DG Health and Food Safety. Overview report Hazards and Management of Risks in the Feed Sector. Health and Food Safety

Transcription

1 DG Health and Food Safety Overview report Hazards and Management of Risks in the Feed Sector Health and Food Safety

2 Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you). Online information about the European Union is available at: Further information on the Health and Food Safety Directorate-General is available on the internet at: Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. Photos : Health and Food Safety Directorate-General Luxembourg: Publications Office of the European Union, 2017 Electronic version ISBN doi: /60288 Catalogue number: ND-BC EN-N Paper version: ISBN doi: / Catalogue number: ND-BC EN-C European Union, 2017 Reproduction is authorised provided the source is acknowledged.

3 Ref. Ares(2017) /01/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) MR OVERVIEW REPORT OF A SERIES OF AUDITS CARRIED OUT BETWEEN 2012 AND 2014 ON IDENTIFICATION OF HAZARDS AND MANAGEMENT OF RISKS IN THE FEED SECTOR IN MEMBER STATES

4 Executive Summary This overview report provides a summary of the audits in the area of feed safety carried out by the Directorate-General for Health and Food Safety in 21 Member States (MS) from 2012 to The overall objective of this series of audits was to evaluate the implementation of requirements concerning the identification of hazards and management of risks along the feed chain. Overall, the audit series indicated that most of the essential measures for the organisation of official controls have been satisfactorily put in place by the MS visited, notably: mechanisms to ensure adequate competence/qualification of staff, and procedures to carry out official controls, follow-up non-compliances and verify the effectiveness of official controls. Moreover, the requirements related to infrastructure, homogeneity of feed and traceability were, in general, effectively checked by the competent authorities in most feed operators. Nonetheless, the following areas showed some weaknesses, namely: a) the planning of official controls, the risk-basing of which was weakened, in most MS visited, by limited knowledge of the activities of certain feed operators, notably those supplying their coproducts and surplus food into the feed chain, and by the fact that some risks were not well assessed by competent authorities (mainly those linked to the cross-contamination with coccidiostats and the direct drying of feed); b) the gaps and lack of specificity in the hazard analysis of ingredients applied by feed business operators and the insufficient level of scrutiny on these issues during the checks carried out by most competent authorities; c) the insufficiency of the measures put in place by the feed operators to ensure and verify that cross-contamination with coccidiostats does not result in the relevant maximum limits being exceeded in non-target feed, and the absence of sufficient controls in this area by most competent authorities. These weaknesses, which, to some extent, were also reported in an overview report on a series of feed audits (DG(SANCO) GR Final), still limit the effectiveness of the overall control systems. The individual audit reports include recommendations addressed to the competent authorities in the MS concerned with a view to rectifying the identified shortcomings and/or further enhancing the implementing and control measures in place. Following the audits, actions aimed at addressing these recommendations were taken or announced by these competent authorities. Therefore, it is emphasised that the picture described in this overview report reflects the situation found at the time of the audits. II

5 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE LEGAL BASIS BACKGROUND Previous audits Methodology OVERVIEW OF MAIN FINDINGS AND CONCLUSIONS Official control systems in the feed chain Competent authorities Planning of official controls Procedures and records of official controls Verification of official controls Registration and approval of feed establishments Action in case of non-compliances Conclusions on the official controls systems in the feed chain Implementation of requirements along the feed chain Sourcing of feed Labelling of feed Infrastructural and organisational requirements Cross-contamination with coccidiostats and other veterinary medicines Homogeneity of feed Undesirable substances Traceability HACCP-based procedures Conclusions on the implementation of requirements along the feed chain Overview of official control systems' assessment OVERALL CONCLUSIONS OVERVIEW OF RECOMMENDATIONS ACTION TAKEN OR ENVISAGED BY THE COMMISION SERVICES Follow-up of audit recommendations Other actions...22 ANNEX 1 - Legal references ANNEX 2 - Report on dioxins in oils, fats and products derived thereof ANNEX 3 - Requirements concerning the marketing of feed ANNEX 4 - Details of individual audits III

6 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation BTSF Cross-contamination EU HACCP MS PCB Explanation Better Training for Safer Food Presence due to production processes, of additives, medicines or ingredients in feedingstuffs that should not contain them European Union Hazard analysis and critical control points Member State Polychlorinated biphenyl IV

