Dietary supplements marking and putting into circulation: legal regulation
Аptека.ua, 27.08.2018 - Kateryna Gorbunova
Peculiarities of marking and putting into circulation of dietary supplements in Ukraine is a topic of the webinar held on August 22nd, 2018 by lawyers of Legal Alliance Company. Senior associate Lidiya Sangarovskaya and associate Nataliia Abramovych dwelled on the issues of legal regulation of dietary supplements circulation and marking, main requirements to marking and procedure for putting into circulation thereof, import, violations in the area of dietary supplements circulation and sanctions.
A dietary supplement is defined in the Law of Ukraine “On Main Principles and Requirements to Safety and Quality of Food Products”. According to it, a dietary supplement is a food product. It means that all norms of legislation related to food products apply to dietary supplements.
The main feature of dietary supplements is that they are consumed in small determined quantities in addition to the everyday diet. They are a concentrated source of nutrients and can be produced in various forms, such as tablets, pills, powders, etc.
Marking of dietary supplements
The current legislation of Ukraine contains definition of “marking” which refers to all words, descriptions, signs for goods and services, name of mark, image or symbols related to food products and placed on any package, label (sticker), consumer packaging, counter-label, tag, cork, insert leaflet accompanying or belonging to this type of food products.
.As it concerns marking of dietary supplements, for better convenience we can divide requirements to marking into general, which is those prescribed for all food products, and special. The general requirements are specified in the Technical Regulation on the Rules of Food Product Marking (hereinafter – the Technical Regulation) approved by Order of the State Committee of Ukraine on Technical Regulation and Consumer Policy No. 487 as of October 28th, 2010. The special requirements have been excluded for dietary supplements by the Hygiene Requirements approved by Order of the Ministry of Health of Ukraine No. 1114 as of December 19th, 2013.
At marking of dietary supplements the whole set of requirements, both general and special, has to be considered.
Depending on the composition and form of dietary supplements, some requirements may to some extent differ, be clarified, etc. This is why at the webinar universal requirements to dietary supplement marking have been presented.
One of the most important requirements is that marking of food products, including dietary supplements, must be in Ukrainian. However, the legislation does not prohibit specifying information in a foreign language along with Ukrainian.
It is not allowed to use for marking and advertisement of dietary supplements the following:
- expressions regarding possible therapeutic effect or pain relief;
- letters of gratitude, acknowledgement or advice if they are related to disease treatment or relief, and also references to such information;
- expressions which cause or facilitate negative psychological feeling.
The lawyers focused more on the information which must be specified in the dietary supplement marking.
First, it must be specified that the product is a dietary supplement. The marking may be supplemented with a commercial name of the dietary supplement which may be in Latin letters, and/or sign for goods and services. According to the Technical Regulation, if a dietary supplement contains sweeteners or other substances the list of which is contained in Annex 5 to the Technical Regulation, a warning, for example “contains sweetener(s)”, “with sugar”, etc. must be specified near name of the dietary supplement.
Speaking about placing information on composition of dietary supplements, N. Abramovych noted that before the list of ingredients there must be a title “Composition:”. The ingredients are listed in the order of their mass fraction decrease. Elements of ingredients are also specified in the composition, for example, are listed near the ingredient name in brackets. Besides, detailed information on presence of sweeteners and presence/absence of genetically modified organisms is provided as well.
Dietary supplements may contain dietary additives, so called Es – substances which are not considered food but are added to it with a technological purpose in the process of production, and as a result become an integral part of the product. Dietary additives must also be specified in the composition.
Under the Ukrainian legislation, only the dietary additives included to the State Register of Dietary Additives Permitted for Use in Food Products are allowed to be used in the production in food products and those in circulation. However, according to N. Abramovych, for now the register has not been created yet, and there is no list of permitted or prohibited additives.
Marking must also contain the quantity of a dietary supplement in the set units of measurement. The quantity of nutrients (vitamins and minerals) is given on the mark in units of measurement specified in Annex 1 to the Hygiene Requirements, and is prescribed based on the recommended daily amount (portion) of the dietary supplement indicated on the label.
What concerns shelf life characteristics, the end date of consumption is specified (for example, “best before…”). Alternatively, date of production and shelf life can be written in a chronological sequence with punctuation marks (full stop, slash, etc.) between them.
Another type of information which must be placed on the marking - nutritional value, which should contain data on:
- energy value (caloric value) in kilojoules (kJ) and / or kilocalories (kcal) per 100 g or 100 ml of product;
- nutritional (food) value, namely: the amount of protein, fats, carbohydrates in grams (g) per 100 g or 100 ml of the product.
Marking of dietary supplements can also contain the following compulsory warnings:
- the amount (portion) of a dietary supplement recommended for daily consumption;
- warning not to exceed the indicated recommended amount (portion) for daily consumption;
- dietary supplements should not be used as a substitute for a complete diet;
- dietary supplements should be kept out of the reach of children;
- warnings regarding the consumption of food products by certain categories of consumers (children, pregnant women, the elderly, etc.) if such a product can adversely affect their health when consumed.
