Ref. Ares(2021)3606514 - 01/06/2021 TABLE OF CONTENTS INTRODUCTION ...... 3 SUMMARY...... 4 1. ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) N° 882/2004 ...... 6 Designation of competent authorities ...... 6 Resources for performance of controls...... 25 Organisation and implementation of official controls ...... 26 Enforcement measures...... 30 Verification and review of official controls and procedures ...... 31 Multi-annual National Control Plan (MANCP)...... 39 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS ...... 42 2.1 Control system for animal health...... 42 2.2 Control system for food of animal origin ...... 45 2.3 Control system for imports of animals and food of animal origin...... 49 2.4 Control system for feedingstuffs and animal nutrition ...... 51 2.5 Control system for TSEs and Animal-By-Products (ABP) ...... 55 2.6 Control system for veterinary medicinal products (VMP) and residues...... 63 2.7 Control system for foodstuffs and general food hygiene...... 69 2.8 Control system for imports of food of non-animal origin...... 76 2.9 Control system for plant protection products (PPPs) and residues...... 78 2.10 Control system for animal welfare...... 82 2.11 Control system for plant health...... 84 2.12 Control system for quality labelling ...... 87 ANNEX- ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS ...... 90
2 DG(SANTE)/2020-6907 Version: May 2021 INTRODUCTION
This overview has been drawn up by the Directorate-General for Health and Food Safety of the European Commission, based on information supplied by Belgium.
The aim is to present, in summary form, the latest information on how control systems for food and feed safety, animal health, animal welfare, plant health and quality labelling are organised in Belgium.
Chapter 1 describes the overall organisation of the Belgian authorities and the respective responsibilities of the ministries and government agencies in relation to the different components of the control system. A chart is used to help the reader better understand the inter-relationships between the responsibilities of the different bodies.
Chapter 2 gives a more detailed description of the main responsibilities for each of the twelve separate systems that form the complete range of control systems in Belgium, covering the whole chain of plant, animal and food production. As in Chapter 1, organisation charts are used to help the reader.
The overview was updated following the most recent administrative follow-up initiated in August 2020, based on information provided by the Belgian authorities.
Acronyms are used extensively throughout this overview for the sake of brevity. A list of acronyms, abbreviations and special terms is given in the Annex as a guide for the reader.
3 DG(SANTE)/2020-6907 Version: May 2021 SUMMARY
The Federal Agency for the Safety of the Food Chain (FASFC) and the Federal Public Service for Health, Safety of the Food Chain and Environment (FPS–HSFCE) are the main federal competent authorities in the areas of food and feed safety, animal health and plant health. By virtue of the sixth state reform the competences concerning animal welfare were attributed to the regions as of July 2014.
The FPS–HSFCE is responsible for the elaboration of policy and relevant legislation, the elaboration of product standards, and the controls and inspections for certain animal by- products, field trials with GMO’s and pesticides.
The FASFC, under the Minister competent for food safety, verifies that all legislation and standards under its competences are respected by all actors within the food chain. It is also responsible for the preparation of process standards. The distribution of competencies between the FPS–HSFCE and the FASFC is laid down in a protocol.
The FASFC Directorate-General Control Policy is responsible for policy on control measures and programmes. The separate Directorate-General Control has central services responsible for co-ordinating and integrating control activities while the controls themselves are carried out by 9 Local Control Units (LCU) of this directorate. The central services of the Directorate-General Laboratories co-ordinates all activities on analyses carried out by the five federal FASFC laboratories under their direction and the external laboratories.
Other federal competent authorities involved are the Federal Agency for Medicines and Health Products (FAMHP), the Federal Public Service Economy, SMEs, Self-employed and Energy (FPS Economy), the Federal Agency for Nuclear Control (FANC), the Federal Public Service Finances – Customs Services, and the Federal Police.
The Regions are responsible for wildlife, several aspects with regard to animal by-products (ABP), Genetically Modified Organisms (GMO), plant protection products (PPP), animal welfare, and quality labelling (organic production and PDO/PGI/TSG). They are also the central competent authorities for measures regarding regulated non-quarantine pests (RNQPs): they are responsible for the transposition of EU legislation in relation to control measures, the implementation of legislation, and technical co-ordination of plant health activities related to RNQPs.
Currently, the single body of Belgium (Art. 109(2) of the Official Controls Regulation – OCR) has not been designated yet. Meanwhile, the FASFC takes a central and co- ordinating role with regard to the Multi-annual National Control Plan (MANCP) and Annual Report, however without taking the responsibilities related to the single body. Until now, the MANCP is prepared by the FASFC, in close cooperation with the other competent authorities involved. As far as the FASFC is concerned, the duration of the MANCP is the same of that of the business plan of the FASFC. This way the strategic and operational objectives of the FASFC are linked to those of the MANCP. The most recent published MANCP for Belgium covers the period 2018-2020. A new MANCP is being prepared. The Annual Report on the implementation of the plan in 2019 was provided to the Commission in August 2020.
The MANCPs are published on the following webpage: http://www.favv- afsca.fgov.be/apropos/mancp/. No decision has yet been taken whether or not to make the
4 DG(SANTE)/2020-6907 Version: May 2021 Annual Report in standard model form (Regulation (EU) 2019/723) publicly available. However, data on official controls can be found in the annual activity report of the FASFC and in annual reports of other competent authorities, which are available via: http://www.favv-afsca.fgov.be/apropos/mancp/.
5 DG(SANTE)/2020-6907 Version: May 2021 1. ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EU) 2017/625
Designation of competent authorities
Description of the general division of competences in Belgium:
The Kingdom of Belgium is a constitutional monarchy and parliamentary democracy. The Constitution was revised six times between 1970 and 2014 (1970, 1980, 1988-89, 1993, 2001 and 2014), creating a federal state on the basis of a three-level structure.
The Federal State, the Communities and the Regions form the top level. All three are equal from the legal viewpoint, but have powers and responsibilities for different areas.
In general, the Federal State has the competences in all areas of public interest including public health, food and feed safety, animal health and plant health. The three Regions (Flemish Region, Walloon Region, Brussels-Capital Region) have powers in the areas connected with their territory such as employment, agriculture, environment, waste, and since 2014, animal welfare. The three Communities (Flemish, French and German) have powers in areas such as culture, education and use of languages.
The Provinces constitute the second level. Each Province is responsible for everything in its territory of provincial interest not covered by the general interest of the Federal State, the Communities and Regions, or by communal interest.
The Belgian Provinces are Antwerp, Limburg, Flemish Brabant, East Flanders, West Flanders, Hainaut, Walloon Brabant, Namur, Liège and Luxembourg. In the Brussels- Capital Region almost all provincial competencies are assumed by its regional institutions.
The 581 Communes form the third level. Depending on the powers exercised, they are supervised by the Federal State, the Community or the Region.
The following chart summarises the organisation of food and feed safety, animal health, animal welfare and plant health in Belgium.
6 DG(SANTE)/2020-6907 Version: May 2021 FPS DGAPF
FPS DGEM
FPS DGEM
Protocol of 2018
7
* The Regions are responsible for wildlife (Animal Health, see section 2.1), several aspects with regard to ABP (see Section 2.5), several aspects with regard to GMO (see Section 2.7), several aspects with regard to PPP (see Section 2.9), Animal Welfare (see Secion 2.10), measures concerning RNQPs (Plant Health, see Section 2.11), and Quality Labelling (see Section 2.12)
7 DG(SANTE)/2020-6907 Version: May 2021
9 LCU Federal Public Services (Ministries) and other responsible bodies - Division of competences on Federal level:
The main federal competent authorities in the areas of food and feed safety, animal health and plant health are:
the Federal Agency for the Safety of the Food Chain (FASFC); the Federal Public Service for Health, Safety of the Food Chain and Environment (FPS-HSFCE); the Federal Agency for Medicines and Health Products (FAMHP). the Federal Public Service Economy, SMEs, Self-employed and Energy (FPS Economy); the Federal Agency for Nuclear Control (FANC).
The following federal authorities are also involved:
the Federal Public Service Finances (FPS Finances), Customs Services (CS); the Federal Police.
The law creating the FASFC determines that it falls under the Minister of Public Health.
By derogation and since end 2007 subsequent terms of governments onwards, several Royal Decrees establishing specific ministerial powers laid down that the Minister of Agriculture is responsible for the safety of the food chain. In addition to these Royal Decrees, protocols were signed by the Minister of Agriculture and the Minister of Public Health establishing the responsibilities of both ministers with regard to the FPS-HSFCE and taking into account their competencies. According to the most recent Royal Decree (of 27 October 2020), the Minister of Agriculture is responsible for the FASFC. The scientific institution called Sciensano falls under the shared responsibility of the Minister of Agriculture and the Minister of Public Health. According to the protocol the Minister of Public Health is – in general – responsible for the FPS-HSFCE, except for DG Animal, Plant and Food (DG APF). However, some exceptions are in place.
The FAMPH falls under the Minister of Public Health.
The distribution of competencies between the FPS-HSFCE and the FASFC laid down in a protocol of October 2003 is as follows:
The FPS-HSFCE:
to prepare policy and define objectives and general principles regarding the safety of the food chain, animal health and plant health; to determine product norms and, as necessary, their approval, registration, authorisation and notification; to develop best practice for laboratories and experimentation; to carry out product risk assessment concerning public health, animal health and environment; to provide funds and their related management; to establish ethical and professional standards and service norms; and approve veterinarians; to develop norms, policy and control co-ordination for the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) 8 DG(SANTE)/2020-6907 Version: May 2021 (meanwhile DG Environment - DGEM has been attributed the competency of CITES instead of DG Animal, Plant and Food - DGAPF); to manage international relationships related to the afore-mentioned competencies; to manage information and communication aspects.
The FASFC:
to carry out risk assessment concerning safety of the food chain (where not covered by Federal Public Service competence of bullet point 4 above); to prepare and supervise the application of operational regulations; to manage own resources; to determine norms for operators and, as necessary, their approval, registration, authorisation and notification; to set up systems, tools and control programmes in relevant sectors; to carry out control of products and certification in the feed and food chain; to control operators in the feed and food chain; to manage international relationships in relevant areas; to manage information and communication in relevant areas.
The protocol also defines the respective responsibilities of the FPS-HSFCE and the FASFC for shared competencies and for responsibilities at international level. For EU issues, the FPS-HSFCE interfaces at Council and European Parliament level and the FASFC at European Commission level. Relations with other international bodies are largely handled by the FPS-HSFCE.
Collaboration between the various authorities is done in accordance with the protocols and service agreements concluded between the organisations.
Description of the organizations
Federal Public Service for Health, Food Chain Safety and Environment (FPS-HFCSE)
The FPS-HSFCE was set up on 23 May 2001. A scientific body provides support to it by carrying out research on policy-supporting matters: Sciensano. The Superior Health Council (SHC) is a scientific advisory body.
The main goal of the FPS-HFCSE is to protect consumer health and ensuring food safety, including animal and plant health, by developing of standards for health aspects of food, feed, pesticides, animals, plants and other consumer products (tobacco, alcohol, cosmetics, GMO’s and certain animal by-products); defending the Belgian position in international bodies (European Union, Codex Alimentarius, Council of Europe, the European Food Safety Authority (EFSA), the World Health Organisation, the Food and Agriculture Organisation); and consulting and informing stakeholders.
9 DG(SANTE)/2020-6907 Version: May 2021 The FPS-HSFCE comprises several vertical Directorate-Generals of which Directorate- General (DGAPF) and Directorate-General (DGEM) are particularly relevant.
DGAPF: Animals, Plants and Foodstuffs
Managment Office
Plant protection Food, feed Inspection and Animal health products and and other controls and Plant health (consumer Fertilizers consumer products products)
DGAPF (animals, plants and food) is responsible for the elaboration of the policy and legislation on health and quality aspects of all products (product standards) in the different stages of the feed and food chain. It is also responsible for the approval of veterinarians and veterinary guidance and the inspection and controls on tobacco products, e-cigarets, alcohol, cosmetics, certain animal by-products and GMO’s (field trials and seeds).
The specific responsibilities of its four divisions are:
Division 1: Plant protection products and fertilisers; Division 2: Sanitary policy for animals and plants; Division 3: Food, feed, and other consumer products; Division 4: Control of other consumer products, and animal by-products for technical use.
DGEM is responsible for policy-making, authorisation and inspection of chemical products and biocides, and for certain inspections in respect of the release on the market of plant protection products and CITES.
The FPS-HFCSE comprises the following horizontal departments:
Executive committee; Chairman’s departments (international relations, public health emergencies, strategy and culture, communication, translation department, contact center, secretariat); Three management departments (human resources and organisation, information and communication technology, budget and management control-logistics).
Superior Health Council (SHC)
The SHC is the scientific advisory body of the FPS-HSFCE. It forms a bridge between the Belgian authorities and the scientific world in all public health related issues. It gives independent advice and makes recommendations to the Minister of Health, either on his request or on its own initiative.
10 DG(SANTE)/2020-6907 Version: May 2021 The SHC deals with all matters relating to public health, in particular, the following six areas:
Mental health: behaviour, addictions, psychosocial factors in public health, training professionals, psychotherapy, etc.; Physical environmental factors: ionising radiation, non-ionising radiation and noise pollution; Chemical environmental factors: chemicals, pollutants, biocides and plant protection products; Nutrition: healthy eating, food additives, food supplements, food for specific groups, safety, packaging, novel foods, contaminants, microbiology; Biological Problems - type 1: blood and derivatives, cells, tissues and organs, tissue and organ banks. Biological problems - type 2: infectious diseases, vaccines, hygiene issues.
The SHC is headed by a chairman and administered by a board comprising a maximum of ninety Belgian experts appointed by the King. It is supported by scientific and administrative staff and external specialists. The board assesses the advice and recommendations submitted by its specialist groups.
Sciensano
Science and health are central to the mission of Sciensano, with more than 700 staff members.. Sciensano’s strength and uniqueness lie within the holistic and multidisciplinary approach to health. More particularly it focuses on the close and indissoluble interconnection between human and animal health and their environment (the “One health” concept). By combining different research perspectives within this framework, Sciensano contributes in its unique way to everybody’s health.
For this, Sciensano builds on the more than 100 years of scientific expertise of the former Veterinary and Agrochemical Research Centre (CODA-CERVA) and the ex-Scientific Institute of Public Health (WIV-ISP).
Sciensano’s scientists explore 5 fields of action:
Animal health
With regard to animal health, Sciensano provides scientific and technical support, not only to the authorities (the Federal Agency for the Safety of the Food Chain and the Federal Public Service Health, Food Chain Safety and Environment), but also to professional organisations and front-line laboratories.
The scope of its activities is wide and includes emerging and epizootic diseases (diseases affecting animals, for example foot and mouth disease or swine fever) and certain enzootic diseases (i.e. those present in our herds, for example infectious bovine rhinotracheitis) that pose a major socio-economic risk. On top of their economic impact, some of these diseases pose a potential threat to public health: so called zoonoses (i.e., diseases or infections that can be transmitted, directly or indirectly, from animals to humans or the other way round), which it monitors closely.
11 DG(SANTE)/2020-6907 Version: May 2021 It is worth pointing out that these diseases all have a direct or indirect effect on public health, if only, for example, with regard to the use of antibiotics they necessitate. Thanks to antibiotics, healthcare in humans has greatly improved. In animals reared for consumption (farm animals, such as cows, sheep, chickens, etc.), the use of antibiotics has contributed to increasing the return on investment for producers. But vigilance must remain because the misuse of antibiotics can cause an increase in bacterial resistance to antibiotics in animals and humans. They become ineffective to cure diseases.
As an expert in the field of animal health, Sciensano:
o conducts and evaluates regulated animal disease monitoring programmes; o assesses the risk and prepares for potential crises by developing analytical methods and techniques; o improves the diagnosis of animal diseases by developing, certifying and validating molecular, microbiological and/or serological testing; o produces and provides front-line laboratories with reference reagents (positive-negative sera, stem collection, RNA-DNA, etc.); o performs diagnostic reagent controls and inter-laboratory testing to certify the quality of tests in front line laboratories.
Some of these actions make it necessary to work in a confined environment to allow the disease to be reproduced in quarantine, which is made possible through the ultra modern infrastructure and efficient teams available to Sciensano. In the field of animal health, Sciensano is the National Reference Laboratory for all animal diseases, such as foot and mouth disease and vesicular diseases, the swine fever virus, bird flu and other bird and exotic viruses, and for highly pathogenic bacterial viruses (plague, anthrax, brucellosis, tuberculosis, tularemia).
Food consumption and food safety
Food and food safety are at the heart of Sciensano’s concerns.
Adopting good eating habits is essential to health. A healthy diet is a source of vitality and well-being and protects against a large number of diseases, such as cardiovascular diseases, diabetes, obesity and certain forms of cancer. That is why, via its food consumption surveys, Sciensano investigates whether Belgian eating habits are in line with nutritional recommendations.
To ensure quality, food is subject to continuous monitoring. In Belgium, the FPS Public Health, Food Chain Safety and Environment and the Federal Agency for the Safety of the Food Chain (FASFC) ensure the safety of the food chain, and call on Sciensano’s expertise to perform this monitoring. Sciensano is the reference body for six major areas related to food chain safety:
o microbiology o Genetically Modified Organisms (GMO) o contaminants and residues in food (pesticides, heavy metals,…) o materials in contact with food (plastic,…) o food additives (aroma’s, colorants,..) o nanomaterials.
12 DG(SANTE)/2020-6907 Version: May 2021 Sciensano’s partners also rely on its expertise for the monitoring of animal health, an important link in the food chain. Indeed, animals can be carriers of microorganisms that can be transmitted to humans through food or through direct contact with the animal.
Health and disease monitoring
Thanks to various monitoring methods (national surveys, network of physicians, registries, etc.), Sciensano collects data on the health of the population: restrictions, drug consumption, eating habits, well-being, etc. This information allows governments to evaluate and adapt health policies to the needs of the population.
Sciensano also monitors infectious diseases such as AIDS, influenza, salmonella and bronchitis. This also includes zoonoses (infectious diseases in wild animals or utility animals that can be transmitted to humans) such as brucellosis and rabies. This monitoring enables Sciensano to detect and evaluate threats. It then supports the authorities in the fight against these diseases.
