1. Cosmetics & Supplements 
    1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?  
    2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
    3. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
    4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
    5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging? 
    6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?  
    7. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products.
    8. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 
    9. Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?  
    10. Do the regulations in your jurisdiction specify what can and cannot be put in supplement products? If so, what are some examples of these restrictions?
    11. Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
    12. Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards before being place in the market? If so, are there any exceptions/particular extra requirements for certain products?
    13. Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?
    14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging? 
    15. Is the advertising and promotion of Supplements allowed in your jurisdiction? If so, under what conditions? Are there any specific requirements or regulations for advertising and promotion?
    16. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regards to the supply of supplements
    17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
  2. Beauty devices
    1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
    2. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic devices and their safety placed on the market?
    3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
    4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations? 
    5. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
    6. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 
  3. Cosmetic (non-surgical) services
    1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
    2. Are there any rules in your national law which prevent an individual under the age of 18 (or other age as relevant) from receiving a particular non-surgical cosmetic service?
    3. Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
    4. Does the (national) law require that businesses and/or practitioners administering these services register with a centralised body? Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services?
    5. Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above. 
    6. Are there any national laws or regulations which are relevant to the advertising of non-surgical cosmetic services? If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?
    7. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 

Cosmetics & Supplements 

1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?  

Cosmetic products are regulated under Government Decree 246/2013 (VII. 2.) on Cosmetic Products, which implements the EU regulations. Specifically, this includes:

  • Regulation (EC) No 1223/2009 on cosmetic products.
  • Commission Regulation (EU) No 655/2013 on claims made for cosmetic products.

Cosmetic products are defined as “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” in Regulation (EC) No 1223/2009. Hungarian law does not have an alternative definition.

Substances and mixtures intended for ingestion, inhalation, injection, or implantation are not classified as cosmetics (Regulation (EC) No 1223/2009 Article 2 (2)).

Products intended for medical purposes are classified as medicinal products and are subject to different regulations. Medicinal products are those which are presented as having properties for treating or preventing disease in human beings or which may be used or administered with a view to restoring, correcting, or modifying physiological functions through pharmacological, immunological, or metabolic action. Such products require marketing authorisation from the relevant regulatory authority, the National Center for Public Health and Pharmacy (NCPHP) to determine if a product is medicinal (Article 1(2), Article 6 of Directive 2001/83/EC, Government Decree 246/2013 (VII. 2.) § 3).

The assessment of the classification of a product as a cosmetic product shall be carried out on a case-by-case basis, taking into account all the characteristics of the product.

2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?

Restrictions on Particular Substances in Cosmetic Products

Hungary adheres to Regulation (EC) No 1223/2009 on cosmetic products, which specifies which substances are prohibited or restricted in cosmetic products. The restriction applies to the maximum permissible quantity, in some cases to the area of use, product type and cleanliness requirements. Prohibited substances are listed in Annex no. II., active substances in Annex no. III., dyes in Annex no. IV., preservatives in Annex no. V., and UV filters in Annex no. VI. of Regulation (EC) No 1223/2009.

Examples of restricted substances include certain colorants, preservatives, and UV filters, which must adhere to the specified limits in these annexes. For instance, products containing hydroquinone are prohibited due to safety concerns, while certain preservatives like parabens have limits on their concentration.

Treatment of Cosmetic Products with Active Ingredients

Cosmetic products containing "active" ingredients, such as acids, retinoids, and their derivatives, are subject to specific guidelines:

  • Concentration Limits: Annex III of Regulation (EC) No 1223/2009 specifies the allowable concentrations for various active ingredients. For example, higher concentrations of alpha hydroxy acids (AHAs) and beta hydroxy acids (BHAs) are often restricted to professional use due to their potential for irritation or adverse effects at higher levels.
  • Government Decree 246/2013 (VII. 2.) incorporates these guidelines and ensures that products with potent active ingredients are labeled with appropriate usage instructions and warnings to safeguard consumer health. 

Home vs. Professional Use

Hungarian regulations do not explicitly differentiate products by use in primary legislation, but:

  • Concentration Restrictions: Higher active ingredient levels are often reserved for professional use.
  • Safety Measures: Professional products require detailed instructions and warnings.

