Law on food safety

APPROVED on 27 NOVEMBER, 2006 THE LAW OF THE REPUBLIC OF ARMENIA ON FOOD SAFETY CHAPTER 1. GENERAL PROVISIONS Article 1. The subject of regulation of the Law The law governs the relations with respect to the safety at stages of import, export, manufacture, processing, packaging, labelling, transport, storage and placing on the market of food, materials in contact with food and food additives, as well as at stages of trading and mass catering. Article 2. General definitions For the purposes of this Law the following definitions have been used: food – any source materials for food or product, whether processed, partially processed or unprocessed, intended to be ingested by humans, including non-alcoholic beverages, chewing gum and potable water (including bottled water) incorporated into food during its preparation, processing or treatment. Food shall not include: a) animal feed; b) farmed animals production prior to slaughter; c) plants prior to harvesting; d) medicinal products; e) cosmetics; f) tobacco and tobacco products; g) narcotic and psychotropic substances; h) residues and contaminants. source materials for food - foodstuff, source materials, substance, products of plant, animal, organic, mineral, synthetic or biotechnological origin and water used for food production; foodstuffs for particular (nutritional) purposes - foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (foods for infants, dietetic foods, foods for special medical purposes, etc) following the criteria set by the authority of state control in a relevant field (hereinafter, Authority). food chain (production and circulation) stages – all stages of manufacturing, processing, distribution, storage, transport, import, export and placing on the market of foodstuff and the ingredients thereof from and including primary production up to and including consumption stages. Food chain also includes the materials intended to come into contact with food or source materials for food, food additives, as well as the trade and mass catering and related services; primary production –production of source materials for food, plants produce including harvesting, farmed animal production prior to slaughter, milking, as well as hunting, fishing and harvesting of wild products; food safety – elimination of risk to human life and health provided by the compliance of foodstuff, materials in contact with food and food additives with the requirements of the technical regulations, sanitary rules, veterinary and plant-related sanitary norms, and hygienic norms prescribed for the items in question by the legislative acts of the Republic of Armenia; risk – probability of an adverse health effect of the foodstuff and the severity of that effect; risk analysis – a process consisting of three interconnected components: risk assessment, risk management and risk communication; Hazard Analysis and Critical Control Point (HACCP) system – precautionary management system providing food safety, which is aimed at the reduction of risks and avoidance, elimination or reduction to acceptable levels of the food safety hazards. It includes the following principles: a) risk analysis; b) identifying critical control points; c) identifying critical limits for each critical control point and establishing a monitoring and control system thereof; d) drawing up the corrective measures plan to eliminate the revealed deviations; e) establishing efficiency checking procedures for the Hazard Analysis and Critical Control Point (HACCP) system; f) documenting and establishing a recording system of the mentioned principles and pertinent procedures . hazard to food safety - a biological, chemical or physical agent in, or condition of food which may cause an adverse effect to human health; unsafe food, unsafe materials in contact with food and unsafe food additives – foodstuff, materials in contact with food and food additives which: a) do not meet the regulative requirements; b) give rise to doubts on their being unsafe due to their organoleptic characteristics; c) possess qualitative charateristics which give rise to doubts on their being unsafe; d) do not possess the documents provided for in Article 9; e) do not match the presented information or where suspects exist on their being fake f) do not contain expiry date marking or are expired g) have been labelled in non-compliance with the mandatory particulars provided for in parts 3 and 4 of Article 8. contaminants – any substance and/or element of chemical, biological, mineral and organic origin, not being an ingredient of the food, which is present in foodstuff or food additives as a result of operations with food or environmental contamination and may have adverse effect on human life and health; food additives - any substance not normally consumed as a food in itself and not normally considered an ingredient of food whether or not it has nutritive value, which is added to food in the technological processing or treatment process to obtain the desirable gustatory and/or other properties; labelling –any particulars, words, trade marks, brand name or symbol related to a foodstuff and placed on any materials in contact with food or accompanying documents; materials in contact with food – any substance not deemed to be food, which is used in the process of manufacture, storage, transport, sale, packaging and labelling of food and is in direct contact with the foodstuff; nutritive value – the notion used to assess the nutrients (proteins, fat, carbohydrates, vitamins and minerals) - the ingredient parts of the foodstuff, which is comprised of energetic and biological values, which: a) generate energy by splitting inside the organism (proteins, fats, and carbohydrates), comprise the energetic value of the foodstuff and are expressed in calories or joules; b) do not generate energy, but are involved in and contribute to the metabolic process of the organism (vitamins, mineral salts, including microelements and water) and comprise the biological value of the foodstuff; technological processes – actions necessary for producing food, by the means of which the source