7 1 INTRODUCTION This report provides an overview of the outcome of a total of 21 audits in the area of feed safety carried out between 2012 and 2014 in 21 Member States (MS) by the Directorate- General Health and Food Safety. These audits were part of the annual audit programmes of the Directorate-General Health and Food Safety. It should be noted that, within the 21 audits, a series of 19 audits focused on the implementation of requirements concerning the identification of hazards and management of risks along the feed chain. Seven of these audits also included the implementation of requirements concerning oils, fats and products derived thereof for use in animal feeding. Two further audits were carried out only on the requirements concerning oils, fats and products derived thereof for use in animal feeding. The main findings and conclusions of the audits on this topic are included in Annex 2 to this report. Moreover, during the series of audits in 19 MS, the audit teams gathered information on a selected number of key requirements related to the marketing of feed as laid down by Regulation (EC) No 767/2009 of the European Parliament and of the Council. Annex 3 to this report includes a summary of the information gathered. 19 MS Risk management in feed chain 7 MS Dioxin in oil/fats 2 MS Dioxin in oil/fats The Member States visited and reference numbers of the individual reports are provided in Annex 4. Directorate-General Health and Food Safety reports are available on the European Commission website at: 2 OBJECTIVES AND SCOPE The overall objective of the audits within this series was to evaluate the implementation of requirements concerning the identification of hazards and management of risks along the feed chain. In support of this objective, the audits took account of the relevant requirements on: a) feed hygiene, as laid down by Regulation (EC) No 183/2005 of the European Parliament and of the Council, and other relevant legislation laying down requirements concerning feed safety, notably Regulation (EC) No 1831/2003 of the 1

8 European Parliament and of the Council, Directive 2002/32/EC of the European Parliament and of the Council and Regulation (EC) No 767/2009 of the European Parliament and of the Council; b) official controls on the implementation of the above legislation, as laid down by Regulation (EC) No 882/2004 of the European Parliament and of the Council. In terms of scope, the series of audits focused on activities and or products which, in the light of experience and past feed crises, are known to pose more of a risk than others (see section 4). The scope of the audits did not include the primary production of feed. 3 LEGAL BASIS The audits were carried out under the general provisions of European Union (EU) legislation and, in particular, Article 45 of Regulation (EC) No 882/2004. A full list of the legal instruments relevant for this report is provided in Annex 1 and refers, where applicable, to the last amended version. 4 BACKGROUND 4.1 PREVIOUS AUDITS The previous series of audits carried out by the Directorate-General Health and Food Safety in Member States in the area of feed took place between 2006 and That series was undertaken with a view to obtaining information about the implementation of requirements laid down by Regulation (EC) No 882/2004 and Regulation (EC) No 183/2005, and other feed legislation, in particular Regulation (EC) No 1831/2003, Directive 2002/32/EC and Regulation (EC) No 767/2009. After completion of the series, a general report (reference DG(SANCO) GR Final) summarising the main findings and conclusions was produced. The report is available at: The report showed major deficiencies across the board on the implementation of official controls on procedures based on hazard analysis and critical control points (HACCP) principles. In parallel, a number of past feed safety crises (e.g. dioxins in fatty acids or in dried food co-products) were linked to poor hazard identification and risk management measures by the feed operators concerned. These crises also showed that some activities could be considered more of a risk than others and, in some cases, this resulted in the legislation being amended. For these reasons, this series of audits focused on some requirements of the legislation concerning key areas where hazards had been identified and, therefore the consequent risks had to be managed. 4.2 METHODOLOGY The outcome of individual reports were assessed and the performance of official control systems categorised into 4 groups based on the severity of the issues identified: satisfactory, largely satisfactory, partially satisfactory and not satisfactory. 2

9 The results of this assessment have been displayed in the form of graphs in each of the relevant sections of this overview report. Sections and contain graphs which represent the overview of the average scores presented in the relevant sections of chapter 5.1 and 5.2, respectively. Section 5.3 contains a graph which illustrates the overall performances of the official controls systems of the various MS visited. Finally, in order to highlight the good practices identified during the series, some sections include a heading "Good practices identified". It should be noted that the good practices highlighted in this overview report are not meant to be exhaustive. 5 OVERVIEW OF MAIN FINDINGS AND CONCLUSIONS 5.1 OFFICIAL CONTROL SYSTEMS IN THE FEED CHAIN Legal requirements Articles 3, 4, 8(1), 8(3)(a), 9 and 54 of Regulation (EC) No 882/2004. Articles 9, 10 and 19 of Regulation (EC) No 183/ Competent authorities Main findings and conclusions In the vast majority of MS visited (14 MS) the audit teams noted that the competent authorities responsible for the official controls in the feed sector were clearly defined, the level of experience and knowledge was largely adequate for staff to perform their tasks and no gaps or overlaps were identified as regards the distribution of responsibilities. In general, adequate arrangements had been put in place to ensure a good co-operation and co-ordination between the competent authorities and central and local levels. In many MS these arrangements consisted of either one or more of the following: a) the setting up of working 3