For compliance and safety, Act LXXXVIII of 2012 on Market Surveillance of Products and Government Decree 6/2013. (I. 18.) on the Detailed Rules for Market Surveillance Activities apply, with oversight from the NCPHP.

3. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?

All cosmetic products available to consumers must have a designated responsible person who ensures that safety measures are followed and legal obligations are met (Article 4 of Regulation (EC) No 1223/2009): 

  • Manufacturer: The individual or entity responsible for the cosmetic product’s formulation and production.
  • Importer: The individual or entity established within the EU responsible for placing the product on the EU market.
  • Distributor: An individual or entity who markets the product in the EU market, other than the manufacturer and the importer.
  • an appointed company or person (who is named by the manufacturer or the importer).

The responsible person may be a legal or natural person designated within the EU.

If a cosmetic product is manufactured within the Community and is not subsequently exported and imported back into the Community, the manufacturer shall be the responsible person, or the manufacturer may, in writing, designate another person established within the Community as the responsible person.

In the case of imported cosmetic products, the importer shall be the responsible person, or the importer may, in writing, designate a person established within the Community as the responsible person.

The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?

Good Manufacturing Practice: The manufacture of cosmetic products shall comply with good manufacturing practice. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.

Safety Assessment: All cosmetic products must undergo a safety assessment before being placed on the market. The product's safety must be evaluated by a qualified expert, and the findings must be documented in a Cosmetic Product Safety Report (CPSR). 

Cosmetic Product Safety Report (CPSR): The CPSR documents the safety of the product, considering its intended use and foreseeable methods of application. Special attention is required for products designed for children under the age of three and for those intended for intimate areas. 

Registration and Notification: Manufacturers must notify the authorities before placing the product on the market and maintain proper records containing all relevant product information.

Labelling and Information: The EC Regulation strictly regulates the labelling of cosmetic products.

Product Liability and Market Surveillance: Manufacturers and distributors are responsible for ensuring that products meet safety standards. Authorities conduct market surveillance to verify compliance and take measures to protect consumers when necessary. 

Regulatory Enforcement: The decree outlines the procedures for regulatory inspections and the sanctions applicable to non-compliant products. Authorities may order the recall of products from the market or prohibit their sale if they do not meet safety requirements.

5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging? 

Making cosmetic products safe for users also covers how a cosmetic product is presented. It must:

  • not be mistaken for food,
  • have clear labelling,
  • have instructions on use and disposal.

The labelling for cosmetic products must be easy to read. The container and any packaging must be labelled with:

  1. the name and address of the responsible person;
  2. the nominal content at the time of packaging, given by weight or volume, except in the case of packaging containing less than five grams or millilitres, free samples and single-application packs;
  3. the date of minimum durability;
  4. particular precautions to observed in us;
  5. the batch number of manufacture or the reference number identifying the product;
  6. the function of the cosmetic product, unless it is clear from its presentation;
  7. the list of ingredients (this may be indicated on the packaging alone).

Points b), c), d) and f) must be indicated in Hungarian (Government Decree 246/2013 (VII. 2.) §1).

In case of not pre-packaged cosmetic products and cosmetic products packaged at the time of purchase at the buyer’s request or pre-packaged for immediate sale, points a), c), d), f) and g) must be indicated on the packaging in indelible, easily legible and visible lettering (Government Decree 246/2013 (VII. 2.) §2).

6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?  

Article 20 of Regulation (EC) No 1223/2009 on cosmetic products requires that in the marketing of cosmetic products, every Responsible Person must ensure that the wording of any claim in relation to a cosmetic product does not imply that the product has a characteristic or function which it does not have. In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

Article 1 (1) of Commission Regulation (EU) No 655/2013 Laying Down Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products: outlines the common criteria that claims made regarding cosmetic products must meet, ensuring that claims are substantiated and that consumer deception is prevented.

In general, any advertising material or communication must be in compliance with the requirements of EC directive 2006/114 on misleading and comparative advertising.

Section 6 (1) of Act XLVII of 2008 on the Prohibition of Unfair Commercial Practices against Consumers prohibits unfair commercial practices, particularly those that deceive consumers. All claims made in the advertising of cosmetic products must be substantiated to avoid misleading consumers. 

