Europese audit van het Voedselagentschap (FAVV)

8/16/2019 Europese audit van het Voedselagentschap (FAVV)

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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.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2014-7151 - MR

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

BELGIUM

FROM 12 NOVEMBER 2014 TO 21 NOVEMBER 2014

IN ORDER TO

EVALUATE THE FOOD SAFETY CONTROL SYSTEMS IN PLACE GOVERNING THE

PRODUCTION AND PLACING ON THE MARKET OF POULTRY MEAT AND

PRODUCTS DERIVED THEREFROM


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Executive Summary

This report describes the outcome of an audit in Belgium. The audit took place from 12 to 21

November 2014 to assess whether the organisation of the competent authorities and the

implementation of national provisions, in respect of controls of poultry meat and products derived

therefrom comply with EU requirements.

The report concludes that a consistent and well documented food safety control system covering

poultry meat and products derived therefrom is in place in Belgium. The system works generally

well. Some non-compliances were identified, mainly related to the actual implementation of the

control system.

The report includes a number of recommendations addressed to the competent authority aimed at

enhancing the control system in place.


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Table of Contents

1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

3 Legal Basis.....................................................................................................................................2

4 Background ....................................................................................................................................2

4.1 Previous Audits .......................................................................................................................2

4.2 Production information............................................................................................................2

5 Findings and Conclusions ..............................................................................................................2

5.1 Legislation and implementing measures .................................................................................2

5.2 Competent authority ................................................................................................................3

5.3 Official controls of production and placing on the market......................................................7

5.3.1 Controls at farm level.......................................................................................................7

5.3.2 Approval procedures........................................................................................................8

5.3.3 Controls in slaughterhouses: Ante-mortem inspection and post-mortem inspection .....9

5.3.4 Animal welfare at slaughter...........................................................................................11

5.3.5 Controls at establishment level ......................................................................................11

5.3.6 Controls on FBO compliance with microbiological criteria for foodstuffs- official

sampling .......................................................................................................................................145.3.7 Controls on traceability-Labelling-Identification..........................................................16

5.3.8 Controls on the use of food additives.............................................................................17

5.4 Rapid Alert System for Feed And Food (RASFF) ................................................................17

5.5 Laboratories...........................................................................................................................18

6 Overall Conclusions .....................................................................................................................19

7 Closing Meeting ...........................................................................................................................19

8 Recommendations........................................................................................................................20


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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

BELAC Belgian Organisation for AccreditationCA Competent Authority

COCO Coordinated Inspections

DG Directorate General

DG(SANCO) Health and Consumers Directorate-General

DMO Appointed Veterinarian

EC European Community

EU European Union

FASFC Federal Agency of the Safety of the Food Chain

FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and

Environment

FBO Food Business Operator

FCI Food Chain Information

HACCP Hazard Analysis – Critical Control Points

IEC Department of Import and Export ControlMD Ministerial Decree

MSM Mechanically Separated Meat

NICU National Implementation and Co-ordination Unit

NRL National Reference Laboratory

PCU Provincial Control Unit

RASFF Rapid Alert System for Feed and Food

RD Royal Decree

SNCP Salmonella National Control Programme


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3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation and, in particular,

Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of

29 April 2004 on official controls in Member States performed to ensure the verification of

compliance with feed and food law, animal health and animal welfare rules.

A full list of the EU legal instruments referred to in this report is provided in the Annex and

refers, where applicable, to the last amended version.

4 BACKGROUND

4.1 PREVIOUS AUDITS

A previous audit took place in 2009 (ref. DG(SANCO)/2009/8063). This audit highlighted

shortcomings in relation to notification of national legislation concerning direct supply by the producer to final consumer of small quantities of meat from poultry slaughtered on farm,

approval of establishments, shortcomings in relation to EU requirements at establishment

level and washing of carcases before post-mortem inspection (PMI).

The audit report, which is published on the SANTE Directorate-General Internet site at

http://ec.europa.eu/food/fvo/audit_reports/details.cfm?rep_id=2400

made a number of recommendations to the CA. Written guarantees have been received from

the CA in relation to the implementation of those recommendations.

4.2 PRODUCTION INFORMATION

The audit team was informed by the CA that 478,049 tonnes of poultry meat were produced

in Belgium in 2013.

5 FINDINGS AND CONCLUSIONS

5.1 LEGISLATION AND IMPLEMENTING MEASURES

Legal requirements

Article 4.2 (e) and Article 8 of Regulation (EC) No 882/2004.

Articles 1(3) (d), Article 1(4) and Article 10 of Regulation (EC) No 853/2004.

Findings

The CA for the poultry sector is the Federal Agency of the Safety of the Food Chain

(FASFC). FASFC informed the audit team that it follows the relevant EU and national

legislation.

The law of 4 February 2000, regarding the creation of FASFC, gives the CA the authority toimplement the control system. The Royal Decree (RD) of 22 February 2001, regarding the



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organisation of the controls performed by the FASFC, is the legal basis for the CA to carry

out control activities and take measures.

Other relevant pieces of legislation as regards the scope of this audit are:-

RD of 16 January 2006 laying down the rules for the registration, authorisation and

approval of establishments.

RD of 22 December 2005 establishing the frequency of inspections requiring the

presence of a staff member of FASFC at premises of the meat and fish sector within

the context of the control programme of the FASFC.

RD of 14 November 2003 on own-checks, notification requirement and traceability in

the food chain.

Ministerial Decree (MD) of 22 March 2013 on the flexibility of own-checks and

traceability rules.

