Law No. 78-XV on foodstuffs

LAW OF THE REPUBLIC OF MOLDOVA On foodstuffs No. 78 –XV from 18.03.2004 Monitorul Oficial of the Republic of Moldova No. 83-87/431 from 28.05.2004 * * * CONTENTS Chapter I GENERAL PROVISIONS Article 1. Purpose and sphere of use of the present law Article 2. Basic notions Article 3. Legislation on foodstuffs Article 4. Main objectives of the foodstuff legislation Chapter II GENERAL REQUIREMENTS REGARDIND THE CIRCULATION OF FOODSTUFFS AND MATERIALS IN CONTACT WITH FOOD Article 5. Circulation of foodstuffs and materials in contact with food Article 6. Providing the safety of foodstuffs and materials in contact with food Article 7. Information regarding foodstuffs and materials in contact with foods Article 8. Traceability Chapter III STATE REGULATION IN THE SPHERE OF CIRCULATION OF FOODSTUFFS AND MATERIALS IN CONTACT WITH FOOD Article 9. State regulation in the sphere of circulation of foodstuffs and materials in contact with food Article 10. Assessment of foodstuff conformity Article 11. Approval of new foodstuffs and materials in contact with food before placement on the market Article 12. State Control and Surveillance, monitoring of foodstuff safety, monitoring of the population `s health. Chapter IV GENERAL PRINCIPLES REGARDING FOODSTUFFS AND MATERIALS IN CONTACT WITH FOOD Article 13. Elaboration and organization of the manufacturing process Article 14. Packing, packaging, and labeling (marking) Article 15. Storing, transportation, and distribution Article 16. Import Article 17. Export Article 18. Fortified foodstuffs Article 19. Foods for particular nutritional uses and food supplements Article 20. Arrangement and implementing of the control of safety of foodstuffs and materials in contact with food in the process of manufacturing Article 21. System of risk analysis and food circulation control at critical checkpoints Article 22. Staff of the enterprises from the alimentary field Article 23. Rapid Alert System Article 24. Withdrawal from the market of foodstuffs and materials in contacts with foods that do not comply with the regulations applicable to foodstuffs and/or are dangerous for the human health Article 25. Expertise, conditional use and destruction of foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous for the human health, and were removed from the market Chapter V RESPONSABILITIES AND SOLVING OF CONFLICT CASES Article 26. Responsibility for not fulfilling the present law Article 27. Responsibility of persons with major posts in Bodies of State Control and Surveillance Article 28. Settlement of controversial issues Chapter VI FINAL PROVISIONS Article 29. Coming into force Parliament passes the present organic law Chapter I GENERAL PROVISIONS Article 1. Purpose and sphere of use of the present law (1) The present law establishes the legal framework of the process of foodstuff manufacturing, processing and distribution, regulates the basic conditions concerning the circulation of these products, inclusively provides the safety of this process, in order to protect population’s health, consumers’ interests on foodstuffs, and to promote an equitable practice in the foodstuff trade. (2) The present law applies to all the foodstuffs, inclusively to the fortified ones, foods for particular nutritional uses, food supplements and other types of foodstuffs intended to be placed on the market. (3) The present law does not apply to raw food material intended for using in home conditions, cooking, manipulating and storing foodstuffs in home conditions with the purpose of private home use, as well as to foodstuffs in transit or temporarily stored as goods that transit the country, if these goods are safe for the human health and environment. Article 2. Basic Notions In the sense of the present law, the following basic notions are used: foodstuff – any substance or product, in natural or refined form, intended to human use, beverages inclusively, potable water and bottled mineral water, chewing gum, food additives, fortified foods, food nutriments and supplements, food products obtained from genetically modified organisms, and any other substances, inclusively water, intentionally integrated as foodstuffs during processing, cooking, manipulating or treating. The involved notion does not comprise: animal feed, live animals, excepting those intended to be placed on the market for human consumption; plants before harvesting; narcotics and psychotropic substances; substances used as drugs only; cosmetic products; tobacco and tobacco items; food additive – any substance not normally used as a food in itself and not normally used as a characteristic ingredient of food whether or not it has nutritive value, the intentional addition of which to food for a technological purpose (inclusively organoleptical) at different stages of foodstuff manufacturing process, results or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods. The notion in question does not include “contamination” or substances added to foodstuffs for the maintenance or increasing the nutritive quality (vitamins, oligoelements, aminoacids etc.); Ingredient – any substance, additives inclusively, used in the process of manufacturing or preparation and present in the final products as such or in a modified form; foods for particular nutritional uses – foodstuffs which, due to their special composition or manufacturing process are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes, as fulfilling the particular nutritional requirements of persons whose digestive process or metabolism are disturbed, or persons who are in special physiological conditions and will benefit from controlled consumption of certain substances, or infants or young children in good health, and which are commercialized in a form adequate to their destination; fortified foodstuffs – foodstuffs into which one or more essential nutriments were added, such as vitamins, minerals, proteins, or other nutritive substances, in order to increase the nutritive value of the respective product, and which are absent in the initial form of the product or were lost in the process of usual manufacturing. Fortified foodstuffs are not considered drugs; nutriments and/or food supplements – nutritive substances such as proteins, lipids, hydrocarbons, vitamins, minerals, essential aminoacids, and/or products marked in forms of tablets, capsules, dragée, powders or liquids, that contain macro- and micronutriments and/or other edible substances and are designed to be taken in measured unit quantities in addition to the normal diet. Nutriments and/or food supplements are not considered drugs; foodstuffs originated from genetically modified organisms and/or genetically modified organisms – foodstuffs that contain a new combination of genetic material obtained by means of biotechnological techniques and/or organisms (any biologic entity able to reproduce itself or to transfer genetic material) in which the genetic material