10 groups, headed by the central competent authorities; b) providing access to internal documents and instructions to all the officials involved in feed controls; and c) joint inspections between officials at central and local level. Nevertheless, in five MS the audit teams identified a number of deficiencies which undermined the overall effectiveness of the official control systems. These weaknesses were mainly related to the lack of experienced staff in three MS. Moreover, in two other MS the audit team identified a lack of adequate communication between competent authorities which resulted, in one case in a limited follow up after the detection of a non-compliance and in another case in a lack of knowledge of certain feed business operators (supplying food-coproducts as feed materials) Planning of official controls Main findings and conclusions In most MS visited, inspections and sampling were generally planned and delivered on a risk basis and in the large majority of them, official controls were carried out without prior notification with the exception of audits (e.g. for the specific assessment of HACCP-based procedures) for which an appointment was generally made. However, the risk-based approach was weak in the vast majority of MS visited (15 MS) and this led to a number of recommendations. The deficiencies identified by the audit teams concerned the following main subjects: A general limited knowledge of certain types of feed operators and activities (see section 5.1.5) which prevented the competent authorities from planning their inspections on a risk basis, in six MS. In particular, this was the case for food establishments supplying co-products and/or surplus food into the feed chain (e.g. breweries, distilleries, sugar factories, confectionaries, bakeries, etc.), stand-alone feed dryers, processors of vegetable oil, fat blenders and transporters. 4

11 Not all relevant risks were adequately taken into account during official inspections: in particular, in eight MS the risk due to the cross-contamination with coccidiostats was overlooked; in five MS it was the specific risk posed by the direct drying of feed materials. The reliability of own-checks carried out by the feed business operators was not adequately taken into account in six MS both in terms of inspection frequencies and sampling for undesirable substances. This was often linked to a lack of assessment of the suitability of the HACCP-based procedures devised by the feed business operators (see section 5.2.8); the official sampling was poorly targeted, notably on cross-contamination with coccidiostats in five MS (see section 5.2.4) where samples to assess the effectiveness of the measures implemented by the feed operators to prevent such crosscontamination had been taken several mixer-runs after the last one containing coccidiostats. In two MS the audit teams highlighted also an excessive turnaround time for the official analyses, and in another MS there were significant weaknesses in the validation of the analytical methods used by the official laboratories carrying out feed analysis. In five of these MS the weaknesses were particularly serious (consequently ranked as "Not satisfactory") because they affected multiple segments of the controls systems, namely: in three MS almost the entire area of official sampling for undesirable substance was undermined by a lack of risk based approach, in another case the official laboratories were not able to provide reliable results of a wide range of feed analysis (namely, mycotoxins and organochlorine compounds) because their methods were not validated and in another one the deficiency concerning the risk based approach for the planning of inspections was worsened by the lack of analytical capability to detect all coccidiostats potentially used (see section 5.2.4). 5

12 Good practices identified In one MS (BE) the authority involved in the feed policy was certified according to ISO 9001:2008 Quality management systems - Requirements and the one involved in inspections was accredited according to ISO 17020:2012 Requirements for the operation of various types of bodies performing inspection. The application of this standard has encouraged the development of software tools and a comprehensive set of checklists, technical sheets and verification measures which enabled the competent authorities to harmonise their controls and, overall, strengthen their effectiveness. In two MS (BE and NL) the competent authorities have put in place mechanisms which enable them to take into account business operators' own-checks and, consequently, to reduce the number of official analyses to be carried out (see section 5.2.5). These mechanisms consist essentially of agreements with the main trade associations of manufacturers of compound feed containing specific conditions to be fulfilled for the sampling and laboratory requirements. The basis for the reduction of official samples ultimately depends on the sampling and analysis plans which are developed by the relevant trade associations for their members taking into account a common risk assessment of the main feed ingredients (based on the type, quantity, country of origin and known associated risks) and the type and quantity of such feed ingredients used by the feed operators Procedures and records of official controls Main findings and conclusions In all MS visited, the audit teams noted that largely comprehensive procedures/checklists to carry out inspections and to take samples were in place and inspectors were making use of them during official controls. These tools enabled competent authorities to ensure consistent and harmonised controls throughout the feed chain. Nonetheless, in three MS it was noted that the checklists used during inspections in food establishments placing co-products into the feed chain did not include any checks of relevant requirements on feed hygiene. 6

