Comprehensive Strategy and Legislative Approximation Programme in Food Safety

Government of Georgia The Comprehensive Strategy and Legislative Approximation Programme in Food Safety Prepared by: The Inter-Agency Working Group for the Development of Food Safety System in Georgia under the Commission for the EU Integration May, 2009 - October, 2010 2 Content Executive Summary ........................................................................................................... 3 1. Introduction ................................................................................................................... 6 2. Georgia’s Agricultural Sector Overview..................................................................... 12 3. Implementation of Food Safety Official Control....................................................... 17 3.1. Registration of Food Business Operators ............................................................ 20 3.2. Inspections Performing Official Controls ........................................................... 21 3.3. Veterinary and Phyto-sanitary Border Inspections and Cooperation between the National Service and the Revenue Service .................................................................. 26 3.4 System of Laboratories in Georgia ........................................................................ 31 3.5. Relaxed Regulatory Schemes for Small Businesses .............................................. 36 3.6. Monitoring System on Animal Diseases .............................................................. 39 3.7. An Early Warning System and the Link to the EU Rapid Alert System for Food and Feed (RASFF) ........................................................................................................ 41 4. Institutional Gap Analysis and Identification of Future Needs................................. 42 4.1. National Service for Food Safety, Veterinary and Plant Protection .................. 42 4.2. Revenue Service..................................................................................................... 46 4.3. Laboratories........................................................................................................... 47 5. Legislative Gap Analysis and Future Legislative Actions by the GoG ..................... 49 6. Technical Assistance Needs in the Food Safety Sector .............................................. 58 7. Conclusions .................................................................................................................. 61 Annex 1. The Legislative Approximation Program with EU Legislation. ................... 63 Annex 2. Preparatpry Process of the Comprehensive Startegy and Legislative Approximation Program in Food Safety...................................................................... 91 Annex 3. Summery of Activities undertaken by the National Service of Food Safety, Veterinary and Plant Protection in 2009-2010.............................................................. 97 3 Executive Summary The aim of the Government of Georgia (GoG) as demonstrated in this Strategy and Legislative Approximation Programme is to further develop legal and institutional framework in the food safety area and establish a solid food safety system in Georgia in line with the EU and international standards. Based on the recommendations of the European Commission, GoG decided to prepare a Comprehensive Strategy and Legislative Approximation Programme in Food Safety. With this aim an Inter-Agency Working Group for the Development of Food Safety System was created under the Commission of EU Integration of Georgia. The Working Group drafted and elaborated a Comprehensive Strategy and Legislative Approximation Programme in Food Safety, which should guide the GoG and private sector activities in the short and long term. The present Strategy and Legislative Approximation Programme is a result of the work undertaken by the Working Group between May 2009 and October 2010. The Present document addresses the following issues: • Description of Georgia’s Agricultural Sector • Introduction of a Solid Food Safety System in Georgia • Establishment of Food Safety Official Control • Analysis of Legislative and Institutional Shortcomings and Identification of Future Needs • Timelines of Legislative Approximation with EU Legislation and Implementation • Enhancement of the Capacity Building In the present Strategy and Legislative Approximation Programme, the GoG commits to streamline and approximate legislative basis and gradually establish and implement food safety provisions based on the proposed Legislative Approximation Programme. 4 Basic legislative framework and institutional structures in the food safety areas exist in Georgia. There is sufficient primary and secondary legislation as well as institutional capacity to start the enforcement of a solid food safety system in the country. However, additional legislative approximation effort and increase of institutional and human capacity is needed to accomplish establishment of a food safety system compliant with the EU and international standards. For this purpose the Government of Georgia adopted the following approach: It started implementation of previously suspended articles of the Law on Food Safety and Quality, namely those related to registration of food business operators and implementation of inspections. In February 2010, registration of food business companies started. This process will be finalized by the end of 2010 and comprehensive company data basis will be created. In July 2010 implementation of food safety legislation related to inspections of food business operators and traceability control started. With this step, implementation of all previously suspended articles of the Law on Food Safety and Quality is commenced. At the first stage, from July 2010, inspections cover food business operators oriented towards export to the European Union. At the second stage, starting from 2011, inspections and traceability control will cover all other food business operators, including high risk, feed and other companies. While implementing food safety official control Georgia will adopt a gradual approach: Initially it will ensure that basic compulsory checks as foreseen in the food safety legislation as of July 2010 are effectively implemented. In parallel Georgia will gradually approximate its food safety legislation with that of the EU to establish a legal basis for the implementation of proper inspections. To define priorities and actions of the Government of Georgia in the short and long run, the present Strategy assesses institutional and legal gaps and identifies necessary needs to address them. Consequently, it identifies a Legislative Approximation Programme with the EU legislation whereby for each relevant basic/horizontal EU legal act a legal and 5 institutional gap assessment and resources needed for approximation, training, implementation and enforcement are included. Timelines of legislative approximation are determined based on realistic assumptions taking full account of the complexity of the EU acquis in the area, as well as needs of government institutions and business community to fully establish a solid and modern food safety system in Georgia. Gradual approximation of main horizontal legislation will be accomplished by 2014. In parallel, vertical food safety legislation will be approximated with relevant vertical EU acquis and implemented. Vertical food safety legislation will be approximated and implemented based on product by product approach. At first stage, during the approximation process, GoG will identify major priority products on which the approximated EU regulations will apply. The priority products will be identified in order to encourage EU-Georgia trade. Approximation of legislation on these priority products will be undertaken in 2011 and 2012. As for the second stage of legislative approximation, the sequence of legislative approximation with vertical EU acquis for other kind of products will be defined during the elaboration of the approximation programme with vertical EU acquis. 6 1. Introduction Government of Georgia (GoG) demonstrates a genuine political commitment to establish a solid food safety system and intends to bring its legislation and institutional framework in conformity with the EU and international standards. The present Strategy aims at: a) Analysing the existing legislative and institutional framework and identifying possible shortcomings and needs. b) Describing the steps, Government of Georgia intends to take in order to introduce a solid food safety system in Georgia. c) Outlining principles and priorities by which the establishment of such a system should be guided. d) Identifying the needs, goals and challenges, associated with implementation of each component of the food safety system. e) Introducing timelines and stages in which the implementation should be ensured. For this purposes the Strategy is accompanied by the Legislative Approximation Programme. While preparing the Comprehensive Strategy and Legislative Approximation Programme in Food Safety, the GoG has taken into consideration relevant EU recommendations. The food safety area is regarded as a key priority for the proper functioning of a future Deep and Comprehensive Free Trade Agreement (DCFTA) between Georgia and the EU. Therefore, Georgia’s goal is to approximate its domestic legislative framework with relevant EU acquis. This Strategy and Legislative Approximation Programme will serve as the guiding document and the framework for further streamlining of the food safety legislative and institutional framework, and ensuring introduction of a solid food safety system in Georgia. The Strategy and Legislative Approximation Programme was prepared by the Inter Agency Working Group for the Development of the Food Safety System, created under the Commission of EU Integration of the Government of Georgia. 7 The present Strategy and Legislative Approximation Programme are living documents and may be updated in course of its implementation. The Inter-Agency Working Group for the Development of Food Safety System may elaborate further amendments to the document, taking into consideration the experience gained in the process of the implementation of the Strategy and Legislative Approximation Programme as well as changing realities on the ground and in the international context. In particular, it should be mentioned that the EU regulatory framework in the food safety area develops gradually. Therefore, Georgia will adopt a dynamic approach where necessary to follow-up on relevant developments in the European Union SPS acquis. The present Strategy and Legislative Approximation Program are based on the following basic principles: • Approximation of food safety system in Georgia with relevant EU legislation, while taking into account specific characteristics of the Georgian agricultural market structure. • Creation of competitive and dynamic agricultural sector in Georgia. • Official control based on the ‘from farm to fork’ principle, which means that it will cover the whole chain from farm level to the final consumer. • Adequate level of consumer protection. • Gradual approach in approximation of relevant horizontal EU legislation: while adhering to the ultimate goal of introduction of a modern food safety system in Georgia, a gradual approach will be applied. This means gradual implementation of food safety regulations in such a way that sufficient adjustment period is provided to both, state institutions and private sector. • A product by product approach to approximation of relevant vertical EU vertical legislation: Vertical food safety legislation will be approximated and 8 implemented product by product. Respective legislative approximation programme for the vertical legislation will be developed in 2011. • Special relaxed regulatory schemes will be established for certain categories of food business operators as regulated in the EC Regulations No 852/2004 and No 853/2004. Relaxed food safety requirements will apply to small food business operators, which: 1. Use traditional methods of production, processing and distribution, 2. Are located in geographical areas placing certain disadvantages (such as geographical constraints) and 3. Directly supply small quantities of food to local consumers. The certain categories of food business operators will be identified by risk analysis. Before applying special relaxed regulatory schemes to certain categories of food business operators, the risk analysis will be conducted. Based on risk analysis of the small food business operators will be identified on which relaxed food safety requirements will be applied. • Ensure and maintain adequate level of food security: Implementation of food safety legislation should take into account its possible impact on food security of vulnerable parts of the population. Based on the above mentioned, the aim of this Strategy is to find a proper balance between developing a solid food safety system and possible social impact of the food safety regulations. The full implementation of food safety regulations will will be accomplished by 2014, as outlined in the Legislative Approximation Programme. As far as the preparation phase of the present document is concerned, to develop a Comprehensive Strategy and Legislative Approximation Programme in Food Safety the GoG undertook the following steps: • The document was drafted in close cooperation with relevant services of the European Commission. The Strategy and Legislative Approximation Programme are based on recommendations provided by the EU Commission as a follow-up of a special EU fact-finding mission to Georgia undertaken in October 2008. The aim of the mission was to assess Georgia’s preparedness for 9 a Deep and Comprehensive Free Trade Agreement (DCFTA) with the EU. Relevant recommendations were provided to Georgia in March 2009. Two technical meetings, one video conference and a number of informal consultations were conducted between Georgian authorities and Commission services in the course of preparation of the present document. • Inter-agency Working Group on Food Safety was created. In order to involve relevant government institutions and agencies in the drafting process of the Strategy and Legislative Approximation Programme an Inter-agency Working Group was created by the decision of the EU Integration Commission. The Working Group is chaired by the Minister of Agriculture. The tasks of the Working Group have been explicitly defined as follows: Study and analysis of the international and the European experience/requirements in the area of food safety. Analysis of Georgian legislation in food safety, veterinary and plant protection and identification of possible shortcomings. Identification of priorities in the food safety sector. Elaboration of a Comprehensive Strategy for the development of the food safety system and coordination of preparatory works for its implementation. Preparation of recommendations and proposals on gradual implementation of the Georgian Food Safety Law. Monitoring and assessment of fulfillment of the EU recommendations and proposals. Members of the Working Group are representatives of the following Ministries and Agencies: Ministry of Agriculture, Advisory Group to the Prime Minister, Ministry of Labour, Health and Social Protection, Office of State Ministry for European and Euro-Atlantic Integration, the National Service for Food Safety, 10 Veterinary and Plant Protection (hereafter NS), Revenue Service (United Customs and Tax Administration). • Based on the EU recommendation, various forms of technical assistance were used to finalise the Strategy and Legislative Approximation Programme. In particular, Estonian and Finnish experts financed by the Estonian Government, Swedish International Development Agency (SIDA), Georgian-European Policy and Legal Advice Centre (GEPLAC) and UNDP Georgia were involved at various stages to work on the legislative and institutional gap assessment and draft relevant parts of the Strategy and Legislative Approximation Programme. A number of workshops and capacity building events were organized, in particular with GEPLAC assistance. • A survey of food business operators was conducted. In order to raise the Government’s awareness towards the situation in the agricultural and food safety area, and to assess private sector’s attitude towards the planned reforms in the food safety sector, a survey of food business operators was conducted. It was undertaken with the assistance of an International Finance Corporation (IFC) funded technical assistance project “Business Enabling Environment in Georgia”. The aim of the survey was to assist the Government in smooth enactment of food safety and quality control mechanisms starting from January 2010 as provided by the Law of Georgia on Food Safety and Quality. More specifically, the aim was to provide a snapshot of enterprises in the food processing sectors, levels of production, consumption, import and export by product, import and export markets, impediments for exporting, state of existing food safety practices, and costs of implementation of relevant food safety legislation. A comprehensive questionnaire had been developed in consultation with local and international food safety experts and the survey was launched in late June 2009. Final results of the survey were presented in January 2010 to the stakeholders. 11 During the preparation phase of this Strategy and Legislative Approximation Programme, intensive consultations with all relevant stakeholders were conducted. A number of meetings were organised with food business operators, NGOs and experts. These efforts were aimed at receiving timely feedback from the stakeholders and ensuring proper understanding of challenges and priorities of the agricultural sector. A number of discussions were held with Members of Parliament and various parliamentary committees. 12 2. Georgia’s Agricultural Sector Overview While drafting the Strategy the following basic features of Georgia’s agricultural sector should be taken into account: First, Georgia’s agricultural sector is characterized by a large number of employed in the sector – 50% of the total employed population. More specifically, a large amount of socially vulnerable population is employed in the agricultural sector. As far as this segment of Georgia’s population is concerned, in the past years the Government concentrated substantial effort on improving their situation through various social programmes including Targeted Social Assistance and investment in rural infrastructure such as irrigation systems and secondary roads. Vulnerability of this segment of population employed in the agricultural sector requires a careful and gradual approach while approximating Georgia’s food safety legislation with that of the EU and establishing a solid food safety system in Georgia. Second, widely spread subsistence farming in the countryside, coupled with a high degree of fragmentation of agricultural land plots, makes large private investment in agriculture challenging. This makes the sector subject to a special tailor-made approach. Agricultural holdings are relatively fragmented, both of land and livestock. Land holdings consist of family holdings and those of agricultural enterprises. Hereby, agricultural enterprises make 0,13% of the total agricultural holdings1. This means that most of the holdings are not run for commercial purposes, but for subsistence farming. Land used for agriculture production is composed of highly fragmented 4 million pieces of land, which are small and rarely exceed 1 hectare. Notably, 99.6 percent of livestock is held by families and the ownership structure is fragmented. The share of agricultural enterprises holding livestock is only 0.4 percent. 