was modified through a process that normally does not take place through pairing and/or natural recombination; foodstuffs of animal origin – foodstuffs that consist of or contain almost exclusively products of animal origin (raw material obtained from animals, birds, fish, bees and hydrobionts); foodstuffs of vegetal origin – foodstuffs made of, or containing almost exclusively products of vegetal origin; materials in contact with food – materials and items that are used at foodstuff manufacturing and distributing, technological equipment inclusively, devices and connections, packages, containers, dishes, utensils in contact with food, and materials intended to this purpose; package – any type of container, wrapping or covering material, having a specific nature and texture that protects the foodstuff from contamination and quality changes, used for transportation, manipulation, storing, and selling foodstuffs; prepackaged foodstuff – any item presented to the ultimate consumer as such, or to the economic agent that manufactures and supplies the population with foodstuffs, representing the foodstuff and the package into which the product had been wrapped before putting it up for sale, the package that fully or partially covers the foodstuff, so that the content cannot be damaged without unwrapping or package modification; foodstuff safety – reasoned assurance of the fact that, in normal conditions of preparation and/or use, foodstuffs are not dangerous and do not present risk for the present and future generation; certificate of quality of foodstuffs and materials in contact with food – a document by means of which manufacturer acknowledge the quality and safety compliance of each foodstuff batch to the prescribed requirements and/or declarations; regulations in food area – legislative acts, decrees of the President of the Republic of Moldova, Governmental decisions, sanitary, sanitary-veterinary, and fitosanitary rules and norms, standards and other pertinent normative documents that settle the essential requirements regarding the safety and control of foodstuffs and materials in contact with food, conditions of manufacturing, distribution and use, methods of sampling, risk assessment, as well as requirements regarding packing and labeling, conditional use or destruction of foodstuffs and of materials in contact with dangerous foodstuffs; food area enterprise – any enterprise, regardless the type of propriety, that provides the development of an activity in the field of food circulation in accordance with the law under consideration; raw food material – raw material of animal, vegetal or other origin, inclusively water used at foodstuff manufacturing; manufacturing process – the entire or partial process of obtaining, manipulating, processing, manufacturing, packing, labeling, storing, or transporting foodstuffs, inclusively the process of combining these products with other ones; circulation of foodstuffs and of materials in contact with food – elaborating, manufacturing, processing, packing, packaging, labeling, storing, transportation, distribution (import and export inclusively) of foodstuffs and materials in contact with food, as well as other ways of delivering products; placing on the market – the action of making foodstuffs available on the Republic of Moldova market, inclusively keeping them for future distribution, offering by selling, or any other type of delivering, for money or free of charge; labeling (marking) – any words, commercial marks, trade marks, signs, drawn, written, sealed, embossed, or printed elements, attached to or on a container with foodstuffs, placed on any package, accompany document, notes, label, banderole or parcel that accompany or refer to the respective food product; minimum durability of the product – a period of time established by the economic agent that manufactures a foodstuff, during which the product must maintain its specific characteristics, with the conditions that the rules on transportation, manipulation, storing, preservation, use, and consumption were kept. The minimum durability of foodstuffs may be expressed through a certain period of time or through expiry date; expiry date – the date established by the manufacturer for foodstuffs that are highly perishable from the microbiological point of view and are susceptible to present an immediate danger for the consumer’s life. The expiry date where the limit day, month, and year are indicated is preceded by the mention “Best before…” traceability – the possibility to identify and pursue a food product along all stages of manufacturing, processing and distribution, an animal that produces foodstuffs or is used in foodstuff manufacturing, as well as any substance that is to be, or may be incorporated in a foodstuff; foodstuffs hygiene – any conditions and measures necessary to guarantee the safety and the stability of foodstuffs while keeping them, undertaken at any stage of manufacturing and distribution, from cultivation, growing or production to the final consumption; contaminant – any substance not intentionally added to food which is present in such food as a result of production (plant and animal growing process, and veterinary practice inclusively), manufacture, processing, preparation, treatment, packing, packaging, transport or holding manipulating and destruction of such food or as a result of environmental contamination. danger – a biological, chemical, or physical agent from a food product, or an estate of a product that may have a baneful effect on human health; risk – the probability of the development of a noxious effect on human health, as well as the seriousness of this effect in case of exposure to danger; critical checkpoint – any stage of food circulation (raw material, building, technologic process, foodstuff network, transporting etc.) that being under control, leads to the removal of risk or its reduction to an accepted limit; system of risk analysis and control of circulation in the critical checkpoints – a systematic, scientific method used to provide the foodstuffs safety along the whole food circulation system, from raw material to consumer, through identification and assessment of the potential danger, critical for the foodstuffs safety, and provide their permanent control and surveillance in the critical checkpoints; risk analysis – a process consisting of three inter-related components: risk assessment, risk management and risk communication; risk assessment – a process based on scientific data that comprises four stages: risk identification, risk description evaluation of the level of risk exposure, and risk exposure description; risk management – the process of analysis of different, possible tactics by consulting the interested parties, taking into account the risk assessment results and other results with negative impact, choosing, if necessary, the corresponding preventive and control measures; risk communication – interactive