materials for food undergo certain technological processing or treatment; technological equipment – equipment applicable for technological processes which provide the implementation of the scheduled regime during the technological process in question; technological instruction – a document approved by the producer, where the technological regime, the order of technological processes and the technological equipment to be used for manufacturing the product in question in accordance with the specified production formula are fixed; genetically modified food – the following three types of foods; a) food obtained as a result of altering the genetic structure of living organisms (animals, plants, microorganisms) by adding a foreign gene or combining genes for the purpose of gaining the desirable qualitative characteristics; b) food obtained as a result of the vital activity of altered living organisms; c) food obtained by using the foodstuff obtained as a result of modifying the genetic structure in foodstuff composition and/or the foodstuff obtained as a result of the vital activity of altered living organisms and/or by using parts thereof. Article 3. The scope of the Law 1. This Law shall apply to all relations between private entrepreneurs and legal entities operating at all stages of food chain and providing services of trade and mass catering, as well as the state authorities responsible for control at that stages. 2. This Law shall not apply to: a) domestic preparation, handling or storage of food for private or domestic consumption; b) transit transfers of foodstuff through the Republic of Armenia save the cases when the transit transfer may imply a hazard to the health of the population and the environment. Article 4. Food Safety Legislation 1. Relations arising in the field of food safety are governed by the present Law, the Civil Code of the Republic of Armenia and other laws and legislative acts. 2. Where international treaties of the Republic of Armenia provide norms other than the present law, the international treaties shall apply. Article 5. The principles of public policies aimed at providing food safety The basic principles of public policies ensuring food safety are as follows: 1. guaranteeing the enforcement of the legislative acts and supremacy of the use of safe food to protect human health and life and the protection of consumers interests; 2. providing guarantees of safety of human life and health and safety of environment at all stages of food chain; 3. providing cooperation and information exchange with relevant international and regional organizations for the purpose of ensuring food safety; 4. establishing international criteria of and requirements on ensuring food safety in the Republic of Armenia. CHAPTER II. THE REQUIREMENTS ON FOOD SAFETY Article 6. Requirements on food production 1. Food production (save mass catering) shall be allowed only in case of availability of technological equipment provided for in the relevant technological instructions; The form of the technical instruction shall be approved by the Government of the Republic of Armenia. 2. Source materials for food, food additives and materials in contact with food intended for processing shall comply to the requirements set by technical regulations or normative legislative acts. 3. Water added to food during its preparation, processing and treatment shall comply with the requirements proposed for the potable water by technical regulations or normative legislative acts. 4. Food additives prohibited by the law of the Republic of Armenia shall not be used during food preparation, processing and treatment or stored in the areas designed for food production and storage. The list of the prohibited food additives shall be determined by the Republic of Armenia. 5. The pesticides, equipment and materials used for cleaning and disinfection of food production and storage areas, technological equipment and tool, as well as for fighting against insects and rodents, shall not contaminate the foodstuff or impair its characteristics thus implying risk to human health. 6. The technological regime and technological process of food production process (save mass catering) shall be implemented in accordance with the applicable technical instruction for the foodstuff in question. 7. In order to ensure food safety it shall be compulsory to input a self-control system based on the Hazard Analysis and Critical Control Point (HACCP) system principles. In order to support the efforts of inputting Hazard Analysis and Critical Control Point (HACCP) system the authority shall perform issuance of methodological handbooks and organise trainings related to the fields of production. The time schedule of inputting Hazard Analysis and Critical Control Point (HACCP) system by the fields of production shall be approved by the Government of the Republic of Armenia. Article 7. Sanitary and hygienic norms posed to the implementation of all stages of food chain and to humans 1. All stages of food chain shall be implemented in compliance with sanitary rules and hygienic norms stipulated by technical regulations. 2. The vehicles used for food transportation shall provide the protection of the qualitative characteristics of food, shall not damage the packaging and protect against contamination - in compliance with sanitary rules and hygienic norms provided for by normative legislative acts. 3. Food transportation shall be performed by vehicles complying with sanitary rules and hygienic norms provided for by normative legislative acts. 4. The premises designated for food production and circulation stages shall be built, equipped, repaired and maintained in compliance with sanitary rules and hygienic norms approved by normative legislative acts for the foodstuff in question. 