LAW OF UKRAINE

of May 18, 2017 No. 2042-VIII

About the state control of compliance with law about foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals

This Law determines legal and organizational basis of the state control exercised for the purpose of check of observance by operators of the market of the legislation on foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals.

Section I General provisions

Article 1. Determination of terms

1. In this Law the following terms are used in the following value:

1) the accredited laboratory laboratory of any pattern of ownership located in Ukraine or other country, accredited on compliance to requirements of the ISO/IEC 17025 standard (DSTU ISO/IEC 17025) national authority of Ukraine on accreditation, foreign accreditation body which is complete member of ILAC (The international organization for cooperation in the field of accreditation of laboratories) or other foreign accreditation body which activities conform to requirements of the ISO/IEC 17011 standard (DSTU ISO/IEC 17011);

2) arbitral laboratory research (testing) - laboratory research (testing) conducted by authorized referens-laboratory with use of the methods confirming (референс) upon the demand of person disputing results of the main laboratory research (testing);

3) audit - systematic and independent check for determination of as far as activities and the related results correspond to the planned measures and as far as such measures are applied productively and are suitable for goal achievement;

4) validation check and providing objective proofs that the plan of accomplishment of actions of any kind including determined by the regulatory legal act, the regulation, the standard, method (technique) of carrying out researches (testing) allows with high probability to achieve effective objective;

5) load - certain number of live animals or certain quantity of products on which one international certificate, official confirmation or other document (if its availability is required under the law) which are transported is issued (move) one vehicle, come from one territory (zone, kompartment) or the third country and which, except remedies of plants, belong to the same type, class or the description;

6) the state veterinary inspector person, working in system of competent authority, conforms the established this Law to qualification requirements and to which service duties implementation of actions of the state control of foodstuff of animal origin, forages of animal origin, by-products of animal origin, hay, straw, health of animals and/or wellbeing of animals belongs;

7) the state inspector person, working in system of competent authority, has the higher education (degree not lower than the specialist/master), work experience at least one year in the field of application (implementation) of sanitary and/or phytosanitary, and/or veterinary and sanitary actions and to which service duties implementation of actions of the state control belongs;

8) the state control action which perform competent authority and/or persons to whom according to article 9 of this Law the powers on implementation of separate actions of the state control directed to check are conferred:

a) compliance of operators of the market to requirements of this Law, and also to requirements of the legislation specified in part one of article 3 of this Law;

b) compliance of animals and products to requirements of the legislation specified in part one of article 3 of this Law, in particular for the purpose of issue of the international certificate (the preexport international certificate) or official confirmation;

9) the state monitoring implementation within measures of the state control of consecutive observations and/or measurements according to the plan of the state monitoring with subsequent their analysis and generalization for the purpose of receipt of general idea about the state of affairs on compliance with law about foodstuff, sterns, by-products of animal origin, health of animals and/or wellbeing of animals;

10) documentary verification check of international certificates, official confirmations and other documents, including business documents which shall accompany load according to requirements of the legislation on foodstuff, sterns, by-products of animal origin, health of animals and/or wellbeing of animals;

11) equivalence - capability of different systems or measures of the state control to provide achievement of the identical purposes;

12) the general veterinary document for import document of the established form, two-piece, in first of which the operator of the market notes (declares) information on load with products or live animals which is subject to import (transfer) to customs area of Ukraine through the appointed boundary inspection post, including about type, the country and capacity of origin, the place of consignment, and in the second part the state veterinary inspector notes information on results of the state control of such load;

13) the general document for import - the document of the established form, two-piece, in first of which the operator of the market notes (declares) information on load with foodstuff of not animal origin or sterns of not animal origin which in case of import (transfer) to customs area of Ukraine are subject to the strengthened state control, including about type, the country and capacity of origin, the place of consignment, and in the second part the state inspector notes information on results of the state control of such load at the appointed check point on frontier of Ukraine;

14) the legislation on wellbeing of animals - the legislation which structure is determined in parts two and third article 2 of the Law of Ukraine "About veterinary medicine and wellbeing of animals";

15) the legislation about health of animals - the legislation which structure is determined in parts one and third article 2 of the Law of Ukraine "About veterinary medicine and wellbeing of animals";

16) the legislation on sterns - the laws and other regulatory legal acts which establish requirements to sterns at any stages of their production, the address and use;

17) the legislation on by-products of animal origin - the legislation which structure is determined in article 3 of the Law of Ukraine "About the by-products of animal origin which are not intended for consumption by the person";

