Significance of Conformity of Food Legislation in Bosnia and Herzegovina with the EU Legislation

Significance of Conformity of Food Legislation in Bosnia and Herzegovina with the EU Legislation Nihada Ahmetovic 1,2, Sejad Mackic 1, Zijad Beslagic 2 Agency for Food Safety of FBiH, Sarajevo, Bosnia and Herzegovina 1 Medical Faculty of University of Tuzla, Bosnia and Herzegovina 2 Summary The European Union and member states have put food safety at the top of political agendas and priorities. Food safety, initially viewed as an isolated concept, because of its great importance over time becomes a factor that is embedded in all horizontal European policy. Basic determinants of food security strategies are: the legal framework for food safety and food for animals, independent and public opinion available to scientists, manufacturing process control compliance with the legal framework and freedom of choice for consumers on the basis of available pertinent information. The basic guiding principles of the White Paper on Food Safety of the European Union, which was made in 2000, is the policy that food safety must be based on a comprehensive integrated approach. One of the results of the White Paper on Food safety is a European Commission Regulation 178/02 (EC Regulation 178/02), which is called the General Food Law EU. Food Law of FBiH (Official Gazette of FBiH, no. 50/04) is compliant with EC Regulation 178/02, governing the area of food safety in Bosnia and Herzegovina. Food Safety Agency of FBiH, as a leading national authority in the field of food safety, according to the provisions of the Food Act initiates, prepares and organizes the development of implementing regulations under this Act. In the period 2006-2009 in BiH, Law on GMOs released a series of implementing regulations in the area of food safety regulations and is consistent with EU directives. Keywords: food safety, EU legislation, regulations, Bosnia and Herzegovina 1. INTRODUCTION Entry into the European Community to Member States brings significant changes in their legal and economic systems. Area of food safety experiencing a transformation from a limited international market and partial adoption of the regulations of the European Community in relation to food to the global market with flexible regulations to ensure the appropriate food standards and guidelines. Participation in the global market, free trade and a high level of protection of life and health of the consumer demands more flexible besides the official control, a high level of standardization in the field of food safety. Legislation on food safety was significantly changed in recent years in the EU. Approach to food safety has been amended in its entirety. The new legislation covers the entire production chain from the farm or farms where the animals are raised until the production of food, or to the end consumer. The high standards are set for safety and quality of food as primary responsibility of the operator on the food. Food that is put on the market must be safe for consumption of high quality and should not cause a disease of people. This is the unconditional application of European legislation. A new approach to food safety is set by making the European Food Safety Act Regulation (EC) 178/2002 (1) of the European Parliament and the Council on 28 January 2002 on the general principles and requirements of food regulations. Bosnia and Herzegovina following changes to EU legislation in the area of food safety since 2004 when was adopted the Food Act (Official Gazette B&H no. 50/04) (2) which gave a framework for harmonization with the EU legal frame in the area of food safety, and which are taken provisions of Regulation (EC) no. 178/2002. In the process of joining the EU, Bosnia and Herzegovina carried out changes to laws and regulations in the field of food safety. Food Safety Agency of Bosnia and Herzegovina was established on the basis of the Law on food by decision on establishing by the Council of Ministers, as an independent administrative organization, the authority for the safety of food and feed with application of international conventions and international agreements in the areas of food safety and quality which is binding for Bosnia and Herzegovina. On the proposal of the Agency, in cooperation with the competent authorities of Entities and Brcko District, the Council of Ministers shall issue regulations governing the quality and food safety to protect consumers, enabling consumers to complete the selection in connection with the food they consume, as well as protect the interests of producers. The agency, according to the provisions for the food preparation initiate sub-regulations which are in accordance with the relevant EU regulations and standards of the Codex Alimentarius Commission, and thus, ensures a high level of health protection of consumers. 1.1. The objectives and principles of EU legislation in the field of food safety The main aim of concern for food safety is to ensure a high level of safety, protection of human health and the interests of consumers using modern integrated ap- 224

