Ref. Ares(2020)1096584 - 20/02/2020
TABLE OF CONTENTS INTRODUCTION ...... 1 SUMMARY...... 2 1 ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EU) 2017/625...... 3 Designation of competent authorities ...... 3 Organisation and implementation of official controls ...... 15 Enforcement measures...... 17 Verification and review of official controls and procedures ...... 17 Multi-annual National Control Plan (MANCP)...... 19 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS ...... 21 2.1 Control system for animal health...... 21 2.2. Control system for food of animal origin ...... 27 2.3 Control system for imports of animals and food of animal origin...... 30 2.4 Control system for feedingstuffs and animal nutrition ...... 33 2.5 Control system for TSE, Animal By-Products (ABP) and feed ban...... 36 2.6 Control system for veterinary medicines and residues ...... 40 2.7 Control system for general food hygiene...... 43 2.8 Control system for imports of food of plant origin...... 46 2.9 Control system for plant protection products (PPP) and residues ...... 48 2.10 Control system for animal welfare...... 52 2.11 Control system for plant health...... 54 2.12 Control system for quality labelling ...... 59 ANNEX I – ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS ...... 64
i DG(SANTE) 2019-6840 Version January 2020 INTRODUCTION
This overview has been drawn up by the Health and Food Audits and Analysis (HFAA), a Directorate of the Directorate-General for Health and Food Safety of the European Commission based on information supplied by Estonia.
The aim is to present, in summary form, the latest information on how control systems for food and feed safety, animal health, animal welfare, animal by-products, plant health, plant protection products, organic agriculture and quality labelling are organised in Estonia.
Chapter 1 describes the overall organisation of the Estonian 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 eleven separate systems that form the complete range of control systems in Estonia, covering the whole chain of plant, animal and food production. As in Chapter 1, organisation charts are used to help the reader.
This overview has been updated during general follow-up desk audit in December 2019 and will be updated at regular intervals based on relevant information received by the Commission from the Estonian authorities.
Acronyms are used extensively throughout this overview for the sake of brevity. A list of acronyms, abbreviations and special terms is given in Annex I as a guide for the reader.
1 DG(SANTE) 2019-6840 Version January 2020 SUMMARY
The Veterinary and Food Board (VFB), under the aegis of the Ministry of Rural Affairs (MRA), is responsible for official controls in the majority of sectors. The Agricultural Board (AB) under the aegis of the MRA is responsible for plant health, plant protection products and organic farming. The Health Board (HB) has responsibility for drinking water safety, including natural mineral water, surveillance and control of communicable disease and health related events preparedness. The Environmental Board (EB), Environmental Inspection (EI) and Environmental Agency (EA) under the aegis of the Ministry of Environment (ME) are involved in plant health surveys and controls of forestry pests and eradication measures.
Estonia has four levels of administration for food, feed, animal health and welfare, animal by- products, plant health, plant protection products and quality labelling controls. These levels are the Ministries, central administrative bodies or agencies, the regional/county levels and the districts/establishment/farm level. It is the responsibility of the Ministries to develop legislation. Central administrations are in charge of planning, co-ordination, and implementation of controls through the regional/county level structures.
The latest version of the Estonian Multi-Annual National Control Plan (MANCP) covers the period 2019-2022.
The MANCP and the Annual Reports on the implementation of the MANCP are available on the VFB website: https://vet.agri.ee/et/kontakt-ametist/kontaktid/mitmeaastane-kontrollikava.
2 DG(SANTE) 2019-6840 Version January 2020 1 ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EU) 2017/625
Designation of competent authorities
In Estonia, executive power functions are divided into areas of government managed by Ministries. The Government of the Republic, comprising the Prime Minister and 14 Ministers, exercises executive power either directly or through government agencies.
Estonia has four levels of administration for food, feed, animal health and welfare and plant health controls. These levels are Ministries, central administrative bodies or agencies, the regional/county levels and the districts/establishment/farm level. It is the responsibility of the Ministries to develop the legislation. Central administrations of competent authorities are in charge of planning, co-ordination, and implementation of controls through the regional/county level structures.
The MRA has the main responsibility for legislation and policies regarding the food and feed chain, plant health and plant protection products. The Ministry of Economic Affairs and Communications (MEA), Ministry of Environment (ME) and Ministry of Finance (MF) are also involved according to their areas of responsibility.
The VFB of the MRA is responsible for official control of all food (including processing, wholesale, storage, retail and catering businesses), quality labelling, animal health and welfare, animal by-products and feed. The AB of the MRA is responsible for plant health surveys and controls, authorisation and control of marketing and use of plant protection products and equipment, as well as approval and control of organic farming for organic production and certification. The EB and EA of the ME are involved in official control of forestry pests for AB. The EI of the ME is responsible for implementing the eradication measures in forests.
Organigram of Main Ministries and Implementing Bodies dealing with Food, Feed, Animal Health and Welfare and Plant Health Controls
Government of Estonia
Ministry of Ministry of Ministry of the Ministry of Ministry Ministry Rural Affairs Social Environment Economic of Finance of the Affairs Affairs and Interior Communica- Environmental tions Board Agricultural Health Tax and Police and Board Board Environmental Consumer Customs Border Inspection Protection Board Guard Board Veterinary and State Agency and Food Board of Medicines Environmental Technical Agency Regulatory Authority
3 DG(SANTE) 2019-6840 Version January 2020 Ministry of Rural Affairs
The Ministry establishes the conditions for the sustainable and diverse development of Estonian rural areas, agriculture, and the fishing industry, to ensure the safety of food and feed, and a high level of animal health and welfare, plant health and protection on usage of plant protection products.
The MRA is responsible for creating Estonian national agricultural policy by drafting development plans, strategies and legislative acts, and co-ordinating the financing, strategies and legislation.
The responsible departments of the MRA in the areas of animal health and welfare, food and feed, animal by-products, quality labelling, plant health and plant protection products are Food Safety Department (FSD), Agricultural Policy Department (APD) and Plant Health Department.
The FSD is responsible for drafting legislation and setting policy for implementing measures in the fields of food safety, feed safety, animal health, animal welfare and farm animal breeding. Additionally, the MRA is responsible for the communication related to the international food standards programme Codex Alimentarius in Estonia and co-ordinates co- operation with the European Food Safety Authority (EFSA), the European Commission and the food supervisory authority of the Member States of the European Union.
The FSD has 3 offices:
General Food Law Office which drafts general legislation for food safety, as legislation for labelling, for food improvement agents, food additives, for food contact materials etc; Animal Health and Welfare Office (AHWO) which drafts legislation for animal disease prevention and control, animal welfare and veterinary activities; Chemical and Biological Food Safety Office, which drafts legislation for hygiene of food/feed and approval of establishments, contaminants, residues and official food and feed control implementing and monitoring systems and laboratories.;
The APD is responsible for development of support measures for food processing industry and development plans and co-ordination of their implementation. The tasks of APD also include the monitoring and analysis of the impact of national measures, trade data and market data analysis. At the international level, the APD is engaged in the implementation of the “European Union food quality certification schemes”, international co-operation and several other activities.
The Plant Health Department of the MRA is responsible for setting up the policies and drafting the legislation in plant health and plant propagating material, plant protection products and organic farming areas.
Veterinary and Food Board
The VFB is a governmental agency under the aegis of the MRA. It functions as a supervising body and ensures that the requirements of legislation are followed on animal health, veterinary services, food safety, feed safety, market regulation, animal welfare and farm animal breeding. It supervises the implementation of these requirements and enforces them by legislative
4 DG(SANTE) 2019-6840 Version January 2020 means. The Food Act covers all sectors of the food chain and assigns regulatory responsibilities to the VFB and Consumer Protection and Technical Regulatory Authority (CPTRA). The central office co-ordinates veterinary and food control activities carried out by the regional departments.
Communication and co-ordination Meetings between central level and the 4 heads of the regional departments, chaired by the VFB Director General, are held at least once per quarter to discuss inspection, sampling planning and management issues. Meetings are also held at least once a year with the specialists from VFB and inspectors from the regions.
The VFB is responsible for: acting as the single central contact point for the multi-annual national control plan required under the Official Control Regulation; prevention and control of infectious animal diseases by means of monitoring, and eradication programmes; sampling and laboratory analysis; contingency planning; and safeguarding the environment from harmful factors resulting from animal production or infectious animal diseases; control of zoonosis and animal welfare; control of production, processing, placing on the market and use of feed; carrying out the approval, registration and supervision of food and feed establishments and organising laboratory analyses to assess the properties of food, feed, (including medicated feed) and drinking water; licensing veterinary services and the control of the use of medicinal products and medicated feed by veterinarians and on farm;
5 DG(SANTE) 2019-6840 Version January 2020 import and export controls through checks on animals, feed, food and their raw materials, including checks of products of animal origin and agricultural products certified as “organic”(competency for checks on organic products is shared with the CPTRA); controls on animal breeding and preservation of farm animal genetic resources; organising control procedures to implement market regulation measures on milk and meat; co-ordination and organising quality controls of products upon the application of measures for organizations of markets.
The VFB central office has three relevant structural units: Food Department (FD); Animal Health and Welfare Department (AHWD; Fisheries and Market Regulation Department (FMRD).
Food Department is responsible for:
co-ordinating and planning of supervision of processing food of animal origin (meat, milk, fish, eggs, honey), private dwelling-house and transportation of all types of food; co-ordinating of approval/ registration of establishments processing food of animal origin (meat, milk, fish, eggs, honey), private dwelling-houses and transportation of all types of food; co-ordinating and planning of national residue monitoring programme in food of animal origin and animals; co-ordinating and planning of national zoonosis and antimicrobial resistance monitoring programs in foodstuffs and animals; designation of laboratories for analysis of samples taken during official controls and Trichinella analysis according to the Regulation (EU) 2017/625. co-ordinating and planning of supervision of laboratories analysing self-control samples; developing and updating inspection guidelines and manuals; assessing the effectiveness of supervision and developing and implementing corrective measures; participation in national and international groups and meetings, projects; communication of information; internal and external audit; participation in the preparation of draft legislation; participation in national and international projects on food safety and food quality compiling reports for the EU and other purposes; co-ordinating and planning of supervision of primary production, wholesale, retail (including catering), the processing food of non-animal origin (including composite products); co-ordinating of approval/registration of establishments of primary production, processing food of non-animal origin (including composite products), wholesale establishments, retail (including catering), Food Contact Material (FCM) establishments; co-ordinating and planning of supervision of primary production, wholesale, retail (including catering), the processing food of non-animal origin (including composite production); co-ordinating and planning of supervision of food additives, food improvement agents, novel foods and foods containing GMO, FCM, food supplements, food intended for particular nutritional uses, presentation of food information to consumer; co-ordinating and planning of national residues monitoring programme under Regulation (EC) 396/2005 assessing the trainings needs of inspectors and planning and conducting training;
6 DG(SANTE) 2019-6840 Version January 2020 co-ordinating of official controls on imports of certain feed and food of non-animal origin; developing and updating inspection guidelines and manuals; administrating of the Rapid Alert System for Food and Feed (RASFF) risk notification system; assessing the effectiveness of supervision and developing and implementing corrective measures; participation in national and international groups and meetings, projects; communications; participation in the preparation of draft legislation on food control; participation in national and international projects on food safety and food quality; compiling reports for the EU and other purposes.
Animal Health and Welfare Department is responsible for: control of infectious animal diseases; implementation of measures to protect human health from zoonotic diseases; supervision of the identification and registration of animals and performance of veterinary checks on domestic movements of animals; environmental protection against hazardous factors resulting from animal production and animal diseases; monitoring the use of medicinal products and medicated feed by veterinarians and on farm; supervision of farm buildings; participation in the preparation of draft legislation on animal health; participation in national and international projects on animal health; compilation of state programmes on monitoring and surveillance of infectious animal diseases; establishing, updating and ensuring the compliant functioning of the control system for feedingstuffs; co-ordinating of approval/registration of feed business operators risk assessment and preparation of the supervision plan; assessing the training needs of inspectors and planning and conducting training; developing and updating inspection guidelines and manuals; assessing the effectiveness of supervision and developing and implementing corrective measures; establishing, updating and ensuring the compliant functioning of the control system for feed; compiling reports for the EU and other purposes in the field of feed; administration of the Trade Control Expert System (TRACES); supervision of import and transit of live animals and products of animal origin from third countries subject to veterinary and food control; and internal trade; arrangement the grant of approval to persons involved in animal breeding; supervision of animal breeding; organisation of controls over the preservation of genetic resources of farmed animals; arrangement and provision of the supervision on the implementation of the animal welfare requirements; registration and approval of farm buildings and means of transport; participation in the preparation of draft legislation on animal welfare;
7 DG(SANTE) 2019-6840 Version January 2020 in the national and international projects in the field of animal welfare; participation in the national and international projects in the field of animal welfare.
The department includes five border Inspection Posts (BCPs): Luhamaa, Narva, Koidula, Muuga and Paldiski.
Fisheries and Market Regulation Department is responsible for:
co-ordinating and planning of supervision over measures related to dairy products’ intervention buying-in, aid for use and private storage. co-ordinating and planning of supervision over implementation of measures regulating the market of fish, live animals, meat and meat products. trains and acknowledges quality grade indicators of slaughter animals’ carcasses. organizes and carries out supervision over determination of quality classes of pork, beef and sheep carcasses and the functioning of classification system of pork-, beef- and sheep meat price reporting; co-ordinating and planning of supervision over compliance of composition and quality requirements (dairy products, spreadable fats) and marketing standards (poultry, egg) with the governing laws within its competence; co-ordinating and planning of supervision of organic food and feed (including production, wholesale, retail, catering); co-ordinating and planning of supervision over lawful use of protected geographical indications.