18) the legislation on foodstuff - the laws and other regulatory legal acts which establish requirements to foodstuff at any stages of their production and the address;

19) detention procedure within which the competent authority provides that animals and the products which are subject of the state control did not move (were not transported) and were not exposed to any intervention before adoption of the decision by it concerning their final destination. This term also covers storage of animals and products by operators of the market according to instructions and under control of competent authority;

20) inspection method of the state control which consists in implementation of check of the state of health of animals, wellbeing of animals, production and turnover of foodstuff, forages, veterinary medicines, the address with by-products of animal origin for the purpose of establishment of compliance to the legislation on foodstuff, sterns, health of animals and/or wellbeing of animals;

21) competent body - the central executive body realizing state policy in the field of the state control of compliance with law about foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals.

The term "competent authority" for other country means body of this country to which powers on the organization and implementation of the state control of compliance with law about foodstuff, sterns, by-products of animal origin, health of animals and/or wellbeing of animals are conferred;

22) composite product - the foodstuff containing in the structure at the same time products of plant origin and the processed animal products;

23) the international certificate - the clean bill of health, the international veterinary certificate or other document issued by competent authority of country of source or the exporting country and certifying health of animal and/or safety of foodstuff, forage, hay, straw, by-product of animal origin, biological product or reproductive material;

24) discrepancy - violation by the operator of the market of requirements of this Law, legislation on foodstuff, sterns, by-products of animal origin, health of animals and/or wellbeing of animals;

25) the operator of the market operator of the market of foodstuff, the operator of the market of forages, the operator of the market in the field of the address with by-products of animal origin, the operator of the market of veterinary medicines, the operator of capacities on which animals contain;

26) person responsible for load (for the purposes of the Section VII of this Law), - the owner of load or its representative;

27) official confirmation - any label, mark or other form of confirmation applied (put down) by the operator of the market under observation of competent authority within the provided authorization on implementation of the state control or directly competent authority, and confirming the compliance to one or several requirements established by the legislation, specified in part one of article 3 of this Law;

28) the official veterinary specialist doctor of veterinary medicine who conforms the stipulated in Clause 13 these Laws to qualification requirements to the state veterinary inspector has work experience in at least two years and to which the competent authority according to article 9 of this Law confers powers for accomplishment of separate measures of the state control on certain capacity (economy);

29) risk assessment - the evidence-based process including identification of dangerous factor, the characteristic of dangerous factor, assessment of its influence, the characteristic of risk;

30) batch - any goods quantity determined by the producer with the identical name and properties made or which is grown up during the period of time determined by the producer under identical conditions on the same capacity (object), has the same appointment and moves one type of the vehicle (irrespective of the number of vehicles into which it is loaded);

31) check of compliance - visual survey for the purpose of check that content and cargo marking, including identification numbers of animals, sealing and the vehicle, correspond to information specified in the international certificates, official confirmations and other documents accompanying it;

32) prelethal survey check, performed before face, on compliance to the requirements concerning health of the person, health of animals and wellbeing of animals and which in appropriate cases includes clinical examination of each certain animal and verification of information on food chain, requirements to content to which form and procedure for provision are approved according to part one of article 34 of this Law;

33) under responsibility of the state veterinary inspector - the order the state veterinary inspector of accomplishment of certain action to the assistant to the state veterinary inspector;

34) under observation of the state veterinary inspector accomplishment by the assistant to the state veterinary inspector of certain action under responsibility of the state veterinary inspector and in case of its direct presence in the place of accomplishment of such action during the time necessary for its accomplishment;

35) postlethal survey - the check performed on slaughter or capacity on conversion of wild animals on compliance to requirements which belong:

a) ink and offal in the values given in hygienic requirements to production and turnover of the foodstuff of animal origin approved according to the Law of Ukraine "About the basic principles and requirements to safety and quality of foodstuff" for the purpose of decision making about whether meat is suitable for consumption by the person;

b) safe removal of risk material; and

c) health of animals and wellbeing of animals;

36) the suitability mark mark put by results of the state control exercised in the form of prebottomhole survey and postlethal survey according to part one of article 32 of this Law also confirms that meat is suitable for consumption by the person;

37) the assistant to the state veterinary inspector representative of competent authority, professional competence of which conform to the requirements established by the legislation about health of animals which works in system of competent authority and which job responsibilities provide participation in accomplishment of the separate tasks connected with implementation of the state control;

38) products (for the purposes of the Section VII of this Law) - foodstuff of animal origin (including composite products), stern of animal origin, hay, straw, by-products of animal origin, biological products, reproductive material;