1Agriculture of Georgia 2007, Department of Statistics of Georgia, 2008 13 Such a fragmented ownership structure is a legacy of the reform undertaken in 1992, which privatized collective farms. As a result, large collective farms were dismantled and livestock was distributed to small and peasant households. This caused reduction of livestock concentration and creation of private ownership of small pieces of land. In order to encourage private ownership and investment in the agricultural sector, in 2005 the Parliament of Georgia adopted the Law on Privatization of State-owned Agricultural Land. Parallel to the land reform, property registration procedures were streamlined and one stop shop mechanism in the form of Public Registry was created. Today, registration of property, including agricultural land and property, is available online taking a single day. In addition, access to the digital database for landowners is ensured. Third, during the recent years growth rate of the Georgian agricultural sector was rather low compared to other sectors of the economy, and in some years it was even negative. In 2004-2009, average growth rate of agricultural sector was negative and amounted -2,4%, while average growth rate of other sectors was rather impressive and equalled 10% in the construction sector, 6,8 in trade, 6,2 in the mining and 4,7 in the transport sector. Thus agriculture has not been the driving force of economic growth and has not benefited from impressive growth rates of Georgia’s economy. Fourth, besides widely used subsistence farming and small scale production, there are recently developed food business companies that produce according to international standards and target Western markets. These companies are interested in the introduction of modern food safety control system in Georgia to increase their competitiveness. Fifth, export of agricultural products is gradually diversifying. Therefore, particular attention should be paid to the food safety control of products designated for export. This will help increase the competitiveness of export-oriented production in Georgia. 14 Georgia’s agricultural export increased by 13% between 2005 and 2009. In 2009 increase of the share of agricultural export in total export amounted to 27.9% (compared to 16,7% increase in 2008). In 2009 among 10 major export products of Georgia were: nuts (10% in total export), alcoholic beverages other than wine (8% in total export), wine (5% in total export) and mineral waters (3% in total export). Except these commodities, citruses, fruit and vegetable juices and non-alcoholic beverages are also among main agricultural export products of Georgia. During the last years agricultural export has been diversifying. Among new export products are: sheep, fish, greens, cabbage, spices. The share of EU in Georgia’s agricultural export amounted to 21,4% in 2009. Main agricultural export products were nuts (65,7% of total export of this product), mineral waters and non-alcoholic beverages (19.2% of total export of this product), fruit and vegetable juices (63.6% of total export of this product) and wine (18.9% of total export of this product)2. Sixth, the sector is undergoing a reform related to the introduction of food safety official control mechanisms. From July 2010 food safety official control covers food business operators oriented towards export to the European Union. Starting from 2011, inspections and traceability control will cover all other food business operators, including high risk, feed and other companies. One of the important issues of food safety control is a control of food related disease. Some infection cases on food related diseases including diseases such as E.coli, Mesophyll aerobic and Facultative anaerobic have been identified in the past years. Rapid response of the NS and relevant carried out measures ensured the detection and eradication of the food related disease. Following the information exchange rules approved by the Government of Georgia between NS and the National Center for Disease Control and Public Health of 2 Source: National Statistics Office of Georgia. 15 Georgia (NCDC), the NS rapidly responds on all human intoxication cases. There are mobile response groups operating throughout the country. Also representatives of the NS on the city or district level carry out the corresponding measures to detect and trace the source of contamination. It should be mentioned, that there is newly introduced Electronic Integrated Disease Surveillance System (EIDSS) in place to which the NS and NCDC have equal access. The EIDSS enables the NS and the NCDC to have an easy and rapid access to the cases of outbreaks in order to take relevant response measures efficiently, which enhances the monitoring system of diseases. The NS regularly presents reports on the animal health situation to the World Organization for Animal Helath (OIE). The NS is conducting active surveillance of relevant animal diseases. In order to better capture the situation and attitude of the business sector vis-a-vis the intended establishment of a solid food safety system in Georgia, a special survey of food business operators was conducted by the International Finance Corporation on the request of the Government of Georgia. The research surveyed 500 randomly sampled companies, including 437 producers, 64 exporters, and 88 importers of food products. The nation-wide stratified sample was selected from the National Statistics Office of Georgia databases of food business operators. 27, 7 % of firms were classified as high-risk and the rest was classified as low risk. 10% of firms already tried to export to the EU and 7% plan to do so. Main findings of the survey are the following: • Measures to ensure food safety and quality of food products. Most frequently, food business operators comply with the requirements of their buyers and distributors (40%), or have developed their own food safety and/or quality management systems (37%). Only 5,9% of food processing companies have introduced food safety systems according to international standards. 16 • Assignment of employees to work on food safety and quality issues. 48% of firms have employees working full-time or part-time on food safety and quality issues. 54% of companies plan to do so in the future. • The level of knowledge of the Law on Food Safety and Quality among entrepreneurs. 70,5% of respondent entrepreneurs are not familiar with the Law. 27% are in general familiar with the Law, while only 2,6% know the Law in detail. Only 4.7% of entrepreneurs provide respective trainings for their staff. Hereby, those firms who are familiar with the law are optimistic regarding its consequences. Positive impact is expected more frequently than negative impact. Namely, more than 1/3 of companies think that the law will enable them to produce safer and better quality food. One quarter hopes to gain additional domestic market share, and 19% expects that the law will enable them to comply with international requirements. One the other hand, one quarter of respondents expects increase of production costs. Only 2% of food business operators think that law will force them to close down the company or lose domestic market. • The level of knowledge of the international standards and regulations. In general, the level of awareness is relatively low. According to the survey only at most 1/5-th of the firms have a basic or detailed knowledge of international food safety standards (EU food safety and quality regulations, Codex Alimentarius, HACCP, Global GAP, ISO22000:2005, ISO9001:2008, GMP and GHP). The Level of Knowledge of International Standards and Regulations International Standards and Regulations Share of Respondents GMP, GHP 15,9% HACCP 15,2% GlobalGAP 13,2% ISO 22000:2005 20,5% ISO 9001:2008 19,4% Codex Alimenntarius 10,7% 17 EU regulations related to food safety 13,8% Overall, there are more positive, than negative expectations among the businessmen with regard to the impact of the new legislation, while the main concern is the expected increase of production costs and need of additional investment. The survey also revealed that there is a considerable information gap, which needs to be addressed through an active information campaign. To summarise, analysis of the agricultural and food sector and the results of the survey reveal that Georgia needs a tailor made approach to draw maximum possible benefit from the establishment of a solid food safety system in the country. Considerable effort is needed to ensure smooth introduction of modern food safety system in Georgia. For the increase of export and competitiveness of Georgian agricultural products, Georgia needs to gradually introduce a solid food safety system. This reform effort should be undertaken in such a manner that particular sensitivities of the agricultural sector, social aspects of introduction of international requirements and realities on the ground are fully taken into account. Relevant European and international standards allow for such an approach through gradual approximation of the regulatory framework and introduction of specific relaxed schemes for certain types of companies. 3. Implementation of Food Safety Official Control The institutional framework of the food safety system in Georgia consists of a number of institutions. Efficient coordination of activities between the following institutions is essential for the establishment of a solid food safety system in Georgia and introduction of food safety official control: • Ministry of Agriculture – responsible for policy-making in the field of food safety. 18 • Ministry of Labour, Health and Social Protection – responsible for participation in setting food safety parameters and norms and contribution to crisis management. • The National Service of Food Safety, Veterinary and Plant Protection (hereafter NS) under the Ministry of Agriculture – responsible for food safety supervision, monitoring and control. • Revenue Service under the Ministry of Finance (hereafter RS) – responsible for SPS border control. Officials performing SPS control at the border are hired by the Revenue Service. A special division for veterinary, sanitary and phyto-sanitary control was created within the Revenue Service in April 2007. This division is in charge of SPS control at the border and has authority to control and supervise daily work of phyto-sanitary and veterinary specialists of territorial units of the RS. In case non-compliance is identified during the SPS control at the border, the RS makes decision on destruction or return of consignment and immediately notifies the NS via electronic means of communication. The RS and NS regularly exchange data and information. The NS provides the RS with potential risks and methodological instructions for adequate actions. The RS provides for the NS with the information on imported products under the veterinary and phyto-sanitary control and their movement within the country. Policy in the food safety area is defined by the Government of Georgia and in particular by the Ministry of Agriculture. The division of labour between the NS and the RS is such that SPS official control activities in the country are undertaken by the NS and SPS official control at the border is the responsibility of the RS. • Laboratories - there is a system of state owned and private laboratories in Georgia, which is a part of the overall food safety system in the country. In order to establish a solid food safety system, particular attention is paid to: 19 • Registration of food business operators and development of proper company databases. • Introduction of official control mechanisms, most notably checks and inspections by the National Service for Food Safety, Veterinary and Plant Protection. • Introduction of official control at the border, in particular by the Revenue Service. • Ensuring efficient coordination between the National Service and the Revenue Service. • Further develop the system of laboratories to facilitate introduction of official control system. Hereby, implementation of inspections and traceability control of food business operators is carried out gradually. Provisions related to the inspection, traceability, creation of the system of hazard analysis and critical control points on the first stage of the implementation, from 1st of July 2010, applies only to food business operators exporting to the EU. The implementation of inspections and traceability control launched on 1 July 2010 started in accordance with the current Georgian food safety legislation, checking compliance of food business operators with quality and safety requirements established by the Georgian Legislation. From 2011 these requirements will apply to all other food business operators. In parallel, approximation of Georgian legislation with the relevant EU legislation is ongoing (according to the Legislative Approximation Programme with EU Legislation, which is the part of the Strategy). 20 3.1. Registration of Food Business Operators The registration of food business operators started on February 1, 2010. Registration requirement applies to all food business operators, which are legal persons or individual entrepreneurs, and produce food and feed for commercial purposes. As of July 2010, by the time of start of inspections 2035 food business operators were registered already out of which 64 food business operators are producing products designated for export to the EU and 279 companies are producing high risk products. Registration of food business operators is ongoing and will be finished by the end of 2010. It is the priority of GoG to create a sophisticated database of food business operators. Company registration, including individual entrepreneurs as well as other legal entities is conducted by the National Agency of Public Registry – an agency under the Ministry of Justice responsible for enterprise registration which has adequate institutional capacity and experience in handing databases. The registration authority is obliged to ensure transparency and accessibility to the database. The NS has full access to the database of registered food processing operators. The registration authority has branches in all regions of the country. Accordingly, companies have possibility to register at a local branch avoiding additional costs related to transport, time etc. An online facility is being elaborated through which food business operators can access the registration forms and introduce relevant company data electronically. 21 3.2. Inspections Performing Official Controls For the purpose of this Strategy, pursuant to the EC regulation No.882/2004 official control is defined as any form of control that the competent authority performs for the verification of compliance with food safety related legislation. Inspections are carried out by the National Service for Food Safety, Veterinary and Plant Protection. At the first stage, from July 1st, 2010, inspections cover food business operators oriented towards export to the European Union. At the second stage, starting from 2011, inspections and traceability control will cover all other food business operators, including high risk, feed and other companies. Both the first stage of inspections performing official control launched on 1 July 2010 and the second stage foreseen to start as from 1 January 2011 are carried out in accordance with Georgia's food safety legislation. In parallel, approximation of Georgian legislation with the relevant EU legislation is ongoing (according to the Legislative Approximation Programme with EU Legislation, which is the part of the Strategy). The entire food safety system and in particular official control activities by the NS will be based on the ‘from farm to fork’ principle. This means that the entire chain of production starting from the farm level to the final consumer will be covered, including the stages of farm production, transportation, storage, distribution, delivery to the final consumer etc. In addition, the NS performs monitoring of food safety and quality under the official control activates. In the framework of special Food Safety Monitoring Programme 2010, monitoring of domestic retail markets is conducted by the NS. According to the above-mentioned Programme, the priority has been given to pesticide residue monitoring in food. Thus, the programme on pesticide monitoring in food products has been launched by using the local accredited laboratory capacities. All the veterinary medicines are registered at the NS. The NS periodically publishes the information on permitted vet medicines in Georgia. Those veterinary medicines 22 not registered by the NS are strictly forbidden by Georgian legislation for production, sale or export. While implementing food safety official control, Georgia will adopt a gradual approach: Initially Georgia will ensure that basic compulsory checks as foreseen in Georgian food safety legislation as of July 2010 are effectively implemented. In parallel food safety legislation will be gradually approximated with relevant EU acquis to establish a legal basis for the implementation of proper inspections. This will contribute to the creation of a solid food safety system in Georgia. Timelines of legislative approximation are determined based on realistic assumptions taking full account of the complexity of the EU acquis in the area, as well as gaps and needs of government institutions and business community to fully establish a solid and modern food safety system in Georgia. Gradual approximation of main horizontal legislation as included in the Legislative Approximation Programme will be accomplished by 2014. In parallel, a program of approximation with vertical EU acquis in the food safety sector will be prepared in 2011. Approximation with vertical EU legislation will be based on the product-by product principle. At first stage, during the approximation process, GoG will identify major priority products on which the approximated EU regulations will apply. The priority products will be identified in order to encourage EU-Georgia trade and Georgia’s potential and needs. Approximation of legislation on these priority products will be undertaken in 2011 and 2012. As for the second stage of legislative approximation, the sequence of legislative approximation with vertical EU acquis for other kind of products will be defined during the elaboration of the approximation programme with vertical EU acquis. This programme will be a living document, and will be subject of revision, according to the needs and changes in the relevant EU acquis. As it was mentioned above, the main approximation process of vertical legislation with EU acquis will be made in parallel with approximation process of horizontal legislation. 