Non-binding sources of law, recommendations in Hungarian jurisdiction: 

NCPHP Guide on the Criteria for Claims Regarding Cosmetic Products:

this guide provides detailed guidelines on how claims related to cosmetic products must be substantiated and proven. Compliance with the guide is mandatory when advertising cosmetic products.

The Hungarian Code of Advertising Ethics:

  • Any cosmetic products’ claims must be supported by adequate and appropriate evidence demonstrating the performance of a product by experimental studies, consumer perception tests, or the use of published information.
  • Digital techniques may be used to enhance the beauty of images to convey brand personality and positioning or any specific product benefit.
  • The use of pre- and post-production techniques such as styling, re-touching, lash inserts, hair extensions, etc., should abide by the following principles:
    • The advertiser should ensure that the illustration of a performance of an advertised product is not misleading (see Product Claim Substantiation).
    • Digital techniques should not alter images of models such that their body shapes or features become unrealistic and misleading regarding the performance achievable by the product.
    • Pre- and post-production techniques are acceptable provided they do not imply that the product has characteristics or functions that it does not have.
  • Testimonials and specialist recommendations may be used to emphasise the characteristics of cosmetic products and create a brand image. Testimonials from  celebrities,  private  persons  or  consumers,  etc.,  maybe  used  provided  they  are presented as a personal assessment or impression of a product.
  • Testimonials should not be considered as proof of product efficacy that can only be established on the basis of adequate and appropriate evidence.
  • Recommendations from medical, para-medical or scientific specialists (referred to as “specialist(s)”) on an ingredient, a product, or a general message on hygiene or beauty, is acceptable provided they are established on the basis of adequate and appropriate evidence. Such specialists must be selected on the basis of their qualifications, expertise or experience in the particular area.

7. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products.

Article 22 of the Regulation (EC) No 1223/2009 on cosmetic products requires market surveillance authorities to ensure that products comply with the relevant regulations. This in-market control means that market surveillance authorities check of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples. Market surveillance authorities also monitor compliance with the principles of good manufacturing practices.

In case of non-compliance:

  • A competent authority must request the Responsible Person to take all appropriate measures to ensure compliance with the regulation, including corrective actions, product withdrawal, or recall, within a specified time limit when non-compliance is identified.
  • If the Responsible Person fails to take the necessary measures within the specified time or if immediate action is required to prevent a serious risk to human health, the authority has the power to take direct measures to halt the product's distribution, withdraw it from the market, or recall it from consumers.
  • The competent authorities are empowered with all necessary legal tools to prevent further distribution or sale of the non-compliant product if the Responsible Person does not fulfil their obligations.
  • Where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.

Section 14 of Act XLVII of 2008 on the Prohibition of Unfair Commercial Practices against Consumers similarly authorizes the Hungarian Competition Authority (GVH) to take enforcement actions against misleading advertising and other unfair practices in the market.

Failure to comply with these regulations may result in significant penalties, including fines or other sanctions, as stipulated under the relevant laws.

There is potential criminal liability for non-compliance with the regulations governing cosmetic products in Hungary.

Criminal Liability:

Non-compliance with corrective actions mandated by market surveillance authorities, especially if it involves serious risks to human health, can lead to legal consequences. In cases of false advertising, if it is found that misleading claims have caused significant consumer harm or were made with intent to deceive, criminal charges may be pursued under Hungarian law.

Complaint Process:

Complaints regarding false advertising can be made to the Hungarian Competition Authority (GVH), as provided by Section 14 of Act XLVII of 2008 on the Prohibition of Unfair Commercial Practices against Consumers. The GVH is responsible for investigating such complaints and can impose penalties, including fines. Additionally, if the case involves potential criminal conduct, it may be escalated to law enforcement authorities for further action.

8. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 

The EU Green Deal and the EU chemicals strategy for sustainability triggered a targeted revision of the EU Cosmetics Regulation. To date, the proposal has not been released yet.  At this point, there is no clear timeline, and we might have to wait until 2027 or 2028 for the adoption of the targeted revision of the EU Cosmetics Regulation.

