CMS Expert Guide on Beauty in Slovenia

Under Regulation (EC) No 1223/2009, a cosmetic product is defined based on its function, area of application, and composition:

• Function: Includes cleaning, perfuming, changing appearance, protecting, keeping in good condition, and correcting body odors.
• Area of Application: Applied to external parts of the body (skin, hair, nails, teeth, etc.).
• Composition: Can be a single substance or a mixture, used alone or in combination.

Products intended to be ingested, inhaled, injected, or implanted are not classified as cosmetics. For example, aromatherapy oils not intended for skin application are excluded.

Under Medicinal Products Act (Zakon o zdravilih; ZZdr-2), medicinal products are defined by their purpose and method of action:

• Purpose: Any substance or combination of substances presented with properties for the treatment or prevention of disease in humans or animals.
• Method of action: Any substance or combination of substances which may be used in, or administered to, human beings or animals with the intention of restoring, improving or modifying physiological functions through pharmacological, immunological or metabolic action, or of establishing the diagnosis of a disease.

Medicinal products in Slovenia require marketing authorization from Agency for Medicinal Products and Medical Devices of the Republic of Slovenia  (JAZMP). Examples of such medicinal products are: products treating acne, dermatitis, or other medical conditions, shampoos claiming to treat itchy scalp or alleviate dermatitis symptoms, etc.

The intended use and claims made about the product are crucial in determining classification. Cosmetic products focus on appearance and hygiene, while medicinal products target treatment and prevention of diseases.

Regulatory Oversight: Cosmetics are regulated for safety and labeling, whereas medicinal products undergo rigorous testing and approval processes to ensure efficacy and safety.

The primary distinction lies in the intended use and claims made about the product. Products aimed at treating or preventing medical conditions are regulated as medicinal products, while those intended for external application to improve appearance or hygiene are considered cosmetic products. For example, a face cream marketed to improve skin texture is a cosmetic product but a cream claiming to treat eczema is a medicinal product.

Yes, Regulation (EC) No 1223/2009 places restrictions on particular substances in cosmetic products. The regulation includes several annexes that list prohibited and restricted substances.

Examples of restricted substances are hydroquinone (restricted due to potential skin depigmentation effects), formaldehyde (restricted because of its classification as a carcinogen) and parabens (certain types are restricted due to concerns over endocrine disruption).

Cosmetic products with active ingredients such as acids (e.g., salicylic acid, glycolic acid) and retinoids (e.g., retinol, retinol derivatives) are subject to specific concentration limits and usage conditions outlined in Annex III. These ingredients are allowed but regulated to ensure safety for consumers.

Regulation (EC) No 1223/2009 does not explicitly distinguish between products intended for home use and those for professional use. However, all cosmetic products, regardless of their intended use, must comply with the regulation’s safety, labelling, and composition requirements.

All cosmetic products, including those with active ingredients, must undergo a safety assessment by a qualified professional to ensure they are safe for use under normal or reasonably foreseeable conditions.

Regulation (EC) No 1223/2009 requires a designated responsible person or entity to ensure that cosmetic products placed on the market are safe and compliant with regulatory standards. This responsible person must ensure product safety, maintain proper documentation, and comply with notification and reporting obligations.

The obligations of the responsible person are (a) ensuring that the product is safe for human health when used under normal or reasonably foreseeable conditions; (b) verifying that the product complies with the relevant requirements of the regulation, including ingredient restrictions and labelling; (c) maintaining a product information file for each cosmetic product, which includes detailed information on the product, its ingredients, safety assessment, and manufacturing methods; (d) notifying the product to the European Commission via the Cosmetic Products Notification Portal (CPNP) before placing it on the market; and (e)  monitoring and reporting any serious undesirable effects to the competent authorities.

In Slovenia, the implementation and enforcement of Regulation (EC) No 1223/2009 is overseen by the Health Inspectorate and the Chemicals Office, which may conduct inspections and request documents from the responsible person to verify compliance with the Regulation.

The regulation ensures that all cosmetic products are safe for human health when used under normal or reasonably foreseeable conditions, so the cosmetic products in Slovenia must pass stringent safety assessment standards before they can be placed on the market. This includes conducting a thorough safety assessment by a qualified assessor, maintaining a comprehensive product information file (PIF), and ensuring proper notification and compliance with regulatory requirements.

According to the Regulation, the responsible person must compile and maintain a PIF for each cosmetic product. The PIF includes the safety assessment, product description, cosmetic product safety report (CPSR), method of manufacture, proof of effect claimed for the product, and data on any animal testing performed.

The CPSR is the key component of the PIF and is divided into two parts, safety information and safety assessment. The former addressed details on the qualitative and quantitative composition of the product, physical/chemical characteristics, microbiological quality, impurities, traces, packaging material, normal and reasonably foreseeable use, exposure to the product, and toxicological profile of ingredients. The safety assessment is an evaluation and conclusion on the product’s safety based on the data provided in the safety information. The safety assessment must be signed by the safety assessor.

Before placing a cosmetic product on the market, the responsible person must notify the product to the European Commission through the Cosmetic Products Notification Portal (CPNP). The notification includes information on the product’s formulation and the responsible person.