Regional Departments of VFB
The Regional Departments are responsible for the practical implementation of food and feed safety, animal health and welfare monitoring programmes.
Agricultural Registers and Information Board
The Agricultural Registers and Information Board (ARIB) is a government institution under the MRA. Its functions are to maintain the register of farms, farm animals and farm support.
8 DG(SANTE) 2019-6840 Version January 2020 Agricultural Board
The AB is a governmental agency under the aegis of the MRA. The AB is the competent authority, which ensures the implementation of legislation on plant health; plant protection products and equipment; fertilisers; seeds and plant propagating material; variety listing and plant breeder's rights; organic production; fresh fruits and vegetables quality standards and land reclamation.
Four central departments (Plant Health and Horticulture Department, Plant Protection and Fertilisers Department, Organic Agriculture and Seed Department and Land Reclamation Department) are responsible for proceeding with the applications and keeping of official registers, planning and co-ordination of control activities, and the quality of performance of controls. Resource planning is co-ordinated by the Director General and Deputy Directors General of the AB.
Action plans, including annual control plans, for each sector are drafted according to the ‘Order on Planning and Reporting the Official Controls’, established by the Decree of the Director General of the AB (last amended 01.12.2015). The compilation of inspection manuals and recording of inspection results, as well as an order on internal control and evaluation of the performance of inspections are regulated by the Decrees of the Director General of the AB (last amended on 01.01.2015 and 24.10.2018 respectively). 4 regional offices and 16 designated plant health import points are responsible for controls at local level.
At the AB service- and process-based management system is introduced where service and process owners and their tasks and responsibilities are identified.
The responsible departments of the AB at central level and their tasks are:
Plant Health and Horticulture Department (PHD) is responsible for:
9 DG(SANTE) 2019-6840 Version January 2020 implementation of plant health legislation at the Border and inside the country and keeping the Official Plant Health Register; implementation of the legislation on plant propagating material (EU marketing directives); co-ordination and planning (including evaluation of risks) of surveys and official controls and enforcing the eradication measures; co-ordination and planning of surveys and official controls on production and marketing of plants, plant products and other objects; certification of seed potato and control on production and marketing of potato; co-ordination and planning of controls on fresh fruits and vegetable external quality standards; co-ordination of inspector’s work, drafting and updating the inspection manuals, training of inspectors, assessing the inspector’s performance and evaluation of the efficacy of control system; participation at national and international meetings and working groups; public communication and awareness raising; participation in the preparation of draft legislation in the areas of responsibility; compiling the reports to the Commission and Member States and others.
Plant Protection and Fertilisers Department (PFD) is responsible for:
implementation of the legislation on plant protection products and fertilisers; evaluation of active substances of plant protection products; authorisation of plant protection products and keeping the official register; issuance of attestations to use the plant protection products for professional operators; co-ordination and planning (including evaluation of risks) of official controls on marketing and use of plant protection products and equipment; co-ordination and planning (including evaluation of risks) of official controls on production and marketing of fertilisers; co-ordination of inspector’s work, drafting and updating the inspection manuals, training of inspectors, assessing the inspector’s performance and evaluation of the efficacy of control system; public communication and awareness raising; participation at national and international meetings and working groups; participation in the preparation of draft legislation in the areas of responsibility; compiling the reports to the Commission and others.
Organic Agriculture and Seed Department (OSD) is responsible for:
implementation of the legislation on organic farming; approval of organic producers on farm level and keeping the Official Organic Agriculture Register; co-ordination and planning (including evaluation of risks) of official controls on organic farming; implementation of legislation on seeds (EU marketing directives); certification of seeds and co-ordination and planning of marketing control;
10 DG(SANTE) 2019-6840 Version January 2020 co-ordination of inspector’s work, drafting and updating the inspection manuals, training of inspectors, assessing the inspector’s performance and evaluation of the efficacy of control system; registration of varieties and granting the plant breeders rights; participation at national and international meetings and working groups; participation in the preparation of draft legislation in the areas of responsibility; compiling the reports to the Commission and others.
The Regional Centres (RCs) of the AB are responsible for conducting controls at production and sales levels as well as plant health surveillance and monitoring activities and implementing the eradication measures. Depending on the division of tasks, most inspectors in regions perform controls in more than one area.
The work of Border Control Points is co-ordinated directly by the Plant Health and Horticulture Department.
EB, ERA and EI under aegis of the Ministry of Environment, having competences on forest pathology, are involved in planning and conducting the plant health controls based on official co-operation agreement.
The EB is responsible for quality control and certification of forest plant propagating material according to the Plant Propagating Material and Variety Protection Act, as well as reporting on findings of forestry pests to the PHD of the AB, and assisting them in the implementation of control and eradication measures.
The ERA is responsible for evaluation risks and conducting the surveys in forestry area.
The EI may be contracted by the PHD for eradication measures in forests.
Other Ministries and Authorities involved:
Ministry of Social Affairs The Ministry is responsible for drafting and implementation of plans for the management of public health protection. The public health department of the Ministry is responsible for legislation in the following areas: Quality of drinking and bathing water Natural mineral water and spring water
Environmental conditions in public establishments such as schools and childcare facilities. Health protection requirements for nutrition in schools, kindergartens and other childcare facilities; hospitals; social care homes; and prisons.
Health Board
The Health Board (HB), a governmental institution of the Ministry of Social Affairs (MSA), in operation since 1 January 2010, incorporates the functions of the former Health Care Board,
11 DG(SANTE) 2019-6840 Version January 2020 the Health Protection Inspectorate and the Chemicals Notification Centre. The HB’s areas of responsibility are: health; communicable disease surveillance and disease control; environmental health (including drinking water and natural mineral water); chemical safety; and safety of medical devices.
In accordance with a governmental decision, the HB transferred its responsibilities on food safety control at retail and catering level to the VFB on 1 July 2007 by Decree of the Minister of Social Affairs (No. 48 of 28 May 2007).
The responsibilities of HB relevant to food and feed safety include: quality of drinking and bathing water quality of natural mineral water and spring water (the HB is competent authority for natural mineral water recognition) communicable disease surveillance and control early warning and response activities (HB is ECDC EWRS and IHR 2005 contact point in Estonia), duty 24/7 investigation of foodborne outbreaks of communicable disease in collaboration with VFB health related events preparedness planning and response coordinating (including epidemic preparedness) consumer goods (cosmetics), safety of chemicals
The HB has an agreement with VFB (cooperation during foodborne outbreak investigation, zoonosis surveillance prevention and control in humans and animals). Under the Ministry of Social Affairs (in force since 15.06.2003) local Regional Department of the HB provide obligatory information to the VFB about all cases of zoonosis diagnosed in humans. VFB notifies HB about notifiable zoonosis in animals and positive findings in food.
The list of zoonoses subject to notification, formal requirements for a relevant notice submitted to the VFB and the procedure for submission are established by the Minister of Social Affairs: https://www.riigiteataja.ee/akt/610394?leiaKehtiv.
The main aims of the HB Central Authority are: formulation and implementation of country wide work-plans; co-ordination and support of the regional services through provision of instructions, manuals and expert advice; analysis of reports submitted from the regions and quality control of their work: training of staff; participation in international groups and meetings; communication of information and knowledge; internal and external audit.
Regional and County Level Services
There are 4 regional, departments namely Northern Department, Southern Department, Western Department and Eastern Department. The Regional department are responsible for planning, co-ordinating of state control and responsible for inspections. Each Regional department is operated under the Head on regional department, who reports to the Director General of the HB.
Communication between central level and the 4 regional departments is via meetings (once a week).
The State Agency of Medicines
12 DG(SANTE) 2019-6840 Version January 2020 The State Agency of Medicines is a governmental body of the MSA, responsible for the protection and promotion of public and animal health, through the supervision of medicines for human and veterinary use. The tasks of the Estonian State Agency of Medicines are: Authorisation of medicinal products; Maintenance of the register of human and veterinary medicinal products; Co-ordination of human and veterinary pharmacovigilance; Evaluation and approval of applications for clinical trials; Issue of activity licences for handling of medicinal products; Supervision over the handling of medicinal products, narcotic and psychotropic substances and precursors; Import and export control of medicinal products; Drug information, advertising and promotion control; Quality control of medicinal products.
Ministry of Economic Affairs and Communications
The Consumer Protection and Technical Regulatory Authority
The Consumer Protection and Technical Regulatory Authority (CPTRA) has three main functions which are based on the Consumer Protection Act: providing state supervision of the consumer market; organising the handling of consumers’ complaints; informing, advising and educating consumers.
The CPTRA has 5 departments one of which (consumer environment department) is responsible of supervision of consumer market. In the consumer environment department, there are 4 divisions: Trade Unit Tourism Division Secretariat of the Consumers Disputes Committee European Consumer Centre
Trade division is also responsible for the control of foodstuff (in particular the control of the labelling of foodstuff at retail level). There are 9 persons in the trade division and 3 of these are directly related to food control. 3 inspectors are located in the counties and one-third of their work is related to foodstuffs.
Tax and Customs Board
The officials of the VFB and AB in the areas of veterinary, food, plant health and plant production products work closely with customs officials in carrying out the tasks of identification, selection and presentation of consignments for official checks. The Tax and Customs Board (TCB) comes under the MF.
13 DG(SANTE) 2019-6840 Version January 2020 Co-ordination and Co-operation between competent authorities
For improving co-operation between the competent and other governmental authorities, the co-operation agreements have been signed laying down rules and principles for carrying out the control activities.
Based on such co-operation agreements, the competent authorities can use if necessary each other’s databases, conduct joint control operations and trainings etc.
Detailed information about co-operation agreements are described in the MANCP.
Contingency planning
See Chapter 2.1 Control System for animal health and Chapter 2.11 Control System for plant health.
Resources for performance of controls
Legal basis for controls
The legal powers to carry out official controls are laid down in the Food Act, the Veterinary Activities Organisation Act; European Union Common Agricultural Policy Implementation Act and the Infectious Animal Disease Control Act.
The Food Act provides for the right of access to food premises; seizure of goods; initiation of proceedings for administrative offences; and other enforcement measures such as the suspension of activity.
The Environmental Board (EB) and the Environmental Agency (EA) which has competences on forest pathology are involved in planning and conducting of controls and surveys of forestry pests, as well as reporting on findings of harmful organisms to the PHD of the AB.
Staffing provision and facilities
Conflict of interest for the staff performing official controls is regulated by Articles 71, 72 and 74 of the Act on Civil Service (13.06.12) and by Article 19 (3) of the Act on Anti- corruption (27.01.1999), as amended.
Officials, employed by the VFB and AB are subject to the provisions of these acts. An official responsible for official control, who wishes to operate or participate in a business, must apply to the DG of the VFB or AB. Based on the application permission is granted or denied. In order to avoid conflict of interest, a declaration for impartiality and independence is required from all officials, as laid down in the Decree No. 85 of VFB of 11 April 2008. The procedure for avoiding conflict of interest was adopted with the Decree of the Director General of the VFB No. 14 of the 25 January 2010.
At the AB the order on ‘Avoiding the conflict of interest while performing official controls' was established by Decree No. 1-2/20 of the Director General (last revised 02 February 2010).
14 DG(SANTE) 2019-6840 Version January 2020 A civil servant from the VFB or AB may not take part in a private business without prior authorisation of the Director General.
Staff qualification and training
Officials and AVs are subject to regular assessments of their work, performed by their hierarchy or through internal audits.
Decree No 56 of 20. March 2018 of the Director General of VFB sets out the training principles for official controls. Annual training plans are available for the staff at the VFB headquarters and in the CVCs. The annual VFB training plan is drafted by the Heads of Departments, approved by the DG and disseminated to the RDs and the central units. The immediate superior of inspectors assesses the needs of training, which are discussed regularly. The annual training programme of the VFB also comprises training for AVs.
The legal obligation for VFB to provide continuous training for inspectors and authorised veterinarians is provided for in paragraph 2 of the Minister of Rural Affairs Decree No. 48 of 16 August 2018 “The Statutes of Veterinary and Food Board”. Training is carried out under an annual training plan established by the Departments of VFB. The inspectors of the central office carry out most of the training. Occasionally, staff from the MRA provides guidance on legal aspects. For other topics, separate training is organised (e.g. HACCP principles, HACCP auditing, inspection and sampling techniques, microbiological criteria) with trainers from other institutions under bilateral projects, BTSF training programmes. Training is carried out either by experts from other MS or by VFB staff.
Staff of the AB Plant Health and Horticulture, Plant Protection and Fertilisers and Organic Agriculture Departments has received training via BTSF training programs and other means. For regional officials responsible departments at central level plan regular annual training programmes and conduct trainings. The personnel bureau of the Administrative Department co-ordinates the compilation of the AB annual training plans. Institutions such as: the University of Life Sciences; Laboratories of the ARC; the Agricultural University and Horticultural High School are invited to carry out elements of planned training activities, if appropriate. Participants in trainings in framework of BTSF programme are obliged to share the knowledge gained with the rest of officials in the area.
Performance and qualification of inspectors has to be regularly assessed according to the Decree of Director General of the AB of 08.09.2015 on internal controls.
Organisation and implementation of official controls
General information is provided in chapters 2.1-2.12.