Even though the European Commission proposal for a target revision has not been published yet, we already know what topics will be included. Among them, there are the following:

  • Strengthened customs enforcement by linking the CPNP with customs IT systems. It will allow an automatic check on cosmetics imported within the European Union.
  • General ban on endocrine disruptors category 1, according to the system established for CMR substances category 1 in Article 15. Additionally, specific provisions on respiratory sensitizers of category 1 and STOTS (Specific Target Organ Toxicity).
  • Inclusion of digital labelling.
  • Reallocation of the Scientific Committee on Consumer Safety (SCCS) within ECHA.
  • Adaptation of the EU Cosmetics Regulation to the Lisbon Treaty, allowing the European Commission to adopt delegated and implementing acts in place of the comitology procedure.

9. Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?  

According to the European Union regulations in force in our country, dietary supplements are foods that serve to supplement the traditional diet and contain nutrients or other substances with a nutritional or physiological effect in a concentrated form, individually or in combination. Their form of appearance can be a capsule, lozenge, tablet, bag containing powder/syrup, ampoule containing liquid, dropper bottle, or other similar form, which is suitable for dosing small amounts of powder or liquid.

Pursuant to ESZCSM decree 37/2004. (IV.26.) on dietary supplements, nutrients are vitamins or minerals. In the territory of Hungary, only dietary supplements complying with the provisions of the aforementioned regulation can be marketed, exclusively for the final consumer in pre-packaged form.

The key regulations are:

EU regulation:

  1. 2015/2283 EU Regulation on novel foods;
  2. 1924/2006 EU Regulation on nutrition and health claims made on foods;
  3. 432/2012 Commission Regulation on establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health;
  4. 1925/2006 EU Regulation on the addition of vitamins and minerals and of certain other substances to foods;
  5. 1169/2011 EU Regulation on the provision of food information to consumers;
  6. 609/2013 EU Regulation on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control;
  7. 2016/127 Commission Delegated Regulation on supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding.

Supplements in Hungary are governed by the following regulations:

  1. ESZCSM Decree 37/2004 (IV. 26.) on the production, distribution, and control of food supplements;
  2. ESZCSM Decree 36/2004 (IV. 26.) on food intended for special nutritional purposes;
  3. ESZCSM Decree 35/2004 (IV. 26.) on processed cereal-based food intended for infants and young children;
  4. EÜM Decree 20/2008 (V.14.) on infant formula and follow-on formula;
  5. NEFMI Decree 55/2011 (IX.20.) on the addition of vitamins and minerals and of certain other substances to foods.

10. Do the regulations in your jurisdiction specify what can and cannot be put in supplement products? If so, what are some examples of these restrictions?

ESZCSM Decree 37/2004 (IV. 26.) on the production, distribution, and control of food supplements precisely records the range of vitamins and minerals that can be used in dietary supplements, as well as their compounds that can be used, and also determines the minimum amount of these in the daily dose of the product (15% of the recommended daily intake). The upper safe level/tolerable upper level of intake (UL- Upper Level, i.e. the upper tolerable level of vitamins and minerals) is the maximum amount of vitamins/minerals which, with regular daily intake from all sources, is not likely to affect health adverse or harmful effect. The UL is a physiologically tolerable value determined as a result of scientific judgment, determined by risk estimation. The UL values are the basis for determining the maximum vitamin/mineral amounts allowed in dietary supplements and fortified foods. The latter work is already underway at the EU level.

Plants not recommended for use in dietary supplements:

Given that a dietary supplement is also food, it has become necessary to review the information on the (medicinal) plants and other substances most often found in foods (including dietary supplements) based on an accurate, developed professional framework. As a result of the review, a list (continuously updated from time to time) was created by the Hungarian supervisory authority, which includes components whose use in food (including food supplements) - based on their effects on the human body - poses a public health risk. Regarding this, the list also plays a role in the risk assessment process of dietary supplements. The list is not just an attention-grabber, but a professionally well-grounded guide ("soft law") that helps manufacturers/distributors/market surveillance authorities/consumers find their way around. However, it is important to point out that if a plant is not on this list, it does not mean that its use in food (including dietary supplements) is considered safe. In any case, it is the responsibility of the manufacturer to make sure of the safety of the plant not included in the list before use and to be able to prove it with scientific data. The assessment of the safety of plants not included in the list must be evaluated individually and will continue to be evaluated individually by the Hungarian supervisory authority.

11. Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?

Yes, the manufacturers and the first Hungarian distributors of dietary supplements are solely responsible for the safety, quality and labelling of the products. Therefore, it is their duty to produce food supplements in an appropriate manner and to ensure that they do not contain any physical, chemical or microbiological contaminants, and that their labelling comply with the relevant legal requirements. This responsibility is outlined in the following regulation:

Act LXXXVIII of 2012 on the Market Surveillance of Products:

The economic operator (manufacturer, authorised representative, importer, logistics provider) is responsible for ensuring that the products it places on the market meet the requirements.

12. Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards before being place in the market? If so, are there any exceptions/particular extra requirements for certain products?

In accordance with the EU Dietary Supplements Directive, with the entry into force of the ESZCSM decree 37/2004. (IV. 26.), the prior mandatory authorisation has been abolished and instead there is only the so-called notification obligation. The Hungarian supervisory authority selects the products that need to be investigated further based on a subsequent risk assessment only after the supplement is placed on the market.

13. Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?

No, there is no such obligation, except for the documents required for the notification procedure (application form, label and certificate of payment of the administrative service fee).

14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging? 

Yes, the following requirements must be applied regarding labelling and packaging:

  • the exact name of the product, which must include the term "dietary supplement"
  • list of ingredients (must be listed in descending order of quantity)
  • net quantity and/or number of pieces
  • expiry date of quality preservation period, special storage required to preserve quality or terms of use
  • instructions for use, if necessary for proper use
  • the recommended daily consumption amount (as well as a warning that the consumer should not exceed this amount)
  • the nutrients (vitamins, minerals) in the product's daily dose, as well as nutritional and quantity of substances with a physiological effect (the amount of vitamins and minerals must also be indicated as a percentage of the recommended daily intake (NRV)
  • Mandatory warnings: (1) the dietary supplement does not replace a mixed diet, and (2) the product must be kept out of the reach of small children.

15. Is the advertising and promotion of Supplements allowed in your jurisdiction? If so, under what conditions? Are there any specific requirements or regulations for advertising and promotion?

It is possible to indicate and highlight a claim regarding nutritional composition and health, which however:

  • cannot be untrue, ambiguous or misleading
  • must not cast doubt on the safety and/or nutritional suitability of other foods
  • it is prohibited to encourage or approve the excessive consumption of the product
  • it is prohibited to state, suggest or imply that a balanced and varied diet usually does not provide adequate amounts of nutrients
  • it may not refer to the physical either textually or through pictorial, graphic or symbolic representation to changes in functions that may cause fear in the consumer and prevent him/her from using them the consumer's fear.

What is not allowed?

  • it is not possible to indicate a disease-preventing or curative effect, or such a property cannot even be implied
  • the labelling, presentation and advertising of dietary supplements shall not state or imply that a varied and balanced diet is not adequate to provide the necessary nutrients
  • statements suggesting that not consuming the product may have an adverse effect on health
  • statements referring to the rate or amount of weight loss.

16. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regards to the supply of supplements

The legality of the distribution of the products is continuously checked by the local authority's specialists within the framework of the annual control plan and targeted controls. If there is a serious problem with the food supplement, the manufacturer/distributor has ana reporting obligation towards the supervisory authority.

The Hungarian supervisory authority carries out a risk assessment of the products notified to it (please see Q 12 above), checking the compliance of the ingredients with the legislation and the labelling and marking of the products. During the risk assessment, when information found about a preparation posing a risk to public health (labelling error, composition error) forwards the data of the preparation in question to the district health authority responsible for the place of residence of the notifier. During an on-the-spot inspection, the district office establishes the fact of the violation of the law and takes measures to correct the error in a decision and, in the case of non-compliance with the composition, orders the prohibition of distribution.

17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?

None at the moment.                  


Beauty devices

1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?