Health and environment
Sciensano devotes a large part of its research and monitoring activities to studying environmental threats to health.
In the field of biosafety, it assesses the potential risks of the use of genetically modified organisms or pathogens such as bacteria and viruses, for human health, and the environment.
Sciensano also develops sustainable development indicators to measure progress in the use of pesticides that are more environmentally friendly and therefore better for consumer health.
Quality and effectiveness of vaccines, medicines and health products Quality of medical laboratories
The prevention and treatment of diseases are impossible without the appropriate resources: vaccines (for humans or animals), medicines, medical devices, etc.
Sciensano supports the FAMHP by assessing these resources with the aim of guaranteeing their quality, safety and effectiveness.
It is active in areas such as quality control of medicines, control of illegal and counterfeit products, antibiotic resistance, quality control of vaccines before they are marketed, evaluation of the effects of vaccination for certain diseases, control of medical laboratories - including for the analysis of samples of human origin - and biosafety assessment of, among others, applications for activities involving GMOs.
13 DG(SANTE)/2020-6907 Version: May 2021 Federal Agency for the Safety of the Food Chain (FASFC)
The FASFC was created by law of 4th February 2000. Since the beginning of 2008, it is under the competency of the Minister of Agriculture.
It is led by the Chief Executive Officer (CEO) appointed by Royal Decree on the proposal of the Minister, after deliberation by the Council of Ministers. The CEO has authority and direct responsibility for the staff and following three services:
Internal Audit, Quality and Prevention; Crisis Prevention and Management; Communication and Consumer Contact Point.
The Internal Audit, Quality and Prevention service is the hub of the quality, safety, environment and internal control system within the FASFC. It also includes the internal service for prevention and protection at work and the mediation service, which handles complaints relating to its operation.
The Crisis Prevention and Management Unit sets up crisis scenarios, organises simulation exercises (for the authorities and operators) and tracks potential signs of crisis. It acts as coordinator and leader in the event of a crisis or incident in the food chain and represent the FASFC in national and international organisations (governmental crisis centre, EFSA, NATO).
The service Communication and Consumer Contact Point is responsible for external communication in every sense of the term (spokespeople, press release, presence at trade fairs and events, website, bulletin). It also manages the consumer contact point, dealing with all complaints and questions. The information service is also part of the communication service; it keeps operators in the B2C sector (operators directly supplying end clients) informed to help them comply with regulations by holding training sessions for groups of operators.
The staff of the CEO are responsible for the general coordination and the secretariat of the Committees: reports of the FASFC Management Board, the Basic Consultation Committee, the Advisory Committee, etc.
The FASFC carries out controls on food, feed, animal and plant health at all stages of the food chain. It is responsible for the preparation of process standards. It provides scientific advice on risks and prevention of problems in the food chain. It is responsible for contact with the general public.
The FASFC is structured into 4 Directorates General (DGs), each headed by a Director General (N-1 with renewable term of six years).
Directorate-General Control Policy; Directorate-General Control; Directorate-General Laboratories; Directorate-General General Services .
14 DG(SANTE)/2020-6907 Version: May 2021 - Internal Audit, Quality and Prevention
- Crisis Prevention- Com andmun Managementication and c oUnitntact point for the consumer - Communication- Cri sandis M Consumeranagemen Contactt Servic ePoints - Quality and Internal Audit Services
SCIENTIFIC Chief Executive CONSULTATIVE COMMITTEE Officer COMMITTEE
DG CONTROL DG GENERAL DG CONTROLE DG LABORATORIES POLICY SERVICES
AFSCA laboratories PCUs LCUs
External Laboratories
Directorate-General Control Policy is responsible for policy making and legislation on hygiene, control measures and programmes for the controls on food, feed, animal and plant health at all stages of the food chain. It is in charge of the preparation of process standards on the basis of risk assessment and multi–annual controls, inspections and sampling plans. It drafts advisory notes and synthesis for DG Control, DG Laboratories and other institutions that perform tasks on behalf of the FASFC. It supports the work of the Scientific Committee with risk assessment guidance. It presents the results of these programmes to the Government, the consumer and various European and international bodies.
It develops and ensures integrity and quality of FASFC databases supporting conversion of data into efficient databases and permitting the gradual introduction of e-government databases and co-operation with other federal public (Crossroads bank for enterprises (a central register of all enterprises including food and feed business operators, crossroads Bank for Social Security), regional or European (EFSA) databases.
It co-ordinates co-operation between the relevant sectors and external bodies, and is responsible for implementation of administrative simplification and reduction of administrative burden. It deals with sector organisations and co-operates with national and international bodies, including the European Commission (Working Groups, Standing Committees, contact point for the DG SANTE Directorate F) and other Member States.
Within DG Control Policy there is also the “Cell Validation of Guides” which approves the sector guides for self-checking systems (SCS), drawn up by the professional associations. This cell also develops checklists and guides to be used by the auditors of SCS and draws 15 DG(SANTE)/2020-6907 Version: May 2021 up FAQ's in order to assist operators in the implementation of self-checking by operators. Audits for the validation of SCS can be done either by the FASFC or by an independent certification body approved by the FASFC for a specific guide.
Finally, through its continuous consultation with the sector organizations, its close collaboration with competent authorities of third countries and the setup of certification policy, the Directorate for International Relations ensures the mission of supporting as much as possible the trade of Belgian food business operators (FBOs) to those countries.
Within DG Control Policy tasks are assigned to:
3 horizontal directorates: Directorate for International Relations; Directorate for Risk Assessment; Directorate for Integration of Business Information (database and traceability principle).
3 vertical directorates: Directorate for Plant Protection and Safety of Plant Production; Directorate for Animal Health and Safety of Animal Products; Directorate for Food Processing and Distribution.
The control programme drawn up by the Directorate-General Control Policy is translated into control plans and instructions by the central departments of Directorate-General Control and is subsequently responsible for the co-ordination and integration of the control activities carried out by the 9 LCUs of the FASFC. It is also responsible for managing RASFF messages, granting approvals and authorizations, issuing certificates, import controls and coordinated anti-fraud investigations.
Within DG Control tasks are assigned to two services: Central Administration Services (Central Directorate – CDC) Regional Services (Regional Directorate)
The Central Administration Services comprise a further four services.
Under the Central Directorate three vertical services have been created based on the classification of all operators in the food chain according to their activity and their control system. Each department is responsible for a given group of activities: Primary Production Sector – PRI (crop and livestock sector); Transformation/Production Sector – TRA; Distribution Sector – DIS.
In addition there is a service with horizontal tasks: the “Notifications and Certification Cell” (CNC). The CNC is active within the domain of certification and notifications. In early 2019, a new cell “projects” was initiated under the Director General of Control with the aim of developing Control-i and ensuring the consistency of future developments and projects at DG Control. The service Dirco and the service for Approvals, Authorizations and Registration (responsible for co-ordination and integration of files concerning registration, authorisation and approval of all food chain operators processed by the 9 LCUs of the FASFC) were merged into a central staff service under the Central Directorate. The IEC (Import-Export Controls) service was transformed into CNC (Notifications and Certification Cell), and the import part shifted to the Thematic Control 16 DG(SANTE)/2020-6907 Version: May 2021 Unit Border Control Posts (TCU BCP) under the National Implementation and Co- ordination Unit (NICU). CNC remains under the CDC. It is responsible for the coordination and organization of certification controls for exports to third countries and intra-community certification. In this context, it provides technical support to the LCUs. In terms of notifications, CNC performs the function of national contact point for the European Commission services RASFF system and the AAC system. It is also responsible for the registration and dissemination to the departments concerned of notifications of non- conformities, including those received from companies and laboratories in the context of the notification requirement.
The Regional Services are supervised by two regional directors which act as co-ordinators between LCUs and Central Services. One director is assigned for the Flemish Region and the other for the Walloon Region. They share the responsibility for the Brussels-Capital Region.
The Implementation and Co-ordination Unit (NICU) acts under the authority of these two co-ordinating directors. It co-ordinates controls, implements instructions and their harmonised application in the LCUs, evaluates these Units' activities and prepares, communicates and reports to the Directorate-General Control, suggests improvements and solutions when problems are identified. The NICU is an important support in the management of independent veterinarians or engineers ''chargés de mission'' (CDM), the development and testing of new IT applications for LCUs, the development and implementation of the quality management system according to ISO 9001 and ISO 17020, in supporting the implementation of internal audits at LCUs level and follow up of the action plans arising from these audits. NICU is involved in the organization of training courses for LCUs staff.
The NICE is divided into four pillars: the Cell Control Tools, the Cell Co-ordination and External Cooperation, the TCU BCP, and the Non-Specific TCU comprising of, among others, a Cell E-commerce.
LCUs level: There are 9 LCUs, managed by the Regional Directorate and supported by NICU, which carries out checks on the spot. Each local control unit is headed by the Head of the LCU who organises the work of the LCU. The 9 LCUs are: Antwerpen, Vlaams-Brabant – Limburg, Brabant wallon Namur, Bruxelles/Brussel, West-Vlaanderen, Oost-Vlaanderen – Vlaams-Brabant, Hainaut, Liège and Luxembourg Namur.
Within the LCUs, controllers and inspectors are grouped under the following three operational sectors: PRI (primary production), TRA (transformation) and DIS (distribution). The LCU for Brussels-Capital has no primary production sector.
17 DG(SANTE)/2020-6907 Version: May 2021 BCP
Each LCU is responsible for the entire food production chain within its territory, from the farm/establishment to distribution, including restaurants and the retail trade (registration of Business Operators and establishment of the entire food chain into the BOOD database, approval and authorisation of food chain operators, control and sampling according to the control and sampling plan, certification, contact point for Business Operators, investigation of complaints).
Within the Directorate-General Control, the National Investigation Unit (NIU) investigates fraud in relation to, among others, false labelling, illegal trade in meat, identification, registration, and hormones. The investigation group comprises veterinarians, agriculture engineers and technical experts. The Unit works in close collaboration with the LCUs and other internal services of the Federal Agency for the Safety of the Food Chain as well as with other regional, federal and international services, including the police and prosecution services, responsible for combating economically relevant illegal practices and maintains these contacts.
A "Committee for management consultation" comprising the Director of the Directorate- General Control, the two co-ordinating regional directors and the 9 Heads of the LCUs meet each month with a view to ensuring the harmonisation of policy.
Directorate-General Laboratories consists of a central office which co-ordinates all activities on analyses carried out by internal laboratories (federal laboratories of the Agency) and external laboratories, to support the Directorates-General Control and Control Policy.
It comprises five accredited federal laboratories (ISO 17025) located in Gentbrugge, Wandre, Tervuren, Melle and Gembloux for the safety of the food chain. Each laboratory 18 DG(SANTE)/2020-6907 Version: May 2021 has a specialisation and its own scope of analysis. In addition to these five federal laboratories, the Federal Agency makes use of a large network of laboratories it approved (currently about 60 external laboratories). A Royal Decree and a procedure describe the requirements for an external laboratory to be approved by the Federal Agency and lays down the way in which the application for approval should be submitted. The primary criterion for approval is to be accredited according to ISO/IEC 17025. The information on the external laboratories is available on the website. This laboratory network receives the scientific and technical support of DG Laboratories specialised in well-defined fields. Their tasks are set out in bilateral conventions. Tests are carried out in one of the five laboratories of the FASFC, in an approved laboratory, or in the NRL, according to their specialisation.
Directorate-General Laboratories also organises the movement of samples taken by the Directorate-General Control in order to ensure that the samples arrive in the best condition and in the shortest time possible in the laboratories. The Federal Agency makes use of two dispatching centres and several vans equipped with cooling facilities. The detailed procedures are communicated to the laboratories and are available on the Internet. Inspectors are kept informed of the results via a FOODLIMS/FOODNET-database. In the case of a non-compliance, the LCU responsible for the sample and the central administration of the Directorate-General Control are directly informed by the laboratory, which sends over an original laboratory report.
Directorate-General Corporate Services is responsible for legal and administrative support, including personnel and organisation, budget, logistics, and information technology.
Scientific Committee (SC)
The SC was set up to support the activities of the FASFC. It has a central position in the assessment of risks related to the food chain. It comprises 22 members, nominated by Royal Decree, and gives independent scientific opinions either on its own initiative, or at the request of the Chief Executive Officer (CEO) of the FASFC or the competent Federal Minister. Its tasks are to give independent scientific advice on all legal proposals related to risk assessment and risk management in the food chain, to perform scientific evaluations of the sector guides and to evaluate risks in the food chain. It is supported in its work by the Staff Directorate for Risk Assessment (formerly: the Secretariat of the Scientific Committee), one of the directorates of DG Control Policy consisting of a team of experts who prepare the risk assessment. In addition, external experts who provide specific expertise depending on the subject are also called upon during the preparation of advice.
Advisory Committee (AC)
The Advisory Committee represents the interests of stakeholders of the food chain. Members are representatives from consumer organisations, agriculture sector, organic production sector, feed producers, food industry, chemical industry, retailers, HORECA (HOtels, REstaurants and bars/CAfés), transport, federal services and the Regions and Communities.
The Advisory Committee of the FASFC provides advice, either on its own initiative or at the request of the Minister competent of the FASFC or its Chief Executive Officer, on all matters relating to the policy pursued and to be pursued by the FASFC. Among other things, it is consulted on legislative initiatives of the FASFC. The updated control programme of the FASFC is also submitted to the Advisory Committee before the
19 DG(SANTE)/2020-6907 Version: May 2021 beginning of each year. In addition, the FASFC control results are periodically presented to this committee.
The Customs Services (CS)
The CS comprises a central administration and seven regional offices (Antwerp, Brussels, Gent, Hasselt, Leuven, Liège and Mons). The structure at central level is reflected at regional level. This means e.g. that there are regional specialized investigation services.
In addition to customs and excise work, the CS carry out tasks for other departments, including public health and safety of the food chain. In relation to import, the CS are responsible for the release of goods for free circulation into the EU or other customs procedures. In the event of any risk discovered by the CS and managed by the FASFC, the CS inform the the FASFC, as required by Council Regulation (EC) No. 765/2008.
Co-operation between the FASFC and CS has been laid down in a protocol. The current protocol dates of 6 November 2018; it replaces the protocol of 13 March 2007..
The Federal Agency for Medicines and Health Products (FAMHP)
The FAMPH was established by the Law of 20 July 2006.
The FAMHP is the competent authority responsible for the quality, safety and efficacy of medicines and health products.
The mission of the FAMHP is: - to ensure, from development to use, the quality, safety and efficacy of medicines for human and veterinary use (including homeopathic medicines, herbal medicines, pharmacy made and officinal preparations) and also medical devices and accessories, and raw materials for the preparation and production of medicines; - to ensure, from collection to use, the quality, safety and efficacy of all the operations involving with blood, cells and tissues.
The FAMHP has 450 fulltime equivalent staff and is headed by an administrator general.
The FAMPH comprise 3 pillars, covering:
Pre-authorisation: all activities prior to the first marketing authorisation; Post-authorisation: all activities after the first marketing authorisation; Inspection: inspection and supervisory activities.
In February 2008, a co-operation protocol between the FASFC and the FAMHP was finalised with a view to clarifying the control competences in the distribution chain of veterinary medicinal products (VMPs) and avoiding overlapping controls of both bodies. The protocol was updated in 2013.
20 DG(SANTE)/2020-6907 Version: May 2021 Regional authorities
Flemish Region
Introduction
The administrative services of the Flemish authorities were restructured on 1 April 2006. They are now subdivided in 13 policy areas, each of which is composed of a department and a number of autonomised agencies. These policy areas are:
Chancellery, Public Governance, Foreign Affairs and Justice; Flemish Foreign Affairs; Finance and Budget; Education and Training; Economy, Science and Innovation; Culture, Youth, Sport and Media; Welfare, Public Health and Family; Agriculture and Fisheries; Work and Social Economy; Mobility and Public Works; Environment.
The policy areas that are relevant for the MANCP are Agriculture and Fisheries and Environment.
Policy area Agriculture and Fisheries
The Flemish Ministry of Agriculture and Fisheries is composed of the Department of Agriculture and Fisheries and of an unincorporated internal autonomised agency, the Flemish Research Institute for Agriculture, Fisheries and Food (ILVO).
The policy area Agriculture and Fisheries has also one private-law external autonomised agency, i.e. the Flemish centre for Agricultural and Fisheries Marketing – VLAM.
And finally there is a Strategic Advisory Council on Agriculture and Fisheries, integrated in the Socio-economic council of Flanders - SERV.
Organic production and the Protected Designation of Origin (PDO), the Protected Geographical Indication (PGI) and the Traditional Speciality Guaranteed (TSG)
The Department of Agriculture and Fisheries is the competent authority for the implementation and supervision of control systems for organic production and for the approval and protection of protected designations of origin, protected geographical indications and traditional speciality guaranteed.
In the Flemish Region, rules for the inspection of organic production are laid down in the decree of the Flemish government of 12 December 2008 on organic production and the labelling of organic products, and in the implementation decrees thereof. Inspections and certification of operators are carried out by recognized control bodies that come under the authority of the Department of Agriculture and Fisheries.
21 DG(SANTE)/2020-6907 Version: May 2021 The approval and protection of PDO, PGI and TSG is the subject of the decree of the Flemish government of 19 October 2007 on the protection of geographical indications and designations of origin of agricultural products and foodstuffs and the traditional speciality guaranteed of agricultural products and foodstuffs, and the implementation decrees thereof. Producers seeking to protect their products under a designation of origin, a geographical indication or a traditional speciality guaranteed should submit an application file to the Department of Agriculture and Fisheries. That department then follows up the handling of the applications up to approval of the protection by the European Commission.
The control on the protection of designations of origin, geographical indications and traditional speciality guaranteed in the Flemish Region is laid down in the decree of the Flemish government of 19 October 2007 and the agreement concluded on 17 July 2006 between the FPS Economy, the Flemish Region and the Flemish Centre for Agricultural and Fisheries Marketing.
The Directorate General Economic Inspection (DGEI) of the FPS Economy is in charge of all controls related to Regulations (EC) No 2012/1152. Controls are performed for both products of the domestic market and foreign products. DGEI will act as control body for files submitted to the Department of Agriculture and Fisheries if the applying group makes a request thereto.