In addition, the CA has prepared RDs as regards hygiene requirements which aresupplementary to Regulations (EC) Nos 852/2004, 853/2004 and 854/2004.

There is national legislation (RD of 07 January 2014) concerning the direct supply by the

producer, of small quantities of meat from poultry slaughtered on the farm to the final

consumer or to local retail establishments directly supplying such meat to the final consumer

as fresh meat (Article 1 (3) d of Regulation (EC) No 853/2004). The relevant national

legislation has been notified to the European Commission.

A wide range of detailed procedures, checklists and internal instructions have been put in

place by the CA to assist all staff performing official controls. These are available via CA

website.

A comprehensive review of Belgian legislation and documented procedures for official

controls in the poultry sector was not carried out as part of this audit. However, the audit

team noted that some discrepancies exist between EU legislation applicable to

microbiological criteria and instructions for officials on this topic (for more information see

Chapter 5.3.6).

Conclusions

National legislation related to the performance of official controls on the production and

placing on the market of poultry meat and products derived therefrom has been issued and, in principle, is in line with EU legislation.

Documented procedures for official controls have been produced and in principle are in line

with EU requirements with the exception of the instructions for official staff related to

microbiological criteria.

5.2 COMPETENT AUTHORITY

Legal requirements

Article 4, 6, 8 and 54 of Regulation (EC) No 882/2004.

Section III of Annex I to Regulation (EC) No 854/2004, in particular Chapter III and IV.


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Findings

A detailed description of the CA responsible for official controls in Belgium can be found in

the country profile at:

http://ec.europa.eu/food/fvo/controlsystems_en.cfm?co_id=BE

The two main responsible authorities as regards food safety are the Federal Public Service for

Health, Safety of the Food Chain and Environment (FPS–HSFCE) and the FASFC.

The FPS–HSFCE is responsible for the preparation of product standards and general policy

for food of animal origin.

The FASFC is the CA for the control, testing and inspection of food at all stages of the food

chain, including poultry meat and products derived therefrom. It is also responsible for the

preparation of process standards in the form of operational legislation.

Within FASFC, the Directorate General (DG) Control co-ordinates control activities while its

eleven Provincial Control Units (PCU) carry out inspections and enforce corrective measures

at establishment level within their territories.

The supervision of PCUs is the responsibility of two regional directors (one for Flanders and

the second covering Wallonia) who are the co-ordinators between PCUs and the central CA.

An important role as regards co-ordination of controls and uniform implementation of

procedures at PCU level is played by the National Implementation and Co-ordination Unit

(NICU). Every year NICU organises co-ordinated inspections known as COCO missions, the

purpose of which is to harmonise controls across Belgium and increase food business

operator (FBO) professionalism, auditors' competence and efficiency of controls. Duringthese inspections, which are carried out in establishments by NICU's representatives and

officials working at central and PCU level, NICU is in the position to verify the consistent

application of instructions and detect problems weakening the control system. NICU report to

the Directorate General (DG) Control and propose improvements when problems are

identified.

The official tasks are carried out at establishment level by official veterinarians, either PCU

officials or private veterinarians appointed by FASFC known as DMOs. The CA informed

the audit team that there are no official auxiliaries in Belgium.

DG Laboratories, which is another directorate within FASFC, co-ordinates all activities on

analyses carried out by the five official CA laboratories and CA approved external

laboratories.

Training

The CA at central level co-ordinates training for FASFC officials and in conjunction with

each PCU decides what training should be provided. Training plans are drafted taking into

consideration the presence of new control areas or findings i.e. from internal/external audits

and COCO missions. Training needs of officials are identified by the PCU through the annual

appraisal system and training tailored on a case by case basis.

http://ec.europa.eu/food/fvo/controlsystems_en.cfm?co_id=BE


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The CA does not provide training to DMOs but these are obliged to ensure their own ongoing

training. At PCU level, DMOs are annually evaluated as regards their performance and

training undertaken.

Evidence of training provided to CA staff was available to the audit team.

In general staff met in various locations by the audit team were suitably qualified and in

general familiar with national and EU requirements.

Audits

Among others, an internal audit on the organisation and inspection of own-check system in

the processing sector was conducted in 2013 by the internal audit service (AIQP) of the CA

on the PCU of the Luxembourg province. This audit did not specifically cover poultry meat,

nevertheless poultry establishments were visited. An action plan was prepared, deadlines for

the shortcomings identified were set and some corrective actions had been already taken. The

audit team noted that one shortcoming related to traceability in a poultry establishment had been identified by the AIQP auditors.

Organisation of official controls

Establishments are subject to official controls at frequencies planned centrally by the CA

every year and on the basis of risk assessment criteria. The official controls at establishment

level are carried out by either PCU officials or DMOs following an annually established

inspection programme.

A fixed frequency is applied to each category of establishment which can be adapted to an

FBO’s risk profile. This risk profile is established applying a score system which takes into

consideration factors such as presence or absence of a CA validated own-check system and

FBO compliance history (both inspection results of the last three years and record of

enforcement measures of the past two years). The higher the score given to an establishment,

the lower its allocated frequency of inspection. The audit team noted that the results of

inspections are taken into account with a time-lag of up to 14 months.

The establishments must have an HACCP programme in place for their approval.