National authorities in Slovenia (the Health Inspectorate) are responsible for market surveillance and ensuring compliance with safety standards. They can inspect the PIF and other documentation to verify adherence to the regulations.

The packaging of cosmetic products in Slovenia must include precise and clear information to ensure user safety and compliance with regulatory requirements. This information includes details about the responsible person, net content, date of durability, special precautions for use, warnings, batch number, product function, list of ingredients, and, where applicable, the country of origin.

In Slovenia, the marketing and promotion of cosmetic products are governed by both national laws and European Union regulations to ensure that advertisements are truthful, not misleading, and substantiated by evidence. Advertisers must comply with the Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1), Regulation (EC) No 1223/2009 and specific regulations on the labelling and advertising of cosmetic products. These regulations protect consumers and ensure fair competition in the market. In addition, the rules of the Slovenian Advertising Code, a self-regulatory tool in the advertising industry, apply to marketing and promotion of cosmetic products, which are otherwise not legally binding.

When making claims about cosmetic products, it is essential to ensure that the claims are truthful, not misleading, and supported by adequate evidence. Regulation (EC) No 1223/2009, along with other relevant laws and guidelines, outlines the types of claims that can be made, and the evidence required to support them. Here are the key points:

Types of claims that are allowed:

• Efficacy claims (claims about the product's effectiveness, such as "reduces wrinkles," "moisturizes for 24 hours," or "improves skin elasticity.")
• Functionality claims (claims related to the product's intended use, such as "cleanses deeply," "protects against UV rays," or "exfoliates dead skin cells.")
• Ingredient claims (claims highlighting specific ingredients, such as "contains hyaluronic acid," "with natural aloe vera," or "enriched with vitamins.")
• Safety claims (claims about the safety of the product, such as "dermatologically tested," "hypoallergenic," or "safe for sensitive skin.")
• Environmental and ethical claims (claims regarding the environmental impact or ethical considerations, such as "eco-friendly packaging," "not tested on animals," or "sustainable sourcing.")

Evidence, required to support the claims made, may be in the form of a scientific study, consumer testing study, documentation and studies that show the benefits of specific ingredients used in the product, safety assessments conducted by qualified professionals that ensure the product is safe for use

All claims must comply with the common criteria for cosmetic claims outlined in Regulation (EC) No 655/2013, which provides guidelines on how to substantiate claims to avoid misleading consumers. PIF should include all supporting evidence for claims, safety assessments, and compliance documentation and be readily available for inspection by regulatory authorities.

In Slovenia, the enforcement of cosmetic product regulations involves a combination of inspections, market surveillance, and review of product documentation by authorities:

• The Chemicals Office, the Health Inspectorate and JAZMP (for medicinal products) are the main authorities responsible for the oversight and enforcement of cosmetic products regulations in Slovenia. They ensure that cosmetic products on the market comply with safety, labelling, and advertising requirements.
• The Market Inspectorate monitors compliance with consumer protection laws, including those related to misleading advertising and unfair commercial practices.
• National Institute of Public Health (NIJZ) may also be involved in monitoring and assessing the safety of cosmetic products, particularly in relation to public health concerns.

Regular inspections of cosmetic products and facilities are conducted by the Health Inspectorate and the Market Inspectorate to ensure compliance with regulatory standards. These inspections can be random or based on specific complaints or reports of non-compliance. The Health Inspectorate may also request to review the PIF for any cosmetic product to verify that all safety assessments and supporting documentation are in place. Continuous market surveillance activities are carried out to monitor the compliance of products available on the market. This includes checking labeling, claims, and packaging. 

If a product is found to be non-compliant or poses a risk to public health, the Chemicals Office and JAZMP have the authority to order the recall or withdrawal of the product from the market. Non-compliance can result in administrative penalties and, in severe cases, criminal liability. Complaints about false advertising or regulatory breaches can be directed to these authorities, who will investigate and take appropriate action to ensure compliance and protect consumers.

Non-compliance can result in administrative penalties, which may include fines (ranging from EUR 500 to EUR 50,000 depending on the severity and nature of the violation), orders to rectify non-compliance, or prohibitions on the sale of the offending product. Serious violations may result in higher fines and additional sanctions to deter future non-compliance.

While the primary response to non-compliance with cosmetic regulations involves administrative penalties, there can be criminal liability for severe breaches, especially if they result in harm to consumers – individuals or entities that intentionally or negligently place unsafe products on the market, provide false information, or fail to comply with safety standards may face criminal charges.

Complaints about false advertising or non-compliance with cosmetic regulations can be submitted to the Market Inspectorate or the Health Inspectorate, as well as JAZMP for medicinal products. Consumers, competitors, or other stakeholders can file complaints if they believe a product is falsely advertised or does not meet regulatory standards. Upon receiving a complaint, the relevant authority will investigate the issue. If the complaint is found to be valid, the authority can take enforcement action, including ordering corrective advertising, imposing fines, or removing the product from the market.