39) simple researches (testing) - organoleptic researches (on smell, color, consistence, taste), simple physical and chemical researches (cutting, defrosting, heating, etc.), researches (testing) by means of the methods of express diagnostics which are not requiring the direction of the selected samples are also conducted to laboratory in the cases determined by this Law at the venue of actions of the state control;

40) disposal Item - the appointed boundary inspection post or any other place in which the animals covered by coverage of requirements to ensuring wellbeing of animals during their transportation and implementation of the accompanying transactions approved according to article 36 of the Law of Ukraine "About veterinary medicine and wellbeing of animals" leave customs area of Ukraine;

41) referens-laboratory - accredited laboratory to which according to requirements of this Law powers on accomplishment of the functions determined by this Law are conferred;

42) fish products - objects of trade and objects of aquaculture (except live clams, live erinaceouses, living coelenterates, live sea Castropoda, and also all mammals, reptiles and frogs), including their edible forms, parts and products received from them;

43) the fish-freezing judgment vessel intended is specially equipped and is used for freezing of fish products which in appropriate cases preparatory work, in particular precedes bleeding, department of the head, visceration and removal of fins after which if it is necessary, the Primary package or packaging in transport container (packaging) is performed;

44) the fishing judgment vessel intended and specially equipped for fishery implementation, in particular catch, acceptance, processing including filetirovaniye, cutting by slices, renting of skin (scraping), renting of cockleshells, cleaning of scales, crushing and/or conversion then the Primary package or packaging in transport container (packaging) is performed, and in case of need - also chilling or freezing, and also overload, movement, storage of fish products;

45) analysis system of dangerous factors and control in critical points (Hazard Analysis and Critical Control Points, further - HACCP) - the system which identifies estimates and controls dangerous factors which are determining for safety of foodstuff, forages and by-products of animal origin;

46) authorized laboratory - accredited laboratory to which the competent authority confers powers to conduct for the purposes of the state control laboratory researches (testing) of the selected samples of foodstuff, forages, hay, straw, by-products of animal origin, biological material, reproductive material, pathological material or any other materials or substances (including from the environment) which are connected with production and/or turnover of foodstuff, forages, by-products of animal origin and other subjects to regulation of the legislation about health of animals;

47) person authorized by the operator of the market - the legal entity or physical person authorized by the operator of the market on representation of its interests based on the law, statutory documents, job descriptions, the power of attorney and/or the order;

48) authorized person - the official veterinarian, the authorized veterinarian, the captain of the fish-freezing or fishing vessel which floats under National Flag of Ukraine, the worker of slaughter, the representative on accomplishment of obligations of the assistant to the state veterinary inspector, authorized laboratory to which the competent authority according to this law confers powers on implementation of the separate measures of the state control determined by this Law;

49) the authorized veterinarian - the specialist of veterinary medicine having work experience in at least one year and to which the competent authority confers powers on implementation of separate measures of the state control;

50) physical check check of animals or products and, if necessary, check of packaging, vehicles, marking and temperature condition, sampling for carrying out analyses, researches (testing) or diagnostics, and also any other checks necessary for establishment of compliance to requirements of the legislation on foodstuff, sterns, by-products of animal origin, health of animals and/or wellbeing of animals.

2. Other terms are used in this Law in the following values:

1) the term "destruction withdrawn from the product circulation" (further - destruction) - in the value given in the Law of Ukraine "About retirement, conversion, utilization, destruction or further use of low-quality and dangerous products";

2) the terms "the by-products of animal origin which are not intended for consumption by the person" (further - by-products of animal origin), "risk material" - in the values given in the Law of Ukraine "About by-products of animal origin, not intended for consumption by the person";

3) the term "objects of trade" - in the value given in the Law of Ukraine "About fishery, industrial fishery and protection of water bioresources";

4) the term "aquaculture objects" - in the value given in the Law of Ukraine "About aquaculture";

5) the terms "long-term flight", "organizer", "carrier", "flight", "accompanying person", "vehicle" - in the values given in requirements to ensuring wellbeing of animals during their transportation and implementation of the accompanying transactions approved according to article 36 of the Law of Ukraine "About veterinary medicine and wellbeing of animals";

6) for the purposes of Item 17 parts one of article 65 of this law the terms "veterinary medicine", "active ingredient", "turnover", "realization", "counterfeited veterinary medicine", "counterfeited active ingredient" - in the values given in the Law of Ukraine "About veterinary medicine and wellbeing of animals";

7) other terms - in the values given in the laws of Ukraine "About the basic principles and requirements to safety and quality of foodstuff", "About safety and hygiene of forages", "About the by-products of animal origin which are not intended for consumption by the person", "About veterinary medicine and wellbeing of animals", "About the basic principles and requirements to organic production, turnover and marking of organic products" and "About state regulation of genetic and engineering activities and the state control of placement in the market of genetically modified organisms and products".