This list is not exhaustive, however it is compulsory for dietary supplements marking. At the manufacturer’s discretion, any additional warnings may be specified.
Other obligatory information placed on marking is: storage conditions if the food product requires special storage conditions; conditions and recommendations on the dietary supplement use; name, location and phone number of the manufacturer or help line, actual address of the manufacturing facility, and for imported food product - name, location and phone number of the importer. Also name, location and phone number of the enterprise accepting complaints from consumers, in case such an enterprise is not a manufacturer, are specified. It is mandatory to indicate the batch number and place of origin for food products that are only packaged or prepackaged in Ukraine.
Procedure for putting dietary supplements into circulation
Natraliia Abramovych dwelled on another important aspect which is peculiarities of putting dietary supplements into circulation. “Since dietary supplements belong to food products, they are subject to sanitary measures. The current legislation of Ukraine prohibits realization of sanitary measures objects if they are not registered under the law”, the lawyer mentioned, adding that under the general rule, dietary supplements are not subject to state registration in Ukraine except for cases when such a dietary supplement is an innovative food product.
It should be noted that for the time being the procedure of state registration of innovative food products has not been approved, as well as there is no state register of innovative food products. Due to this fact, innovative food products are not accepted for registration.
Nataliia Abramovych recommended to follow news on this matter and changes in legislation in this area.
What is considered an innovative food product? The criteria which distinguish them from usual are that, first of all, such a product or ingredient does not have a history of safe consumption in Ukraine and has significant change and/or impact due to the following:
- use of cultivation of animals and / or plants that have not previously been used for these purposes;
- production by applying a production process that has not previously been used for this type of product or ingredient.
Second, the food product or ingredient does not have the history of safe consumption in Ukraine, but it has a history of safe consumption in other country/countries and significant change and/or impact.
Another aspect of putting dietary supplements into circulation is the need for obtaining an operating permit or state registration of the facility by market operators engaged in the production and / or storage of food products of animal origin. A number of exceptions, when no operating permit is required, is contained in Article 23(2) of the Law of Ukraine “On Main Principles and Requirements to Safety and Quality of Food Products”.
The operating permit is issued for each facility before it is used, and is indefinite in time. The procedure for issuing the operating permit is approved by Resolution of the Cabinet of Ministers of Ukraine No. 930 as of November 11th, 2015.
Food product manufacturing and/or circulation facilities, for which operating permit is not required, are not subject to state registration. The state registration is carried by an authorized body for free by entering information to the register. Manufacturing facilities in the register are given specific registration number.
Import of dietary supplements
State control is exercised at the time dietary supplements are imported to the territory of Ukraine. Depending on a dietary supplement composition, different control procedure is applied.
Thus, dietary supplements of animal origin are subject to state control carried out by the state veterinary inspector in the form of documentary and factual inspections at the designated border inspection post. Dietary supplements must be accompanied by an international certificate, a general veterinary document for import and other documents, for example, a consignment note. The mentioned list of documents is not exhaustive, but is mandatory.
For other dietary supplements, state control is exercised as scheduled or can be unplanned at any entry point at the state border of Ukraine or in the area of customs control on the customs territory of Ukraine. In this case dietary supplements must be accompanied by the international certificate and other documents.
Liability for violation in the area of dietary supplement circulation
For non-observance of the established requirements for the marking and putting into circulation of dietary supplements, the current legislation of Ukraine establishes liability for market operators, in particular, in the Law of Ukraine "On State Control Over Compliance with Legislation on Food Products, Feed, Animal By-Products and Animal Welfare" (Article 65) and the Code of Ukraine on Administrative Offenses (Article 166-22).
As it was specified, liability subjects are market operators, namely:
- entities conducting business with or without the purpose of profit and managing facilities of production, sale and / or circulation of food products and objects of other sanitary measures, and which are responsible for observing the requirements of the legislation on safety and some food quality indicators;
- individuals, if they carry out activities for the purpose or without the purpose of profit, and produce and / or engage in circulation of food products and other sanitary measures;
- agro-food market.
Main violations in the area of dietary supplement circulation are the following:
- violation of the established hygienic requirements for the production and / or circulation of food products, if this poses a threat to human life and / or health;
- production and / or circulation of food products using unregistered facilities, if the law prescribes their compulsory state registration;
- production and storage of food products without obtaining an operating permit for the corresponding facility, if the obligation to obtain it is established by law;
- realization of food products, the marking of which does not comply with the law, if it poses a threat to human life and / or health.
For legal entities and private entrepreneurs different amounts of fines are prescribed which are calculated based on the number of minimum salaries.
At the end of the webinar the participants received competent answers to their questions which mostly concerned aspects of dietary supplement marking.Connect with the speakers: senior associate Lidiya Sangarovskaya, email@example.com; associate Nataliia Abramovych, firstname.lastname@example.org