Due to the nature of cosmetics, there are several trends that are expected to trigger further changes in the cosmetics regulation and rules:

1. Increased focus on ingredient safety and transparency – As new cosmetic ingredients are developed, regulatory bodies are expected to update the lists of approved, restricted, and banned substances. This includes stricter scrutiny on the safety of nanomaterials, preservatives, and other chemical compounds. There may be increased requirements for transparency regarding the sourcing, safety testing, and environmental impact of ingredients used in cosmetics.
2. Sustainability – Regulations on promotion of the use of sustainable and recyclable packaging materials to reduce environmental impact are becoming more stringent. Green Claims Directive is bringing new guidelines for environmental, and sustainability claims to ensure they are substantiated and not misleading (e.g., claims of "biodegradable," "organic," or "natural").
3. Enhanced consumer protection – Improved mechanisms for reporting and monitoring adverse effects from cosmetic products to ensure timely action and updates to safety standards, and stricter advertising rules.
4. Ban on animal testing – Emphasis on banning animal testing for cosmetics and promoting the development and validation of alternative testing methods.
5. Regulation of customized products – Personalized and custom-made cosmetics are gaining popularity, regulations should evolve to address safety, labeling, and marketing.

In Slovenia, a “supplement” product is classified as a food supplement. Food supplements are defined as concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form (such as capsules, tablets, powders, or liquids).

Applicable regulations:

1. EU regulations:
   • Regulation (EC) No 1924/2006 on nutrition and health claims made on foods governs the use of nutrition and health claims made on food, including food supplements.
   • Directive 2002/46/EC on the approximation of the laws of Member States relating to food supplements harmonizes the regulations for food supplements across the EU. It sets out rules on labelling, the use of vitamins and minerals, and the maximum and minimum amounts allowed.
   • Regulation (EC) No 1169/2011 on the provision of food information to consumers governs labelling of food products, including food supplements.
2. National Legislation:
   • Rules on Food Supplements (Pravilnik o prehranskih dopolnilih) implements the EU directives and regulations and provides specific guidelines for the Slovenian market. It covers aspects such as permissible ingredients, labelling requirements, and notification procedures.
   • Act on the health suitability of foodstuffs, products and substances coming into contact with foodstuffs (Zakon o zdravstveni ustreznosti živil in izdelkov ter snovi, ki prihajajo v stik z živili;  ZZUZIS) ensures the health suitability of food products, including supplements, and sets out safety standards and inspection procedures.

Slovenian regulations, aligned with EU directives, clearly specify what can and cannot be included in supplement products to ensure consumer safety. These regulations cover permissible ingredients, recommended daily dosage, prohibited substances, and safety requirements:

• Directive 2002/46/EC on the approximation of the laws of Member States relating to food supplements sets the framework for the composition of food supplements, particularly focusing on vitamins and minerals. Only vitamins and minerals listed in the directive can be used in supplements, and these must be in forms that are bioavailable and safe for consumption.
• Rules on Food Supplements (Pravilnik o prehranskih dopolnilih) implements the EU directive and provides specific guidelines for Slovenia. It includes lists of permissible vitamins, minerals, and other substances.

Examples of restrictions:

Vitamins and minerals:

• Only certain forms of vitamins and minerals are allowed. For example, calcium can be included as calcium carbonate, calcium citrate, etc.
• There are upper limits for vitamins and minerals to prevent excessive intake.

Prohibited substances:

• Certain herbal ingredients are restricted or prohibited due to potential health risks. For example, ephedra (Ephedra sinica) is banned because of its association with serious cardiovascular events.
• Some artificial additives are restricted or must comply with specific conditions. For instance, the use of certain artificial colors is limited or banned in supplements.

Bioavailability and safety:

• The forms of vitamins and minerals used must be bioavailable and safe for consumption. For example, chromium picolinate is an approved form of chromium, while other forms may not be permitted due to bioavailability or safety concerns.
• Supplements must not contain contaminants like heavy metals, pesticides, or other harmful substances above specified limits. There are stringent purity criteria to ensure consumer safety.

Other Bioactive Substances:

• Plant sterols and stanols can be included in supplements but must adhere to specific labelling and usage conditions to ensure they are used safely and effectively.
• There are guidelines on the types and amounts of amino acids and enzymes that can be included in supplements to prevent adverse effects.

In Slovenia supplements must comply with the general food safety regulations, which require that all foods, including food supplements, placed on the market must be safe for consumption. This means that food supplement must not contain substances in a form or amount that would pose a risk to human health. The Health Inspectorate conducts regular monitoring and inspections to ensure compliance with regulations and to verify that products on the market are safe and correctly labelled.

In Slovenia the food business operator (natural or legal person) is responsible for the safety and compliance of food supplements placed on the market. This includes ensuring regulatory compliance, maintaining proper documentation, monitoring product safety, and providing accurate information to consumers. All food business operators with a registered seat in Slovenia must register with the Health Inspectorate.

Slovenian law requires that food supplements undergo rigorous safety assessments before being placed on the market. These assessments ensure that supplements are safe for consumption and meet established quality standards. Specific products, such as those containing novel foods or certain botanical ingredients, may have additional requirements.

Safety and quality control:

• Each ingredient used in the supplement must be evaluated for safety and efficacy. This includes assessing the bioavailability and potential health impacts of the ingredient.
•  Safety assessments must include toxicological data to ensure that the ingredients do not pose a risk to health at the levels used in the supplement.
• Supplements must adhere to established recommended levels for vitamins and minerals as specified in Directive 2002/46/EC, Regulation 1169/2011 and national regulations.

