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Cosmetics & Supplements
- How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
- Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
- 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?
- Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
- Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
- 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?
- 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.
- 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?
- 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?
- Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
- 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?
- 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?
- Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
- 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?
- 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
- Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
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Beauty devices
- Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
- 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?
- Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
- 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?
- 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.
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Cosmetic (non-surgical) services
- Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
- 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?
- Is botulinum toxin (BT) a prescription only drug in your jurisdiction?mIf so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
- 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?
- Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above.
- 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?
- 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.
jurisdiction
Cosmetics & Supplements
1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
The key applicable regulations in Austria that apply to cosmetic products are:
- Regulation (EC) No 1223/2009 on Cosmetic Products (Cosmetic-Regulation)
- Commission Regulation (EG) No 655/2013 on common criteria for the justification of claims used in relation to cosmetic products
- Austrian Cosmetic Implementation Regulation (BGBl. II Nr. 330/2013)
- Austrian Food Safety and Consumer Protection Act (LMSVG)
Additionally, the Austrian Food Codex (österreichisches Lebensmittelbuch) is an objective expert opinion which sets out regulations for food, organic cosmetics and natural cosmetics. The Codex is not legally binding, but is used to publish technical terms, definitions, test methods and assessment principles as well as guidelines for the manufacture and marketing of goods.
General regulations, such as the Austrian Unfair Competition Act (UWG) and the Austrian Product Liability Act (Produkthaftungsgesetz) are also applicable.
According to the Cosmetic-Regulation a ‘cosmetic product’ is 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.
Therefore, products that are intended for ingestion, inhalation, injection or are made for the implantation in the human body are not considered cosmetic products. For example, face masks, make-up products, perfumes or soaps are cosmetic products, whereas vitamin-pills are not considered cosmetics as they have to be ingested and are thus regarded as food products (see below).
E.g.: Face-Peelings are intended for the use on the body but are not always considered cosmetics. Depending on all characteristics, in particular the composition, the intended purpose and the depth of the peeling, it must be assessed how the peeling affects the normal skin physiology and its barrier function. Cosmetic products may remove dead cells and the uppermost layers of the skin, provided they do not significantly affect the normal skin physiology and barrier function. Exfoliants that expose deeper layers of the skin or lead to complete removal of skin layers have a significant effect on the skin physiology and its barrier function - Such products are not considered cosmetic products.
The determination whether a product is a cosmetic product must be made on a case-by-case basis, considering all characteristics of the product. A distinction must be made as to whether
- the product is a substance or a mixture
- it is applied externally on parts of the human body (skin, hair system, nails, lips and external intimate regions or teeth and mucous membranes of the oral cavity)
- the product has a cosmetic purpose (i.e. the exclusive or predominant purpose of cleaning, perfuming, changing the appearance, protecting, keeping in good condition or influencing body odor)
Medicinal products are substances or preparations of substances which are intended for use in or on the human body and as agents having properties for the cure or for the alleviation or prevention of human diseases or pathological conditions. Their purpose is to either restore, correct or influence physiological functions through a pharmacological, immunological or metabolic action, or serve as the basis for a medical diagnosis.
Organic cosmetics and natural cosmetics are subject to additional regulations, namely the Food Safety and Consumer Protection Act. Furthermore, Chapter B33 of the Austrian Food Codex is applicable.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
Yes. According to the Cosmetic-Regulation, there are generally prohibited substances in cosmetic products (Annex II), restricted substances (Annex III), as well as restrictions on certain colorants (Annex IV), preservatives (Annex V) and UV-fillers (Annex VI).
The restrictions set out in the regulation define rules for the general prohibition of certain chemicals, the maximum concentration of certain substances, and differentiations with regard to professional and private use.
For example CMR substances (substances classified as carcinogenic, mutagenic or toxic for reproduction) are generally prohibited for the use in cosmetics.
Active substances such as salicylic acid for example count as restricted substances. Such substances are restricted by a maximum concentration in cosmetics and depending on the substance in question, a distinction is made between general and professional use.
Retinols and equivalents are also restricted in the form of a maximum concentration (Annex V; currently 0,05 % in the finished product). In 2025, a new EU-Regulation on the maximum concentration of Retinol in cosmetics will enter into force, restricting the concentration of retinol in cosmetics to a maximum of 0,05 % for body lotions and to 0,03 % for cosmetics applicable on the face.
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?
Yes. According to Art 4 Cosmetic-Regulation, a “Responsible person” is required to make sure that all the safety measures for the product are followed and that the legal obligations are met for every cosmetic product that is placed on the market in the European Union.
