Ref. Ares(2016) /11/2016

Transcription

1 Ref. Ares(2016) /11/2016

2 TABLE OF CONTENTS INTRODUCTION...3 SUMMARY ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) N 882/ Designation of competent authorities...6 Resources for performance of controls...13 Staff qualifications and training...14 Organisation and implementation of official controls...14 Enforcement measures...17 Prioritisation of official controls...18 Sampling and Laboratory analysis...19 Verification and review of official controls and procedures...20 Multi-annual National Control Plan (MANCP) COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS Control system for animal health Control system for food of animal origin Control system for imports of animals and food of animal origin Control system for feedingstuffs and animal nutrition Control system for TSE/ABP Control system for veterinary medicines and residues Control system for foodstuffs and food hygiene Control system for imports of food of plant origin Control system for Plant Protection Products (PPPs) Control system for animal welfare Control system for plant health...55 ANNEX I ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS...58 ANNEX II OVERVIEW OF STAFF RESOURCES...60 ANNEX III TRAINING SYSTEMS

3 INTRODUCTION This overview has been drawn up by the Directorate-General for Health and Food Safety of the European Commission, based on information supplied by Sweden. The aim is to present, in summary form, the latest information on how control systems for food and feed safety, animal health, animal welfare and plant health are organised in Sweden. Chapter 1 describes the overall organisation of the Swedish 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 Sweden, covering the whole chain of plant, animal and food production. As in Chapter 1, organisation charts are used to help the reader. 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. Annex II provides details on the number of control staff in Sweden. The statistics on staff resources have been provided by the Member State on a non-standardised basis. Annex III provides supplementary information on training. The overview was updated following the most recent general follow-up audit in May, 2016 and will be updated at regular intervals based on relevant information received by the Commission from the Swedish authorities. 3

4 SUMMARY At the national level, the Riksdag (Swedish parliament) has legislative powers. Proposals for new laws are presented by the Government which also implements decisions taken by the Riksdag. The Government can also adopt rules known as ordinances, provided the Government has regulatory authority based either directly on the Constitution or on delegation from Parliament. All laws and ordinances are published in the Swedish Code of Statutes (SFS). The Government is assisted in its work by the Government Offices, comprising a number of ministries, and some 400 central government agencies and public administrations. The public agencies are all accountable to the Government and put into practice the decisions taken by the Riksdag and the Government. These agencies have an independent status. The Government issues the guidelines for their work. Within this framework, each agency works on its own responsibility. In Sweden "ministerial rule" is prohibited. This means that the Government can direct but cannot intervene in the everyday work of the public agencies. There are three principal legislation levels in Sweden. National laws are adopted by Parliament, secondary legislation i.e. ordinances are adopted by the Government and tertiary legislation i.e. regulations are adopted by some of the central authorities. The structure of the Swedish system for the control of food and feed safety, animal health, animal welfare and plant health comprises of three central authorities, the National Food Agency (), The Swedish Board of Agriculture () and the National Veterinary Institute (SVA). They are all accountable to the Ministry of Enterprise. At regional level, there are 21 County Administrative Boards (CAB). At local level, there are 290 municipalities (MUP). The is the central authority responsible for food control. is competent authority for establishments which are approved according to regulation EC (No) 853/2004 and performs risk assessments. The MUPs of Stockholm and Gothenburg have been approved by the to continue to control establishments which are approved according to regulation EC (No) 853/2004. The is the central competent authority responsible for the control of feed, animal health, animal welfare and plant health. Three Divisions share responsibilities for implementing policy in these areas, while its Inspection Division performs controls on feed, animal by-products (ABP) and plant health. The SVA is the national reference laboratory for most feed and animal health areas and has expertise in animal health, veterinary medicines and feed. It performs research and routine diagnostics in the field of contagious animal diseases, carries out analyses in response to requests from the and performs risk assessment. The 's laboratory is the national reference laboratory for most food areas. 4