13 As regards records of official controls, although in the majority of MS visited (14) reports contained adequate information on how official controls were carried out, this was not the case in five MS. The main weakness identified in these MS was linked to the use of checklists containing generic questions, notably when the assessment of the compliance with a given requirement was positive. In such cases, the practice to record relevant checks only by ticking the "Yes" or "No" boxes beside the question without any further comment or detail was considered not in line with relevant requirement of Regulation (EC) 882/2004 because it did not make it possible to identify the control method used by inspectors and the basis of his/her assessments. Good practices identified In three MS (DE, FR and PL) it was noted that inspection reports included comprehensive details and supporting documents which can be used retroactively to better verify the inspection method used and the basis of the assessments of the various checks Verification of official controls Main findings and conclusions In general terms, in all MS visited, regular supervisory activities of official controls were in place in accordance with documented procedures. In the majority of MS these included joint inspections, and in some cases, the weaknesses identified through internal supervision coincided with those observed by the audit teams. However, these procedures were not developed enough in nine MS. In these cases the audit teams identified a wide range of shortcomings, including: the lack of records of verification activities, the assessment of noncompliances and their follow-up not included in the scope of the verification, limited 7

14 verification of effectiveness (e.g. verification mainly limited to the review of inspection reports) and performance of new inspectors not assessed Registration and approval of feed establishments Main findings and conclusions In all MS visited, the competent authorities had mechanisms to ensure that feed operators were registered and approved when necessary and relevant official lists of feed operators were, in general, largely updated. However, in 12 MS the audit teams noted a lack of knowledge of those establishments supplying part of their production to the feed chain but whose main activity is not in the feed area, namely, food establishments placing co-products and/or food surplus, in seven MS and transporters in two other MS. Moreover, in five MS the competent authorities did not have a complete picture of the feed operators involved in drying activities of feed materials and in three other MS the official lists did not reflect the activities carried out by the operators. This limited knowledge of certain feed operators is one of the main causes of the weaknesses identified in the planning of official controls (see section 5.1.2). 8

15 5.1.6 Action in case of non-compliances Main findings and conclusions of the individual reports In most MS visited (16), the competent authorities had put in place procedures to ensure that non-compliances identified during official controls triggered actions to rectify them, manage any non-compliant products, and address the cause(s) of the non-compliances. In general terms, these procedures were implemented satisfactorily and in a timely fashion, although in three MS certain weakness were identified in relation to the lack of records, a poor enforcement of the measures designed to rectify the non-compliance and long delays in the subsequent follow-up. Further minor weaknesses (for which no recommendations were made by the Directorate-General Health and Food Safety were identified in nine MS; these were mainly related to the lack of adequate follow-up. Good practices identified In one MS (FR), in the case of transport of feed and issues identified in relation to crosscontamination, the competent authority sought contact with the transport federation to raise awareness of transporters of feed. 9

16 5.1.7 Conclusions on the official controls systems in the feed chain The numbers at the top of each column represent the average scores obtained by all MS audited Overall, as illustrated by the graph above, most of the essential measures for the organisation of official controls have been satisfactorily put in place by the MS visited. These refer to the following subjects: the designation of competent authorities, the level of competence/qualification of the staff, the procedures/checklists to carry out official controls, the mechanisms put in place to follow-up non-compliances and the measures to verify the effectiveness of official controls. However, the outcome of the audit series indicates that the planning stage of official controls in the majority of MS (15 MS) was negatively affected by certain deficiencies, notably: a) the limited knowledge of certain feed operators (mainly food operators supplying coproducts and/or surplus food into the feed chain and transporters) and certain activities, in particular, the drying of feed. b) the limited or unreliable information collected by the competent authorities concerning the own-checks carried out by the feed operators, often linked with superficial checks on the suitability of the HACCP based-procedures, particularly in relation to the risk of cross-contamination with coccidiostats. This lack of knowledge and information, although limited to certain segments of the feed chain, activities and hazards, overall, prevented the competent authorities from fully planning their official controls on a risk basis. 10

17 5.2 IMPLEMENTATION OF REQUIREMENTS ALONG THE FEED CHAIN Legal requirements Articles 5(2), 5(6), 6 and 7 of Regulation (EC) No 183/2005. Articles 16 and 17 of Regulation (EC) No 767/2009. Article 16 of Regulation (EC) No 1831/2003. Directive 2002/32/EC Sourcing of feed Main findings and conclusions In the majority of the MS visited (11 MS) the obligation for feed operators to source only from registered/approved feed operators was satisfactorily (six MS) or largely satisfactorily (five MS) taken into account during official controls. In these MS the audit teams noted a variety of arrangements (checklists and guidelines) put in place by the competent authorities to support inspectors during official controls. In the remaining eight MS this requirement was overlooked by the competent authorities and in four of them the audit teams saw evidence of feed materials purchased from non-registered business operators. Such feed materials consisted mostly of food co-products dispatched by food business operators to either food surplus recyclers or to feed manufactures, and minerals (e.g. clay and calcium carbonate) and other feed materials originating from oleochemical activities (e.g. glycerine). It can be reasonably deduced that one of the main reasons for this deficiency was linked with the weaknesses related to the registration of these particular feed business operators (see section 5.1.4). However, in this regard, two MS expressed doubts about the legal interpretation of the provision requiring feed business operators (including food surplus recycler and manufacturers of additives/premixtures of additives) to purchase feed materials/ingredients only from registered feed operators ( 1 ). 1 This issue has been discussed during various meetings of the Standing Committee on Plants, Animals, Food and Feed since The Commission services are in the process of elaborating a guidance document to clarify the registration requirements under Regulation (EC) No 183/