Detailed information is provided in MANCP.
Prioritisation of official controls
The VFB central office has responsibility for co-ordination of the inspection activity falling under the competence of that organisation. Meetings between VFB management and heads of the regions are held at least once per quarter. There are also meetings, at least once a year,
15 DG(SANTE) 2019-6840 Version January 2020 between specialists from the VFB central office and officials of 4 regions from the 15 counties to discuss general and specific issues.
The AB central offices are responsible for planning and co-ordination of the controls performed at local level. Meetings between management and heads of 4 regions are held at least once per quarter. There are also meetings, at least once a year, between specialists from central office and officials from counties to discuss general and specific issues related with official controls.
Sampling and Laboratory analysis
Information is provided in the following sectoral chapters 2.1-2.12.
Procedures for performance and reporting of control activities
The MANCP describes documented procedures for regional/county offices reporting to central level of: VFB, HB, AB and CPTRA.
Transparency and confidentiality
Information is available on the VFB website http://www.vet.agri.ee, concerning Responsibilities of the VFB in official controls; Results of official controls carried out by the VFB (veterinary import controls, animal welfare controls, controls of food and FCM); Animal health risks and vaccination campaigns; List of registered laying hen farms, allowing the geographical location of the farm to be identified; Food and FCM related guidelines for operators and the general public; Information on food suspected of presenting a risk to human health; There is an active link to the weekly overview reports of the RASFF notifications published by the European Commission;
Results of monitoring and official controls carried out by the HB and recognition of natural mineral waters are published on the HB website: https://www.terviseamet.ee/et/valkonnad/keskkonnatervis/vesi/pakendatud-vesi.
The website of the AB (http://www.pma.agri.ee/index.php?main=1) includes information on plant health legislation, procedures, regulated articles and pests and results of surveys. There can be also found: - Responsibilities of the AB in official controls; - Results of official controls carried out by the AB (report on Action Plan); - Authorised plant protection products; - Approved organic producers; - Other relevant to the client information.
16 DG(SANTE) 2019-6840 Version January 2020 Enforcement measures
Measures in the case of non-compliance
The Administrative Procedure Act, General Part of the Economic Activities Code Act and Law Enforcement Act provides the basis for administrative proceedings.
The powers granted to the VFB inspectors are laid down in the Food Act and include, inter alia, the right of access to food and FCM premises, seizure of goods, the initiation of proceedings for administrative offences and other precautionary measures such as the suspension of activity. Food and FCM operators have the right to appeal.
In relation to animal health, the Veterinary Activities Organisation Act, Animal Protection Act and the Infectious Animal Disease Control Act (IADC) provide the legal framework for the imposition of sanctions. The powers granted to the VFB inspectors of Animal Health and Welfare are similar to VFB inspectors dealing Food and FCM operators, including for example the right of access into premises and the right to take the animal away from the owner.
Administrative procedures for imposing sanctions in cases of non-compliance are described in the Law Enforcement Act chapter 3 and in the General Part of the Economic Activities Code Act articles 36 to 38 and articles 42 and 43. The Code of Misdemeanour Procedures provides a legal basis for proceedings leading to the application of a fine and ensures that sanctions are effective, proportionate and dissuasive.
There are three levels of sanctions: Warning (this is not recorded on State Database) Fast procedure (Acceptance of protocol, on the spot with a fine) General procedure (Larger fine with possibility to appeal)
Separate procedures exist for criminal sanctions.
The powers granted to the AB inspectors are laid down in the Plant Protection, Plant Propagating Material and Organic Agriculture Act and include, inter alia, the right of access premises, seizure of goods, initiate the proceedings for administrative offences and other precautionary measures such as the suspension of activity. Operators have the right to appeal.
Operators are entitled to appeal against any decision issued by the relevant inspector. The appeal can be made within 30 days to the central authority of the relevant organisation: VFB, HB, CPTRA or AB. Once received, an appeal is examined and a written response provided within ten days. The decision of the Director General of the relevant organisation can be appealed in court within 30 days. There is a legal requirement for statistics on sanctions to be published.
Verification and review of official controls and procedures
VFB The main elements of the system are as follows:
17 DG(SANTE) 2019-6840 Version January 2020 Regulation 48 of the Minister for Agriculture of 16 August 2018 assigns responsibility to the Director General of VFB for internal control system. Quality manager is responsible for the uniform implementation of procedure of verification process in the VFB. Assessment of inspections to verify the effectiveness of official controls is regulated by the new procedure (the Decree of Director General, 08.07.2019 no 73). According to that procedure verification process should discover weaknesses of inspections bring out best practices and ensure that corrective actions are taken when needed. The procedure regulates general principles of verification and 5-year plan/schedule (updated every year), preparation of verification report and determines responsibilities of carrying out verifications of official controls. Verification checks include documentation controls, interviews with inspectors, on-spot-controls and other methods. General reports are prepared and necessary corrective actions are implemented. The job descriptions of the Chief specialists in regions require them to review/supervise inspectors to ensure uniform inspections.
AB
Plans and reports on official controls for each sector shall be drawn up according to the respective Decree of Director General of AB (an order on planning and reporting, in force since 2007, last amended by Decree of 01.12.2015 no 1-2/27). Both action plans and reports compiled by the responsible departments are published on AB website. On a quarterly basis each process owner has to compile a report on taken actions and results of the controls.
Guidelines for performance of official controls (inspection manuals) are given by the Decree of Director general (an order on compiling the manuals, in force since 2007, last amended by Decree of 01.01.2015 no 1-2/23). One of the process owners’ responsibilities is to check the protocols and other official documents compiled by the inspectors, as well as inform them immediately, in case of violations have been identified.
Assessment of performance of official controls is regulated by the Decree of Director General (an order on evaluation of performance of official control activities, in force since 2007, last amended by Decree of 24.10.2018 no 1-2/16); each official has to be checked at least once in 3 years by the responsible official at central level. Checks are performed together with an official at the place, where controls are conducted or in a short period after he/she has performed the control.
Additionally, all official’s individual performance (clients feedback, working in compliance with inspection manual, accuracy of protocols etc.), is evaluated by the end of each year.
AUDIT
Audit systems
VFB
The requirement for audit under Article 6 of Regulation (EU) No 2017/625 is being met by VFB through the Internal Audit Department in the Ministry of Rural Affairs. The Internal
18 DG(SANTE) 2019-6840 Version January 2020 Audit Department of the Ministry of Rural Affairs has the main responsibility for Estonian NAS (including co-ordinating of other bodies work related to Article 6).
The Internal Audit Department of the Ministry of Rural Affairs carries out audits and also outsource the internal auditing services to external partners. The external audit firm reports to the Director General of the VFB and to the Internal Audit Department of the Ministry of Rural Affairs.
Further details regarding audit system is available in the following link: http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3710
Other bodies
Competent Authorities organise their audit arrangements to ensure that their audit system covers all the control activities based on the Regulation (EU) No 2017/625 in the field of food and feed safety, animal health and animal welfare.
The responsibilities are divided as following: The Internal Audit department of the MRA carries out audits in AB; The Internal Audit department of the MF carries out audits in TCB; The Internal Audit department of the MEA and Communications carries out audits in CPTRA; The Internal Audit department of the MSA carries out audits in HB.
Regulation on internal auditor’s professional activities is based on Auditors Activities Act and Government Regulation of internal audit. The internal audit activity must comply with International Audit Standards published by the Institute of Internal Auditors.
The ARC and VFL are acting as the official laboratories and follow the quality system of EN ISO/IEC 17025 on "General requirements for the competence of testing and calibration laboratories". They have been accredited by the Estonian Accreditation Centre (EAC). Quality specialists of the laboratories and EAC carry out quality audits every year.
Multi-annual National Control Plan (MANCP)
The current Estonian MANCP for the period 2019-2022 was finalised and submitted to the Commission and follows closely the structure of the European Commission Guidelines.
Annual Report
The Annual Reports on the implementation of the MANCP are available on the VFB website: https://vet.agri.ee/et/kontakt-ametist/kontaktid/mitmeaastane-kontrollikava.
19 DG(SANTE) 2019-6840 Version January 2020 Distribution of responsibilities in relation to control systems
The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels. More detailed descriptions of the allocation of responsibilities between authorities in relation to each control system are given in the following chapters.
Co- Risk assessment, Policy Implementation Sector ordination Laboratories scientific co-ordination of controls of controls advice 1. Animal Health MRA, Food Safety VFB RDs, ARIB VFL VFB, EULS RAU Dept. 2. Food of Animal Origin MRA, Food Safety VFB RDs VFL; HB VFB, EULS RAU Dept labs, ARC 3. Imports of animal and MRA, Food Safety VFB VFB, TCB VFL; HB labs VFB, EULS RAU food of animal origin Dept 4. Feedingstuffs MRA, Food Safety VFB VFB, RDs VFL; ARC; VFB, EULS RAU Dept. HB labs
5. TSEs/ABP MRA, Food Safety VFB, ME VFB, RDs VFL VFB, EULS RAU Dept. 6. Veterinary medicines MSA, ESAM VFB, ESAM RDs, ESAM ARC, VFL VFB, ESAM - authorisation, marketing &distribution Veterinary medicines MRA, Food Safety VFB, ESAM RDs, ESAM ARC, VFL VFB, ESAM - residues Dept. ESAM 7. Foodstuffs and MRA, Food Safety VFB, HB, RDs, CPTRA, HB, VFL, HB VFB, EULS RAU Food hygiene Dept, MSA. CPTRA labs, ARC HB Regional Department (NM and drinking water) 8. Imports of food of plant MRA, Food Safety VFB VFB VFL, ARC, VFB origin Dept. HB labs 9. Plant protection MRA, Plant Health AB RC ARC AB products - authorisation, Dept. marketing and use Plant protection MRA, Food Safety VFB, AB RDs, RC ARC, HB ARC, VFB, HB, products - residues Dept. (production) labs AB 10. Animal Welfare MRA, Food Safety VFB VFB, RDs VFL VFB, EULS RAU Dept. 11. Plant Health MRA, Plant Health AB AB, EB, ERC ARC AB Dept
20 DG(SANTE) 2019-6840 Version January 2020 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS
2.1 Control system for animal health
MRA Ministry of Rural Affairs VFB Veterinary and Food Board HB Health Board ME Ministry of the Environment ARIB Agriculture Registers and Information Board CDB Central Database RD Regional Department AHWD Animal Health and Welfare Department NRL National Reference Laboratory
21 DG(SANTE) 2019-6840 Version January 2020 Competent Authorities
The VFB's central level Animal Health and Welfare Department (AHWD) is competent for animal health issues (including semen and embryos). The ARIB is responsible for maintaining the Central Database (CDB). Enforcement of the requirements concerning animal identification and holdings registration is the responsibility of the VFB and ARIB.
The functions of the AHWD regarding animal health are described in part 1.
15 counties are divided into 4 RDs are responsible for the practical implementation of the monitoring programmes. Animal health inspectors from RDs and the authorised veterinarians (AV) are responsible for animal health and welfare tasks at farm level and carry out comprehensive inspections once every five years in farms, including holding registration, animal identification, the waste food feeding ban and related issues. Leading specialists of RDs are responsible of coordinating animal health activities on RD level.
Supervision of animal health is based on Veterinary Activities Organisation Act that establishes the bases of organisation of veterinary activity. Veterinary activity is a system of measures, applied for protection of animal and human health and for guarantee of animal welfare, including activities in the field of animal health, animal product hygiene and animal protection.
In the field of animal health, the Infectious Animal Disease Control Act is very important, and contains both common (for example commitment to identify and register animals) and concrete (for example directions for activities to be taken during epidemic) measures of precaution and control of infectious animal diseases. In prevention, suspicion or presence of animal epidemic there is need for compact co-operation with Veterinary and Food Laboratory, performing necessary laboratory examination.
In case of suspicion or presence of infectious animal disease activity is based on the infectious animal disease control rules, established by the Ministry of Agriculture. According to infectious animal disease, control rules the spreading of infectious animal disease has to be blocked and the source of infection has to be eliminated. The infectious animal disease control rules are obligatory for all animal-breeders, handlers of animal products, persons in the spreading area of infectious animal diseases, supervising officials, authorized veterinarians, licensed veterinarians and veterinary laboratories and other persons, connected with the infectious animal disease control due to of their jobs.
Training for AVs provided at central level covers, inter alia, recommendations made in SANTE- HFAA reports and diseases and areas that interest AVs.
Within the framework of contingency plans for African swine fever and avian influenza five similar table top simulation exercises were held from April to May 2017 in different veterinary county centres. The main objectives were to practise the actions of local infectious animal disease control centres, also practice how to divide the different functions since the disease is confirmed until the carcasses are destroyed.
A simulation exercise on foot and mouth disease was held from 14 March to 7 June 2018 in different parts of Estonia. The simulation exercise comprised 2 seminars, 11 table-top exercises in local veterinary centres and a conclusive seminar for all participants. The overall aim of this simulation exercise was to:
22 DG(SANTE) 2019-6840 Version January 2020 - Recognise foot and mouth disease, - Take, pack and store samples in case of foot and mouth disease suspicion, - Set up a disinfection point at the entrance to a farm, - Practise proper biosecurity measures for entering and leaving the farm, - Deal with emergency response for foot and mouth disease. The simulation exercise was directed to official veterinary inspectors responsible for animal health control in the country.