5 The CABs are responsible for performing official controls on food and feed in primary production, and on animal welfare. CABs are also responsible for managing the controls performed in respect of animal health and animal identification. CABs perform certain control tasks on animal health delegated to it by. In addition, CABs perform controls on transport of ABP and on distribution of veterinary medicines by veterinary practitioners. They also carry out audits of MUPs' food controls. The MUPs are competent authorities for the food establishments (excluding the approximately 1400 "Regulation 853/2004" establishments controlled by ). MUPs also perform controls on ABP and the marketing and distribution of plant protection products (PPPs). The first Swedish multi-annual national control plan (MANCP) covered the period The most recent updated plan for is on the website: The plan identifies increased co-operation between the competent authorities as a strategy to achieve a high level of health protection by control authorities and in all control areas. The aim is to ensure that the general and specific objectives of the plan will be reflected in goals for control activities at local, regional and central level. The general objectives, directed at three stakeholders (consumers, food and feed business operators, and control bodies) are to ensure that: consumers have safe food and confidence in control activities food and feed business operators have confidence in controls, and control authorities co-operate, take responsibility for their part of the food chain, and perform controls which are risk-based, legally secure, effective and suitable to achieve the objectives The updated MANCP describes follow-up, evaluation and verification of the control process and each CA has the responsibility to have a system for follow-up, evaluation and verification. Sweden s MANCP is a guidance document and not binding for the control authorities. The MANCP includes specific objectives for feed, ABP and plant health for the period of There are also specific objectives for animal health valid for and specific objectives for food for the period of The most recent Annual Report on controls, required under Regulation (EC) No 882/2004, for the year 2015, was submitted to the Commission in June

6 1. ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) N 882/2004 Designation of competent authorities The Swedish system for the control of food and feed safety, animal health, animal welfare and plant health is composed at national level, of ministries and state authorities; at regional level 21 CABs; and, of 290 MUPs at local level. While the MUPs are governed by national legislation, in organisational terms they are under the control of the relevant municipal council, operating independently and taking their own decisions. The Government decides the allocation of competencies between the various bodies. The Swedish Parliament (Sveriges Riksdag) is the supreme political decision-making body in Sweden. National laws (lagar) are adopted by the Parliament, Ordinances (förordningar) by the Government, and regulations (föreskrifter) by state authorities. MUPs have certain powers to issue regulations e.g. on fees and rates for official controls. At central level, the is responsible for controls and risk assessment on food. The is responsible for controls on: feed; animal health; animal welfare; plant health; and animal health personnel. The SVA is a state authority which performs risk assessments for the animal health and feed sectors, and provides expert advice to on prevention and control of contagious diseases. Ministries/other Responsible Bodies Ministries Ministry of Enterprise (ME) As from January 2015, the responsibilities and tasks of the Ministry for Rural Affairs are included in the Ministry of Enterprise (ME). ME has four divisions and about 490 staff members. The four divisions are: Bostäder och transporter (Housing and transporters), Innovation och bolag (Innovation), Hållbar tillväxt (Sustainable growth) and Näringsliv och villkor (Enterprise conditions). The division Näringsliv och villkor (Enterprise conditions) has the overall responsibility for agriculture, food, animal health, feed, ABP, animal welfare, plant health, forestry and fisheries. The division consists of 7 units; enheten för konkurrens, statsstöd och ramvillkor (Competition, State aid and framework conditions), enheten för företag och företagande (Enterprise and entrepreneurship), enheten för fiske, jakt och rennäring (Fisheries, Hunting and reindeer husbandry), enheten för djur och livsmedel (Animals and foodstuffs), enheten för skog och klimat (Forestry and Environment), enheten för jordbruk och miljö (Agriculture department) and enheten för styrning och uppföljning av näringsliv och villkor (Governance and monitoring of business conditions). There are eight authorities related to the above mentioned areas within the Ministry s sphere of operations, including the, the, and the SVA. 6

7 Ministry of Finance (MF) The MF, with approx. 400 staff, has 12 central authorities within its area of activity, including the Swedish Customs Service. The Municipal Legislation Department has the task of monitoring municipal self-government issues and the general rules on the activities of the MUPs. The 21 CABs will also report to MF as from 1 January Other Ministries Other ministries involved in food chain controls are the Ministry of the Environment and Energy (MEV) and the Ministry of Health and Social Affairs (MHSA). The Swedish Chemicals Agency (KEMI) and the Swedish Agency for Marine and Water Management (SwAM), which is responsible for issues regarding marine and freshwater environments, reports to MEV. The Public Health Agency and the Medical Products Agency (MPA) report to MHSA. Authorities The Role of Government The Government decides on the focus of activities for each authority, through the Government Authorities Ordinance, legislation, and an annual "letter of directions" addressed to each authority, setting out objectives, tasks and financial conditions. The activities of each authority are followed up and evaluated through annual reports submitted to the appropriate ministry. Annual reports, together with budget proposals, constitute the basis for the following year's state budgets and "letters of directions". The National Food Agency () The is the central competent authority for matters concerning food. `s head office is located in Uppsala. There are four regional Departments in the country. It operates under a Government Authorities Ordinance which requires to perform tasks in relation to the MANCP, under Regulation (EC) No 882/2004. The 's primary mandate is to: prepare legislation in the food area; perform controls; direct and co-ordinate controls under the Food Act; conduct risk assessment; and act as the National Reference Laboratory (NRL) for food. Section 31 of the Food Decree (2006:813), as implemented by Regulations LIVSFS 2009:13, authorises to require control authorities such as MUPs, to submit reports on their control activity. The has some 515 full time equivalent staff (fte). is also responsible for import controls and the five border control posts at: Port of Gothenburg, Landvetter airport, Port of Stockholm, Arlanda airport and Port of Helsingborg. Since the beginning of 2014 the has re-organised its activities, relevant to the country profile, into three Divisions: Food Control Division (-FCD); Science Division (- SD); and Strategic Development and Support Division (-SDSD). 7