18 Furthermore, in four MS the audit teams reported that feed business operators selected the suppliers on the basis of their certification against an assurance standard (third party certifications) rather than on the basis of a verification on whether they were registered/approved or not. Nonetheless it was noted that, with the exception of one transporter, in all other cases reviewed by the audit teams, certified suppliers were also registered in accordance with Article 9 of Regulation (EC) No 183/2005 since this was one of the prerequisites contained in the relevant standards Labelling of feed Main findings and conclusions In the majority of MS (12) relevant requirements were satisfactorily or largely satisfactorily taken into account during official controls. In these MS, similarly to the above section, a number of arrangements (namely, guidelines and checklists) had been put in place by competent authorities. These contributed to ensuring that feed ingredients (feed materials and feed additives) and compound feed (complete or complementary) were labelled in compliance with relevant requirements. However, in seven MS the audit teams noted that the label on some feed materials did not include the required indication of feed material. In particular, this concerned mineral ingredients in manufacturers of mineral feed in two MS, and co-products, purchased either by feed manufacturers, farmers or food surplus recyclers in three MS where these co-products were labelled in some cases as waste. 12

19 5.2.3 Infrastructural and organisational requirements Main findings and conclusions Requirements at the level of facilities and equipment, production, storage and transport were generally taken into account during official controls in all MS visited. Moreover, in the vast majority of the establishments visited, the audit teams noted that equipment, facilities, production processes, storage and transport, within the scope of the audits, were generally designed to prevent or minimize the risk of cross-contamination between feed and technical (non-feed) grade products Cross-contamination with coccidiostats and other veterinary medicines Main findings and conclusions The risk posed by the cross-contamination (usually known as carry-over) with coccidiostats and other veterinary medicines in manufacturers of compound feed was one of the main 13

20 topics covered during the series of audits because it was an issue highlighted in the previous overview report (DG(SANCO) GR Final) where it was concluded that there were many deficiencies both at feed business operator and at official control level. For the sake of clarity, the hazard is due to the presence of residues of coccidiostats and other veterinary medicines in non-target feed (feed supposed to be free of such substances). In the case of coccidiostats the maximum limits are laid down by Directive 2002/32/EC, whereas, for all veterinary medicines no residues are allowed. In the current series, the audit teams noted that some improvements had been made since the last series of audits, both in terms of measures taken by feed business operators and attention paid during official controls on the risk of cross-contamination. However, in 13 MS it was noted that, although feed manufacturers had put in place a number of measures (usually flushing and sequencing of production), they were not in a position to prove the effectiveness of such measures. In some cases neither samples nor any other verification had been foreseen, and even in those cases where samples were taken, it was noted they were poorly targeted along the production line (often several mixer-runs after the last one containing coccidiostats). Concerning official controls, the audit teams noted that the aforementioned deficiencies were mostly overlooked during inspections. In general, the competent authorities checked how feed manufacturers managed the risk of cross-contamination only by taking samples from the final products, rather than by evaluating the hazard analysis carried out by the feed manufacturers and asking them to prove the effectiveness of the measures put in place. This approach was particularly ineffective in six MS where, similarly to the own-samples taken by the feed manufacturers, official samples were taken several mixer-runs (or even batches) after the last one containing coccidiostats (see section 5.1.2). Moreover, in most of these 13 MS the sampling method to verify compliance with Directive 2002/32/EC was observed as inadequate, since the number of incremental samples taken was significantly fewer than what is required by Commission Regulation (EC) No 152/2009. Finally, in two MS the situation was worsened by the fact that the methods used by the competent authorities to detect coccidiostats did not cover all coccidiostats used (or potentially used) in the EU. 14

