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LAW OF UKRAINE

of December 23, 1997 No. 771/97-BP

About the basic principles and requirements to safety and quality of foodstuff

(as amended on 30-06-2023)

This Law governs the relations between executive bodies, operators of the market of foodstuff and consumers of foodstuff and determines procedure for safety and separate indicators of quality of foodstuff which are made, are in circulation, are imported sent) on customs area of Ukraine and/or exported sent) from it.

Section I General provisions

Article 1. Terms and their determinations

1. In this Law the following basic concepts are used:

1) the agrofood market - subject of managing which creates proper conditions for realization (wholesale) of agricultural products, including foodstuff, on specially equipped and allocated places according to the law;

2) it is excluded;

3) risk analysis - the process consisting of three interconnected components: risk assessment, risk management and message on risk;

4) it is excluded;

5) No. 3221-IX Is excluded according to the Law of Ukraine of 30.06.2023

6) it is excluded;

7) safe foodstuff - foodstuff which does not make harmful effects on health of the person and is suitable for consumption;

8) it is excluded;

8-1) verification - check of observance of the established requirements by inspection and provision of objective proofs;

9) withdrawals of foodstuff - the measures directed to prevention of distribution, demonstration or the offer of dangerous foodstuff to consumers;

10) production - the activities connected with production of objects of sanitary actions including all stages of engineering procedure, namely primary production, preparation, mixing and procedures connected with it, processing, filling, packaging, conversion, recovery and other changes of condition of object;

11) withdrawal of foodstuff - the measures directed to return of dangerous foodstuff which is sold or transferred to the consumer or which is available to the consumer;

12) relevant international organizations - The World Health Organization (WHO), the Commission on the Code Alimentarius, the International Epizootic Bureau (IEB) and other international organizations which develop recommendations, instructions, standards, other documents concerning health protection and life of people from the risks connected with the use of foodstuff, and also other separate indicators of quality of foodstuff;

12-1) water for baby food - the drinking water which is specially processed for consumption by children of chest and early age, intended for preparation of baby food and drink;

13) water sea net - the natural, artificial or purified sea water which is not containing the polluting microorganisms or toxic sea plankton in the quantities capable to affect directly or indirectly suitability of foodstuff;

14) drinking water - water which meets the requirements established by the legislation of Ukraine to the water intended for consumption by the person. Drinking water is foodstuff;

15) clear water - water sea net or fresh water which corresponds to indicators of safety of water of sea net;

16) hygienic requirements - measures and the conditions necessary for management of dangerous factors and ensuring suitability of foodstuff for consumption by the person taking into account their proper use, including, but it is not exclusive, measures and conditions for:

primary production;

foodstuff;

production processes, including for supply with water, and also processing, conversion, packaging of foodstuff;

equipment and stock;

capacities, separate types of rooms, including for the agrofood markets, public catering institutions;

transportation of foodstuff and corresponding vehicles;

the address with food wastes;

the personnel of capacities working in address zone with foodstuff;

pest control and rodents;

16-1) state register of objects of sanitary actions (further - the state register of objects) - the information and communication system providing collection, accumulating, preserving, accounting, reflection, processing of register data and provision of register information except information with limited access, about objects of sanitary actions which address is authorized in Ukraine;

17) it is excluded;

18) it is excluded;

19) it is excluded;

20) dietary additive - foodstuff, which:

is the concentrated source of nutrients (including proteins, fats, carbohydrates, vitamins, mineral substances) or other substances with nutritious or physiological effect;

it is made in the form of capsules, pastils, tablets and sachet, ampoules with liquids, bottles for drop dispensing or in other forms of liquids and/or powders;

it is intended for consumption in small certain amounts;

it is consumed as amendment to regular diet separately or in combination with other foodstuff;

20-1) children's mix for further feeding - the baby food intended for feeding of children of chest age which is the main liquid component of diet during introduction of products of feeding up in the course of gradual variety of diet;

20-2) children's mix initial - the baby food intended for feeding of children of chest age within the first months of life which completely provides all needs of the child for nutrients and energies until introduction of products of feeding up;

