Materials and objects intended to come into contact with foodstuffs in Ukraine
Introduction
1. Requirements for materials and objects in Ukraine
1.1. General requirements for materials and objects
1.2. General requirements for active and intelligent materials and objects
1.3. Special requirements for certain groups of materials and objects
1.4. Substances permitted for use in components
2. State registration of objects
2.1. General requirements for state registration of objects
2.2. State register of objects
2.3. Procedure for state registration of objects
3. Labelling, declaring conformity, traceability
3.1. Labelling materials and objects in Ukraine
3.2. Declaring conformity
3.3. Ensuring traceability of materials and objects
4. Proper manufacturing practices in Ukraine
4.1. General requirements for proper manufacturing practices
4.2. Quality assurance system
4.3. Quality control system
4.4. Requirements for documentation
On 19 November 2025, the Law of Ukraine ‘On Materials and Objects Intended to Come into Contact with Foodstuffs’ (hereinafter referred to as the Law) came into force. The Law defines the legal and organisational basis for ensuring the safety of materials and articles intended to come into contact with foodstuffs in order to protect human life and health, as well as other consumer rights and interests. The Law aims to minimise the risks of harm to citizens’ health from the consumption of foodstuffs, as well as to bring Ukrainian legislation on requirements for materials and objects that come into contact with foodstuffs into line with EU legislation.
1. Requirements for materials and objects in Ukraine
1.1. General requirements for materials and objects
The law sets out general requirements for materials and objects intended to come into contact with foodstuffs (hereinafter referred to as materials and objects):
- the production of materials and objects shall be carried out in compliance with the requirements of proper manufacturing practices;
- under normal or reasonably foreseeable conditions of use, they must not transfer their constituent elements to foodstuffs in quantities that could harm human health, cause unacceptable changes in the composition of foodstuffs, or cause deterioration in their organoleptic properties;
- the labelling, advertising and presentation of materials and objects shall not mislead consumers.
1.2. General requirements for active and intelligent materials and objects
Active materials and objects – materials and objects intended to extend the shelf life of prepackaged foodstuffs and/or to maintain or improve the condition of prepackaged foodstuffs, containing intentionally included components that release substances into prepackaged foodstuffs or their surrounding environment, or absorb substances from them.
Intelligent materials and objects – materials and articles that monitor the condition of packaged foodstuffs or their environment.
As an exception to the requirements of paragraphs 2 and 3 of the general requirements, changes in the composition of a food product and/or its organoleptic properties caused by active materials and objects are permitted.
Note! Condition: such changes must not lead to a violation of the requirements of legislation on food safety and certain quality indicators!
Active materials and objects shall not:
- cause unacceptable changes in the composition of a food product and/or cause deterioration in its organoleptic properties, including by concealing signs of its unsuitability, which may mislead consumers.
- provide information about the condition of the food product that may mislead consumers.
Active and intelligent materials and objects must be clearly labelled as such, so that consumers can identify their non-edible parts.
1.3. Special requirements for certain groups of materials and objects
Specific requirements may be adopted for groups of materials and objects such as: active and intelligent materials and objects, adhesives, ceramics, cork, rubber, glass, ion exchange resins, metals and alloys, paper and cardboard, plastics, printing inks, regenerated cellulose, silicone, textiles, varnishes and coatings, wax, wood.
Special requirements may include, in particular:
- a list of substances permitted for use in the manufacture of materials and objects;
- a list (lists) of substances permitted for inclusion in active and/or intelligent materials and objects;
- requirements for the purity of substances that are components of active materials and articles;
- general, specific or cumulative specific limits for the migration of constituent elements into or onto foodstuffs, etc.
Note! The above lists are compiled in accordance with EU legislation and are part of the state register of objects.
1.4. Substances permitted for use in components
As a general rule, only substances included in the state register of objects may be used in the components of active and intelligent materials and articles.
As an exception, substances that have not undergone state registration may be used in components if they meet the conditions specified by the Law:
- released active substances;
- substances covered by legislation on food safety and specific quality indicators, which are added and/or included in active materials and objects using grafting or immobilisation methods in order to achieve a technological effect in foodstuffs;
- substances used in components that do not come into direct contact with the foodstuffs or their environment and are separated from the foodstuffs by a functional barrier, provided that such substances:
- are not classified as mutagenic, carcinogenic or toxic to reproductive function;
- are not intentionally reduced to particle sizes that have physical and chemical properties significantly different from those in their original state.
2. State registration of objects in Ukraine
2.1. General requirements for state registration of objects
The following are subject to state registration:
- substances used in the production of materials and objects (e.g., active and intelligent materials and objects, ceramics, plastics, regenerated cellulose);
- processes for recycling used plastics that are reused in the production of materials and objects.
The decision on state registration of objects is made by the Ministry of Health, on the basis and in the manner established by the Law.
State registration of objects is carried out:
- free of charge;
- for an unlimited period.
In the production of materials and objects, it is prohibited to use objects that are not included in the state register of objects or in violation of the conditions specified in the decision on state registration.
2.2. State register of objects
The state register of objects (hereinafter referred to as the Register) is maintained by the Ministry of Health of Ukraine in electronic form. To this end, the Ministry:
- provides open and free access to the Register by posting it on its official website;
- approves the procedure for maintaining the Register and the list of information to be included in it.