Nevertheless Belgium has introduced an additional guarantee concerning the HACCP plans:

FBO could apply for the validation of the own-check systems on a voluntary basis. The

validation of the own-check system is carried out through audits by either the CA or CA

approved independent auditing bodies. A list of the approved auditing bodies, which hold

accreditation issued by the Belgian Organisation for Accreditation (BELAC), is available on

the CA website. Validation of own-check system is dependent on a favourable audit result

from the CA or independent auditing body and this has an impact on the determination of the

inspection frequency which is reduced.

When the above mentioned audits are carried out by auditing bodies, the report with the

outcome of the audit is only given to the FBO audited. However, where the auditing body

identifies serious deficiencies posing a risk to public health they must inform the CA. The CA

official responsible for the control of such an establishment has discretion as to whether or

not she/he asks the FBO to provide the audit results and take them into account during

official inspections (for more see Chapter 5.3.5 under the section Findings related to HACCP


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based procedures).The CA informed the audit team that a new procedure which allows them

to suspend the validation when official controls identify that establishments do not meet the

necessary requirements has been introduced1.

The audit team noted that:-

based on the inspection results in the three preceding years, the highest an

establishment can score is 20 points (positive results),

where no infringements have been recorded over the last two years the highest an

establishment can score is 20 points,

an establishment with a validated own-check system is awarded 40 points.

In one meat processing establishment visited where multiple activities were taking place,

(one of which had a validated own-check system), the general hygiene conditions were

inadequate and a low inspection frequency (four inspections per year) was allocated by the

CA. The audit team observed that according to CA instructions, the establishment should be

inspected eight times per year. The PCU had not questioned the low frequency allocated by

the central CA to this establishment although there was a history of numerous repeated

shortcomings detected on-site during official visits. The CA at central level explained that a

mistake had been made in the calculation of the frequency and the PCU should have checked

the inspection plan received and informed the central CA as regards its correctness.

All the establishments visited were under regular official control and the inspection frequency

was respected in all cases. Evidence was seen that the PCUs receive the annual inspection

programme produced by the CA, which indicates the number of inspections to be performed

and the areas (known as scopes) to be covered in each establishment during official controls.

In all establishments except slaughterhouses, the PCU official is obliged to carry out at least

an annual comprehensive inspection while the DMO performs checks in specific targeted

areas as planned by the CA. In the case of slaughterhouses, exclusively comprehensive

inspections are carried out and always performed by PCU officials. DMOs conduct specific

checks on animal welfare, refrigerated vehicles and own-check systems.

Several uniform checklists specifically weighted for each area to be inspected and for each

type of establishment are used during official visits and are available to relevant staff via

intranet and internet. When an official creates an inspection (called a mission) in a CA

database known as FoodNet, the electronic system generates automatically the requiredchecklists along with the technical sheets to facilitate the official while performing controls.

The areas covered by the checklists to verify compliance with legal requirements are, among

others: infrastructure, equipment and hygiene, own-check system, microbiological criteria,

animal by-products, packaging and labelling, traceability and animal welfare. Each item sets

out the legal requirement the FBO has to comply with, has a specific score and is ranked into

one of the three possible categories (major, minor or item weighted 0 where a different

authority is competent). The final results of these checklists are categorised automatically and

1 In their response to the draft report the CA noted that it is correct that there was no procedure drawn up by theCA before November 2014, but the possibility of suspension was already provided for in the legislation (Royal

Decree of 14 November 2003) and this possibility of suspension was implemented, although rarely, by the CA

before November 2014, based solely on the Royal Decree.


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indicated as favourable, favourable with remarks or unfavourable. Each control report is

countersigned by the FBO and the information recorded in the checklists is entered by the

official into FoodNet, which is accessible at central level.

The audit team was informed by PCU officials and it was noted during visits to the

establishments that enforcement measures are not always taken when non-compliances aredetected during the official inspections. The checklist system in place identifies whether or

not the specific non-compliance/s detected require corrective actions and follow-up.

Consequently it was observed that some non-compliances which did not requir e corrective

actions/follow-up were recorded as remarks in the relevant checklists and were repeatedly

reported.

The audit team noted that inspection reports produced by the DMOs are not recorded in

FoodNet and as a result do not impact on the determination of inspection frequency. The

audit team was informed by the CA that the shortcomings detected by DMOs may be

considered by PCU officials at their discretion during their official visits at the premises (seechapter 5.3.5 – General findings).

Conclusions

The CA responsible for official controls along the poultry production chain is clearly

designated.

In line with Articles 4 and 8 of Regulation (EC) No 882/2004 Belgium has put in place a

system for ensuring co-ordination and consistency in the performance of official controls and

for the verification of their effectiveness.

A training system to ensure competence of all official staff involved in official control

activities has been implemented.

An internal audit system involving on-the-spot visits to food businesses is in place. Poultry

meat establishments are covered by this system.

Belgium has put in place a risk-based system for the determination of the frequency of

official controls in order to meet the requirements of Article 3 (1) of Regulation (EC) No

882/2004.

5.3 OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET

5.3.1 Controls at farm level

The audit team did not visit poultry farms during this audit. A recent poultry audit on

Salmonella National control Programmes (SNCP) (ref. DG(SANCO)/2014/7152) was carried

out from 9 September to 18 September 2014 in Belgium covering the official controls

performed at farm level by the CA. The report of that audit has been published on the

SANTE Directorate- General Internet site at:-


http://ec.europa.eu/food/fvo/audit_reports/details.cfm?rep_id=3478http://ec.europa.eu/food/fvo/audit_reports/details.cfm?rep_id=3478http://ec.europa.eu/food/fvo/audit_reports/details.cfm?rep_id=3478http://ec.europa.eu/food/fvo/audit_reports/details.cfm?rep_id=3478


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At the time of that audit, farms were found by the audit team appropriately registered and

under regular official supervision. Controls were in place at farm level to prevent Salmonella

contamination. However, some shortcomings concerning official controls on biosecurity

standards were detected.