5. The employees in direct contact with food at production and circulation stages shall pass medical examination in compliance with the law. Article 8. The requirements on safety, labelling and packaging of foodstuff, materials in contact with food and food additives sold in the Republic of Armenia 1. Foodstuff, materials in contact with food and food additives placed on the market in the Republic of Armenia shall meet the requirements provided by technical regulations and normative legislative acts. 2. Foodstuff, materials in contact with food and food additives (save the exported items) produced, processed, packaged in the Republic of Armenia shall be labelled in Armenian. 3. The labelling in Armenian of foodstuff, materials in contact with food and food additives placed on the market in the Republic of Armenia shall include the following particulars: a) the name, net weight or volume if prepackaged; b) the list of the main ingredients; c) the list of the food additives added to foodstuff (if any); d) the day, month and year of production, storage terms, special instructions for storage (if any) and the date of minimum durability; e) instructions for use of the foodstuff, materials in contact with food and food additives when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions (especially food additives and foodstuff for particular purposes), special conditions of use (if any), information about contraindications (if any); f) particulars of the manufacturer (address and business name); g) country of origin of the foodstuff, materials in contact with food and food additives; h) alcoholic strength by volume for alcoholic beverages; i) nutritive value of the foodstuff in case of foodstuff for particular purposes; j) other information provided for by the Law; k) information on “genetically modified food” if applicable. 4. The labelling in Armenian of foodstuff, materials in contact with food and food additives imported to the Republic of Armenia shall contain relevant information, the form and content of which is determined according to separate assortment by the Government of the Republic of Armenia. 5. The labels of foodstuff, materials in contact with food and food additives shall not be modified unless the ingredients thereof have been modified, save the cases when it is done eliminate possible quid pro quos . 6. Expired foodstuff and food additives shall not be repackaged and placed on the market as foodstuff. 7. The information which is made available on the package (consumer package), label, additional label or insert of the foodstuff and food additives shall be understandable, complete and reliable. 8. The packaging of foodstuff, materials in contact with food and food additives shall ensure their safety at all stages of production and circulation. 9. Foodstuff, materials in contact with food and food additives with damaged packaging shall not be placed on the market. 10. The provisions of the present article shall not govern the food which is produced and consumed on the spot in the sphere of mass catering and related services. Article 9. Documentary evidence of the safety of foodstuff, materials in contact with food and food additives at all stages of production and circulation. 1. No foodstuff, materials in contact with food or food additives shall be imported, incorporated into production or placed on the market unless documents evidencing their safety are available. The documents evidencing the safety of foodstuff, materials in contact with food and food additives are as follows: 1) certificate of conformity or the declaration of conformity (for foodstuffs provided for by technical regulations, or in case of their absence, by the list of products and services subject to compulsory certification approved by the Government of the Republic of Armenia); 2) for source materials of animal origin – the accompanying veterinary sanitary document. 2. Foodstuff, materials in contact with food and food additives placed on the market in the Republic of Armenia shall be subject to compulsory certification of conformity in the manner prescribed by the Law. The list of the products and services subject to compulsory certification of conformity is approved by the Government of the Republic of Armenia. 3. Foodstuff of animal origin placed on the market in the Republic of Armenia shall be subject to compulsory expertise in compliance with the Law of the Republic of Armenia “On Veterinary Medicine”. 4. Foodstuff of plant origin placed on the market in the Republic of Armenia shall be subject to plant-related sanitary expertise and quarantine expertise in compliance with the Law of the Republic of Armenia “On Plant Quarantine and Plant Protection”. 5. The trade of foodstuff and mass catering services shall be compliant with the provisions of the Law of the Republic of Armenia “On Trade and Services”. Article 10. The database of the foodstuff for particular purposes produced in the Republic of Armenia The Authority shall run the database of the foodstuff for particular purposes (save mass catering) produced in the Republic of Armenia, which contains the names, types, main ingredients and the nutritional value of the produced foodstuff for particular purposes. The order of running the database of the foodstuff for particular purposes and the order of information retrieval is prescribed by the Government of the Republic of Armenia. Article 11. Restrictions on import, use and placing on the market of unsafe foodstuff, materials in contact with food and food additives 1. Unsafe food, unsafe materials in contact with foodstuff and unsafe food additives shall not be produced, imported, placed on the market or used in mass catering services. 2. Where any unsafe foodstuff, unsafe materials in contact with food and unsafe food additives are part of a lot, it shall be presumed that all the foodstuff, materials in contact with food and food additives in that lot are also unsafe unless an expertise has proven there is no evidence that the rest of the lot is unsafe. 3. Where there exist additional requirements and/or instructions provided for the specific assortment of the foodstuff by the regulations of the Republic of Armenia, foodstuff that complies with them shall be deemed safe insofar as the aspects covered by that requirements and/or instructions. Article 12. Withdrawal from the market, suspension of use and destruction of unsafe foodstuff, materials in contact with food and food additives 1. Unsafe foodstuff, unsafe materials in contact with food and unsafe food additives shall be subject to separate register and storage, withdrawal from the market and expertise. 