“Quality Food Law”), dated 23 December 1997, as amended, sets requirements for producers, suppliers, and sellers of food products for the development, production, import, supply, storage, transportation, sale, usage, consumption, and utilization of these products. On 24 October 2002 the Verkhovna Rada (Parliament) introduced changes to the Quality Food Law, which modified these requirements. The Quality Food Law no longer applies to tobacco or tobacco products, or to food products manufactured for personal consumption.
Under the Quality Food Law, all food products produced in Ukraine must be safe and suitable for consumption, properly labeled and meet sanitary standards and technical regulations. To ensure the safety of produced food it is prohibited to use: 1) food additives that are not registered for use in Ukraine; 2) flavorings and related materials for production that are not registered for use in Ukraine; 3) dietary supplements that are not registered for use in Ukraine; 4) aids and materials for production and circulation that are not allowed for direct contact with food; 5) aids and materials for production and circulation that by their nature and composition may transfer contaminants to food; 6) use food ingredients in manufacturing, including agricultural
products, if they contain hazardous substances at levels that exceed the mandatory safety parameters.
On 2 December 2010, changes to the Law on Food for Children (the “Children’s Food Law”) tightened the requirements for the raw materials, permissible additives and the manufacturing of foodstuffs for children of various ages. In particular, raw materials can be used only if they were produced in a specially certified area and comply with the minimal safety and quality requirements established by the Ministry of Health. Certain raw materials may not be used for the production of food for children (e.g., hydrated soybean protein, certain oils, fish and meat). The manufacturing facilities must have a special certificate issued pursuant to the procedure established by the Cabinet of Ministers. Moreover, in the production of food for children, use of artificial substances is prohibited: flavors (except vanilla, vanilla extract and ethyl vanilla); dyes; sweeteners (except special-purpose food for children); food additives, stabilizers, and aromas.
On 6 January 2015, the Chief Inspector of Veterinary Medicine of Ukraine enacted an order approving the list of products of high and low risk for human and animal health (the “Inspection Order”). Under the Inspection Order, products posing a high risk to human and animal health are in category I (fresh and frozen meat and fish, eggs, etc.) and category II (poultry, milk and dairy products, honey and bee products, etc.). Low risk products such as milk and milk products (for
processing, not for consumption as is), frogs’ legs and snails, bone and bone products, etc. are in category III.
All products that are imported into Ukraine are subject to standard veterinary and sanitary control by way of examination of documents and visual inspection of the goods. If contradictions are revealed or there are suspicions about the safety of the products, laboratory examinations must be conducted. In some cases extended control is obligatory, including if: 1) the shipment is chosen for it in accordance with the program of selective veterinary and sanitary control; 2) the products in at least in one of the last five shipments of certain goods from certain production facilities were recognized as dangerous, unfit
for consumption, incorrectly labeled, or otherwise did not comply with the relevant technical regulations and sanitary measures; 3) obvious violations of the relevant sanitary requirements were revealed during the visual inspection; 4) the goods of this manufacturer or supplier are being imported into the customs territory of Ukraine for the first time.
17.4.1 Food Quality Assurance
Under the Quality Food Law, food products (except food products produced for personal consumption, tobacco or tobacco products) intended for human consumption may not be produced in or imported into Ukraine, or supplied for sale, sold, or otherwise used before their quality and safety have been proven by means of the appropriate documents. Among these documents are:
• A declaration of conformity issued by the producer of agricultural products, other products intended for human consumption, food additives, flavorings or related materials for processing that shall be issued before the relevant products are released to market. This declaration certifies the
compliance of food, food additives, flavorings or related materials for processing if the requirements set by the producer are further observed by this producer;
• A certificate of compliance issued by the relevant chief state sanitary or veterinary doctor after an examination that certifies that food products are fit for human consumption;
• An expert (veterinary) conclusion issued by the state veterinary laboratory that certifies the suitability or
unsuitability for human consumption of food products subject to veterinary control, or their subsequent processing or other use, as well as an analysis of the processing technology that should be employed by the producer and supplier to ensure food safety;
• An international veterinary (sanitary) certificate issued by the relevant state veterinary doctor in the state of export that stipulates special requirements pursuant to the instructions of the relevant international organization and certifies the state of health of animals and / or other requirements related to human health protection that every food product must comply with; • Veterinary documents for food products for human
consumption;
• An operational permit issued by the relevant chief public health doctor to the producer that is issued for each of the food production units used for production, processing and sale of food products.
In November 2010, the Ministry of Health of Ukraine enacted an order prescribing the list of food ingredients that must be tested for the presence of genetically modified organisms (the “Order”), i.e., any organisms in which the genetic material has been altered using artificial gene transfer techniques that do not occur under natural conditions. The food ingredients that must be tested include soya, corn, potatoes, tomatoes, wheat, rice, sugar beet, melons, cotton and many other similar products and their derivatives. Among the products that must be tested are products for children and the raw materials used for their production, special dietary foods, special-purpose foods, dietary supplements, nutritional supplements that are produced with the use of ingredients specified in the Order.
17.4.2 State Product Examination
Under the Law of Ukraine on Ensuring the Sanitary and
Epidemiological Well-Being of the Population, dated 24 February 1994, as amended (the “Sanitary Law”), particular food products are subject to state sanitary and epidemiological expert examination on food safety carried out by the state sanitary and epidemiological service in order to prevent, reduce and eliminate possible harmful effects on human health.
According to the Quality Food Law, all new food products, food products used for special diets, special-purpose food products, dietary supplements, food additives, flavorings and related materials, aids and materials for production, food imported to Ukraine for the first time (if the supplier does not have a valid conclusion of the state sanitary and epidemiological expert examination or a producer’s declaration) are subject to mandatory sanitary and epidemiological expert
examination. The procedure for state expert examination, except for new food products, may be completed within 30 working days following the receipt of a complete application for such examination. The state expert examination of new food products may be completed within 90 working days.