The responsible person can be a natural or legal person, namely the manufacturer, the importer or (if they label the product as their own or modify a product already placed on the market in such a way that the compliance with the applicable requirements may be affected) the distributer of the product. The manufacturer or the importer can furthermore appoint another company or person as responsible person.
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
Yes. Before a cosmetic product is placed on the market, according to Art 10 and Annex I of the Cosmetic-Regulation a qualified safety assessor has to ensure that the cosmetic product has undergone a safety assessment on the basis of its relevant information and that a Cosmetic Product Safety Report (CSPR) is set up in accordance with Annex I of the regulation.
The safety information must cover all the essential characteristics of the cosmetic product and its ingredients that may be relevant to the safety of the product. Among other things, a toxicological assessment of the ingredients has to be carried out, considering the exposure conditions (application concentration, application duration, application site).
The CPSR provides evidence of how the product is safe for its intended cosmetic use and takes account of reasonably foreseeable use.
Depending on the cosmetic product a more specific safety assessment can be required.
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
In accordance with Article 19 of the Cosmetic-Regulation, the following information must be clearly visible, easily legible and indelible on the packaging and the container of the cosmetic product:
- Name and address of the responsible person
- Nominal content of the product (except for packs containing less than 5 g or less than 5 ml, free samples and single-use packs)
- Shelf life (Not mandatory for cosmetic products with a minimum durability of more than 30 months)
- Any precautions for use
- The function of the cosmetic product (unless it is clear from its presentation)
- Batch number
- Intended purpose
- Ingredients: May be indicated on the packaging alone. The ingredients shall be indicated using the common name of the ingredients as given in the glossary published in the Official Journal of the EU. Perfume and aromatic compositions as well as their raw materials must be referred to by the terms ‘parfum’ or ‘aroma’. All nanomaterials must be clearly indicated in the list of ingredients, and their names must be followed by the word ‘nano’ in brackets.
For small products, such as soap or bath balls where, due to their small size, it may not be possible to display the information mentioned above on the packaging, a notice must be displayed in close proximity to the product in order to ensure consumers have access to all the information required by law.
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
The advertising of claims must be useful, understandable and reliable and enable consumers to make an informed purchasing decision. The requirements for the advertising of cosmetic products are set out in Regulation (EC) No. 1223/2009 Article 20 "Advertising claims" and Regulation (EU) No. 655/2013 establishing common criteria for substantiating claims made in relation to cosmetic products.
According to these two regulations, the labeling, making available on the market and advertising of cosmetic products may not use texts, names, trademarks/brands, images and other figurative or non-figurative signs that suggest characteristics or functions that the products in question do not possess.
Regulation (EU) No. 655/2013 includes the following criteria for advertising claims:
Honesty: Claims about product effects must be evidence-based. It is not permitted to make claims that attribute special properties to a product if similar products have the same properties (Advertising with self-evident facts). If a product's effect depends on certain conditions, these must be explained accordingly.
Fairness: The admissibility of the advertising statement depends on how the average end consumer perceives the statement. Products cannot be advertised as having a specific benefit when they only meet the minimum legal requirements.
Sound decision-making: The advertising claims must be clear and understandable. The claims must contain information to enable an informed purchasing decision.
Marketing statements must be clear, precise, relevant and understandable for the target group.
Advertising claims must be supported by sufficient and verifiable evidence. Studies must be relevant to the product and the claimed benefit, be based on properly developed and applied methods (valid, reliable and reproducible) and take ethical considerations into account. The weight of evidence must be consistent with the nature of the claims made, particularly for claims where a lack of efficacy could cause a safety issue.
Properties of an ingredient that relate to the final product must be substantiated by sufficient and verifiable evidence such as proving an effective concentration of the ingredient in the product.
Environmental claims which are related to the cosmetic product must be justified in the same way as any other cosmetic product claims. Additionally, these claims hold a risk of non-compliance with the Unfair Commercial Practice Directive.
If a cosmetic product advertises that the product is intended to cure or alleviate or prevent human diseases or pathological conditions, it may fall under the definition of a medicinal product and will therefore have to comply with the relevant 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. Is there criminal liability for non-compliance?
According to Article 25 of the Cosmetic-Regulation, competent authorities must request the responsible person to take appropriate measures —such as correcting, withdrawing, or recalling the product—within a set timeframe based on the risk level, if there is non-compliance with the Cosmetic-Regulation.
If the responsible person fails to act within the given timeframe or if immediate action is needed to prevent serious risks to human health, the competent authority must take all appropriate measures to stop the product from going on the market, or to withdraw or recall the products if they are already on the market.