8 The -FCD, responsible for 's control activities, comprises six Departments: Regional Department of Northern and Central Sweden, Regional Department of Western Götaland, Regional Department of Eastern Götaland, Regional Department of Southern Götaland, Department of Control Support, Department of Control Management and Followup. The -FCD has approximately 323 staff (fte). It has responsibility for controlling some 1400 food plants and administrative management. The -SDSD comprises seven Departments: Communications, Evaluation, Human Resources, Finance and Accounting, IT and Service, Legal Affairs Department and International Affairs Department. Evaluation Department audits, evaluates the controls, works with the annual report and the reporting system. Within the scope of the competence of the, the -International Affairs Department supports the government in its participation in the European Union and other international organizations. For example the Department participates and represents Sweden in different Council and commission working groups, in standing committees etc. The Legal Affairs Department provide legal advice to the and to other relevant parties, is responsible for drafting the s regulations and represents the in court cases. The Department of Control Management and Follow-up directs and co-ordinates the control. The Department of Control Support is a contact point for the RASFF for foods. The division of Science comprises four Departments: Chemistry, Biology, Risk Benefit Assessment and Advice and Emergency Awareness preparedness. Scientific risk assessment is conducted at the SD of and is the focal point for EFSA. The SD is NRL for foodstuffs within 23 different areas. Swedish Board of Agriculture () The Swedish Board of Agriculture s head office is located in Jönköping. There are local offices in the south and central Sweden. The total number of staff is approx of which more than half is located at the head office. The Board has overall responsibility for agriculture and horticulture, including: animal and plant health; guidance on control and use of plant protection products; control and prevention of contagious diseases; and feed and animal by-products and animal health personnel. The Board is also the central authority for animal welfare issues. The Board s district veterinarians make up a substantial part of the organisation, and constitute the principal body for performing official veterinary controls and for emergency measures to combat contagious diseases. The Board of Agriculture reports to the government on its domestic livestock controls, including: health control programmes; semen operations and breeding controls; feed controls; and the coordination of regional contingency planning, in the event of a disease outbreak. Numbers of cases of epizootic and zoonotic diseases must also be reported. The Board is also obliged to report animal healthcare statistics to government (e.g. diagnoses for preventative healthcare, numbers of treatments per animal type and average price per treatment). The Swedish Board of Agriculture is led by the director general. The management team consists of the director general, the head of director general's office, the deputy head of director general s office, together with four heads of division. Those are for service and control, promotion and management, the paying agency function and the district veterinarians. The head of the department for animal health is CVO and Sweden s representative at the OIE (World Organisation for Animal Health). 8

9 Under the divisions are eleven departments. Those are the department for animal welfare and health; district veterinarian department; plant and environment department; department for control; department for rural development; department for support applications, department for support administration, department for support process; IT department; market and trade department; and customer service department. The Board is also the central competent authority for crisis management of epizootic diseases, contamination in feed, harmful organisms for plants and radioactive fallout as well as other incidents related to animal and plant health. There is a crisis management organisation that is designed to coordinate the work of the Board in all types of emergencies. In the case of an incident, the Board also co-operates with other authorities on central, regional and local level. The department for animal welfare and health () The department for animal welfare and health is responsible for: guidance of control in animal welfare; species protection; breeding and production; GMOs; organic livestock farming; feed safety issues; feed additives; animal by-products; bees; decisions on quarantine; and animal health personnel. Coordination of official veterinarians is included in the department s area of responsibility, as are pharmaceutical matters. The department provides support on strategy and development in the field of animal policy to the ministry of enterprise, and emergency matters. The department coordinates with other supervisory authorities, provides advice and assistance, and is responsible for developing animal health and welfare regulations. It has approx 80 staff. The district veterinarian department () The district veterinarian department consists of the district veterinary division and 100 district veterinary stations located in four regions. The department has approx. 400 veterinarians including assistants who provide administrative support. Veterinarians employed in the district veterinary stations are responsible for providing clinical services to farmers on behalf of the state, in addition to performing official control functions. The main official control functions performed by district veterinarians relate to animal health, import controls on live animals, and residues of veterinary medicines. The district veterinarian department is responsible for operational controls, such as sampling and animal certification, through official veterinarians. In addition to official controls, most district veterinarians' work is on emergency and preventive animal healthcare on behalf of the state. The district veterinarians services have an obligation to be available on a 24 hour basis to deal with contagious diseases. They are also the core personnel in the field organisation for combating animal disease outbreaks. There are approx 4500 private veterinarians in Sweden. All veterinarians are obliged by law to report any suspected cases of contagious epizootic and zoonotic diseases to the Board and to the County Administrative Boards. 9

