The state registration procedure is the same for both food additives and flavorings, and food enzymes. To carry out such registration, market operators apply to the Ministry of Health with a relevant application, registration dossier and summary thereof, as well as other documents.
After checking the documents for compliance, they are sent with a corresponding request to conduct a risk assessment of the facility and obtain a scientific opinion on the safety of the facility.
According to Article 31-1 The Law of Ukraine "On Basic Principles and Requirements for the Safety and Quality of Food Products", market operators have the right to circulate and use food additives, flavorings and food enzymes under two conditions:
- such objects have passed state registration;
- included in the state register and/or registered (recognized as safe) in the European Union.
Order of the Ministry of Health No. 1874, which approved the Procedure for maintaining the state register of food additives, food flavorings, and food enzymes, entered into force recently - January 17, 2025.
This Procedure defines the features of maintaining and accessing the Register - an information and communication system created to record, process and provide information on registered food additives, flavorings, raw materials for the production of smoke flavorings and food enzymes. The holder and administrator of the Register is the Ministry of Health.
It is currently unknown when the Register will be operational. As stated in the Ministry of Health order itself, The date of commencement of the Registry will depend on the date of technical feasibility.At the same time, the functioning of the Register will be mandatory announced on the official website of the Ministry of Health.
Since the Register includes only those food additives, flavorings, and food enzymes that have undergone mandatory state registration, we will consider the procedure for conducting such registration in more detail.
The procedure for registering sanitary facilities is defined in Section V.-1 The Law of Ukraine "On Basic Principles and Requirements for the Safety and Quality of Food Products".
Let us recall that such objects are:
- food additive– a food product, whether or not it has nutritional value, is not normally consumed as a separate food product and is not its main ingredient. It is added for a technological purpose during the process of production, packaging, transportation or storage and as a result becomes an integral part of that product;
- food flavorings– food products (except those with an exclusively sweet, sour or salty taste) that are not consumed separately and are added for the purpose of imparting or modifying aroma and/or taste in a food product and may contain food products, flavorings, food additives (These are aromatic substances, heat-treated preparations, smoke flavourings, flavour precursors, other flavourings and their mixtures);
- food enzyme– obtained from plants, animals, microorganisms, products thereof, including products obtained in the fermentation process using microorganisms, which contains one/several enzymes capable of catalyzing characteristic biochemical reactions. It is added to solve technological problems at the stages of processing, production, processing, preparation, packaging, transportation or storage of food products.
The state registration procedure is the same for both food additives and flavorings, and food enzymes. To conduct such registration, market operators apply to the Ministry of Health with a relevant application, registration dossier and summary for it, and other documents.
After checking the documents for compliance, they are sent with a corresponding request to conduct a risk assessment of the facility and obtain a scientific opinion on the safety of the facility.
The time frame for conducting such a risk assessment for food additives, food flavors, food enzymes is 180 working days from the date of the market operator's application with documents for registration. After receiving a scientific conclusion on the safety of the facility, a decision is made on its state registration or refusal of such registration.
Please note! Risk assessment services are provided on a fee basis in accordance with the agreement between the market operator and the authorized person. In case of failure to make payment, state registration will be refused.
The decision on state registration must necessarily determine:
- conditions and/or restrictions on the use of the facility;
- name and address of the food market operator
(indicated only in decisions on the registration of raw materials for the production of smoke flavorings).
What about the validity period of such decisions? State registration is indefinite. Exception – registration of raw materials for the production of smoke flavorings – valid for 10 years.
The inclusion of food additives, food flavorings and food enzymes in the Register is carried out exclusively on the basis of a decision on state registration of such objects.
Unauthorized (General) access to the Register is provided on the official website of the Ministry of Health. Thus, the following information will be available in open and free access:
- name, code, registration number of the object;
- specification and conditions of use of the facility;
- decision on state registration of the facility and other decisions of the Ministry of Health;
- scientific conclusion on the safety of facilities;
- information about the food market operator for whom raw materials for the production of smoke flavorings are registered.
Requirements and conditions for the use of food additives, food flavorings and food enzymes approved by order of the Ministry of Health No. 45 dated 08.01.2024.
Such requirements establish general conditions for the use of food additives, food enzymes, flavorings, food ingredients with aromatic properties, and the features of their labeling by food market operators.
SEPARATELY, THE REQUIREMENTS FOR FOOD ADDITIVES DEFINE:
- which food products and substances are not subject to the established requirements;
- levels of use of food additives;
- functional classes of food additives;
- features of the use of food additives in food products;
- transfer principle (In what cases is the presence of a food additive allowed?);
- features of labeling of food additives;
- list of functional classes of food additives in food products, food additives and food enzymes;
- list of food product categories;
- a list of traditional food products for which states may prohibit the use of certain functional classes of food additives, individual food additives;
- list of food products in which the presence of food additives and dyes is prohibited on the basis of carry-over;
- a list of dyes, the labeling of food products with which must contain additional information.
REQUIREMENTS FOR FOOD FLAVORS DEFINE:
- which flavorings, ingredients and products are not subject to the established requirements;
- general conditions for the use of food flavorings;
- labeling of food flavorings;
- a list of production conditions and maximum permissible levels of individual substances in food flavorings to which the heat treatment process was applied;
- a list of substances that are prohibited from being added to food products and maximum permissible levels of individual substances in multi-component food products;
- list of starting materials and restrictions on their use for the production of food flavourings and food ingredients with flavouring properties.
REQUIREMENTS FOR FOOD ENZYMES ARE DEFINED AS:
- which enzymes are not subject to the established requirements;
- general conditions for the use of food enzymes;
- labeling of food enzymes.
We inform you additionally! In accordance with the Law of Ukraine "On Basic Principles and Requirements for the Safety and Quality of Food Products", the procedure for state registration of food additives, flavorings and enzymes contains features that take into account the requirements of European Union legislation regarding the registration of such objects.
Information on the authorisation of food additives, flavourings and enzymes is contained in the following EU Regulations:
- food supplements– Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16.12.2008 on food additives.
- food flavorings– Commission Implementing Regulation (EU) No. 872/2012 of 01.10.2012 establishing the list of flavourings, as provided for in Regulation (EC) No. 2232/96 of the European Parliament and of the Council, including the list in Annex I to Regulation (EC) No. 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No. 1565/2000 and Commission Decision 1999/217/EC.
- food enzymes - Regulation (EC) No. 1332/2008 of the European Parliament and of the Council of 16.12.2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No. 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No. 258/97.
The introduction of the State Register of Food Additives, Food Flavorings, and Food Enzymes is an important step for Ukraine towards harmonization with European food safety standards. For market operators, this means not only new responsibilities, but also more transparent rules of the game. Careful adherence to established procedures will avoid legal risks and ensure the safety of food products on the Ukrainian market.
Source: Quality Management.