exchange of information and notifications, along the whole risk analysis process, regarding risks and dangers, factors connected with these risks, their identification among people responsible for risk assessment and management, consumers, enterprises from food area, university means, and other interested parties, and especially explaining the results of risk evaluation and arguing the undertaken managerial decisions; identification of foodstuffs and materials in contact with food – establishing the compliance of foodstuffs and materials in contact with food to the requirements provided by the regulations applicable to foodstuffs, as well as the information regarding these products and materials, comprised in the annexed documents and labels; foodstuffs and materials in contact with falsified foodstuffs – foodstuffs and materials in contact with foods that were intentionally or unintentionally modified, so that they can represent a risk for the human health, may incorrectly inform or affect consumer’s interests, and the composition, characteristics and proprieties of which do not comply to the requirements provided by the regulations applicable to foodstuffs, but pretend to be products as such by their appearance, presentation and publicity. Article 3. Legislation on foodstuffs (1) Legislation on foodstuffs regulates the area of foodstuffs in general and foodstuff safety in particular, comprising all the stages of foodstuff manufacturing, processing and distribution, and consists of the law under consideration and other laws and normative acts. (2 If the international treaties to which the Republic of Moldova is a signatory contain other provisions than those comprised by the legislation of the Republic of Moldova, provisions of the international treaties are applied. Article 4. Main objectives of the foodstuff legislation The main objectives of the legislation on foodstuffs are: a) protection of human life and health regarding foodstuffs and materials in contact with food; b) protection of consumer’s interests in order to prevent the fraudulent or deceptive practice of falsification of foodstuffs and of materials in contact with foods, as well as any other practice that could mislead the consumer; c) providing an equitable practice in food trade. Chapter II GENERAL REQUIREMENTS REGARDIND THE CIRCULATION OF FOODSTUFFS AND MATERIALS IN CONTACT WITH FOOD Article 5. Circulation of foodstuffs and materials in contact with food (1) Only safe foodstuffs and materials in contact with food that comply to the requirements provided by the regulations applicable to foodstuffs, approved in the established way, may be placed on the market. (2) foodstuffs offered to human consumption shall satisfy the physiological needs of people in the necessary nutritive substances and energy, to be safe, free of contaminants, microorganisms, and other organisms and biological substances exceeding the limiting values established by rules and sanitary standards, to be safe for people in other aspects as well, to be manufactured and placed on the market in adequate sanitary conditions, in accordance with the regulations applicable to foodstuffs. The indicated nutritive value of a food product offered for human consumption shall correspond to the real nutritive value and not mislead the consumer. (3) Manufacturing and distribution of foodstuffs and materials in contact with food shall be carried out in spaces and conditions corresponding to the sanitary and sanitary-veterinary regulations and standards in force, for which economic agents hold sanitary and sanitary-veterinary authorizations, depending on the case. (4) It ifs forbidden production and placing on the market of foodstuffs and materials in contact with food that: a) do not correspond to the requirements provided by the regulations applicable in the alimentary field and were not approved in the established way; b) are dangerous and may imperil the human life in usual conditions of usage by the consumer, taking into account the information on the label or delivered to the consumer in any other way; c) are not appropriate for human consume, being contaminated and/or impure, presenting signs of putrefaction, decomposition or any other signs of alteration; d) are falsified e) do not contain on the label information provided by the regulations applicable in the alimentary field; f) do not have an established expiring date (in the case when the food product limitation term is compulsory to be established) or if the expiring date has passed. d) do not have certificate of quality, certificates of declarations of correspondence issued in conformity with the low in force. (5) foodstuffs and materials in contact with food specified in paragraph (4) are considered not corresponding to the regulations applicable in the alimentary field, dangerous, and cannot be placed on the market following to be used conditionally or to be destroyed. (6) the correspondence of foodstuffs and materials in contact with foods with the regulation requirements applicable to foodstuffs, do not hamper the state surveillance bodies on foodstuffs harmlessness to establish restrictions on the placing on or removal from the market these products and materials, regardless their correspondence, if they are suspicious concerning their danger. (7) Economic agents from food area will undertake necessary measures to eliminate the risk of contamination or food product decaying and their transformation into products dangerous for people. Article 6. Providing the safety of foodstuffs and materials in contact with food. The harmlessness of foodstuffs and of materials in contact with food is ensured through: a) state regulations, control and surveillance in the field of ensuring their harmlessness; b) undertaking of some organizational, agro-chemical, veterinary, technological, sanitary-antiepidemic, and fitosanitary measures by economic agents from food area regarding the observance of the requirements applicable in the alimentary field; c) control of foodstuffs and of materials in contact with food, undertaken by economic agents from food area along the whole food product circulation, inclusively through the use of system of danger analysis and control of food circulation in critical checkpoints; d) application of repressing measures against the infringements of the present law, inclusively of regulation requirements applicable in the alimentary field, measures of administrative, civil, and criminal responsibility against people who perpetrated such infringements. Article 7. Information regarding foodstuffs and materials in contact with food (1) Economic agents from food area are obliged to present to the customer and to the Bodies of State Control and Surveillance complete, truthful and precise information regarding foodstuffs and materials in contact with food, regarding keeping to the regulation requirements applicable in the food field while performing operations