20-3) baby food - the foodstuff intended for requirements satisfaction of children of chest and early age in nutrients and energy, including water for baby food;

20-4) baby food on the basis of grain - the baby food intended for satisfaction of food needs of healthy children of chest age in the period of their excommunication from chest feeding and healthy children of early age - as amendment to diet and/or for gradual adaptation to regular foodstuff which belongs to one of the following categories:

porridges and other grain products which are dissolved or recovered by milk or other liquid, suitable for this purpose, has nutrients;

porridges and other grain foodstuff which ingredients/ingredients have the high content of protein are dissolved or recovered by drinking water or other liquid, suitable for this purpose, which does not contain squirrels;

the pasta consumed after preparation in the boiling drinking water or other suitable liquids;

the crackers, cookies, small loafs and other similar grain foodstuff intended for direct consumption or for consumption after crushing with addition of drinking water, milk or other suitable liquids;

20-5) children of chest age - children aged from the birth up to one year;

20-6) children of early age - children aged from one up to three years;

21) No. 3221-IX Is excluded according to the Law of Ukraine of 30.06.2023

22) operational permission - the document of allowing nature which is issued by territorial authority of competent authority to the operator of the market by results of inspection of its capacity and certifies the right of the operator of the market to perform the activities for production and/or storage of foodstuff of animal origin determined by this Law;

23) No. 2639-VIII is excluded according to the Law of Ukraine of 06.12.2018;

24) pollution - availability or emergence of dangerous factor in foodstuff;

25) pollutant - any biological substance, including organisms, microorganisms and their parts, or chemical, foreign impurity or other substance which unintentionally got to foodstuff and poses foodstuff safety hazard;

26) the interested trading partner - the state and other subject of international law who is participant of multilateral and/or bilateral agreements which participant is also Ukraine, regulating application of sanitary measures, and also the member of relevant international organizations which include Ukraine;

27) institution of public catering - restaurant, bar, cafe, the dining room, snackbar, pizzeria, cookery, restaurant or other institution, irrespective of territorial signs (place) of implementation of economic activity on public catering and degree of availability of food to any persons;

27-1) applicant operator of the market of foodstuff, the Merging of operators of the market, the authorized person (the legal entity or the physical person - the entrepreneur) representing the interests of one or several operators of the market of foodstuff which filed documents for state registration of object or modification of data on state registration of object, or cancellation of state registration according to requirements of this Law;

27-2) history of safe food consumption - the confirmed information on safety of foodstuff based on aggregated data and experience of permanent use of foodstuff within at least 25 years in regular diet of significant amount of the population of the country. Such information can include, in particular, scientific results, results of statistical observations, the data from the corresponding registers;

28) No. 2639-VIII is excluded according to the Law of Ukraine of 06.12.2018;

29) No. 2639-VIII is excluded according to the Law of Ukraine of 06.12.2018;

30) the final consumer - the consumer who uses foodstuff only for own consumption;

31) competent authority - the central executive body which provides forming and realizes state policy in the sphere of safety and separate indicators of quality of foodstuff;

32) component - set of ingredient (ingredients) and substance (substances);

33) corrective action - action which is determined and performed for the purpose of elimination of the reason of the revealed discrepancy;

34) correction - action which is determined and performed for the purpose of elimination of the revealed discrepancy, including the address with dangerous foodstuff, directed to non-admission of their consumption by the person;

34-1) lot - any part of one or several batches of the same foodstuff, is made, made or packed actually under identical conditions;

35) the maximum limit of remaining balance (the most admissible level of remaining balance) - the most admissible content in foodstuff of certain substance, including pesticides, veterinary medicines, feed additives, and other chemical or biological substance which consciously is applied and/or required by technology of cultivation, storage, transportation, production of foodstuff and their remaining balance, including derivatives of such substance, such as products of conversion of metabolism, the reactions having toxicological value and are dangerous to human body in case of excess of their most admissible content in foodstuff which is consumed by people;

36) the most admissible level - the maximum admissible content (concentration) of pollutant in foodstuff which is admissible for such product;

37) low power on production of foodstuff of animal origin - the capacity making foodstuff of animal origin or composite products in number of no more than 1000 kilograms or 1000 liters a week on average within year;