A field simulation exercise on foot and mouth disease (FMD) took place on 22 May 2019 in the county of Tartu in Estonia. Participants to this simulation exercise were the specialists from the centre of Jõgevamaa-Tartumaa and representatives from the local authority, Estonian Rescue Board, Estonian Road Administration, Police and Border Guard Board and animal by- products company. The main objective of this exercise was to practice cooperation with other authorities in the event of an outbreak of FMD. The activities were the following ones: - practice the disease event management; - exercise fieldwork with collaborators (cooperation with related institutions, localization of the outbreak and implementation of biosecurity measures); - resolve emergency situation in case of interruption of communication. The simulation exercise was divided into two parts starting with the field exercise and followed by the theoretical part.
Field simulation exercises on foot and mouth disease (FMD) took place on 6 June in the county of Hiiu, on 19 June in the county of Põlva, on 20 June in the county of Ida-Viru and on 29 August in the county of Järva 2019. Participants of the simulation exercise were the specialists from the Veterinary and Food Board county centres. The main objective of these exercises was to practice fieldwork, operations management, tasks dividing in the event of an outbreak of FMD. The activities were to practice the disease event management and to exercise fieldwork (localization of the outbreak and implementation of biosecurity measures).
Animal health controls
In the state programme of surveillance and monitoring of infectious animal diseases the volumes of control measures for infectious animal diseases and animal species have been defined to monitor the general situation of infectious diseases in Estonia. The volumes of vaccinations and inspection of animal breeding facilities have also been presented. The Director General of Veterinary and Food Board establishes the national infectious animal disease control program and all the costs of its application are being covered by the state budget.
The program of next year is compiled on the basis of the number of animals and the prognoses presented by the counties. Diagnostic tests are concentrated on the diseases with avoiding of which the veterinary service has dealt systematically every year, for example leucosis and diseases which are not lethal, but in spite of this may cause essential harm for animal breeding through fall in the production, breeding and other indirect factors. The program contains tests carried out both in domestic and wild animals.
23 DG(SANTE) 2019-6840 Version January 2020 AVs have individual contracts with the VFB including a job profile in the annex to the contract listing their duties and obligations. They carry out testing, vaccination and inspection duties laid down in the annual plan under the supervision of CCA. AVs provide a monthly report on their activities to the CCA. Quarterly reports on progress are submitted to the CCA by each region (county-based).
Vaccination against rabies is compulsory for pets (dogs and cats) and free of charge to the owners. Vaccination of grazing farmed animals is not compulsory but, if rabies re-emerges, is also state-funded in the outbreak site. Estonia is running oral vaccination program for wildlife in buffer-zone in its eastern border.
Disease status
According to Commission Decision 2010/695/EEC amending the Annexes to Decision 93/52/EEC as regards the recognition of Estonia, Latvia and the Autonomous Community of the Balearic Islands in Spain as officially free of brucellosis (B. melitensis) and amending Annexes I and II to Decision 2003/467/EC as regards the declaration of Estonia as officially tuberculosis-free and officially brucellosis-free as regards bovine herds, Estonia has gained officially tuberculosis – free and brucellosis –free member state status.
According to Commission Decision from 7.of July amending the Decision 2003/467/EEC Estonia is officially leucosis free country. With the adoption on 20 October 2014 of Commission Implementing Decision 2014/732/EU, which is based on the World Animal Health Organisation (OIE) Resolution No 18 of May 2014, Estonia has been recognised as having a negligible BSE risk status.
In April 2013 Estonia declared itself officially free from rabies (OIE official announcements, No. 3, 2013, page 58-61)
Following outbreaks of Newcastle disease in 2007 the authorities took measures to eradicate the disease and the country has been declared free.
The last outbreak of FMD and classical swine fever (CSF) respectively were in 1982 and 1994.
First case of African swine fever of wild boar was confirmed in September 2014 and the first African swine fever in domestic pigs was confirmed in July 2015. Since that there have been numerous cases of ASF in wild boar (decreasing annually) every year, the last outbreak in domestic pigs was in 2017 (3 outbreaks).
Contingency Planning Contingency plans (CPs) for FMD, CSF and AI/ND were approved by Commission Decisions 2004/435/EC, 2004/431/EC and 2004/402/EC respectively. CPs for African Swine Fever, Swine Vesicular Disease, Rinderpest, Peste des Petits Ruminants, Vesicular Stomatitis, Transmissible Spongiform Encephalopathies, Lumpy Skin Disease, Sheep and Goat Pox, African Horse Sickness, Bluetongue, Epizootic haemorrhagic disease of deer and Rift-Valley Fever, Viral haemorrhagic septicaemia and Infectious salmon anaemia, exotic and emerging
24 DG(SANTE) 2019-6840 Version January 2020 fish diseases have been approved by decree of the Director General. CPs are available on the VFB website: https://vet.agri.ee/et/loom-soot/loomataudide-torje/torje-tegevusjuhendid-ja- nende-lisad.
A horizontal (general) plan describes the legal basis, chain of command and actions to be taken in case of suspicion or confirmation of disease. National infectious animal disease control committee established at national level comprises representatives from VFB, VFL, Environmental Board, Police and Border Guard Board and Estonian Rescue Board. In case of the outbreak of especially dangerous infectious animal disease, headquarters is established and it will coordinate eradication measures, members of the headquarters are from VFB.
The CPs include specific provisions on resources. They also specify that staff from the Health Board and the Army will co-operate with the VFB in a crisis situation. Contingency plans are available at CVC level. Sampling equipment to be used by veterinarians investigating a case of suspected epizootic disease is available at CVCs.
Holdings registration, animal identification and movement controls
Data on identified farm animals and the places in which animals are kept are recorded in the register of farm animals (manage by ARIB).
Officials in RD can access the register of farm animals online. Users can generate a list of animals registered to a specified holding. The systems are used to cross-check information, for example when issuing health certificates and on animal disease reports submitted by AVs (TBC checks). The official veterinarians inspect dairy farms once per year and all other farms on the risk-based surveillance (with minimum frequency once in five-year period).
If the identification and registration requirements are not followed, then the procedure for applying financial penalties is initiated.
Bovine: all bovines shall be identified within 20 days from birth and in any case before the animal leaves the holding on which it was born. Bovine animals will be allowed to be identified using two means of the identifications: conventional ear tag and an electronic identifier. Operators may choose the electronic identifier amongst e.g. an electronic ear tag, a ruminal bolus or an injectable transponder.
Sheep and goats: all sheep and goats on a holding shall be identified within six months from birth and in any case before the animal leaves the holding on which it was born. Sheep and goats shall be identified with double identifiers:
1 electronic identifier: a ruminal bolus or an electronic eartag, and 1 visible identifier: a conventional ear tag, tattoo or mark on the pastern)
Pigs: all pigs in the herd must be identified with eartags or tattoos with holding number before leaving the farm on which it was born.
Equidae: are identified with following elements:
25 DG(SANTE) 2019-6840 Version January 2020 a single lifetime identification document (including a narrative and a diagrammatical description)
a method to ensure an unequivocal link between the identification document and the equine animal (transponder, alternative methods like DNA profile and retinal scan)
Laboratories
Central Veterinary and Food Laboratory in Tartu is the National Reference Laboratory (NRL) for foot and mouth disease (FMD), swine vesicular disease (SVD), rabies, classical swine fever (CSF), African swine fever (ASF), Bluetongue, brucellosis and bee health, Transmissible Spongiform Encephalopathies (TSE), avian influenza (AI), Newcastle disease (ND), equine diseases other than African Horse Sickness (AHS) and fish diseases. The NRL has participated with success in ring tests organised by the different EU Reference Laboratories (EU - RLs). The laboratory is equipped to identify subtypes H5 and H7 of the AI virus. The tests are performed according to the OIE standard methods.
AHS, rinderpest (RPV), peste des petits ruminants (PPR),capripox (lumpy skin disease and sheep and goat pox), vesicular stomatitis and epizootic haemorrhagic disease (EHD) diagnostic services are not available in Estonia, there is an agreement between Veterinary and Food Board and Pirbright Institute in the UK and for vesicular stomatitis the reference laboratories are Centro Panamericano de Fiebre Aftosa OPS/OMS in Brazil and National Veterinary Services Laboratories in United States of America.
26 DG(SANTE) 2019-6840 Version January 2020 Control system for food of animal origin
MRA Ministry of Rural Affairs VFB Veterinary and Food Board ME Ministry of the Environment RD Regional Department VFL Veterinary and Food Laboratory ARC Agricultural Research Centre HB Health Board
Competent Authorities
The VFB is the competent authority for food of animal origin.
The functions of the Food Department of the VFB are described in Chapter 1.
The VFB has a formal co-operation and co-ordination agreement with the Environmental Inspectorate to enhance the monitoring of the fisheries sector (fishing vessels, landing points, fish establishments, retail, carriers, etc.).
27 DG(SANTE) 2019-6840 Version January 2020 The VFB has developed a guides for each sector how to plan the risk based official control of establishments including the risk based criteria for setting the frequency of controls. The frequency of official controls in establishments is based on risk assessment. Based on these guides, inspectors of RDs draw up their annual inspection and sampling plans. The main factors taken into account in the preparations of such plans are: the risk level of an establishment; production capacity; the results of previous official controls; relevance and functioning of the self-control system; business start-up; RASFF notifications; and SANTE- HFAA recommendations. The frequency of inspection is based on risk categorisation of the food establishments.
Official controls and inspection at establishments
The RDs carry out, at least once a year, comprehensive inspections in all processing establishments following standard protocols. All inspection reports are inserted in the Official Control Information System.
Red meat and wild game: Ante-mortem (AM) inspection of animals is carried out by the Official Veterinarian (OV) in high-capacity slaughterhouses and in the low-capacity slaughterhouses. Post-mortem (PM) inspection is carried out by OVs In high-capacity slaughterhouses, Official Auxiliaries (OAs) under the supervision of the OV may carry out the PM inspections.
Specialists from the RD visit meat establishments according to the inspection plan
Poultry meat: AM inspection is carried out by OV in high-capacity slaughterhouse and in the low-capacity slaughterhouse. PM inspection is carried out by OV in the low-capacity slaughterhouse. y In the high-capacity slaughterhouse trained slaughterhouse staff working under the supervision of the OV may carry out the PM inspections.Specialists from the RD visit poultry establishments according to inspection plan.
Milk: Specialists from the RD visit milk establishments according to inspection plan.
Fish: Fishery products (FP) establishments are visited according to inspection plan. Supervision of fish and fishery product establishments is similar to that for milk. Factory vessels are inspected once every three years.
Egg packaging centres are inspected by a RD specialist according to inspection plan.
The list of approved establishments and vessels for the sectors listed above is at: https://ec.europa.eu/food/safety/biosafety/food_hygiene/eu_food_establishments_en.
28 DG(SANTE) 2019-6840 Version January 2020 Registration and approval of establishments
The approval procedure of establishments is described in detail in the Decree of the Director General of VFB. Applications for approval of establishments are submitted to the inspector of the RD of the VFB responsible for inspecting the establishment. The inspector is responsible for checking the fulfilment of requirements by the establishment and channelling the application together with his conclusions and last inspection record to the head of the RD. The approval decision is issued by the head of the RD. Upon approval, a unique approval number is given to the establishment. The central register of approved establishments is kept at State Food and Feed Business Operator Register which is available on the VFB website (https://jvis.agri.ee/jvis/avalik.html#/toitKaitlemisettevotedparing).
State Food and Feed Business Operator Register is one part of the Official Control Information System (OCIS). The OCIS contains several information related to the official controls (e.g. list and on-line data of food/FCM and feed business operators/establishments; results of official controls-inspections protocols, approval decisions, establishments- based official control plans and annual reports, sampling data’s). The VFB’s separate sample recording database DSA was closed 01.01.2017. The sample recording database is now one part of OCIS.
Laboratories
The VFB has contracts with three laboratories authorised to undertake analyses concerning official control activities, namely the Agricultural Research Centre (pesticide residues, mycotoxins and other contaminants), the HB laboratories (microbiology, pesticide residues, certain contaminants and additives) and the Veterinary and Food Laboratory (VFL) in Tartu which has three branches (Tallinn, Rakvere and Saaremaa). All laboratories involved in official control of foodstuffs are accredited according to ISO 17025 by the Estonian Accreditation Centre and designated for analysis of samples taken during official controls by the VFB.
The scope of accreditation of the VFL includes histamine analyses, microbiology, and heavy metals analyses of fish and fishery products.
The scope of accreditation of the HB Laboratory includes analyses of polycyclic aromatic hydrocarbons (PAH), non-dioxin-like PCBs (polychlorinated biphenyls), pesticide residues, food additives and microbiological analyses.
The scope of accreditation of the ARC includes analysis of mycotoxins and trace elements.
29 DG(SANTE) 2019-6840 Version January 2020 2.3 Control system for imports of animals and food of animal origin
MRA Ministry of Rural Affairs VFB Veterinary and Food Board VFL Veterinary and Food Laboratory ARC Agricultural Research Centre HB Health Board BCP Border Control Post
Competent Authority
The FSD of the MRA is responsible for the transposition of legislation relating to import controls. The VFB is the competent authority for veterinary checks of live animals and products of animal and non-animal origin in BCPs. AHWD of the VFB at central level has administrative and supervisory responsibilities for the BCPs since 2004.