If a supplement contains ingredients classified as novel foods (i.e., ingredients not widely consumed in the EU before 15 May 1997), it must undergo a separate safety assessment and authorization process by the European Food Safety Authority (EFSA) before being marketed.

Certain botanical ingredients may have additional safety assessment requirements due to their potential health impacts. These requirements can include providing detailed toxicological data and evidence of traditional use.

Slovenian law requires the responsible entity to keep detailed records in relation to supplements made available to customers. These records are essential for ensuring compliance with safety, quality, and regulatory standards, as well as for facilitating transparency and traceability:

1. Product Information File (PIF) needs to include a comprehensive list of all ingredients used in the supplement, including their quantities and sources, documentation of safety assessments conducted for each ingredient and the final product, detailed records of the manufacturing process, including the methods used, quality control measures, and compliance with Good Manufacturing Practices,  labelling information and information on the stability of the product, including shelf life and storage conditions.
2. Regulatory compliance documentation:
   1. Copies of any relevant certificates, such as organic certifications, third-party testing results, and approvals for health claims.
3. Batch records:
   1. Detailed records of each production batch, including batch numbers, production dates, and quantities produced.
   2. Results of quality control tests conducted on each batch to ensure consistency and safety.
4. Traceability records:
   1. Information on all suppliers of raw materials, including contact details and certification of the materials’ compliance with regulatory standards.
   2. Details of the distribution network, including the entities to which the supplements are supplied, and the quantities distributed.
5. Adverse event reports:
   1. Records of any consumer complaints related to the product, including the nature of the complaint and the actions taken to address it.
   2. Documentation of any reported adverse effects linked to the product, along with investigations conducted and outcomes.
6. Marketing materials:
   1. Copies of all marketing and advertising materials used to promote the product, ensuring they comply with regulations on health claims and do not mislead consumers.
   2. Records of any promotional activities, including events, sponsorships, and partnerships.

There are specific labelling and packaging requirements for supplements in Slovenia, aligned with both EU regulations and national legislation. These requirements ensure that consumers receive clear, accurate, and essential information about the supplements they purchase.

The following information should be included in labelling/packaging:

• Product name and description: The name of the product and the word "prehransko dopolnilo" (food supplement) must be prominently displayed.
• Ingredients list: A comprehensive list of all ingredients in descending order of their weight. This includes active substances, excipients, and any additives used in the supplement.
• Nutritional information: The amounts of vitamins, minerals, or other substances with a nutritional or physiological effect must be expressed in numerical form. This information should include the percentage of the recommended daily allowance where applicable.
• Recommended daily dose: Clear instructions on the recommended daily dose and a statement not to exceed the recommended dose.
• Warnings such as: “Prehransko dopolnilo ni nadomestilo za uravnoteženo in raznovrstno prehrano.” (Food supplement is not a substitute for a balanced and varied diet.) and “Shranjujte nedosegljivo otrokom.” (Keep out of reach of children.) Additional warnings related to specific ingredients or populations, if necessary.
• Storage instructions: Information on proper storage conditions, such as temperature, humidity, and protection from light.
• Net quantity: the net quantity of the product, expressed in weight or volume for liquids, and in the number of units (capsules, tablets, etc.) for solid forms.
• Manufacturer and importer information: The name and address of the manufacturer, packer, or importer established within the European Union.
• Batch no. and expiry date: A batch number for traceability and an expiry date indicating the minimum durability of the product.
• Health claims: Any health or nutritional claims made on the label must comply with Regulation (EC) No 1924/2006 on Nutrition and Health Claims and must be authorized and substantiated by scientific evidence.
• Instructions for use: Clear instructions on how to use the product, including the method of consumption and any preparation required.
• Allergen Information: If the product contains any allergens, these must be clearly indicated in accordance with Regulation (EU) No 1169/2011 on the provision of food information to consumers.

Advertising and promotion of supplements are allowed in Slovenia. However, there are specific requirements and regulations that must be followed to ensure compliance with Slovenian law. The advertising and promotion of supplements in Slovenia are primarily governed by the following laws and regulations:

• the Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1);
• the Medicinal Products Act (Zakon o zdravilih; ZZdr-2);
• the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods;
• the Act on the health suitability of foodstuffs, products and substances coming into contact with foodstuffs (Zakon o zdravstveni ustreznosti živil in izdelkov ter snovi, ki prihajajo v stik z živili; ZZUZIS)).

Any health claims made in advertising must be authorized and listed in the EU Register of nutrition and health claims. Claims that are misleading, false, or not scientifically substantiated are prohibited. All claims made in the advertising of supplements must be truthful and supported by scientific evidence. Advertisers should be prepared to provide evidence substantiating any claims made about the supplement. Advertising must not imply that supplements can prevent, treat, or cure diseases. Such claims are reserved for medicinal products and are not allowed for food supplements. Advertising materials must include specific information to ensure that consumers are adequately informed. This includes: (a) the name and address of the manufacturer or distributor, (b) the fact that supplements should not be used as a substitute for a varied diet, (c) a statement advising that the recommended daily dose should not be exceeded, (d) a warning to keep the product out of the reach of children.

The same rules apply across all advertising channels, including print media, online advertising, television, and radio.