Policy area Environment
The Flemish Ministry of Environment consists of the Department of Environment (OMG) , the Nature and Forest Agency – ANB, the Research Institute for Nature and Forest – INBO and the Flemish Energy Agency – VEA.
The bodies that intervene within the context of animal by-products (ABP) are the Department of Environment, Nature and Energy that comes under the authority of the Ministry of Environment, Nature and Energy, the Public Waste Agency of Flanders (OVAM) and the Flemish Land Agency (VLM).
Department of Environment
This department aims at achieving a high quality environment in which the various resources are used in a sustainable manner. Within that department the sections Environmental licences and Environmental inspection respectively deal with issuing environmental licences and the enforcement and maintenance of environmental hygiene regulations.
The Environmental inspection section plays a leading part in the enforcement of all environmental hygiene regulations. It is, in fact, in charge of the first line supervision of the establishments subject to authorisation presenting the highest risk, i.e. so-called class one establishments (including all animal by-products processing businesses subject to authorisation). It is also active in the supervision of small establishments considered to cause fewer nuisances and the handling of waste materials in breach of the provisions of the waste materials decree.
The Department of Environment also hosts the animal welfare unit since this competence has been transferred to the Regions in 2014.
Public Waste Agency of Flanders (OVAM)
22 DG(SANTE)/2020-6907 Version: May 2021 The OVAM is the point of contact in Flanders for all issues concerning waste materials, environmental friendly use and consumption of materials and soil decontamination.
Flemish Land Agency (VLM)
The VLM is an external autonomised agency that is active in the policy area Environment, Nature and Energy of the Flemish administration. The most important sections of the VLM are: rural planning, manure bank and rural environment. It has a central office in Brussels as well as an office in each of the five Flemish provinces that are in charge of the realisation of projects.
Mestbank
The Mestbank is the Flemish competent authority with respect to manure as an animal by- product.
Walloon Region
Introduction
The administration of Wallonia consists of an integrated unit called “Service Public de Wallonie” (public Service of Wallonia). The Public Service of Wallonia is in charge of economics, agriculture, environment, animal welfare, transport, infrastructures, and all other matters that are under the regional competence.
In addition, there are some public bodies that perform specific tasks of regional interest.
Direction Générale Opérationnelle Agriculture, Ressources Naturelles et Environnement
Within the framework of the MANCP, the Service Public de Wallonie Agriculture, Ressources Naturelles et Environnement (SPWARNE), one of the directorates general of the Ministry of the Walloon Region, is of interest.
Organic production and PDO, PGI and TSG
The Direction de la Qualité et du Bien-être animal of the SPWARNE is the competent authority of the Walloon Region with respect to the implementation and enforcement of control systems for organic production. It is also the authority entrusted with the recognition and protection of protected designations of origin, protected geographical indications and traditional speciality guaranteed, if there is a geographical link to that Region.
In the Walloon Region, rules on the control on organic production are laid down in the Walloon Government decree of 11 February 2010 on the production method and labelling of organic products and repealing the Walloon Government decree of 28 February 2008. Controls are performed by approved control bodies.
The decree of 19 October 2002 and the Walloon Government decree of 25 September 2003 deal with the recognition and protection of PDO, PGI and TSG that are geographically connected to the Region. The competent authority for the protection of TSG, PDO and PGI is, however, the FPS Economy. At the moment, one independent certifying body has been approved by the Walloon Region with respect to supervision and observance of approved specifications.
23 DG(SANTE)/2020-6907 Version: May 2021 Animal by-products
The authorities of the Walloon Region that are in charge of issues related to Regulation (EC) No 1069/2009 are the Département du Sol et des Déchets (Office Wallon de Déchets, OWD) and the Département de la Police et des Contrôles.
Animal welfare
The Public Service of Wallonia develops norms and policy for, and co-ordinates controls on animal welfare.
Brussels-Capital Region
Introduction
The Regional government has an administration, the Brussels Regional Public Service (BRPS) and various para-regional bodies and non-profit associations of regional interest, to implement its policy.
The BRPS is the major instrument of the Brussels government for implementing its policy. It consists of six administrations:
Brussels Regional Coordination; Brussels Economy and Employment; Brussels Finances and Budget; Brussels Mobility; Brussels Housing; Brussels Local Authorities.
Brussels Economy and Employment
This administration promotes sustainable economic development and job creation in the Brussels-Capital Region. It grants financial support and allowances to self-employed people, SME managers or social economy actors for the development of economic activities. It also offers advice and carries out analyses with regard to food products with the Brussels Centre for Food Expertise BRUCEFO. Within Brussels Economy and Employment, the directorate of Economy is the competent authority of the Brussels-Capital Region for implementing and supervising the control system for organic production. It is also responsible for the recognition and protection of protected designations of origin, protected geographical indications and traditional speciality guaranteed.
In the Brussels-Capital Region, the rules on organic production were laid down in the decree of the Brussels Capital government of 3 December 2009. Controls are performed by approved control bodies.
The approval and protection of PDO, PGI and TSG in the Brussels-Capital Region is provided for in the decree of the Brussels Capital government of 22 October 2009. The applications for registration of a PDO, PGI or TSG are to be submitted to the Directorate Economy- agriculture..
The DGEI of the FPS Economy is in charge of controls on (the labelling of) PDO, PGI and TSG. This was formalised at the beginning of 2021 through an agreement between these different authorities. 24 DG(SANTE)/2020-6907 Version: May 2021 Brussels Environment (BE/LB)
The Brussels Environment is an "A type" institute of public interest. It is the environment and energy administration of the Brussels-Capital Region and its task is to manage the various environmental aspects: air, waste, soil, green space and biodiversity, noise, energy, health and environment as well as ecologically sound mobility. Since January 1st, 2015, BE/LB is in charge of animal welfare and has created a dedicated service.
Resources for performance of controls
In order to ensure that control and other personnel have the appropriate qualifications, experience and training, a number of measures are taken. Within the different administrations, the P&O services are responsible for recruitment, mapping out the skills and training needs of employees and, if necessary, taking action to meet these needs. Employees are therefore given the opportunity to participate in internal or external training programmes.
For federal officials, the Training Institute of the Federal Government is responsible for providing guidance to federal officials throughout their entire careers in the form of further training programmes and a range of courses.
Federal officials may receive training leave of a maximum of 120 hours per school year under certain conditions.
Newly hired "level A" permanent employees must complete a year-long internship in order to be appointed. During this internship, a number of courses must be followed that pertain to the performance of their duties. This occurs alongside on the job training.
There is a series of legal and other documents which lays down the rules for recruitment and ethical conduct of FASFC staff and private veterinarians:
Circular No. 573 on the ethical framework for administrative public officials; Circular PEBE/DVO/2006/6 on the code of conduct for officers of the Flemish administration; Royal Decree of 2 October 1937 establishing the status of state officials; Royal Decree of 8 March 2004 laying down special statutory conditions for public officials and contractual staff recruitment in order to prevent conflicts of interest; Royal Decree of 11 November 2013 laying down the conditions under which the FASFC may allow independent veterinarians, bio-engineers, master’s degree holders, industrial engineers or bachelor’s degree holders or legal persons practising activities related to control, sampling, certification and audits, to carry out activities; and The Charter of the Inspector.
The Charter of the Inspector requires staff to conduct controls in a professional manner and to seek dialogue. The Charter enshrines the principles of integrity, impartiality, and discretion.
Some 710 staff in the LCUs (external services of the FASFC) perform controls.
Private veterinarians can be requested/recruited by the Agency in two ways: they can be appointed for a certain task, period and location included in an ''agreement for execution''
25 DG(SANTE)/2020-6907 Version: May 2021 and in this case are called ''vétérinaire chargé de mission/dierenarts met opdracht” (about 570 appointed independent veterinarians were involved in missions in 2019 equivalent to approximately 300 full time equivalent staff) or they can perform tasks as an approved veterinarian. In order to carry out official tasks they must have passed an interview assessment with an Evaluation Committee whose composition has been determined by the Managing Director of the Agency, before being recruited and signing an agreement for execution/general contract with the CCA.
FASFC may also recruit bio-engineers, industrial engineers, master and bachelor degree holders and legal persons to carry out certain tasks (Royal Decree of 11 November 2013).
Training participation is at the discretion of the official private veterinarian. However the completion of training is a pre-condition for the performance of controls and competence is an element of staff evaluation. They must undergo a repeat assessment before signing a new contract with the CCA.
The official private veterinarians can carry out activities such as certification, border control post tasks and official controls in meat establishments and on farms (epidemic- surveillance, animal welfare).
Organisation and implementation of official controls
Organisation: Concept and procedure
The FASFC organises official controls based on a MANCP in the framework of Regulation (EU) 2017/625 (correlated with the FASFC Business Plan) and its core process. The core process of the FASFC refers to the cycle from programming through planning and execution to reporting. By working with this core process, the FASFC is able to focus on the core tasks, which leads to an improvement of the work. The core process is scientifically based and drawn up in consultation with the stakeholders.
Besides FASFC, other competent authorities are involved in the MANCP, such as the FPS- HSFCE, the FAMPH, the CS, the FPS Economy, Small and Medium-sized Enterprises (SMEs), Self-Employed and Energy, the FANC, regional authorities, as well as various external control bodies.
As far as the FASFC is concerned, the duration of the MANCP is the same as that of the business plan of its CEO. This way the strategic and operational objectives of the FASFC are linked to those of the MANCP.
The FASFC programme of controls distinguishes between the planning of analyses and the planning of inspections. The first is re-evaluated each year to take into account updated data (core process: risk assessment stage). Inspections, on the other hand, are planned on a multiannual basis and adjusted on an ad hoc basis. This approach is described in detail in the MANCP.
The development and implementation of the programme of controls follows three stages:
drawing up of the programme of controls by DG Control Policy, on a risk basis. In this context, the programme of analyses is revised annually to take into account the monitoring data and the latest scientific opinions and to diversify the products to be sampled and the dangers sought. This revision uses a statistical approach which integrates risk criteria. The multiannual inspection programme covers the whole 26 DG(SANTE)/2020-6907 Version: May 2021 food chain, with inspection frequencies linked to the risks associated with the activities carried out in the establishments; DG Control Policy sends the programme of analyses to the DG Laboratories, which groups them into samples (the rationalised programme). At this stage, the samples to be analysed are assigned to the laboratories. The rationalised programme is then sent to the DG Control, which plans the sampling and allocates them among the different LCUs; LCUs carry out the controls (inspection and sampling) and report their findings. In this context, the LCUs plan the missions (visits) of the inspectors taking into account the frequency established in the programme of inspections. Establishments are inspected for one or several scopes, according to the activity exercised and also according to the risk profile of the operator. Where relevant, programmed samples are taken during inspection visits. Each control report is countersigned by the operator and uploaded in the FOODNET database. The laboratories report the results of analyses.
FASFC also pays attention to the information supplied by businesses within the context of obligatory notification, RASFF and complaints or findings.
Some basic approaches which determine the official control plan:
a mission can have several scopes (a mission means a visit to an establishment where several tasks/inspections have to be carried out - different type of inspections or/and sampling); most inspections have only one scope and may be of different types (for example in case of an establishment: infrastructure, facilities and hygiene, self-control system, notification, traceability); the scope of an inspection is pre-defined in the FOODNET (i.e. infrastructure, facilities and hygiene, labelling, traceability; etc.); during inspections, each scope is used at a given percentage (%) laid down by the central administration, and a weighted checklist is used; these tools allow a standardization of measurements which is an essential part of the scope of ISO 17020; each checklist used by an inspector is encoded into FOODNET;
Most of the FASFC inspections are performed by applying inspection frequencies. An inspection system with 3 frequencies, and another system with 2 frequencies supplemented with follow-up inspections can be distinguished. Frequencies may be adjusted to the risk profile of operators. There are three risk criteria that determine the risk profile of an operator:
the presence/absence of a certified/validated self-checking system; the penalties issued over the past two years; the results of previous inspections in case of a base frequency of ≥ ½ year.
In some cases, the number of inspections is fixed on an annual basis (e.g. transporters, itinerant food business operators, producers/traders of wood packaging material).
FASFC Strategy concerning the implementation and validation of the self-checking system in FBOs' establishments: 27 DG(SANTE)/2020-6907 Version: May 2021 In order to boost the implementation and validation of the self-checking system in FBOs establishments, FASFC has introduced a range of mechanisms to encourage the FBO to achieve a high level of hygiene such as the " Smiley System'', ''the Bonus System'', training as an alternative to administrative fines, information campaigns (coverage in trade magazines, press, TV) and sectoral guides for most operators (big to small sized business).
The ''Smiley System'': is a voluntary scheme; officially launched in January 2008, it is a sticker certifying that the company has put in place a trustworthy system of hygiene control, meaning that the self-checking system has been validated. Each "Smiley" has a unique number of identification in the BOOD database of FASFC and has a validity of 3 years. In 2012, the FASFC smiley, which up to that point was only intended for restaurants and institutional kitchens that have a validated self-checking system, was extended to all establishments that directly deliver food to consumers (B2C).
The ''Bonus System'': is a voluntary scheme; operators with a validated self-checking system are granted a bonus on the levy due to the FASFC and have a lower inspection frequency. An analysis of the impact of self-checking systems on the inspection results shows that in an FBO with a validated self-checking system, the results are significantly better. In 2014 the FASFC introduced a procedure that makes it possible for private system owners to demonstrate equivalence with the guides. Equivalence means that in case of a favourable audit based on the equivalent system, no additional audit is required based on the relevant guide, but that the audited business can still benefit from a bonus on its contribution to the FASFC and a reduction of the inspection frequency.
The ''Training as an alternative to administrative fines'' - this applies to official offence reports (procès-verbal) issued to operators of HORECA with a FASFC authorisation after 1 January 2011. For those cases, the FASFC foresees the possibility of exoneration of the administrative fine if the operator commits himself to following a training course set up by the ''information cell of the FASFC'' or in co-operation with the hotel or catering business federations (in 2019, about 1.029 FBOs took this option).
Self-checking guides for B2C businesses are managed by the FASFC (starting from 2013) and drawn up in consultation with the sectors involved, printed and published on its website. Also, they were complemented with a ‘quick start’ files.
Also, in order to facilitate the implementation of self-checking businesses, a number of leniencies to the self-checking requirements were granted. Until early 2013, these leniencies were limited to SMEs in the distribution sector, the hotel and catering industry and to micro enterprises in the processing sector. However, since March 2013, these leniencies have been extended to al B2C establishments by means of a ministerial decree, regardless of the establishment’s size. These leniencies allow establishments to implement the hazard analysis critical control points (HACCP) procedures described in the guide, so that they will no longer have to conduct their own hazard analyses. This makes it easier to implement self-checking systems in small businesses that have little human resources and scientific expertise at their disposal.
Technical support for Implementation of the MANCP/Annual Control Plan
The entire system is supported by:
various well-developed and integrated databases and planning/check/reporting/follow -up tools which are centrally set up in the system.
28 DG(SANTE)/2020-6907 Version: May 2021 The previous control history of the FBOs is automatically transferred into the planning process; BOOD: is the database for the management of the operators of the food chain, and veterinarians; ALPHA: is the database for the management of the sampling plan. Alpha is used for encoding the programme of analyses, for its rationalisation into a sampling programme and the distribution of those samples, as well as for the monitoring of the sampling plan. Alpha is used by CCA of DGC to distribute samples and to follow them up; FOODNET: is the database used for the management of all data concerning the inspections/controls uploaded by the inspectors (control plan, re-control, complaints, RASFF, authorisation etc.); ''Offline Mission Generator'' is an application that allows staff to create a mission off-line or transfer the mission into FOODNET using the laptop (operational since 2010); FOODLIMS: LIMS = laboratory information management system (is the database used for the management of all data related to laboratory activities); SANITRACE: is the database used for the Identification and Registration, and traceability of farm animals; FOODWEB is a Customer Relationship Management or Operators Platform within FASFC (operational since 2010); is an application in which the active operators and their test results are available; the operators can use it to apply for different issues (complains, requests, declarations, payments) and can consult their personal data available at FASFC; DEBOHRA and PRONET are databases for the management of the FASFC staff databases; FINFOOD manages the financing system of the FASFC. For what concerns the fees, the work of FINFOOD is based on the inspection data collected in ADMINLIGHT; BUSINESS INTELLIGENCE or BI uses the data of all databases.
About 50% of control reports are uploaded in the first 24 hours following the missions in FOODNET, and 100% must be uploaded within about 7 days (see KPIs, part of KPIs – key performance indicators).
A. Detailed procedures and guidelines: all official staff has access to the FASFC intranet which contains information on legislation and documented procedures (standard weighting checklists, detailed instructions for implementation of controls and interpretation of the checklists scores and follow - up actions) and has to complete standard reports /or follow up reports which should be loaded into the database. Procedure 2010/250/CONT (revised on a regular basis) describes the conduct of an inspection and Procedure 2010/251/CONT and the associated annexes (revised on a regular basis) describe all the procedures related with sampling. B. Weighted check-lists with automatically calculated compliance statuses which are encoded into the system using portable computers. The checklists are published on FASFC website (see enforcement measures).
Laboratory NETWORK
Official control laboratories are accredited by BELAC managed by the FPS Economy. BELAC is a member of the Mutual Recognition Agreement of the European co-operation
29 DG(SANTE)/2020-6907 Version: May 2021 for Accreditation. Its accreditation status is subject to a periodic surveillance and a renewal assessment every three years (for the first term) and five years (for the next renewals).
Accreditation
All control services of FASFC are accredited to ISO 17020. Within this framework all aspects of the FASFC process were audited ranging from independence, impartiality and integrity of the service to the quality systems in place, the control methods and procedures to the handling of inspection reports and certificates.
Enforcement measures
Enforcement is the prerogative of the Public Prosecutor, but many cases are dealt with by the Commissioner of Administrative Fines of the FASFC whose work reduces the courts' workload. In cases of high risk for public health, legislation provides for the Agency's competences to take immediate action (e.g. closing of establishments).
The legal basis for measures taken for non-compliances, enforcement measures and sanctions, are the Royal Decrees of 28 February 1994 and 22 February 2001 and the Law on Product Standards of 21 December 1998.
