CMS Expert Guide on Beauty in Slovakia

• Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (“Cosmetic Products Regulation”)
• Commission Regulation (EU) No. 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products (“Commission Regulation No. 655/2013”)

According to the Cosmetic Products Regulation, “cosmetic product” means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

The definition of a cosmetic product comprises three parts: a function, field of application, and product composition.

• The Cosmetic Products Regulation specifies 6 functions including to clean, perfume, change appearance, protect etc.
• The field of application relates to external parts of the body e.g., skin, hair, nails, teeth etc.
• A cosmetic product may be a substance or mixture of a number of substances.

Products that are intended to be ingested, inhaled, injected or implanted are not classified as cosmetic products.  For example, aromatherapy products not intended for use on the skin would not be classified as a cosmetic product. Products which are ingested but claim to have “cosmetic benefits” i.e. improving skin, hair and nails, would likely fall under the food supplement regime.

As compared to the cosmetic product, “medicinal product” is a drug or a mixture of drugs and excipients, which are modified by a technological process into a dosage form and are intended to protect against disease, to diagnose disease, to cure disease or to influence physiological functions (according to the Slovak Act No. 362/2011 Coll. on medicinal products and medical devices). Medicinal products would require authorisation from the State Institute for Drug Control.

The Cosmetic Products Regulation prescribes what substances are prohibited (Annex II) or restricted (Annex III) in use in cosmetic products.

Annex III specifies a variety of restrictions, for example, on the concentration of certain chemicals permitted in products for home use and for professional use. Tooth whitening products which contain or release between 0.1%-6% hydrogen peroxide are only available for professional use. Products containing or releasing less than 0.1% hydrogen peroxide are deemed safe for home use.

If colourants, preservatives, or UV-filters are being used, any restrictions or prohibitions which apply must be followed. This is a positive list, meaning only substances listed in Annex IV, Annex V or Annex VI may be used.

Under the Cosmetic Products Regulation, all cosmetic products available to consumers must have a ‘Responsible Person’ who makes sure safety measures are followed and legal obligations are met (Article 4).

A Responsible Person can be either:

• the manufacturer
• the importer
• the distributor, if they label the product as their own (for example, using their brand name) or
• an appointed company or person (who is named by the manufacturer or the importer).

Before making a cosmetic product available to consumers, its safety must be checked by a qualified safety assessor. The safety assessment should take the form of a cosmetic product safety report (CPSR) signed by a qualified safety assessor. The CPSR provides evidence of how the product is safe for its intended cosmetic use and takes account of reasonably foreseeable use. In addition, a specific safety assessment is required for cosmetic products intended for use on children under the age of three, and for cosmetic products intended exclusively for use in external intimate hygiene.

The following information must be included on packaging:

• the name and address of the Responsible Person;
• the country of origin in case of imported products;
• the nominal content - weight or volume;
• the date of minimum durability;
• any precautions for use;
• the batch number (or the reference for identifying the cosmetic product);
• the function - what the cosmetic product does;
• the ingredients - these can be provided solely on the packaging. Note that nanomaterial ingredients must be followed by ‘(nano)’.

It may not be practical to include precautions and ingredients for certain cosmetic products on the label, for example due to available space on packaging. If this is the case, it is important to include this information within the packaging, for example on a leaflet; unless impracticable, a symbol or abbreviated information should refer to this information.

Under the Cosmetic Products Regulation, advertising of cosmetic products shall not imply that these products have characteristics or functions which they do not have.

Under the Commission Regulation No. 655/2013, the wording of the claim in relation to cosmetic products must be in compliance with the common criteria (relating to legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making) set out in the Annex to the Commission Regulation and also consistent with the documentation proving the effect claimed for the cosmetic product in the product information file (stipulated in Article 11 of the Cosmetic Products Regulation).

Article 25 of the Regulation requires competent authorities to request the Responsible Person to take all appropriate measures over a product that does not comply with the Regulation, including corrective actions bringing the product into conformity, the withdrawal of the product from the market or its recall, within an expressly mentioned time limit.