30 DG(SANTE) 2019-6840 Version January 2020 Requirements for BCPs are transposed in Government Regulation No. 154 of 28 April 2004. Requirements for veterinary checks at BCPs are implemented by Regulation of the Minister of Agriculture No 191 of 22 December 2004. Requirements for veterinary fees are laid down by the Veterinary Activities Organisation Act. Supervision is based on the Veterinary Supervision over Trade, Import and Export of Animals and Animal Products Act, Food Act, Infectious Animal Disease Control Act, Veterinary Activities Organisation Act, Animal Protection Act and other related legal acts.
A general co-operation agreement between the Estonian Tax and Customs Board and the VFB entered into force on 15 December 2005. In addition to the general agreement, guidelines have been agreed between the DGs of the VFB and the Customs Board which include: a general description of import/export terms; legal bases for actions taken during import/export procedures; a description of veterinary checks and subsequent decisions taken in BCPs; instructions on completing CVEDs; descriptions of control stamps; and procedures for dealing with non-compliant cargo and cargo subject to delayed checks or transit, instructions of entering of pet animals into the EU. Officials of the AHWD have access to the electronic databases COMPLEX of the Tax and Customs Board. COMPLEX monitoring is performed regularly by VFB. BCP officials and officials on the central level have also access to the electronic database of the Port of Tallinn and to Estonian Maritime Documents Delivery System.
Training is carried out under an annual training plan established by the AHWD of the VFB. Trainings are carried out for BCP inspectors and also for customs officials.
Planning priorities are based on the previous year’s import figures. Weekly priorities are based on notifications in the TRACES database, RASFF alerts and guidance from the AHWD of the VFB to the BCPs.
Import Controls
Audits of the BCPs must be carried out at least once a year by the officials of AHWD responsible for the internal audits. Checklists are used to carry out these audits. A BCP approval procedure laid down by Government Regulation is in force. A Decree of the Director General of the VFB describes the inspection protocol for buildings and equipment required at the BCPs. In addition to the inspection procedures, there is an auto-control plan for each BCP and inspections are carried out by the head of the BCP. Monthly meetings (if needed) are held between the CCA of VFB and BCP staff to discuss problems and to take appropriate measures where necessary.
A general sampling plan for imported products has been drawn up by FD and distributed to the operating BCPs. Priorities for sampling at BCPs are based on: level of imports of the product in the previous two years; country of origin of the product; and RASFF notifications. There are two separate sampling plans: one for microbiological contamination and parasites and another for residues, heavy metals and contaminants.
The officials of VFB are required to work closely with customs on identification, selection and presentation of consignments for veterinary checks.
31 DG(SANTE) 2019-6840 Version January 2020 Laboratories
The VFB has contracts with three laboratories authorised to undertake analyses concerning official control activities: the ARC (pesticide residues, mycotoxins and other contaminants); the HB laboratories (pesticide residues, certain contaminants and additives); and the VFL (veterinary drug and hormone residues, heavy metals).
32 DG(SANTE) 2019-6840 Version January 2020 2.4 Control system for feedingstuffs and animal nutrition
MRA Ministry of Rural Affairs VFB Veterinary and Food Board ARC Agriculture Research Centre VFL Veterinary and Food Laboratory FBO Food Business Operators AHWD Animal Health and Welfare Department
Competent Authorities
The VFB is responsible for supervision and control of feed business operators including producers, traders, importers, exporters, transporters, storers, primary producers and farms.
The VFB´s central level officials of Animal Health and Welfare Department (AHWD) are responsible for:
drawing up the control programme for feed safety (CPFS);
providing guidance and training to regional officials;
carrying-out internal supervision;
33 DG(SANTE) 2019-6840 Version January 2020 granting approval and ensuring registration;
managing national lists of Feed Business Operators (FBOs),
organising controls on imports of feed of animal and non-animal origin.
Three officials of AHWD at regional level are responsible for implementing the CPFS and carrying out controls. One of them is responsible for supervision in four counties, second official in five and third is responsible for supervision in six counties (15 counties in total).
Registration and approval of FBOs
FBOs registered and/or approved in accordance with Regulation (EC) No 183/2005. In 12.06.2014, the Regulation No 31 established the specified list of the areas of activity and the substances used upon handling in case of which a feed business operator is required to submit a notice of economic activities or hold an activity licence. The approval and registration procedure of FBOs is described in detail in the Decree of the Director General of VFB. For the approval, FBOs must submit an application and supporting documents and data to the VFB. The official AHWD performs an initial evaluation of the application and carries out official control in the site of FBO. If the FBO fulfils the requirements, the AHWD recommends its approval to the general Directors of the VFB. The approval is issued by a decision of the Director General. For registration of an undertaking, a relevant application shall be submitted to the VFB. The official AHWD shall register the data on the undertaking in the State Food and Feed Business Operator Register within three business days as of the receipt of the application. The updated list of approved and registered FBOs is available and publicly accessible via the VFB website by the link to the State Food and Feed Business Operator Register. The Register is one part of the Official Control Information System (OCIS). The OCIS contains information related to the official controls (e.g. list and on-line data of feed and food business operators; results of official controls-inspections protocols, approval decisions; establishments–based official control plans and annual reports, data of sampling protocols and analytical results).
Official controls
The annual control plan for feedingstuffs details the inspections and sampling priorities are defined taking into account: legislation, recommendations from the European Commission, SANTE- HFAA mission reports, national priorities, results of previous years analyses, complaints and RASFF reports. The annual control plan includes a programme of audits on approved FBOs. Regional plans are based on the annual plan. The frequency of control is based on risk categorization of FBOs. FBOs are divided into four risk categories (high, medium, low and very low). The inspection frequency is applied according to the risk assessment. General principles for risk assessment are adopted by the Decrees of the Director General.
The officials of AHWD at regional level are carrying out controls of FBOs and are taking samples from feed, including during import from feed of non-animal origin.
In the farms, officials of RD are carrying out the feed controls (feed ban, requirements for stable and feeding equipment, feed hygiene, feeding) as part of the regular farm control. The controls are carried out in farms with the frequency according to the risk assessment done by the AHWD, but at least once within five years.
34 DG(SANTE) 2019-6840 Version January 2020 Import of feed of non-animal origin
Import controls are the responsibility of the AHWD. Importers must submit an application for import of feedingstuffs and supporting documents 24 hours in advance of arrival for assessment by a specialist at central level, who decides whether physical checks should be carried out on the consignment. Physical checks are performed on all feed imported by companies not on a centrally held list, or on new types of feed imported by companies on the list. The consignments are held under customs control until the test results are known.
Laboratories
The VFB has contracts with two laboratories to undertake analyses concerning official control activities. Analyses are carried out in the following laboratories:
VFL; ARC.
The ARC is the National Reference Laboratory (NRL) for the analysis of heavy metals in feed and feed additives (only amino acids and trace elements in feed additives).
35 DG(SANTE) 2019-6840 Version January 2020 2.5 Control system for TSE, Animal By-Products (ABP) and feed ban
MRA Ministry of Rural Affairs ME Ministry of Environment TSE Transmissible Spongiform Encephalopathies VFB Veterinary and Food Board ABP Animal By-Products VFL Veterinary and Food Laboratory FBO Feed Business operators AHWD Animal Health and Welfare Department PP Primary Production SH Slaughterhouses
TSE
Competent Authorities
The VFB is responsible for implementing the BSE/TSE epidemio-surveillance programme, which forms part of the Infectious Animal Disease Control Programme. It is also responsible for Specified Risk Materials (SRM) controls in high and small capacity slaughterhouses carried out by the official veterinarians. The AHWD is responsible for the development and implementation of the official programme for control of the feed ban, including inspection and sampling.
36 DG(SANTE) 2019-6840 Version January 2020 A breeding programme for the selection for resistance to TSEs was introduced since 2005. Breeders who have joined breeding programmes prepared by breeding societies and approved by the Veterinary and Food Board, have the opportunity to join a part of a breeding programme aimed at the achieving of TSE resistance in ovine animals (TSE programme). The aim is to increase the frequency of the ARR allele within the sheep flock and reduce the prevalence of alleles, being shown to contribute to susceptibility to TSEs. The success of the breeding program is measured by the increase of the frequency of sheep with the ARR / ARR genotype (i.e., at risk group 1). In herds enrolled at the TSE programme, the PrP genotype of the rams used for mating shall be determined before being used for breeding. The need for testing of ewes shall be evaluated in relation to the desired level of TSE resistance.
Epidemio-surveillance
The official veterinarians inspect dairy farms once per year and all other farms on the risk- based surveillance (with minimum frequency once in five-year period). A protocol for these inspections includes checks on compliance with the identification and registration rules. Sanctions may be imposed where violations are found. A quarterly report of the results of inspections is sent by each Region (county based) to the central level.
Specified Risk Materials (SRM)
Estonia as country has a negligible BSE risk status. TSE contingency plan is last amended 11 November 2015 (Decree of the Director General No 198).
Total Feed Ban
There are feed ban controls in the FBOs and farms.
Each year, the programme is prepared by the AHWD at central level and each official of AHWD at regional level is allocated a number of inspection and sampling activities to be performed. The officials of AHWD are required to draw up their own inspection plans based on these figures and the results of their own risk analysis.
In farms, the officials of RD carry out the feed ban controls as part of the regular farm control. The controls are carried out in farms with the frequency according to the risk assessment done yearly by the AHWD, but at least once within five years. The inspection protocols include the species of animals farmed and documentary and physical checks on the source of protein used in feed and risks of cross feeding. Where there is a suspicion of non-compliance with the feed ban, the official may take additional samples as part of the national programme for monitoring and surveillance of animal infectious diseases.
Laboratories
The VFL is the NRL for TSE and animal protein. It is the only laboratory authorised to perform investigations for TSE and analyses of samples for the presence of proteins of animal origin using the Microscopic Analytical Method (MAT) and the PCR method.
37 DG(SANTE) 2019-6840 Version January 2020 ABP
Competent Authorities
The VFB is the competent authority responsible for the supervision and control of ABP premises, farms, slaughterhouses and food industry (including the retail sector) and catering waste transport from means of transport operating internationally.
The Environmental Inspectorate of ME controls the incineration plants and landfill sites in relation to waste.
Co-operation between CAs is based on both formal and informal communications. Co- ordination between VFB and Environmental Inspectorate takes place on a case-by-case basis.
The ABP legislation has been in force since 1 May 2004. Estonia has applied several derogations including the intra-species recycling for fur animals and burial/burning on site in the remote areas (small islands). Authorisation of derogations and conditions and procedures for derogations are adopted by decree of the Director General of VFB.
Fallen animals from farms are collected by vehicles following different routes. The animals are subsequently transported to the Category 1 or Category 2 processing plant. Contracts are in place for farms from which ABP are collected on a regular basis; for other animal holdings or occasional clients, no specific contractual arrangements are in place. ABP from farms over 5000 tons of fallen stocks per year is collected.
ABP from animals slaughtered for own consumption or in slaughterhouses are collected and transported generally by the same scheme.
Category 3 ABP from the retail sector and other food industry is transported usually to the approved composting plants, and from the fish industry also to the Category 3 processing plant which produces fishmeal.
Official Controls
There are ABP controls in the food industries, slaughterhouses, retail sector, farms and ABP premises (including transporters and traders).
In farms, the ABP controls (collection of ABP, identification, arranging the transport and disposal) are carried out as part of the regular farm control by the officials of RD. The controls are carried out in farms with a frequency according to the risk assessment done yearly by the AHWD, but at least once within five years. Also in the case of fallen stocks the farmers are obligated to submit the application for rendering the fallen stock using the ARIB system. The processing plant that has rendered the fallen stock, are obligated to confirm the application for rendering submitted by the farmer (confirmation takes place also in the ARIB system).
The ABP controls in food business operators and slaughterhouses are carried out with a frequency depending on the type of establishment by the officials of RDs.
All ABP plants (rendering plants, composting plants, pet food plants and other plants and operators which must be approved and/or registered according to the Regulation 1069/2009) are controlled by the officials of RD or by the official of AHWD (depending on the type of premises). The minimum frequency to carry out controls is depending on the risk category of
38 DG(SANTE) 2019-6840 Version January 2020 the plant or establishments. All rendering plant are categorised as high-risk plants and the official controls must carried out at least twice a year. In ABP plants and establishments categorised as medium risk premises must be controlled at least once in a year (composting plants, biogas plants, storage plants, plants handling ABP after the collection). In ABP plants, establishments and users with low risk the official control must carried out at least once in a three years (technical plants, specific users, transporters, traders, retailers and others).
In rendering plants, composting plants, biogas plants, plants producing organic fertilisers or soil improvers or pet food or feed material (like fishmeal), the official sampling are organised and carried out during the regular official controls (usually once in a year). The sampling is for analysing of glyceroltriheptanate - GTH (meat-and-bone meal of category I and II) or Salmonella spp (compost, petfood, feed material, organic fertilisers, soil improvers, biogas residues).
Risk assessment, minimum frequencies for official controls, check-lists, guidelines, sampling plan and forms and procedures to report the results of official controls carried out during the reporting period are adopted by decree of VFB.
Approval of ABP plants and other premises
The procedure for the registration or approval of plants that use or process ABP is adopted by decree of the Director General of VFB.
For the approval, establishments must submit an application to the VFB. The supporting documents and data (like technological scheme, cleaning procedures, pest control system and other) must be added to the application for approval.
In case of approval, the official of RD or AHWD (depending on the type of ABP plant) performs an initial evaluation of the application and carries out official control in the site of establishment. If the establishment fulfils the requirements, the RD or the AHWD recommends its approval to the General Director of the VFB. The approval is issued by decision of the Director General.