This legal basis is assisted by the following tools:
documented procedures: ''Procédure Exécution du plan d'inspection'' (revised on a regular basis); The ''inspection weighted checklists'' provide legal guidelines and instructions under a particular topic. This is intended to assist the facility in developing the topic by providing additional information under a particular topic. The checklists have an emphasis on "Management of Enforcement", on how the officials have to act for different scores. The results of checklists are weighted automatically and categorised as either 'favourable', 'favourable with remarks' or 'unfavourable', or result in sanctions if a certain score is reached (formal warnings, ''Procès-Verbal'', re-visit etc.). There are 5 types of weightings divided into three categories: major (10, 10*), minor (1,3) and weighting value 0. When a 10 or 10* is reached a ''Procès-Verbal'' is generated and a re-visit is required. Any non-conformity relating to a ''Procès-Verbal'' or warning gives rise to a re-inspection, which must take place within a reasonable time that is proportional to the time allowed for the operator to take corrective action. These may also lead to suspension or withdrawal of approvals.
30 DG(SANTE)/2020-6907 Version: May 2021 Assessment of a checklist that contains more than 10 applicable items
Categorisation of the results of Number of non-conformities in the CL Measures taken inspection
Starting with 1 NC = 10* PV 'unfavourable'
Starting with 1 NC = 10 and T*> 20% PV 'unfavourable'
Starting with 1 NC = 10 and T*< 20% Warning 'unfavourable'
Starting with 1 NC = 3 and T*> 20% Warning 'unfavourable'
Starting with 1 NC = 3 and T* < 20% No measures 'favourable with remarks'
Only NC = 1 or no NC No measures 'favourable'
Where T* = the total NC % of CL and is calculated as follows
T = NCX100/C+NC
NC = the number of non-conform items in the CL (with weighting # ''0'')
offline ''weighted checklist'' filled offline on PCs, and transferred to the FASFC system afterward.
Verification and review of official controls and procedures
Largely the system set up is designed based on the following:
A) Approach
Management ethics: Continued quality and improvement of the system, Plan – Do – Check – Act (PDCA) cycle,
“PLAN"
“CHECK “DO” K
31 DG(SANTE)/2020-6907 Version: May 2021 B) The staff and management commitment and the Charter of the Control Officer
A ''Quality policy statement” and “Environmental policy statement” were made by the management on 19/09/2008 and 04/02/2010 and a ''Quality and environmental policy statement" was made by the DG Control management on 01/04/2012. It is updated on a regular basis.
These quality policies are formal statements from management, closely linked to the objectives of the business plan (and, as far as the FASFC is concerned, also to the MANCP) and to the stakeholders needs. The policies are followed by all employees. Each employee works towards measurable objectives.
The Charter of the Control Officer requires the staff to conduct controls in a professional manner and to seek dialogue. The Charter enshrines the principles of integrity, impartiality, and discretion.
C) International Quality Management standards
The search for quality is permanently included in the strategic targets of the FASFC. One of the targets of the 2009-2011 business plan was to achieve compliance of all the activities with the international quality management standards that are relevant for the Agency, i.e. ISO 9001, ISO 17020 and ISO 17025. At the same time, the FASFC had developed an environmental management plan.
That target has now been concretized. The requirements of the different standards have been brought together within one quality and environment system in order to obtain a more efficient and more user-friendly tool. This integrated system has now led to a platform that is firmly embedded in the FASFC and makes it possible to comply with the different legislations, standards or other requirements and to develop, support or encourage efforts and activities with respect to quality.
The quality-system comprises the following standards:
ISO 9001 (covering among others the core process and activities of the FASFC dedicated to the safety of the food chain, and all activities with major significance or influence on consumers, the community, operators, national and international authorities and instances, and the external partners) ISO 17020 (for control activities in the business sectors primary production, processing, distribution and import controls carried out in the BCP) ISO 17025 (all federal laboratories are accredited and similar requirements are laid down for contracted external laboratories)
A quality cell has been established in each DG of FASFC and each LCU (i.e. see Chapter on organisation: NICU and LCUs). The Regional Directorate ensure the co-ordination between the LCUs and the centre. As a whole they are co-ordinated by the Internal Audit and Quality Management Services which is the main pillar of the FASFC QMS, and which has a Quality Assurance Cell (for ISO).
Accreditations are issued by the BELAC according to the criteria of each international standard, following an external audit. Certificates for ISO 9001 are delivered by independent certification bodies.
32 DG(SANTE)/2020-6907 Version: May 2021 D) Integrated information flows
The FASFC IT structure is as follows (see also the databases description under the Organisation and Implementation of Official Controls chapter).
All the structured collected/reported data concerning TRA, DIS and PRI sectors is stored in several databases which are integrated. Control/inspection and sampling plans, frequencies, number of controls and sampling instructions are set centrally in the system.
The ''Checklists Dynamo'' application transformed the static current FOODNET checklists into dynamic checklists to avoid duplication, increase readability and facilitate the work for inspectors. ''Planifood and Cockpit'' allows the central services to immediately identify any major shortcomings made by inspectors.
In order to carry out these projects, FASFC set up organisational, methodologies and management processes consistent and integrated with those of its stakeholders. The Directorate for Integrating Information across all Services develops and ensures the quality and appropriateness of raw data collected and transforms the raw data into meaningful and useful information for the Agency and is supported by the services of the Information Technology and Communication section which ensures that the agency has at any time tools necessary to accomplish its mission.
All official staff have access to the FASFC Internet and Intranet (the applications and the databases) which contains information on legislation and documented procedures (standard weighted checklists, detailed instructions for implementation of controls and interpretation of the checklists scores and follow up actions, control and sampling plan, operators BOOD database) and mission orders, standard reports and follow up reports which should be loaded into the FOODNET database. LIMS interfaces with FOODNET and is the database for recording sampling results. Some of the checklists of inspections carried out by the approved veterinarians are not included in the FOODNET database. However, the results of those inspections are duly communicated to the LCUs, and all non-conformities are handled with as for any other inspection.
As regards verification, these applications allow:
LCUs to carry out qualitative checks over the control reports uploaded by the inspectors in the databases (BOOD, FOODNET and ADMINLIGHT). In accordance with strategic objectives of LCUs, the ''Chef de Secteur'' has to carry out monthly verification of 1% of control reports without enforcement measures and 3% of control reports with enforcement measures (process verbal, warnings etc.). The verification process covers, inter alia, compliance with documented procedures, use of templates, timely reporting and completeness and correctness of the forms filled. When non-compliances are found, recommendations should be issued to the staff concerned and the results/report should be submitted to the Head of LCU. FASFC and LCUs to supervise the progress of implementation of sampling and controls programmes. Any decision by inspectors to deviate from normal intervention levels should be made in co-ordination with the head of sector and recorded in FOODNET. The LIMS interfaces with FOODNET. FASFC Management to measure and compare results with expectations, analyse (define indicators, draw trends) and decide whether the organisation/processes are fit for purpose and/or need review and therefore new projects are initiated.
33 DG(SANTE)/2020-6907 Version: May 2021 E) Reporting – use of standard tools:
Weighted checklists with automatically calculated compliance statuses have been included for the inspectors (see description under the Enforcement Measures chapter). These represent a set of consistent reporting standards and allow a well-defined and regular way of treating issues that need to be measured by the FASFC.
F) Management measurement tools (performance and impact indicators)
The role of the central management is to monitor and evaluate effectiveness of controls and their results, based on the strategic objectives established in the business plan and on the resulting operational objectives, and to develop and preserve the quality system in DG Control.
A set of KPIs have been set out by FASFC. Each year, objectives are set up for each local control unit and an evaluation is carried out by means of these KPIs. These KPIs include a number of measurable parameters, such as time, distance, number of missions carried out, number of inspections, number of missions with warnings, Procès Verbal, divergent measures, re-visit, closing dates of files etc. In this way, inspection work is assessed from the perspective of productivity and quality. The individual KPIs are evaluated only by the LCU. Only global figures concerning the sectors or LCUs are transmitted/reviewed by the central office.
Measuring outcome: the Food Safety Barometer
In 2010 three barometers measuring the safety of the food chain in Belgium were developed by the SC of the FASCF: the food safety barometer, the animal health barometer and the plant health (phytosanitary situation) barometer. These barometers are practical instruments allowing to observe the national annual evolutions in food safety, animal health and plant health and to communicate in simple and clear terms about the outcome. The barometers are based on a basket of carefully selected indicators which are annually measured. Their respective weight in the final result of the barometers have been determined by the stakeholders of the food chain. The majority of these indicators are measured within the context of the control program of the FASFC. In 2018, the food safety barometer was re-evaluated leading to a new version of the barometer, version 2. In this new version, a number of indicators from the original basket were deleted, reformulated or merged. Consequently, the results of the new version of the barometer are not comparable with the results of the first version.
More information about the three barometers can be found at the following link: http://www.favv-afsca.be/scientificcommittee/barometer/introduction/ http://www.favv.be/activiteitenverslag/2019/barometers/voedselveiligheids/
G) On-going progress review by Management (the feedback loop to complete the PDCA cycle)
Management reviews take place at FASFC level ("Management Consultative Committees''), in each DG (in particular DG Control during the ''Consultative Committee of Management DG Control''), and at regional level.
A general procedure (2011/397/CONT) available on the intranet describes all the elements that should be taken into account during the ''Consultative Committee of Management DG Control'' (frequency, information flow, reports, action plan etc.). Monthly meetings of the 34 DG(SANTE)/2020-6907 Version: May 2021 heads of sector are organised by DG Control to review progress. A fixed Agenda is distributed before these meetings. This Agenda includes themes like annual objectives and KPIs (twice a year the heads of LCUs present and discuss their figures) results of internal and external audits (the DG SANTE Directorate F and others), recommendations and action plans, non-conformities, complaints and solutions, training etc. These discussions are based on statistics and graphs.
At the FASFC level, review by the Management Board (Board of Directors) is done by topic. A ''dashboard'' combines all the recommendations made by internal or external auditors, including the DG SANTE Directorate F recommendations. This is updated 3 times per year during the meetings. These kinds of dashboards exist at the FASFC level but also at each DG level. The dashboard has a KPI.
The KPIs are used by FASFC as indicators of performance and benchmarking across LCUs and sectors. The objectives and KPIs of the first and third trimester are reviewed during the regional meetings, and the objectives and KPIs of first semester/all year are discussed during the Management Consultation Committee.
Each month, the heads of LCUs and/or head of sectors review the LCUs' objectives and the KPIs during regional/sectorial meetings. Preventive or corrective measures are taken if necessary. Quarterly, the objectives and KPIs/ results of control plans for each LCU and by sector are sent to the regional directorates for review.
H) Supervision and coaching at LCU level
The NICU acting as a coordinator for the centre is an important pillar in the management of CDM, in supporting the implementation of the QMS according to ISO 9001, ISO 17020 and ISO 14001, and internal audits at LCUs level and follow up of the action plans arising from these audits. Official controls performed by approved veterinarians are verified at local level by the head of the LCU and by the head of the relevant sector. A written assessment is made twice a year to evaluate if the veterinarian is meeting the objectives of his contract and respecting its conditions. This evaluation is again assessed before renewing the annual contract with the Provincial authorities.
This evaluation is done by: reviewing the inspection reports and other documentation received; performing on the spot inspections.
Documentary checks: as part of the LCUs' objectives plan, each LCU has to carry out monthly checks on 1% control reports without enforcement measures and 3% of control reports with enforcement measures (PV, reports, divergent measures etc.) uploaded by the inspectors to the databases (in BOOD, FOODNET and ADMINLIGHT).
On the Spot inspections: two times per year, joint inspections of all veterinaries on assignment (part of ISO 9001), and all inspectors (as part of LCU's objectives) with the scope for a better assessment of these appointed veterinaries/inspectors performances and/or better targeting for further amendments, followed by coaching as necessary are carried out by LCUs.
NICU is involved in the organisation of training courses for LCUs staff. Annually, training needs of staff are identified during the evaluations. Based on these the DG Control tailors a plan. Training is mandatory and competence is an element of staff evaluation.
35 DG(SANTE)/2020-6907 Version: May 2021 Since 2011, FASFC have introduced a new approach '' co-ordinated controls – COCO''. This is a task of the NICU. The co-ordinated controls are performed according to a standardised framework in several establishments across the country performing the same activity. NICU establishes the nature, timing and operation reports. They are carried out by several inspectors / controllers of DG Control. The aim is to verify/improve the quality of control in this area and to streamline the work between LCUs and inspectors.
Reporting results
The FASFC publishes an annual report on control activities which can be accessed on the FASFC Web. Until the date of application of Regulation (EU) 2019/723, this annual report formed a basis for the annual report on the implementation of the MANCP. The system of measurement used by the CA in the Annual Report to quantify control performance for outcome and/or activities indicators is the compliance rates for inspections.
Besides the above mentioned FASFC annual report, the FASFC also informs its stakeholder regularly of the control results by means of dedicated presentations in the Consultative Committee of the FASFC.
Audit
The Belgium system of audit comprises several structural layers:
Federal Audit Committee (FAC); FASFC Audit Committee (FASFC–AC); FASFC Internal Audit and Quality Management Services (FASFC-IAQMS); Pool of auditors.
Federal Audit Committee (FAC)
The FAC has been established by the Royal Decree of 17 August 2007. Its members have been appointed by the Council of Ministers on 12 February 2010. The aforementioned Royal Decree gives wide powers to this Committee concerning internal audit. The head of FASFC-IAQMS attends monthly co-ordination meetings organized by the FAC.
FASFC Audit Committee (FASFC-AC)
The FASFC-AC has been established based on Royal Decree of 20 December 2007 and Ministerial Decree of 22 September 2009. It comprises 5 representatives and 4 replacements. The President must be an external expert in internal audit and quality systems. There is one member of the Management Board of the FASFC (and one replacement), two representatives of the stakeholders - representatives of industry and consumer organisations (and 2 replacements), and one representative of the Minister in charge (and one replacement).
Its mission is to assist the Management Board and the CEO of the Agency in monitoring the operation of the FASFC. Their task is to evaluate the annual audit programme and interim audit requests, and its implementation; to develop an overview on all internal and external audits, evaluate all audits carried out, and present an annual report. The Annual Report of internal audit is published by the FASFC-Audit Committee.
36 DG(SANTE)/2020-6907 Version: May 2021 Independence and independent scrutiny of internal audit is guaranteed by the FASFC Audit Committee which has been appointed under Royal Decree of 20/12/2007.
The Audit Committee meets usually 4 times per year.
The charter and the rules of procedure are approved by the Minister. According to the Charter, the duties of the President are externalised since 2012. All its members have to sign a declaration of confidentiality. The charter describes the rights, obligations and the incompatibilities of members, and the rules for the organisation of meetings.
The FASFC Internal Audit and Quality Management Services (FASFC-IAQMS) and the Pool of auditors
Based on Royal Decree of 20 December 2007 establishing the location, organisation and mission of FASFC and Royal Decree of 17 August 2007 concerning internal audit services in federal authorities, an internal audit section was created within the FASFC in September 2006 with the mandate of developing procedures, a code of conduct and a plan for internal audits in FASFC. Since the completion of a pilot phase in the first half of 2007, internal audit has become fully operational.
The FASFC-IAQMS is the main pillar of internal audit and quality within the FASFC.
The audit system achieved certification ISO 9001 in 2008 and accreditation ISO 17020 in 2010 (by BELAC) and is subject to quality audits every 5 years.
The audit service is subject to KPIs.
It comprises approximatively 3 full time auditors.
Their activities are governed by the Internal Audit Charter, Code of Ethics, and Standard Operating Procedures.
Responsibilities and competences
Management has delegated the ''internal audit mission'' to the FASFC-IAQMS department. The department has full and unrestricted access to all activities, properties, files, personnel information of FASFC unless this is prohibited by court. Internal audit does not prejudice the financial and operational responsibilities of the management of the FASFC.
Reporting
The Head of the FASFC-IAQMS reports quarterly to the FASFC Audit Committee. The department also reports to the CEO, the Management Board of the FASFC and the FAC. The audit role of the audit committee is laid down in the Royal Decree of December 2007.
An audit report is produced annually.
The Program and annual audit report is submitted to the FASFC Audit Committee, FASFC Management Board and the FAC.
Pool of technical experts
A pool of technical experts from the NICU, the LCUs and laboratory quality team assist the audit service. It can draw on this pool of technical experts to work under its supervision. 37 DG(SANTE)/2020-6907 Version: May 2021 Many inspectors were trained as auditors. A full time auditor participates in each audit. The range of expertise is wide-ranging (technique, quality teams, laboratory experts, externs for specialised tasks such as IT and finances).
The scope of the audit programme / '' Audit Universe''
The audit unit has introduced the new concept of an Audit Universe for risk based planning. The audit programmes cover the whole audit range - from technical operations (primary sector animals, primary sector plant, feed, transformation of food of animal or non-animal origin, distribution sector, import – export – internal EU trade), transversal operations (risk analysis, control program, sampling process, collaboration with other organisations, crisis management, registration of operators) and to support operations (Human Resources, IT, logistics, financial processes, procurement).
Preparation of the annual audit program (procedure)
An annual plan of internal audits is prepared based on:
input from all DGs, the FASFC Audit Committee, Audit Department, recommendations made by internal and all external auditors (the DG SANTE Directorate F, ISO, the FAC, the Minister of Interior); requirements of Regulation (EU) 2017/625 (5-year cycle - planned to cover all relevant areas within a five year time frame); requirements of the QMS; risk analysis (impact X probability of the proposed input); new concept ''Audit Universe''.
The Plan is submitted to the FASFC Audit Committee for assessment and to the Management Board for approval.
Process of audit (procedure)
The steps to be followed by auditors when conducting audits are:
Announcement / and first contact with the service that should be audited Planning and Preparation Performance: opening meeting, period referred, closing meeting Reporting: draft, comments to the draft, final report (The auditee has the right to comment on each audit report) Action plan by the audited service and validation of the action plan by the auditor
The audit reports are widely circulated (audited service, the FAC, Regions, and all DGs in the FASFC). After the development of the final action plan, all audit reports along with the action plan are published on the intranet of the FASFC and forwarded to FAC.