concerning food circulation. (2) State bodies authorized to control and supervise the circulation of foodstuffs and of materials in contact with food will ensure the informing process of central public authorities, consumers and economic agents of food area about: the harmlessness of foodstuffs and of materials in contact with food, the regulation requirements applicable in the alimentary field and keeping to these regulations, and the measures undertaken to prevent the placing on the market of foodstuffs and materials in contact with food that are dangerous for human health. Article 8. Traceability (1) Economic agents from food area will ensure the process of Traceability of foodstuffs and materials in contact with food at all stages of their circulation, of the animals that produce foodstuffs or are used in the process of food production, as well as Traceability of any substance is to be or may be used in foodstuffs and materials in contact with food. (2) Producers from food area will ensure the surveillance of food product batches and of materials in contact with food. (3) Economic bodies from food area will ensure the identification of all the people that supply raw food material, semi-finished products, food additives, foodstuffs or any other substances that are to be or may be used in foodstuffs and material in contact with foodstuffs. For this purpose, they shall dispose of systems and procedures that will enable delivering the information in question to the Bodies of State Control and Surveillance at their solicitation. (4) Economic bodies from food area shall dispose of systems and procedures that will enable to identify the enterprises to which the foodstuffs were delivered and to deliver the information in question to the Bodies of State Control and Surveillance at their solicitation. (5) Foodstuffs placed or susceptible of being placed on the market shall be labeled or identified in an adequate way by means of documents or pertinent information in order to facilitate the process of their Traceability in accordance with the regulations applicable in the field of food. Chapter III STATE REGULATION IN THE SPHERE OF FOOD PRODUCT CIRCULATION AND OF MATERIALS IN CONTACT WITH FOOD Article 9. State regulation in the sphere of food product circulation and of materials in contact with food (1) Requirements related to the nutritive value of foodstuffs; the quality of fortified foodstuffs, foods with particular nutritional uses, food nutriments and supplements; safety of foodstuffs, in general, inclusively of those genetically modified and of materials in contact with food, safe conditions of foodstuff elaboration, organization of manufacturing process, manufacturing, placing on the market, distribution inclusively; exactingness regarding procedures of foodstuff safety control, inclusively of sampling and investigation, methods of risk evaluation, as well as packaging and labeling, requirements and exigencies related to the foodstuff safety ensuring, are established in correspondence with the regulations in the field of food safety. (2) Requirements regarding the insurance of foodstuff safety are enforced by the Agreement on enforcement of the sanitary and fitosanitary measures of World Organization of Commerce, to which Moldova is a signatory. They are established on the basis of the risk evaluation and are mandatory. (3) Requirements regarding safety in the veterinary aspect in foodstuffs of animal origin, and those regarding foodstuff safety in the veterinary aspect, concerning their conditions of obtaining, manufacturing and distribution, are established in the corresponding regulations in the field of food. (4) Requirements referred to in paragraphs (1)–(3) are based on the results of scientific researches regarding peculiarities of alimentation and nutrition and the population health, on the identification and assessment of the danger factor in foodstuffs and materials in contact with food, assessment and analysis of the risk to endanger the human life after their consumption, assessment of safety, and on social and economical consequences of introducing such requirements. (5) When establishing requirements with regard to the safety of a food product, the following factors will be taken into account: a) the probable immediate and/or short-term and/or long-term effect of this foodstuff both on the consumer and on his future generations; b) the probable cumulative toxic effects; c) particular sanitary sensitivity of a certain category of consumers, in case when the product is intended to them. (6) The basic regulation requirements in the alimentary field comprise minimal quality requirements through which the food product is identified and are mandatory for all the economic agents involved in the foodstuff circulation. (7) International standards and recommendations in force or in course of adoption, Codex Alimentarius Commission and European Union recommendations inclusively are considered at the elaboration and adaptation of the regulations in the food area with regards to the circulation of foodstuffs and of materials in contact with food. (8) Regulations in the food area will ensure the protection of consumer’s interests by establishing the basic requirements of foodstuffs and materials in contact with food identification along the whole food circulation, inclusively by enclosing of provisions concerning consumer’s information regarding the foodstuffs they consume with full knowledge of the case and depending on their financial possibilities. (9) Sanitary standards and rules are approved by the State Body of Sanitary-Epidemic Surveillance, sanitary-veterinary standards and rules - by the Body of State Sanitary-Veterinary Surveillance, fitosanitary standards and rules - by the Body of State Fitosanitary Surveillance, national standards – by the National Standardization Body in accordance with the competencies provided by the acting legislation. Article 10. Assessment of the of foodstuff conformity Assessment of foodstuff conformity is performed in accordance with the acting legislation. Article 11. Approval of new types of foodstuffs and of materials in contact with food before placing on the market (1) Before placing on the market, new types of foodstuffs and materials in contact with food, manufactured in the country and those imported, shall be subjected to safety assessment and approved in the established way. At the same time, imported foodstuffs and materials in contact with food will be approved before they entered the territory of the Republic of Moldova. (2) Approval (notification) is performed by the state body of sanitary-epidemic surveillance and has the aim to assess the safety of foodstuffs and of materials in contact with food for the human health and assessment of their appropriation for human consumption. The approval encloses: a) the expertise of the documents presented by the economic agent from food area that manufactures or distributes