21 5.2.5 Homogeneity of feed Main findings and conclusions In the majority of MS (14 MS) it was noted that feed manufacturers had assessed the ability of their mixers to achieve homogeneous mixes. When unsatisfactory results were obtained, subsequent corrective actions were taken (such as maintenance of mixers or increase of mixing time) and the operators had verified that these measures were effective. In these MS the audit teams also noted largely satisfactory arrangements put in place by the competent authorities to ensure effective official controls in this area. However, in five MS a number of deficiencies were identified requiring actions to be taken by the competent authorities. In particular, in three MS feed manufacturers were using poor or not documented procedures to determine the homogeneity of feed; in one other MS the verification of homogeneity was not carried out on a regular basis and in two MS it was noted that when fluctuations and non-compliances as regards the composition of feed had been detected, this had not triggered an investigation on the performance of the mixer by the feed manufacturer. All these deficiencies had not been identified during official controls and for that reason it was deemed necessary to request the relevant competent authorities to strengthen the checks in this regard. 15

22 5.2.6 Undesirable substances Main findings and conclusions In relation to the monitoring of undesirable substances the overall picture is non-uniform, characterised by both good practices and significant deficiencies. On the one hand, in 13 MS the audit teams noted that feed manufacturers had devised and implemented satisfactory or largely satisfactory risk-based sampling plans for monitoring of all relevant undesirable substances and comprehensive official controls were carried out by the competent authorities. Moreover, in two MS the audit team noted interesting examples of sector-wide sampling programmes developed by the main associations of manufacturers of compound feed for its members (see "Good practices identified" in section 5.1.2). The competent authorities made use of these sampling programmes to reduce the intensity of their official sampling. This approach was, in general, favourably assessed by the audit teams because the sampling programmes largely covered the relevant undesirable substances, there was a risk-based approach underpinning the number and type of samples taken and the establishments followed the sampling plan in terms of number of samples allocated to them. The only minor weakness identified concerned the tendency of the feed operators to rely on the trade associations' schemes without assessing the specific hazards associated with their own production systems. On the other hand, in six MS the audit teams identified a number of deficiencies not identified during official controls. The most common deficiency concerned the lack of links between the outcome of the hazard analysis for ingredients and the subsequent sampling plan for undesirable substances devised by feed operators. In several cases, the absence of any test to detect the presence of heavy metals in additives and feed materials of mineral origin (which is well documented in the scientific literature) was not supported by any evidence in the hazard analysis. In other cases a number of analysis for certain undesirable substances 16

23 were foreseen (e.g. certain mycotoxins for cereals) but these were not correlated with the hazard analysis Traceability Main findings and conclusions In the large majority of MS visited (16 MS) the audit teams noted that feed inspectors paid attention to the requirements regarding the obligation of operators to take adequate measures to ensure effective tracing of the products. In general, checklists used by feed inspectors contained questions covering this topic. In these MS, samples for almost all ingredients and final products were adequately kept and in most cases practical exercises on the spot showed that the business operators traceability systems were able to trace products backwards and forward. Although, in a broader perspective, the benefits of these systems were limited by the lack of registration of certain categories of feed business operators (see 5.1.5). Only in three MS some minor deficiencies needed to be addressed by the competent authorities. In two of them these concerned the lack of attention paid during official controls on the way samples for all ingredients were kept, in particular as regards additives. To some extent, this shortcoming was also noted in other MS, although, its severity was deemed not to require a recommendation. 17

24 5.2.8 HACCP-based procedures Main findings and conclusions Similarly to the issue of the cross contamination with coccidiostats (see section 5.2.4) the implementation of procedures based on HACCP principles was another critical weakness highlighted in the previous overview report (DG(SANCO) GR Final). Overall, it was noted that in a significant number of MS visited (16), HACCP-based procedures were incomplete and the level of official controls was still not satisfactory. The main problem, identified in 12 MS, was the poor hazard analysis of ingredients by feed business operators. As a consequence, the control measures devised by feed business operators (e.g. guarantees required from the suppliers, checks at the reception, sampling, etc.) were often inadequate, because not risk-based. In many cases the hazard identification was of a generic nature, or even missing, for ingredients like food co-products, surplus food and additives/feed materials of mineral origin. In three MS, this concerned the presence of dioxins or heavy metals in the bleaching earth used for the oil refining which was not included in the hazard analysis. In three other MS this deficiency resulted in a lack of correlation between risks and intensity of sampling for undesirable substances which was, consequently, poorly targeted. A poor hazard analysis by the feed business operators was also noted in four MS where it was associated with the risk due to presence of dioxins in feed being subject to direct drying. Another problematic area on the implementation of the requirements on HACCP-based procedures, identified in four MS, was the incomplete scope of the HACCP plans, which, in three cases, concerned food operators supplying co-products/surplus food into the feed chain, and in the other one regarded the activity of importation of feed. As a result, these products/activities had not been considered by the feed business operators during their hazard analysis. 18