In the case of registration (transporters, traders, technical plants and other), the official of RD performs an initial evaluation of the application and RD confirms the registration by official letter.
The updated list of plants, operators and users approved or registered according to the ABP Regulation is available on the website of VFB (linked to the Commission website).
Laboratories
The samples taken from the ABP production are analysed in VFL.
39 DG(SANTE) 2019-6840 Version January 2020 2.6 Control system for veterinary medicines and residues
NRCP Control
MRA Ministry of Rural Affairs MSA Ministry of Social Affairs ESAM Estonian State Agency for Medicines NRCP National Residue Control Plan VFB Veterinary and Food Board AHWD Animal Health and Welfare Department VMP Veterinary Medicinal Products VFL Veterinary and Food Laboratory ARC Agricultural Research Centre HB Health Board EBRSD Environmental Board, Radiation safety Department RD Regional Department
Residues
Competent Authorities
The State Agency of Medicines (ESAM) is a governmental agency of the Ministry of Social Affairs (MSA) responsible for: the marketing authorisation, quality control, import, export and distribution of Veterinary Medicinal Products (VMP).
40 DG(SANTE) 2019-6840 Version January 2020 The VFB is responsible for approval of producers of medicated feed; and supervision and controls on the use of VMP and medicated feed at farms and at approved feed establishments producing medicated feed. Officials of ESAM supervise all other aspects of the distribution of VMP. The VFB has responsibility for preparing the National Residue Control Plan (NRCP) in consultation with AM, relevant laboratories and AHWD. In the sample-planning phase, data from previous analyses, inspection results and production figures are taken into account. The FD of VFB issues the sampling plan for residues control to the RDs annually.
Official Controls on Residues
Supervision and controls on the use of VMP at farms and approved feed establishments producing medicated feed, is supervised by the RDs and AHWD. The RDs are responsible for the practical implementation of the NRCP. Samples are taken at farms, processing establishments and slaughterhouses by VFB inspectors. Sampling is planned to ensure an even distribution of samples throughout the year. Written instructions on sampling methods and targeting of sampling are issued to the RD by the FD of VFB. The samples taken by the RD are sent directly to the relevant laboratory. The laboratory and the RD notify the FD and AHWD of VFB immediately where non-compliant results are found.
Laboratories
The VFB has a contract for the performance of NRCP sample analyses with four different laboratories reporting to three different ministries, administratively and financially independent from the VFB.
VFL (Kreutzwaldi 30, Tartu) carries out analyses and is the National Reference Laboratory (NRL) for contaminants B3c in animal origin foodstuffs and veterinary residue analysis. The VFL is the NRL for the residue analysis A1, A2, A3, A4, A5, A6, B1, B2a, B2b, B2d, B2e, B2f and for B3e.
The VFL has drawn up an action plan for the full validation of existing and new methods in accordance with Commission Decision 2002/657/EC. The objective is to achieve flexible accreditation where reasonable and ensure that only validated methods according to Commission Decision 2002/657/EC are used for NRCP analysis. Existing accredited methods according to 2002/657/EC are available on the following website (Estonian Accreditation Centre): http://www.eak.ee/dokumendid/pdf/kasitlusala/L005_1.pdf.
The Laboratory for Residues and Contaminants of the Agricultural Research Centre is the NRL for analysis of B3d. Tartu Laboratory and Central Laboratory of the Health Board (HB) in Tallinn carry out analyses for B2c, B3a, B3b, B3d, and B3f (PAH). Tartu Laboratory of HB is the NRL (B2c, B3a, B3b) for pesticide residues in food of animal origin, Polychlorinated biphenyls (NDL-PCBs) and PAH. The Radiation Protection Centre Laboratory in Tallinn, which reports to the Ministry of the Environment, carries out analyses for B3f (radionuclides).
In addition to the four laboratories, a number of foreign laboratories perform analyses of NRCP samples on a contract basis for the VFL.
41 DG(SANTE) 2019-6840 Version January 2020 Authorisation of Veterinary Medicinal Products and Medicated Feed
Competent Authorities
ESAM is the CA for the supervision of manufacturing, marketing authorisation, quality control and market surveillance of veterinary medicinal products (VMP). Medicated feed may only be manufactured from medicated pre-mixes authorised as VMPs by ESAM. ESAM supervises manufacturing, import, export and distribution of medicines.
The VFB is responsible for approval of medicated feed producers and intermediaries and for the control of the use of medicated feed from feed mills authorised to produce medicated feed.
The VFB is responsible for the control of the use of VMPs by veterinarians and farmers.
Authorisation of VMP
ESAM is the competent authority responsible for authorisation of VMPs.
The legal basis for authorisation and supervision of marketing is the Medicinal Product Act and relevant regulations of the MSA.
Assessment of the marketing authorisation documentation submitted by the applicant is performed either by ESAM itself or in co-operation with other member states depending of the type of the marketing authorisation application (national-, de-centralised- or mutual recognition procedure). The final assessment is presented to the marketing authorisation committee for VMP for its opinion. Marketing authorisations in respect of VMP are issued and renewed by the State Agency of Medicines. The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications. Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein. The VMP granted marketing authorisation is entered into the register of VMPs. The register is available on the ESAM website and updated every month. Information concerning authorized and/or renewed VMP is also published on ESAM website.
Official Controls on Marketing and Use
VMP are available through a network of veterinary wholesalers and veterinary pharmacies which are authorized for their respective activities by ESAM. ESAM supervises the distribution chain of VMP through inspection every 2-3 years. Good distribution practice is implemented. Sanctions may be imposed by ESAM under the Medicinal Products Act.
The AHWD of VFB has issued instructions, including standardised procedures and protocols, to the RDs on the controls to be carried out on farms and private veterinary practitioners (PVPs)
PVPs are subject to controls by RD staff according to the risk-based annual control plan issued by the AHWD. Farmers may purchase VMP, classified as ‘prescription-only’, from a pharmacy by a written prescription, or directly from their veterinarian.
42 DG(SANTE) 2019-6840 Version January 2020 2.7 Control system for general food hygiene
MRA Ministry of Rural Affairs VFB Veterinary and Food Board RD Regional Department VFL Veterinary and Food Laboratory ARC Agricultural Research Centre HB Health Board
General Food Hygiene
Competent Authorities
The VFB of the Ministry of Rural Affairs has primary responsibility.
The Food Department is responsible for:
co-ordinating and planning of supervision of primary production, wholesale, retail (including catering) and the processing food of non-animal origin (including composite products), FCM;
43 DG(SANTE) 2019-6840 Version January 2020 co-ordinating of approval/registration of establishments of primary production, processing food of non-animal origin (including composite products), wholesale establishments, retail (including catering), FCM establishments and; co-ordinating and planning of supervision of novel foods and foods containing GMO, food contact materials, food supplements, food intended for particular nutritional uses, presentation of food information to consumers. The HB Environmental Health Department is responsible for official recognition of natural mineral water and surveillance of natural mineral water, drinking water and spring water. VFB is responsible for bottled water once it leaves the production site. The four Regional Department are responsible for planning, co-ordinating of state control and responsible for the inspection of waterworks and water producers.
Official controls of food premises
The Food Act contains the main legislation in this area. Powers granted to the inspectors of VFB are also set out in the Food Act.
The VFB inspection and sampling priorities are defined taking into account the legislation in place; recommendations from the European Commission; SANTE-HFAA mission reports; national priorities; production capacity; results of previous years’ analyses, proposals from regional services; complaints and applications; random checks; RASFF reports; and the results of internal audit.
The VFB annual plan is approved by Decree of the Director General. Regional plans are based on the annual plan. The frequency of VFB inspection is based on risk categorization of the food establishments. The minimum frequency of inspection is established in the annual inspection plan.
All food and FCM establishments are divided into four risk categories (high, medium, low and very low). The inspection frequency is applied according to the risk assessment. General principles for risk assessment are adopted by the decrees of the Director General.
Guidelines for the implementation of annual plans are prepared and issued as a Decree of the Director General of VFB.
Licensing and Registration of food premises
Approval and registration of establishments of primary production, processing food of non- animal origin (including composite products), retail, catering, FCM and storage (including wholesale) establishments is the responsibility of RDs.
The system for licensing and registration is described in part 2.2.
44 DG(SANTE) 2019-6840 Version January 2020 Rapid Alert System for Food and Feed (RASFF)
The FD of the VFB is the national contact point for food and feed for the EU RASFF system. It also acts as the co-ordination point for the official control services of the VFB, the HB, the CPTRA and Customs. Incoming RASFF notifications system are reviewed by the contact person and following an initial risk assessment, circulated to the relevant services. A manual of procedures on handling food alerts has been circulated to all relevant CA. The National Contact Point (NCP) decides whether the alert should be notified to the Commission. The NCP ensures the immediate transmission of information provided by competent authorities through the RASFF upstream to the Commission's contact point and, based on its content, of information transmitted by the European Commission downstream to the appropriate competent authorities. Manuals and instructions are issued by NCP: General guideline for competent authorities for handling of food and feed notifications; RASFF instruction for the RDs and BCPs. There are also contact persons in the county offices of RDs in order to ensure smooth and rapid transmission of up- and downstream information.
Laboratories
The VFB has contracts with 3 laboratories authorised to undertake analysis for official control activities, namely: the ARC (pesticide residues, mycotoxins and other contaminants); the VFL in Tartu which has 3 regional laboratories in Tallinn, Rakvere and Saaremaa; and the HB laboratories.
The HB has 3 laboratories authorised to perform official analysis; namely, Tallinn Central Laboratory (consisting of the laboratory of chemistry, the laboratory of communicable diseases, the laboratory of physics); Tartu Laboratory; Kohtla-Järve Laboratory.
All laboratories involved in official control of foodstuffs are accredited according to ISO 17025 by the Estonian Accreditation Centre.
Laboratory analyses for GMO are carried out at Eurofins in Germany.
45 DG(SANTE) 2019-6840 Version January 2020 2.8 Control system for imports of food of plant origin
MRA Ministry of Rural Affairs VFB Veterinary and Food Board ARC Agricultural Research Centre HB Health Board VFL Veterinary and Food Laboratory RD Regional Department DPEs Designated Points of Entry DPIs Designated Points of Import
Competent Authorities
The Food Safety Department of the MRA is CA for the transposition of legislation relating to import controls. The CA for checks and sampling of products of non-animal origin at the DPEs and DPIs and at the point of destination is the VFB.
The FD of the VFB at central level has administrative and supervisory responsibility for the DPEs (Designated Points of Entry) and DPIs (Designated Points of Import). Supervision and sampling is based on the Food Act and other linked legal acts. Requirements for DPEs, DPIs and official controls are set out in Government and MRA Regulations and EU legal acts.
46 DG(SANTE) 2019-6840 Version January 2020 Import Controls
Information on goods listed in relevant Commission Regulations and Decisions and sampling frequencies is available from the VFB website, accessible to all staff and to the stakeholders.
The Estonian Master Tariff System (EMTS) automatically flags relevant products. Customs perform documentary checks and, using an electronic database, notify the VFB of consignments to be inspected. The inspection covers documentary, random identity and physical checks including sampling. Inspection and sampling for commodities listed in relevant Commission Regulations and Decisions are performed by the VFB either at the DPE, DPI or in some cases at the customs warehouses.
In cases where the identity and physical checks are carried out, the samples are collected and sent to the relevant laboratory (ARC, HB, VFL) for analysis. Sampled consignments may not be released into free circulation until the favourable results are received and a document (common entry document, official decision by the VFB) allowing Customs clearance is issued by the VFB.
The DPEs defined pursuant to Regulation (EC) No 2019/1793 on the increased level of official controls on imports of certain feed and food of non-animal origin are: Luhamaa BCP, Muuga BCP, Narva BCP, Paldiski BCP. The DPIs defined pursuant to the relevant Commission Regulations are: Luhamaa BCP, Muuga BCP, Narva BCP and Paldiski BCP.
Import procedures are detailed in the Guidelines for Inspecting Certain Foodstuffs of Non Animal Origin at Import. These guidelines apply to the VFB and Customs. The guidelines are updated regularly.
Laboratories Official control analyses for food hygiene are carried out in the central and regional laboratories of the VFL, ARC and of the HB. The VFB is the CA for designating official control laboratories. The decision designating each official control laboratory describes the scope of parameters to be determined by methods of analyses or food groups. The VFB has the right to withdraw the designation if the laboratory fails to perform in line with the requirements of Regulation (EU) 2017/625.
The VFB has contracts with three laboratories authorised to undertake analyses concerning official control activities: namely the ARC (pesticide residues, mycotoxins and other contaminants); the HB (pesticide residues, certain contaminants and additives); and the bulk of sampling with the VFL in Tartu which has 2 regional laboratories (Tallinn and Saaremaa). All laboratories involved in official control of foodstuffs are accredited according to ISO 17025 by the Estonian Accreditation Centre and designated for analysis of samples taken during official controls by the MRA.
The HB has 3 laboratories authorised to perform official control analysis: Tallinn Central Laboratory; Tartu Laboratory; and Kohtla-Järve Laboratory.