foodstuffs and the confirmation of their compliance with the sanitary rules and standards in force, conditions of manufacturing or delivering and, depending on the case, the expertise of the investigation results of these food product and of materials in contact with food; b) introduction of new types of foodstuffs and materials in contact with food, approved to be manufactured or imported and placed on the market of the Republic of Moldova, in the State Register of Surveillance of these products and issuing of a sanitary approval notification. (3) The economic agent from food area will present truthful and argued data regarding assessment of foodstuff safety. (4) State registration of new types of foodstuffs and materials in contact with food, that were approved to be manufactured, imported, and placed on the Republic of Moldova market, and maintenance of the State Register of Surveillance of these products, is performed by the State Body of Sanitary-Epidemic Surveillance in accordance with the regulations approved by the Government. (5) State registration under one and the same name of few new foodstuffs and materials in contact with food, as well as multiple registration under the same name or under different names of one and the same new food product and of material in contact with foodstuffs is prohibited. Article 12. State control and surveillance, food product safety observation, monitoring of population’s health (1) State control and surveillance in the field of food product and material in contact with food product safety and quality, population’s Health Care, protection of consumer’s rights is performed by the State body of sanitary-epidemic surveillance, State body of sanitary veterinary surveillance, State body of consumers’ right protection, and by other control bodies, in accordance with the attributions provided by the acting legislation. (2) State bodies of control and surveillance, in association with the interested central and local public authorities, organize and perform the monitoring of food safety and population’s health notably in the alimentary factor. The monitoring has the aim to establish the main directions of the state policy regarding safety of foodstuffs, population’s health care, and consumer’s right protection, as well as to draw up measures to impede placing of unsafe foodstuffs and materials in contact with food on the market. (3) High-rankers and specialists of the state bodies of control and surveillance referred to in the paragraph (1) can solicit, during inspection, depending on the case, personal protection and police support. Chapter IV GENERAL PRINCIPLES REGARDING FOODSTUFFS AND MATERIALS IN CONTACT WITH FOOD Article 13. Elaboration and organization of the manufacturing process (1) While elaborating new types of foodstuffs and materials in contact with food and/or of new technological processes of manufacturing and distributing, economic agents from the food area are obliged to: argue the exigencies regarding the safety of foodstuffs and materials, packing, packaging, labeling, maintenance of harmlessness during manufacturing and distribution, elaborate programs of safety control at manufacturing, investigation methods, establish the minimum durability of foodstuffs and of materials in contact. The minimum durability of the product is established by the manufacturer, upon his responsibility, or in corroboration with research institutions, after a previous testing, being given the notification of the State Body of Sanitary-Epidemical Surveillance. (2) The regulations applicable to foodstuffs shall enclose indexes of quality and safety of new types of foods and materials in contact with food, requirements regarding packaging and labeling of these products, conditions of manufacturing and distribution, programs of safety control of the process of manufacturing, investigation methods regarding foodstuffs and materials. (3) The technical prescriptions projects and experimental samples of new foodstuffs and materials in contact with food will undergo sanitary-hygienic examination, sanitary – veterinary, and, depending on the case, examination in the frame of the body responsible for providing essential rules, other than those on safety human health protection, and will obtain respective notifications. Only when the notifications were received, the manufacturer can approve the mentioned projects. (4) New types of foodstuffs and materials in contact with food can be manufactured, placed on the market, and distributed after they were approved in the way provided by the law. (5) During the process of manufacturing foodstuffs and materials in contact with food, regulatory provisions applicable to foodstuffs will be observed. (6) During the process of foodstuff manufacturing, safe alimentary raw materials that correspond to the regulations applicable to foodstuffs shall be used. While obtaining alimentary raw material it is allowed to use feed additives, stimulators of animal growth, (hormonal preparations inclusively), veterinary preparations, pesticides, fertilizers, and other products for plant and soil treatment, that underwent sanitary-epidemical examination, were assessed as safe to human in certain conditions of usage, and were approved in the way established by the legislation in force. (7) Raw material of animal origin can be used at manufacturing foodstuffs only after it underwent sanitary veterinary examination and the manufacturer received the notification of the State Veterinary Service, which certifies the compliance of the raw material of animal origin with the sanitary veterinary rules and standards. (8) Food additives used at manufacturing foodstuffs, nutritive substances used as fortifying products, food nutriments and supplements, as well as materials in contact with food do not have to be dangerous for the human life and health. Only food additives, nutritive substances used as fortifying products, food nutriments and supplements, as well as materials in contact with food that were approved in the way established by the law in force, can be used at manufacturing foods intended to human consumption. (9) The manufacturer is obliged to cease immediately the process of manufacturing of foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous, for a period of time necessary to remedy the deficiencies. In case of impossibility to remedy the deficiencies, the manufacturer is obliged to cease the manufacturing process and distribution of the mentioned products and materials, to remove the products from the market, from buyers and consumers inclusively, and to organize, in the established way, their examination, conditional use or destruction. Article 14. Packing, packaging, and labeling (marking) (1) Foodstuffs shall be packed and packaged in a way that will provide maintenance of their quantity, quality, and safety while storing, transporting and distributing. (2) At foodstuff packing, packaging and labeling, the