Categorisation, Follow up and Closure of recommendations (procedure)
Audit recommendations are issued to all levels of CA. After the initial audit the recommendation is classified as "open" and included in monitoring tables. The follow up of these recommendations can be carried out administratively by the QMS (the approach is not systemic, is based only on documentary evidence and information reviewed during
38 DG(SANTE)/2020-6907 Version: May 2021 meetings) or follow up audits are planned and included in the planning of the following years (within one or two years depending on the risk and priorities).
After the evaluation/follow up audit of the Action Plan, recommendations can be classified as: Closed – as action has been effectively implemented or recommendation / action is no longer relevant; Recommendations can be closed only by the Internal Audit Service. Open after follow up – the action has not been taken despite the elapsed period provided. In progress after follow up – action has not been fully implemented or is not effective. Reformulation – the recommendation and action must be reviewed following a change in circumstances since the initial audit.
The following classification of non-conformities is applied:
A: the non-conformity represents an immediate and serious danger and/or has an immediate and serious effect on one or more specified criteria such as human, animal or plant health, the achievement of the objectives of the FASFC, or the implementation of national and/or European legislation; B: the non-conformity represents a potential danger and/or has a potential impact on one or more specified criteria such as human, animal or plant health, the achievement of the objectives of the FASFC, or the implementation of national and/or European legislation; S: suggestion that is communicated with the intention of improving the entity’s system; suggestions include points for attention and possibilities for improvement that may have an efficiency-enhancing role for the processes and/or the QMS; no plan of action is needed from the auditee.
Multi-annual National Control Plan (MANCP)
Currently, the single body of Belgium has not been designated yet. Meanwhile, DG Control Policy of the FASFC takes a central and co-ordinating role with regard to the MANCP and Annual Report, however without taking the responsibilities related to the single body.
Until now, the MANCP is prepared by the FASFC, in close cooperation with the other competent authorities involved. As far as the FASFC is concerned, the duration of the MANCP is the same of that of the business plan of the FASFC. This way the strategic and operational objectives of the FASFC are linked to those of the MANCP. The most recent published MANCP for Belgium covers the period 2018-2020. A new MANCP is being prepared.
The MANCPs are published on the following webpage: http://www.favv- afsca.fgov.be/apropos/mancp/.
Annual Report
No decision has yet been taken whether or not to make the Annual Report in standard model form (Regulation (EU) 2019/723) publicly available. However, data on official
39 DG(SANTE)/2020-6907 Version: May 2021 controls can be found in the annual activity report of the FASFC and in annual reports of other competent authorities, which are available via: http://www.favv- afsca.fgov.be/apropos/mancp/.
40 DG(SANTE)/2020-6907 Version: May 2021 The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels.
Risk assessment, Policy Co-ordination Implementation Sector Laboratories scientific co-ordination of controls of controls advice Animal Health FPS- HSFCE FASFC FASFC Ext. approved SC/FASFC FASFC (LCU) laboratories Food of Animal Origin FPS- HSFCE FASFC FASFC FASFC Lab SC/FASFC FASFC (LCU) Ext. approved laboratories Imports of animal and food FASFC FASFC FASFC FASFC Lab of animal origin (LCU) Ext. approved SC/FASFC /CS laboratories Feedingstuffs and animal FPS- HSFCE FASFC FASFC FASFC Lab SC/FASFC nutrition /FASFC (LCU)
TSEs/ABP FPS- HSFCE Various CAs Various CAs FASFC Lab SC/FASFC/ /FASFC/ / Accord. to / Accord Ext. approved convention – to convention- laboratories see chapter see chapter 2.5 2.5 Veterinary medicines FAMHP FASFC/FA FASFC FASFC Lab FAMHP authorisation, marketing M (LCU)/ Ext. approved distribution H laboratories P FAMHP Veterinary medicines FPS- HSFCE FASFC FASFC FASFC Lab SC/FASFC - residues /FASFC (LCU) Ext. approved laboratories Foodstuffs and Food hygiene FPS- HSFCE FASFC FASFC FASFC Lab SC/FASFC /FASFC (LCU) Ext. approved laboratories FPS- HSFCE FASFC FASFC(LCU) Biosafety Council, - GMO FASFC Lab Sciensano /FASFC Regions/ FPS (fields) Ext. approved laboratories Imports of food of plant FASFC FASFC FASFC FASFC Lab SC/FASFC origin (LCU)/CS Ext. approved laboratories Plant protection products - FPS- HSFCE / FPS-HSFCE FASFC FASFC Lab FPS (authorise.) / authorisation, marketing and FASFC /FASFC (LCU)/ SC/FASFC use FPS-HSFCE Plant protection products - FPS- HSFCE FASFC FASFC FASFC Lab SC/FASFC residues /FASFC (LCU) Ext. approved laboratories Animal Welfare Regions
Plant Health FPS- HSFCE FASFC FASFC FASFC Lab SC/FASFC /FASFC CRA-W/ILVO Ext. approved laboratories Quality Labelling Regions
More detailed descriptions of the allocation of responsibilities between authorities in relation to each control system are given in the following chapters.
41 DG(SANTE)/2020-6907 Version: May 2021 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS
2.1 Control system for animal health
FPS-HSFCE DGAPF
CMPU Crisis Management and Prevention Unit CS Customs services DG Directorate General FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NICU National Implementation and Co-ordination Unit NRL National Reference Laboratory OIE World Organisation for Animal Health LCU Local Control Unit SANITEL National Bovine Database SC Scientific Committee Sciensano Scientific expertise on animal health and public health (including laboratories)
42 DG(SANTE)/2020-6907 Version: May 2021 Competent Authorities
The FPS-HSFCE and the FASFC are the Central Competent Authorities (CCAs) for animal health. The FPS-HSFCE prepares the policy for animal health and sets standards. The FASFC verifies that all animal health legislation and standards are respected and implements the control strategy by establishing more detailed standards and instructions. The Regions are competent for wildlife.
The single authority for animal health is the FASFC.
Holding registration, animal identification and movement controls
All bovine, porcine, ovine and caprine herds are registered in the national bovine database (SANITEL). Bovines, ovines and caprines are individually identified with eartags. Pig eartags bear the holding code. The central bovine database was recognised as fully operational by Commission Decision 1999/377/EC of 19 May 1999. Movements of bovines are recorded in the SANITEL system on an individual basis. For pigs, identification is by groups. All transport of small ruminants must be recorded by the transporter in a transportation register and disinfection log.
The identification models for bovine, ovine and caprine animals and horses can be accessed on the FASFC website.
Animal health controls
The veterinary services in the LCU are responsible for animal health controls. In exercising their tasks, the inspectors must be given free access to slaughterhouses, plants, warehouses and office buildings. In practice, for security reasons, roadside controls are carried out jointly with the police and the CS. The minimum number of annual controls, by activity area, to be carried out by the inspection services is established in the FASFC control programme.
The co-ordinators are responsible for the application of the programme for the relevant site as well as for the follow-up. The veterinary inspector, responsible for the site, devises the planning of the programme and supervises its application. If there are special controls, i.e. suspect cases, the number of controls on the site is adjusted accordingly. Planning of controls takes into consideration the animal population and the risk analysis. International co-operation with neighbouring countries exists in relation to classical swine fever (CSF) and food and mouth disease (FMD), e.g. information exchange on hunting policy, mutual participation in simulation exercises.
Contingency Plans (CP)
A general CP as well as the specific parts for FMD, CSF, Aujeszky’s disease, bluetongue disease, avian influenza (AI), West-Nile virus (and nuclear incidents) is in place. Contingency manuals are managed at central level by the Crisis Management and Prevention Unit – CMPU, and are regularly kept up-to-date. Up-to-date checklists are provided to the LCUs. Where relevant (e.g. for African horse sickness, lumpy skin disease, and African swine fever), new specific operational contingency manuals are elaborated.
An animal disease fund is used for financing specific disease control programmes, veterinary fees, and compensation for culling and destruction of carcasses. The fund
43 DG(SANTE)/2020-6907 Version: May 2021 comprises mandatory fees for farmers. Its organisation, structure and functions are based on the Law of 23 March 1998 and relevant Royal Decrees.
The CMPU is located at the FASFC headquarters in Brussels. It co-operates with the government co-ordination and crisis centre, which has overall responsibility for the management of crises. It also provides access to, and co-ordination with, the police, army and fire services. Lists of contact persons are available including those in the provincial offices. These are updated every three months. The weekly skeleton staff lists are established by the government co-ordination and crisis centre. Expert groups have been established for each major epizootic disease. In the event of an outbreak/suspicion of an outbreak, the relevant group is activated and advises the chief veterinary officer on the policy to be taken. The groups comprise staff of the veterinary services, the veterinary faculties, the NRL and other experts.
Each LCU has a local crisis unit. The LCU are responsible for the fieldwork and implementation of the crisis management strategy (controls, epidemiological enquiries, culling).
A geographical information system is in place at the CMPU for pig, bovine, goat and sheep farms. Belgium has chosen one high capacity rendering plant for carcase disposal. A written contract exists between the FASFC and the plant. Clear procedures have been established for different alert levels (peacetime, threat of infection, outbreak situation). In the event of a crisis, some of the plant's normal activities can be taken over by another plant.
The FASFC has a contract with a commercial medical company for the delivery of FMD vaccine, based on strains of types O, A, C and Asia. The company guarantees the delivery of the first batch within four days. The FASFC also participate in the EU vaccine bank for FMD, bluetongue disease and CSF vaccines.
Laboratories
Sciensano is the NRL for the "list A" diseases of the World Organisation for Animal Health (OIE). In the event of an epizootic outbreak, the laboratory staff can be transferred from other Sciensano departments to help with testing. The laboratory is accredited to ISO 17025 standard for general quality system and methods. The laboratory uses virus isolation, antigen identification and serological methods. Clear procedures and documentation are in place. The laboratory participates annually in the ring tests organised by the Community Reference Laboratory – CRL and by the NRLs of some other Member States.
Sciensano receives the assistance of two regional laboratories in relation to the OIE “list A" diseases. All tasks carried out by these two laboratories are laid down in a bilateral convention with the FASFC.
44 DG(SANTE)/2020-6907 Version: May 2021 2.2 Control system for food of animal origin
FPS HFSCE DG APF
BELTRACE Computerised system for traceability in the meat sector DG Directorate General FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NICU National Implementation and Co-ordination Unit LCU Local Control Unit SC Scientific Committee
45 DG(SANTE)/2020-6907 Version: May 2021 Competent Authorities
The FPS-HSFCE and the FASFC are the CCAs for food of animal origin. The FPS-HSFCE prepares the policy for food of animal origin and sets the product standards. The FASFC sets process standards (operational legislation) and verifies that legislation on food of animal origin is complied with.
Within the FASFC, DG Control is responsible for the application of controls and the inspection of establishments. Under DG Control, the 9 LCUs are responsible for operational activities. Each LCU is responsible for the entire food production chain within its territory, from the farm/establishment to distribution, including restaurants and the retail trade.
The FASFC is the single authority for “food safety”.
Registration and approval of establishments
A system of registration and approval of establishments has been established in conformity with the requirements of the OCR and Regulations (EC) No. 852/2004 and 853/2004.
The detailed rules for prior registration, authorisation and approval of establishments and registration of food business operators are laid down in the Royal Decree of 16 January 2006 which assigns responsibility to the FASFC.
Official controls and inspection of establishments
The system of control of the operators´ activities, applicable since January 2006, provide for checklists reflecting the legislation. Specific checklists apply for each sector of activity and for each type of control. The modifications also affect the frequency of control visits (audits, inspections and sampling) based on risk assessment and the involvement of the operator providing comments on the report and signing it.
According to Royal Decree 22/12/05 on inspection frequencies for the food business operators of the meat and fish sector in the inspection program of the FASFC, requiring the presence of an inspector of the FASFC, the frequency of visits is calculated on the basis of: existence of a validated own-checking system, results of former inspections to the establishment over the previous three years and corrective measures or administration measures applied to the establishment over the previous two years.
The results of all inspections and audits are processed in the FASFC databases. The results of ante-mortem and post-mortem inspections are registered into the computerised system BELTRACE.
Analyses are conducted in one of the five FASFC laboratories, in an approved laboratory or in an NRL, depending on their specialisation.
The temporary association ILVO-CER is designated as NRL in the framework of Council Directive 96/23/EC, for the following substances defined according to Annex I of the aforementioned Directive: substances having anabolic effect and unauthorised substances (i.e. group A), veterinary drugs (i.e. groups B1 and B2) other than carbamates and pyrethroids (group B2c), contaminants and substances (i.e. group B3) other than organochlorine compounds (group B3a), organophosphorous compounds (group B3b), chemical elements (group B3c), mycotoxins (group B3d) and other environmental contaminants (group B3f).
46 DG(SANTE)/2020-6907 Version: May 2021 The CODA-CERVA is the designated NRL in the field of elemental and mycotoxin analysis, in the framework of Council Directive 96/23/EC (groups B3c and B3d) and the OCR.
The CART is designated NRL for the instrumental (gas chromatography) analyses of dioxins and Polychlorinated biphenyls (PCBs) in the framework of Council Directive 96/23/EC (B3a excluding organochlorine pesticides) and the OCR. It is also NRL for the analyses of other environmental contaminants in the framework of Council Directive 96/23/EC (group B3f, e.g. poly brominated compounds) and the OCR on polycyclic aromatic hydrocarbons (PAHs).
The FASFC laboratory situated in Tervuren is designated NRL for dioxin and dioxin-like PCBs analyses with bioassay in the framework of Council Directive 96/23/EC (group (B3a excluding organochlorine pesticides) and the OCR.
Sciensano is the designated NRL in the field of pesticide residue analysis in the framework of Council Directive 96/23/EC (group B2c, group B3a excluding dioxins and PCBs, group B3b) and the OCR.
For milk and dairy products, the ILVO and the Walloon Agriculture Research Centre (CRA-W) are designated NRL. Sciensano is also NRL for food microbiology, foodborne outbreaks, antimicrobial resistance and bivalve molluscs in the framework of the zoonosis Directive.
A centralised laboratory information management system, FOODLIMS, is in place since 2008. The system includes not only the nature of the sample (matrix), and the analyses requested (parameters), but it also records sampling dates, transportation information and the dates on which results are reported back by the laboratories.
Official controls on identification mark and traceability
The identification mark controls are carried out by the operator who is required to implement the control system. FASFC checks during its inspections if identification marks have been applied correctly and if traceability principles are duly implemented. Establishments are also obliged to have internal traceability control systems in place (Royal Decree of 14 November 2003 on own-checking, notification obligation and traceability in the food chain).
47 DG(SANTE)/2020-6907 Version: May 2021 2.3 Control system for imports of animals and food of animal origin
Co-operation protocol of 2018
7 Regional CS centres
BCP Border Control Post CS Customs services DG Directorate General FASFC Federal Agency for the Safety of the Food Chain MF Federal Public Service Finance NICU National Implementation and Co-ordination Unit LCU Local Control Unit SC Scientific Committee
Competent Authorities
The FASFC is the CCA for import controls of live animals and products of animal origin. Within FASFC, DG Control Policy establishes process standards and develops the control program. DG Control is responsible for inspection/audit services, enforcement of process standards and the supervision of the Border Control Posts (BCPs).
48 DG(SANTE)/2020-6907 Version: May 2021 The LCU are, inter alia, administratively responsible for the relevant BCPs. The transposition of legislation on imports of animals and food of animal origin is the responsibility of FASFC.
Import Controls
The FASFC is responsible for import controls at BCPs. The CS executes the import controls on customs matters (SPS matters included if appropriate) for all freight and is the competent authority at non-BCP crossing points for: personal baggage checks, non- commercial pet animals; and checks for illegal imports of veterinary and phytosanitary products and live animals.
The BCPs are responsible for supervision of delivery and destruction of kitchen waste. At BCP level, public health and animal health services are fully integrated. At local level, co- operation between the different services is based on personal contacts between responsible staff.
In agreement with the CS, the LCU supervise the customs warehouses and ship suppliers approved as cold stores.
The co-operation between the FASFC and CS has been laid down in a protocol. The current protocol dates of 6 November 2018; it replaces the protocol of 13 March 2007. The objectives of the protocol are to improve the drafting and implementation of relevant legal provisions and to ensure enhanced safety as well as efficient and effective action. It furthermore pursues the provision of better service and continuous follow-up via the establishment of a co-ordination unit.
The protocol provides for co-operation between FASFC and CS and covers legislation and its implementation, exchange of information, control policy, official controls, training and communication and also the collection of fees. Its scope comprises customs controls and FASFC controls on the import, export and intra-EU trade in the following areas which are laid down in seven annexes: live animals, food of animal origin, food of non-animal origin, feedingstuffs, plants and plant products, animal by-products and products that fall under FASFC competence delivered by postal and parcel services.
The seven annexes provide a legal framework in relation to: the place and activity of the control to be carried out; the exchange of data; and measures in the case of infringement. More detailed developments of the relevant aspects of the legal framework are the responsibility of the co-ordination unit and instructions are issued to both FASFC and CS control officials.
Listed BCPs
The list of Belgian BCPs, designated by the FASFC, is available in TRACES-NT and available on the FASFC website (https://www.favv-afsca.be/professionelen/invoer/).
Laboratories
Analysis of samples is conducted in one of the five FASFC laboratories, in an approved laboratory, or in the national reference laboratory.
49 DG(SANTE)/2020-6907 Version: May 2021 2.4 Control system for feed
FPS HFSCE DGAPF
FeBO
DG Directorate General FASFC Federal Agency for the Safety of the Food Chain FeBO Feed business operator FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NICU National Implementation and Co-ordination Unit LCU Local Control Unit PS Primary production sector of the Provincial Control Unit SC Scientific Committee TS Processing sector of the Provincial Control Unit
50 DG(SANTE)/2020-6907 Version: May 2021 Competent Authorities The FPS-HSFCE and the FASFC are the CCAs for feed and animal nutrition. The FPS- HSFCE is responsible for policy and setting of product standards for all types of animal feed and animal nutrition in general. It also deals with: authorisation of feed additives, the establishment of the maximum levels for undesirable substances and rules for labelling and marketing of feed (feed materials, compound feed, dietetic feed, medicated feed). In the framework of Regulation 1831/2003/EC, the Flemish Institute for Technological Research – VITO, CRA-W and the FASFC laboratory of Tervuren have been officially designated NRLs for feed additive authorisation by the FPS-HSFCE.