10 Plant and environment department () The plant and environment department has a staff of approx 100, of whom more than half is located at the head office in Jönköping and the remainder in regional postings. The department deals with: plant health, crop production and horticulture; organic production; seed and plant propagating material; GMOs; biological diversity; plant genetic resources; diversity in the farmed landscape, evaluation of environmental effects of the EU Common Agricultural Policy and of environmental measures in the Rural Development Program. There is a chief plant health officer which is a management function with general responsibility for plant heath issues. The plant regulation unit has responsibility for implementing the regulations and participating in developing legislation at EU-level. The environmental analysis unit carries out analyses of regulatory aspects in the field of plant health. The Board has overall responsibility for controls on use of plant protection products, and guidance to the municipalities within the agricultural sector. Control department () The inspection and control department is responsible for performing offical controls. The control department has 12 staff who are responsible for performing offical controls on feed; animal by-products; meat classification as well as coordination of official control in other areas e.g. health surveillance of aquaculture and border inspection controls. Most of the plant control unit s staff (in total 24) is located in three regional offices. The unit is responsible for performing offical controls on harmful organisms in plants (both domestic and imported production); quality controls on fruit and vegetables and control of marketing of seed. The inspection and control department is also responsible for the register of animal holdings (inter alia pigs, cattle and laying hens), animal identification and movement controls for all cattle, pigs, sheep and goats. Poultry farms are, in certain cases, also subject to an obligation to register with the Board s holdings register. There is a central database for monitoring the movements of cattle (CDB). There is also a central database for pigs in which movements of animals must be registered. There is coordination between the inspection and control department and the other departments responsible for guidance and policy implementation within their specific sectors. Rural development department () The department for rural development is responsible for compensation in connection with outbreaks of contagious animal diseases. Paying agency function () The paying agency function is responsible for cross-compliance controls. 10

11 The County Administrative Boards County Administrative Boards' (CABs) activities are determined partly by the CABs Ordinance, and partly by the Government's annual "letter of directions". A total of 21 CABs operate at regional level, each directed by a government-appointed county governor. The Deputy County Governor is the county director, and manages day-today activities.the internal organisation of CABs varies from one county to another. However, policy delivery and the enforcement of legislation related to the food chain are largely dealt with by the County Veterinary Officers and the Animal Welfare Officers. CABs are responsible for: Official controls on: animal welfare; food and feed hygiene in primary production; veterinary medicines; cross compliance; and some areas related to animal byproducts, animal health and animal identification. Performing audits of food safety controls performed by MUPs to verify compliance with Food Act. Co-ordinating food safety activities by MUPs Assuring preparedness to manage animal disease outbreaks within the county. Appeals on municipality decisions. Referring serious legal infringements to a Public Prosecutor. Granting approvals for: livestock buildings; certain professional and other bigger animal activities; public exhibition of animals and ABP collection points. CABs report to,, and to the MF. Reports are normally submitted annually. The role of the CABs was expanded in recent years. In January 2009, powers were transferred from the MUPs to the CABs in relation to controls on animal welfare, and food and feed in primary production. The CABs are now responsible for a range of tasks in various sectors, as described in Table 1 below. Table 1 - Tasks of County Administrative Boards Sector Task/role of CABs CCA Animal health and identification Controls e.g. Animal ID and movement controls Control of horse passports Salmonella control in laying hens Food of animal origin Co-ordination and audit of municipality controls Control of primary production Feed Control of primary production TSE/ABP Control of transport of ABP Veterinary medicines Control of distribution and use by veterinary practitioners Control of use at farm level Food hygiene: Co-ordination and audit of municipality controls Control of primary production 11