25 All the above-mentioned weaknesses had not been identified by the competent authorities who, in general, did not pay sufficient attention to the appropriateness of the hazard analysis on the basis of which the HACCP plans were developed. This, in general, negatively affected the planning of official controls on a risk basis (see section 5.1.2) Conclusions on the implementation of requirements along the feed chain The numbers at the top of each column represent the average scores obtained by all MS audited Overall, as shown by the graph above, the series of audits highlighted that there was a general satisfactory level of implementation of requirements on feed hygiene across MS, although it varied, depending on the particular subjects considered. The requirements concerning infrastructure, homogeneity of feed and traceability were satisfactorily fulfilled by feed business operators and adequately checked by the competent authorities. On the other hand, other subjects still presented some weaknesses, both in terms of arrangements put in place by feed business operators and concerning the level of checks carried out by the competent authorities during official controls. These were, namely: a) the hazard analysis of ingredients that feed business operators should carry out in the context of their HACCP study, and b) the verification of the effectiveness of the measures in place to prevent the crosscontamination with coccidiostats, still presented some weaknesses. To some extent, the deficiency related to the hazard analysis of ingredients can be associated with the little progress made in terms of registration and awareness of relevant requirements of those business operators placing certain products (e.g. food co-products, surplus food, additives or feed material of mineral origin, etc.) on the feed market. 19

26 5.3 OVERVIEW OF OFFICIAL CONTROL SYSTEMS' ASSESSMENT The overall performances of the official controls systems of the various MS visited are illustrated in the graph above. It can be noticed that whilst in six MS the overall performance of the official controls systems falls into the groups which could be considered as satisfactory, in the majority of MS visited (14) the performance of official controls systems were only partially (or not) satisfactory, as a result of several weaknesses identified by the audit teams. In particular, the poor assessment (not satisfactory) in four MS could be linked with the weak performance observed in relation to the planning of official controls, since in three of them, the audit teams identified major failures in this regard (see section 5.1.2). 6 OVERALL CONCLUSIONS Overall, the audit series indicated that most of the essential measures for the organisation of official controls have been satisfactorily put in place by the MS visited, notably: mechanisms to ensure adequate competence/qualification of staff, and procedures to carry out official controls, follow-up non-compliances and verify the effectiveness of official controls. Moreover, the requirements related to infrastructure, homogeneity of feed and traceability were, in general, effectively checked by the competent authorities in most feed operators. Nonetheless, the following areas showed some weaknesses, namely: a) the planning of official controls, the risk basing of which, in most MS visited was weakened, by limited knowledge of the activities of certain feed operators, notably those supplying their co-products and surplus food into the feed chain, and by the fact that some risks were not well assessed by competent authorities (mainly those linked to the crosscontamination with coccidiostats and the direct drying of feed) 20

27 b) the gaps and lack of specificity in the hazard analysis of ingredients applied by feed business operators and the insufficient level of scrutiny on these issues during the checks carried out by most competent authorities; c) the insufficiency of the measures put in place by the feed operators to ensure and verify that cross-contamination with coccidiostats does not result in the relevant maximum limits being exceeded in non-target feed, and the absence of sufficient controls in this area by most competent authorities. These weaknesses, which, to some extent, were also reported in an overview report on a series of feed audits (DG(SANCO) GR Final), still limit the effectiveness of the overall control systems. 7 OVERVIEW OF RECOMMENDATIONS The graph above shows the percentages of recommendations for the 13 main subjects assessed during the series of audits. The first four highest percentages, which represent more than 55% of the total number of recommendations made during the series, are the following: HACCP (16%): most of recommendations are linked to the limited hazard analysis of ingredients often overlooked by the competent authorities. Planning of official controls (14.7%): these recommendations pertain to the weaknesses in the risk based approach as a result of limited information regarding mainly food operators supplying co-products and/or surplus food into the feed chain, drying activities and the results of feed operators' own checks. 21