23 From the 1st of July 2010 National Service is authorized to conduct basic checks of food business operators oriented towards export to the EU. For this purpose NS developed an inspections plan for 2010. Planned checks of export-oriented companies will be undertaken according to this plan. The basic legislation regulating official control mechanisms including inspections is composed of, among others, the Law on Food Safety and Quality, Government Resolution on General Hygiene Rules for Food/Feed Business Operators and Government Resolution on Official Control, Monitoring and Surveillance laying down the rules and procedures governing official control activities. Further active legislative work is planned to bring the existing legislation in conformity with EU requirements and adopt new pieces of legislation in areas where gaps exist (for a detailed overview see the chapter on legislative gap analysis and the Legislative Approximation Programme). Georgian legislation envisages two types of inspection: planned inspections carried out regularly based on the priorities established under the risk assessment and laid down in annual inspection plans, and ad hoc inspections, carried out without prior warning, when there is sufficient doubt that food/feed is not in conformity with the safety norms. National Service has the responsibility for elaboration of risk assessment, and management and communication of risks. Hereby, elaboration of risk assessment methodology can be outsourced to the third party whereby introduction and implementation of risk assessment is under the responsibility of the NS. The third party may be a scientific or any other relevant institution, or qualified experts who provide necessary expertise and assistance for elaboration of risk assessment. In that case if such a decision is made in the future, the coordination of risk assessment activities should remain under the responsibility of the NS. 24 The frequency of annual planned inspections by the NS depends on the risk categories of food business operators (risk based approach). As a matter of principle, high risk companies are inspected more frequently than all other companies. Planned inspections are implemented by the NS in compliance with the annual plan, which will be approved by the Ministry of Agriculture of Georgia and will include: • Criteria for elaboration of the planned inspection program. • Quantity and type of the inspections to be conducted. The NS is entitled to carry out inspections without prior warning, in certain cases regulated in the secondary legislation. In all cases inspection protocols are prepared by inspector on the spot and co-signed by the food business operator. Comprehensive description of terms and procedures for inspections are provided in the secondary legislation adopted by the Georgian Government in June 2010, namely Government Resolution on Official Control, Monitoring and Surveillance. Annual Reports on the results of inspections will be presented by the NS to the Ministry of Agriculture of Georgia. These reports shall include: • Quantity and type of conducted inspections and their compliance with the approved plan. • Quantity and type of revealed violations. • Measures implemented in response to the violations revealed. In case of non-compliance with relevant food safety regulations, NS inspectors have several options to act. The type of measures undertaken by the NS depends on the scale of violation of food safety requirements and can include the following actions: • Elaborate recommendations and give reasonable time frame to food business operator to eradicate non-compliance. 25 • Suspend placement of the food and feed on the market. • Temporarily suspend the operations of food business operator. • Withdraw/remove of the products from the market. • Introduce fines for food business operators. At the present stage it is Government of Georgia’s priority to streamline and strengthen the institutional system in charge of food safety official control. This entails: • Institutional strengthening and capacity increase of the NS. • Institutional strengthening and capacity development of the RS. • Further improvement and intensification of coordination between the NS and RS. • Adequate involvement of all official institutions in the establishment of a solid food safety system in Georgia . The above-mentioned will be achieved through streamlining of the entire institutional system including all components, approximating domestic legislation and implementation practice with EU requirements and increase of human capacity in relevant official institutions. Budgetary resources as well as various types of assistance programmes will be deployed with this purpose. At a later stage, the Government might consider development of necessary legal basis to enable involvement of private control bodies in the overall official control system. The above-mentioned legislative basis, if and when created, will be approximated with the relevant EU legislation, namely EC regulation No. 882/2004. The latter introduces the term ‘Control Body’ and defines it as an independent third party to which the competent authority delegates certain control tasks. According to the international practice, independent third parties include private inspection bodies and private laboratories. 26 In case private control bodies are introduced in Georgia at a later stage, overall official control system will be implemented based on the following principles. • Activities of private inspection bodies will not substitute the activities and functions of the National Service. In certain cases they will only supplement the official control activities of the NS. • Future possible private control bodies will act under the strictest supervision of the NS and only in those areas where NS delegates certain tasks to them. • Overall responsibility for the existence of a solid food safety system in Georgia will remain with the Government of Georgia, the NS and RS. • In order to be able to perform official control tasks, future possible control bodies have to be accredited by the Georgian Accreditation Centre (GAC ) in accordance with European Standard EN 45004 ’General criteria for the operation of various types of bodies performing inspection,’ have to hold ISO 17 020 ’General criteria for the operation of various types of bodies performing inspection,’ or be accredited by the relevant authorities of the EU and OECD countries. 3.3. Veterinary and Phyto-sanitary Border Inspections and Cooperation between the National Service and the Revenue Service The objective of phyto-sanitary and veterinary border control is to safeguard animal and public health and the environment from diseases, pests and contaminants that may enter Georgia through import or transit of live animals, plants and products of animal and plant origin. To this end an efficient, transparent and risk based border control regime should be applied, facilitating free but safe international trade in line with EU SPS requirements and best practices. According to primary legislation of Georgia (Georgian Laws On Veterinary, On Agricultural Quarantine, and Customs Code) Revenue Service of the Ministry of 27 Finance (RS) implements official phyto-sanitary and veterinary border-quarantine control based on rules defined by the Ministry of Agriculture. Issues related to phyto-sanitary and veterinary border control, cooperation mechanisms and division competences between the National Service and Revenue Service are regulated by the Joint Order N987-N2-184 of the Minister of Agriculture and Minister of Finance approved on the 31st December 2008 (hereafter Joint Order). The sphere of competence of the RS is defined as the operational/implementing authority, and that of the Ministry of Agriculture as the policy making authority. According to the Joint Order, it is in the competence of the veterinary or phyto sanitary officer of the RS to undertake documentary check, identity check, and physical check as well as laboratory sampling. This joint order was elaborated with the assistance of an EU funded technical assistance project aimed at streamlining secondary customs legislation and SPS border control issues. From July 1, 2009 the RS started to undertake full identity as well as physical checks, and if required laboratory sampling of import food products. Full identity check includes visual inspection to ensure that the veterinary or phyto-sanitary certificate(s) or other document(s) required by the Georgian legislation correspond to the product itself, as well as check of the presence and conformity of the marking which must appear on the animals or on the packaging of products. The procedure also includes thorough examination of transportation means. At the border all consignments (except those consignments which were chosen according to the monitoring plan, and consignments which are conveyed via train) are subject to documentary and identity checks. The RS officer (phyto-sanitary or veterinarian specialist) performs physical check, if results of documentary and identity checks are unsatisfactory. Such physical check is performed at the border premise (Border Inspection Post (BIP)). 28 All consignments which were chosen according to the monitoring plan, and consignments which are conveyed via train are subject to documentary check at the border premises, however identity check for these kind of consignments is undertaken at the in-land premise (Customs Clearance Post). Consignments which were chosen according to the monitoring plan, and consignments which are conveyed via train and passed the documentary and identity checks, are the subject to physical check undertaken by the RS based on risk assessment at in-land premises. There are designated special parts of premises where phyto-sanitarian or veterinarian specialists prepare goods for sample taking and transporting samples and perform visual examination of goods via Binocular (stereomicroscope). These rooms are equipped by equipment, which were purchased by the RS (e.g. Microwave, Refrigerator, Thermometer, Hammer, Cold boxes, Seals (metal/plastic), Sealing tape, Pinsetter and etc) in 2009. The EU compliant standard list of equipment is purchased under project funded by the World Bank. The building design projects for two land border inspection posts and also virtual model for border inspection post and border crossing point were elaborated by Estonian experts in the framework of project funded by the World Bank. Monitoring plans are worked out based on statistical data of previous year. RS takes into account quantity of goods subject to control which were moving via each BIP in the previous year. Monitoring plans of the RS are agreed with the NS. In order to develop monitoring plans, RS used the assistance of an EU funded technical assistance project to the secondary customs legislation and SPS import control. As for the cooperation mechanisms between the National Service and Revenue Service, according to the Joint Order, RS has obligation to regularly send information to the NS which consists of data on consignment, serial number of control act and 29 results from checks. Based on this information the monitoring plan should be updated, adjusting the frequency of physical checks and sampling at the border points. Positive results of tests, undertaken either based on monitoring plan or due to a suspicion, are immediately notified by the RS to the NS. In this case, the NS should re-examine the case, and provide the RS with relevant notification. The RS has obligation to take into account the notification of the NS and accordingly either continue, stop or prohibit the clearance process of these goods. In case of urgent situations, communication and cooperation between the RS and the NS is performed via electronic means. The contact points are identified within the services via which such type of communication is done. In case non-compliance is identified during the SPS control at the border, the RS makes decision on destruction or return of consignment and immediately notifies the NS via electronic means of communication. As it was mentioned above the RS and the NS regularly exchange data and information. The NS provides the RS with potential risks and methodological instructions for adequate actions. The RS provides the NS with the information on imported products under the veterinary and phytosanitary control and their movement within the country. It is planned to introduce automated decision making system before the end of 2010 for choosing consignment which has to be controlled according to a monitoring plan. This process will be undertaken based on Automated System of Customs Data. 30 31 3.4 System of Laboratories in Georgia The effective functioning of the national system of laboratories is one of the crucial components to support establishment of a solid food safety system in Georgia. The national system of laboratories in Georgia consists of public laboratories as well as private laboratories. In general, the majority of public laboratories are responsible for veterinary and disease control. As for the private laboratories, they provide laboratory testing only on food, alcohol and non-alcohol drinks. The aim is to create a unified system of laboratories with a clear division of competences among various laboratories and a well developed cooperation and information flows between the laboratories and official institutions responsible for food safety control, such as the NS and the RS. Currently, all the control, detection and surveillance of animal diseases are provided by the State Unified System of Laboratories on Identification of Reasons of Especially Dangerous Infections, Epidemic Supervision and Response. The State Unified Laboratory System was established according to the Law on Public Health adopted in June, 2007 and Governmental Decree #36 dated February 22, 2008. The State Unified Laboratory System is supervised by the Coordination Board, statute of which is adopted by the Government of Georgia (252 Decree of Government, November 15, 2007). It consists of high-ranking representatives of Georgian Government and chaired by the Minister of Labour, Health and Social Protection (159 Decree of Government, July 30, 2008). The State Unified Laboratory System consists of laboratories with different bio-safety levels. The Coordination Board of the State Unified Laboratory System facilitates coordination and cooperation between these laboratories. It should be emphasized that all laboratories under the State Unified Laboratory 32 System provide all necessary information to the Coordination Board on regular basis. The State Unified Laboratory System consists of: 1. National Center for Disease Control and Public Health of Georgia (NCDC). NCDC consists of 3 zonal and 3 regional field laboratories. There are 3 zonal laboratories under the NCDC, namely: • National Laboratory on Disease Control (Tbilisi) • Zonal Laboratory (Kutaisi) • Zonal Laboratory (Batumi) As for the 3 regional field laboratories, they are already built and it is planned to renovate them. It should be emphasized, that 5 regional field laboratories will be established under the NCDC by the end of 2011. 2. A number of Public Veterinary Laboratories under the Ministry of Agriculture such as: • Zonal Diagnostic Laboratory in East Georgia (Tbilisi) • Zonal Diagnostic Laboratory in West Georgia (Kutaisi) • Zonal Diagnostic Laboratory in South-West Georgia (Akhaltsikhe) • 8 Field Laboratory Stations almost in all of the regions of Georgia. The above-mentioned laboratories under the Ministry of Agriculture and NCDC under the Ministry of Labour, Health and Social Protection are dealing with Especially Dangerous Pathogens (EDPs) and function under the Biological Threat Reduction Programme (BTRP). This programme started in 2002 under the Department of Defense of the US, namely, Defense Threat Reduction Agency (DTRA). The aim of the Programme is consolidation of pathogens into safe and secure laboratories and integration of scientists into the high-technology research environment. It should be mentioned that under the Biological Threat Reduction Programme (BTRP), Central Reference Laboratory (CRL) will be established. The construction of the Central Reference Laboratory in Tbilisi (Alexeevka) is scheduled to be completed 33 by October 2010. CRL will have reference testing function. Bio-safety level of this laboratory is 3. About USD 60 million has been allocated for its construction. Furthermore, upon request of the Ministry of Agriculture the World Bank (WB) is funding the project aimed at establishment of the capacity within Veterinary Zonal Diagnostic Laboratory in Tbilisi for the purpose of testing food from safety point of view including plant origin products. This project will be completed by the end of 2010. It should be emphasized that besides the above-mentioned laboratories there are also other state laboratories, namely: • Samkharauli National Forensics Bureau under the Ministry of Justice, which provides state expertise on food, alcohol and non-alcohol drinks. • Institute on Gardening, Vine-growing and Wine-making under the Ministry of Agriculture, which provides laboratory testing on food and alcohol drinks. • Laboratory of Ministry of Agriculture of Autonomy Republic of Adjara, which provides laboratory testing on food, alcohol and non-alcohol drinks. • Institute of Sanitary and Hygiene, which provides laboratory testing on food and non-alcoholic drinks. • Wine Laboratory, which is able to provide only alcohol laboratory testing. As it was mentioned above, besides public laboratories, there are 13 private laboratories. These laboratories are accredited on food, alcohol, and non-alcohol drinks and a number of them provide testing of residues (e.g. pesticides) and contaminants, namely: • 10 laboratories are able to provide only food (including water and non-alcohol drinks) laboratory testing. • 3 laboratories provide alcohol laboratory testing as well as food. 34 Laboratories in Georgia are accredited by the Georgian Accreditation Centre (GAC). GAC is a legal entity of public law under the state supervision of the Ministry of Economic and Sustainable Development of Georgia. Operation of GAC is based on international standard ISO/IEC 17 011. GAC offers accreditation of Conformity assessment bodies in different fields according to the following standards: • ISO/IEC 17025:2006 General requirements for the competence of testing and calibration laboratories • EN 45011 or ISO/IEC Guide 65 General requirements for bodies operating product certification systems • ISO/IEC 17021 Conformity assessment -- Requirements for bodies providing audit and certification of management systems • ISO/IEC 17024 Conformity assessment -- General requirements for bodies operating certification of persons Accreditation according to the following standard will start soon: • ISO 15189 Medical laboratories -- Particular requirements for quality and competence GAC is an affiliate member of International Laboratory Accreditation Cooperation (ILAC) and signatory of Contract of Co-operation with European Cooperation of Accreditation (EA). GAC is actively working to become a full member of the EA. Since 2008, GAC with assistance of TACIS project promotes the laboratories to participate in proficiency testing organized by international proficiency testing providers. For the development of effective system of laboratories, GoG requested Comprehensive Institution Building (CIB) for the Georgian Accreditation Center. The CIB will aim at ensuring effective institution-building of the GAC. With the aim to achieve the goal of developing a unified system of laboratories mentioned above, a special intra-agency working group on laboratories was created in 35 June, 2010. The working group consists of representatives of relevant state authorities as well as representatives of laboratories. The working group evaluates gaps in the system of laboratories in Georgia, identifies basic needs for development of the system of laboratories, and determines future steps for enhancing and streamlining cooperation between laboratories and relevant state institutions such as the NS and the RS. In parallel to the work of the above mentioned group two different gap assessments are being undertaken to analyze the needs in the system of laboratories. One of them is assessment of institutional gaps in food safety area, which is being prepared by an Estonian expert. This gap assessment includes gap analysis of the system of laboratories as part of the entire food safety institutional framework in Georgia. As for the second document, it reflects gap analysis in the system of laboratories and is being prepared by the new contractor of DETRA. Based on these two gap assessments, future needs regarding development and effective functioning of laboratories will be identified by the inter-agency working group. 