5.3.2 Approval procedures

Legal requirements

Article 6 of Regulation (EC) No 852/2004.


Article 31 (2) of Regulation (EC) No 882/2004.

Findings

The PCUs are responsible for the approval of establishments located in the area under their

control. Approval is granted following favourable result of the assessments carried by PCU

officials to verify FBO compliance with EU requirements.

The CA has established comprehensive procedures for the approval, withdrawal and

suspension of food business establishments. The approval procedures require official staff to

use the same checklists used during routine official inspections.

An FBO who wishes to start an activity requiring approval has to submit an application form

to the PCU. Under national legislation the FBO is also obliged to provide to the PCU a plan

of the establishment indicating facilities and process flows. If the review of this

documentation is satisfactory, the PCU carries out an on-site visit to verify infrastructural

conditions and to take a decision as regards the granting of conditional approval. A second

visit takes place after three months to verify operational conditions and to decide whether to

either grant definitive approval or to extend the conditional approval for a further three

months.

The approval procedures indicate that definitive approval cannot be granted if establishments

do not comply with EU legislative requirements. This was confirmed during examination of

the approval process through documentary reviews carried out by the audit team at

establishment level and in the PCU office visited. All documents reviewed were found

satisfactory as regards timeliness and procedures applied.

In one establishment the audit team noted that after the initial approval visit the FBO was told

by the PCU he could start operating prior to receiving the official letter which was sent ten

days later than the given date to start operations.

All establishments visited were approved by the CA for activities carried out on-site and the

approval documents were provided to the audit team.

The updated list of approved poultry establishments are publicly available on the CA website.

Conclusions

Establishment approval procedures are in place and aligned with relevant EU requirements.


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5.3.3 Controls in slaughterhouses: Ante-mortem inspection and post-mortem

inspection

Legal requirements

Article 4 and 5 of Regulation (EC) No 854/2004.

Findings

Ante-mortem inspection (AMI) :

AMI is carried out by a DMO at slaughterhouse level.

The MD of 20 September 2010 lays down the model form and the contents of the Food Chain

Information (FCI). In all slaughterhouses visited the FCI was received by the DMO 24 hours

before the arrival of the poultry flock at the premises. In all cases reviewed, poultry flocks

were accompanied by the FCI which included, among others, production data, veterinary

treatments and Salmonella test result. The FCI was always signed by the farmer and checked

by the slaughterhouse FBO before being submitted to the DMO.

The AMI consisted of:-

documentary check covering the examination of the FCI;

identification of the consignment;

check on animal welfare;

clinical examination of the birds, including check on dead birds.

In all the slaughterhouses visited the AMI was performed as required. All relevant

information, including the outcome of the AMI, was entered in a CA database known as

Sanitrace, which is also accessible to the FBO as regards its own data.

PMI:

PMI is carried out either by the DMO or slaughterhouse staff under his/her supervision.

The poultry slaughterhouses can use their own slaughterhouse staff to perform PMI if

conditions set by relevant national legislation (RD of 25 January 2011 laying down rules for

the organisation of involvement of slaughterhouse staff in poultry slaughterhouses) are met,

namely:-

the possession of a CA validated own-check system, which must be under the

responsibility of the veterinarian of the establishment,

the effective application of good manufacturing hygiene practices based on HACCP

principles during at least twelve months before the FBO request,


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the presence of a minimum number of staff members of the slaughterhouse available

to assist the DMO with PMI.

According to the information provided by the CA, theoretical and practical training for the

training of staff assisting with PMI is organised by the FBO. The FBO's own veterinarian and

the DMO provide respectively training as regards infrastructure/hygiene and slaughtered poultry and meat.

Staff must pass a test set by the PCU official who grants the certificate if the outcome of the

test is satisfactory. Evidence of training and related certificates was provided to the audit

team.

As regards the performance of slaughterhouse staff participating in PMI, detailed rules are

described in a memorandum available to relevant officials. Regular performance tests on the

individuals helping the officials with this specific task must be carried out and recorded.

Procedures have been prepared by the CA to standardise this evaluation which is based on a

score system. If the result of this assessment is unfavourable, the operative concerned is

removed from this duty and extra training is provided by the FBO to the individual before

he/she is allowed to carry out this task again. The audit team noted that, although CA

procedures indicate that slaughterhouse staff has be assessed on a monthly basis, the

evaluation of each individual was taking place every six months in one of the two

establishments visited where slaughterhouse staff participated in PMI.

In the slaughterhouses visited the audit team noted that the DMO personally carries out the

daily inspection of the viscera and body cavities of a representative sample of birds (first

1000 birds of each flock). These checks were documented.

All the birds rejected by the authorised slaughterhouse staff are kept for the DMO who

carries out detailed PMI. The audit team noted that PMI results are adequately recorded by

the DMO in Sanitrace, related to each flock and communicated to the relevant FBO. The

audit team noted that the FBO provides feedback to farmers as regards the outcome of the

PMI related to the flocks from their holdings.

In four out of five slaughterhouses visited, the PMI was not fully in line with EU

requirements. Precisely:-

In one slaughterhouse the location of the PMI point did not allow the DMO to inspect

the offal and to view all external surfaces of the carcasses.