The FASFC is responsible for the implementation of Regulation (EC) No. 183/2005. Controls are organised by FASFC according to the OCR and aim to verify that feed business operators (FeBOs) and feedingstuffs comply with the specific legislations in force. FAFSC is the single CCA for the controls of imports of feedingstuffs. Within the FASFC, DG Control Policy is responsible for the design of the annual control programme. Official inspections are carried out by the 9 LCUs under the supervision of the central services of DG Control. Within each LCU, controls of feedingstuffs are divided between the processing sector (TS) and the primary production sector (PS). The TS controls all FeBOs, including home compounders using pre-mixtures, but excluding other farms which are controlled by PS. TS is also in charge of controls of imports of feedingstuffs.
The FASFC is the single authority for “feed safety”.
Registration and approval of establishments and intermediaries
All approvals were automatically renewed before entry into force of Regulation (EC) No. 183/2005 and all establishments are properly approved with a detailed description of all activities conducted.
An authorisation has been introduced for certain FeBOs. These FeBOs which require a registration under Regulation (EC) No. 183/2005, such as home compounders using pre- mixtures, also require an authorisation. An authorisation may be given based on an assessment of documents submitted or on an on-the-spot visit.
Official controls
The frequency for inspecting individual establishments is defined by the program of inspections and is based on specific risks and compliance history and on whether the establishment has a certified system of own-checks.
The implementation of the sampling plan at LCU level is based on pre-defined criteria established in the program of analyses: type of establishment; nature of feed material; and substances to be analysed.
The national control plan takes into account the risk criteria listed in the OCR. It also takes into account the principles outlined in Commission recommendations on the co-ordinated inspection programme in the field of animal nutrition and on the reduction of the presence of dioxins, furans and PCBs in feedingstuffs and foodstuffs.
The national control plan is regularly updated to reflect new information on possible risks. In the event of urgent and very serious risk an additional sampling plan can be established.
51 DG(SANTE)/2020-6907 Version: May 2021 Controls on imports are conducted through inspections and sampling activities which are part of the national control plan.
Internal supervision at local level to ensure harmonised implementation of official controls between LCUs is the responsibility of the NICU.
A specific technical annex to the FASFC – CS co-operation protocol has been adopted and covers in particular, feed.
Analysis of samples is conducted by the FASFC laboratories. The FASFC laboratory in Tervuren is the NRL for feed additives control and for control of processed animal proteins (PAP) in feed.
52 DG(SANTE)/2020-6907 Version: May 2021 2.5 Control system for TSEs and Animal-By-Products (ABP)
TSE
FPS HFSCE DGAPF
ARSIA Regional Association for Health and Animal Identification DG Directorate General DGZ Regional animal health association Flanders FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NICU National Implementation and Co-ordination Unit LCU Local Control Unit Sanitel National bovine database Sciensano Scientific expertise on animal health and public health (including laboratories)
53 DG(SANTE)/2020-6907 Version: May 2021 Competent Authorities The FPS-HSFCE and the FASFC are the CCAs for transmissible spongiform encephalopathies (TSE). The FPS-HSFCE is the policy and legislative body for political direction and definition of objectives.
The FASFC and the FPS-HSFCE liaise on TSE under a protocol of October 2003 stipulating the distribution of competencies. Meetings between the two bodies are held at different levels: at management level and technical levels.
The TSE database facilitates the co-ordination of procedures for sampling, testing and dissemination of results. TSE related tests are carried out in 1 private laboratory approved by the FASFC (and accredited according to ISO 17025, hence). This laboratory must also comply with the requirements of Sciensano as the TSE reference laboratory.
Epidemio-surveillance Suspect animals in abattoirs are: those displaying clinical signs of TSE; those slaughtered without ante-mortem examination (always rejected, regardless of the results of the tests); dead animals without determined cause; animals presented at the abattoir with major identification problems; and animals not subject to the rapid test when they should have been tested. Active surveillance measures have been taken to ensure full geographical representation, proper selection of the age groups concerned and adequate sample size.
In case of animal destruction for bovine spongiform encephalopathy (BSE), the LCU sends the animal information to the rendering plant and the animal passport to the regional Animal Health Association of Flanders (DGZ) or to the regional Association for Health and Animal Identification of Wallonia (ARSIA). DGZ and ARSIA then update the SANITEL database. At the same time, the destruction plant carries out an electronic check in Sanitel to confirm the information. In all other cases of animal destruction, the breeder sends the animal information to the destruction plant and the animal passport to DGZ or ARSIA. A Chronic Wasting Disease survey was carried out between autumn 2006 and spring 2009.
Specified Risk Material (SRM) A number of Royal Decrees provide for the implementation of EU requirements in relation to SRM and set out procedures in relation to collection, transport, destruction and its traceability. Every registered outlet is authorised to remove the vertebral column, provided it meets the provisions of the relevant Ministerial Decision. An exemption from these provisions can be obtained if the outlet signs a declaration stating that it will not use meat of animals over 30 months old containing the vertebral column. The outlet must have an arrangement with an approved collector for collection of SRM at least once a week. All other SRM is removed at the slaughterhouse.
Total Feedban The annual programme for the official controls of feedingstuffs contains a description of the feed ban measures in place. The annual sampling plan for ''prohibited animal protein to certain categories of animals'' covers all matrices: compound feeds for ruminants and non- ruminants, fishmeal, blood meal, blood products, protein concentrates and other raw materials. Testing for impurities is performed on ruminant and mixed animal fats. The number of administrative controls as well as the number of samples to be taken is fixed annually for each of the LCU. The final selection of actual premises to be controlled is at the LCU level. There the inspectors carry out a risk analysis based on their experience and
54 DG(SANTE)/2020-6907 Version: May 2021 information delivered by the central services via technical cards, procedures and other documents linked to each type of control.
Inspectors are required to input their inspection activity into the FOODNET database.
Analysis of samples is conducted by the FASFC laboratories. The NRL for control of PAP in feed is located in the FASFC laboratory in Tervuren.
ABP
Protocol of 2020
DGAPF
BE/LB Flanders OVAM VLM-Mestbank OMG
DG Directorate General DPE Division of the Environmental Police FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment FAMHP Federal Agency for medicines and health products BE/LB Brussels Environment OMG Flemish Department for Environment NICU National Implementation and Co-ordination Unit OVAM Regional Waste Authority in Flanders OWD Regional Waste Authority in Wallonia OF Organic Fertilizer LCU Local Control Unit SI Soil Improvers VLM Flemish Land Agency
55 DG(SANTE)/2020-6907 Version: May 2021 Competent Authorities
The FPS-HSFCE and the FASFC are the CCAs for ABP. Waste policy and control is the competence of the three Regions. The major part of the industry is located in the Flanders Region where most of the category 1, 2 or 3 processors, feed industry and technical plants are based. While the Walloon Region has fewer plants in the ABP sector, a significant part of the Belgian incineration capacity is located there. The Brussels-Capital Region has few or no farms and little industry.
The FASFC is the single authority for the prevention and minimisation of risks to human and animal health arising from ABP and derived products.
The respective regional authorities are:
Flemish Region
Regional Waste Authority in Flanders (OVAM) Flemish Land Agency (VLM-Mestbank) Flemish Department for Environment (OMG)
The OVAM is inter alia responsible for waste policy. In Flanders manure is not considered as ‘waste’, the competent regional authority is the VLM-Mestbank. The Department of Environment (OMG) is responsible for the environment, nature, and land and water management and is the control body for waste (other than manure) in Flanders.
Walloon Region
Regional Waste Authority Wallonia (OWD), responsible for the management of waste, including manure Walloon Division of the Environmental Police (DPE)
Brussels Region
Brussels Environment (BE/LB) is the competent authority in the Brussels-Capital Region (policy and control).
The Convention of January 2014 determines the tasks of each authority and their collaboration. This Convention is a revised Convention to accommodate the handover of competences for organic fertilizers and soil improvers from the regions to FASFC, as well as the new requirements of Regulation (EC) No. 1069/2009. In January 2014, the Convention was signed by the concerned ministers. The new Convention introduces also the shift of competence for medicines and health products from the FPS-HSFCE to the FAMHP.
A Commission of Animal By-products has been established for co-ordination between the competent authorities (competences laid down in the Convention). This Commission is the central body to discuss, harmonise and report ABP issues. The Commission meets 6 times per year. A discussion platform with representative organisations and authorities of all ABP-related sectors meets 2 times per year.
The regions are competent for category 1, 2 or 3 processors, incinerators, combustion plants, landfill, biogas, manufacturers of organic fertilizers and soil improvers with raw manure and composting plants and storage plants for ABP and derived products for these 56 DG(SANTE)/2020-6907 Version: May 2021 destinations. In general, the regions control the materials that were considered as ‘waste’ before the directive 2008/98/EC, while the federal authorities are competent for ABP considered as ‘products or raw materials for products’. Accordingly, the FASFC controls pet food, OF/SI without raw manure and the use of ABP or derived products in feed for farmed animals and storage plants for the above mentioned destinations; and the FPS- HSFCE controls uses for research and diagnosis, special feeding purposes, cosmetics, biodynamic preparations, plants where products intended for use outside the food chain are handled, collecting and storage plants for the above mentioned destinations. The FAMHP controls ABP used for medicines and health products.
The VLM-Mestbank is responsible for the approval and the control of the installations and co-installations for the treatment of manure and OF/SI producers using raw manure in Flanders.
Approval of ABP plants and other premises
In general, issues linked to waste and the environment are the responsibility of the three Regions. As regards ABP, the Regions are responsible for inspection and control of all processing plants and storage plants for ABP and derived products for all categories of ABP other than those destined solely for feed or technical products. They are also responsible for manure and for sites for disposal of ABP, including: incinerators; biogas and compost plants; landfill sites; and the application to land of fertilizers or soil improvers without prior processing.
Checklists are available to operators in the Flemish Region and those falling under the FASFC competence to enable them to verify whether the approval conditions are already met before applying for approval. The Brussels-Capital Region has no processing plant for ABP on its territory (the only operators in the ABP sector are the producers). One category 2 processing plant is located in Walloon Region.
As regards the approval procedure in Flanders and Brussels-Capital Region, approvals have been granted on the basis of an application, including the checklist submitted by the operator. On-the-spot visits were carried out prior to approval being granted. The FASFC and FPS-HSFCE give approvals using checklists prepared by FASFC and only after on the spot visits. The OWD has started to give administrative attestations which have the value of an approval.
The list of approved ABP establishments according to technical specifications can be accessed on the FASFC website. All approvals of all the competent authorities are consolidated on these lists.
Official Controls
All categories of ABP collected by collectors registered especially for ABP. For commercial reasons, category 1 and 2 materials are generally transported as category 1. Collection of international catering waste is organised by the individual companies using collectors or transporters authorised or registered for this purpose.
One private firm collects and renders all fallen stock of Belgium and the Grand Duchy of Luxembourg and other ABP from farms. In the Walloon Region, this is done under a public service contract. In the Flemish Region, farmers pay through a subscription system, with fixed rates by the government. It is the only category 1 material rendering plant (eventually mixed with category 2 material) in Belgium. 57 DG(SANTE)/2020-6907 Version: May 2021 A number of intermediate centres (storage plants) consolidate small loads of ABP into larger consignments to facilitate more efficient transport to processing or disposal sites. If the ABP falls under the competency of the Regions, its collection and transport is carried out by approved or registered collectors and transporters.
The majority of category 1 and 2 ABP, including all fallen stock, is processed in a single processing plant using method 1. The resulting fat and meat and bone meal – MBM is disposed of by (co-)incineration in Belgium or in other Member States, or, in the case of fat, used as fuel. Other category 1 and 2 ABP, including international catering waste from airports, is incinerated. International catering waste collected at the ports is collected and destroyed as category 1 material. Other authorised options for category 1 and 2 are used to a limited extent.
A number of options are available for the collection and the processing or use of category 3 materials. A number of storage plants trade in, and sometimes purify, rendered fats for use in feed or for technical purposes.
Municipal waste, which may contain former foodstuffs and catering waste, is mostly incinerated but in exceptional cases it can also be land filled (outside the scope of regulation (EC) No. 1069/2009). Only former foodstuffs and catering waste that is separately collected, can be processed into biogas or compost (inside regulation (EC) No. 1069/2009) for use as fertiliser or soil improver.
Some biogas and compost plants are permitted to process ABP.
Landfill of all organic waste, including ABP, is prohibited by environmental legislation.
58 DG(SANTE)/2020-6907 Version: May 2021 2.6 Control system for veterinary medicinal products (VMP) and residues
Veterinary medicinal products
Protocol of 2013
DG Directorate General FAMHP Federal Agency for Medicines and Health Products FASFC Federal Agency for the Safety of the Food Chain NICU National Implementation and Co-ordination Unit LCU Local Control Unit
59 DG(SANTE)/2020-6907 Version: May 2021 Competent Authorities
The FAMHP is the CCA for the national marketing authorisation of VMPs. It took over all the tasks of the former DG 3 of FPS-HSFCE and all operations involving blood, tissues and cells from collection to usage. It is responsible for the regulation and surveillance of the distribution of medicinal products for human and veterinary use. According to the Law of March 1964, as amended in May 2006, the marketing authorisation is valid for five years. Once renewed, the marketing authorisation is valid for an unlimited period unless an additional five year renewal is required for safety reasons. With the entry into application of the Regulation 2019/6/EC, from 28/01/2022 on all marketing authorisations will have an unlimited duration of validity. Under the current Legislative framework, the marketing authorisation expires within three years after its granting if the product is not marketed in the meantime. This provision will cease to exist with the entry into application of the Regulation 2019/6/EC.
In general, the FAMHP is responsible for the inspection of the VMP distribution chain from the manufacturer and the wholesaler to the pharmacist and veterinary practitioner, while the FASFC is responsible for the control of the end users at farm level. The FPS-HSFCE is responsible for the licensing of veterinary warehouses.
The co-operation protocol between the FASFC and the FAMHP was finalised in February 2008 with a view to clarifying the control competences in the distribution chain of VMPs and avoiding overlapping controls of both bodies. The protocol was updated in 2013.
Official controls on marketing/use
Wholesale distribution of VMPs and operation of pharmacies is regulated by national legislation. VMPs are sold by pharmacies and veterinarians to the animal holder. Veterinarians may order VMPs directly from the pharmacies or from the wholesaler.
Many farmers have permanent contracts with a veterinarian for the treatment of their animals. Farmers under contract are allowed to stock certain types of VMPs on the farm for a maximum of two months. The administration of these VMPs is delegated to the farmer after the veterinarian has made an initial diagnosis and has given a plan of treatment. The contract veterinarian is required to visit the farm at least every two months to inspect stock and records. If no contract exists, no stock is allowed at the farm but the veterinarian may delegate the treatment to the farmer for a maximum of five days after diagnosis.
The FAMHP is responsible for the licensing of wholesalers and pharmacies. In both cases, an audit must first be carried out before a permanent licence is granted. This licence has no expiry date but any change must be notified, and, if necessary, approved before being implemented. There is no formal schedule for regular controls of wholesalers and pharmacies. The objective is, however, to control wholesalers every three years. These checks are announced in advance, but in suspect cases, they may be unannounced. The pharmaceutical inspectors of the FAMHP are responsible for the control of all wholesalers and pharmacies distributing human medicinal products and VMPs.
In order to optimise working processes, structures and the deployment of available resources, the FAMHP structure was reorganised. The structure is based on three pillars "pre-authorisation", "post-authorisation" and "inspection".
The database of medicinal products for veterinary use authorised in Belgium is available on the FAMPH website providing all relevant information on the medicinal products. 60 DG(SANTE)/2020-6907 Version: May 2021 Some 46 feed mills are authorised by FASFC to manufacture medicated feedingstuffs. These feed mills are inspected annually by the LCU via unannounced inspections. The authorised feed mills are advised to check for cross-contamination every two years. The manufacture of medicated feedingstuffs is subject to the issue of a prescription by a veterinarian. Prescriptions have colour-coded copies one of which is retained at the level of the feed mill.
The FAMHP carries out controls on the VMPs kept by veterinarians, and is also responsible for controls of the veterinarians concerning distribution and prescription of VMPs.
RESIDUES
FPS HFSCE DG APF
AC Advisory Committee DG Directorate General FASFC Federal Agency for the Safety of the Food Chain 61 DG(SANTE)/2020-6907 Version: May 2021 FAMHP Federal Agency for Medicines and Health Products FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NIU National Investigation Unit NICU National Implementation and Co-ordination Unit NRCP National Residues Control Plan LCU Local Control Unit SC Scientific Committee
Competent Authorities
The FPS-HSFCE and the FASFC are the CCAs for residues.
The FPS-HSFCE prepares the policy for veterinary residues. The FASFC is responsible for the National Residue Control Plan (NRCP), in accordance with Art. 4 of Council Directive 96/23/EC. Three DGs of FASFC are responsible for the planning, administration and implementation of the NRCP, i.e. DG Control Policy, DG Control and DG Laboratories.
The single authority for “food safety” is the FASFC.
The NRCP is drafted at central level by DG Control Policy, taking into account: Directive 96/23/EC; Decision 97/747/CE; the results from previous years; input from the Commission expert group; input from the AC and the SC; and scientific papers. The analytical laboratories may also be requested to provide technical advice. At the end of each year, DG Control Policy forwards the NRCP for the coming year to DG Control and DG Laboratories. The plan is administered by DG Control and implemented by DG Control and DG Laboratories.
Sampling is co-ordinated at central level by DG Control which distributes an annual overview and monthly detailed sampling plan to the 9 LCUs via a web-based application. Sampling of live animals and animal products is carried out by LCU staff. The allocation of samples is based on the following criteria; food basket, history of non-compliant results, risk of use / exposure/ totality of the imported products.
Official controls on residues
At central level, DG Control is responsible for the overall supervision of the NRCP. During the sampling year, the LCUs continuously monitor sampling against monthly targets. Each LCU has a co-ordinator for the NRCP who assigns tasks to the mobile sampling staff.
As for all other samples taken in the frame of the MANCP, the samples taken each month are recorded by the LCU in the web-based application. DG Control has direct access to this data and evaluates the total numbers of samples against the annual target at the end of each year. Results from all analyses are sent by the laboratory to the sampling officer, the relevant LCU and to DG Control. The turnaround times in the laboratories are monitored by DG Laboratories which may redirect samples to another laboratory in the next monthly plan if the turnaround times from one laboratory are considered too long. A supplementary monitoring programme is in place for PCBs and dioxins.