36 3.5. Relaxed Regulatory Schemes for Small Businesses The food safety legislation of the European Union and in particular the EC Regulations No 852/2004 and No 853/2004 provide for the creation of special, more relaxed regulatory environment for small enterprises producing, processing or distributing food. Special relaxed schemes apply if food business operators: 1. Use traditional methods of production, processing and distribution 2. Are located in geographic areas placing certain disadvantages such as geographical constraints 3. Directly supply small quantities of food to local consumers Guided by relevant EU legislation and best EU practice the Government of Georgia will introduce special regulatory environment for certain types of small food business operators. Before applying special relaxed regulatory schemes to certain categories of food business operators, the risk analysis will be conducted. Based on risk analysis the small food business operators will be identified on which relaxed food safety requirements will be applied. The main rationale behind the need for the relaxed regulation schemes is to ensure the viability and competitiveness of small food business operators in Georgia and avoid undue burden on them, as well as to preserve traditional methods of production closely intertwined with country’s history and culture. In more detail, the relaxed regulatory schemes will apply to small food business operators of the following categories: 1. Traditional national food production, processing and distribution. Georgia has a long-standing history of national food production and processing. Georgian cuisine as diverse as it is across Georgian regions has been prominent worldwide for its authenticity. It is part of Georgia’s cultural and historic heritage and is one of the main tourist attractions of the country. In this regard, preserving traditional methods of food production, processing and distribution is an important priority 37 for the Government of Georgia. For this reason, the Government will identify a list of the food/product groups characterized as ‘traditional national production’, which will fall under the relaxed food safety regulatory scheme. The list of traditional national products will be set up by the end of 2010. 2. Food business operators with special geographic constraints placing them in unequal conditions (transportation, production conditions, etc). Georgia is a mountainous country and part of the population lives in the high mountainous regions. Due to the geographic and climatic conditions, permanently or temporary during the year, and with the aim of creating sufficient conditions for sustainable development of these regions and decent life conditions for their population, Georgian legislation has introduced special approaches towards these regions in various fields. The main legislative framework in this direction was created in 1999 when the Parliament adopted a Law on Social-Economic and Cultural Development of the High-Mountainous Regions. The law defines the height level of the regions (generally 1500 meters above the sea level) and contains specific list of regions specified high-mountainous regions. The Government of Georgia considers this legal basis as a baseline for the definition of the geographic locations to which the food safety relaxed regulatory regime will apply. 3. The direct supply, by the producer, of small quantities to the final consumer or to local retail establishments directly supplying the final consumer. The precise share of food business operators qualifying in the categories mentioned above will be determined by the end of 2010 once the registration of food business operators is finalized. A special secondary legislation in form of Government Resolution was adopted in the 3rd quarter of 2010 to regulate requirements applied to the above-mentioned categories of food business operators. 38 39 3.6. Monitoring System on Animal Diseases Georgian Law on Veterinary, which was adopted in 1995, regulates the monitoring system of animal diseases. Official veterinary control and monitoring are carried out in Georgia by the NS (See report on activities in the Annex 3). Border control on import/export of animals is carried out by the RS. Veterinarian officers of the RS undertake documentary, identity check, and clinical examination during the importation of live animals. Clinical examination is performed based on risk assessment. To guarantee animal health and improve animal diseases monitoring mechanisms, registration of animal holdings started from 2010 and is ongoing. In the framework of animal disease surveillance the NS prior to each upcoming year elaborates special contingency plans in relation to the main diseases of concern, such as anthrax, foot and mouth disease (FMD), brucellosis and rabies. According to the identified risk zones the vaccination campaign is implemented with regard to every disease. Concerning rabies the NS conducts each year preventive vaccination of domestic animals such as cats and dogs. In order to detect brucellosis in cattle, the NS carries out the serology monitoring activities. In relation to FMD the NS regularly implements disease control measures. Thus, animals are vaccinated in buffer zones mostly in the cross border areas. Notably, vaccination campaigns are executed with the involvement of certified private veterinarians under the supervision by the NS staff. Animal health monitoring is regularly carried out. During 2006-2009, state programme was implemented for preventive measures against animal diseases (brucellosis, tuberculosis, etc). Among others, measures for eradication of African Swain Fever (hereafter ASF) were carried out. ASF was suspected based on epizootic, clinical and patanatomic signs. All appropriate state authorities have been involved in the implementation of the action plan in order to eradicate the disease and avoid its further 40 spread. Restrictions and relevant control measures have been carried out in relation to movement of animals and animal origin products. In the framework of the FAO technical assistance project for the Control of ASF in 2009 (TCP/GEO/3103), the Laboratory of the Ministry of Agriculture have tested samples of domestic pigs, samples of wild boar and ticks. The laboratory testing was conducted by the use of PCR method. It should be mentioned that for enhancing monitoring system of animal diseases, the BTRP envisages an introduction of Electronic Integrated Disease Surveillance System (EIDSS) from animal as well as from human health standpoint. The EIDSS enables NS and (National Center for Disease Control) NCDC to have an easy and rapid access to the cases of outbreaks in order to take relevant response measures efficiently. The staff of NS and NCDC is undergoing appropriate trainings of managing the mentioned information system. DTRA will assist the NS and NCDC in introduction of EIDSS program first in the regional offices and further on the level of districts. The EIDSS is the system that will allow the NS, the Laboratory of the Ministry of Agriculture (LMA) and special services of the Ministry of Labour, Health and Social Protection, to enforce effective information and data exchange mechanisms with the aim to have rapid response in place with regard to high pathogenic diseases, as well as communicable diseases. 41 3.7. An Early Warning System and the Link to the EU Rapid Alert System for Food and Feed (RASFF) On 3 December, 2008 order of the Prime Minister on Measures for the Provision of the Integration in the EU Rapid Alert System for Food and Feed (RASFF) was adopted. Thus Georgia has become a member of the EU RASFF system. The National Service has its own window and code that are used to exchange information. Accordingly, the contact person for RASFF has been appointed in the National Service of Food Safety, Veterinary and Plant Protection. The special contact point is responsible for risk communication with EU member states. There is a well established communication between the National Service and the Revenue Service. Alerts received through the RASFF are rapidly sent to the Revenue Service where necessary and relevant response is prepared by the National Service. The system assists the NS in taking relevant information on the products traded within and outside of Georgia. Thus, the Service is able to take prompt and adequate response to the threats which are detected and communicated via RASFF. Designated contact person in the National Service provides the EU RASFF system with the following types of information: • Alerting notification in case there is alarming threat stemming from food/feed placed on the market. • Informational notification in case the threats associated with food/feed placed on the market is estimated, but the products are not any more on the market. • Any type of information not communicated through alerting and informational notifications. • Information on import products originated in foreign countries in case such import is declined and products are returned back to their country of origin. 42 Notifications are accompanied by detailed information about the measures implemented, planned and/or recommended with the aim to handle the risks associated with food and feed. In order to fulfill WTO transparency obligations, Government of Georgia sends notifications on creation or modification of SPS measures. 4. Institutional Gap Analysis and Identification of Future Needs 4.1. National Service for Food Safety, Veterinary and Plant Protection The Georgian Law on Food Safety and Quality, adopted by the Parliament of Georgia in December 2005, established the National Service for Food Safety, Veterinary and Plant Protection (NS) by the way of unifying different institutions under the Ministry of Agriculture. Thus a unified institutional structure, responsible for SPS control was created. At present, the NS consists of the Veterinary Supervision Department, the Plant Protection Department, the Food Safety and Quality Supervision Division and several other supportive divisions such as administrative, legal, economic etc. The NS is managed by the Head of the Service and two Deputy Heads. National Service has a head office in Tbilisi and 58 district divisions throughout Georgia. The National Service currently employs 314 persons, including the staff in district offices. The NS has suitable physical resources at the central level and in some district offices. Necessary physical infrastructure and facilities in most district offices need further investment and upgrade. Organizational and institutional structure of the NS needs further improvement as there are several gaps in the institutional arrangement reflected in inefficient inner and outer communication and command chains. It is essential to streamline the structure and develop a clear chain of command. Some of the functions of the Veterinary 43 Supervision Department overlap with the essence of the food safety. In addition, supervision and assignment tasks of the two deputies in respect to departments and divisions are not clearly defined. Further structural inefficiencies exist such as the Risk Management and Communication Division is outside the Veterinary Department and Food Safety Division, Finance and Accounting Division is under NS Head while the Procurement and Economic Division is under Administrative Department. Currently, NS is under reorganization regime to be completed by September 2010. The aim of the reorganization effort is to streamline the structure and remove existing inefficient practices of management. Professional competency of the staff at this stage can allow for appropriate administrative activities of the NS. However, with gradual extension of activities and additional functions of the NS associated with further approximation of Georgia’s legislation with that of the EU and introduction of full-scale official control mechanisms, improvement of staff skills and capacity acquires increased relevance. Particular attention should be paid to structured and systemic training of the NS staff. Specialised trainings as well as field trips to relevant institutions in EU member states will be necessary to broaden and improve qualification of the staff. It is important to build local capacity of trainers to address human capacity issues in a sustainable manner. Train the trainers’ manual, developed in cooperation with GTZ in 2010 will be utilized in this respect. The amount of district offices seems to be quite large, while duties performed by the district officials may not be adequate. Some consolidation of duties at the district level may be necessary to make possible delivery of better services by the NS. Risk analysis capacity is essential for the activities of the NS as official control should be performed based on the risk assessment. No proper risk assessment is provided yet neither in the food safety nor in the veterinary and plant protection. Special training in risk assessment is required. To facilitate adequate risk assessment, management and 44 communication functions performed by the NS, a well developed database of food business operators and their regular analysis is needed. National Service needs to develop an efficient coordination and cooperation with other institutions in the area in order to establish a solid food safety control system in Georgia. In particular coordination is essential with the Revenue Service under the Ministry of Finance, which performs official control at the border and Public Registry under the Ministry of Justice, which registers food business operators. Currently this coordination exists to a considerable degree but needs to be further improved and streamlined. Further collaboration will be essential in access to and sharing of company databases, where development of interconnected information will allow all three institutions to implement the food safety management in a regular and sophisticated way. Upgrade of physical infrastructure is essential for the efficient implementation of food safety official control activities. The NS has suitable physical resources at central level, but lacks recourses at the local level, including inadequate facilities and insufficient amount of telecommunication means at the majority of district level offices. Construction of new offices at district level is planned under the support of World Bank. In total 10 new offices will be constructed and equipped at district level and 680 000 USD will be spent. Construction will be finalized in 2011. In addition a prioritized list of infrastructure and equipment as well as related budget requirements needs be developed for the medium to long term. 45 46 4.2. Revenue Service Food safety, veterinary and phyto-sanitary border control is performed by the Revenue Service. The latter belongs to the system of the Ministry of Finance. Officials performing SPS control at the border are phyto-sanitary and veterinary specialists hired by the Revenue Service. A special division for veterinary, sanitary and phyto-sanitary control was created within the Revenue Service in April 2007. This division is in charge of SPS import control at the border and has authority to control and supervise daily work of phyto-sanitary and veterinary specialists of territorial units of the Revenue Service. Currently phyto-sanitary and veterinary border control is undertaken at 14 out of 17 border crossing points. Coordination and division of competences between the NS and RS is regulated by the Joint Order of the Minister of Agriculture and Minister of Finance. There is a need to further streamline coordination and communication flows between the National Service and the Revenue Service in practice. Joint action plan for development of very efficient cooperation between the RS and NS for urgent situations will be elaborated. Revenue Service pays particular attention to the increase of staff efficiency as well as upgrade of infrastructure necessary for SPS control at customs check-points. As a first step, an evaluation of investment needs including building projects at land border points has been made in cooperation with Estonian experts in the framework of a project funded by the World Bank. The aim is to build and equip with necessary infrastructure at least one land customs check-point at the border with each neighbouring country. Preliminary estimation of the required investment needs is up to 10 mln USD, which needs to be further specified. Building and equipment at land check-points will be financed partly from the State Budget and partly from external fund. As a second step, evaluation of investment needs for establishing and/or upgrading necessary infrastructure for phyto-sanitary and 47 veterinary control in customs check-points in ports and airports will be undertaken in 2011. Capacity and institutional needs will be addressed in a systemic and structured way in the framework of a twinning project to be commenced in the 1st quarter of 2011. 4.3. Laboratories There are government owned and private laboratories in Georgia. For major zoonooses and animal diseases the national Service has possibility to use laboratory services to obtain a correct diagnosis. All laboratories are very well equipped and maintained. The laboratory staff is well trained and receives continuing education. Some laboratories used by the NS are utilizing formal quality assurance systems, some private laboratories are accredited according to ISO 45001. However, the current capacity of the laboratories is not fully used. There is also a need to improve coordination schemes between the National Service, the Revenue Service and the laboratories. Two different gap assessments are being undertaken to assess the needs in the system of laboratories, namely: 1. A detailed and comprehensive assessment of institutional gaps and future needs is being prepared by an Estonian expert, specifically invited to Georgia for this purpose. This gap assessment includes gap analysis of the system of laboratories as a part of the institutional framework for food safety in Georgia. The assessment will be finalized in 4th quarter 2010, and will provide a solid basis for future actions by the Georgian Government and donors in the area. In particular, the institutional gap assessment will serve as a guiding document for future activities of the Comprehensive Institution Building (CIB) program to be launched in 2011. 2. The second document on gap analysis of the system of laboratories will reflect and assess the situation of the laboratories in the following directions: the equipment of 48 the laboratories, human recourses, infrastructure, established diagnostic methods, etc. The document on gap analysis of the system of laboratories3 will be elaborated by the new contractor of the US Defense Threat Reduction Agency (DETRA). This gap analysis will be submitted to the Government of Georgia by the end of 2010. Based on these two gap assessments future actions regarding development and effective functioning of laboratories will be identified by the Government of Georgia in order to streamline horizontal and vertical cooperation of the laboratories among each other and their cooperation with the NS and RS. 3 CH2M Hill, which is a new contractor of DETRA, with its subcontractors (BATTLE, Curatio International Foundation), is working on elaboration of a document on gap analysis of the laboratories established under the Biological Threat Reduction Program (BTRP). 