47 DG(SANTE) 2019-6840 Version January 2020 2.9 Control system for plant protection products (PPP) and residues
MRA Ministry of Rural Affairs (Plant Health Department) ARC Agricultural Research Centre AB Agricultural Board VFB Veterinary and Food Board PPP Plant Protection Products
Plant Protection Products (PPP)
Competent Authorities
The AB is the CA for the authorisation and controls on marketing and use of plant protection products. The AB Plant Protection and Fertilisers Department (PPD) is responsible for: authorisation of PPPs; post-Annex I re-registration of PPPs; assessment of active substances for inclusion in the Annex of Commission Implementing Regulation (EU) No 540/2011, as Member State rapporteur; organising the control on marketing and use of PPPs, including
48 DG(SANTE) 2019-6840 Version January 2020
Planning, Co-ordination, ARC & Guidance, Supervision Tartu Laboratory of Health Board
Samples results Samples results
Veterinary and Food Board AB Regional Centres Food Department (RC)
Inspection Pesticide residue control plan, Supervision National Monitoring Sampling Summary Report on Pesticide Residues in Food planning activities; registration of importers and suppliers (including storing and marketing facilities) of PPP and importers and users of very toxic PPPs; control of plant protection equipment and authorisation of persons conducting the technical inspections of sprayers; training of inspectors; preparing inspection manuals, inspection protocol forms and providing technical advice on conducting inspections; monitoring the work of counties officials and evaluating the quality of inspections; analysis of inspection results; co-ordinating and control of the issuing of plant protection certificates; and planning measures for improvement of the PPP control system.
The legal basis for authorisation and controls on the marketing and use of PPP is Regulation (EC) No 1107/2009 of the European Parliament and the Council of 21 October 2009 concerning the placing of PPPs on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and delegated and implementing acts. National requirements are set by the Plant Protection Act and implementing acts.
Where non-compliance is identified, the AB official may issue a written notice on enforcement of measures or, in case the marketing or use of un-authorised PPP is identified, initiate infringement procedures.
Authorisation of PPP
The PPD of AB evaluates the documentation submitted by companies for authorisation, makes the decision and on where acceptable enters the PPP into the register. Applications are processed in accordance with the requirements of Regulation (EC) No 1107/2009 of the European Parliament and the Council. A list of authorised PPP is up-dated on an annual basis and published on the AB website (http://www.pma.agri.ee).
The annual control plan for marketing and use of PPPs includes sampling from plant production at primary level and inspections of plant protection equipment. All marketing places of PPPs as well as approximately 10% of farms using PPPs, are inspected annually. There are no national manufacturers of PPP. Majority of PPPs can be sold and used by professionals only. A user shall have an attestation issued by the AB confirming they have passed regular training. Very toxic PPPSs may not be marketed at retail. Fourteen companies are registered as specialised in the use of very toxic PPPs.
Official controls on marketing/use
Controls on marketing and use of PPPs and controls of plant protection equipment are carried out by AB officials in the counties. Samples are taken by inspectors of the AB according to the annual control plan and in case of suspicion of misuse or use of illegal products. Inspections at market places take place without prior notice. In some cases, such as for reasons of access to small farms, minimal notice is given, normally on the same day. If problems are identified, co-ordinated action may be taken with other authorities involved in PPP residue control (VFB). Samples are analysed in the Laboratory for Residues and Contaminants (LRC) of the ARC.
49 DG(SANTE) 2019-6840 Version January 2020 Obsolete PPP
The CA for detection, supervision and disposal of obsolete PPP is the ME. Obsolete PPP are considered as hazardous waste within the meaning of the Directive of the European Parliament and the Council No 2008/98/EC on waste.
By the end of 2013, 18.299 tonnes of obsolete pesticides were left in stock.
In 2014, 36.877 tonnes of obsolete pesticides were collected and in total 46.479 tonnes were reused for energy production (in Kunda Cement Factory for production of derived fuel). By the end of 2014, 8.227 tons were stored.
In 2015, 21.148 tonnes of obsolete pesticides were collected and 13.325 tonnes were also reused for energy purposes. 16.019 tons of obsolete pesticides were left in stock.
Laboratories
The LRC of the ARC is responsible for formulation analysis.
Residues
Competent authorities
The VFB is the CA for surveillance controls on pesticide residues in foodstuffs of plant origin, including baby-food. The VFB is responsible for sampling at industrial production, storage (including wholesale) and retail level. The VFB compiles the annual surveillance plan for pesticide residues monitoring. The analytical results of samples taken by AB to check for compliance of using PPPs at primary production level (and contains the most cultivated crops) are also included in the monitoring results.
Commission Directive 2002/63/EC on sampling for pesticide residue analysis was transposed by Regulation of the Minister of Agriculture No. 99 of 11 November 2014. Regulation (EU) No 609/2013 of the European Parliament and of the Council (amended by Commission Delegated Regulation (EU) 2017/1091) on food for infants and young children, food for special medical purposes, and total diet replacement for weight control have been transposed by Regulation of Minister of Rural Affairs No. 43 of 11 July 2016. Staff involved in control of pesticide residues in foodstuffs of plant origin receives training as required. A guide for inspectors contains directions for taking samples (based on Commission Directive 2002/63/EC) and for evaluating analytical results (based on guidance document method validation and quality control procedures for pesticide residues analysis in food and feed - Document No SANTE 11945/2015)
An integrated plan for surveillance and monitoring is in place for each county. The list of commodities, the number of samples to be taken, the residues analysed and the sampling period are specified in the plan. The plan is based on: Commission Regulations, the results of the previous year’s sampling activities, the consumption and RASFF notifications.
Competence of the AB
50 DG(SANTE) 2019-6840 Version January 2020 The analyses’ results of the samples taken by the AB are taken into account by the VFB. A more detailed procedure is regulated by the co-operation agreement between AB and VFB.
Official controls on residues in food
Officials of RD of VFB carry out sampling for residues of foodstuffs of plant origin in the context of food control activity and as laid down in the surveillance plan. Samples are taken from domestic and non-domestic (Third countries and internal market) commodities of plant and animal origin at primary production, industrial production, storage (including wholesale) and retail level and baby-food/ poultry/liver at production, wholesale and retail level.
VFB samples are analysed in the LRC of the ARC and the HB Tartu Laboratory.
AB samples are analysed in the LRC of the ARC.
Based on co-operation agreement the results of analyses from samples taken by the AB officials at primary production level are taken into account.
Estonia has participated in the EU co-ordinated multiannual Community control programme of pesticide residues in and on foodstuffs of plant origin since 2005.
Laboratories
The following laboratories carry out the analysis for pesticide residues in foodstuffs of plant origin:
1. The LRC of the ARC in Saku which is NRL for pesticide residues in cereals, fruit and vegetables and feed. 2. Central laboratory of the HB and Tartu Laboratory of the HB.
The LRC of the ARC is accredited by the Estonian Accreditation Centre according to the EVS-EN ISO/IEC 17025.
The laboratory has participated in a number of proficiency tests - for pesticide residue analysis organized by FAPAS and EURLs with good results.
The laboratories of the HB are accredited by the Estonian Accreditation Centre according to the EVS-EN ISO/IEC 17025.
Tartu laboratory of the HB is the NRL for pesticide residues in food of animal origin and single residue methods.
The laboratory annually participates in proficiency tests for pesticide residue analysis organized by EU-RLs.
Both laboratory staff training consists of: courses organised by equipment suppliers; participating in international workshops on pesticide residues; and training at EU-RLs.
51 DG(SANTE) 2019-6840 Version January 2020 2.10 Control system for animal welfare
MRA Ministry of Rural Affairs AHWD Animal Health and Welfare Department RD Regional Department VFB Veterinary and Food Board
Competent authority
The VFB is the competent authority for animal welfare.
The VFB's central level the Animal Health and Welfare Department (AHWD) is responsible for co-ordination guidance and instruction. The Police and Border Guard Board (PBGB) is responsible for criminal cases and transport checks. The Environmental Inspectorate of the ME is responsible for the welfare of zoo, wild, and pet animals, and CITES matters.
The AHWD
co-ordinates the activities of the supervisory officials dealing with animal welfare; drafts decrees, guidelines, protocols and forms for carrying out inspections;
arranges training for the supervisory officials; transporters, farmers, and police officials;
communicates and co-operates with other bodies such as the Society for the Protection of Animals and the Estonian Academic Society for Animal Welfare;
52 DG(SANTE) 2019-6840 Version January 2020 liaises with CAs of other countries and international organisations dealing with animal welfare matters;
co-operates with the Ministry of Environment.
The ARIB is responsible for the registration of laying hen farms (under Directive 2002/4/EC).
Supervision in the field of animal welfare is based on the Animal Protection Act regulating the protection of animals, the Veterinary Activities Organisation Act, and the Infectious Animal Disease Control Act and related implementing acts.
The VFB has a written co-operation agreement with the Police and Border Guard Board (PBGB) and the Environmental Inspectorate (19 February 2008). An annual meeting between the PBGB, the Environmental Inspectorate and the VFB has been formalised.
The Animal Protection Act (APA), applicable since 1 July 2001, lays down sanctions for animal welfare violations. Sanctions or penalties imposed at administrative or judicial level for breaches of law vary depending on whether the breach is committed by an individual or a legal entity.
Official Controls
Controls of animal welfare tasks at farm level are carried out by RD officials of animal health on a risk basis and with appropriate frequency, but at least once every five years. The RD official of animal health also carry out regular controls on vehicles for transporting livestock’s and tasks of animal welfares in slaughterhouses.
In each RD there is one official of animal welfare, who carries out at least once a year additional animal welfare controls in slaughterhouses. Those officials also deal with complaints regarding animal welfare (including pet animals), approval and registration of transporters, and carries out the controls of animal welfare of laboratory animals.
Leading specialists of RDs are responsible of coordinating animal welfare activities on RD level.
A report on the results of the controls carried out by the officials of RD to meet their target is sent twice a year to AHWD
53 DG(SANTE) 2019-6840 Version January 2020 2.11 Control system for plant health
AB Agricultural Board (Plant Health and Horticulture Department) ARC Agricultural Research Centre
Competent Authorities
The Plant Health and Horticulture Department (PHD) of the AB is responsible for implementing legislation and official controls in the plant health sector, including:
- planning and co-ordinating of official controls and surveys of harmful organisms;
54 DG(SANTE) 2019-6840 Version January 2020 - control on imports and exports of plants, plant products and other objects subject to plant health control; - maintaining a register of producers, importers and exporters (plant health register); - certification of seed potato, - control on production and marketing of plant propagating material; - issuing plant passports and authorisation of producers to issue plant passports; - approval and official control of wood processing enterprises; - co-ordinating of control activities with the Tax and Customs Board and the Environmental Board and Environmental Research Agency. The VFB is responsible for control of the movement of bees.
The PHD of the AB is also responsible for: preparing inspection manuals and protocols; providing technical advice on conducting inspections; planning and organising the training of officials; performing internal controls and evaluating the quality of inspections; planning measures to improve the plant health control system; analysing inspection results; and reporting to the Commission. All inspection reports are entered into the electronic system for review by the CCA.
The EB is responsible for carrying out quality control and certification of forest plant propagating material under the Law on Plant Propagating Material and Variety Protection and related Ministerial legislation, as well as control on forestry pests and reporting their findings to the PHD of AB. Orders for co-operation, as well as formats for reporting, are set up by the formal contract (22 September 2009, last amended 14.07.2016).
The EA is involved in conducting of surveys of forestry pests, as well as reporting findings of harmful organisms to the PHD of AB. An order for co-operation, as well as formats for reporting are set up by the formal contract (21 June 2010, last amended 25.11.2016).
Sawmills and surrounding areas are under the control of the AB.
The EI may be requested to accompany emergency and eradication measures in forests.
The Plant Protection Act confers powers of the officials to conduct the official controls and take quarantine measures and to verify compliance with legal requirements.
The PHD of the AB is responsible for planning of official controls and surveys. For each survey an annual plan is prepared, detailing the number of inspections to be carried out and the relevant area to be covered, based on risk assessment, data in the official plant health register, analyses of previous inspection results and proposals sent by the officials of counties. It takes into account the approx. number of samples that may be analysed by the ARC, which is agreed annually.
The PHD collects data on inspection results and the plant health situation received from the counties, including outbreaks. The results are regularly analysed, if needed, the corrective measures are taken. The data are also used to plan and amend sampling and inspection activities, if needed.
55 DG(SANTE) 2019-6840 Version January 2020 The AB has co-operation agreements with EB and EA; the results are withdrawn and joint activities are reviewed annually. Based on these contracts, inspections of nurseries producing forestry plant material for plant passport purposes are carried out by the EB, and, and, if necessary, together with AB inspectors at regional level. The EA has a formal agreement with the EB.
The PHD is compiling the situation plans and organising simultaneous exercises accompanied with other parties involved, including in the area of forestry.
Plant passport system and internal market checks
The system for plant passports has been operational since April 2002. Regulation No 96 of the Minister of Agriculture of 24.05.2004 contains a list of plants, plant products and other material that must be subject to a plant health inspection at the place of production. All seed potato producers and most of commercial ware potato producers are registered in Plant Health Register. Registered premises that deal with plants which require a plant passport must be inspected at least once a year by the AB. Registered ware potato producers must be inspected once every three years. Plant passports, except for seed potatoes, may be issued by registered growers, if authorised, or by the AB. Plant passports for seed potatoes are issued by the Plant Health Department of the AB. The plant health register is available at http://www.pma.agri.ee.
The PHD of the AB organises meetings with representatives of the sector; issues press releases, provides leaflets to inform stakeholders and public of plant health issues and requirements; and publishes relevant information on the AB website.