12 Sector Task/role of CABs CCA Animal welfare Controls on transport; on farms; on slaughterhouses (the latter is shared with details in Section 2.10) Animal health personnel Controls on veterinary activities Municipalities There are 290 municipalities (MUPs) in Sweden. The organisation and activities of the MUPs are governed by the Swedish Local Government Act. The highest decision-making body for MUPs is the municipal council (MC), and its highest executive body is the municipal executive board (MEB). The MC appoints committees to carry out the tasks of the MUPs in accordance with special statutes. The MC and MEB are composed of elected representatives. In general, each municipality may adopt a committee structure of its choice. The committees which carry out food controls also generally carry out environment and hygiene controls. To improve efficiency and to facilitate recruitment of a greater range of specialists, some MUPs have established common organisations for environment and health with neighbouring municipalities. The powers of the MUPs and their role in the food chain are governed by laws such as the Food Act, and the Law on Feeds and ABPs, and derived legislation. MUPs perform controls on establishments producing food of animal origin, and of nonanimal origin. They also perform official controls of ABP. The National Veterinary Institute (SVA) The National Veterinary Institute (SVA) is a veterinary expert Authority under the Ministry of Enterprise. The number of staff is veterinarians, researchers, biomedical analysts and laboratory technicians. In the group of veterinarians and researchers approximately two thirds has a PhD. SVA maintains an emergency capacity for outbreaks of serious diseases 365/24; prevents and controls infectious animal diseases and diseases transmissible from animals to humans; performs risk assessment in the food and feed chain; contributes to environmental work by monitoring diseases in fauna; supplies vaccines and diagnostic products; and participates in animal disease contingency planning. SVA is Sweden s largest veterinary laboratory. Its main role is to align the activities towards contagious and other serious infectious diseases of animals that imply a threat to supplies of animal foodstuffs, which lead to losses for the production of animals that concern pets, or involve diseases that can be transferred to humans, i.e. zoonoses. The main task of the SVA relates to veterinary medicines. It also performs official duties, and commissioned activities and research. It investigates all aspects of contagious diseases in animals; carries out diagnoses of animal diseases (including those prescribed in EC legislation); investigates microbial and chemical contamination in feed; and acts as the National Reference Laboratory (NRL) for zoonoses and infectious animal diseases and feed as defined in Regulation (EC) No 882/2004. It also: assists in the prevention of animal diseases; contributes to preventive measures for feed hygiene; conducts research and development work; and monitors and analyses the development of resistance to antibiotics in animals. In 2008 SVA was assigned additional responsibility for monitoring diseases in 12

13 wild animal populations as well as with questions related to climate change. SVA is responsible for collecting and reporting zoonoses data to EFSA. Laboratory Services SVA performs veterinary diagnostic analyses (including TSE) and is the NRL for a number of animal diseases and pathogens of feeding stuffs. SVA also performs diagnostic analyses for private veterinary practice. Some accredited private laboratories also perform veterinary diagnostics. is the NRL for most food areas. It performs routine analyses for residues of veterinary medicines and pesticides residues in foodstuffs. Some changes focussing on continuous improvement Changes to the Government Authorities Ordinance for were made in 2015 in line with the Swedish National Audit Office s (SNAO) previous recommendations on further improvements of the system of food control. The responsibility for the to follow up the national food control was clarified and the authority was assigned a new obligation to report to the government, on a yearly basis, on how the control system can be improved. There are proposed additions to the national Swedish regulation on official controls of food (LIVSFS 2005:21), to clarify the obligations of CAs regarding planning of controls, assuring competence in staff and follow up and evaluation of the CA s official controls. These additions are aimed to be implemented by 1 January There is a Governmental commission given to to improve the control system and system of information concerning fish and fishery products from the Baltic sea under exemption on EU dioxin/pcb limits in fish. Resources for performance of controls See also Annex II. The has a coordinator for import issues. In addition, each unit of DAWH, allocated resources for import controls. In the annual report on the implementation of the MANCP, which was sent to DG Health and Food Safety in June 2016, it is mentioned that the CABs have almost 8 fte staff for working on food control in primary production. In this area, the CABs estimate that there is need for approximately 5 fte additional staff. In relation to auditing controls by MUPs on general food hygiene and food of animal origin, the same annual report mentions that a total of 37 such audits had been carried out by CABs in The number of staff for food control, after primary production, in MUPs and has increased from 592 fte in 2013 to 618 fte in A small shortage of resources is still identified, i.e. a requirement for an additional 37 ftes (inspectors). Several reports have pointed out that full cost coverage is not always achieved for the official control, sometimes leading to a lack of resources for the MUPs. The Swedish Agency for Public Management was hence assigned by the Government offices to evaluate the fee system for official control and to present how the effectiveness can be improved. The report was published in June 2015 and confirmed in one of the main conclusions of the 13

