,000 €), in order to gather information on whether the maximum dioxin content of their meat 11 is exceeded or not: – sows: to confirm the assumption that the limit is not exceeded after completion of one additional reproductive cycle (due to the excretion of dioxins in maternal milk). – laying hens: to clarify how long their meat remains above the limit after the last exposure to contaminated feed. – piglets and fattening pigs: to confirm the assumption that the the limit is not exceeded in pigs that weighed less than 60 kg at the end of the exposure to contaminated feed and are subsequently fed until they reach a slaughter weight of at least 110 kg. Observations: • LAVES noted that the extended risk categorisation results in fewer unnecessary analyses being carried out, and the transfer of released capacity to the analyses of monitoring samples. Ultimately, the monitoring programmes will provide information that could be used for the management of other incidents. • LAVES noted that it was essential for the extended risk categorisation to establish the end of the exposure of animals to contaminated feed and, to that end, farms were being individually contacted to gather as much information as possible. • On 20 January 2011 the extended risk categorisation was presented to the Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung – BfR), BVL, BMELV and the authorities in other Länder. LAVES adapted the extended risk categorisation following the receipt of comments from BfR and BVL on 24 January 2011. • At the time of the mission, the extended risk categorisation had not been implemented yet. According to LAVES this would occur in the coming days following consultation with BMELV.

4.2.3 Food of animal origin

Once the contamination had been detected, ML immediately instructed the Landkreise authorities to inform farmers that had received potentially contaminated compound feed about their responsibility of not placing on the market unsafe products 12; the Landkreise authorities were also asked to start the sampling of food products originating from animals that had received potentially contaminated feed; an analytical result showing the maximum permitted levels for dioxins 11 had not been exceeded was necessary prior to any unblocking of farms (or before food products were allowed to be placed on the market, if the products had already left the farms). Given the scale of the contamination, ML decided to also rely on analyses carried out by operators (farmers, egg collectors, dairy plants, etc.), in order to establish the dioxin content in the concerned food products; these operators had already expressed an interest in analysing samples of their food products. To that end, instructions to Landkreise and operators concerning sampling were issued on 3, 4 and 5 January 2011; the following was required per flock or group of animals which had been fed from a given batch of compound feed: – Eggs: analysis of a pooled sample from 20 eggs per flock.

11 As laid down by the Annex to Commission Regulation (EC) No 1881/2006. 12 In accordance with Articles 14 and 19 of Regulation (EC) No 178/2002.

12 – Poultry (broilers and laying hens): analysis of a mixed sample of meat from seven animals. – Pigs: analysis of a mixed sample of meat from two animals. – Cattle: analysis of a mixed sample of meat from two animals. – Cow milk: analysis of a pooled sample of one litre. If necessary, details about the weight of the sample had to be clarified directly with the laboratories carrying out the analysis (a list of private, accredited, laboratories was also provided), with which arrangements could be made for taking the sample during slaughtering (if applicable); food products would be detained until the analytical results became available. Samples had to be taken by the farmer, together with either the private veterinarian (in the case of eggs and milk) or the official veterinarian at the slaughterhouse (in the case of meat). Moreover, the authorities informed operators that the use of a bioassay for the analysis of dioxins was not acceptable. Observations: • As of 25 January 2011, the following samples of food of animal origin had been found to exceed the maximum permitted levels for dioxins 11 in Niedersachen: – eggs and egg products: eight (three official and five operators') out of 147 samples; – pig meat: one (official) out of 120 samples; – turkey meat: none out of 56 samples; – laying hen meat: none out of four samples; – chicken meat: none out of three samples; – cattle meat: none out of one sample; – cow milk: none out of 26 samples. • ML noted that at the beginning of January 2011 pig slaughterhouses became increasingly concerned about ensuring that pigs from blocked farms were not being slaughtered; the authorities from the Landkreis Vechta confirmed that prior to 10 January 2011 they had received numerous requests from slaughterhouses to certify that pigs intended for slaughter came from unblocked farms. Given that the certification was not sustainable in the face of other obligations of the authorities during this period, on 11 January 2011 ML decided to make use of the QS quality scheme in order to reassure slaughterhouses in this respect. To this end, LAVES submitted on a daily basis an updated list of blocked farms to staff working at the QS scheme who, in turn, transmitted this information to their associates 13. • ML noted they had found no evidence of attempts to slaughter animals from blocked farms. The authorities from the Landkreis Vechta confirmed this information. • ML noted that the ante mortem inspection carried out at poultry farms was used to ensure that animals from blocked farms were not slaughtered. • ML noted that for cattle and dairy farms, the monitoring of the blocking of farms was not a problem, given that only a few of them were blocked. LAVES was in frequent contact with dairy plants in order to inform them about whether milk could be placed on the market or not. • For consumer protection reasons, ML and LAVES published on their websites the production codes of potentially contaminated eggs.