The Health Inspectorate, the Market Inspectorate  and other relevant authorities monitor and enforce compliance with these regulations. Non-compliance can result in fines and other penalties.

Future developments in the field of supplements in Slovenia could be influenced by broader trends within the European Union and global regulatory changes, such as stricter regulation of health claims, increased focus on safety and quality, online advertising regulations, ESG, personalized nutrition and supplements, innovation and new ingredients.                 

Slovenia regulates cosmetic devices separately from cosmetic products. While cosmetic products fall under specific regulations concerning their formulation, labelling, and safety, cosmetic devices are subject to different regulatory frameworks focused on their functionality, safety, and efficacy. The primary regulations applicable to cosmetic devices in Slovenia are:

• Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri) which implements the EU Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and governs the placement of medical devices on the market, their safety, and performance.
• General Product Safety Act (Zakon o splošni varnosti proizvodov; ZSVP-1) which ensures that all products, including cosmetic devices, meet general safety requirements.
• Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1) which provides guidelines on consumer rights, including information, safety, and fair-trading practices.

The main regulatory body responsible for managing cosmetic devices in Slovenia is the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). JAZMP oversees the regulation, approval, and monitoring of medical devices to ensure they meet safety and efficacy standards.

Distinguishing between cosmetic and medical devices

Cosmetic devices are devices intended for cosmetic purposes, such as improving appearance, skin texture, or hair removal, without therapeutic or diagnostic claims. According to the EU MDR and the Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri), medical devices are defined as instruments, apparatus, appliances, software, implants, reagents, materials, or other articles intended for medical purposes, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease.

Some of the devices might be considered medical devices if they are intended for therapeutic purposes or have a significant impact on the body's functions, e.g.:

• microneedling tools may be classified as medical devices if they are intended to treat scars, acne, or other medical conditions ;
• laser hair removal devices may be classified as medical devices if they claim permanent hair removal or treatment of hirsutism;
• radio frequency and microcurrent devices may fall under medical device regulations if used for purposes beyond cosmetic enhancement, such as skin tightening for medical conditions.

General product safety rules

In the absence of specific regulations for cosmetic devices, they must adhere to the General Product Safety Act. This ensures that all products placed on the market are safe for use and do not pose any risk to consumers when used under normal or reasonably foreseeable conditions.

Manufacturers of cosmetic devices must:

• Ensure that their products meet safety and quality standards.
• Provide clear instructions for use and warnings about potential risks.
• Conduct risk assessments and maintain technical documentation.
• Report any incidents or safety issues to the relevant authorities.

The law in Slovenia requires that a person or entity be responsible for the safety of cosmetic devices placed on the market. This responsibility is outlined under the regulatory framework governing medical devices and general product safety.

Legal responsibility under the Medical Devices Act

The Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri) mandates that there must be a responsible person or entity for the safety and compliance of medical devices, including cosmetic devices that fall under this regulation.

Manufacturers are responsible for ensuring that their devices comply with applicable regulations. This includes performing conformity assessments, maintaining technical documentation, and ensuring the device meets safety and performance standards. If the manufacturer is not based in the EU, they must appoint an authorized representative within the EU to act on their behalf in relation to regulatory obligations. This representative must be clearly identified on the device's labelling and documentation. Importers and distributors also have specific responsibilities, such as verifying that the device has the required CE marking, that it is accompanied by the necessary documentation, and that the manufacturer and authorized representative are identified.

Legal responsibility under the General Product Safety Act

The General Product Safety Act (Zakon o splošni varnosti proizvodov; ZSVP-1) applies to all consumer products, including cosmetic devices not classified as medical devices. Under this act both producers (i.e. manufacturers, importers, and anyone presenting themselves as the producer) and distributors are responsible for ensuring that products placed on the market are safe.

Producers must ensure that the products are safe under normal or reasonably foreseeable conditions of use.  They must provide consumers with relevant information to assess the inherent risks and to take precautions and undertake measures to monitor the safety of products and report any incidents to the relevant authorities. If a product is found to be unsafe, they must take corrective actions, such as product recalls or withdrawals.

In Slovenia, cosmetic devices must pass safety assessment standards to ensure they are safe for consumer use. Devices classified as medical devices must comply with the EU Medical Devices Regulation (MDR), including performing conformity assessments and obtaining CE marking. For other cosmetic devices, the General Product Safety Act (Zakon o splošni varnosti proizvodov; ZSVP-1) mandates safety assessments and adherence to relevant standards. The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) and the Market Inspectorate are the regulatory bodies responsible for ensuring compliance with these safety standards.

Medical Devices Regulation (MDR) compliance

For cosmetic devices that fall under the definition of medical devices, compliance with the EU Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) is mandatory. The MDR sets stringent safety and performance requirements, including:

• Manufacturers must perform a conformity assessment to demonstrate that their devices meet the essential safety and performance requirements. This involves, risk management and clinical evaluation, testing and validation to ensure that the device performs as intended without posing any risk to users, and ensuring compliance with relevant harmonized standards.
• Devices must bear the CE marking, indicating that they comply with EU safety, health, and environmental requirements. The CE marking process involves preparation of technical documentation and potentially involvement of a notified body to conduct a conformity assessment.
• Manufacturers must maintain comprehensive technical documentation, including device description and specifications, design and manufacturing information, safety and performance data, risk analysis and mitigation measures.
• Continuous monitoring of the device's performance and safety once it is on the market (i.e. the post-market surveillance). This includes reporting incidents and taking corrective actions if necessary.