2.3. Procedure for state registration of objects
To register an object, the applicant shall submit the following documents to the Ministry of Health of Ukraine:
- an application for state registration of the object, containing information about the applicant’s name and location;
- the object’s registration dossier;
- a summary of the object’s registration dossier.
If the documents do not comply with the requirements of the Law, the Ministry of Health of Ukraine shall, within 3 working days, send the applicant a notification that the application has been put on hold, provided that the person’s right to participate in administrative proceedings is ensured in accordance with the Law of Ukraine ‘On Administrative Procedure’.
If the documents comply with the requirements of the Law, the Ministry of Health of Ukraine shall, within 10 working days, send:
- to the applicant – written confirmation of receipt of the documents, indicating the date of receipt;
- to the authorised person – the documents submitted for the object’s state registration in order to obtain a scientific and expert opinion on its safety.
Within 6 months (in complex cases, the period may be extended but not by more than 6 months), the authorised person shall conduct a scientific assessment of the object’s safety (risk assessment) and submit a scientific and expert opinion on the object’s safety to the Ministry of Health.
The Ministry of Health of Ukraine shall:
- publish the above-mentioned documents on its official website, while complying with the confidentiality of information recognised as confidential in accordance with the procedure provided for by the Law;
- make a decision on the object’s state registration or denial of state registration within one month of getting the scientific and expert opinion on the object’s safety from the authorised person.
A decision to deny registration may be appealed under administrative procedure in accordance with the Law of Ukraine ‘On Administrative Procedure’ and/or to an administrative court.
A copy of the decision shall be sent to the applicant within 10 working days after its adoption.
The decision on state registration of the facility:
- is published on the official website of the Ministry of Health;
- comes into force on the day following the day of its publication;
- determines the conditions and/or restrictions on the object’s use;
- is binding on market operators using the object from the date of the decision coming into force.
3. Labelling, declaring conformity, traceability
3.1. Labelling materials and objects in Ukraine
Materials and objects that do not come into contact with food products at the time of their sale must be accompanied by information containing:
- the words ‘for contact with food’ or a special designation regarding their use (e.g., ‘coffee maker,’ ‘tablespoon,’ etc.), or an appropriate graphic symbol (except for those that are clearly intended for contact with food);
- special instructions for their safe and proper use (if necessary);
- the name and address of the market operator who manufactures, processes and/or places them on the market;
- labelling that ensures their traceability;
- for active materials and objects – information on permitted use and other information on use, in particular the name and quantity of substances released by the active component.
3.2. Declaring conformity
Materials and articles subject to special requirements must be accompanied by a written declaration confirming that the requirements for the relevant material or article have been met.
Active and intelligent materials and objects at all stages of their circulation, except at points of sale to end consumers, must be accompanied by a written declaration of conformity certifying compliance with the requirements for such active and intelligent materials and objects.
The declaration of conformity shall be drawn up in accordance with the requirements for its content set out in the specific requirements.
3.3. Ensuring traceability of materials and objects
Market operators shall ensure traceability of materials and objects at all stages of their production and circulation in order to:
- ensure state control;
- withdraw from circulation;
- recall defective materials and articles;
- inform consumers; and
- bring persons to justice for violations of the legislation on materials and articles intended to come into contact with food.
Market operators shall implement systems and procedures that enable the identification of the facilities from and to which materials and objects, as well as components and substances, if necessary, are supplied, taking into account technological capabilities.
To ensure traceability, materials and objects placed on the market or intended for placement on the market in Ukraine must be properly marked or identified by means of appropriate documentation and/or information accompanying such materials and objects.
4. Proper manufacturing practices in Ukraine
4.1. General requirements for proper manufacturing practices
Groups of materials and items subject to special requirements, including combinations of such materials and items, as well as processed materials and items used in their production, must be manufactured in accordance with the requirements of Good Manufacturing Practice (hereinafter referred to as GMP).
GMP requirements apply to all areas and stages of production, processing and circulation of materials and objects, except for the production of raw materials.
GMP requirements consist of:
- requirements for quality assurance and control systems, and documentation requirements;
- requirements for the use of printing inks;
- requirements for the quality assurance system for plastic processing.
4.2. Quality assurance system
The market operator must establish, implement and ensure the continuous functioning of an effective and documented quality assurance system. Such a system shall:
- take into account the qualifications of employees, their knowledge and skills, as well as the organisation of production (availability of premises and equipment) necessary to ensure that finished materials and objects comply with the established requirements;
- be applied taking into account the number of employees and the income of the relevant market operator in order to prevent the creation of an inadequate financial and administrative burden on it.
4.3. Quality control system
The market operator must establish, implement and apply on an ongoing basis an effective quality control system that:
- includes monitoring the definition and achievement of GMP objectives;
- defines corrections and corrective actions to eliminate non-compliance with GMP requirements.
4.4. Requirements for documentation
The market operator shall develop and maintain documentation:
- on specifications, production formulas and process charts necessary to determine the safety and compliance of finished materials or items with the established requirements;
- which records information on:
- the implementation of manufacturing processes related to ensuring the safety and compliance of finished materials or items with established requirements;
- the results of the quality control.