In another slaughterhouse the correlation between carcasses and offal was not

maintained, the liver was removed by an operative before PMI and all external

surfaces of the carcasses could not be viewed by the DMO.

In a third establishment, the design of the automatic slaughter line combined with its

speed did not allow PMI staff to exclude carcases when a decision taken on the

related viscera deemed the carcass unfit for human consumption.

In a fourth slaughterhouse a batch system was established and offal of birds of the

same origin was collected in a container for PMI. The audit team was informed by the


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DMO that the batch of carcases is declared fit for human consumption also when the

condemnation of the batch of offal should require the rejection of the correlated

carcasses. (i.e. in case of generalised septicaemia, pyaemia, toxaemia or viraemia).

Conclusions

The EU requirements as regards AMI are complied with by the CA.

The control system in place complies with EU requirements with regard to training provided

to slaughterhouse staff involved in PMI and supervision of their work by the official

veterinarian to ensure suitable performance.

PMI is not carried out fully in accordance with the requirements of Regulation (EC) No

854/2004 on PMI, in particular as regards the inspection of all parts of the carcasses and

accompanying viscera and the decision taken on meat.

5.3.4 Animal welfare at slaughter

CA official controls on FBO’s compliance with animal welfare requirements were not

checked during this audit as an audit to evaluate the animal welfare controls in place at

slaughter and during related operations took place from 24 November to 5 December 2014

(ref. DG( SANCO)/2014/7059) in Belgium. The report has been published on the SANTE

Directorate- General Internet site at:-


5.3.5 Controls at establishment level

Legal requirements


Findings

General findings

In the majority of the establishments visited the CA had already identified some non-

compliances related to structural/hygiene conditions and practices noted by the audit team.

However, a number of deficiencies repeatedly detected and recorded by the CA in their

inspection reports were still present at the moment of our visits.

In one slaughterhouse visited the audit team reviewed the last inspection report. The report

did not contain references to numerous deficiencies which were detected by the audit team

during the inspection visit (i.e. absence of hygiene facilities, lack of pest control, insufficient

separation between lairage and slaughter-hall, structural deterioration of a wall etc.). The

official responsible of the inspection explained to the audit team that he did not consider

these shortcomings as significant. The audit team noted also that the score allocated to this

establishment was the highest (resulting in four visits per year for this type of establishment)

and that a DMO was present on a daily basis on site. In the adjacent cutting plant the

inspection frequency allocated was high (16 times per year), however numerous non-



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compliances detected by the audit team had not been considered as significant by the official

(e.g. absence of or hygiene facilities not suitably located). Furthermore, in the freezer

approved as a cold store, heavy ice and snow formation which could not have built up

recently was present on walls, ceiling, floor and packaged meat. No records of such

deficiencies were available to the audit team.The audit team identified a number of shortcomings not previously detected/recorded during

official controls (not all present in each establishment). In some cases the officials recognised

that the problems had been overlooked, in other cases they had been considered as not

significant2. For example:-

Regarding maintenance and structure:

Premises not protected against condensation and ice formation. Dripping of

condensation over exposed meat in some cases. Several wet and damaged meat packages boxes caused by the ice were observed in a cold store.

Some rusty elements of equipment and rusty fittings in processing areas.

Premises with a lack of wash-hand basins in production rooms, in the majority of

cases not suitably located and in one case not accessible to permit operatives washing

of hands and tools when necessary. Where wash-hand basins were available, in some

instances splashing on exposed meat and meat packages could not be avoided.

Absence of hygiene facilities for washing shoes for personnel entering clean areas

from dirty areas such as animal by-products room or lairage.

Insufficient protection of production areas from contamination i.e. incomplete

separation between lairage or adjacent compressor room from slaughter-halls, no

isolation of production area from parts of premises still under construction).

In two establishments the work layout could not ensure that the flow of operations would not

cause cross contamination (i.e. cooked products and raw products transiting in the same area,

operations on cooked products and meat preparations taking place in the same room and insome cases on the same working table).

Regarding hygiene of operations:

Inadequate storage conditions of wrapping and packaging material (i.e. storage of

packaging and wrapping material in corridors). Contaminated wrapping material

being used which was in contact with dirty equipment and with waste material in

production room (cooking area). Storage of cardboard boxes in cutting room with

liners in contact with the wall.

2 In their response to the draft report the CA noted that in the light of the audit findings, a warning was issued to

the operator.


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Storage of unused equipment and machinery (in some instances damaged and in a

dirty condition) in production rooms.

Unsatisfactory cleaning of crates used for storage of meat.

Dirty moulds being used in processing plants.

Wooden pallets in close proximity to work station where packaging of exposed meat

was taking place.

Storage of dirty trolleys in close proximity of a slaughter-line or food conveyor belts

during production.

Knives with wooden handles used to bleed birds.

Inadequate pest control in place (i.e. gaps under external doors, storage of dirtyanimal by-product containers in the external area, inadequate separation between

lairage and slaughter-hall).

Unfit meat collected in containers used also for meat fit for human consumption,

although a colour code system was established by FBO.

Liquid waste from leaking containers running on the floor of the slaughter-hall.

As regards disinfection of tools in establishments the CA had issued a circular stating that if a

FBO wishes to use an alternative disinfection system, it is necessary to have prior approvalfrom the FASFC. In two establishments visited alternative methods for disinfecting tools

which did not have CA approval were in use. In one case the official has considered in his

checklist the unapproved alternative method used by the FBO as in compliance with legal

requirements.