The veal industry has its own programme for control of anabolic substances, and private monitoring programmes also exist for certain products sold under protected labels (poultry, pigs, bovines and animal feed). The dairy industry also has a routine quality control programme for antibiotics in milk. These samples are sometimes analysed in the same laboratories as the NRCP samples, but may also be analysed in private laboratories. All
62 DG(SANTE)/2020-6907 Version: May 2021 non-compliant results are reported to the FASFC. These programs are executed in addition to official controls.
63 DG(SANTE)/2020-6907 Version: May 2021 The LCUs are responsible for all follow-up actions for authorised substances, while the NIU is responsible for follow-up, including sampling, when non-compliant results are obtained for Group A1-A5 and B2f substances. The LCUs handle Group A6 violations in co-operation with the NIU. All files of follow-up activities and results are collated at central level. A “hormone cell” of specially trained police officers follows up on non- compliant results for hormonal substances.
Laboratories
A number of laboratories are involved in the delivery of analytical services under the NRCP. Besides the internal laboratories of the FASFC (Gentbrugge, Tervuren and Wandre), several external laboratories analyse NRCP samples. These external laboratories are also funded by the State and come under the provinces and regions. No private laboratories are involved in the testing of NRCP samples.
All laboratories involved are accredited to ISO 17025 by BELAC. The accreditation status is the subject of annual control inspections and a renewal assessment every five years. In addition to the general accreditation requirements, there is a specific accreditation procedure for the analytical methods used. In addition, all laboratories involved are approved by DG Laboratories. The FASFC organises regular meetings with all laboratories involved in testing of NRCP samples. Monthly meetings of the internal laboratories of the FASFC are also held.
The temporary association ILVO-CER is designated as NRL in the framework of Council Directive 96/23/EC, for the following substances defined according to Annex I of the aforementioned Directive: substances having anabolic effect and unauthorised substances (i.e. group A), veterinary drugs (i.e. groups B1 and B2) other than carbamates and pyrethroids (group B2c), contaminants and substances (i.e. group B3) other than organochlorine compounds (group B3a), organophosphorous compounds (group B3b), chemical elements (group B3c), mycotoxins (group B3d) and other environmental contaminants).
Sciensano is the designated NRL in the field of elemental and mycotoxin analysis, in the framework of Council Directive 96/23/EC (groups B3c and B3d) and the OCR.
The CART is designated NRL for the instrumental (gas chromatography) analyses of dioxins and PCBs in the framework of Council Directive 96/23/EC (B3a excluding organochlorine pesticides) and the OCR. It is also NRL for the analyses of other environmental contaminants in the framework of Council Directive 96/23/EC (group B3f, e.g. poly brominated compounds) and the OCR concerning PAHs.
The FLSFC laboratory situated in Tervuren is designated NRL for dioxin and dioxin-like PCBs analyses with bioassay in the framework of Council Directive 96/23/EC (group (B3a excluding organochlorine pesticides) and the OCR.
Sciensano is the designated NRL in the field of pesticide residue analysis in the framework of Council Directive 96/23/EC (group B2c, group B3a excluding dioxins and PCB, group B3b) and the OCR.
Besides the NRL functions, these laboratories carry out a limited number of routine residues analyses for the NRCP and supplementary analysis and research work in the framework of the official food control system.
64 DG(SANTE)/2020-6907 Version: May 2021 2.7 Control system for foodstuffs and general food hygiene
FPS HFSCE DG APF
DG Directorate General FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NICU National Implementation and Co-ordination Unit LCU Local Control Unit SC Scientific Committee
Competent Authorities
The FPS-HSFCE and the FASFC are the CCA for foodstuffs and food hygiene. The FPS- HSFCE is the policy and legislative body for product normalisation in relation to food hygiene. FASFC is the policy and legislative body for process normalisation. It plans, organises and executes controls.
65 DG(SANTE)/2020-6907 Version: May 2021 Official control is organised at LCU level. DG Control co-ordinates the implementation of LCU official controls.
The FASFC is the single authority for “food safety”.
Registration, authorisation and approval of food premises
Food business operators who process, sell or prepare foodstuffs must be registered, authorised or approved by the FASFC, according to national legislation.
The detailed rules for registration, authorisation and approval are laid down in the Royal Decree of 16 January 2006 which assigns to the FASFC responsibility for the registration, authorisation and approval. Registration is a purely administrative procedure. The authorisation can also be given on the basis of an administrative investigation, but the FASFC may perform a prior visit on the spot, if considered necessary. The approval procedure always requires a prior visit on the spot. The authorisation and approval are valid for a period of indefinite duration (until they are suspended or withdrawn or the activity terminated).
Butcher shops need an authorisation. If they choose to remove the vertebral column on the premises, they need an additional authorisation for this purpose.
Butchers may sell to retail establishments (hotels, restaurants, cafés, institutional catering, shops) provided that the supply of food of animal origin to these other retail establishments is only a local, marginal and restricted activity, as laid down in Art. 1 point 5 of Regulation (EC) No. 853/2004. According to national legislation, this derogation allows an activity within a range of 80 km with a maximum of 30% of the butcher's production. If the butcher wishes to sell more to other retail shops, he needs an approval (as a cutting plant or establishment manufacturing meat products) depending on the type of meat.
Official controls of food premises
The methodology on HACCP controls has the following objectives: to control the implementation of the own-check systems in the establishments in the processing and distribution sector, to integrate this control into the control plan and to organise this control in a uniform fashion.
Good Hygiene Practice Guides
Currently, 37 guides have been approved. The list of approved guides is available on the FAFSC website (https://www.favv-afsca.be/professionelen/autocontrole/gidsen/). A sector guide is currently available for more than 99% of operators. For the few activities that are not yet covered by a guide, the FASFC has set up specific tools to help the companies involved.
A unit has been created within DG Control Policy of the FASFC to follow-up on the validation of guides. For each guide, an evaluation team is created within the FASFC consisting of staff from DG Control Policy and DG Control to evaluate whether the guide is compliant with legislation in force. Following approval of the guide, the co-ordinator of the validation unit notifies the applicant. A request is also made for publication in the Belgian Official Journal. BELAC is also informed of the validation of the guide. The organisation submitting the guide is responsible for printing and distribution, and publication on the Internet. 66 DG(SANTE)/2020-6907 Version: May 2021 A voluntary ''Smiley'' scheme for operators who deliver directly to the consumers was officially launched in January 2008 as a visualisation of a validated own-check system. The complete list of enterprises that have obtained the “Smiley” can be accessed on the FASFC website (https://www.favv-afsca.be/smiley/nl/wie/). Laboratories
Analysis is carried out in one of the five FASFC laboratories, in an approved laboratory, or in a national reference laboratory, according to their specialisation.
The microbiological and chemical criteria to be taken into account under the annual control plan are those described in the relevant national and European legislation. If samples are taken for analyses of parameters for which no legal criteria exist, action limits are determined by the FASFC. Two documents with action limits have been developed by the FASFC, one for microbiology and one for chemical parameters.
67 DG(SANTE)/2020-6907 Version: May 2021 Genetically modified organisms (GMO)
Minister of Health and Minister of Environment
FPS HFSCE DG APF + DGEM
Seeds
CRA-W Walloon Agricultural Research Centre DG Directorate General FAMHP Federal Agency for Medicines and Health Products FASFC Federal Agency for the Safety of the Food Chain FPS- HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment ILVO Flemish Research Institute for Agriculture, Fisheries and Food NICU National Implementation and Co-ordination Unit LCU Local Control Unit Sciensano Scientific expertise/research, including laboratories
Competent authorities
The FPS-HSFCE under the Minister of Health/Agriculture/Environment and the FASFC under the Minister of Agriculture are the CCAs for GMO and derived products. A protocol between the Ministers of Health, Agriculture and Environment precises that competence for GMO is shared between them. The FPS-HSFCE prepares the policy for GMO and sets
68 DG(SANTE)/2020-6907 Version: May 2021 standards and the FASFC verifies that all GMO legislation and standards are respected for products used in the feed and food chain. FASFC implements the control strategy by establishing more detailed standards and instructions. Within the FASFC, DG Control Policy is responsible for preparing the annual food and feed control programme. DG Control provides the working instructions and protocols to be used by inspectors on the spot and is also responsible for the supervision and execution of the control plan by the LCUs. All LCUs have specialised departments for the implementation of EU legislation on food and feed. Control activities for feed cover all stages of processing and marketing, including imports.
The implementation of controls for GMO fields, seeds and their contained uses is the responsibility of the regions and the FPS-HSFCE. The FPS-HSFCE is responsible for the control of the experimental field releases of GMO as well as for traceability control and GMO labelling obligations for purposes other than food and feed. The regions are responsible for the co-existence measures related to GMO fields and for the implementation of contained uses of GMO. The FPS-HSFCE is responsible for the controls for GMO presence in conventional seeds in cooperation with the regions.
The single authority for the deliberate release into the environment of GMO for the purpose of food and feed production is the FPS-HSFCE. The single authority for “food safety” is the FASFC.
Official controls of GMO in food, including at import
Technical annexes to the FASFC and the CS co-operation protocol provide the legal framework for GMO controls.
DG Control Policy facilitates communication among the authorities and other relevant actors. It supports LCU inspectors on interpretation of legislation or when non-authorised GMO have been detected and specific follow-up is necessary. The NICU works to standardise control practices in all LCU.
Under the NRL convention, twice yearly meetings are organised between the NRL consortium and FASFC (with representatives of DG Laboratory, DG Control Policy and DG Control). Representatives of the FPS-HSFCE are invited as observers.
A GMO steering group provides co-ordination between the different services and colleagues who work with GMO at federal level. Representatives from DGAPF of the FPS- HSFCE (Animals, plants and foodstuffs) and DGEM (Environment), FASFC, FAMHP, staff of the ministries, the permanent representation of Belgium to the EU and scientific institutes attend the meetings.
As far as food is concerned, the main focus is on the labelling of authorised GMO and derived products, and the absence of non-authorised GMO. If GMO presence above the established thresholds (0,9%) was not indicated on the product label, proof must be provided by the processor of adventitious or technically unavoidable presence of GMO. All non-adventitious presences under 0.9% have to be indicated on the product label.
Maize, soy, rice, papaya, linseed and vegetal milk products already on the market in the retail and processing sector, potentially containing GM material, are targeted. Because of analytical limitations regarding the detection of GMO in highly processed foodstuffs, inspectors have been instructed not to take samples from materials such as lecithin and food
69 DG(SANTE)/2020-6907 Version: May 2021 additives. GMO inspections consist of sampling and traceability checks of the product sampled, as laid down in the technical instructions.
Planning of feedstuffs controls follows the same principles as for foodstuffs. For feedstuffs, the procedures require importers to notify the FASFC of imports 72 hours prior to arrival of the goods. Imports of feedstuffs are checked by LCU inspectors responsible for feedstuffs only when declared as such.
Official controls of GMO in propagating material
The Regions are responsible for the implementation of seed legislation. For controls on propagating materials, including GMO, the Department of Agriculture and Fisheries of the Flemish region and the DG for Agriculture of the Walloon Region are responsible within their regions. The FPS-HSFCE is responsible for the implementation of the traceability and labelling obligations, including seeds. It controls conventional seeds for GMO content.
No GMO varieties listed in the common catalogue are grown for food, feed or seed cultivation in Belgium, and no requests have been made to the Commission for national authorisation for experimental growing under Commission Decision 2004/842/EC.
Laboratories
Before 2009, official GMO analysis in the area of food, feed and seed in Belgium was carried out by three public laboratories, Sciensano (former WIV-ISP), the ILVO and the CRA-W. These laboratories work as a consortium and function as the NRL, and, as formal members of the European Network of GMO laboratories, assist the European Union Reference Laboratory – EURL with the inter-laboratory validation of official EU methods. The FASFC meets with the three laboratories on a semi-annual basis.
Complementary to the three laboratories mentioned, the FASFC laboratory at Melle also carries out the official GMO control analyses since, in February 2009, it finalised the validation of the real time polymerase chain reaction method based on GMO detection technique.
The FASFC-laboratory and CRA-W are formally accredited under the ISO/IEC 17025 for GMO screening; ILVO is accredited for the qualitative and quantitative analysis of authorised GMO (flexible scope) and Sciensano is accredited for screening, identification and quantification of GMO (flexible scope).
70 DG(SANTE)/2020-6907 Version: May 2021 2.8 Control system for imports of food of non-animal origin
Co-operation protocol of 2018
7 Regional CS centres
CS Customs services DG Directorate General FASFC Federal Agency for the Safety of the Food Chain MF Federal Public Service Finance NICU National Implementation and Co-ordination Unit LCU Local Control Unit Sciensano Scientific expertise on animal health and public health (including laboratories)
Competent Authorities
The FASFC is the CCA for imports of food of plant origin at the point of entry in co- operation with the CS. The FASFC is responsible for legislation on control measures, such as sampling, approval of laboratories, and other areas which directly affect the control services. The CS is responsible for the release of goods for free circulation into the EU.
71 DG(SANTE)/2020-6907 Version: May 2021 According to Regulation (EC) No. 765/08, officials are obliged to inform the LCU if they identify a risk to consumer health.
Import controls
Annex 3 to the FASFC and the CS co-operation protocol provides the legal framework on imports of food of non-animal origin.
Goods imported must be declared to CS by importers in a single administrative document which acts as a customs declaration. Import procedures depend on whether products are subject to specific health control measures, or for transit to another destination under a transfer declaration (T1). The CS officials may physically inspect consignments of foodstuffs. In cases where an official detects a consignment with characteristics which may lead to serious or immediate danger to public health, or if marks or documents are missing, Article 22 (2) of Council Regulation (EEC) No. 765/08 is applied, which requires notification of the relevant BCP.
Products submitted to specific control measures before being released for free circulation in the EU may be allowed into free circulation in Belgium only at Antwerp, Brussels, Brussels-Airport, Bierset-Airport, Zeebrugge and Aalst. In the case of non-conformity of documents or elevated levels of mycotoxins, the head of the local CS office is informed by the BCP. In that event, circulation of the product within the EU is refused.
Products not submitted for import in Belgium are transferred to another destination (Member State or third country) under a transfer declaration. In this case, after a documentary check, no other specific control measures are applied, as these are undertaken at the country of final destination. The container remains sealed until the final destination where the T1 documents must be completed by the CS of the receiving country.
Laboratories
Sciensano is NRL for the various areas of pesticide residue analysis. It is also designated NRL for mycotoxins and heavy metals.
Analyses in the framework of Regulation (EU) 2019/1793 are carried out by FASFC laboratories or by the external laboratories approved by the FASFC: mycotoxins (FASFC laboratory at Tervuren, or external approved laboratories); pesticide residues (external laboratories); heavy metals (FASFC at Gentbrugge, or external laboratories); Sudan red (external laboratories).
Other analyses are carried out in either FASFC laboratories (melamine) or external approved laboratories (pentachlorophenol, melamine, mineral oil).
72 DG(SANTE)/2020-6907 Version: May 2021 2.9 Control system for plant protection products (PPPs) and residues
PPPs
DGAPF DGEM
Regional Departments
CS Customs Services FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NIU National Investigation Unit LCU Local Control Unit
Competent authorities
The FPS-HSFCE, FASFC, the CS and Regional Agricultural and Environmental Authorities are the competent authorities in the area of PPPs.
FPS-HSFCE – DGAPF is responsible for granting PPP authorisations, for parallel trade permits and for maintaining the register of PPPs. The register of authorised PPPs is published and available on the internet (www.fytoweb.be)
FPS-HSFCE – DGEM is responsible for the safe storage of PPPs (FASFC include storage conditions in their controls and cross report any infringements) and for controls on non- food producing PPP users - e.g. growers of flowers/ornamental crops. DGEM are also responsible for the labelling of treated seed and shares competence with FASFC for controls on seed treatment operators relating to the safe use of PPPs.
FASFC is responsible for controls on marketing and use, except non-food producing users. FASFC is also responsible for the formulation analysis programme.
The CS is responsible for controls on PPPs at the point of import and for counterfeit PPPs.
73 DG(SANTE)/2020-6907 Version: May 2021 The single authority for “placing on the market and use of PPP” is the FASFC, the single authority for “sustainable use of pesticides (with the exception of pesticides application equipment)” is the FPS-HSFCE – DGEM.
Official controls on marketing and use
FASFC is responsible for controls on manufacturers, re-packers and distributors of both professional and amateur use PPPs as well as for controls on food-producing PPP end users. Within FASFC, DG Control Policy draws up the annual risk-based control programme on marketing and use of PPPs. DG Control oversees the 9 LCUs and the NIU. The LCUs conduct routine controls, while the NIU conducts targeted controls on both distributors and users. Within each LCU, the sector responsible for primary production performs controls on users and the sector responsible for processing performs controls relating to marketing. The inspectors use detailed checklists/inspection reports for controls which cover, inter alia, storage conditions, packaging/labelling, records and own-control systems.
Regional Agricultural departments are the paying agencies under cross-compliance and can access FASFC inspection results of end users to satisfy Statutory Management Requirement 9 on PPPs, under the cross-compliance. The regional services are also responsible for Integrated Pest Management (IPM): for Flanders the “Department of Agriculture and Fisheries”, for Wallonia the “Direction de la Qualité et du Bien-être animal” and for Brussels Capital “Brussels Environment / Brussels Economy and Employment”. Several Environmental departments are also involved.
There is a protocol in place between FASFC and FPS-HSFCE – DGEM, dating from 2018, which clarifies the scope of competence of both organisations in relation to the controls on PPPs. There is also a protocol in place between FASFC and the Regional Agricultural Authorities on the sharing of inspection results.
Imports
Customs conduct risk-based documentary controls on approximately 10% of PPP imports through sea ports. Consignments destined for operators previously found to be non- compliant are examined in all cases, while other consignments are selected for controls on a random basis.
There is close co-operation between NIU and CS, and with CAs in other MS, involved in controls on imports of PPPs and illegal/counterfeit PPPs.
Laboratories
The FASFC Laboratory at Wandre carries out analyses on the identity and content of active substances and the chemical properties of PPP for the control programme.