14 report that the official control of food in some MUPs is not sufficiently extensive due to lack of resources. The report presents a number of recommendations and is being processed in the Government offices during the spring of 2016 considering comments from relevant stakeholders. More information about resources can be found in the annual report on the implementation of the MANCP which is available at: livsmedelskedjan- Staff qualifications and training In general, staff performing controls directly employed by are qualified for the tasks they perform and receive regular training. The have since 2011 provided, in-service training for different subjects. There have, for example, been courses in food fraud/food crime for about 300 inspectors. For more information see Annex III. CABs arrange meetings every year where all MUPs in the county are invited. These meetings often include an educational element from the. The CABs have been trained on control of feed and food in primary production. The training was sometimes performed jointly by the and. The organises training courses for staff performing animal welfare controls including for example control management in animal control records, training in the new case management system, assessment of animal welfare in pig herds and the handling of animal control register (DSK). organised several training actions in 2011 for the CABs and MUPs on control of ABP. In order to gain more competence, auditors from the, and CAB, have, since 2011, participated in BTSF training on audit systems and internal auditing. Organisation and implementation of official controls Co-ordination between Competent Authorities Between and, there is regular co-ordination such as for: implementation of the NRCP and other control programmes; food and feed in primary production; coordination with Customs; contingency plans; MANCP and annual reports. They are also coordinating through projects, training and ad hoc meetings to discuss specific issues. Cooperation takes place for zoonotic diseases, in particular between and. provides support to for control areas where is the CCA and is responsible for inspections in establishments, such as ABP, animal health and animal welfare. In general co-ordination between the and the CABs takes place at a technical level. The MANCP describes CAB co-ordination with and for various issues, such as MANCP, annual report, staff competence and zoonoses. A co-operation group for audits of the food chain has been formed to; - Give support and advice - Discuss competence and development - Exchange of experiences and information 14

15 MUPs co-operate with in preparing the MANCP and annual report. A working group, with participants from,, SVA, CABs, General Surgeon, SALAR and representatives from some MUPs, addresses issues of a fundamental nature. Co-operation may also take place through control projects, RASFF or other emergency incidents. There is also a network between MUPs, CABs, Swedish Association of Local Authorities and Regions (SALAR) and, Livssamverkan, initiated by some MUPs. The group works with equivalence for food control. If needed also invites user representatives and system suppliers at the CAs before each annual reporting of control results to the. In general, co-ordination between the, and the CABs takes place at a technical level and at a management level within the 28 Network. The purpose of the 28 Network is to facilitate and improve the effectiveness of achievement of objectives by CABs in the animal welfare and veterinary areas, defined in table 1, through co-ordination and exchange of experience within the network. The Network also aims to facilitate communication between CABs, as well as between the CABs and other authorities and organisations. It is composed of one representative from each CAB. Meetings take place monthly. It contains subgroups/working groups such as for primary production of food and feed, animal welfare, ABP, and contagious diseases. Meetings are also used for providing information on new EU legislation and changes to guidelines, and to plan future training. The and participate in some meetings. In addition the has been commissioned by the government (March 2012) to establish a council for coordination of strategic issues relating to animal welfare control. The council is composed of representatives from all stages of the and the CABs. and arranges regularly information days attended by the CABs. For SVA, in the event of an outbreak of epizootic disease there is a co-operation in accordance with contingency plans, between SVA and and, where relevant, and other stakeholders such as farmer organisations. For zoonotic outbreaks, co-operation takes place between SVA,, and their medical counterparts (the Public Health Agency of Sweden) and other relevant authorities. In cases of contaminated feed there is close cooperation between SVA and as well as with the feed industry and, where relevant, farmer organisations. Between CABs: There is since 2013, a group for co-operation between CABs the network for animal welfare and veterinary issues ( 28 Network, also described above), coordinating both general and specific questions within the areas defined in table 1. There is also an informal co-operation group for controls in the food chain, maintained by county veterinary officers ( Länsveterinärföreningen ). 15

16 Between MUPs: The highest decision-making body for MUPs is the MC. The council appoints committees to carry out the tasks of the MUPs. Committees which carry out food controls also generally carry out environment and hygiene controls. To make these committees more effective and to enable them to employ specialists for various tasks, certain neighbouring MUPs pool resources to create common organisations, or have agreements with other MUPs to carry out food control tasks. This co-operation results in that 290 municipalities become 246 reporting control authorities. No central authority is responsible for co-ordination of controls by MUPs on the marketing and use of PPPs. Co-operation within Competent Authorities Within, the Director-General organises regular meetings attended by the Deputy- Director General and the heads of all divisions. In the -FCD, the Head of Division organises regular meetings attended by all Heads of Departments. There are many ongoing projects involving internal co-operation. There are regular meetings held between -CD and the policy implementation departments. At those meetings it is decided about the nature of documents to be shared. However, there is no formal basis for this co-operation. Contingency planning (CP) The is the central competent authority for crisis management of epizootic diseases, contamination in feed, harmful organisms for plants and radioactive fallout as well as other incidents related to animal and plant health. There is a crisis management organisation that is designed to coordinate the work of the Board in all types of emergencies. In the case of an incident, the Board also co-operates with other authorities on central, regional and local level. Exercises and real incidents took place in 2010, 2011 and Delegation of tasks This far has carried out all wood import inspection. In case of an increase in wood imports, may delegate some inspection tasks to the Wood Measurement Society, a private ISO certified company whose control staff have been trained by. In that event, undertook to establish a system to ensure that the Wood Measurement Society fulfils the requirements of Council Directive 2000/29/EC, including in particular Article 2.1 (g). Official control of organic production and organic products is delegated to control bodies. Conflict of interest There are rules concerning conflicts of interest involving the case officers in Sections of the Administrative Procedures Act which apply to the processing of cases by the administrative authorities and thereby also to the processing of cases by the MUPs. 16