General Product Safety compliance

For cosmetic devices not classified as medical devices, the General Product Safety Act (Zakon o splošni varnosti proizvodov; ZSVP-1) applies.

Under the General Product Safety Act, producers must carry out a safety assessment to ensure that the product does not pose any risk to health and safety when used under normal or reasonably foreseeable conditions. This includes:

• identifying potential hazards;
• assessing the likelihood and severity of risks;
• implementing measures to mitigate identified risks.

In addition to the above, compliance with relevant European and international standards can help demonstrate that the product meets safety requirements. These standards provide specific guidelines for testing and performance criteria.

There are specific laws and regulations in Slovenia that govern the marketing and promotion of cosmetic devices, ensuring that advertising is truthful, not misleading, and provides adequate information to consumers.

Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1)

The Consumer Protection Act sets out general principles for advertising and marketing, including those related to cosmetic devices:

• Advertisements must be truthful and not misleading. This means that all claims made about the cosmetic device must be accurate and substantiated by evidence.
• Advertisements must provide clear and understandable information to enable consumers to make informed decisions. This includes the device's purpose, benefits, and any potential risks.
• The law prohibits deceptive practices, including false claims about the effectiveness or benefits of a cosmetic device.

Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri)

For cosmetic devices that fall under the classification of medical devices, additional advertising regulations apply under the Medical Devices Act:

• Advertising must not be misleading regarding the device's intended use, effectiveness, or safety.
• Any claims made in advertising must comply with the requirements of the MDR, including those related to clinical evaluation and evidence of performance.
• Certain types of medical devices may have restrictions on direct-to-consumer advertising, particularly if they require professional application or supervision.

General Product Safety Act (Zakon o splošni varnosti proizvodov; ZSVP-1)

The General Product Safety Act also influences advertising practices by ensuring that products placed on the market, including cosmetic devices, are safe and that consumers are adequately informed about any risks. Advertisements must include relevant safety information, warnings, and instructions for use to ensure consumer safety.

Slovenia also has an Advertising Code that sets out ethical standards for advertising. It is overseen by the Slovenian Advertising Chamber and includes provisions for honesty, social responsibility, and respect for consumer rights. It also includes specific provisions for advertising of beauty and health products.

Market Inspectorate  monitors compliance with advertising regulations and can take enforcement actions against misleading or false advertising. JAZMP oversees the advertising of medical devices and ensures compliance with MDR and other relevant regulations.

The enforcement mechanism for compliance with regulations regarding the supply of cosmetic devices in Slovenia involves several regulatory bodies and legal frameworks. Non-compliance can lead to administrative penalties, and in certain cases, there can be criminal liability.

Regulatory bodies

•  JAZMP is responsible for the oversight of medical devices, including cosmetic devices that fall under this category. JAZMP monitors the market, conducts inspections, ensures compliance with the Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri), and takes action against non-compliance. They can issue warnings, require corrective actions, withdraw products from the market, and impose fines for non-compliance.
• Market Inspectorate  oversees the general safety and compliance of consumer products, including cosmetic devices. It conducts market surveillance, investigates complaints, and ensures that products comply with the General Product Safety Act (Zakon o splošni varnosti proizvodov; ZSVP-1) and the Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1). The Inspectorate can impose fines, order product recalls, and take legal action against non-compliant entities.

Enforcement mechanisms

• Routine inspections: regulatory bodies conduct routine inspections of manufacturers, importers, and distributors to ensure compliance with safety standards and regulatory requirements.
• Complaint investigations – authorities investigate complaints from consumers or other entities regarding the safety or compliance of cosmetic devices.

Administrative penalties

• Fines – the amount of the fine depends on the severity of the violation and the specific regulation breached;
• Product recalls – authorities can order the recall of unsafe or non-compliant products from the market to protect consumers.
• Corrective actions – entities may be required to take corrective actions, such as modifying product labelling, providing additional information, or improving safety measures.

Reporting and compliance

• Manufacturers, importers, and distributors are required to report any incidents or safety issues related to their cosmetic devices to JAZMP.
• Entities are encouraged to establish compliance programs to ensure ongoing adherence to regulatory requirements and to promptly address any potential issues.

In certain cases, non-compliance with regulations can result in criminal liability, particularly if it involves serious breaches of safety standards or fraudulent practices. The Slovenian Criminal Code (Kazenski zakonik; KZ-1) provides for criminal liability for offenses related to consumer safety and fraudulent practices. Criminal penalties can include fines, imprisonment, and other legal sanctions, depending on the severity of the offense.

Any future developments in the regulation of cosmetic devices in Slovenia are likely to focus on greater alignment with EU regulations, addressing the challenges posed by digital health technologies, enhancing consumer protection and transparency, promoting sustainable and ethical practices, supporting innovation, and strengthening post-market surveillance.