In addition, all food products of animal origin, projects for facilities that produce and circulate food products, production facilities that produce and circulate food products, facilities that produce and circulate food products with the purpose of obtaining or renewing an operational permit, facilities that produce and circulate food products for import and export, systems that ensure quality and safety at the facilities that produce and circulate food products are subject to sanitary and veterinary expert examinations.
Moreover, under the Sanitary Law, economic activities that are related to potential hazards to human health are subject to obligatory
licensing. Under the Law on Licensing Particular Types of Economic Activities, dated 1 June 2000, among such activities are the production and sale of ethyl, cognac and fruit spirits, alcoholic beverages and tobacco.
Besides, pursuant to the Quality Food Law, all producers of food products must obtain an operational permit for each food production unit. This permit is issued to legal entities producing / trading food products by the relevant chief public health officer.
17.4.3 State Registration of Food Products
subject to mandatory state registration. The Ministry of Health is in charge of the state registration of such food additives and flavorings. After state registration is carried out, the registered food additives and flavorings are included in a special register. The Quality Food Law provides for the expedited registration of both food additives and flavorings, if these particular food additives and flavorings are approved for use by the relevant international organizations. In the event of the expedited registration of food additives and flavorings, the registration should be completed within 30 working days. For comparison, the ordinary registration procedure may take up to 120 working days.
Under the Children’s Food Law, all food products for children either produced in Ukraine or imported into Ukraine are subject to
obligatory state registration.
Food products for special diets, special-purpose food products and dietary supplements are no longer subject to state registration, except for novel (non-traditional) food products, which must be registered. 17.4.4 State Certification of Products
Only tobacco products are currently subject to state certification. Since 2015, all food products have been exempt from such certification.
17.4.5 Labeling Requirements
The Quality Food Law establishes labeling requirements for food products. Such labeling must be in Ukrainian and convey the required information in a manner intelligible for consumers. Such labeling should indicate 1) the name of the food product; 2) the name and full address / telephone number of the food production unit (the name and full address / telephone number of the importer); 3) the net quantity of food in the established units; 4) the food ingredients in order of significance, including food additives and flavorings used during production; 5) the amount of calories and nutritional value indicating the protein, carbohydrates and fats; 6) the final consumption date, or
date of production and expiry date; 7) the number of the lot of goods; 8) the conditions of storage and use; 9) the warning that the
consumption of certain food products may be harmful for certain groups of consumers (such as children, pregnant women, sportsmen, etc.); 10) the presence or absence in food of genetically modified organisms (the product should be labeled “contains GMO” or “ GMO free” respectively).
The Quality Food Law provides that the description of special symbols used in the labeling and marking of food products with a bar code must be carried out in the manner provided by the Cabinet of Ministers. The text for labeling food products for special dietary needs, special-purpose food products and food additives is subject to obligatory confirmation by the Ministry of Health of Ukraine. Law of Ukraine No. 1778-VI, dated 17 December 2009, introduced the requirement for provision of information about the presence of genetically modified objects in products into the Quality Food Law. At present the information about food products must contain a statement on the presence or absence of genetically modified components. Food products must be labeled in Ukrainian and must convey the information about the presence or absence of genetically modified objects (GMOs) in the food in a manner which is intelligible for consumers and which is achieved by placing the words “Contains GMO” or “GMO free”, as the case may be, on the label of the product.
Under the Order on Labelling Food Products Containing Genetically Modified Organisms, labeling food products that do not contain genetically modified organisms or whose content is less than 0.1 % with the words “GMO free” is voluntary. Food products that contain more than 0.9 % of genetically modified organisms, or have been produced from agricultural products in which the amount of
genetically modified organisms exceeded 0.9 %, must have these facts stated on the label, or , the producer (seller) must withdraw such products from the market. In February 2011, in furtherance of the provisions of the Quality Food Law, a detailed technical regulation for
labeling foodstuffs was introduced by the State Committee on Technical Regulation and Consumer Policy. In particular, under this technical regulation, the labeling of food products shall 1) contain no information that can mislead the consumer; 2) include information that particular food products can contribute to the prevention, healing and treatment of any disease, or refer to such properties (except for natural mineral waters and foodstuffs for special dietary needs, special-purpose food products and dietary supplements). 17.4.6 Hazard Analysis and Critical Control Point System Under the Quality Food Law, subjects of entrepreneurial activity (defined as individuals and legal entities which engage in economic activities) connected with the production of food products, food additives, flavorings, dietary supplements and other related materials shall apply the international system of food products quality assurance “Hazard Analysis and Critical Control Point” (“HACCP”) at their enterprises and / or other systems to ensure the safety and quality of the production and release of food products onto the market. 17.4.7 Limitation on Consumption of Alcohol and Tobacco
In January 2010 the Verkhovna Rada of Ukraine adopted restrictions on consumption of alcohol and tobacco (the “Amendments”),
including special labeling requirements, zoning and other rules for sales of these products. Under the Amendments, low-alcohol
beverages have the legal status of alcohol. Moreover, all restrictions regarding alcohol consumption and sales are currently applied with regard to low-alcohol beverages. Also, amendments to the
Administrative Violations Code have been made whereby specific liability for violation of the abovementioned restrictions has been established.
17.4.8 Prohibition on Non-Milk Ingredients in Traditional Dairy Products
In May 2013, amendments to the Law on Milk and Dairy Products expressly prohibited the use of any non-milk derived proteins or fats,
as well as any stabilizers and preservatives, in traditional dairy
products. These include butter, cheese, and various types of fermented milk products (yoghurts). Imported dairy products are subject to control in this respect prior to customs clearance.