49 5. Legislative Gap Analysis and Future Legislative Actions by the GoG The Georgian food Safety legislation lays down the general principles of food and feed safety, and is partially in line with the relevant EU legislation. There are a number of issues which still need to be included into the legislation and relevant update and approximation of the national legislation with international and EU regulations is required. For this purpose, the Government of Georgia is intensively working on the elaboration of normative acts, which ensures establishment of a solid food safety system and makes the legislative base and its implementation compliant with European and international regulations. It should be emphasized, that in Georgia SPS related legislation consists of primary legislation and secondary legislation. Primary legislation includes laws whereas secondary legislation consists of normative acts such as: orders of relevant authorities and government resolutions. It was decided that, as SPS related issues are of cross agency nature and touch competences of several state authorities such as National Service of Food Safety, Veterinary and Plant Protection under the Ministry of Agriculture, Ministry of Labour, Health and Social Protection, Ministry of Environmental Protection, Revenue Service under the Ministry of Finance, Georgian Accreditation Center and National Agency of Technical regulations, Standardization and Metrology under the Ministry of Economy and Sustainable Development, major secondary legislation in SPS area should be approved in form Government Resolutions instead of orders of separate Ministers and Heads of Agencies. Having carefully and thoroughly analysed existing domestic legislation and relevant EU acquis drawn necessary international expertise, the Government of Georgia decided to approximate the EU legislation in a gradual manner. At the first stage, before the start of official inspections on the 1st of July 2010, the following necessary legal acts were drafted and adopted by the Government of Georgia to ensure proper enforcement of inspections and traceability related measures: 50 • Order of the Ministry of Justice on Registration of Enterprises • Government Resolution on General Hygiene Rules for Food and Feed Business Operators • Government Resolution on Official Control, Monitoring and Surveillance • Government Resolution on Destruction of Food and Feed During the elaboration of the above-mentioned legal acts, Working Group took into consideration relevant horizontal EC regulations (EC Regulation 178/2001, EC Regulation 852/2004, and EC Regulation 882/2004). The aim was to bring the secondary legislation in conformity with EC regulations and streamline the legislative base including methods for hygienic requirements, inspections, sampling and testing, monitoring etc. Streamlined new rules will serve for better coordination and fulfillment of official control activities, including official inspections. The legal acts were enacted in June, 2010 and implementation of inspections related legislation started on 1st of July, 2010. Government Resolution on special relaxed schemes for small food business operators was adopted in 3rd quarter 2010. The process of drafting and elaboration of relevant secondary legislation is ongoing. Currently, a specially created Working Group is drafting Government resolution related to the general plan for food/feed crisis management, which should be adopted on the 4th quarter of 2010 as it is envisaged by the Legislative Approximation Programme. The Law of Georgia on Food Safety and Quality includes general requirements for food/feed crisis management. However, this issue should be reflected in Georgia’s relevant legislation in a more detailed manner. For these purposes, Government Resolution will be elaborated and adopted in conformity with Commission Decision 2004/478/EC. In addition to the legislative working process described above, substantial resources will be dedicated in 2010 to draft amendments to the Law on Food Safety and Quality 51 and the Law on Veterinary. These laws need to be amended as they are only partially approximated with relevant EC regulations. There are a number of legislative gaps in the above-mentioned laws, for example: most of the definitions related to official control are not explicitly stated but implied by the Law, thus leaving room for possible misinterpretation; clear definitions of official control and its terms and conditions are lacking. As the Law on Veterinary was adopted in 1995, much earlier than the Law on Food Safety and Quality, it needs first harmonization with the food law, and second approximation with relevant international and EU requirements. There are a number of inconsistencies between the Law on Food Safety and Quality and the Law on Veterinary. Such inconsistencies concern, among others, different definitions of the scope of official control and non-uniform definition of institutional framework in food safety and veterinary, especially against the background that one institution, the NS, is responsible for both areas. Law on Veterinary was adopted much earlier than the Law on Food Safety and Quality and the institutional reform related to unification of several institutions into one agency, the National Service, is not reflected in the veterinary law. There is a clear need to streamline and harmonize the two legal acts with each other. For further improvement of these and other gaps in the above mentioned laws, the Working Group will elaborate a new single legal act, which will be in compliance with EC Regulation 178/2004 on general principles and requirements in food safety, EC Regulation 882/2004 on official controls, and Council Directive 96/93/EC on certification of animals and animal products. The new Law on Food Safety and Veterinary will unite the two above mentioned laws and will be adopted in the 1st quarter of 2011 as it is envisaged by the Legislative Approximation Programme. Accordingly, approximately six months (2010 Q4 – 2011 Q1) will be dedicated to the drafting process and parliamentary procedures. Thus, the Law on Food Safety and Quality and Law on Veterinary will be amended with the aim of: 52 • Ensuring approximation of the Georgian legislation with relevant EU acquis and best practice. • Harmonization of the two laws with each other elimination of collisions. • Definition of terms and principles more clearly. As it was mentioned above, Government of Georgia adopted General Hygiene Rules for Food and Feed Business Operators and Rules on Official Control, Monitoring and Surveillance. However, for proper implementation of official control of the products of animal origin (as high risk products), legal acts laying down specific hygiene rules and specific rules for the organization of official controls on products of animal origin should be elaborated. For these purposes, in the 2nd quarter of 2011, Georgian legislation will be approximated with the EC Regulation No 853/2004 on specific hygiene rules for food of animal origin and EC Regulation No 854/2004 on specific rules for the organization of official controls on products of animal origin intended for human consumption. It should be emphasized, that until the adoption of the above mentioned specific rules on hygiene and official control for products of animal origin, already existing specific Sanitary-hygienic Norms are applied. It should be mentioned, that currently there are several legal acts on labeling and materials coming into contact with food, namely: Order of the Minister of Labour, Health and Social Protection on Sanitary-hygienic Norms related to Food and Tare adopted in 2007, on Issuance of Hygienic Certificate related to Food and Food Tare adopted in 2007, and Order of the Minister of Agriculture on Labeling of Foods adopted in 2010. These legal acts are partially approximated with relevant EC regulations, but they need further improvement in order to reflect in the legislation remaining issues related to health including claims made on foods and presentation and advertising of food stuffs. For this purpose, during the 3rd quarter of 2011, the Working Group will work on further improvement and approximation with EC regulations related to labeling, materials and articles intended to come into contact with food, health claims made on foods. Accordingly, Georgian legislation will be 53 brought in conformity with Directive 2000/13/EC, EC Regulation 1924/2006, EC Regulation 1935/2004. New Government resolution covering issues reflected in the above-mentioned EC regulations will be adopted in the 3rd quarter of 2011. One of the main groups of EU acquis in SPS area is related to microbiological criteria, food additives, food enzymes and food flavorings, contaminants, residues, vitamins and minerals and certain other substances of food for identification and prevention of the risk of usage of undesirable substances in food. To regulate this area, Order of the Minister of Labour, Health and Social Protection on Sanitary-Hygienic Norms related to Food was adopted in 2001. This order is very comprehensive and it covers various issues such as food additives, microbiological criteria, contaminants, etc. However, the above mentioned legal act needs to be brought in conformity with relevant EC regulations to eliminate legislative gaps such as difference from EC regulations in permissible levels of additives, contaminants and residues, permissible types of additives, etc. For this purpose, during the 4th quarter of 2011, and 1st, 2nd, 3rd and 4th quarters of 2012, as envisaged by the Legislative Approximation Programme, the above mentioned Order will be gradually approximated with EC regulations. This group of legislation covers eleven EC regulations and proper approximation of the Georgian legislation with relevant EC regulations needs comprehensive work. As for the rules related to veterinary and phyto-sanitary border control, it should be mentioned that in 2008 a Joint Order of the Minister of Finance of Georgia and the Minister of Agriculture of Georgia on Approving the Procedure of Implementation of State Phyto-sanitary Border-quarantine and State Veterinary Border-quarantine Control was adopted. This Joint Order needs to be revised as it is partially approximated with relevant EC regulations. Accordingly, in the 1st and 2nd quarters of 2013 the Joint Order will be approximated with the following directives: Council Directive 97/78/EC on principles of organization of veterinary checks on products entering the Community from third countries, Council Directive 89/662/EEC on veterinary checks in intra-community trade, Council Directive 90/425/EEC on 54 veterinary and zootechnical checks on certain live animals, Council Directive 91/496/EEC on veterinary checks on animals entering the community from third countries and Commission Directive 92/90/EEC on obligations of importers and producers of plants, plant products and other objects. The 3ndquarter of 2013 will be dedicated to the approximation of Georgian legislation with the following EC regulations: • EC Regulation 183/2005 on requirements for feed hygiene whereby general requirements on feed hygiene will be reflected in the above mentioned unifies Law on Food Safety and Veterinary. As for a more detailed explanation of feed hygiene rules, secondary legislation in form of Government Resolution will be adopted. • Council Directive 89/108/EEC on quick-frozen foodstuffs for human consumption whereby this regulation will be integrated in the Governmental Resolution on Specific Hygiene Rules on Products of Animal Origin. As mentioned above, this Government Resolution will be adopted in the 2nd quarter of 2011. In the 3rd quarter of 2013 issues related quick-frozen foodstuffs will be integrated and reflected in this resolution. • Directive 1999/2/EC foods and food ingredients treated with ionizing radiation whereby a Government Resolution will be adopted to cover issues related to foods and food ingredients treated with ionizing radiation, their treatment, labeling of irradiated foods, etc. During 4th quarter of 2013, the rules for placing on the market of feed and plant protection products will be elaborated and adopted. Accordingly, a Government Resolutions will be adopted on the above-mentioned issues in compliance with EC Regulation 767/2009 on placing on the market and use of feed and EC Regulation 1107/2009 on placing of plant protection products on the market. It should be emphasized, that in the same quarter of 2013, Georgian legislation will be approximated with the Council Directive 2000/29/EC on protective measures against the introduction of organisms harmful to plants or plant products. 55 Georgian food safety legislation regulates animal by products and animal welfare rules according to the EU acquis to a limited extent. Most of legislation needs approximation with international and EU standards. Accordingly, approximation with EU regulations related to the animal welfare issues is envisaged by Legislative Approximation Programme. During the 1st, 2nd and 3rd quarters of 2014, a single secondary legal act in form of Government Resolution will be elaborated on animal health related issues. General parts of EC regulations related to animal health will be integrated in the main part of the Government Resolution. As for specific requirements for specific types of animals, they will be adopted as annexes of the Resolution. This single legal act will be brought in conformity with the following EC regulations: Council Directive 64/432/EEC, Council Directive 2002/99/EC, Council Directive 91/68/EEC, Council Directive 90/426/EEC, Council Directive 2009/158/EC, Council Directive 2006/88/EC, Council Directive 92/118/EEC, Council Directive 92/65/EEC, Directive 2003/99/EC. The above mentioned part of the EU acquis regulates animal health rules related to trade in various types of animals as well as animal health rules governing the production, processing, distribution and introduction of animal products for human consumption. In addition, a programme of approximation of Georgian legislation with vertical EU acquis in the food safety sector will be prepared in 2011 including the approximation of EU regulations on animal by product. As for health issues related to plants there are some legal acts in place (e.g. concerning residues of pesticides), but most of them need updating and approximation with international and EU standards. The Law on Protection of Plants from Harmful Organisms was adopted in 1994 and needs improvement. The 4th quarter of 2014 will be dedicated to revision of this law with the aim to approximate with the following EC regulations: Council Directive 2009/128/EC on establishing a framework for Community action to achieve the sustainable use of pesticides, and EC Regulation 56 396/2005 on maximum residue levels of pesticides in food and feed of plant and animal origin. The above mentioned analysis demonstrates that at this stage sufficient legal basis exists in from of primary and secondary legislation to make efficient official control activities, including basic compulsory checks, possible. After the gradual approximation effort with main horizontal EU legal acts, sufficient legal basis for proper implementation of official inspections, including those at the border, will be created. Intensive legislative work is needed to fully approximate Georgia’s legislative framework with relevant EU acquis. This effort will take approximately 4 years. Hereby it should be mentioned that a dynamic approach is essential as the EU SPS legislation is a moving target and keeps further developing. In the course of time, Georgian legislation will need to be approximated accordingly. As for the approximation of Georgian Legislation with relevant vertical EU legislation, the Working Group with support of a Finnish expert financed by SIDA identified vertical regulations which should be reflected in the Georgian legislation. The Group is working on the prioritization of vertical EC regulations and Legislative Approximation programme for vertical EC regulations will be elaborated in 2011. Approximation with vertical EU legislation will be based on the product-by-product principle. At first stage, during the approximation process, GoG will identify major priority products on which the approximated EU regulations will apply. The priority products will be identified in order to encourage EU-Georgia trade and Georgia’s potential and needs. Approximation of legislation on these priority products will be undertaken in 2011 and 2012. As for the second stage of legislative approximation, the sequence of legislative approximation with vertical EU acquis for other kind of products will be defined during the elaboration of the approximation programme with vertical EU acquis. This programme will be a living document, and will be subject of revision, according to the needs and changes in the relevant EU acquis. As it was 57 mentioned above, the main approximation process of vertical legislation with EU acquis will be made in parallel with approximation process of horizontal legislation. 