28 Cross-contamination with coccidiostats (13%): these recommendations are related to the need to check how feed manufacturers verify the effectiveness of their arrangements to prevent cross-contamination. Registration and approval of establishments (12%): these recommendations mainly pertain to the registration of establishments supplying part of their production to the feed chain, but whose main activity is not in the feed area, namely, food establishments placing co-products and/or food surplus. 8 ACTION TAKEN OR ENVISAGED BY THE COMMISION SERVICES 8.1 FOLLOW-UP OF AUDIT RECOMMENDATIONS For each individual audit, a copy of the final report was sent to the competent authorities of the Member State visited with a request for a proposal of actions aimed at addressing the report s recommendations. A deadline was set for the receipt of these proposed corrective actions, which were then reviewed by the Directorate-General Health and Food Safety. In the majority of Member States, the Directorate-General Health and Food Safety took the view that the proposed actions were satisfactory or largely satisfactory, but where it was considered that they did not address the recommendations, the Commission services actively pursued the matter with the competent authorities concerned. In addition, the abovementioned corrective actions proposed by the competent authorities have been subjected to regular Directorate-General Health and Food Safety follow-up in the framework of general audit reviews. 8.2 OTHER ACTIONS Better Training for Safer Food (BTSF) is an initiative of the European Commission's Directorate-General for Health and Food Safety launched in 2006, which provides training for Member State control staff and third country participants. In 2014 and 2015, six training sessions per year focused on EU feed hygiene rules and HACCP auditing. The sessions have been repeated in Directorate-General Health and Food Safety has delivered a specific BTSF event in the course of 2016 where the main findings and conclusions highlighted in the present overview report were discussed. 22

29 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, , p Regulation (EC) No 178/2002 of the European 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 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 183/2005 OJ L 35, , p Dir. 2002/32/EC OJ L 140, , p Reg. 1831/2003 OJ L 268, , p Reg. 767/2009 OJ L 229, , p Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed - Council statement Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC 23

30 Dir. 98/51/EC OJ L 208, , p Reg. 152/2009 OJ L 54, , p Commission Directive 98/51/EC of 9 July 1998 laying down certain measures for implementing Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed 24

31 ANNEX 2: REPORT ON DIOXINS IN OILS, FATS AND PRODUCTS DERIVED THEREOF Background Regulation (EU) No 225/2012 amending Regulation (EC) No 183/2005 introduced new requirements for establishments placing on the market, for feed use, products derived from vegetable oils and blended fats. These requirements concern the approval of these establishments, conditions for production, storage and transport, as well as the dioxin testing of fats, oils and products derived thereof. Between 2013 and 2014 the Directorate-General Health and Food Safety carried out a series of audits in nine Member States (seven as part of the series in 19 MS, plus two other stand-alone audits, see section 1) with the purpose of assessing the level of implementation of, among others, these requirements, and of providing an input for the review of the aforementioned Regulation, which resulted in the adoption of Commission Regulation (EU) No 2015/1905. The following are the main findings and conclusions from the series. Organisation of official controls Main findings and conclusions In all MS, with the exception of one, official inspections programmes had already included checks on the new requirements on dioxins, however, in more than half of them the effectiveness of these controls was weakened by the fact that the relevant guides and checklists were not yet updated to include the requirements introduced by Regulation (EU) No 225/ this was particularly the case for the requirements on dioxin monitoring (see relevant section of this Annex). Registration and approval of establishments Main findings and conclusions The vast majority of MS visited had put in place measures to ensure that establishments processing crude vegetable oil, oleochemical plants manufacturing fatty acids, biodiesel plants and fat blenders, were approved as required by the new provisions introduced by Regulation (EU) No 225/2012. Only in two MS were these measures not yet properly developed: as a result in one MS (DE), establishments had been approved without a prior inspection and in another (IT), establishments had been approved without clear evidence of compliance with relevant requirements. 25

32 Sourcing and labelling Main findings and conclusions A correct sourcing and labelling of oils, fats and their derivatives was ensured in most MS. In the relevant establishments the audit teams noted that feed placed on the market was generally labelled as feed material and accompanied by delivery notes/invoices indicating feed material followed by further detailed information. Similar products not destined for use in the feed chain, were also labelled specifying purposes other than feed. However, in four MS products from establishments handling oil derived products were not always labelled either as feed or for other uses. In such cases, relevant competent authorities overlooked this deficiency. Infrastructural and organisational requirements Main findings and conclusions The system of official controls is largely effective in verifying that infrastructure and organisational requirements, notably those aimed at preventing feed coming into contact with non-feed products, are satisfactorily implemented by feed operators and those visited by the audit teams were largely in line with relevant requirements. Dioxins monitoring Main findings and conclusions In most of the MS visited, operators had put in place measures to ensure that the requested analyses were carried out and relevant records of analysis were provided. Moreover, with the exception of two MS, measures were put in place to ensure that laboratories directly inform the competent authorities whenever the dioxin testing detected levels of dioxins and polychlorinated biphenyl PCBs in samples received from the feed operators exceeding the legal limits. Guidance documents were provided to inspectors to deal with the processors of fats and oils, the products and co-products from the different production processes and steps and the monitoring requirements. However, in four MS, certain weaknesses were identified, mainly related to the lack of (or superficial) checks of certificates of incoming batches, difficulties in the interpretation of the requirement on dioxin testing related to the batch sizes (2,000 tonnes) and weak checks of outgoing products requiring 1% of dioxin testing (i.e. compound feed). 26