In Hungary, cosmetic products are not regulated by Regulation (EC) No 1223/2009 or Government Decree 246/2013. (VII. 2.), both of which deal specifically with the regulation of cosmetic products. Instead, cosmetic devices are regulated by the Act LXXXVIII of 2012 on the Market Surveillance of Products. This Act stipulates that all cosmetic products must comply with the established safety standards before being placed on the market.

The NCPHP is the regulatory authority responsible for ensuring that cosmetic products comply with the safety guidelines. The NCPHP requires these products to be safe for consumer use, to be accompanied by comprehensive documentation detailing their safety requirements, and to be registered with the Cosmetic Product Notification Portal (CPNP).

2. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic devices and their safety placed on the market?

Section 3 of Act LXXXVIII of 2012 on the Market Surveillance of Products requires manufacturers to comply with EU safety regulations, which include cosmetic devices. NCPHP specifically supervises cosmetic device manufacturers to ensure that the products they produce are manufactured, sold and used in a safe manner. 

NCPHP provides guidelines and carries out inspections in accordance with Government Decree No. 6/2013. (I. 18.), which details the specific rules of market surveillance, including inspection criteria to ensure product safety and compliance.

3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?

There are currently no specific regulations for cosmetic devices in Hungary. Therefore, the safety requirements for cosmetic devices fall within the scope of the general product safety regulation of the EU. Certain regulations and requirements for electrical equipment also apply to cosmetic devices (e.g. laser hair removal devices).  

Likewise to all products in circulation in the EU, cosmetic devices must bear the “CE” marking to certify that a product meets all legal requirements. The NCPHP oversees cosmetic devices manufacturers and certifies that the products are indeed safe.  

4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations? 

Act XLVIII of 2008 on the Conditions and Certain Restrictions on Commercial Advertising sets out the advertising regulations in Hungary, namely the ethical and fair competition practices in marketing. The Hungarian Competition Authority (GVH) oversees the advertising and marketing laws and enforces compliance with the Advertising Act. Cosmetic devices are subject to the same general advertising regulations that apply to all products in Hungary.  

5. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?

The Market Surveillance Act, in addition to the soft law regulations issued by the NCPHP, act as administrative regulations, which means that there is no specific criminal liability in case of non-compliance. 

The enforcement measures of the NCPHP include the power to enter manufacturing premises and carry out inspections, to request technical documents and to require formal registrations. 

Failure to comply with these and other such requirements may result in penalties and fines, forced product recalls. In the most serious cases of non-compliance with safety regulations, there is the possibility of legal action, i.e. civil lawsuits by affected consumers. 

6. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 

As an EU member state, Hungary continues to align itself with EU regulations. As Hungary continues to align with EU standards, developments in product safety and consumer protection are likely. 

Similarly, the EU's focus on sustainability through the Green Deal is likely to encourage Hungary to further align with EU regulations and improve sustainability standards (regarding the environmental impact of cosmetic products). 


Cosmetic (non-surgical) services

1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?

 In Hungary, cosmetic treatments, which are performed primarily for aesthetic purposes, are not regulated by specific legislation to ensure safety and compliance. These treatments include a range of procedures such as lip fillers, semi-permanent makeup, and various skin care techniques.

The most commonly used legislation relevant to the regulation of cosmetic treatments in Hungary includes:

  1. Government Decree 246/2013. (VII. 2.) on Cosmetic Products: This decree regulates the market and use of cosmetic products. It outlines requirements for the safety, composition, and labelling of cosmetic products, which are important for treatments involving these products.
  2. ESZCSM Decree 6/2004. (II. 10.): This decree provides methods for examining the composition of cosmetic products, ensuring that treatments involving such products are performed with safe and approved substances.
  3. EMMI Decree 42/2014. (VIII. 19.) on Good Laboratory Practice: This decree ensures that laboratories conducting tests related to cosmetic treatments follow good laboratory practices, which is crucial for validating the safety and efficacy of treatments involving devices such as lasers and IPL.
  4. Act LXXXVIII of 2012 on the Market Surveillance of Products: This law deals with market surveillance of products, including cosmetic products, ensuring that they meet the required safety standards.

In Hungary, practitioners performing cosmetic procedures with technologies such as IPL or lasers must adhere to these regulations to ensure the safety and quality of their treatments. While there is no specific licensing regime for IPL or laser treatments alone, compliance with these general cosmetic and safety standards is mandatory.