17 Additionally, it is stated in Section 7 of the Public Employment Act that an employee may not have any employment or assignment or exercise any activities which may adversely affect confidence in his or any other employee s impartiality in the work or which may harm the reputation of the authority. As regards the municipal authorities, the independence of the board and individual officers is guaranteed through the Local Government Act. Chapter 6 Sections of the Local Government Act contains rules on conflicts of interest. Enforcement measures has produced guidelines on sanctions and other measures arising from non-compliance in relation to food controls. The current version was last revised in November These guidelines are not binding on MUPs. stated that enforcement measures are an integral part of the instructions/guidelines being prepared by for the CABs for all the controls described in Table 1. Each CAB has a legal unit. A range of sanctions is available to all CAs in national food and general administrative legislation, which inter alia provides for sanctions to be proportionate and effective The available criminal sanctions in the Food Act are fines. The Food Act is subsidiary the Penal Code where criminal acts can be punishable by either prison sentences or fines. Examples of criminal acts in the Penal Code that may take precedence over those of the Food Act are fraud, spreading of disease, and negligent causing of bodily harm. The government launched an inquiry regarding sanctions for crimes against the food legislation in March The possibility and expediency to re-introduce prison sentence as a penalty will be investigated as a part of this inquiry. Despite a general prohibition on central authorities prescribing MUP activities, there are certain situations where implementation of controls by MUPs may be reviewed and evaluated. For example, appeals against MUP decisions are always submitted to the CAB. Appeals against CAB decisions are submitted to the relevant administrative court. The Food Act contains certain provisions for the state to sanction MUPs where they do not satisfactorily fulfil their control obligations. Under food legislation, the may decide, in consultation with the MUP in question, that official control of a specific establishment is to be transferred to. In addition, if a MUP does not fulfil its obligations as a control authority, may order the MUP to rectify its deficiencies. While may request the government to allow the MUP s control tasks for a certain establishment to be transferred to it, this seldom happens. The annual report contains information on sanctions in food control. For food control in primary production 2014, there were injunctions issued in 3 cases. For control of nonprimary producing food business operators there were injunctions issued in 2599 cases for In addition to this there were injunctions for non-compliance to specific regulations e.g. residue control. The annual report contains information on sanctions in various sectors. considers the level of sanctions until now for animal welfare non-compliances to be too low, however the number of sanctions has increased due to better quality and efficiency in the controls carried out by the CABs during

18 Submission / prohibition Decisions on taking animals into care Decisions dispose animals on of ? Registration / approval of food business establishments The is from 1 of January 2014 responsible for approval of and control on all establishments approved according to Regulation (EC) No 853/2004. The control of establishments in Stockholm and Gothenburg MUPs is transferred back. An updated list of approved establishments, and information indicating which authority is conducting controls at the establishment, is at webpage: kontroll/livsmedelskontroll/livsmedelsanlaggningar/ For foodstuffs and food hygiene, responsibility for registration of food establishments is divided between, CABs and MUPs. is responsible for registration of certain designated establishments (pointed out in the 23 Food Decree). CABs are responsible for establishments in primary production. MUPs are responsible for the remainder. For feed, all large establishments are registered. For primary production, considers that most of the establishments are registered. Today primary producers of feed are registered in the database. The register of all feed business operators (in and out of primary production) is available on the website. For ABP, has approved approx. 550 establishments in accordance with Regulation (EC) No 1069/2009, of which approx. 200 are incinerating establishments at farm level, for which controls are performed by MUPs. Approx. 250 transporters are registered in addition. Prioritisation of official controls The CABs are responsible for animal welfare controls since January In 2012, about controls were carried out and about 13 % of the control items had a control. The number of controls carried out in 2011 was in the same level as Approximately one third of the controls under 2012 was carried out because of a notification. In half of these controls the CABs found non-compliances. On slaughterhouses, the official veterinarians, carried out about controls. The numbers of slaughterhouses was about 120. Under 2012 and 2013 the has developed a model for risk assessments at control items on animal welfare. The model is completed and implemented in the register of control items (DSK). The model contains eight modules based on risks from different aspects according to article 3, Regulation (EC) No 882/2004. The model is constructed with large flexibility for quick adjustments to new knowledge and for integrations with new modules. The introduction of the model is intended to rectifier and quality assurance the outlet of control items for controls. Operators with similar risks according to animal welfare should have the 18