economic agents from food area shall comply with the regulation requirements applicable to foodstuffs. (3) At foodstuff packing and packaging shall be used materials that comply with the regulations applicable to foodstuffs, do not eliminate in the food components with risks to human health, provide maintenance of product characteristics, are recyclable or may be revaluated and destroyed without prejudice to the environment, in accordance with the legislation in force. (4) Labeling, advertising, and presentation of foodstuffs, inclusively shape, appearance, packaging, materials used at packing and packaging, the way they are presented, the environment in which they are manufactured, as well as information broadcasted by any means shall not mislead the consumer. (5) The foodstuff label will offer to the consumer necessary, sufficient, truthful and easy to compare information that will allow them to choose the foodstuff corresponding to their exigencies and financial possibilities, inform them on the possible risks to which they can be subjected, in order not to be mislead. (6) The label shall be placed in such a place that cannot be separated from the container and the information rubbed. (7) The label shall obligatory contain information provided by the regulations applicable to foodstuffs, inclusively: a) name under which the foodstuff is commercialized; b) list of ingredients; c) net quantity, volume; d) date of manufacture and minimum term of durability; e) conditions of storage; f) instructions on usage g) name and address of the manufacturer and/or importer, and distributor; h) data regarding batch identification; i) name of the country of origin; j) other specific information. (8) The information on the foodstuff label shall be clearly visible, easily legible and in indelible characters. (9) It is forbidden to extent the minimum term of durability of foodstuffs, inclusively by re-labeling or re-packaging. (10) At foodstuff labeling the following inscriptions are prohibited: a) those that attribute or by which it is suggested that the food product has prophylactic or treating characteristics of human diseases, with the exception of cases when these characteristics were proven or confirmed by the Ministry of Health; b) those that mislead the consumer indicating false information regarding foodstuff characteristics, origin, identity, peculiarities, composition, minimum term of durability, way of manufacturing, other that the natural ones. (11) Interdictions referred to in paragraph (10) are also referred to the foodstuff advertisement. (12) It is prohibited to distribute incorrectly labeled foodstuffs. (13) Labeling of foodstuffs treated with ionizing radiation, is done by writing on the label “Treated with ionizing radiation”. (14) Labeling of genetically modified foodstuffs is done by writing on the label the inscription: “Genetically modified food product” or “Food product obtained from genetically modified organism”. (15) The labels of foods with particular nutritional uses and food supplements shall contain supplementary information regarding their proprieties and characteristics. (16) Labeling of foods with particular nutritional uses for infants or young children shall not contain information that will prejudice or impede breast-feeding. (17) To the foodstuff labels, displaying and advertising prophylactic and treating characteristics shall not be attributed or invoked. Article 15. Storing, transportation, and distribution (1) Storing, transportation and distribution of foodstuffs and materials in contact with food shall be carried on in conditions that will provide their safety and will maintain their basic characteristics. (2) Economic agents from the food area involved in the storage, transportation, and distribution of foodstuffs are obliged to comply with the regulations applicable to foodstuffs and to confirm their compliance in the accompanying documents. (3) Transporting of foodstuffs shall be performed by special means of transportation that will guarantee adequate conditions of hygiene and temperature provided by the regulations applicable to foodstuffs, and will hold a sanitary passport received in the established way. (4) If while storing, transportation, or distribution of foodstuffs and materials in contact with food, there were committed infringements that lead to the change of quality, loss of their safety, becoming dangerous or falsified, economic agents from the food area that hold them, are obliged to cease the supplying and distribution of these products and materials, to inform the addressees and consumers, organize their withdrawal from consumers and customers, and provide the examination, conditional use or destroy of these products. (5) It is forbidden to retail the unpacked and unpackaged foodstuffs, with the exception of some new foodstuffs, enumerated by the Government in a classified list. Article 16. Import (1) Foodstuffs and materials in contact with food, imported to be placed on the market shall comply with the regulations applicable to foodstuffs in the Republic of Moldova or to the provisions of a special agreement signed between the Republic of Moldova and the exporting country, if such an agreement exists. (2) The responsibility of the manufacturer and distributor to observe, while importing, the regulatory requirements applicable to foodstuffs is the essential clause in the contract of delivering foodstuffs and materials in contact with food. (3) It is prohibited to import foodstuffs and materials in contact with food that were not approved by the Ministry of Health as being safe and appropriate to human consumption in accordance with art.11, as well as those lacking accompanying documents certifying their safety and legal origin. (4) Once imported, foodstuffs and materials in contact with food shall undergo customs inspections in the way established by the Government. Article 17. Export (1) Foodstuffs and materials in contact with food, intended to the export or reexport, so as to be placed on the market of an other country, shall comply with the regulation requirements applicable to foodstuffs in the respective country, with the exception of the cases when the bilateral agreement between parties provides other requirements. (2) Foodstuffs and materials in contact with food, intended to export that do not comply with the regulation requirements applicable to foodstuffs of the Republic of Moldova, but comply with the requirements of the importing country, may stay in the Republic of Moldova for no more that 90 days since the date of manufacturing or date of entrance the country. These products shall be clearly marked as being intended exclusively to export, shall be stored and kept separately from other foodstuffs. (3) If foodstuffs and materials in contact with food intended for export do not comply with the regulatory requirements applicable to foodstuffs in the Republic of Moldova and during the period of 