Marketing of plant propagating material and certification schemes is regulated by the Law on Propagating of Plants and Variety Protection and related Regulations of the Minister of Agriculture. Inspection guidelines are in place for: seed potatoes; propagating material produced in greenhouses (ornamental plants and vegetable plants); and propagating material produced on open land (fruit trees, ornamental trees). A certification scheme for forest plants has been established by a Regulation of the Minister of Environment. Certification schemes include inspections for some quarantine organisms. For plants covered by Regulation of the Minister of Agriculture No. 96, the additional data required for marketing of plant propagating material, may be included on the plant passport.
The AB is seeking to improve awareness amongst producers on harmful organisms, including ring rot, by means of web-site information, technical magazines and national and local newspapers.
Nurseries dealing with forestry planting material (84) come under the control of the EB. The AB provides the forestry officials with: a manual of instructions; a check list; a standard inspection report form; and guidelines on how to perform inspections. The inspection results are described by EB specialists in AB plant health electronic system. The AB must be immediately notified of the detection or suspicion of quarantine organisms. The PHD of the AB is responsible for applying the relevant official measures. The EB and EA take part in survey for forestry pests, and, if necessary, for imposing control measures.
The phytosanitary certificates are issued by the officials in counties. From BCPs consignments may be certified for export at the Muuga BCP (for consignments stored at the Port). Timber is usually certified at ports before loading.
56 DG(SANTE) 2019-6840 Version January 2020 Establishments (other than those producing seed potatoes) may apply to the PHD for authorisation to issue plant passports. A number of conditions must be met for authorisation, including: registration in the Plant Health Register for at least one year; good previous history; no records of infringements or findings of HOs; and a favourable result of the general assessment of the establishment. A fee is payable for the authorisation. Authorisation is valid for an indefinite period, subject to compliance with the obligations for registered establishments. In case of finding of HO or violations, the approval can be stopped or cancelled.
Contingency planning
(Overall) contingency plan on implementation of eradication measures in case of outbreak of HO (approved by the Director General of the AB on 16.09.2010)
Specific contingency plans
- Contingency plan on Bursaphelencus xylophilus (approved by the Director General of the AB on 17.09.2010) - Contingency plan on Erwinia amylovora (approved by the Director General of the AB on 07.09.2016) - Contingency plan on Xylella fastidiosa (approved by the Director General of the AB on 07.09.2016) - Contingency plan on Anoplophora glabripennis (draft) (both table exercise in 2016 and simulation exercise 2018 have been conducted, the contingency plan is amended; to approve the plan, the amendments to the Law are required
In 2016 a contingency plan on Anoplophora glabripennis was drafted. In November, 2016 the table exercise was conducted. As a follow-up, the contingency plan will be amended, precise guidelines for actions will be drawn and pre-agreements with parties involved will be prepared to react successfully in case of outbreak.
Import Controls
There are 16 designated plant health BCPs., while 3 of those are opened permanently. Collaboration between Customs and the AB is based on provisions in Regulation No. 112 of the MRA of 10 July 2007 and the official co-operation agreement between the authorities. Required checks are carried out at the border. Consignments declared to contain regulated articles must be inspected and approved for entry by the plant health service before it may be cleared by Customs. Special phytosanitary conditions for import of regulated articles are inserted in the Customs information system EMTS. AB inspectors at the borders carry out documentary, identity and physical checks on all consignments. This includes a check to confirm that the importer is registered in the official plant health register and that the phytosanitary certificate complies with all the relevant requirements. Under prescribed conditions the physical inspection can still be conducted at the place of destination under Customs control, if designated (according to the Plant Protection Act). In such cases the BCP plant health official notifies the local inspector of the appropriate region using the messaging facility in the AB database, who then carries out the physical check. Customs officers are not authorised to release consignment until all plant health checks are completed. When samples are taken, the consignment is not Customs cleared until the results of analyses have been received.
57 DG(SANTE) 2019-6840 Version January 2020 Importers must provide 24 hour advance notification. The notification may be provided in written format. The inspection of Wood Packaging Material (WPM) is carried out in co-operation with Customs and the plant health officials at the BCP or inland. Monitoring and sampling is carried out by plant health officials in and around warehouses, dispatching centres and BCPs.
List of Plant health BCPs:
Koidula railway; Luhamaa (road); Muuga (port); Narva 1 (road) and Narva railway; Paldiski 2 (Paldiski South port); Paldiski 1 (Paldiski North port); Pärnu 2 (port); Kunda (port), Sillamäe (port); Tallinn 5 (Paljassaare port), Tallinn 2 (Meeruse port), Tallinn 3 (Bekkeri port), Tallinn 1 (airport), Loksa (port), Tallinn Central Mail Office.
Plant Health Surveys
Information about surveys carried out by the PHD of the AB and their results is available at: http://www.pma.agri.ee/index.php?id=102
Laboratories
The ARC is responsible for providing laboratory services, including identification of pests, to the PHD of the AB and, on a commercial basis, also to private clients and research. The laboratory of plant health and microbiology is accredited according to ISO 17025. The ARC is the National Reference Laboratory (NRL) for plant health. The ARC has had access to the AB plant information system since July 2003. Data from laboratory analyses are automatically inserted into the plant health information system and are available to both PHD and the inspectors. In addition, hard copies of the results are sent to the PHD of the AB.
58 DG(SANTE) 2019-6840 Version January 2020 2.12 Control system for quality labelling
Organic farming
AB Agriculture Board (Organic and Seed Farming Department) FVB Veterinary and Food Board HB Health Board ARC Agriculture Research Centre
The basic rules for organic farming are regulated by the Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 and Commission
59 DG(SANTE) 2019-6840 Version January 2020 Regulation (EC) no 889/2008. At national level organic farming is regulated by the Organic Farming act and implementing acts.
Pursuant to the law, the official control on organic plant and animal production is performed by the AB; over a person who is involved in preparing, marketing (including import) by the VFB. Control over compliance with the requirements as established in the law for the presentation of information is carried out by the Consumer Protection and Technical Regulatory Authority (CPTRA).
According to the Organic Farming Act a company that wishes to engage in organic handling must have approval and its data must be entered into the organic farming register. The chief processor of the register is the Ministry of Rural Affairs and the authorised processors are AB and VFB.
Competent Authorities
AB
The main tasks of the Organic Farming and Seed Department (OSD) of the AB is to implement the legislation and organise official controls on organic plant production, animal husbandry, beekeeping, mushroom growing, greenhouse production, production and sale of organic seeds and propagating materials and aquaculture production.
The OSD of the AB is also responsible for: drafting and updating of inspection manuals, training of inspectors, assessment of risks, planning and co-ordination of controls, assessment of performance of inspections and analysing results, reporting to the Commission and keeping of the Organic Farming Register.
Official controls
26 inspectors in 4 Regions of AB carry out inspections at farm level. Registered producers are inspected at least once a year. All inspection reports are entered into the electronic system for review by OSD.
In case a violation of requirements is identified, a precept can be issued, or a fine imposed, as well as a requirement to start a new conversion period may be enforced or a decision to revoke approval can be taken.
Organic farmers have to pay state fees for inspections. Every year the conformation document is issued to the operator listing the range of their products identified as organic. Information about issued documents is published at the AB website (http://www.pma.agri.ee).
Laboratories
Samples are taken by AB inspectors according to annual control plan and in case of suspicion of violation. Samples are analysed in the Laboratory for Residues and Contaminants (LRC) of the ARC. The LRC of the ARC is accredited by the Estonian Accreditation Centre according to the EN ISO/IEC 17025:2005. Hard copies of the results are sent to AB.
60 DG(SANTE) 2019-6840 Version January 2020 VFB
The Fisheries and Market Regulation Department of VFB is responsible for:
co-ordinating supervision of wholesale, retail (including catering), processing of organic food and importing of organic food co-ordinating supervision of wholesale, retail and the processing of organic feed; co-ordinating of approval/registration of establishments processing, wholesale and retail (including catering) of organically farmed products.
Approval and registration of establishments of processing or marketing organic food and feed, is the responsibility of regional departments.
Official controls of food and feed premises
Guidelines for the implementation of annual plans for controlling establishments processing, wholesale and retail (including catering) of organically farmed products are prepared and issued as a Decree of the Director General of VFB.
61 DG(SANTE) 2019-6840 Version January 2020 PDO (protected designation of origin), PGI (protected geographical indication) and TSG (traditional speciality guaranteed) products
MRA, Agricultural Policy Department
Policy Co-ordination Guidance, Legislation
VFB, Fisheries and results Laboratories Market VFB External Regulation VFL Auditors Department
Co ordination Guidance, Inspection Audit
4 Regions samples
Inspection Supervision Sampling Controls on the marketplace and controls ensuring the respect of specifications
MRA Ministry of Rural Affairs (Trade and Agro-Food Department) VFB Veterinary and Food Board VFL Veterinary and Food Laboratory
Competent Authorities
The VFB on competent authority for PDO - (protected designation of origin), PGI - (protected geographical indication) and TSG - (traditional speciality guaranteed) products controls.
Fisheries and Market Regulation Department is responsible for controls on the marketplace and authority for controls ensuring the compliance with specifications.
Official controls
The annual control plan for PDO-, PGI- and TSG products details the inspections, samples and analyses to be carried out.
The annual control plan is confirmed by the directive of the Director General.
62 DG(SANTE) 2019-6840 Version January 2020 Regional plans are based on the annual plan. The inspection frequency is applied according to the risk assessment. General principles for risk assessment are adopted by the decrees of the Director General.
A physical control on the marketplace and ensuring the compliance with specifications is carried out according to the supervisory procedures which are confirmed by the directive of the Director General.
Training is carried out under an annual training plan established by the Fishing and Market Regulation Department of the VFB.
Laboratories
Analyses are carried out in the VFL laboratory.
63 DG(SANTE) 2019-6840 Version January 2020 ANNEX I – ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS
ACRONYM DESCRIPTION AB Agricultural Board ABP Animal by-products as defined in the ABP Regulation AHS African Horse Sickness AHWD Animal Health and Welfare Department (VFB) AI Avian Influenza APD Agricultural Policy Department (MRA) ARC Agricultural Research Centre ARIB Agricultural Registers and Information Board AV(s) Authorised Veterinarian(s) BCP Border Control Post BSE Bovine Spongiform Encephalopathy CA Competent Authority CCA Central Competent Authority CDB Central Database (cattle and pigs) CHI County Health Inspectorates CP Contingency Plan CPTRA Consumer Protection and Technical Regulatory Authority CRL Community Reference Laboratory CSF Classical Swine Fever Common veterinary entry document for products of animal origin and for CVED live animals CVO Chief Veterinary Officer DG Directorate-General DG SANTE Directorate General for Health and Consumer Protection DSA VFB sample recording Database EA Environment Agency EB Environmental Board EI Environmental Inspection EBRSD Environmental Board, Radiation Safety Department EC European Community EEC European Economic Community ELISA Enzyme Linked Immunosorbent Assay EMTS Estonian Master Tariff System ERA Environmental Research Agency ERC Environmental Research Centre ESAM Estonian State Agency for Medicines
64 DG(SANTE) 2019-6840 Version January 2020 ACRONYM DESCRIPTION EU European Union EULS RAU Estonian University of Life Sciences, Risk Assessment Unit FAO Food & Agricultural Organisation FBO Food (or feed) Business Operator (depending on context/section) FCM Food Contact Material FD Food Department (VFB) FMRD Fisheries and Market Regulation Department (VFB) FMD Foot and Mouth Disease FSD Food Safety Department (MRA) GMO Genetically modified organism GMP Good Manufacturing Practice HACCP Hazard Analysis Critical Control Point HB Health Board HC/SH(s) High capacity slaughterhouse(s) HFAA SANTE Directorate F- Health and Food Audits and Analysis IF Immunofluorescence test ISO International Organization for Standardization LC/SH(s) Low capacity slaughterhouse(s) LIMS Laboratory Information System MRA Ministry of Rural Affairs Microscopic analytical method for the determination of constituents of MAT animal origin for the official control of feedingstuffs according to Directive 2003/126/EC MBM Meat and Bone Meal ME Ministry of Environment MEA Ministry of Economic Affairs and Communications MF Ministry of Finance MSA Ministry of Social Affairs ND Newcastle Disease NRCP National Residues Control Plan NRL National Reference Laboratory OCIS Official Control Information System OSD Organic Agriculture and Seed Department (AB) OV Official Veterinarian PAH Polycyclic aromatic hydrocarbon PAO Products of animal origin (art. 7 of Regulation (EC) 999/2001) PAP Processed animal protein
65 DG(SANTE) 2019-6840 Version January 2020 ACRONYM DESCRIPTION PCB Polychlorinated biphenyl PCR Polymerase Chain Reaction PHARE Pre-accession instrument financed by the European Communities PHD Plant Health and Horticulture Department (AB) PM Post-mortem inspection PFD Plant Protection and Fertilisers Department (AB) PVP Private Veterinary Practitioners RASFF Rapid Alert System for Food and Feed RC Regional Centres (AB) RHS Health Board Regional Department (HB) RD Regional Department (VFB) SRM Specified Risk Materials TAIEX Technical Assistance Information Exchange Office TCB Tax and Customs Board TAED Trade and Agro-Food Department Prohibition of feeding PAO to farmed animals and exceptions applicable Total feed ban to this ban, as laid down in Regulation (EC) 999/2001 Trade Control and Expert System introduced by Commission Decision TRACES 2004/292/EC TSE Transmissible Spongiform Encephalopathies VFB Veterinary and Food Board VFL Veterinary and Food Laboratory
66 DG(SANTE) 2019-6840 Version January 2020