38) No. 2639-VIII is excluded according to the Law of Ukraine of 06.12.2018;

39) methodical manuals manuals on accomplishment of the general hygienic requirements and other requirements determined by the legislation on safety and the separate indicators of quality of foodstuff developed by merging of operators of the market and approved by relevant organ of the government;

40) it is excluded;

41) international standards, instructions and recommendations - the standards, instructions, recommendations and documents of other type in the sphere of sanitary and phytosanitary actions developed and approved by relevant international organizations;

42) the proper level of protection of human health - the protection level which is considered sufficient when implementing sanitary measures for protection of health and life of people from adverse effect on which such sanitary measures, in particular acceptable risk level of approach of harmful effects are developed;

43) dangerous factor in foodstuff - any chemical, physical, biological factor of foodstuff or its condition that can give harmful effects on health of the person;

44) dangerous foodstuff - foodstuff that is unhealthy and/or unsuitable for consumption.

In case of installation of danger of foodstuff are considered:

usual conditions of use of foodstuff by the consumer, each stage of its production, conversion and address;

information on foodstuff provided to the consumer, in particular by specifying in marking, and another public to the consumer information on avoidance of the consequences, negative for health, connected with foodstuff or category of foodstuff.

In case of installation of harm of foodstuff for health are considered:

possible short-term or long-term influence of foodstuff on health of the person who consumes it, and on future generations;

possible accumulative effect of toxicity;

special sensitivity of organism of separate category of consumers if foodstuff is intended for this category of consumers;

45) it is excluded;

46) the processed foodstuff - foodstuff which was not exposed to conversion, except separation into parts, cuttings, allocations of bones, rubleniye, withdrawal pains, removal of skin, cleaning, trimming, removal of shell or other cover, chilling, freezing and defrosting;

47) incorrectly marked foodstuff - foodstuff which marking does not conform to requirements of the legislation;

48) unsuitable foodstuff - the foodstuff containing foreign substances and/or objects which is damaged in a different way and/or spoiled as a result of mechanical and/or chemical, and/or biological factors.

The unsuitable product, in case of consumption to destination in case of usual conditions of such consumption, has no harmful effects on health of the person;

49) the latest foodstuff - foodstuff which did not address in Ukraine as of the established date and is characterized at least by one of the following signs:

has new or intentionally the modified molecular structure which is not applied in foodstuff before the established date;

consists or is allocated or made of microorganisms, mushrooms or seaweed;

consists or is allocated or made of material of mineral origin;

consists or is allocated or made of plants or their parts, except cases if foodstuff has history of safe food consumption in Ukraine and consists or it is allocated or made from plant or plant variety of the same type which are received by application:

traditional methods of cultivation of plants which were used for production of foodstuff in the territory of Ukraine before the established date; or

nonconventional methods of cultivation of plants which were not used for production of foodstuff in the territory of Ukraine before the established date and which cannot lead to considerable changes in structure or structure of foodstuff, to affect its nutritional value, metabolism or level of content of undesirable substances;

consists or is allocated or made of animals or their parts, except the foodstuff allocated or made from the animals divorced by traditional methods which were used for production of foodstuff in the territory of Ukraine before the established date and have history of safe food consumption in Ukraine;

consists or is allocated or made of culture of cages or culture of the fabrics received from animals, plants, microorganisms, mushrooms or seaweed;

made by application of production process which was not used in the territory of Ukraine before the established date and which can lead to considerable changes in structure or structure of foodstuff, to affect its nutritional value, metabolism or level of inclusion of undesirable substances. Production process which was not used in the territory of Ukraine before the established date can include, in particular, new types of heat treatment, not thermal methods of preserving, processes of chilling and freezing of products, processes of dehydration, fermentation processes, new technologies of packaging, use ultra-violet, microwave and other types of radiation, and also application of nanotechnologies for any types of the address with foodstuff;

consists of the created nanomaterials;

is vitamin, mineral or other substance in case of which production production process which was not used in the territory of Ukraine before the established date and/or which contains or consists of the created nanomaterials is applied;

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