2. The person in possession of unsafe foodstuff, unsafe materials in contact with food and unsafe food additives in case of their being unsafe or when having reasonable doubts about or being informed on that matter shall immediately commence the withdrawal process undertaking the following steps: a) to take the oodstuff, materials in contact with food and food additives of the specified lot under separate registration and storage; b) to immediately inform the supplier, the consequent purchaser of the specific foodstuff, materials in contact with food and food additives, as well as the Authority. 3. The Authority shall control the process of withdrawal from the market of all of the lot of the discovered unsafe foodstuff, unsafe materials in contact with food and unsafe food additives and analyse the type, volume and toughness of the involved risk related to the circulation thereof, as well as inform the population through mass media as required. Where the unsafe foodstuff, unsafe materials in contact with food and unsafe food additives have been sold to the consumer the vendor shall take back those foodstuff, materials in contact with food and food additives and satisfy the claims of the consumers in the manner prescribed by the Law of the Republic of Armenia “On Consumer Rights Protection”. 4. Basing on the results of the expertise performed by a laboratory accredited in compliance with the Law, the foodstuff, materials in contact with food and food additives of the unsafe lot shall be subject to separate registration and storage for consequent suspension of use or destruction. 5. The withdrawal from the market, expertise, transport, storage, suspension of use or destruction of the unsafe foodstuff, unsafe materials in contact with food and unsafe food additives shall be made at the expenses of the possessor of these foodstuff, materials in contact with food and food additives. 6. The order of the suspension of use and destruction of unsafe foodstuff, unsafe materials in contact with food and unsafe food additives shall be prescribed by the Government of the Republic of Armenia. 7. On revealing production of unsafe foodstuff or unsafe food additives the Inspection of the Authority in charge of control shall have the right to suspend the activity of the business operator or particular functions thereof based solely on the conclusion of the state inspector which has revealed the violation. The inspector having revealed the violation shall have the right to immediately temporarily suspend the production or particular functions thereof and recommend or instruct the business operator on eliminating the violation. The Head of the Inspection shall issue the decree on suspending the activity of the business operator or particular functions thereof, which shall come into force from the moment of handing it over to the business operator in a proper manner. If within 3 days after issuing the decree on prohibiting activities or particular functions thereof the conclusion of the inspector having revealed the violation isn’t confirmed by the authority in charge of control, the decree shall be deemed invalid. In that case the inspector of the Authority in charge of control shall be obliged to compensate the damages incurred to the business operator in the result of the prohibiting decree. The business operator in compliance with the Law shall bear the responsibility for producing unsafe food at the stage of production and shall undertake the steps aimed at eliminating the hazard at his own expense. 8. The restrictions shall be released by a relevant decision of the Head of the Inspection of the Authority basing on the conclusion of the Inspector having revealed the violation. Article 13. The cooperation of the state food safety authorities 1. The state authorities performing functions with regards to the safety of foodstuff, materials in contact with food and food additives at the production and circulation stages shall periodically exchange information on investigations, analyses, revealed violations and shortcomings, detected unsafe foodstuff, materials in contact with food and food additives carried out within their competency. The Authority in charge of state control at stages of production and circulation of foodstuff and food additives shall in the manner prescribed by the Law of the Republic of Armenia “On Conformity Assessment” present to the national authority of conformity assessment the information on the results of the state control at stages of production and circulation of foodstuff and food additives The order and forms of information retrieval shall be approved by the Government of the Republic of Armenia. 2. In case of food intoxications and epidemics the state authorities performing functions with regards to the safety of foodstuff, materials in contact with food and food additives at the production and circulation stages shall jointly work out precautionary and antiepidemiological measures. Article 14. Requirements on advertising foodstuff and food additives. 1. Foodstuff and food additives not having the documents to evidence their safety shall not be advertised. 2. Medical properties of the foodstuff and foodstuff intended for particular purposes shall not be advertised unless approved by the Authority. 3. Hidden advertising using trademarks and brand-names shall be prohibited where such types of foodstuff are being produced under trademarks and brand-names for which certain restrictions have been imposed by the Law of the Republic of Armenia “On advertising”. Article 15. State control of the safety of food and food additives. 