90 days from the date of manufacturing were not exported or complied with these regulations, they are confiscated in accordance with the law in force, subjected to examination, and depending on the results are used conditionally or destroyed. Article 18. Fortified foodstuffs (1) Fortified foodstuffs shall contain nutritive substances, added in the limit established by the Ministry of Health and shall be safe for human consumption. (2) The decisions regarding fortification of foodstuffs with scarce nutriments are made by the Ministry of Health, which also establishes the requirements for these foodstuffs. (3) The fortification of foodstuffs decided by the Ministry of Health is mandatory for all the economic agents form the food area involved in the circulation of these foodstuffs. (4) Economic agents from food area involved in the circulation of fortified foodstuffs are obliged to ensure the prescribed content of nutriments in these products. (5) Foodstuffs fortified with scarce micronutriments have priorities at transporting, storing and distributing in comparison with non-fortified foodstuffs from the same category. Article 19. Foods for Particular Nutritional Uses (1) Foods for particular nutritional uses must fulfill the special nutritional requirements of persons whose digestive processes or metabolism are disturbed, or persons who are in special physiological conditions and will benefit from controlled consumption of certain substances from foodstuffs, as well as the requirements for infants or young children. Foods for particular nutritional uses shall be safe for the health of persons to whom they were intended. (2) The food nutriments and supplements shall contain pre established quantities of nutritive substances and be safe for the human health. (3) At manufacturing foods for particular nutritional uses is not allowed to use raw material attained with the use of feed additives, stimulators of animal growth (inclusively of hormonal preparation), certain veterinary preparations, pesticides, fertilizers, or other products used for plant and soil treatment, as well as other substances and components unsafe for human health. (4) It is forbidden distribution for human consumption of foods for particular uses that: a) do not comply with the quality requirements and do not contain the nutriments provided by the Ministry of Health; b) are manufactured and distributed in conditions that do not comply with the sanitary rules and standards in force. Article 20. Arrangement and carrying out the control of the safety of foodstuffs and materials in contact with food in the process of manufacturing (1) Economic agents from the food area are obliged to organize and carry out, during the manufacturing process, the control of the safety of foodstuffs and materials in contact with food, and the control of the compliance of the regulatory requirements applicable to foodstuffs with the conditions of manufacturing and distributing of these products and materials. (2) Manufacturers are obligated to organize and carry out, during the technological flow, the safety control of each food product batch and materials in contact with food, record the results of the control, store them a certain period of time, hand to the buyer along with the products the certificate of quality, certificate of conformity or declaration of conformity, with the exception of foods prepared in places of public alimentation. (3) The safety control of foodstuffs and materials in contact with food is carried in accordance with the programs drawn up by economic agents from the food area on the basis of regulations applicable to foodstuffs. Article 21. System of risk analysis and food circulation control at critical checkpoints Economic agents from food area implement systems of risk analysis and control of food circulation in the critical checkpoints basing on the followings: a) analysis of the possible risks to contaminate foodstuffs during the technologic process in the frame of foodstuff enterprises; b) finding the stages of the technologic process that may present risks and establishing the critical checkpoints; c) conducting the control at critical checkpoints; d) periodic assessment of the control efficacy conducted in accordance with the provisions refereed to at letters a)-c) and updating these provisions in case of modification of foodstuff manufacturing process. Article 22. Staff of the enterprises from the alimentary field (1) Manufacturing and distributing of foodstuffs is carried out only by persons that underwent prophylactic medical examination when employed, and subsequently undergo periodical medical checks, meet the health requirements established by the Ministry of Health, have the necessary professional qualification for the operations they perform, underwent hygienic training, and have sufficient knowledge in the fields of Public Health, foodstuff hygiene, labor hygiene, and are attested in accordance with the regulations applicable to foodstuffs. (2) Persons suffering from infectious diseases or those suspected of suffering from such diseases, persons that were in contact with such diseased, carriers of the pathogenic germs of infectious diseases are not allowed to conduct operations that implies a direct contact with foodstuffs and materials in contact with food. Article 23. Rapid Alert System (1) To notify any direct or indirect risk of foodstuffs for human health, the Government shall found the Rapid Alert System that will function in the frame of Bodies of State Control and Surveillance of food safety. (2) If it is clear that foodstuffs are likely to constitute a serious risk for the human health, Bodies of State Control and Surveillance of food safety shall immediately adopt prompt measures of canceling the placement of foodstuffs on the market, import or use of the products under question, or adopt other adequate measures in accordance with the attributions established by the legislation in force. Article 24. Withdrawal from the market of foodstuffs and materials in contacts with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous (1) Foodstuffs and materials in contact with food that do not comply with the regulations and/or are dangerous shall be withdrawn from the market. Economic agents from the food area that hold these products and materials are obliged to recall them from the market, out of personal initiative or on basis of a written disposition (prescription) of the State Body of Control and Surveillance. (2) Foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuff, but are safe for the human health and are not falsified, can be reconditioned before selling or distributing them in an other way. The economic agent from the food area that holds these products and materials shall provide their storage in conditions that would impede the access to them, keep them under observation for the whole period of reconditioning. (3) The economic bodies from the food area