13 ML noted that most pig slaughterhouses, encompassing nearly 99% of the pig meat production in Germany, are part of the QS quality scheme.

13 4.2.3.1 Pig meat delivered from Germany to the Czech Republic and Poland

On 5 January 2011 a Landkreis in Niedersachsen learnt from LAVES that some farms had received potentially contaminated feed from the second feed mill visited. The farms (among which the farm next to this feed mill was included) were verbally blocked the same day. On 6 January 2011 a sample from the meat of pigs from (among others) the above farm was taken at slaughterhouse level. The Landkreis in Niedersachsen learnt about the analytical result on 10 January 2001 (1.51 pg/kg), which showed that the maximum permitted levels 11 were exceeded, and immediately informed the farm and started the tracing back of any possible movement of animals. From this tracing exercise, the Landkreis in Niedersachsen found out that some animals which had been fed the same feed had been sent to Saxon-Anhalt for slaughtering in December 2010. On 11 January 2011 the Landkreis in Niedersachsen drafted a RASFF notification concerning the above slaughtering and sent it to LAVES. On 12 January 2011 the Landkreis in Niedersachsen contacted the Landkreis in Saxon-Anhalt where the slaughtering of animals had taken place. On 13 January 2011 at 15:00 BVL received a RASFF notification from Saxon-Anhalt, concerning the delivery of pig meat (from the concerned cutting plant) to the Czech Republic and Poland. BVL requested that the information be verified, which is a requirement under German legislation. On 14 January 2011 at 9:06 BVL sent an informal notification to the Czech and Polish authorities. At 10:19 BVL sent the follow-up RASFF notification to the Commission. Observations: • On 11 January 2011 the Landkreis in Niedersachsen held a press conference concerning the dioxin contamination issue; the same day they also had to attend a follow-up actions meeting in Oldenburg. According to this Landkreis, the pressure from the media on that day would explain why they only phoned the Landkreis in Saxon-Anhalt the following day. • According to the information provided by the authorities from Saxon-Anhalt: – on 12 January 2011 at 13.30, the Land authorities in Saxon-Anhalt were informed by the Landkreis in that Land about the pig meat; – on 12 January 2011 at 13:51, the Land authorities in Saxon-Anhalt requested additional information on the pigs in question from the Land authorities in Niedersachsen; – on 12 January 2011 at 13:58, the Landkreis in Saxon-Anhalt informed their Land authorities about the distribution of the pig meat from the cutting plant; – on 12 January 2011 at 16:50, the Land authorities in Saxon-Anhalt received the requested additional information from the Land authorities in Niedersachsen; – on 12 January 2011 at 17:57, the Landkreis in Saxon-Anhalt informed their Land authorities that the information had been verified; at the same time, the concerned establishments in the Czech Republic and Poland were informed by the cutting plant; – on 12 January 2011, subsequent to the above action, the Land authorities in Saxon-Anhalt requested further information from the Landkreis in that Land, notably as regards the identification of the pig meat; – on 13 January 2011 at 13:26, the Landkreis in Saxon-Anhalt provided the requested information to their Land authorities, which the latter authorities subjected to plausibility checks;

14 – on 13 January 2011 at 15:00, the Land authorities in Saxon-Anhalt sent the RASFF message to BVL.

5 CLOSING MEETING

A closing meeting was held on 28 January 2011 with representatives from BVL and BMELV and from the authorities in Schleswig-Holstein and Niedersachsen. The FVO team used this meeting to recapitulate the findings of the mission and to ensure that they were factual and correct. The German authorities did not express any disagreement with these findings.

15 ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Reg. 178/2002 OJ L 31, 1.2.2002, p. Regulation (EC) No 178/2002 of the European 1-24 Parliament and of the Council of 28 January 2002 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

Dir. 2002/32/EC OJ L 140, 30.5.2002, Directive 2002/32/EC of the European Parliament p. 10-22 and of the Council of 7 May 2002 on undesirable substances in animal feed - Council statement

Reg. 183/2005 OJ L 35, 8.2.2005, p. Regulation (EC) No 183/2005 of the European 1-22 Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene

Reg. 1881/2006 OJ L 364, 20.12.2006, Commission Regulation (EC) No 1881/2006 of 19 p. 5-24 December 2006 setting maximum levels for certain contaminants in foodstuffs

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