Findings related to HACCP based procedures

A guide has been prepared by the industry for FBOs "Generic guide for own-checks for

slaughterhouses and cutting plants for poultry and for establishments of production of minced

meat, preparations of meat and MSM from poultry ". This guide has been validated by

FASFC and is available on the CA's intranet. Information on the distribution of this guide is

available on the internet.

All the establishments visited by the audit team had a documented own-check system based

on HACCP principles. Two uniform checklists were used during inspections which cover

respectively the full HACCP based procedures or some items of it on a random basis. In the

majority of cases where these were reviewed no significant deficiencies were found by the

audit team.

The validated own-check system is audited once a year by the CA or an independent auditing

body authorised by the CA. Evidence of detailed audit reports were provided to the audit

team. When deficiencies were detected an action plan was produced by the FBO with


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indication of deadlines and, depending on the type of shortcoming, the establishment was re-

visited or a documentary check was performed by the auditors concerned.

The audit team noted that the resulting audit reports might be taken into consideration at the

discretion of the officials while conducting their inspections.

Conclusions

A regular and documented system of official controls of poultry meat and products derived

therefrom is in place at establishment level. However official controls do not ensure that

FBOs meet all relevant EU requirements as some shortcomings are not detected/reported

during the inspection visits.

Moreover, when non-compliances which are deemed minor by the CA are detected, the CA

does not take actions to ensure that the FBO remedies the situation3.

HACCP based procedures were present in all the establishments visited which were,

generally, well implemented.

5.3.6 Controls on FBO compliance with microbiological criteria for foodstuffs-

official sampling

Legal requirements



Regulation (EC) No 2073/2005, in particular Article 1.

Findings

In one establishment visited the FBO was extending the shelf-life of incoming products after

repackaging. The audit team was informed by the FBO that this practice was based on an

internal instruction which gives an extension of the shelf-life of seven days to all re-packaged

products. The decision on extending the shelf-life of the product was not supported by any

study carried out in accordance with Article 3.2 of Regulation (EC) No 2073/2005.

Checklists for official controls do not include a specific question in relation to shelf-life

studies.

FBO sampling activities

In all establishments visited sampling and testing for the relevant food safety and process

hygiene criteria were in place. Guidelines approved by the CA are available for FBO own-

check system implementation in slaughterhouses, cutting plants and establishments producing

minced meat, meat preparations and MSM.

3 In their response to the draft report the CA noted that it is only in the case of isolated, minor non-compliances

that these corrective measures are not imposed.


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Microbiological analyses of products, water and surfaces were carried out in private

laboratories (either FBO laboratories or external laboratories) and in most cases the results

observed by the audit team were compliant with EU requirements. FBO laboratories are not

obliged to be accredited but must participate as a minimum in collaborative testing and use

approved analytical methods.In all the slaughterhouses visited the neck skin samples had been collected and analysed for

Salmonella as foreseen by EU requirements except in two cases where alternative methods

for analysis were used without being validated by the CA. A checklist requires officials to

verify the use of CA authorised methods, however the officials interviewed confirmed that

the laboratory method in use is not checked during their official controls.

As mentioned under Chapter 5.1 – Findings, a comprehensive review of Belgian documented

procedures was not carried out by the audit team. However, the team noted that some

discrepancies exist between EU legislation applicable to microbiological criteria and both CA

validated guidelines for FBOs and instructions for officials, namely:-

As regards sampling for Salmonella in fresh poultry meat, the limit set is “absence in

1g” instead of the “absence in 25g” as required by EU legislation. Nevertheless, in all

relevant establishments the FBO was applying the correct criteria.

Concerning the testing against the food safety criteria in ready-to-eat products

(Listeria monocytogenes), the sample consisted of one sample unit instead of the

required five. This had led to an incorrect number of sample units being taken by the

FBO in two establishments visited.

In one establishment visited the hygiene process criteria applied for minced meat indicates

limits of E. coli ten times above the limits required under EU legislation (500-5000 instead of

50-500). This was not detected during official controls. However, the analyses results

reviewed by the audit team did not exceed the limits set by the relevant EU Regulation.

A national derogation exists for establishments slaughtering less than 150,000 birds per year

and producing less than ten tonnes of poultry meat per week. The audit team visited two such

establishments with this derogation. The audit team was informed by the CA that no risk

analysis had been carried out to justify the derogations.

Official sampling

In Belgium, the CA takes official samples to verify the implementation of FBO own-check

sampling programmes. In addition, other microbiological criteria are monitored.

The official sampling is planned at central level and the resulting plan is sent to the PCUs on

a monthly basis for their implementation. The PCU is instructed by the CA at central level on

the number of samples to be taken for each commodity, the parameters to be analysed, the

technical sheets to be used and at which stage of the food chain the samples must be

collected. The PCUs allocate the specific samples to be taken to the various establishmentsunder their responsibilities.


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The audit team was informed by the CA that guidelines for official sampling are available to

the PCU staff in the form of specific technical sheets, which are based on the provisions of

Regulation (EC) No 2073/2005. The CA has prepared technical documents for each type of

commodity included in the official sampling plan.

The official sampling programme at establishment level includes residues (Directive96/23/EC) and food additives.

Conclusions

CA controls do not ensure that studies are conducted by the FBO in order to investigate

compliance with microbiological criteria throughout a product's shelf-life.

In general the CA regularly verifies the implementation of FBO own-check sampling

programmes and their results. However this verification and FBO implementation are

weakened respectively by instructions for officials and CA approved guidelines for FBOs that

in some instances differ from EU requirements, and by the failure to perform checks on theuse of approved analytical methods.