In Slovenia, the administration of cosmetic (non-surgical) services is regulated under various national laws. Injectable treatments, laser and IPL therapies, microneedling, chemical peels, and other procedures are subject to specific regulations that require them to be performed by qualified professionals in appropriate settings. The Ministry of Health, JAZMP, and professional bodies play key roles in overseeing compliance and ensuring that these services meet regulatory standards. Cosmetic (non-surgical) services are generally regulated under a combination of healthcare, consumer protection, and professional practice laws:

• Healthcare Services Act (Zakon o zdravstveni dejavnosti; ZZDej) governs the provision of healthcare services, including certain cosmetic procedures, ensuring that they are performed by qualified professionals in appropriate settings;
• Medicinal Products Act (Zakon o zdravilih; ZZdr-2) regulates the use of medicinal products, including botulinum toxins and other injectable substances;
• Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri) implements the EU Medical Devices Regulation (MDR) and governs the use of medical devices such as lasers, IPL machines, and dermarollers;
• Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1) provides general protections for consumers, ensuring that services are provided safely and with adequate information.

Specific Regulations for Cosmetic Services

• Injectable Treatments (botulinum toxins, fillers, vitamin drips, and weight loss injections)
  These treatments must be administered by licensed healthcare professionals, such as doctors or trained nurses, in a clinical setting. The administration of injectable treatments is overseen by the Ministry of Health and relevant medical professional bodies. Injectables must be approved by the Agency for Medicinal Products and Medical Devices (JAZMP).
• Laser, LED, and IPL skin treatments
  Devices used for laser, LED, and IPL treatments must comply with the Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri) and the EU Medical Devices Regulation (MDR). They must be CE marked and meet safety standards. Practitioners must undergo specialized training and certification to operate these devices safely.
• Microneedling, mesotherapy, chemical skin peels, and microdermabrasion
  These procedures must be performed by trained and qualified practitioners, often requiring healthcare professionals or certified aestheticians. Equipment and products used in these procedures must comply with relevant safety regulations and standards.
• Dermarolling/dermaplaning, professional skin lightening, infrared skin treatments
  Practitioners must have appropriate training and certification. Some treatments may require medical supervision. Products used must comply with safety regulations, and any devices must be CE marked.
• Vampire facials/platelet-rich plasma (PRP)
  These treatments must be performed by medical professionals due to the invasive nature and use of blood products. Procedures must comply with healthcare regulations, and products used must be approved by JAZMP.
• Whole body cryotherapy
  Facilities offering cryotherapy must adhere to strict safety protocols to prevent risks associated with extreme cold exposure. Devices and equipment used must meet regulatory standards for safety and efficacy.
• Semi-permanent make-up
  Practitioners must be certified and trained in semi-permanent makeup application. The practice must adhere to strict hygiene and safety standards to prevent infections and complications.

Oversight and enforcement

The Ministry of Health oversees the implementation of healthcare regulations, including those applicable to cosmetic services to ensure that providers are licensed and that treatments are performed in accordance with safety standards.

JAZMP is responsible for the approval and monitoring of medicinal products and medical devices used in cosmetic procedures.

Medical and professional associations oversee the certification and practice standards of their members, providing guidelines, training, and certification for practitioners.

In Slovenia, there are specific rules and regulations that prevent individuals under the age of 18 from receiving certain non-surgical cosmetic services. These regulations are designed to protect minors from potentially harmful procedures and to ensure that any cosmetic treatments they do receive are medically justified and safe.

Healthcare Services Act (Zakon o zdravstveni dejavnosti; ZZDej) provides the general framework for medical and cosmetic procedures in Slovenia, emphasizing the need for appropriate medical justification and the protection of vulnerable populations, including minors. For any medical or cosmetic procedure on a minor, parental consent is required. This is a standard requirement to ensure that the minor's guardian is aware of and agrees to the treatment.

Specific regulations for cosmetic procedures

• Injectable are generally restricted for minors unless there is a strong medical justification, and they are performed under strict medical supervision with parental consent;
• Laser, LED, and IPL treatments are typically restricted for minors due to the potential risks and long-term effects. Parental consent and a strong medical justification are necessary for any exceptions;
• Microneedling, mesotherapy, chemical skin peels, and microdermabrasion treatments require parental consent and a valid medical reason for being performed on minors;
• Dermarolling/dermaplaning, professional skin lightening, infrared skin treatments are generally discouraged for minors and require parental consent and medical justification;
• Vampire facials/platelet-rich plasma (PRP) are typically not recommended for minors unless there is a compelling medical reason and parental consent.
• Whole body cryotherapy is generally not recommended for minors due to the potential health risks. Parental consent and a strong medical reason are necessary for exceptions.
• Semi-permanent make-up is often restricted for minors due to the permanent or semi-permanent nature of the results. Parental consent is required for any exceptions.

The Ministry of Health oversees the implementation and enforcement of healthcare regulations, including those related to cosmetic procedures. They ensure that procedures performed on minors comply with all legal requirements and are medically justified.

In Slovenia, botulinum toxin is classified as a prescription-only drug, and its prescription and administration are strictly regulated. Only qualified healthcare professionals, such as trained doctors and, in some cases, supervised nurses, are authorized to prescribe and administer botulinum toxin. These regulations are enforced by the Ministry of Health and the JAZMP to ensure the safe and effective use of botulinum toxin.