Article 26 of the Regulation requires competent authorities to request the distributor to take all appropriate measures corrective actions over a product that does not comply with a distributor's responsibilities under the Regulation, in a similar way to Article 25.

Article 27 of the Regulation allows an enforcement authority to take direct provisional action where there is a serious risk to human health, or there are reasonable grounds for concern.

Damaging a consumer, while causing the consumer at least minor damage (damage exceeding EUR 700), by lying on the quality, quantity or weight of goods, or by introducing products to the market with concealed material defects, could qualify for a criminal offence under the Slovak Act No. 300/2005 Coll., the Criminal Code.

No upcoming future developments in this field that we are aware of.

• Directive No. 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (“Directive No. 2002/46/EC”);
• Slovak Act No. 152/1995 Coll. on foodstuffs (“Act on Foodstuffs”);
• Decree of the Ministry of Agriculture of the Slovak Republic and the Ministry of Health No. 16826/2007-OL of the Slovak Republic of 25 July 2007 issuing the Title of the Food Code of the Slovak Republic regulating the requirements for foodstuffs for special nutritional purposes and for food supplements (“Decree No. 16826/2007-OL”), transposing the Directive No. 2002/46/EC.

Directive No. 2002/46/EC defines food supplements as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form.

The Act on Foodstuffs and the Decree No. 16826/2007-OL define food supplements as foodstuffs to supplement the natural diet which is a concentrated source of nutrients such as vitamins and minerals or other substances having a nutritional or physiological effect, alone or in combination; they are placed on the market in dosage form, such as capsules, lozenges, tablets, pills and other similar forms, powder sachets, liquid ampoules, dropper bottles and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

Directive No. 2002/46/EC specifies the vitamins and minerals (Annex I) and the form of vitamin and mineral substances (Annex II) which are permitted for use in the manufacture of food supplements. 

The respective specification is contained also in the Decree No. 16826/2007-OL (Annex 17 and Annex 18).

Supplements cannot contain, for example, prohibited novel foods, such as CBD, L-alfa GPC or DIM, prohibited substances according to Annex III to the Regulation (EC) No. 1925/2006 of the European Parliament and of the Council, or prohibited substances according to annex to the Slovak Act No. 397/2015 Coll.

Food business operators are primarily responsible for food safety, including food supplements safety.

As long as supplements comply with the law specific to food supplements and all other applicable food law, then they are permitted for sale.

The person placing the supplements on the market is obliged to submit to the Public Health Authority of the Slovak Republic a notification of the composition and labelling of the food supplements to be placed on the market at the latest on the date of its placing on the market.

Where based on new information, or following a reassessment of existing information, it is established that a food supplement poses a risk to human health, even if it complies with the legal requirements, the use of such requirements and of such supplements may be temporarily suspended or restricted; this fact shall be immediately notified to the other EU Member States and the EU Commission, stating the reasons of that decision.

Each natural person-entrepreneur and legal entity is obliged to keep records of all suppliers and customers for the sake of traceability of foodstuffs (including food supplements).

On top of general requirements for labelling of foodstuffs, Decree No. 16826/2007-OL stipulates further mandatory labelling information:  

• the words “food supplement”;
• the name of the category of nutrients or substances which characterise the food supplement or an indication of the nature of those nutrients or substances;
• recommended daily dose of the food supplement;
• a warning not to exceed the stated recommended daily dose;
• a warning that food supplements should not be used as a substitute for a varied diet;
• a warning that the product should be stored out of the reach of young children.

Amount of nutrients or substances with nutritional or physiological effect present in the food supplement must be indicated in the labelling as a numerical value.

Amount of nutrients or other declared substances expressed per dose of the food supplement must be identical to the recommended daily allowance stated in the labelling.

Information on vitamins and minerals in the food supplement must be expressed also as a percentage of the reference values for the vitamins and minerals listed in Annex 19 to Decree No. 16826/2007-OL, which may also be expressed in graphical form.