The derogation applied in small establishments for the exemption from the sampling

frequencies is not in line with the provisions of Regulation (EC) No 2073/2005 as no risk

assessment has been carried out by the CA to justify it.

The CA takes official samples for microbiological testing from poultry meat cuts, meat

preparations, meat products and ready-to-eat products in order to verify FBO compliance

with microbiological criteria.

5.3.7Controls on traceability-Labelling-Identification

Legal requirements

Traceability: Article 4.6 of Regulation (EC) No 854/2004

Labelling: Chapter IV, Section V, Annex III of Regulation (EC) No 853/2004

Identification marking: Article 4.6 of Regulation (EC) No 854/2004

Section I, Annex II of Regulation (EC) No 853/2004

Findings

Evidence was provided to the audit team that checks on traceability, identification mark and

labelling are part of official controls. Uniform checklists are available to officials for this

purpose.

Traceability systems were in place in all the establishments visited. Traceability was

satisfactory other than in one establishment where some packages of meat and offal were

found without label and as a result the traceability was lost. In all other establishments labels

and identification marks were correctly applied.

In two out of three establishments producing MSM, the denomination “MDM” (MechanicallyDeboned Meat) was used on the label of final products containing MSM.


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Conclusions

Traceability systems were in place all the establishments visited and in general

implementation was satisfactory. The CA performs traceability checks during official

controls.

In general labels and identification marks were correctly applied and their application is

under regular official control.

The CA controls do not ensure that the labelling of final products containing MSM is in line

with EU legislation.

5.3.8Controls on the use of food additives

Legal requirements

Regulation (EC) No 1333/2008.

Findings

The use of food additives were included in the HACCP based procedures reviewed by the

audit team in poultry processing establishments.

A checklist includes a general question for the verification of FBO compliance with

Regulation (EC) No 1333/2008 (the use of permitted food additives for products to which

they are intended and the respect of legal maximum quantities) Specific guidelines for

official staff have not been prepared by the CA. The CA explained that the officials have

access to the relevant EU legislation via the CA website.

Control on food additives was found to be satisfactory in the establishments visited by the

audit team.

A pre-defined risk-based annual sampling plan drafted by the CA is in place. The samples are

analysed in laboratories that are approved by the CA.

Conclusions

The CA ensures that food additives are used in a manner permitted under the relevant EU

Regulation.

5.4 R APID ALERT SYSTEM FOR FEED AND FOOD (RASFF)

Legal requirements

Article 50 of Regulation (EC) No 178/2002; Chapter I, Title VII of Regulation (EC) No

882/2004.

Findings

The Department of Import and Export Control (IEC) from DG Control of the CA, is the

contact point with the RASFF network.

IEC is responsible for managing RASFF notifications within Belgium, through the exchangeof information between stakeholders, PCUs and RASFF network. The CA explained to the

audit team the flow of information and actions to be taken in cases where RASFF


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notifications are triggered from Belgian stakeholders or in cases where RASFF notifications

are generated from food from other Member States.

In Belgium, every FBO is statutorily obliged to immediately notify FASFC, through its

provincial interface, PCUs, if it considers or has reason to believe that a product that was

imported, produced, grown, raised, processed, manufactured or distributed may bedetrimental to human, animal or plant health. Relevant forms are available on the CA

website.

There have been 24 RASFF notifications linked with poultry meat and products derived

therefrom since the last audit, of which 14 RASFF were due to Salmonella presence (7

occurred in 2014).

The audit team visited two establishments whose products had triggered RASFF notifications

in 2014 (presence of Salmonella in poultry meat and product derived therefrom).

In both cases, the FBO notified the relevant PCU on the same day Salmonella positive resultswere received from the laboratory. The PCU carried out an investigation in the

establishments involved and checked FBO documentation related to the batch in question.

The result of this investigation was sent to IEC, along with the location of the batch. The

audit team noted that further investigation, in the case of result positive to Salmonella spp, is

carried out after serotyping.

Conclusions

There is a system in place for notifications of RASFF. The CA takes appropriate action in

response to RASFF notifications.

5.5 LABORATORIES

Legal requirements

Articles 11, 12 and 33 of Regulation (EC) No 882/2004

Findings

In Belgium, the National Reference Laboratory (NRL) for Listeria monocytogenes,

Salmonella, Coagulase-positive staphylococci, including Staphylococcus aureus, Escherichiacoli, including Verocytotoxin producing Escherichia coli, Campylobacter and food borne

infections is the Scientific Institute for Public Health of the Ministry of Public Health.

Serotyping of all isolates from food samples is carried out in this NRL.

There are five official laboratories designated for analysis of official food samples. These

laboratories are integrated in DG Laboratory within FASFC and must be approved by the CA

to perform the above mentioned tests. In order to be approved, laboratories must be

accredited according to ISO 17025.

BELAC carries out accreditation of the laboratories. The accreditation scopes of thelaboratories can be found on BELAC website while the list of approved laboratories is

available on the CA website.


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Two official laboratories perform testing for microbiological parameters of food samples

(excluding the NRL) and functions as dispatch centres for official samples collected

respectively in the southern and in the northern area of Belgium. The electronic system in

place (known as FoodLIMS) in the two dispatch centres ensures that the samples are

forwarded to the laboratories accredited and approved by the CA to perform the specific tests.The audit team visited one official laboratory. The laboratory visited was accredited and

approved by the CA. The current accreditation is valid until 21/06/2015.