Vol. 21 No.4 2009 MATERIA SOCIO MEDICA proach from farm to table, including all sectors of the food chain: production, processing and storage of food, transportation and sale. Food safety, health and welfare of animals and plants have been identified in Articles 37, 95, 152 and 153 of Agreement on EC Green Paper on the basic principles of food legislation as the first serious attempt to create a coherent legislation in food safety. However, the principles of European policy on food safety are the default White Paper on Security of food. Implementation of the document in the European legislation introduce new measures to make the new legislative framework for animal nutrition, animal health and welfare, hygiene, additives, sweeteners, contaminants and residues, flavorings, genetically modified ingredients in food, irradiation and packing. The white book also introduces a mechanism for monitoring the implementation of legislation that is in charge by the European Commission in cooperation with the authorities at the national level. One of the most important results of the document is the introduction of foundation of food safety: scientific advice, data collection and their analysis, regulation, supervision and consumer protection. At the meeting of the Economic and Social Council of the EU in June 2003 was pointed out that the White Paper on food safety aimed at transforming the European legislation on health and soundness of a modern food safety system that will respond to the challenges of the 21st century The basic principles of proactive, dynamic and comprehensive policy to food safety and consumer protection policy are: Integrated and comprehensive approach follow the food chain from farm to table; Responsibility of all actors in the food safety policy (manufacturers, farmers, vendors); Traceability, the possibility of entering the track the origin of food ingredients; Transparency of scientific opinions and inspection reports; Risk Analysis; Other factors (environmental protection, sustainable agriculture, consumer expectations, etc.). 1.2. Law on Food by the European Community Framework for regulations on food safety in the European Union is set in Article 3 of Roman law, which ensures free movement of products in the common market. On this basis, the general objectives of food law are: Protection of public health (people, animals and plants); Providing information to consumers to base their selection and protection of their interests as being good informed; Ensuring fair trade and competition conditions for the subjects in the food sector; Provision of appropriate and necessary official control of food products. General Food Law Regulation (EC) no. 178/2002 establishes common principles and definitions for national laws on food for people and animals and EC legislation governing this area. In circumstances where the conditions for food security for people and animals do not differ between Member States, it is possible to achieve the free movement of food for humans and animals. Convergence of different concepts, principles and procedures is necessary for the purpose of forming a common basis for measures relating to food for humans and animals. The main aim of the Regulation is to ensure a high level of protection of human health and consumer interests in relation to food, determined by common principles and responsibilities, ways to ensure a strong scientific base, efficient organizational systems and procedures, relating to all phases of production, processing and distribution of food for humans and animals. 1.3. Institutions in the field of food safety For food safety in the EU are in charge the following institutions: the European Commission: DG Health and Consumer Protection, European Parliament: Committee on Environment, Public Health and Consumer Protection is responsible for the issue of food safety, the European Food Safety Agency (EFSA) provides scientific consulting services and timely information on existing and emerging risks in food. The objectives of the European Agency for the establishment of a system of food safety risk assessment, information gathering and analysis, system information and a quick warning. 1.4. Adopting the acquis communautaire Acquis communautaire is one of the most important legal and political principles of European integration. The term refers to the total rights, obligations and responsibilities of the European Community, or to the total achievement of the European legal community, view on the entire legislation and EU law accumulated to date. Often used as synonymous terms: EU law, EC law, the communitarian right etc. Adopting acquis communautaire, or the harmonization of legislation with its provisions is a complex job in the process of European integration. Harmonization of legislation requires inter-agency cooperation in the horizontal and vertical levels, and participation of the legal community. Each state that applies for membership in the EU must be ready to accept the acquis communautaire in its entirety and must be able to implement it. For the aspect of food are important chapters: the free movement of goods, agriculture and rural development, food safety, veterinary and phytosanitary policies, and Fishing (4). 1.5. Types of legal harmonization There are different types of legal harmonization: Unification: national regulations are replaced by EU regulations in certain areas where the EU has full jurisdiction. The main instruments for the process of unification of the Regulation; Harmonization of: national legislation to harmonize with the objectives prescribed by the acts of the EU. The main instruments for the process of harmonization of the Directive; Coordination: coordination of activities, exchange of information, conclusion of agreements, etc. In case of harmonization is different a full harmonization when in detailed and fully is regulated specific area, or set maximum standards or a single standard, and applies 225