Article 27 of the Cosmetic-Regulation allows the competent authority to take provisional measures in the event of a reasonable concern or a serious risk to human health.
According to Article 26 competent authorities must also instruct distributors to take appropriate actions, such as correcting the product to meet standards, withdrawing it from the market, or recalling it, within a reasonable timeframe that reflects the risk, if there is non-compliance with the requirements set out in the Regulation.
Violations of the provisions on cosmetics regularly constitute a breach of Art 1 UWG (breach of law).
Violation of UWG may result in claims for injunctive relief, removal, damages and publication of judgements as well as reimbursement of costs. These claims may be asserted by competitors and consumer organisations.
In addition, the advertising or placing on the market of cosmetic products which do not comply with their intended use, or which bear misleading information or prohibited disease-related claims or are presented in a misleading or prohibited disease-related manner constitutes a breach of LMSVG. The violation of the LMSVG is an administrative offence and punishable with a fine of up to EUR 35,000 or up to EUR 70,000 in the event of a repeat offence. In the event of non-payment of the fine, the offender may be imprisoned for up to six weeks.
Furthermore, according to the LMSVG, the placing on the market of harmful cosmetic products can be a criminal offence with a penalty of up to one year's imprisonment or a fine of up to 360 daily rates.
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.
From 1 May 2025 the new Retinol Regulation will apply in all EU member states, setting new maximum concertation measures for products containing retinols. (see above)
Regulation 2024/1328 enforces a complete ban on D5 and D6 (cyclic silicones) in concentrations over 0.1% in all cosmetic products. This new regulation builds upon existing restrictions on rinse-off cosmetics containing D4 and D5, extending these limits to broader applications within the beauty and personal care industry.
Environmental Claims:
The Empowering Consumers for the Green Transition Directive needs to be implemented by 27.3.2026 and its provisions will be mandatorily applicable by 27.9.2026. Environmental claims in relation to cosmetic products will have to comply with the provisions of the Directive.
Furthermore, the Green Claims Directive (GCD) will implement minimum requirements for substantiating, communicating, and verifying explicit environmental claims. Certain green claims will have to be verified upfront by independent third parties. The CDG has not yet been adopted but will probably be applicable by 2027.
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?
Supplements are legally classified as food products in Austria and are therefore subject to Austrian food law. The following regulations apply:
- Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
- Austrian Food Safety and Consumer Protection Act (LMSVG)
- Food Supplement Regulation BGBl II No. 88/2004
- Food Labeling Regulation 1993
- Regulation (EG) No 1169/2011 on the provision of food information to consumers
- Regulation (EC) No 1924/2006 on nutrition and health claims made on foods
- Regulation (EU) 2015/2283 on Novel foods
Food supplements are defined as foods which are intended to supplement the normal diet and which consist of single or multiple concentrates of nutrients or other substances with a nutritional or physiological effect and which are placed on the market in dosed form. (i.e. in the form of capsules, pastilles, tablets, pills and other similar dosage forms, powder sachets, liquid ampoules, bottles with droppers and similar dosage forms of liquids and powders for ingestion in measured small quantities). 1
The placing on the market of food supplements is regulated in the Austrian Food Supplement Regulation. It specifies requirements for the labeling or composition of food supplements.
Additionally, it is to be noted, that Food Supplements can contain Novel Foods such as CBD or algae oil. Supplements are then subject to the Novel Food Regulation and have to comply with its provisions.
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?
Yes. The Food Supplement Regulation specifies that it is prohibited to include vitamins and minerals other than those listed in Annex I to Regulation (EC) No 1170/2009 in Food Supplements.
Additionally, vitamins and minerals listed in Annex II of the Regulation are subject to the Austrian Regulation on additives other than colorants and sweeteners (ZuV; BGBl II No. 383/1998) and the Austrian Regulation on the addition of colorants to foodstuffs (Colorant Regulation; BGBl No. 541/1996).
If novel foods, such as CBD or algae oils, are included in food supplements, the rules of the Novel Food Regulation apply. Novel foods must undergo a uniform safety assessment before they can be placed on the market in the EU.
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?
Under the LMSVG, manufacturers and distributors of food supplements are responsible for ensuring that their products are safe and comply with all legal requirements. If necessary, they must take measures to minimise and eliminate risks as part of self-monitoring.
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?
No notification, registration or declaration of food supplements is required in Austria.
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?
Around 450 samples of food supplements are officially inspected each year to ensure their safety. The controls on food supplements are carried out by the food supervisory authorities of the federal states. The results of these checks are published in the food safety report according to the LMSVG by the Federal Minister for Social Affairs, Health, Care and Consumer Protection.