The laboratory is accredited under standard ISO/IEC 17025 by BELAC.
74 DG(SANTE)/2020-6907 Version: May 2021 Pesticide residues in food (for feed, see Section 2.4)
Protocol of 2020
DGAPF
DG Directorate General FASFC Federal Agency for the Safety of the Food Chain FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment NICU National Implementation and Co-ordination Unit LCU Local Control Unit
Competent Authorities
The FPS-HSFCE and the FASFC are the CCAs for pesticide residues in foodstuffs of plant origin, including baby-food. The FPS-HSFCE is responsible for setting maximum residue limits – MRLs. The FASFC is responsible for controls on residues of plant protection products and the operation of the RASFF. The LCUs controllers (inspectors and assistants)
75 DG(SANTE)/2020-6907 Version: May 2021 who report to DG Control are responsible for the implementation of the control plan for pesticide residues in foodstuffs of plant origin.
The single authority for “food safety” is the FASFC.
Official controls on residues
The annual control programme of DG Control Policy provides for sampling for the presence of pesticide residues in fruit, vegetables, cereals and processed products of plant origin including baby-food. The number of samples and the pesticide to analyse for each crop is decided by FASFC on the basis of the risk analysis, in particular taking into account the results of previous checks, the toxicity of residues and food consumption figures. The EU co-ordinated programme is part of the control programme. Procedures for these controls, in particular regarding sampling, reporting and follow-up, are in place.
Sampling is carried out at import, at importers´ premises, at auctions and at the wholesalers, and may also be carried out at retail level. Samples collected by inspectors of the various LCUs are collected from a central point of the FASFC and arrive at the laboratories within one day where the information is entered into the computer system. Samples are usually processed on the same day and the turnaround is generally seven days. The laboratories report the results to DG Control and, in case of non-compliances, to the LCU that carried out the sampling.
When non-compliant samples are identified, the lot is seized, if available, and prevented from entering the market. An assessment of risk to the consumer is performed on all non- compliant samples and the appropriate measures such as recall and RASFF notification are taken. Follow-up action is taken to verify the violation and to identify its cause. Under the procedures for controls on plant protection products, when non-compliant samples are identified, the producer or importer is subject to enhanced control.
Laboratories
Analysis under the national programme for monitoring pesticide residues in food of plant origin are carried out by several privately owned external laboratories and the NRL (Sciensano).
The FASFC stipulates the target plant protection products and analytical methods used for each sample type. It also allocates samples to the different laboratories.
76 DG(SANTE)/2020-6907 Version: May 2021 2.10 Control system for animal welfare
FASFC Federal Agency for the Safety of the Food Chain
Competent Authorities
Animal welfare is a regional competency which means that the Flanders, Walloon and Brussels-Capital Regional governments are fully competent for animal welfare on their territory and can draw up their own legislation. The animal welfare units are located in different departments in the different Regions. In Flanders the animal welfare unit is part of the Department of Environment (OMG), in Wallonia it is part of the SPWARNE and in Brussels-Capital Region it is part of the Brussels Environment.
Each Region has an inspection unit dedicated to animal welfare.
The FASFC, being a federal institution, is no longer competent for animal welfare. However, given the greater number of personnel and the fact that the FASCF regularly visits farms and slaughterhouses, an agreement was reached between the Regions and the FASFC.
77 DG(SANTE)/2020-6907 Version: May 2021 If inspectors of the FASFC inspect an animal holding, they also check the respect of the animal welfare legislation. Their observations are noted down in a checklist and communicated to the Regional authorities, who then take the appropriate measures. This agreement is officialised by a protocol between the three Regions and the FASFC.
The majority of the inspections in slaughterhouses and on transport are carried out by private veterinary practitioners – PVP’s. At least 5% of all incoming trucks at each slaughterhouse (with a minimum of one truck per day) are inspected. The vehicles are inspected and the animals are checked to verify if they are fit for transport. A further inspection is made on the handling of animals at the slaughterhouse.
Checks concerning animal welfare at slaughter are part of the ante mortem and post- mortem inspections performed on each animal by the veterinarians responsible for the controls. Additionally, a checklist for animal welfare at slaughter must be completed every fourteen working days.
These private veterinarians are appointed by the FASCF (and are also called “veterinarians on assignment”), but in the Flanders Region there are also additional private veterinarians employed by the Region, who carry out inspections specifically targeted at animal welfare.
The FASFC also carries out roadside inspections in cooperation with the police. If infringements of the animal welfare legislation are observed, the police can take the necessary legal actions.
In addition, the Regional animal welfare inspection units carry out their own inspections based on information provided by the FASFC or in follow-up to complaints.
78 DG(SANTE)/2020-6907 Version: May 2021 2.11 Control system for plant health
Co-operation DGAPF protocol of 2028
7 Regional CS centres
CS Customs services CRA-W Walloon Agricultural Research Centre DG Directorate General FASFC Federal Agency for the Safety of the Food Chain FPS- HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment ILVO Institute for Agriculture and Fishery Research MF Federal Public Service Finance NICU National Implementation and Co-ordination Unit LCU Local Control Unit PP Plant Passport PPS Plant protection services SC Scientific Committee
Competent authorities and responsibilities
The FPS-HSFCE and the FASFC are the CCAs for plant health issues related to quarantine pests. The regions are the CCAs for measures concerning the regulated non-quarantine pests (RNQPs). The FPS-HSFCE is responsible for policy, the transposition of EU legislation in relation to standards and is the designated single point of contact for IPPC (International Plant Protection Convention) and EPPO (European and Mediterranean Plant 79 DG(SANTE)/2020-6907 Version: May 2021 Protection Organization). The Federal Scientific Research Unit of FPS-HSFCE finances and coordinates scientific research on plant health matters (national as well as international) related to quarantine pests. The FASFC is responsible for the transposition of EU legislation in relation to control measures, the implementation of legislation, and technical co-ordination of plant health activities related to quarantine pests and the regions are responsible for the transposition of EU legislation in relation to control measures, the implementation of legislation, and technical co-ordination of plant health activities related to RNQPs.
The single authority for plant health is the FASFC.
In January 2021, a cooperation agreement was concluded between the competent ministers of agriculture whereby the federal government and the regions entrusted control tasks to each other. Controls on quarantine pests, including the control on the issuing of plant passports (PP) for plant propagating material where the regions conduct official certification are performed by the regions which are obliged to immediately inform the FASFC in case of irregularities related to quarantine pests. For the propagating material without official certification, the analogous controls on RNQPs are delegated from the regions to the FASFC.
Plant health inspections are being integrated in the MANCP. Based on risk assessment, inspection frequencies for occasional checks have been determined. The data on the inspectors' checklists related to quarantine pests is entered in the FOODNET database system.
Plant passport system and internal market checks
National procedures concerning the issuing of PP related to quarantine pests are defined in a Royal Decree of 2021 and those related to RNQPs will be published, where necessary, in Regional Decrees. All registered establishments that produce, introduce, sell/market, export or import plants or plant products using PP, require an authorisation from the FASFC for quarantine pests and from the regions for RNQPs.
Official checks are carried out by the inspectors of the LCUs and by the inspectors of the regions in the authorised establishments at least once a year and in registered establishments at the frequencies specified in the inspection program. The cooperation agreement arranges the assignment of tasks in such a way that 1 authority carries out both the controls for the Qs and for the RNQPs. During each inspection a checklist is completed and a copy is given to the responsible person of the establishment.
Import controls
The list of Belgian Border Control Posts and control points, designated by the FASFC, is available in TRACES-NT and on the FASFC website (https://www.favv- afsca.be/professionelen/invoer/).
FAFSC carries out the import controls on RNQP on behalf of the regions, as agreed in the cooperation agreement.
In the FASFC and the Custom Services (CS) co-operation protocol annex 5 is dedicated to plant health checks. Consignments containing regulated goods are cleared by the CS only when a CHED-PP, duly signed by the inspector, is presented to the CS. The CS are informed of the plant health import requirements through their own administrative 80 DG(SANTE)/2020-6907 Version: May 2021 instructions issued by the central CS office, as well as by personal contact with the plant protection services at local level. Passenger controls are organised on regular basis in cooperation with the CS.
Laboratories
The FASFC has 2 own laboratories (in Melle and Gembloux) that carry out certain plant health analyses.
CRA-W and ILVO are the Belgian NRL for plant health. ILVO is also member of the consortium of EURL for bacteriology and nematology. The list of designated official laboratories for the quarantine pests is available at the FASFC website (http://www.favv- afsca.fgov.be/laboratoires/laboratoiresagrees/). The list of official laboratories for the RNQPs will be available on the websites of the regions.
81 DG(SANTE)/2020-6907 Version: May 2021 2.12 Control system for quality labelling
Organics
CBs (3)
CBs SPWARNE (4) DQBEA
Brussels Brussels Capital Region Economy and Employment
CB Control Body SPWARNE Public Service of Wallonia - Agriculture, Natural Resources and Environment FPS Federal Public Service DGEI Directorate General Economic Inspection
Competent authorities and responsibilities
Organic production is a competence of the Regions. In addition to relevant EU rules, the main regional legislation on organic production and labelling of organic products of the Flemish, Walloon and Brussels-Capital Regions, respectively, are:
Decree of the Flemish Government of 12 December 2008 and related implementing Ministerial Decree of 22 June 2009, 27 May 2011, 17 June 2015 and 16 October 2017; Decree of the Walloon Government of 11 February 2010 (repealing an earlier Decree) and related Ministerial Decrees of 26 June 2012 and 15 April 2015; and Decree of the Government of the Brussels-Capital Region of 3 December 2009.
The relevant competent authorities, responsible also for supervision of the control bodies (CBs), are the Flemish Department of Agriculture and Fisheries, the SPWARNE and the Brussels Economy and Employment - Economy Directorate within the Brussels-Capital Region.
82 DG(SANTE)/2020-6907 Version: May 2021 In all Regions, organic production controls are delegated to a number of approved CBs – currently four. Three CBs are approved in all Regions while a fourth is approved only by Wallonia. The responsibilities of the CBs are set out in the legislation, including in relation to initial inspections, design and execution of risk-based controls, random checks, sampling and analysis, sanctioning of irregularities and regular reporting of results.
The Regions are responsible for market surveillance, while non-conformities on labelling are reported as appropriate to the regional authorities by the FPS-Economy DGEI within the Federal Public Service.
The single authority for organic production is the Agricultural Office (LB/BCA).
Cooperation and coordination among the CAs is the subject of Protocols between each of the Regions and between the Regions and the Federal Public Service.
(See also Section 5.3 of the MANCP 2018-2020)
PDO/PGI/TSG
information exchange 2x/year
CBs (2)
SPWARNE DQBEA Brussels Capital Brussels Region Economy and Employment
CB Control Body SPWARNEPublic Service of Wallonia - Agriculture, Natural Resources and Environment DQBEA Department of Quality and Animal Welfare FPS Federal Public Service DGEI Directorate General Economic Inspection
Competent authorities and responsibilities
83 DG(SANTE)/2020-6907 Version: May 2021 PDO/PGI/TSG is a competence of the Regions. In addition to relevant EU and national rules, the main relevant regional legislation of the Flemish, Walloon and Brussels-Capital Regions, respectively, are:
Decree of the Flemish Government of 19 October 2007 (agricultural products and foodstuffs) and Decree of the Flemish Government of 17 February 2012 (wine products and spirits); Decree of the Walloon Government of 14 July 2016 and Ministerial Decree of 14 July 2016; Decree of the Government of the Brussels Capital Region of 22 October 2009 and Ministerial Order of 27 April 2012.
The single authority for PDO/PGI/TSG is the Agricultural Office (LB/BCA).
The relevant competent authorities for the recognition and protection of PDO/PGI/TSG are the Flemish Department of Agriculture and Fisheries, the SPWARNE - DQBEA for the Walloon Region and the Administration of Economy and Employment - Conception and Coordination Directorate, for the Brussels-Capital Region.
The FPS Economy – DGEI is the competent authority for controlling PDO/PGI/TSG products already on the market and their labelling, for the whole country of Belgium.
The SPWARNE-DQBEA is also competent for controlling PDO/PGI/TSG products already on the market and their labelling, only on Walloon territory, in support of the FPS Economy - DGEI.
With regard to controls on compliance with product specifications at producer/processor level, the situation is as follows:
For products registered in Flanders these controls are carried out by the FPS-DGEI under an agreement with the Flemish Region of 17 July 2006. As a follow-up of this agreement, both authorities meet structurally twice a year to discuss on the results of the controls and on policy issues.
For the Walloon Region, official controls at producer/processor level has been delegated by SPWARNE - DQBEA to CB’s (currently two CB’s are involved).
For the Brussels-Capital Region, compliance with the product file is carried out by the FPS- DGEI under an agreement (letter) signed in January 2021.
At present, there are no producers/processors of PDO/PGI/TSG products known in the Brussels-Capital Region.
Cooperation and coordination among the CAs is the subject of Protocols between each of the Regions and between the Regions and the Federal Public Service (with the Walloon Region, the agreement is under construction).
(See also Section 5.4 of the MANCP 2018-2020)
84 DG(SANTE)/2020-6907 Version: May 2021 ANNEX- ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS
ACRONYM DESCRIPTION AAC Administrative Assistance and Co-operation ABP Animal by-products AC Advisory Committee AI Avian Influenza ANB Nature and Forestry Agency ARSIA Regional Association for Health and Animal Identification B2C Business-to-consumer BCP Border Control Post BE/LB Brussels Environment (Leefmilieu Brussel/Bruxelles Environnement) BELAC Belgian Organisation for Accreditation BELTRACE Computerised system for traceability in the meat sector BRPS Brussels Regional Public Service BSE Bovine Spongiform Encephalopathy CA Competent Authority CB Control body CCA Central Competent Authority CDC Central Directorate CDM ''chargés de mission'' – independent veterinarians or engineers CITES Convention on International Trade in Endangered Species of Wild Fauna and Flora CMPU Crisis Management and Prevention Unit CNC Notifications and Certification Cell CODA-CERVA Veterinary and Agrochemical Research Centre COCO Co-ordinated controls CP Contingency Plan CRA-W Walloon Agricultural Research Centre CS Customs Services CSF Classical Swine Fever DG Directorate General DGAPF Directorate-General Animals, Plants and Food of the FPS-HSFCE DGEM Directorate-General Environment of the FPS-HSFCE DGEI Directorate General Economic Inspection (FPS) DGZ Regional animal health association Flanders DMO Appointed veterinarians DPE Division of the Environmental Police DQBEA Department of Quality and Animal Welfare (Walloon Region) DS Distribution sector of the LCU EFSA European Food Safety Authority EPPO European and Mediterranean Plant Protection Organization EU European Union FAC Federal Audit Committee
85 DG(SANTE)/2020-6907 Version: May 2021 ACRONYM DESCRIPTION FAMHP Federal Agency for Medicines and Health Products FANC Federal Agency for Nuclear Control FASFC Federal Agency for the Safety of the Food Chain FASFC-AC FASFC Audit Committee FASFC-IAQMS FASFC Internal Audit and Quality Management Services FBO Food business operator FeBO Feed business operators as defined in Art. 3 of Regulation 183/2005/EC FMD Foot and Mouth Disease FOODLIMS Food Laboratory Information Management System FPS-HSFCE Federal Public Service for Health, Safety of the Food Chain and the Environment FPS Economy Federal Public Service Economy, SMEs, Self-employed and Energy FPS Finances Federal Public Service Finances DGEI Directorate General Economic Inspection DG SANTE Directorate F – Health and Food Audits and Analysis of the European Directorate F Commission DG Health and Food Safety (prior 1 February 2016 the Food and Veterinary Office – FVO) GMO Genetically Modified Organism HACCP Hazard Analysis Critical Control Point HORECA Hotels, Restaurants, Cafés (Catering) IEC Import-Expert Controls ILVO Flemish Research Institute for Agriculture, Fisheries and Food INBO Research Institute for Nature and Forest IPM Integrated Pest Management IPPC International Plant Protection Convention ISO International Standard Organisation KPI Key performance indicator LB/BCA Agricultural Office (Landbouwbureau/Bureau de la coordination agricole) LCU Local Control Unit LIMS Laboratories Information Management System MANCP Multi-annual National Control Plan MBM Meat and bone meal MF Federal Public Service Finance MRL Maximum Residue Limit NICU National Implementation and Co-ordination Unit NIU National Investigation Unit NRCP National Residues Control Plan NRL National Reference Laboratory OCR Official Controls Regulation OF/SI Organic fertilisers/soil improvers OIE Office International des Epizooties OMG Flemish Department for Environment
86 DG(SANTE)/2020-6907 Version: May 2021 ACRONYM DESCRIPTION OVAM Public Waste Agency of Flanders, the Regional Waste Authority in Flanders OWD Regional Waste Authority in Wallonia PAH Polycyclic aromatic hydrocarbon PAP Processed animal protein PCB Polychlorinated biphenyl PDO Protected Designation of Origin PGI Protected Geographical Indication PP Plant passports PPP Plant protection product PS Primary production sector of the LCU PVP Private veterinary practitioner QMS Quality management system RASFF Rapid Alert System for Feed and Food RNQP Regulated non-quarantine pest SANITEL National bovine database SC Scientific Committee Sciensano Scientific expertise and research, including laboratories, based on the "One Health" concept. [Merger of the former Veterinary and Agrochemical Research Centre (CODA-CERVA) and the former Scientific Institute of Public Health (WIV-ISP)] SCS Self-checking system SERV Socio-economic council of Flanders SHC Superior Health Council SME Small and medium-sized enterprises SPWARNE Public Service of Wallonia for Agriculture, Natural Resources and Environment (Walloon Region) SRM Specified Risk Material TCU Thematic Control Unit TRACES Trade Control and Expert System introduced by Commission Decision 2004/292/EC TS Processing sector of the LCU TSE Transmissible Spongiform Encephalopathy TSG Traditional Speciality Guaranteed VEA Flemish Energy Agency VLAM Flemish centre for Agricultural and Fisheries Marketing VLM Flemish Land Agency VMM Flemish Environment Agency VMP Veterinary Medicinal Products WIV-ISP Scientific Institute of Public Health
87 DG(SANTE)/2020-6907 Version: May 2021