Article 2. Legislation on the state control

1. The legislation on the state control consists of the Constitution of Ukraine, this Law, the Customs code of Ukraine, the laws of Ukraine "About the basic principles and requirements to safety and quality of foodstuff", "About veterinary medicine and wellbeing of animals", "About safety and hygiene of forages", "About the basic principles of the state supervision (control) in the field of economic activity", "About the basic principles and requirements to organic production, turnover and marking of organic products", "About the materials and objects intended for contact with foodstuff", "About hop and hmeleprodukta" and other regulatory legal acts published according to it.

2. If the international treaty of Ukraine which consent to be bound is provided by the Verkhovna Rada of Ukraine establishes other rules, than those which are provided by this Law are applied rules of the international treaty.

3. The relations on acceptance, entry into force, appeal administratively, to accomplishment, cancellation of administrative acts in the field of the state control of compliance with law about foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals are regulated by the Law of Ukraine "About ministerial procedure" taking into account the features determined by this Law.

Article 3. Law coverage

1. Operation of this Law extends to the public relations connected with implementation of the state control of activities of the operators of the market performing production and/or turnover of foodstuff, other objects of sanitary actions, forages, by-products of animal origin, biological products, veterinary medicines, reproductive material and/or content, cultivation, cultivation, turnover of live animals for the purpose of check of these activities on compliance to the legislation on foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals. Operation of this Law extends to the public relations connected with implementation of the state control of activities of the operators of the market performing organic production and/or turnover of organic products, including import (transfer) to customs area of Ukraine for the purpose of check of these activities on compliance to the legislation in the field of organic production, turnover and marking of organic products.

2. Operation of this Law does not extend to the public relations relatively:

1) protection of life and health of plants;

2) foodstuff, forages, by-products of animal origin intended (made) for own consumption (use);

3) ceased to be valid.

Section ІІ System of the state control. Powers of executive bodies in the field of the state control. Rights and obligations of operators of the market

Article 4. Executive bodies in the field of implementation of the state control

1. In the field of the state control treat executive bodies:

1) Cabinet of Ministers of Ukraine;

2) the central executive body providing forming also realizes state policy in the field of the state control of compliance with law about foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals (further - the central executive body providing forming and realizing state policy in the field of the state control);

3) competent authority.

Article 5. Powers of the Cabinet of Ministers of Ukraine in the field of the state control

1. In the field of the state control treat powers of the Cabinet of Ministers of Ukraine:

1) ensuring carrying out state policy in the field of the state control;

2) the direction and coordination of work of executive bodies in the field of the state control;

3) approval of the list of the appointed boundary inspection posts;

4) approval of the list of the appointed check points on frontier of Ukraine;

5) approval of criteria by which the risk degree from implementation of economic activity, and procedure for determination of frequency of implementation of planned actions of the state control of capacities is estimated;

6) approval of procedure and criteria of authorization of accredited laboratories, including referens-laboratories, procedure for test by competent authority of observance by them corresponding to criteria of authorization and deprivation of such power;

7) approval of procedure for carrying out arbitral laboratory researches (testing) and accounting of their results for the purposes of the state control;

8) approval of procedure for carrying out audit of competent authority and its territorial authorities;

9) implementation of other powers provided by this Law.

Article 6. Powers of the central executive body, providing forming and realization of state policy in the field of the state control

1. The central executive body providing forming and realization of state policy in the field of the state control claims:

1) forms of the acts of the state control applied by the state inspectors and the state veterinary inspectors during inspection and audit and also forms of sampling reports;

2) long-term plan of the state control;

3) control methods of zoonoz;

4) requirements for import (transfer) of customs area of Ukraine of foodstuff of animal origin, forages, hay, straw, and also by-products of animal origin and products of their processing, conversion, and also live animals, biological products and reproductive material;

5) the procedure for determination and use of frequency of documentary checks, checks of compliance, physical controls, laboratory researches (testing) of loads which are imported (are sent) on customs area of Ukraine according to requirements of the Section VII of this Law;

Limit 6) rates (amounts) of sampling;

