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LAW OF UKRAINE

of November 3, 2022 No. 2718-IX

About the materials and objects intended for contact with foodstuff

This Law determines legal and organizational basis of safety of the materials and objects intended for contact with foodstuff for the purpose of ensuring protection of life and human health, and also other rights and consumer interests.

Section I. General provisions

Article 1. Terms and their determination

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

1) active materials and objects - the materials and objects intended for prolongation of deadline (calendar date) of consumption of the packed-up foodstuff ("use dates to") and/or for maintenance or improvement of condition of the packed-up foodstuff containing in the structure intentionally are included components which release substances the packed-up foodstuff or on environment that surrounds them, or absorb substances from the packed-up foodstuff or from the circle which surrounds them;

2) active materials and objects with release component - the active materials and objects containing in the structure intentionally the included components releasing substances in / or the packed-up foodstuff or on the environment surrounding foodstuff;

3) the released active agents - the substances intended for release from active materials and objects with release component in / or the packed-up foodstuff or on the environment surrounding foodstuff for prolongation of deadline of its consumption and/or for maintenance or improvement of its condition;

4) the test test with loading – demonstration of efficiency of process of conversion of plastic on removal of chemical pollution from materials or objects from plastic;

5) production cycles in the closed and controlled chain – cycles of production and the address in which materials and objects address within controlled system of reuse and the address in which the processed material comes only from links of such chain, and technical capability of accidental hit in chain of foreign material minimum;

6) the state register of the substances permitted for use in production of materials and objects, and also processes of conversion of plastic (further - the state register of objects), - the information and communication system providing collection, accumulating, storage, accounting, display, data processing and provision of information about the substances permitted for use in production of materials and objects and also about processes of conversion of plastic;

7) general limit of migration (Overall Migration Limit – OML) – the most admissible total quantity of the nonvolatile substances emitted from material or subject on model environment;

8) the applicant - person who submitted the provided by this Law the application and other documents for the purpose of state registration of object or modification of conditions of use of object and/or to the other information containing the decision on state registration of object;

9) intellectual materials and objects – the materials and objects providing monitoring of condition of the packed-up foodstuff or the environment surrounding such foodstuff;

10) component – substance or combination of the substances providing active and/or intellectual function of materials or objects, including products of in situ of reactions of such substances. Passive parts, including materials in which it is added or included the corresponding substance or combination of substances do not belong to components;

11) the materials and objects intended for contact with foodstuff (further - materials and objects), - intended for the direct and/or mediated contact with foodstuff (including through functional barrier) materials and objects which are used for the purpose of production, packing, storage, transportation, realization, use and/or consumption of foodstuff, including:

equipment and stock;

container, packaging (packaging materials) and ware;

tableware;

active materials and objects, including active materials and objects with release component;

intellectual materials and objects;

functional barriers;

12) the model circle - the circle imitating foodstuff which properties allow to research migration of substances from materials and objects in foodstuff;

13) proper production practice (Good Manufacturing Practice - GMP) - set of organizational and technical rules and requirements to quality assurance which guarantee that materials and objects are consistently made and controlled for ensuring compliance to the requirements and the quality standards established concerning them, answer their appointment, do not do harm to health of the person, does not cause unacceptable changes in structure of foodstuff, do not predetermine deterioration in its organoleptic properties;

14) objects - the substances and processes specified in part one of article 11 of this Law which according to this Law are subject to state registration;

15) the operator of the market of the materials and objects intended for contact with foodstuff (further - the operator of the market), - the legal entity or physical person performing the activities connected with any production stage, conversions and/or addresses of materials and/or objects;

16) person performing conversion - the operator of the market responsible for ensuring compliance with this Law concerning process of conversion of plastic within the activities which are under its control;

17) person performing transformation - the operator of the market responsible for ensuring compliance with this Law concerning materials and objects from the processed plastic within the activities which are under its control;

18) traceability – opportunity to identify and trace materials and objects at all stages of their production, conversion and address;

19) raw materials from plastic – the materials and objects from plastic collected and their uses which are raw materials in processes of conversion of plastic sorted later;

20) system of quality assurance - set of documentary regulated organizational and technical actions performed by the operator of the market for the purpose of ensuring compliance of materials and objects to the requirements and the quality standards established to them which observance is necessary condition for use of such materials and objects to destination;

21) quality control system – application on permanent basis of the measures established within system of quality assurance, providing compliance of raw materials, intermediate and ready materials and objects to the specifications established in system of quality assurance;

22) the specification - information on structure, criteria of purity, physical and chemical characteristics of substance, and also information on production process of subject of the specification or the additional information on migration borders;

23) specific limit of migration (Specific Migration Limit – SML) – the most admissible amount of the separate substance emitted from material or subject in foodstuff or the model circle;

24) the surface contacting to foodstuff - the surface of material or subject which is directly contacting to foodstuff;

25) the surface which is not contacting to foodstuff - the surface of material or subject which is directly not contacting to foodstuff;

26) cumulative specific limit of migration (Total Specific Migration Limit – SML(T) – the most admissible amount of amounts of the separate substances emitted from material or subject in foodstuff or the model circle expressed as total quantity of particles of these substances;

27) the authorized person - the state company (organization or the organization) to which, (which) the central executive body providing forming and the implementing state policy in the field of health care confers powers on carrying out scientific assessment of safety of object (risk assessment) for the purpose of its state registration;

28) functional barrier – the barrier consisting of one or more layers of the material which is directly contacting to foodstuff, and providing compliance of material, ready to use, or subject to requirements of article 6 of this Law.

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

the term "consumer" – in the value given in the Law of Ukraine "About consumer protection";

the terms "production", "pollution", "corrective action", "correction", "unsuitable foodstuff", "dangerous foodstuff", "equipment and stock", "packaging", "capacities", "turnover", "risk", "foodstuff" - in the values given in the Law of Ukraine "About the basic principles and requirements to safety and qualities of foodstuff";

the terms "water supply system", "individual and collective installations (devices) of drinking water supply" - in the values given in the Law of Ukraine "About drinking water, drinking water supply and water disposal";

terms of "retirement", "response" - in the values given in the Law of Ukraine "About general safety of non-food products";

the term "international standardization organization" – in the value given in the Law of Ukraine "About standardization";

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