responsible for the retailing or distribution of foodstuffs and materials in contact with food, during which their package, label, safety or integrity are not affected, will implement, in the limit of their own activities, procedures of withdrawal from the market of the mentioned foodstuffs and materials that do not comply with the safety conditions provided by the regulations applicable to foodstuffs, contributing to the withdrawal, will pass the information necessary for the withdrawal and will co-operate to fulfil the measures taken by the manufacturer and/or by the State Bodies of Control and Surveillance. (4) Economic agents from the food area shall immediately inform the Bodies of State Control and Supervision of any cases when there is a suspicion of placement on the market of products that are dangerous to human health, as well as of the measures taken to prevent, diminish and eliminate risks. (5) If in a batch of foodstuffs or of materials in contact with food of the same category, was found a dangerous product or material, it is considered that all the products or materials from this batch are, to the same extent, dangerous with the exception of the cases when the rest of the batch was proved safe as a result of a detailed examination. (6) The economic agent from the food area that holds foodstuffs and materials in contact with food, which do not comply with the regulations applicable to foodstuffs and/or are dangerous, is obligated to provide their temporary storage in conditions that would exclude the access to them, and would provide their strict observation. (7) If the economic agent from the food area, holder of foodstuffs and materials in contact with food, which do not comply with the regulations applicable to foodstuffs and/or are dangerous, has not taken steps to recall these foodstuffs and materials from the market, they are confiscated in accordance with the legislation in force. Article 25. Expertise, conditional use and destruction of foodstuffs and of materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous, which were removed from the market (1) Foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous, and were recalled from the market, shall be subjected to a corresponding examination (sanitary-epidemic, sanitary-veterinary etc.) carried out by the Bodies of State Control and Surveillance, in accordance with the attributed competence, so as to determine the possibility of conditional use or destruction. If the economic agent from the food area, holder of foodstuffs and materials in contact with food, cannot confirm their origin, if these products have visible signs of taint, and are dangerous for human health and life, they shall be used conditionally or destroyed without examination. Previous to the conditional use or destruction, the holder of these foodstuffs and materials, in the presence of the representatives from the State Body of Control and Surveillance, shall modify their characteristics by any accessible and reliable method, action that will exclude the possibility of using them in accordance with their destination. (2) Foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous are stored, during the examination, in conditions that would exclude the access to them. The mentioned products and materials will be kept under strict observation. The responsible for the integrity of these products and materials is the economic agent from the food sector that holds them. (3) Basing on the results of the examination of foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and or/are dangerous, the respective Body of State Control and Surveillance decides the conditional use or destruction of these products. The economic agent from the food area that holds these products and materials chooses the way and conditions of conditional use or destruction in accordance with the regulations applicable to foodstuffs, coordinating with the Body of the State Control and Surveillance that issued the respective decision. (4) The possibility to use the foodstuffs that do not comply with the regulations applicable to foodstuffs and /or are dangerous, as pet food is coordinated with the State Veterinary Service. (5) The expenses for the expertise, storage, transportation, conditional use and destruction of foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous are borne by the economic agent from the food area that holds them. (6) The economic agent from the food area, holder of foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous, shall present to the State Body of Control and Surveillance that issued the decision about the conditional use or destruction, the document or its copy, legalized in the established way, which confirms the conditional use of these foodstuffs and materials. (7) The Bodies of State Control and Surveillance that issued the declaration regarding the conditional use and destruction of foodstuffs and materials in contact with food that do not comply with the regulations applicable to foodstuffs and/or are dangerous, are obliged to carry out the control over the conditional use or destruction of these products. Chapter V RESPONSABILITY AND SOLVING OF CONFLICT CASES Article 26. Responsibility for not fulfilling the present law Infringement of the present law regulations entails administrative, civil, or criminal responsibility in accordance with the acting legislation. Article 27. Responsibility of persons with major posts in the Bodies of State Control and Surveillance Activities unsuitable to the position, hiding of actions that may put in danger the human’ s life and health entail responsibility of the persons with major posts in the Bodies of State Control and Surveillance in conformity with the legislation in force. Article 28. Settlement of controversial issues Controversial issues arisen between the economic agents from the food area and the Bodies of State Control and Surveillance shall be solved judicially. Chapter VI FINAL PROVISIONS Article 29. Coming into force (1) The present law comes into force at the expiring of 12 months from the date of issuing, with the exception of art.6 point c), which deals with the system of risk analysis and circulation of foodstuffs in the critical checkpoints, and art.21, that will come into force on January 1, 2007. (2) In 3 months the government will: a) present to the Parliament the suggestion to bring the legislation in force in concordance with the present law; b) bring the normative acts in concordance with the present law. (3) In 12 months the economic bodies from the food area involved in the circulation of foodstuffs and materials in contact with food shall bring their activities in concordance with the present law, taking into account the exception specified in paragraph (1). SPEAKER OF Eugenia Ostapciuc PARLIAMENT Chişinău, March 18, 2004 N. 78-XV The laws of The Republic of Moldova 78/18.03.2004 regarding foodstuffs// Monitorul Oficial 83-87/431, 28.05.2004