58 6. Technical Assistance Needs in the Food Safety Sector Government of Georgia will put a special emphasis on the mobilization of resources necessary for the establishment of a solid food safety system in Georgia and for addressing existing gaps. With the introduction of the food safety system in Georgia, additional resources will be required, both from the state budget and from donor funds. Besides the resources available from the state budget, additional funds will be mobilized in coordination with donors, in particular the European Union and its member states. In this process special attention will be paid to establish efficient mechanisms of donor coordination. For this purpose a special coordination group on food safety is created, which includes relevant Government Ministries and Agencies, representatives of the EU Commission delegation in Georgia and providers of assistance such as SIDA, GEPLAC (a project funded by the EU), GTZ. The aim is to coordinate and create synergy between the TA projects and the assistance providers on the one hand, and the recipients of assistance, on the other. It is Government’s priority to focus on longer term, systemic and well targeted assistance based on prior assessment of the needs. In the medium to long term assistance will be concentrated on mainly three directions: 1. Strengthening of institutional framework, 2. Capacity building and increase, including training and 3. Creation of necessary physical infrastructure. To strengthen institutional framework and bring it in compliance with EU requirements, Government of Georgia requested EU assistance for the key institutions responsible for the implementation of food control in the country, National Service and Revenue Service. CIB for the National Service will start from 2011 and will be ongoing until 2013. Twinning for the Revenue Service will start from 2011. Both 59 assistance mechanisms will address institutional and capacity needs of these institutions. CIB for the NS will be based on the institutional gap assessment of the current framework undertaken by an Estonian expert. The work is funded by the Estonian Government and UNDP and will be finalised in the 4th quarter of 2010. This will enable smooth start of CIB from the beginning of 2011. In the period before the start of the above mentioned projects from 2011, several forms of assistance will be used to continue human capacity building both at the relevant institutions. In this period (2010-1st quarter 2011) for capacity building activities technical assistance from three main donors will be used: GEPLAC (project phase June 2010- February 2012), GTZ (project phase June 2010- June 2011) and IFC’s ‘Food safety Project’ (project phase March 2010 – March 2013). These projects will concentrate on training and capacity, whereby training of staff of relevant institutions, of private sector as well as trainers will be undertaken. Particular attention is paid to bridging the gap before the start of CIB and Twinning activities mentioned above. However, cooperation with the above mentioned donors will continue throughout their project phases. GEPLAC will concentrate on training of food safety inspectors and their managers. GTZ, which already developed a Train-the-Trainer Programme for the NS will continue to cooperate with the Government of Georgia in this direction, to create sustainable resource of trainers locally. IFC food safety project will concentrate not only on training of inspectors but foremostly on training of private sector representatives in requirements related to the establishment of a modern food safety system in Georgia. Physical infrastructure and equipment needs at the National Service and Revenue Service (including customs check-points) will be addressed from budget resources and external funds allocated mainly by the World Bank. Certain but limited resources to address infrastructure needs will also be available in the framework of the CIB. 60 WB allocated resources for the construction and equipment of 10 district offices of the NS, which will be finalized in 2011. Total amount to be spent is 680 000 USD. As for the Revenue Service, estimation of resources for land customs check points for SPS control has also been undertaken by the WB. Preliminary estimation is up to 10 mln USD, but needs to be further specified. Government is currently working with the World Bank on identification of funding sources for the construction and equipment of these land check-points. Further needs related to SPS control infrastructure at ports and airports will be undertaken in 2011. Other infrastructure needs will be identified in the framework of the institutional gap assessment mentioned above. As it was mentioned previously, based on the EU recommendations, various forms of technical assistance are used for approximation Georgian legislation with EU food safety acquis, addition technical assistance for the further legislative approximation process will be requested based on needs. Government will continue active cooperation with partner countries and donor orgnisations to ensure efficient coordination and creation of systemic and well structured assistance mechanisms. 61 7. Conclusions The present Strategy lays down all elements necessary for the establishment of a solid and integral food safety system in Georgia based on the ‘from farm to fork’ principle. For this purpose it defines a long-term vision of the Government, outlines the framework and describes future plans with respect to creation of legislative basis, institutional framework and human capacity in the food safety area. The Strategy describes the entire institutional framework in the food safety area and outlines cooperation and coordination schemes between various institutions in charge such as the National Service, the Revenue Service, the laboratories and policy defining institutions of the Government of Georgia. Based on the Strategy, implementation of official control activities started from the 1st of July 2010 and is undertaken in two stages. At first stage, from the 1st of July official control including inspections and traceability checks cover companies oriented towards export to the EU. At the second stage, from the beginning of 2011, official control requirement will apply to all food business operators. Both the first stage of the inspections performing official control launched on 1 July 2010 and the second stage foreseen to start as from 1 January 2011 are carried out in accordance with Georgia's food safety legislation. In parallel, approximation of Georgian legislation with the relevant EU legislation is ongoing (according to the Legislative Approximation Programme with the EU legislation, which is the part of the Strategy). The primary institution responsible for the implementation of official control is the National Service for Food Safety, Veterinary and Plant Protection. Food safety border control is undertaken by the Revenue Service. Particular attention is paid to efficient cooperation between these two institutions. Moreover, the entire system of food safety control including the National Service, the Revenue Service, the system of laboratories and accreditation should function in a coordinated and streamlined way. To strengthen these institutions, GoG plans to allocate necessary resources. It also cooperates with 62 the EU and its member states and is planning to start systemic assistance projects such as CIB and Twinning from 2011. In order to create a solid legislative basis for the food safety system and approximate its legislation with that of the EU, the Government of Georgia developed a legislative approximation program for main horizontal EU legislation for the years 2010 and 2014, and started its implementation. The aim of this program is to approximate Georgia’s legislation in food safety, veterinary and plant protection with relevant EU acquis. The program indicates timetable, steps and resources needed for approximation with basic horizontal legislation. Legislative approximation program for vertical legislation is being prepared and will be finalized by 2011. The present Strategy includes institutional and legislative gap assessments and bases future priorities and actions on those. Extensive assessment of needs of the entire institutional system in the food safety area was undertaken in cooperation with an Estonian expert and will be finalized in the 4th quarter of 2010. Future actions and donor assistance activities, including the CIB, will be based on this assessment. The Strategy also outlines technical assistance plans aimed at introduction of a solid food safety system in Georgia. The Comprehensive Strategy and Legislative Approximation Programme in Food Safety is a living document and can be revised according to changing realities on the ground or in the EU. In particular, the Legislative Approximation Programme may reflect developments in the EU food safety acquis. The Strategy was prepared in consultation with the European Commission and relevant external experts as well as with various stakeholders. This Strategy is a government document and its approval and modification needs consent of the Government of Georgia. Annex 1. The Legislative Approximation Programme with EU Legislation The Legislative Approximation Programme defines timeframes, steps, responsible institutions and resources needed for approximation of the Georgian food safety, veterinary and plant protection legislation with basic horizontal EU acquis. It is differentiated between a) legislative work required for approximation and b) enforcement. For each EU horizontal legal act existing Georgian legislation is listed and it is evaluated whether domestic legislation is approximated, partially approximated or not approximated with the EU acquis. This effort was undertaken with two external experts, Estonian and Finnish. ‘Approximated’ means that no further approximation effort is needed. ‘Partially approximated’ means that domestic legislation is to some extent aligned with the EU legislation but further approximation work is needed. The Programme defines timeframes by quarter when approximation is done and human resources in form of man months needed for approximation of each legal act. Apart from that it specifies responsible institutions. The Programme also indicates estimated financial resources on annual basis needed for the enforcement of approximated legislation. These resources include additional funding needs compared to the 2010 budget including salaries and technical equipment requirements of new staff hired for official control purposes and responsible for enforcement of approximated legislation. This funding estimation may be subject to revision according the existing needs. EC regulations in the Programme include regulations concerning food safety, veterinary and phyto-sanitary. EC regulations concerning food safety are marked as “FS”; regulations related to veterinary are marked as “VET”, as for regulations on phyto-sanitary, they are marked as “PS”. 64 65 The Legislative Approximation Programme with EU Legislation Approximation Enforcement Major EU legal instrument, other international act/standard planned adoption date;4 (Quarter 1-4 year) Respective Georgian law, normative act, ministerial order or technical regulation to be amended/adopted Present Status Responsible body Human resources (Funding) Planned enforcement date(s)5 Responsible body Funding 2010 Q2 Government Resolution on General Hygiene Rules for Food/Feed Business Operators is in force since June, 2010. Approximated Ministry of Agriculture, Ministry of Labour, Health and Social Protection, National Service, Office of the Prime Minister 3 man-months (State budget) 2010 Q2 National Service, Ministry of Agriculture. 2010 Q2 Governmental Resolution on Official Control, Monitoring and Surveillance (This resolution includes procedures for taking samplings) is in force since June, 2010. Approximated Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2010 Q2 National Service. FS - Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. 2010 Q3 Governmental Approximated Ministry of 2010 Q3 National 4 Describes the adoption dates of normative acts, including the time-period for drafting procedures of the normative acts. 5 Describes the enforcement dates of normative acts, including the time-period for formal procedures after the adoption of normative acts: preparation procedures, publication in official Journal and etc. 66 Resolution on Destruction of Food and Feed is in force since July, 2010. Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) Service, Ministry of Agriculture, Revenue Service. 2010 Q3 New Government Resolution on relaxed schemes for small food business operators will be elaborated and adopted. Not approximated. Ministry of Agriculture, National Service, Office of the Prime Minister 2 man-months (State budget) 2010 Q3 National Service, Ministry of Agriculture, Revenue Service. N/A Law of Georgia on Food Safety and Quality is in force since December, 2005. Approximated Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister N/A (State budget) N/A National Service, Ministry of Agriculture. FS - Commission Decision 2004/478/EC of 29 April 2004 concerning the adoption of a general plan for food/feed crisis management. 2010 Q4 New Government Resolution on food/feed crisis management will be elaborated and adopted. Not approximated. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2010 Q4 National Service, Ministry of Agriculture. Additional annual funding for enforcement of EC Regulations planned to enforce in 2010 No additional funds will be needed. FS - Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general N/A Governmental Resolution on Integration Measures into European Rapid Alert System of Food and Feed (RASFF) is in force since Approximated Ministry of Agriculture, National Service, Revenue Service, Ministry of Finance, Office of N/A (State budget) N/A National Service, Ministry of Agriculture, Revenue Service. 67 December, 2008. the Prime Minister N/A Order of the Ministry of Justice on Registration of Enterprises is in force since February, 2010. Approximated Ministry of Agriculture, National Service, Public Registry of the Ministry of Justice, Office of the Prime Minister N/A (State budget) N/A National Service, Public Registry of the Ministry of Justice. 2011 Q16 Law of Georgia on Food Safety and Quality is in force since December, 2005. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Office of the Prime Minister, Office of the Prime Minister 5 man-months (State budget) 2011 Q1 National Service, Ministry of Agriculture, Revenue Service. 2011 Q17 Law on Veterinary is in force since June, 1995. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Office of the Prime Minister 5 man-months (State budget) 2011 Q1 National Service, Ministry of Agriculture, Revenue Service. principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 2011 Q1 Order of the Minister of Agriculture on Traceability and Hazard Analysis Critical Control Points in Food Production is in force since August, 2006. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Georgian Accreditation Center, 3 man-months (State budget) 2011 Q1 National Service, Ministry of Agriculture. 6 This law will be improved and the amendments to the law will be elaborated from 2010 Q4 till 2011Q1. The amended law will be adopted by 2011 Q1. 7 This law will be improved and the amendments to the law will be elaborated from 2010 Q4 till 2011Q1. The amended law will be adopted by 2011 Q1. 68 Office of the Prime Minister 2011 Q1 Order of the Minister of Agriculture on Risk Assessment and Risk Communication in Risk Analysis is in force since August, 2006. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Georgian Accreditation Center, Office of the Prime Minister 3 man-months (State budget) 2011 Q1 National Service, Ministry of Agriculture, Revenue Service. 2011 Q1 Law on Food Safety and Quality is in force since December, 2005. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 5 man-months (State budget) 2011 Q1 National Service, Ministry of Agriculture, Revenue Service. FS - Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. 2010 Q 2 Governmental Resolution on Official Control, Monitoring and Surveillance is in force since June, 2010. Approximated Ministry of Agriculture, National Service, Revenue Service, Public Registry under Ministry of Justice, Georgian Accreditation Center, Office of the Prime Minister 3 man-months (State budget) 2010 Q 2 National Service, Ministry of Agriculture, Revenue Service. Vet - Council Directive 96/93/EC of 17 2011 Q1 Law on Veterinary is in force since June, 1995. Partially approximated, however needs to be Ministry of Agriculture, 5 man-months 2011 Q1 National 69 amended. National Service, Office of the Prime Minister (State budget) Service, Ministry of Agriculture. December 1996 on the certification of animals and animal product. 2011 Q1 Order of the Minister of Agriculture on State Certification of Veterinarians is in force since October, 2004. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Office of the Prime Minister 5 man-months (State budget) 2011 Q1 National Service, Ministry of Agriculture. 2010 Q2 Government Resolution on General Hygiene Rules for Food/Feed Business Operators is in force since June, 2010. Approximated. Ministry of Agriculture, Ministry of Labour, Health and Social Protection, National Service, Office of the Prime Minister 3 man-months (State budget) 2010 Q2 National Service, Ministry of Agriculture. FS - Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. 2011 Q2 New Government Resolution laying down specific hygiene rules for food of animal origin will be elaborated and adopted. Not approximated. Ministry of Agriculture, Ministry of Labour, Health and Social Protection, National Service, Office of the Prime Minister 3 man-months (State budget) 2011 Q2 National Service, Ministry of Agriculture. FS - Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down 2011 Q2 Order of the Minister of Agriculture on State Certification of Veterinarians is in force since October, 2004. Partially approximated, however needs to be amended. Minister of Agriculture 3 man-months (State budget) 2011 Q2 National Service, Ministry of Agriculture. 70 2010 Q2 Governmental Resolution on Official Control, Monitoring and Surveillance is in force since June, 2010. Approximated. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2010 Q2 National Service N/A Order of the Minister of Agriculture on Animal Slaughterhouses is in force since September, 2005. Approximated. Minister of Agriculture N/A (State budget) N/A National Service 2011 Q 1 Law on Veterinary is in force since June, 1995. Partially approximated, however needs to be amended. Ministry of Agriculture, Ministry of Labour, Health and Social Protection, National Service, Revenue Service, Office of the Prime Minister 5 man-months (State budget) 2011 Q 1 National Service, Ministry of Agriculture, Revenue Service. 2011 Q 1 Law on Food Safety and Quality is in force since December, 2005. Partially approximated, however needs to be amended. Ministry of Agriculture, Ministry of Labour, Health and Social Protection, National Service, Revenue Service, Office of the Prime Minister 5 man-months (State budget) 2011 Q 1 National Service, Ministry of Agriculture, Revenue Service. specific rules for the organisation of official controls on products of animal origin intended for human consumption. 2011 Q2 New Government Resolution on laying Not approximated. Ministry of Agriculture, 3 man-months 2011 Q2 National 71 dawn specific rules for the organisation of official controls on products of animal origin intended for human consumption will be elaborated and adopted. National Service, Office of the Prime Minister (State budget) Service. FS - Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labeling, presentation and advertising of foodstuffs. 2011 Q3 Order of the Minister of Agriculture on Labeling of Foods is in force since December, 2009. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Ministry of Labour, Health and Social Protection, Office of the Prime Minister 3 man-month (State budget) (EU-Delegatio Food safety TA) 2011 Q3 National Service, Ministry of Agriculture. FS - Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. 2011 Q3 Order of the Minister of Agriculture on Labelling of Foods is in force since December, 2009. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Office of the Prime Minister 3 man-months (State budget) 2011 Q3 National Service, Ministry of Agriculture. FS - Regulation 1935/2004/EC of the European Parliament and of the Council of 27 2011 Q3 Issuance of Hygienic Certificate Related to Food and Food Tare, Order of the Minister of Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Georgian National 2 man-months (State budget) 2011 Q3 Ministry of Agriculture, National 72 Agriculture is in force since August, 2007. Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister Service. October 2004 on materials and articles intended to come into contact with food. 2011 Q3 Sanitary-hygienic Norms Related to Food and Tare, Order of the Minister of Labour, Health and Social Protection is in force since June, 2008. Partially approximated, however needs to be amended. . Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 2 man-months (State budget) 2011 Q3 Ministry of Agriculture, National Service. FS - Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. 2011 Q4 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001 Partially approximated, however needs to be amended. Ministry of Agriculture, Ministry of Labour, Health and Social Protection, National Service, Office of the Prime Minister 3 man-months (State budget) 2011 Q4 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. Additional annual funding for enforcement of EC Regulations planned to enforce in 2011 GEL 292 400 73 FS - Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. 