the regulations on food, life-threatening products, cosmetics or pharmaceuticals, or minimum harmonization relating to the establishment of minimum legal regulation for a given area which allows further regulating and prescribing more strict standards than used in the regulations on consumer protection and environmental protection. There are three types of harmonization: transposition (prescriptions), reformulation (adopting the essence of the obligations arising from the directive) and reference (a reference to regulations) (5). 1.6. The structure of regulations on food safety the secondary sources of law Secondary sources of law are acts of community institutions bring in the jurisdiction. System regulations of the European Community use the following instruments: Regulations, Directives and Decisions as legally binding documents, and Recommendations and opinions as nonbinding legal acts: Regulation of the European Parliament and Council (EC) or the Commission, which is directly relevant to all member states and become binding immediately upon its adoption and publication, and binding for all member states. Binding in its entirety, directly and immediately applied, not adopted into national law; Directive of Council (EC), which describe the binding targets, but allow Member States flexibility in transferring these goals into national legislation through the national implementing regulations to allow exceptions or deviations for national legislation or practice. Each directive states where prohibited products allow disharmony in the market. Binding in terms of objectives to be attained, but leave the freedom to choose forms and methods of implementation. In contrast to the Regulation Directive can be implemented into national law and not put out of force the national regulations, but they agreed with the EC regulations; Decisions are documents that are binding for the parties which have been referred (Member States, companies, individuals). Indicate the member-state, legal or individual person, the whole bound; Recommendations and opinions contain the views of the EC institutions addressed to the Member States or individuals, are legally non-binding acts, but must be taken into account in the process of interpretation and implementation of national regulations, and they precede the adoption of binding legal acts. European regulations on food are often described as horizontal and vertical in its importance. Horizontal dealing with some aspect of law that applies to all foods or food groups (e.g., hygiene, labeling, additives, packaging). Vertical legislation dealing with certain foods and prescribes the standards that control all aspects of food (e.g. raw materials, ingredients, processing and labeling). 1.7. Other acts Sources of information on the objectives that need to be achieved by the EU legal acts are: Green Paper Documents on specific areas of particular policies, which include a description of some problems with potential legal solutions; White papers documents containing proposals for future activities of the community in certain areas. EU White Paper on food safety was adopted by the European Commission on 12th January 2000r, which set an action program of legislation on food safety. The basic principle of the White Paper is that food safety policy must be based on a comprehensive integrated approach, and laid responsibility with the business subjects in food. At the meeting of the Economic and Social Council of the EU in June 2003 was pointed out that the White Paper on food safety aimed at transforming the European legislation on health and soundness of a modern food safety system that will respond to the challenges of the 21st century. Initiated is the establishment of the European Food Safety Authority EFSA, production legislation in the field of food safety, control of implementation of legislation, consumer information and global access. Tasks laid down the White Paper resulted in creating the Regulation 178/2002 (European Commission Regulation 178/2002) or the General Food Law. Another result is the establishment of the European Food Safety Agency (EFSA), the establishment of Rapid Alert System for Food and Feed, RASFF, made and adopted a series of Regulation, Directive, decisions, recommendations and opinions related to food safety. 1.8. Codex Alimentarius Codex Alimentarius (6) is a set of standards, codes of practice, guides and other recommendations adopted by the Codex Alimentarius Commission. Founded in 1960 by the Organization of the United Nations Food and Agriculture FAO and World Health Organization WHO. The standards of Codex Alimentarius as a reference for the implementation of agreements on the application of sanitary and phytosanitary measures (SPS) of the World Trade Organization (WTO). Bosnia and Herzegovina became a full-fledged member of the Codex Alimentarius Commission; the Food Safety Agency ofbih became the contact point for Codex Alimentarius. The European Community is the Codex Alimentarius Commission member. 1.9. Legislation in the field of food safety in B&H In Bosnia and Herzegovina in 2004 was adopted and published the Food Act (Official Gazette B&H no. 50/04) (hereinafter: the Food Act) that adopted the provisions of Regulation (EC) 178/2002, which gave a framework to comply with legal heritage in the EU food safety. Food Law defines the unique principles and authority, achieving the scientific basis of the assumptions, procedures and responsibilities that are the basis of decision making on issues of health and correct quality of food and feed, and applies to all stages of production, processing, food processing and distribution. Food Act regulates the basis for ensuring a high level of protection of human health and consumer interests in relation to food. The main objective of this law is to protect life and health, protection of consumer interests and the protection of global interests ofbih at the international market. Mentioned Law, together with the by-laws which are enacted or are 226