The declared values on the packaging shall be expressed as the average values of nutrients or substances having a nutritional or physiological effect obtained by analysis of the food supplement by the manufacturer.

Decree No. 16826/2007-OL orders that the labelling, presentation and advertising must not attribute to food supplements the ability to prevent, treat or cure human disease or refer to such abilities.

Further under Decree No. 16826/2007-OL, the labelling, offering and advertising of food supplements shall not include any information which claims or gives the impression that a balanced and varied diet does not generally provide an adequate amount of nutrients.

Yes, advertising and promotion of supplements is allowed in Slovakia.

Under Directive No. 2002/46/EC and under Decree No. 16826/2007-OL, the labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.

Further under the Decree No. 16826/2007-OL, the labelling, offering and advertising of food supplements shall not include any information which claims or gives the impression that a balanced and varied diet does not generally provide an adequate amount of nutrients.

Finally, according to the Slovak Act No. 147/2001 Coll. on advertising, the advertising must not present the foodstuffs and foods supplements as if they had the effects of medicinal products.

Public Health Authority of the Slovak Republic is the competent authority/official supervisory body in relation to food supplements.

Placing on the market a food supplement, which does not fulfil the legal requirements, is sanctionable by a fine of EUR 100 – EUR 100,000.

No upcoming future developments in this field that we are aware of.

Cosmetic devices do not fall under the definition of cosmetic products.

Regulation of some cosmetic devices without an intended medical purpose is contained in the following legislation:

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“Regulation on Medical Devices”);
• Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (“Implementing Regulation”).

General product safety requirements are stipulated in the Slovak Act No. 281/2023 Coll. on general product safety (“General Product Safety Act”).

As from 13 December 2024, new EU general product safety regulation will become directly effective in Slovakia:

• Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (“GPSR”).

According to the Regulation on Medical Devices, manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. Micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

Each economic operator placing the products on the market is responsible for their safety under the General Product Safety Act.

Under the GPSR a product covered by the GPSR shall not be placed on the market unless there is an economic operator (within the meaning of the Regulation (EU) No. 2019/1020) established in the EU who is responsible for the tasks set out in Article 4(3) of the Regulation (EU) No. 2019/1020 (concerning declaration of conformity or declaration of performance and technical documentation and cooperation with market surveillance authorities) as well as the tasks under the GPSR.

The common specifications for each of the groups of products without an intended medical purpose stated in Annex XVI to the Regulation on Medical Devices, contained in the Implementing Regulation, address the application of risk management and, where necessary, clinical evaluation regarding safety.

All cosmetic devices must also comply with the general product safety requirements under the General Product Safety Act; as from 13 December 2024 they will have to comply with the general product safety requirements under the GPSR.

In relation to the advertising, the Regulation on Medical Devices prohibits to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

1. ascribing functions and properties to the device which the device does not have;
2. creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
3. failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
4. suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

The advertising of cosmetic devices must also comply with the general requirements under the Slovak Act No. 147/2001 Coll. on advertising.

The Slovak Trade Inspection carries out supervision pursuant to the General Product Safety Act. It is entitled to request from economic operators all necessary information, to take samples of products and to arrange tests of compliance with obligations; fines imposed by the Slovak Trade Inspection vary from EUR 50 to EUR 30 000, depending on the gravity, extent, consequences and time of the infringement.

Damaging a consumer, while causing the consumer at least minor damage (damage exceeding EUR 700), by lying on the quality, quantity or weight of goods, or by introducing products to the market with concealed material defects, could qualify for a criminal offence under the Slovak Act No. 300/2005 Coll., the Criminal Code.

GPSR will become effective on 13 December 2024.

• Slovak Act No. 576/2004 Coll. on health care, services related to the provision of health care and on amendment and supplementation of certain acts (“Health Care Act”)
• Slovak Act No. 355/2007 Coll. on the Protection, Promotion and Development of Public Health (“Act on Public Health”).

There is no national law that would prohibit individuals under the age of 18 from receiving a non-surgical cometic services.