Below are the specific regulations and their references for each type of service:

  1. Botulinum toxins / Fillers: Act LXXXVIII of 2012 on the Market Surveillance of Products: This law deals with market surveillance and could apply to claims related to cosmetic products and treatments.
  2. Vitamin drips and injections: Act LXXXVIII of 2012 on the Market Surveillance of Products: Similar to botulinum toxins, this law governs aspects of market surveillance which may impact the regulation of such treatments.
  3. Weight loss injections: Act LXXXVIII of 2012 on the Market Surveillance of Products: This law applies to the monitoring and regulation of product claims and may be relevant for weight loss injections.
  4. Laser, LED and IPL skin treatments: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: This decree regulates cosmetic treatments, including those involving lasers, LEDs, and IPL.
  5. Microneedling: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: This decree covers microneedling as part of its regulations on cosmetic products and procedures.
  6. Mesotherapy: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: This decree also includes regulations for mesotherapy under its provisions for cosmetic treatments.
  7. Chemical Skin Peels: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: Chemical skin peels are regulated under this decree as a cosmetic treatment.
  8. Micro dermabrasion: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: This treatment is included in the regulations for cosmetic products under this decree.
  9. Dermarolling / Dermaplaning: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: Both dermarolling and dermaplaning are regulated under this decree.
  10. Professional Skin Lightening: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: Professional skin lightening treatments are governed by this decree.
  11. Infrared Skin Treatments: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: Infrared skin treatments fall under the regulations of this decree.
  12. Vampire Facials/Platelet-Rich Plasma (PRP): Act LXXXVIII of 2012 on the Market Surveillance of Products: While PRP is more of a medical treatment, aspects of its regulation may intersect with market surveillance laws.
  13. Whole Body Cryotherapy:  Government Decree 246/2013 (VII. 2.) on Cosmetic Products: Whole body cryotherapy is included under this decree as a cosmetic treatment.
  14. Semi-permanent Make Up: Government Decree 246/2013 (VII. 2.) on Cosmetic Products: Regulations for semi-permanent makeup are also found within this decree.

2. Are there any rules in your national law which prevent an individual under the age of 18 (or other age as relevant) from receiving a particular non-surgical cosmetic service?

No. In Hungary, while there is no specific legislation directly prohibiting non-surgical cosmetic procedures for individuals under 18, general consumer protection laws must be adhered to. According to Act XLVIII of 2008 on the Conditions and Certain Restrictions on Commercial Advertising, commercial practices targeting minors are subject to stricter scrutiny, particularly in the context of advertisements that are able to harm the physical, psychological development of minors. Parental consent is required for minors, and service providers must ensure that they adhere to ethical standards and avoid any practices that could be deemed misleading or harmful to younger consumers.

3. Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?

Yes, in Hungary, botulinum toxin (BT) is classified as a prescription-only medicine. Such products can only be prescribed and administered by qualified healthcare professionals, typically medical doctors with relevant specializations, such as dermatology. The prescriber must have the appropriate medical training and must ensure that the administration of BT complies with both the safety standards outlined in the Government Decree and ethical guidelines provided by professional bodies such as the Hungarian Dermatological Society.

The Ethical Guidelines of the Hungarian Dermatological Society and the Medical Professional Ethical Code prohibit the prescription of BT via remote consultations, ensuring that all such prescriptions are based on a thorough in-person medical examination. Furthermore, these guidelines emphasize the importance of administering BT in a safe, controlled environment, as required by Act CLIV of 1997 on Health (§ 120).

4. Does the (national) law require that businesses and/or practitioners administering these services register with a centralised body? Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services?

In Hungary, there is no specific national requirement for businesses or practitioners administering non-surgical cosmetic services to register with a centralized body solely dedicated to this sector. However, relevant regulations and oversight mechanisms are in place to ensure compliance with safety and quality standards.