2012 Q1 Order of the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 3 man-months (State budge 2012 Q1 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorization procedure for food additives, food enzymes and food flavourings. 2012 Q1 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 3 man-months (State budget) 2012 Q1 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Regulation (EC) No 1332/2008 of the 2012 Q2 Order of the Minister of Labour, Health and Social Partially approximated, however needs to be Ministry of Labour, Health 3 man-months 2012 Q2 Ministry of 74 European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97. Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. amended. and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister (State budget) Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. 2012 Q2 Order or the Minister of Labour, Health and Social Protection on Fortification of Food is in force since October, 2007. Partially approximated, however needs to be amended Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 3 man-months (State budget) 2012 Q2 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. 2012 Q2 Order of the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since Partially approximated, however needs to be amended Ministry of Labour, Health and Social Protection, Ministry of 3 man-months (State budge 2012 Q2 Ministry of Labour, Health and Social 75 August, 2001. Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC. 2012 Q3 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 3 man-months (State budget) 2012 Q3 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Directive 2002/32/EC of the European Parliament and the Council of 7 May 2002 on undesirable substances in animal feed. 2012 Q3 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National 3 man-months (State budget) 2012 Q3 Ministry of Labour, Health and Social Protection, National Service, 76 Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister Ministry of Agriculture, Revenue Service. FS - Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. 2012 Q3 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 3 man-months (State budget) 2012 Q3 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC 2012 Q4 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical 3 man-months (State budget) 2012 Q4 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue 77 and 91/664/EEC Regulations and Metrology, Office of the Prime Minister Service. FS - Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food 2012 Q4 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister 3 man-months (State budget) 2012 Q4 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. FS - Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs 2012 Q4 Order or the Minister of Labour, Health and Social Protection on Sanitary Hygienic Norms related to Food is in force since August, 2001. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Georgian National Agency of Standards, Technical Regulations and Metrology, Office of the Prime 3 man-months (State budget) 2012 Q4 Ministry of Labour, Health and Social Protection, National Service, Ministry of Agriculture, Revenue Service. 78 Minister Additional annual funding for enforcement of EC Regulations planned to enforce in 2012 GEL 357 200 2013 Q1 Joint Order of the Minister of Finance of Georgia and the Minister of Agriculture of Georgia on Approving the Procedure of Implementation of State Phytosanitary Border quarantine and State Veterinary Border quarantine Control is in force since December, 2008. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Ministry of Finance, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2013 Q1 National Service, Revenue Service. VET - Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries. 2013 Q1 Law of Georgia on Agricultural Quarantine is in force since May, 1997. Partially approximated, however needs to be amended. Ministry of Agriculture 3 man-months (State budget) 2013 Q1 National Service, Revenue Service. VET - Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra Community trade with a view to the completion of the internal market. 2013 Q1 Joint Order of the Minister of Finance of Georgia and the Minister of Agriculture of Georgia on Approving the Procedure of Implementation of State Phytosanitary Border quarantine and State Veterinary Border quarantine Control is in Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Ministry of Finance, Revenue Service, Office of the Prime Minister 3 man-months (State budge) 2013 Q1 National Service, Revenue Service. 79 force since December, 2008. N/A Governmental Resolution on Integration Measures into European Rapid Alert System of Food and Feed (RASFF) is in force since December, 2008. Approximated. Ministry of Agriculture, National Service, Ministry of Finance, Revenue Service, Office of the Prime Minister. N/A (State budget) N/A National Service, Ministry of Agriculture, Revenue Service. VET - Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra Community trade in certain live animals and products with a view to the completion of the internal market. 2013 Q1 Joint Order of the Minister of Finance of Georgia and the Minister of Agriculture of Georgia on Approving the Procedure of Implementation of State Phytosanitary Border quarantine and State Veterinary Border quarantine Control is in force since December, 2008. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Ministry of Finance, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2013 Q1 National Service, Revenue Service. VET - Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending 2013 Q2 Joint Order of the Minister of Finance of Georgia and the Minister of Agriculture of Georgia on Approving the Procedure of Implementation of State Phytosanitary Border quarantine and State Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Ministry of Finance, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2013 Q2 Revenue Service, National Service. 80 Directives 89/662/EEC, 90/425/EEC and 90/675/EEC. Veterinary Border quarantine Control is in force since December, 2008. 2013 Q2 Law of Georgia on Access on Distribution of Agricultural Species, High Quality Seeds and Seedlings is in force since June, 1999. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Public Registry under Ministry of Justice, Office of the Prime Minister 3 man-months (State budget) 2013 Q2 Revenue Service, National Service. PS - Commission Directive 92/90/EEC of 3 November 1992 establishing obligations to which producers and importers of plants, plant products or other objects are subject and establishing details for their registration. 2013 Q2 Joint Order of the Minister of Finance of Georgia and the Minister of Agriculture of Georgia on Approving the Procedure of Implementation of State Phytosanitary Border quarantine and State Veterinary Border quarantine Control is in force since December, 2008. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Public Registry under Ministry of Justice, Office of the Prime Minister 3 man-months (State budget) 2013 Q2 Revenue Service, National Service. FS - Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying 2010 Q2 Government Resolution on General Hygiene Rules for Food/Feed Business Operators Approximated8. Ministry of Agriculture, National Service, Office of the Prime Minister 3 man-months (State budget) 2010 Q2 National Service. 8 Government Resolution on General Hygiene Rules for Food/Feed Business Operators covers general issues reflected in Regulation (EC) No 183/2005. As for the detailed requirements, they will be reflected in new Government Resolution on requirements of feed hygiene, which will be adopted in 2013 Q3. 81 down requirements for feed hygiene. 2013 Q3 New Government Resolution on requirements of feed hygiene will be adopted. Not approximated. Ministry of Agriculture, National Service, Office of the Prime Minister 2 man-months (State budget) 2013 Q3 National Service. FS - Council Directive 89/108/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to quick frozen foodstuffs for human consumption. 2013 Q3 New Government Resolution will be adopted. Not approximated. Ministry of Agriculture, National Service, Office of the Prime Minister. 3 man-months (State budget) 2013 Q3 National Service, Revenue Service. FS - Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation. 2013 Q3 New Government resolution on foods and food ingredients treated with ionising radiation will be elaborated and adopted. Not approximated. Ministry of Agriculture, National Service, Ministry of Labour, Health and Social Protection, Office of the Prime Minister. 3 man-months (State budget) 2013 Q3 National Service. FS - Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation 2013 Q4 New Government Resolution will be elaborated and adopted. Not approximated. Ministry of Agriculture, National Service, Office of the Prime Minister. 2 man-months (State budget) 2013 Q4 National Service. 82 (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC 2013 Q4 Law of Georgia on Pesticides and Agrochemicals in force since November, 1998. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Office of the Prime Minister 2 man-months (State budget) 2013 Q4 National Service. PS - Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. 2013 Q4 Law of Georgia on Access on Distribution of Agricultural Species, High Quality Seeds and Seedlings is in force since June, 1999. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Office of the Prime Minister 2 man-months (State budget) 2013 Q4 National Service. Additional annual funding for enforcement of EC Regulations planned to enforce in 2013 GEL 484 800 VET - Council Directive 64/432/EEC9 of 26 June 1964 on animal health 2014 Q1 Order of the Minister of Partially approximated, however needs to be Ministry of Agriculture, National Service, 3 man-months 2014 Q1 National Service, Revenue 83 Agriculture of Georgia on Approval rules on animal quarantine is in force since May 1 2006. amended. It will be included in a single act (see footnote N10). Revenue Service, Office of the Prime Minister (State budget) Service. 2014 Q1 Order of the Minister of Agriculture of Georgia on Approval forms and issuing rules of veterinary certificates, used during export of animals, animal breeding materials and products is in force since September, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. 2014 Q1 Law of Georgia on Agricultural Quarantine is in force since May, 1997. Not-approximated. Needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. problems affecting intra Community trade in bovine animals and swine10. 2014 Q1 Order of the Minister of Agriculture on Approval rules on veterinary check of slaughtering animals and veterinary-sanitary expertise of meat and meat products is in force since October, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. 10 It will be elaborated one single legal act on animal health which will approximate the fallowing EU directives: Directive 64/432/EEC , Directive 2002/99/EC, Directive 91/68/EEC, Directive 90/426/EEC, Council Directive 2009/158/EC, Directive 2006/88/EC, Directive 92/118/EEC, Directive 92/65/EEC, ,Directive 2003/99/EC. During the 1st, 2nd and 3rd quarters of 2014, the single legal act as Government Resolution will be elaborated on animal health related issues. 84 2014 Q1 Order of the Minister of Agriculture on Approval veterinary-sanitary rules on animal movement (including summer-winter pastures) is in force since August, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. 2014 Q1 Law on Veterinary is in force since June, 1995. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. VET - Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption. 2014 Q1 Order of the Minister of Agriculture on Approval rules on veterinary check of slaughtering animals and veterinary-sanitary expertise of meat and meat products is in force since October, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. VET - Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra Community trade in ovine and caprine animals. 2014 Q1 Order of the Minister of Agriculture on Approval rules on veterinary check of slaughtering animals and veterinary-sanitary expertise of meat and meat products is in force since October, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. 85 2014 Q1 Order of the Minister of Agriculture of Georgia on Approval rules on animal quarantine is in force since May, 2006. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. 2014 Q1 Order of the Minister of Agriculture of Georgia on Approval forms and issuing rules of veterinary certificates, used during export of animals, animal breeding materials and products is in force since September, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q1 National Service, Revenue Service. 2014 Q1 Order of the Minister of Agriculture of Georgia on Approval veterinary sanitary rules on animal movement (including summer-winter pastures) is in force since August, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budge 2014 Q1 National Service, Revenue Service. 2014 Q2 Law on Bees is in force since May, 2002. Not approximated. Needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budge 2014 Q2 National Service, Revenue Service. VET - Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae. 2014 Q2 Order of the Minister of Agriculture of Georgia on Approval veterinary Partially approximated, however needs to be Ministry of Agriculture, National Service, 3 man-months 2014 Q2 National Service, 86 sanitary rules on import, export, re-export, transit of animals (including poultry, bee, fish, all kind of water-land mammal animals, amphibians, embryos, animal egg cells, fertile fish roe and etc), animal breeding materials and products is in force since May, 2006. amended. It will be included in a single act (see footnote N10). Revenue Service, Office of the Prime Minister (State budget) Revenue Service. VET - Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra Community trade in, and imports from third countries of, poultry and hatching eggs (codified version). 2014 Q2 Order of the Minister of Agriculture of Georgia on Approval rules on veterinary check of slaughtering animals and veterinary-sanitary expertise of meat and meat products is in force since October, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q2 Revenue Service, National Service. VET - Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic 2014 Q2 Have no legislative bases Not approximated. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q2 Revenue Service, National Service. 87 animals. VET - Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC. 2014 Q3 Order of the Minister of Agriculture of Georgia on Approval rules on veterinary check of slaughtering animals and veterinary-sanitary expertise of meat and meat products is in force since October, 2005. Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q3 Revenue Service, National Service 2014 Q3 Law of Georgia on Cattle breeding is in force since September, 1996. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q3 Revenue Service, National Service. VET - Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC. 2014 Q3 Order of the Minister of Agriculture of Georgia on Approval rules on veterinary check of slaughtering animals and veterinary-sanitary expertise of meat and meat products is in force Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q3 Revenue Service, National Service. 88 since October, 2005. 2014 Q3 Order of the Minister of Agriculture of Georgia on Approval rules on animal quarantine is in force since May, 2006. . Partially approximated, however needs to be amended. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 4 man-months (State budget) 2014 Q3 Revenue Service, National Service. VET - Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC. 2014 Q3 New Government resolution on the monitoring of zoonoses and zoonotic agents. Not approximated. It will be included in a single act (see footnote N10). Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 4 man months (State budget) 2014 Q3 Revenue Service, National Service. 2013 Q4 Law of Georgia on Protection of Plants Against Harmful Organisms is in force since October, 1994. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 4 man-months (State budget) (EU Delegation Food Safety TA) 2013 Q4 National Service, Revenue Service. 2013 Q4 Law of Georgia on Pesticides and Agrochemicals is in force since November, 1998. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 4 man-months (State budget) (EU Delegation Food Safety TA) 2013Q4 National Service, Revenue Service. PS - Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community. 2013 Q4 Law of Georgia on Agricultural Quarantine is in force since May, Partially approximated, however needs to be Ministry of Agriculture, National Service, 4 man-months 2013 Q4 National Service, 89 1997. amended. Revenue Service, Office of the Prime Minister (State budget) (EU Delegation Food Safety TA) Revenue Service. 2013 Q4 Order of the Minister of Agriculture on Introduction, Preservation, Realization and Rationalized Usage of Agrochemicals is in force since January, 2005. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 4 man-months (State budget) (EU Delegation Food Safety TA) 2014 Q4 National Service, Revenue Service. PS - Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. 2014 Q4 Law of Georgia on Protection of Plants against Harmful Organisms is in force since October, 1994. Partially approximated, however needs to be amended. Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q4 National Service, Revenue Service. PS - Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council 2014 Q4 Law of Georgia on Protection of Plants against Harmful Organisms is in force since October, 1994. Partially approximated, however needs to be amended. Ministry of Labour, Health and Social Protection, Ministry of Agriculture, National Service, Revenue Service, Office of the Prime Minister 3 man-months (State budget) 2014 Q4 National Service, Revenue Service. 