7) procedure for sampling and their transportation (transfer) to authorized laboratories for the purposes of the state control;

8) procedure for the authorization of the captain of the fish-freezing or fishing vessel floating under National flag of Ukraine on issue of the international certificates and other documents required by the legislation of the country of destination of fish products;

9) form of the annual status report of accomplishment of long-term and annual plans of the state control;

10) it is excluded;

11) rules of functioning of electronic client information control system on the state control and its system components;

12) methods (techniques) of laboratory researches (testing);

13) the methods (techniques) confirming (референс);

14) rules of carrying out laboratory researches (testing) of foodstuff in the agrofood markets;

15) requirements to implementation of system of the bystry message on the threats connected with foodstuff and sterns;

16) it is excluded.

2. The central executive body providing forming and realization of state policy in the field of the state control performs other powers provided by this Law.

Article 7. System and powers of competent authority in the field of the state control

1. Competent authority in the field of the state control:

Will organize 1) and exercises the state control, including on frontier of Ukraine;

Develops 2) and implements the long-term plan of the state control, annually reports to the Cabinet of Ministers of Ukraine on condition of its accomplishment;

Develops 3) and implements the action plan in case of the force majeure connected with foodstuff and/or sterns (further - the action plan in case of force majeure);

4) is approved by the annual plan of the state control and the annual plan of the state monitoring;

5) is provided by carrying out prebottomhole and postlethal survey of animals on the corresponding capacities, postlethal survey of the animals got in the course of hunting;

6) exercises the state control of implementation of the permanent procedures based on the principles of HACCP;

Provides 7) to persons determined by this Law, powers by implementation of separate measures of the state control, controls legitimacy and efficiency of their activities, deprives of such powers in the presence of the bases determined by the legislation and also records and publishes data on authorized persons on the official website;

8) provides legitimacy and efficiency of activities of the structural divisions, territorial authorities and their officials;

9) is established in the annual plan of the state control by frequency of inspection, audit, sampling and laboratory researches (testing) concerning capacities on production and/or the address of foodstuff, forages, by-products of animal origin, veterinary medicines and livestock capacities;

Approves 10) according to the procedure, determined by the legislation, frequency of documentary checks, checks of compliance, physical controls, laboratory researches (testing) of loads which are imported (are sent) on customs area of Ukraine;

11) involves in case of need in implementation of the state control law enforcement agencies within the powers conferred to them by the law;

12) takes within the powers measures for elimination of violations of this Law, the legislation on foodstuff, sterns, by-products of animal origin, health of animals and wellbeing of animals, and also for involvement of perpetrators to the responsibility established by the law;

13) performs other powers provided by this Law.

2. The system of competent authority is constituted by competent authority, its territorial authorities, and also the public institutions, the companies and the organizations subordinated to competent authority.

3. Territorial authorities carry out powers of competent authority within the corresponding administrative and territorial units. The head of competent authority assigns execution of powers of the chief state inspector and chief state veterinary inspector to the head of territorial authority or his deputies, on condition of their compliance to requirements, the established this Law according to the state inspector and the state veterinary inspector.

4. The head of competent authority or its deputy at the same time for position the Chief state veterinary inspector of Ukraine.

The head of independent structural division as a part of the competent authority which is responsible for realization of state policy in the field of veterinary medicine, and his deputies at the same time are deputy chief state veterinary inspectors of Ukraine on position.

The chief state veterinary inspector of Ukraine and his deputies shall meet the requirements to the state veterinary inspector, the established this Law.

The head of competent authority or its deputy at the same time for position the Chief state inspector of Ukraine.

The head of independent structural division as a part of the competent authority which is responsible for realization of state policy in spheres of safety and separate indicators of quality of foodstuff, and his deputies at the same time are deputy chief state inspectors of Ukraine on position.

The chief state inspector of Ukraine and his deputies shall meet the requirements to the state inspector, the established this Law.

5. Heads of territorial authorities of competent authority within the corresponding administrative and territorial units assign accomplishment of powers of the state inspector and/or state veterinary inspector to persons working in system of competent authority on condition of their compliance to requirements, the established this Law.

Article 8. The basic principles of activities of competent authority in the field of the state control

1. The competent authority shall:

1) to implement procedures and/or mechanisms for ensuring effective and proper state control;

2) to implement procedures and/or mechanisms for ensuring impartiality, quality, coordination of the state control at all levels;

3) to implement procedures and/or mechanisms for ensuring lack of any conflict of interest at the personnel exercising the state control;

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