19 same probability to be withdrawn for controls, no matter where in the country they conduct their activity. The model is in use to support risk based control. The CABs became responsible for animal welfare controls in 2009 during which controls were carried out. Since 2009, the inspections have increased and in controls were performed. About 10% of the control items had a control. This is a clear improvement since previous control responsibility by the CABs, but it is still a too low level and the distributions of controls between CABs are not adequate. The Swedish authorities consider that with s published risk classification guidelines, all MUPs are in a position to plan and perform controls on a risk basis. The guidelines also help MUPs to allocate sufficient time when performing controls at specific establishments. There is also a general guide for risk classification in primary production Riskklassificering av livsmedelsföretag och foderföretag inom primärproduktionen - CABs may use the guide when they risk classify and plan the controls of primary producers of food and feed. The guide takes into account if the primary producer apply any of the, in the guide, specified secondary and third party quality systems. Evaluation of the effectiveness of these secondary and third party quality systems used by food and feed producers started in 2008 and is ongoing. The evaluation is done together by and for appropriate areas. Sampling and Laboratory analysis Staff in -DVD, acting as official veterinarians, carries out sampling for animal health purposes. Sampling carried out according to Directive 96/23/EC is done by personnel from, and CABs. organises sampling for certain substances in food. In addition to laboratories forming part of the control bodies, or SVA, some international laboratories and private laboratories are used within the official control. has Guidelines for Procuring Laboratory Services, which include procedures for designating laboratories and ensuring that they fulfil the necessary requirements and provide information on auditing the procurement of laboratory services by MUPs. National accreditation bodies The accreditation body in Sweden is the Swedish Board for Accreditation and Conformity Assessment (SWEDAC), which in its website ( presents details of the accredited laboratories in EU countries that may be used by the Swedish control authorities. 19

20 Verification and review of official controls and procedures Verification Article 31 of the Foodstuffs Ordinance (2006:813) authorises to prescribe reports to be submitted by CAs on their control activities. In this regard, has issued Regulation LIVSFS 2009:13, requiring MUPs carrying out food controls to provide with information. has been taking action against MUPs for failing to provide reports. The accuracy of MUP reports needs further validation. take account of these reports to identify the MUPs to be audited. Article 65 of the Animal Welfare Ordinance, authorises to issue regulations requiring control authorities to submit reports on their controls to the. The Swedish Regulation and General Recommendations (SJVFS 2008:67), on the Official Control of Animal Welfare, states that in accordance with 's instructions, CABs should plan for annual reporting on their animal welfare activities. Each year, compiles the results of animal welfare controls carried out by CABs, which form part of the annual report on the MANCP. Under the Ordinance on Feed and Animal By-Products, may issue regulations concerning a MUP's obligation to provide information to it. There is now an obligation for MUPs to report the results from the control of ABP to (set out in national legislation SJVFS 2007:21). In 2015 the responsibility for the to follow up the national food control was clarified in the food legislation through a change in the Government Authorities Ordinance in response to a recommendation from the SNAO. Audit has an internal audit system in place for its own food related controls. The CABs started to perform audits on MUP controls on food in published a guideline in the end of September 2008 for these CAB audits of MUPs. The guideline was complemented with a report-template/checklist in April The has produced a new guideline for audits carried out by and CAB. The guideline has been implemented since 1 January Both and CABs perform audits on MUP. The 2015 annual report on the implementation of the MANCP sent to DG Health and Food Safety in June 2016, records that there were 69 audits carried out by and CABs in the food area during 2015 (61 such audits were carried out in 2014). audits of the CABs started in 2011 and to the end of 2014 all CABs have been audited. During 2015, started a second round of audits of the CABs. The Internal Audit Unit was given the responsibility for audits according to article 4.6 of Regulation (EC) no 882/2004 within competence in Since then the Internal Audit Unit has performed the following audits: In 2009; the introduction of procedures according to Regulation (EC) no 882/2004 at the responsible departments for animal welfare, import, fodder, ABP and TSE regarding general obligations for risk analysis, guidelines, reporting and follow-up. In 2010; the ABP process on the basis of applicable regulations and central guidelines. 20