90 Directive 91/414/EEC (pending the update according to 1107/2009). Additional annual funding for enforcement of EC Regulations planned to enforce in 2014 GEL 653 000 Annex 2. Preparatory Process of the Comprehensive Strategy and Legislation Approximation Programme in Food Safety The present Annex summaries various activities undertaken by the Government of Georgia, in cooperation with relevant donors, aimed at preparing of the Comprehensive Strategy and Legislative Approximation Programme in Food Safety. These activities include Government actions and initiatives, involvement of stakeholders, technical assistance used and capacity building activities specifically related to the Strategy work. Preparatory Process of the Comprehensive Strategy and Legislation Approximation Programme in Food Safety Objective Activities Responsible Body/Involved Body Timeline Funding Ensure effective coordination of a preparation process for reforms in SPS area Creation of Inter-agency Working Group on Food Safety Issues EU Integration Commission of the Government of Georgia April 14, 2009 State Budget Enhancement of knowledge in food safety area Analysis of EU legislation in food safety area Inter-Agency Working Group on Food Safety Issues Created in the framework of the EU Integration Commission and chaired by the Prime Minister of Georgia April 2009 present State Budget Obtain feedback from the food business operators Survey of Food Processing Enterprises Government of Georgia with support of the IFC Form June, 2009 to January, 2010 IFC Elaboration of Food Safety Policy Drafting the Comprehensive Strategy on Food Safety Inter-Agency Working Group on Food Safety Issues May, 2009 present State Budget 92 Elaboration of initial draft strategy based on EC recommendations regarding Georgia’s preparedness for the DCFTA negotiations Inter-Agency Working Group on Food Safety Issues May-September, 2009 State budget Submitting of concept and basic principles of the Comprehensive Strategy on Food Safety to the EU Integration Commission Inter-Agency Working Group on Food Safety Issues July 28, 2009 State budget Sending initial draft Strategy for comments to the relevant agencies and authorities Inter-Agency Working Group on Food Safety Issues Beginning of September, 2009 State budget Approval of initial draft Strategy by the EU Integration Commission Inter-Agency Task Force for Coordination of Preparatory Works for the Deep and Comprehensive Free Trade Agreement with the EU Inter-Agency Working Group on Food Safety Issues September 8, 2009 State budget Submitting initial draft Strategy to Commission services The Office of the Prime Minister September 10, 2009 N/A Receiving Commission Services’ comments on Strategy to Georgian authorities GoG November 5, 2009 N/A Expert meeting between Commission services and Georgian authorities on Food Safety Issues The Office of the Prime Minister, Ministry of Agriculture, National Service Brussels, November 12, 2009 State budge Elaboration of initial draft Strategy Agreement on Expert Meting Operational Conclusions Georgian authorities January, 2010 N/A Bring the Strategy in conformity with EC requirements Revision of the draft Strategy with support of EU Technical Assistance: • Various seminars; • Mission of Estonian expert in March, 2010 GEPLAC Experts Inter-Agency Working Group on Food Safety Issues February – March, 2010 State budget, GEPLAC 93 • Study visit to UK The Office of the Prime Minister Submitting revised draft strategy to the EU Integration Commission Inter-Agency Task Force for Coordination of Preparatory Works for the Deep and Comprehensive Free Trade Agreement with the EU Inter-Agency Working Group on Food Safety Issues The Office of the Prime Minister March, 2010 State budget Present revised draft Strategy to COM services Providing revised draft Strategy and Legislative Approximation Programme to Commission Services GoG By 13th of March, 2010 State budget Receiving Commission Services’ comments on revised draft Strategy and Legislative Approximation Programme to Georgian authorities GoG April 30, 2010 N/A Expert Meeting between Georgian Authorities and COM Services on Food Safety Issues National Service, Georgian Accreditation Center, National Agency of Standards, Technical Regulations and Metrology, Office of the Prime Minister Brussels, June 9, 2010 State budget Receiving Commission Services’ comments on revised draft Strategy and Legislative Approximation Programme to Georgian authorities GoG June 24, 2010 N/A Finalization of the draft Comprehensive Strategy and Legislative Approximation Programme in Food Safety Video-conference between Georgian Authorities and COM Services on Food Safety Issues dedicated to the finalization of the draft Strategy and providing information on the recent developments in the food safety area Ministry of Agriculture, National Service, Revenue Service, Georgian Accreditation Center, Finnish expert, Office of the Prime Minister July 9, 2010 N/A 94 Providing revised draft Strategy and Legislative Approximation Programme to Commission Services GoG July 30, 2010 State budget Receiving Commission Services’ comments on revised draft Strategy and Legislative Approximation Programme to Georgian authorities GoG September 20, 2010 N/A Reflecting COM servicies’ comments into the final draft Strategy and Legislative Approximation Programme and providing it to COM servicies Inter-Agency Task Force for Coordination of Preparatory Works for the Deep and Comprehensive Free Trade Agreement with the EU Inter-Agency Working Group on Food Safety Issues The Office of the Prime Minister October 8, 2010 State budget Technical Assistance and Capacity Building Activities Objective Activities Responsible Body/Involved Body Timeline Funding Trainings and seminars for public officials involved in the preparation process for negotiation on the DCFTA Office of the Prime Minister, State Minister Office on European and Auro-Atlantic Integration, Ministry of Agriculture, National Service, National Accreditation Center, National Agency of Standards, Technical Regulations and Metrology. 2009 - 2010 GEPLAC Facilitation of a better understanding Sharing experience and increase capacity with the aim to prepare draft Comprehensive Strategy and Legislative Approximation Programme in Food safety Training on "Organization of Food Control under in the Food Safety Legislation of the EU and particularly in relation to SME’s" Office of the Prime Minister, State Minister Office on European and Auro-Atlantic Integration, Ministry of Agriculture, National Service, National Accreditation Center, National Agency of Standards, Technical Regulations and Metrology. December, 2009 GEPLAC 95 A seminar on EU best practice of setting special food safety regime for small businesses Office of the Prime Minister, Ministry of Agriculture, National Service January, 2010 GEPLAC Training on Food Safety and Quality National Service December, 2009 IFC A seminar for public officials on Main Principles of Food Safety Management Systems Office of the Prime Minister February, 2010 IFC Study visit to London on involvement of private control bodies in the overall food safety system Ministry of Agriculture, National Service, Office of the Prime Minister February, 2010 GEPLAC Training on Derogations from EC regulations 852/2004 and 853/2004 Ministry of Agriculture, National Service, Office of the Prime Minister February, 2010 IFC Consultancy service to support NS in institutional gap analysis and needs assessment H. Kuusk, Estonian expert 30 working days, started from 14 June 2010 Government of Estonia, UNDP Consultancy assistance in revision of the Comprehensive Strategy and Operational Program in Food Safety to improve legal environment approximation needs and identify gaps in food safety legislation M. Lampi, Finnish expert 2 months (from mid June to mid August 2010) SIDA SPS roundtable aimed at finalization of the Strategy and Legislative Approximation Programme National Service, Office of Prime Minister, GEPLAC experts, Estonian expert, and Finnish expert. July 18-19 GEPLAC Involvement of Stakeholder Objective Activities Responsible Body/Involved Body Timeline Funding To enhance involvement of Parliament Consultations with parliament on future DCFTA related issues including SPS. EU Integration Committee of Parliament Inter-agency Task Force, Inter-agency Ongoing State Budget 96 Working Group Roundtable on Food Safety – Sanitary and Phitosanitary ,Ministry of Agriculture, Food business operators, Office of the Prime Minister, IFC, GEPLAC December 14, 2009 Eurasian Partnership Foundation Dialogue between Government Authorities and Food Business Operators Ministry of Agriculture, Food business operators, Office of the Prime Minister January 28, 2010 Business Association of Georgia Presentation of the Results of Survey on Food Processing Enterprises provided by the IFC for stakeholders Ministry of Agriculture, National Service, Office of the Prime Minister, Food business operators, NGOs January 28, 2010 IFC Donor Roundtable Coordination for identification of TA in food Safety Office of Prime Minister, State Minister Office on European and Euro-Atlantic Integration, representatives of various International Organizations and embassies January 25, 2010 State budget Providing with revised draft Strategy to Commission Services GoG By 13th of March, 2010 State Budget Improvement of involvement of stakeholders Meeting between Government and food business operators, also NGOs to discuss draft legal acts with support of IFC Ministry of Agriculture, National Service, Office of Prime Minister, NGOs, Business Associations, IFC. June, 2010 IFC Annex 3. Summary of activities undertaken by National Service of Food Safety, Veterinary and Plant Protection in 2009-2010 The present Annex outlines official control activities undertaken by the NS in 2009 2010, before the start of implementation of food safety legislation related to inspection of food business operators, traceability, creation of the system of hazard analysis and critical control points. 1. State Inspections and implementation of HACCP According to the Law on Food Safety and Quality, in the period prior to the start of implementation of inspection related articles, official control as envisaged by the Law could be implemented at the request of a food business operator. Accordingly, provisions on state inspection and HACCP implementation took place on a voluntary basis. There are a number of companies in Georgia, which implemented the HACCP system on the voluntary basis. There are several consulting companies in Georgia, which provide relevant information, recommendations and consultations on issues related to HACCP implementation. 2. Certification on Voluntary Basis Export-oriented enterprises may receive official certificates on the basis of their request to the NS. These certificates are issued by the NS. The NS issues 3 kinds of official certificates for products designated for export, namely: phyto-sanitary, veterinary and hygiene certificates. 98 3. State Monitoring The NS performs state control of food quality aiming at monitoring of food safety and quality. On the retail trade level, state monitoring activities include procurement and testing of samples in an accredited laboratory. For this purpose, the NS elaborates and implements state programs. 3.1. Food Safety and Quality Supervision During the 2006-2009 and first half of 2010, 2900 samples of food and drinking water were studied by the NS. For procurement of samples and laboratory testing, 1 600 000 GEL was allocated from the state budget. As a result of the revealed falsifications and harmfulness of the products, the NS took decisions on the prohibition of realization of these products. The NS requirements on withdrawal of the products from the realization were sent to the relevant entrepreneurs and finally, these products were withdrawn from the market. For the purpose of detecting unsafe and counterfeited products on Georgian market a Special State Program on Laboratory Research of Food Stuff has been implemented. During the 2009, more than 2400 samples of 34 different types of foodstuffs including drinking water have been tested. As for first half of 2010: • 246 hygienic certificates have been issued. • 72 samples have been taken. Among them: Milk and dairy products – 50 Ready food – 7 Sunflower oil – 5 Chocolate – 5 Potable water – 5 99 • Penalties have been issued on 16 companies for not fulfilling labeling rules. 3.2. Veterinary-Sanitary Supervision 676 veterinary certificates were issued for live animal movement that accompanied the movement of 42 724 cattle and 192 233 small ruminants in Georgia. There were issued 2 014 International Veterinary Certificates that accompanied the following amount of live animals and regulated materials: • 39 174 cattle • 209 520 small ruminants (most of them sheep, among them: 59 226 in Lebanon, 92 452 in Saudis Arabia, 11 735 in Hashemite Kingdom of Jordan and 46 107 in Azerbaijan) • more than 10 millions of eggs • 478 tones wool • more than 20 thousands tones fish • 3 107 tones leather materials Under veterinary-sanitary supervision have been slaughtered and after appropriate veterinary check were placed on market 13 760 animal carcasses, also 88,5 tones dairy products and 46,4 tones fish products for which were issued 14 568 Product Veterinary certificates by the District veterinary inspectors. During 2009 the veterinary control was conducted in 263 facilities, among them 69 agricultural markets and 194 other producing places and meat trade places. From aforementioned 263 inspected facilities, the penalties have been issued only for 35 veterinary related places. The following amount of infection cases were identified in 2009: 100 • 146 lethal cases of rabies in animals and 6 lethal cases in humans; also 12 968 cases of bite, according to which were established 10 days supervision on biter animals and were vaccinated 111 190 susceptible animals. • 12 cases of anthrax in animals and 28 cases in humans, mostly in skin type; were vaccinated 71 204 cattle, small ruminants and solid-hoofed animals, among them mandatory vaccination were carried out in outbreaks for 13 053 animals. • In order to maintain country as free zone from animal diseases and establish buffer zones there were vaccinated 241 149 cattle and 43 959 small ruminants against FMD in border regions to Azerbaijan, Republic of Turkey and Armenia; Vaccination against FMD is continuing in Samtskhe-Javakheti Region. It is planned to vaccinate about 90 381 cattle. • In the frames of National Brucellosis Monitoring Program 40 820 animals were tested. There were 2 117 positive results that equals 5% of whole tested materials. There were applied appropriate veterinary measures in outbreaks according to the Georgian legislation. • With the assistance of FAO African Swine Fever Sero-Monitoring Program is ongoing taking samples from domestic pigs. It is planned to take samples from wild boar. As for first half of 2010: • Registration of animal holdings has been started. 2611 holdings (54706 cattle and 118 695 small ruminants) are already registered. • 177188 cattle and 2557 small ruminants have been vaccinated on FMD; • 54903 cattle have been vaccinated on Anthrax; • Forced immunization on rubies has been carried out on outbreaks for 5968 animals. • 32630 cattle have been sampled on Brucellosis. 617 of them were positive. 101 • 47 cases of rubies and 3 cases of Anthrax were detected. • Reserve fund of vaccines (FMD, Anthrax, Rubies) was created. • 9066 veterinary certificates have been issued (among them 1142 export certificates). Plan for second half of 2010 includes the following activities: • Additional vaccination on FMD will be carried out. • Taking into account the existence of non-reliable territories with regard to anthrax, the vaccination of the agricultural animals is deemed necessary. Additionally, for the purposes of the effective liquidation of a possible disease outbreak and for creation of the vaccine reserves for animal immunization (37950 doses), funds have been allocated. • For the reason of severe epizootic situation regarding the spread of rabies, the vaccination of the domestic meat-eating animals is required (100000 dogs and cats overall). Additionally, for the purposes of the effective liquidation of a possible rabies outbreak and for creation of the vaccine reserves for animal immunization (35,000 doses), funds have been allocated. • A research has been planned with the aim to learn the level of the tuberculosis spread in the country. For the purposes of conducting relevant animal examination on tuberculosis, and for creating the diagnosticum reserves (9,000 doses) – funds have been allocated. • For the reason of investigating the level of spread of brucellosis in Georgia, it has been planned to undertake blood testing from the cattle. 3.3. Plant Protection During the 2006-2009 and first half of 2010, under the state targeted program “Plant Protection”, the quarantine actions were carried against different plant pests. 102 During the 2009, under the state targeted program “Plant Protection”, the state monitoring of quality of pesticides and agro-chemicals was undertaken. 320 samples of chemicals were studied by the NS and tested in accredited laboratories. Consignment monitoring plan has been elaborated with the collaboration of Revenue Service for improvement of import regulated product system. It should be emphasized, that 25 000 tones of pesticides, 10 universal spraying machines and 4 pickup cars for installation of spraying machines have been purchased: The above mentioned technique has been used against dangerous quarantine pest: • 18 165 hectares have been treated in the regions of Guria and Samegrelo against Fall Webworm • 6 618 hectares have been treated in Dedoplistskaro, Akhmeta and Signagi districts against locusts. • Phytosanitary monitoring has been carried out on 10 000 hectares to forecast locust and Fall Webworm spread. • 41 000 tones of exported plant products have passed phytosanitary control and accordingly 7 087 Export Phytosanitary Certificates have been issued. As for first half of 2010 following activities have been carried out by NS: • 2 500 hectares have been treated in the Samegrelo region against Fall Webworm. Biological affectivity of activities is about 80-85%; • 9536 hectares have been treated in Kakheti and Kartli regions against locusts. • Phytosanitary monitoring has been carried out on 15 000 hectares to forecast locust and Fall Webworm spread. • 2359 Export Phytosanitary Certificates have been issued. • 14 samples of pesticides and 11 samples of agrochemicals are taken and sent to the accredited laboratories. • Export Phytosanitary Certificates have been issued 103 Plan for second half 2010 includes the following activities: • Plant protection and agrochemicals supervision, 167 pesticides and 19 agrochemicals were registered in 2009. In first half 2010 were registered 26 agrochemicals and 18 pesticides. List of newly registered pesticides and agrochemicals has been sent to the Revenue Service. The process of registration is ongoing. • In the framework of the state program ‘Plant protection’, it is planned to undertake quality monitoring of the pesticides and agrochemicals available on the market. The NS plans to take overall 200 samples (130 pesticides and 70 agrochemicals), which will subsequently be examined and analyzed in the accredited laboratories. The funds have been allocated for these purposes. 4. Other Issues • The NS carries out registration of veterinary medicine produced or imported in Georgia. 51 kinds of veterinary medicines have been registered by NS in 2009. By the first half of 2010, were registered 26 veterinary medicines. In 2009, the Law on Veterinary was amended. According to this amendment, if veterinary pharmaceutical is produced in EU or OECD countries their registration will be performed with simplified regime only in 10 days. Amount of required documentations is significantly reduced. • Registration process of agrochemicals has been simplified. Statute has been amended and requirements are brought into close equality to European regulations. Specifically, pesticides and agrochemicals registered in EU and OECD countries are not subject to test in Georgia. They will be registered only according to the presented documentations. In addition, there have been removed some unnecessary points and procedures and registration time is maximally optimized. 104 • The NS supported the establishment of 12 service centers for farmers, where farmers are consulted on plant protection, new technologies of crops cultivate, etc. • Animal health monitoring is regularly carried out. During 2006-2009, state program was implemented for preventive measures against animal diseases (brucellosis, tuberculosis, etc). The measures for eradication of African Swain Fever were carried out. Vaccination against different kind of animal diseases and investigations on brucellosis and tuberculosis has regularly taken place. • Starting from 2007, the official certification of private veterinaries is taking place. Currently, approximately 400 private veterinaries have official certificates in 3 specializations, namely: medical-preventive activity, veterinary-sanitary supervision and veterinary pharmacy.