Oversight and Complaints:

  • The National Center for Public Health and Pharmacy (NCPHP) is responsible for overseeing cosmetic products and ensuring compliance with safety regulations. OGYÉI handles issues related to the safety and compliance of cosmetic products and can address complaints related to misleading claims and product standards as specified in Government Decree 246/2013 (VII. 2.).
  • Act XLVII of 2008 on the Prohibition of Unfair Commercial Practices against Consumers also provides a framework for addressing complaints related to unfair commercial practices, including those associated with non-surgical cosmetic services.

Medical Practitioners:

  • For procedures that require medical expertise, such as certain non-surgical cosmetic treatments, medical professionals must adhere to broader healthcare regulations. They must be licensed and registered with the appropriate medical authorities, following the standards set by the Medical Chamber and other relevant bodies.
  • Members of these associations can be removed for breaching the professional codes of conduct.

While there is no specific centralized registration requirement for cosmetic service providers, compliance with product safety regulations and consumer protection laws is enforced by NCPHP and other relevant authorities. Complaints regarding non-surgical cosmetic services can be directed to these bodies for resolution.

If you have any concerns about a medical or aesthetic practice, salon, clinic, or individual practitioner, you should contact the National Center for Public Health and Pharmacy (NCPHP) or the National Consumer Protection Authority.

5. Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above. 

  1. Government Decree 246/2013 (VII. 2.) on Cosmetic Products:
    The National Center for Public Health and Pharmacy (NCPHP) oversees the enforcement of this decree. NCPHP is responsible for ensuring that cosmetic products meet safety, labelling, and efficacy requirements. Non-compliance can result in sanctions such as fines, product recalls, or market withdrawal.
  2. ESZCSM Decree 6/2004 (II. 10.) on Methods for Testing Cosmetic Product Composition:
    Compliance with this decree is monitored by NCPHP. The authority ensures that testing methods for cosmetic products are applied correctly. Violations may lead to administrative actions, including penalties or mandatory corrections.
  3. EMMI Decree 42/2014 (VIII. 19.) on Good Laboratory Practice (GLP):
    The enforcement of GLP standards falls under the jurisdiction of NCPHP. This includes supervising laboratories to ensure adherence to GLP. Non-compliance can lead to sanctions such as the suspension of laboratory certifications or legal actions.
  4. Act LXXXVIII of 2012 on the Market Surveillance of Products:
    This act is enforced by market surveillance authorities which ensure that products, including cosmetics, comply with regulatory standards. These authorities have the power to conduct inspections, impose fines, and order product withdrawals if necessary.
  5. Government Decree 6/2013 (I. 18.) on the Detailed Rules of Market Surveillance Activities:
    This decree outlines the specific procedures for market surveillance. Local authorities and the National Consumer Protection Authority (NFH) are involved in enforcing these rules, conducting investigations, and addressing non-compliance issues.
  6. Act XLVII of 2008 on the Prohibition of Unfair Commercial Practices Towards Consumers:
    The National Consumer Protection Authority (NFH) is responsible for monitoring and enforcing this act. It addresses issues related to misleading advertising and unfair commercial practices, with the authority to impose fines and mandate corrective actions.
  7. Regulation (EC) No 1223/2009 on Cosmetic Products:
    Compliance with this EU regulation is managed by national authorities, such as NCPHP, in coordination with EU regulatory bodies. Enforcement includes market inspections and penalties for non-compliance.
  8. Commission Regulation (EU) No 655/2013 on Common Criteria for Cosmetic Product Claims:
    This regulation is enforced by national authorities, including NCPHP, which ensure that claims made about cosmetic products are substantiated. Non-compliance can result in regulatory actions such as fines or product removal.

Enforcement mechanisms include inspections, fines, product recalls, and legal actions administered by NCPHP, local authorities, the National Consumer Protection Authority, and in coordination with EU regulatory bodies.

6. Are there any national laws or regulations which are relevant to the advertising of non-surgical cosmetic services? If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?

Act XLVII of 2008 sets out advertising regulations in Hungary, namely detailing ethical and fair competition practices in marketing. The advertising and marketing laws are overseen by the Hungarian Competition Authority (GVH), who enforce compliance to the advertising law.  

Cosmetic devices are subject to the same general advertising regulations that apply to all products in Hungary.  

7. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 

No, however, should EU legislation be subject to reforms, Hungarian legislation must also be updated to be in line with EU rules.