Vol. 21 No.4 2009 MATERIA SOCIO MEDICA in the stage of adoption, constitutes the legal framework for food security in B&H. In Bosnia and Herzegovina is in effect a certain number of implementing regulations that are still in force, on the basis of decrees with the force to take over the federal law and other legislation that Yugoslavia as well as Bosnia and Herzegovina as Republic applicable laws, and other implementation regulations in the field of food that are outdated. In the meantime, the country environment, as well as EU countries, adopted new regulations in this field that the other, contemporary way to regulate the problems in the field of food in relation to the regulations in force in Bosnia and Herzegovina. These differences in the regulations in force in B&H in relation to the regulations in force in the countries surrounding the EU create significant difficulties in the functioning of local producers, both domestic and foreign on the market. On the basis of Article 16 Law on Food, the Council of Ministers, on draft of Food Safety Agency ofbih, in cooperation with the competent authorities of Entities and Brcko District, brings the implementing regulations on the application of any process in the production, processing, processing and distribution, which may affect the hygiene and safety of food and feed, according to Art. 72. Law on Food on the proposal of the Council of Ministers shall issue regulations on the new food regulations on labeling and advertising of food regulations on the food label of traditional prestige, originality and regulations on the label of geographic origin of food and other regulations in this area. Food Safety Agency ofbih, according to Article 54 Law on Food, initiates, prepares and organizes the development of implementing regulations in the Law on Food, in order to protect the interests of consumers, enabling consumers to complete the selection in connection with the food in use and protect the interests of producers. The agency according to Art. 53 of the Law on Food shall act in close cooperation with the competent authorities that are required within their jurisdiction, to ensure fulfillment of the tasks of the Agency. In the process of implementing regulations in addition to legal obligations defined by the Law on Food, the Agency is in accordance with the following regulations: Unique rules for drafting of legal regulations in the institutions ofbih (Official Gazette B&H, no. 11/05) (7), Rules for consultation in the development of legal regulations (Official Gazette B&H, no. 81/06) (8), Decision on the procedures in the process of harmonization ofbih legislation with the acquis communautaire ( Official Gazette B&H, no. 44/03) (9), and the decision to form a working group for harmonization B&H legal regulations with the acquis communautaire ( Official Gazette B&H, no. 52/05) (10). Agency proposes implementing regulations, which is estimated to have a significant impact on the public, to ensure a high level of consumer protection, enabling customers to complete the selection in connection with the food they use, and protection of the manufacturer, and as such represent a novelty in the process of adjusting the modern technical and technological changes, and the process of development of regulations significantly affect the whole country and contributes to the high level of protection of life and health of citizens, and have significant financial impact on certain economic sectors. 1.10. Law on Genetically Modified Organisms (GMO) According to Article 30 Law on Food, food and food ingredients containing Genetically Modified Organisms or consisting of them (hereinafter: GMO), food and food ingredients, except for food additives (flavor and enzymes), which are produced from GMOs but not containing GMOs, fall into the category of new foods, and as such should not be dangerous to the health of endconsumers, create misleading the consumer or end-vary so much from the food or food ingredients that make for its purpose should be to replace their consumption was for the end consumer in the food unfavorable terms. Bosnia and Herzegovina was one of the few countries that did not have this law, the remark was addressed by the European Commission to report on progress for 2007. During 2008 by the Food Safety Agency ofbih, in cooperation with experts and scientists, as well as all relevant bodies invested are enormous efforts in preparing the draft Law on GMO, which has passed all the required legal procedures, and in 2009 was adopted and published (11). 