Under the Healthcare Services Act (Zakon o zdravstveni dejavnosti; ZZDej), all healthcare providers, including those offering non-surgical cosmetic services, be registered with the appropriate authorities. This ensures that only qualified and authorized professionals provide these services. Practitioners must hold a valid license to practice, which is issued by the relevant professional chamber or regulatory authority, such as the Medical Chamber of Slovenia for doctors.

Businesses offering non-surgical cosmetic services must register their facilities with the Ministry of Health or another relevant regulatory body.

The Ministry of Health, through its various departments and agencies, handles complaints related to non-surgical cosmetic services. This includes investigating complaints, enforcing regulations, and taking disciplinary actions if necessary.

Complaint mechanisms:

• Consumers can directly file complaints with the relevant regulatory bodies, such as JAZMP or the Ministry of Health. These complaints can pertain to the safety, quality, and ethical standards of the services provided.
• Professional chambers, such as the Medical Chamber of Slovenia, also handle complaints against their members. They investigate allegations of professional misconduct, malpractice, or breach of ethical standards. Professional chambers and regulatory bodies can impose disciplinary actions, such as suspending or revoking licenses, against practitioners found to be in violation of regulations.
• The Consumer Protection Act (Zakon o varstvu potrošnikov, ZVPot-1) provides additional mechanisms for consumers to file complaints about non-surgical cosmetic services. Consumer protection agencies and ombudsmen can assist in resolving disputes between consumers and service providers.

In Slovenia, the enforcement mechanisms for non-compliance with regulations related to non-surgical cosmetic services involve several key regulatory bodies and can result in various consequences:

• Ministry of Health oversees the overall regulation of healthcare services, including non-surgical cosmetic services.
•  JAZMP is responsible for the regulation and monitoring of medical devices and medicinal products used in non-surgical cosmetic procedures.
• Professional chambers, such as the Medical Chamber of Slovenia, regulate the conduct and practices of healthcare professionals.

Inspections

• Regulatory bodies conduct regular inspections of facilities and practitioners to ensure compliance with safety and hygiene standards.
• Targeted inspections may also be triggered by specific complaints or reports of non-compliance.

Administrative penalties

• fines, the amount of the fine can vary depending on the severity and nature of the violation;
• warning notices – regulatory bodies may issue formal warnings to non-compliant entities, requiring them to rectify issues within a specified timeframe;
• suspension of license – practitioners or businesses may have their licenses temporarily suspended if they are found to be in violation of regulations;
• revocation of license – In severe cases of non-compliance, licenses may be permanently revoked, prohibiting the entity or individual from providing non-surgical cosmetic services;
• product and service restrictions – unsafe or non-compliant products used in cosmetic procedures may be subject to recalls by JAZMP or Market Inspectorate;
• specific non-surgical cosmetic services may be prohibited if they are deemed unsafe or if the provider is non-compliant with regulations;
• regulatory bodies may publicly disclose the sanctions imposed on non-compliant entities, which can damage their reputation and business operations.

Criminal liability

In cases involving fraudulent practices, gross negligence, or actions resulting in significant harm to consumers, criminal charges may be brought against the responsible individuals. Criminal penalties can include imprisonment and substantial fines, depending on the severity of the offense.

There are national laws and regulations in Slovenia that are relevant to the advertising of non-surgical cosmetic services. They also apply to any third-party booking platforms that facilitate the booking of non-surgical cosmetic services. Below is an overview of the relevant laws and how they apply:

• Consumer Protection Act (Zakon o varstvu potrošnikov; ZVPot-1) which ensures that advertising must be truthful, not misleading, and must provide all necessary information for consumers to make informed decisions. Advertisements must also not contain false information or mislead consumers about the nature, characteristics, or benefits of the services.
• Healthcare Services Act (Zakon o zdravstveni dejavnosti; ZZDej) includes provisions that regulate the advertising of healthcare services, including non-surgical cosmetic procedures. It ensures that such advertising is ethical and does not exploit consumers' vulnerabilities.
• Medicinal Products Act (Zakon o zdravilih; ZZdr-2) regulates the advertising and promotion of medicinal products, including those used in non-surgical cosmetic procedures like botulinum toxin. It ensures that all claims are scientifically substantiated and not misleading.
• Medical Devices Act (Zakon o medicinskih pripomočkih; ZMedPri), implementing the EU Medical Devices Regulation (MDR), ensures that advertising of medical devices used in non-surgical cosmetic services is accurate and provides sufficient information about the safe use of these devices.

Ministry of Health oversees the advertising of healthcare services and ensures compliance with the Healthcare Services Act (Zakon o zdravstveni dejavnosti; ZZDej). JAZMP regulates the advertising of medicinal products and medical devices, ensuring that all promotional content meets safety and efficacy standards. Market Inspectorate monitors compliance with consumer protection laws and can take action against misleading or deceptive advertising.

Penalties for non-compliance:

• non-compliant advertisements can result in administrative fines for both service providers and third-party platforms;
• regulatory bodies may require corrective actions, such as modifying or removing misleading advertisements;
• in severe cases, legal action can be taken against entities that consistently violate advertising regulations.

Any future developments in the regulation of cosmetic services in Slovenia are likely to focus on greater alignment with EU regulations, specifically in relation to stricter advertising rules, greater focus on training and certification, consumer protection measures, updated safety and quality standards and regulation of new compounds and technologies.