1. State control of safety of food and food additives at all stages of production and circulation shall be implemented by the Government of the Republic of Armenia through its authorities. State control shall be implemented over the following processes: a) compliance of the requirements and rules set to the vehicles, workshops, storage and other premises at stages of production and circulation of food and food additives; b) compliance with requirements set by technical regulations or normative legislative acts and maintaining storage conditions of source materials for food, water, supplementary materials, food additives, materials in contact with food and processed foodstuff used for food production; c) provision of technological equipment and technological regimes prescribed for in the technological instructions (save mass catering); d) compliance with the requirements on contaminants and pesticides for exterminating vermin and rodents and the storage terms thereof; e) compliance with the requirements on labelling; f) other procedures provided for by the Law. 2. State control over food safety shall be implemented in a manner prescribed by the Law of the Republic of Armenia “On organizing and implementing check-ups in the Republic of Armenia”. 3. The experiments for the purpose of state food safety control shall be carried out in experimental laboratories authorised due to the results of the tender held in the manner prescribed by the Government of the Republic of Armenia. 4. In compliance with the Law of the Republic of Armenia “On Standardising” the Inspectors of the Authority in charge of state control at stages of foodstuff and food additives production and circulation shall have the qualification of the expert in the field of conformity assessment, which will be fixed in the passport for the position of civil service prescribed for the specific position. CHAPTER III. RIGHTS AND LIABILITIES OF LEGAL ENTITIES AND PRIVATE ENTREPRENEURS OPERATING AT FOODSTUFF AND FOOD ADDITIVES PRODUCTION AND CIRCULATION STAGES, AS WELL AS OF THE INSPECTORS OF THE STATE CONTROL AUTHORITIES Article 16. Rights and liabilities of legal entities and private entrepreneurs operating at foodstuff and food additives production and circulation stages 1. Legal entities and private entrepreneurs operating at food and food additives production and circulation stages shall have the right to: a) receive from the Authority the necessary information and consultation on legislative acts relevant to ensuring food safety, as well as on operations at stages of production and circulation of foodstuff and food additives; b) in order of seniority or by judicial means to protest against the actions and decisions of the Authority or inspector implementing control. 2. Legal entities and private entrepreneurs operating and rendering services at stages of production and circulation of foodstuff and food additives shall be obliged: a) to provide for meeting the requirements of legislative acts governing operations related to foodstuff and food additives production and circulation, as well as the services rendered; b) in a prescribed manner to present to the Authority the list of foodstuff for particular purposes (save mass catering) being produced by them to be included in the database of foodstuff for particular purposes produced in the Republic of Armenia; c) to provide necessary documents provided for in the present Law, ensure the entry of the authority’s inspectors to relevant workshops and provide charge-free trial samples needed for the expertise; The order of taking trial samples for expertise shall be approved by the Government of the Republic of Armenia. d) to organise measures jointly with the Authority aimed at preventing or reducing the risk related to the food, materials in contact with food or food additives having been supplied e) to ensure environmental safety during their activity; f) to implement other duties provided for by the present law or other legislative acts. Article 17. Rights and liabilities of the inspectors of the Authority at food and food additives production and circulation stages 1. At food and food additives production and circulation stages the inspectors of the state control Authority shall have the following rights: a) within their competency –to receive without barriers the documents necessary for control implementation, enter relevant workshops, storage and other premies and take trial samples necessary for expertise; b) where revealing violations of the requirements of the legislative acts governing operations related to food and food additives, or having reasonable doubts about the unsafe nature of the food, materials in contact with food and food additives – to impose restrictions in compliance with the provisions of the present law and in the framework of the competency; c) other rights provided for by the present law or other legislative acts. 2. The inspectors of the state control Authority shall be obliged: a) to provide mandatory instructions aimed at the elimination of revealed violations and shorcomings and to establish control over the implementation thereof; b) to ensure the confidentiality of the information retrieved on-duty and deemed to be a commercial secret; c) not to pose barriers to the day-to-day activity of the business operators unless necessary; d) to implement other duties provided for by the present law or other legislative acts. CHAPTER IV. LIABILITY FOR VIOLATING THE PRESENT LAW, CONCLUDING AND TRANSITIVE PROVISIONS Article 18. Liability for violating the present law The violation of the provisions of the present Law shall cause responsibility in a manner prescribed by the Law. Article 19. Concluding and transitive provisions 1. This Law shall enter into force on the tenth day following that of its official publication. 2. For this Law: a) part 6 of Article 7 shall apply from the day provided for in the time schedule approved by the Government of the Republic of Armenia; b) part 4 of Article 8 shall apply according to the time-schedule drawn up by the Government of the Republic of Armenia; c) following the entering into force of part 4 of Article 8, part 3 of the same article shall be deemed invalid with regard to food, materials in contact with food and food additives imported to the Republic of Armenia; 3. From the moment of the entrance into force of the present Law the Law of the Republic of Armenia dating 8 Dec. 1999 “On Food Safety” shall become inoperative.