1.11. Regulations in the field of food safety Acting in accordance with the above legal framework, regulations compiled by the Food Safety Agency ofbih, in cooperation with the competent authorities of Entities and Brcko District, adopted by the Council of Ministers and published in 2008 2009: Regulations on conditions of use of food additives in foods intended for human nutrition; Regulations on the use of sweeteners in food; Regulations on the use of food additives other than colors and sweeteners in food; Regulation on refreshing soft drinks and similar products; Regulations on labeling of nutritional values of packed food; Regulations on the use of color in food; Regulation on strong alcoholic drinks and alcoholic beverages; Regulations on general declaration or packed food labeling; Regulation on fruit juices, fruit nectars and similar products; Regulation on honey and other bee products; Regulations on methods to control honey and other bee products; Regulations on conditions to be fulfilled by an authorized test laboratory which carried out the analysis of food and the process of laboratory accreditation; Regulation on salt for human consumption; Regulation on the maximum level for certain contaminants in food; for official control of the amount of dioxin and dioxin like polychlorinated biphenyls in food; 227

for official control the amount of lead, cadmium, mercury, inorganic tain, 3-MPCD and benzo(a) pyrene in food; for official control of mycotoxins in food quantity; for official control of the amount of nitrates in food. Adoption of these Regulations as national regulations and/or harmonized with European legislation, eliminating the differences in the regulations in force in the countries surrounding the EU, ensuring the smooth functioning of the internal market, protection of consumer interests, obligations of entities in the business of food and protection of interests manufacturers, both domestic and foreign on the market. Implementing regulations create and provide the preconditions for the legal and sub-system arranged in the area of food safety throughout Bosnia and Herzegovina. 2. DISCUSSION Decision on acceptance of the Agreement on Stabilization and Association Agreement between European Communities and their Member States and Bosnia and Herzegovina and the Interim Agreement on trade and trade-related matters between the European Community and Bosnia and Herzegovina (Official Gazette ofbih no.5/08 from 20 June 2008) Food Safety Agency ofbih is actively included in the processes of European integration in the way of Bosnia and Herzegovina to the EU. Decision on acceptance of this Agreement on Stabilization and Association Agreement between European Communities and their Member States and Bosnia and Herzegovina and the Interim Agreement on trade and trade issues between the community and B&H have opened new chapters on free movement of goods (industrial products Chapter I and of agriculture and fisheries Chapter II) that must be implemented in accordance with the relevant provisions of the WTO. EU legal heritage is one of the most important legal and political principles of European integration and the rights and obligations of Member States and their commitment to the European Union. Accepting the new concept of food safety, Food Safety Agency of Bosnia and Herzegovina is actively involved in developing and drafting new regulations and implementing acts in accordance with fulfilling obligations towards the EU requirements in the area in which it operates as an independent administrative organization, particularly in the work of harmonizing the legal regulations ofbih with the acquis communautaire (EU legal heritage). In this sense, the acceptance of the food and the establishment of Food Safety Agency of Bosnia and Herzegovina, Bosnia and Herzegovina has accepted the validity of the health criteria. Drafting the Law on GMOs, Bosnia and Herzegovina is becoming a country that was edited a new category of food that should not be a health hazard to the end consumer, create problems in the final consumer, and differ so much from the food or food ingredients that make for its purpose should be to replace that that their spending was for the end consumer in terms of adverse food. Adoption of the Rules as well as national regulations and/or harmonized with European legislation, eliminating the differences in the regulations in force in the countries surrounding the EU, ensuring the smooth functioning of the internal market, protection of consumer interests, obligations of entities in the business of food and protect the interests of producers, both on the domestic and the foreign market. Implementing regulations create and provide the preconditions for the legal and sub-structured system of food safety throughout Bosnia and Herzegovina. 3. REFERENCES 1. Regulation (EC) 178/2002: laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 2. Zakon o hrani ( Službeni glasnik BiH br. 50/04) 3. White Paper on Food Safety (2000). Commission of the European Communities, Brussels. 4. EU acquis communautaire (http://www.europa.eu.int/eur-lex/ 5. Priručnik za usklađivanje pravnih propisa BiH sa propisima EU (2005). Direkcija za evropske integracije Bosne i Hercegovine, Sarajevo. 6. Food standards FAO/WHO (http://www.codexalimentarius.net) 7. Jedinstvena pravila za izradu pravnih propisa u institucijama BiH ( Službeni glasnik BiH, broj 11/05) 8. Pravila za konsultacije u izradi pravnih propisa ( Službeni glasnik BiH, broj 81/06) 9. Odluka o procedurama u postupku usklađivanja zakonodavstva BiH sa Acquis communautaire ( Službeni glasnik BiH, broj 44/03) 10. Odluka o formiranju radnih grupa za usklađivanje pravnih propisa BiH sa Acquis communautaire ( Službeni glasnik BiH, broj 52/05) 11. Zakon o GMO ( Službeni glasnik BiH br. 23/09) Corresponding author: Nihada Ahmetovic, MD, PhD. Medical faculty of University of Tuzla. Univerzitetska 1. Tuzla. 228