The methods used for testing of poultry meat and products derived therefrom are either the

EU reference methods or validated alternative methods recognised by NRL. These methods

used were within the scope of accreditation and are published on the website of the CA.

Evidence was seen that the official laboratory was subject to audits carried by the CA twice

per year and resulting reports were made available.

The laboratory receives scientific and technical support from DG Laboratory and from the NRL. Meetings are organised at least three times per year with the NRL to discuss, among

other topics, new techniques, new methods and validation.

The audit team noted that staff regularly participate in training.

Evidence of successful participation of this laboratory in the relevant collaborative testing

schemes for food pathogens was available (i.e. for Salmonella and Listeria monocytogenes).

The official laboratory visited had adequate equipment and qualified staff.

Conclusions

Laboratories have been designated by the CA to perform analyses on official samples in the

poultry sector in accordance with Articles 11 and 12 of Regulation (EC) No 882/2004.

6 OVERALL CONCLUSIONS

A consistent and well documented food safety control system covering poultry meat and

products derived therefrom is in place in Belgium. The system works generally well. Some

non-compliances were identified, mainly related to the actual implementation of the control

system.

7 CLOSING MEETING

During the closing meeting held in Brussels on 21 November 2014, the CA acknowledged

the main findings and preliminary conclusions presented by the audit team.


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8 R ECOMMENDATIONS

No. Recommendation

1. To ensure that requirements of Regulation (EC) No 854/2004 on PMI are

respected, in particular Part D, Chapter II, Section I of Annex I concerning

inspection of all parts of the carcasses and accompanying viscera and Point 1,

Chapter V, Section II, Annex I concerning the exclusion of the carcase and

related viscera when the decision taken on one element deems both unsuitable

for human consumption.

2. To ensure that as required by Article 4 of Regulation (EC) No 854/2004

official controls verify FBO compliance with all the relevant EU

requirements; in particular the CA has to ensure that the official controls at

establishments cover all the relevant requirements laid down in Regulations(EC) Nos 852/2004 and 853/2004 and verify their compliance.

3. To ensure that when the CA identifies non-compliances that have been

classified as minor, appropriate actions are taken to guarantee that the FBO

remedies the situation in order to meet the requirements of Article 54 of

Regulation (EC) No 882/2004. In particular the CA should take into account

the operator's past record with regard to non-compliances which are classified

as minor and should ensure these are followed-up and rectified.

4.To ensure that official controls cover all the requirements of Regulation (EC)

No 2073/2005, in particular the carrying out of studies established by the FBO

in order to investigate compliance with microbiological criteria throughout the

shelf-life of its products, as required by Article 3.2 thereof.

5. To ensure that controls covering Regulation (EC) No 2073/2005 include the

correct requirements, in particular to ensure that CA instructions and FBO

protocols comply and are implemented in accordance with this Regulation,

and that such controls are performed to verify the use of approved analytical

methods.

6. To ensure that, when the exemption of small slaughterhouses andestablishments from the sampling frequencies is authorised by the CA as

permitted by Annex I, Chapter 3.2 to Regulation (EC) No 2073/2005, the

exemption is justified on the basis of a risk analysis.

7. To ensure that products containing MSM destined to final consumers are

correctly labelled, in order to meet the requirements of Article 3 of Directive

2000/13/EC.


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The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=2014-7151

http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=%3cproj_component.object_name/%3e


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ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal Title

Dir. 96/23/EC OJ L 125, 23.5.1996,

p. 10-32

Council Directive 96/23/EC of 29 April 1996

on measures to monitor certain substances

and residues thereof in live animals andanimal products and repealing Directives

85/358/EEC and 86/469/EEC and Decisions

89/187/EEC and 91/664/EEC

Dir. 2000/13/EC OJ L 109, 6.5.2000,

p. 29-42

Directive 2000/13/EC of the European

Parliament and of the Council of 20 March

2000 on the approximation of the laws of the

Member States relating to the labelling,

presentation and advertising of foodstuffs

Reg. 178/2002 OJ L 31, 1.2.2002, p.1-24

Regulation (EC) No 178/2002 of theEuropean 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. 852/2004 OJ L 139, 30.4.2004,

p. 1, Corrected and

re-published in OJ L

226, 25.6.2004, p. 3

Regulation (EC) No 852/2004 of the

European Parliament and of the Council of

29 April 2004 on the hygiene of foodstuffs

Reg. 853/2004 OJ L 139, 30.4.2004,

p. 55, Corrected and


226, 25.6.2004, p. 22



29 April 2004 laying down specific hygiene

rules for food of animal origin

Reg. 854/2004 OJ L 139, 30.4.2004,

p. 206, Corrected and


226, 25.6.2004, p. 83



29 April 2004 laying down specific rules for

the organisation of official controls on

products of animal origin intended for humanconsumption

Reg. 882/2004 OJ L 165, 30.4.2004,

p. 1, Corrected and


191, 28.5.2004, p. 1



29 April 2004 on official controls performed

to ensure the verification of compliance with

feed and food law, animal health and animal

welfare rules


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Reg. 2073/2005 OJ L 338,

22.12.2005, p. 1-26

Commission Regulation (EC) No 2073/2005

of 15 November 2005 on microbiological

criteria for foodstuffs

Reg. 1333/2008 OJ L 354,

31.12.2008, p. 16-33


European Parliament and of the Council of16 December 2008 on food additives

Europese audit van het Voedselagentschap (FAVV)

Documents

Transcript of Europese audit van het Voedselagentschap (FAVV)