However, the Health Care Act orders the informed consent be obtained from the patient when a procedure is conducted by a healthcare professional within a healthcare facility. For minors, informed consent must be provided by a legal guardian.

Yes, BT is subject to medical prescription.

Under the Act No. 362/2011 Coll. on medical products and medical devices, a medical doctor and a dentist who provides health care is authorised to prescribe, dispense and administer human medicine products and medical devices.

The administration of BT is authorized exclusively for medical doctors with the appropriate medical specialty, and it must be performed within a medical facility.

Rules in this regard depend on whether the facility is classified as a medical facility or as premises providing only cosmetic, non-invasive, services (mesotherapy, microneedling, laser, LED and IPL skin treatments etc.) classified only as beauty salons.

Medical facilities

Cosmetic (non-surgical) services involving for example the application of BT or hyaluronic acid may only be performed in medical facilities that operate with the approval of the competent self-governing region or the Ministry of Health of the Slovak Republic. According to the Act on Public Health, the operation of such premises is also subject to the decision of the Regional Office of Public Health (“ROPH”).

• These authorities may carry out surveillance in the medical facility in accordance with the Act on Public Health.
• Control of compliance with the legal rules in the field of aesthetic medicine is the responsibility of the Health Care Supervision Authority (“HCSA”), which results from the Act No. 581/2004 Coll. on health insurance companies, supervision over health care and on amendment and supplementation of certain acts, and from the Health Care Act.

Beauty salons

• A beauty salon does not require a formal decision from the ROPH to begin operations. However, the salon must submit a notice of commencement to the ROPH, along with its operating rules, which should detail the services to be provided.
• Nonetheless, if the salon intends to offer laser treatments, it must submit an application for commissioning to the ROPH, including the technical documentation of the laser equipment.

When addressing complaints, it is also important to distinguish the type of service involved:

Healthcare services

For services provided in a healthcare facility, such as medical procedures, complaints should be directed to the HCSA, which is responsible for overseeing the quality and safety of medical care, addressing issues such as malpractice, professional misconduct, or patient safety.

Cosmetic services

In cases where the service pertains to cosmetic treatments, particularly involving a breach of hygiene regulations, complaints should be submitted to the ROPH, which monitors compliance with health and safety standards in establishments offering cosmetic or personal care services.

Control activities are conducted through state health supervision to ensure compliance with the provisions of the Act on Public Health.

Where the Health Care Supervision Authority finds misconduct in the health care provided, it may impose sanctions, make proposals for the imposition of sanctions to other competent authorities, impose measures to remedy the deficiencies found or impose an obligation to take measures to remedy the deficiencies found.

Depending on the severity of the deficiencies identified and their impact, the authority may impose a fine of up to EUR 3,319 on a healthcare provider who is an individual or EUR 9,958 in the case of a legal entity. Additionally, it may impose a prohibition on practicing the healthcare profession for up to one year.

Slovak Act No. 147/2001 Coll. on advertising (“Advertising Act”) establishes the general conditions for advertising as well as specific guidelines for certain areas, such as special requirements for advertising pharmaceuticals (including pharmaceuticals containing BT).

Further rules on the advertising of pharmaceuticals and medical devices (including dermal fillers, body sculpting equipment, body hair removal devices etc.) are contained in the Slovak Act No. 362/2011 on medical products and medical devices.

According to the Advertising Act, not only the advertiser may be liable for advertising, but also the provider of the communication medium.

However, according to the Code of Ethics for Advertising Practice, the advertiser, the provider of the communication medium and also advertising agency are jointly responsible for compliance with the Code of Ethics for Advertising Practice according to the degree of their fault. It should be noted, however, that the Code of Ethics for Advertising Practice is not legally binding.

The Ministry of Health of the Slovak Republic has announced the registration of a proposal for a new certified specialization. This specialization will focus on surgical, physical, and chemical treatment methods designed to correct congenital and acquired skin appearance defects, as well as to prevent premature aging and reduce its visible effects. This certified specialization will be integrated into the medical education system through upcoming legislation, following a consensus among healthcare practitioners.