Further monitoring or control is carried out by the food supervisory authorities as part of sample checks and in the event of complaints or indications of possible safety risks.
Under the LMSVG Business operators at all stages of production, processing and distribution of food must ensure its traceability.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
Misleading and disease-related claims are prohibited when placing food supplements on the market. The labelling, presentation and advertising of food supplements must not give the impression, that a balanced and varied diet cannot ensure a general adequate intake of nutrients. 2
Food Supplements must be labelled as such and have to list the following information and their label:
- The name of the categories of nutrients or other substances that characterise the product
- The recommended daily intake in portions of the product
- A warning not to exceed the stated recommended daily intake
- A warning that the food supplements should not be used as a substitute for a varied diet
- A warning that the product should be stored out of the reach of small children
- The amount of nutrients or other substances with a nutritional or physiological effect contained in the product
- Vitamins and minerals listed in Annex XIII, Part A, of the Regulation No 1169/2011 on the provision of food information to consumers, must additionally state the percentages of the reference values on the label.
Food supplements must not have any "cosmetic" recommendations for use (e.g. for application to the skin).
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?
Food supplements may only be supplied directly to the final consumer in packaged form.
When placing a food or food supplement on the market, it is prohibited to ascribe to it properties of preventing, treating or curing a human disease or to create the impression of such properties (prohibition of "curative claims") in the context of the overall presentation of the supplement, including in electronic communication media. Truthful statements about the purpose of a diet are permitted.
Health claims such as 'Calcium is needed for the maintenance of normal bones' can be used if they are scientifically proven and explicitly authorized by the 'Health Claims Regulation', which currently includes around 250 claims (EU Register of Health Claims). Since 2012, food manufacturers are required to obtain approval of health claims from the European Food Safety Authority (EFSA).
Health Claims that advertise weight loss and that it will occur within a certain period of time or to a certain extent are prohibited.
Food supplements may only be supplied in packaged form and may only contain certain vitamins and minerals. (See above)
Private individuals may not be approached with regard to the sale of food supplements. Promotional events in private households are also not permitted. Mail order sales are permitted.
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 violation of the LMSVG constitutes an administrative offence and is punishable with a fine of up to EUR 35,000, or up to EUR 70,000 in the event of a repeat offence. In the event of non-payment of the fine, the offender may be imprisoned for up to six weeks.
In addition, the placing on the market of harmful foodstuffs can be subject to a criminal penalty of up to one year's imprisonment or a fine of up to 360 daily rates.
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
Yes, regarding environmental claims the following will apply:
The Empowering Consumers for the Green Transition Directive needs to be implemented by 27.3.2026 and its provisions will be mandatorily applicable by 27.9.2026. Environmental claims in relation to supplements will have to comply with the provisions of the Directive.
Furthermore, the Green Claims Directive (GCD) will implement minimum requirements for substantiating, communicating, and verifying explicit environmental claims. Certain green claims will have to be verified upfront by independent third parties. The CDG has not yet been adopted but will probably be applicable by 2027.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
Cosmetic devices are not regulated by special national regulations in Austria. They do not fall under the Cosmetic-Regulation, as they are not classified as cosmetic products. Therefore, the Austrian Product Safety Act (Produktsicherheitsgesetz 2004) as well as general consumer protection rules apply.
Cosmetic devices can be medical devices if they are ascribed a medical purpose or are considered as medical devices without medical purpose (see below). In this case Regulation (EU) 745/2017 on Medical Devices (MDR) as well as the Austrian Medical Devices Act (Medizinproduktegesetz 2021 – MPG 2021) are applicable.
Medical devices are products that are intended by the manufacturer for the use in humans and are intended to fulfil a medical purpose. The intended purpose of a product means the purpose as stated by the manufacturer on the labelling, in the instructions for use or in promotional or sales material, or in the advertising or sales claims and in the clinical evaluation.
Devices intended for the use on the human body that emit high-intensity electromagnetic radiation (such as infrared radiation, visible light, ultraviolet radiation), coherent and non-coherent light sources as well as monochromatic light and light in the broadband spectrum (such as lasers and intensely pulsed light devices used for skin resurfacing, tattoo or hair removal or other forms of skin treatment) are regarded as medical devices without intended medical purpose. These medical devices are specified in Annex XVI of Regulation (EU) 745/2017 on Medical Devices (MDR). Medical Devices and such without intended medical purpose need to undergo a conformity assessment and be CE-certified.
The main distinction between cosmetic devices and medical devices is made according to the intended purpose of the product. As soon as a cosmetic product is ascribed any medical purpose or is by definition regarded as medical device without medical purpose, it is subject to the regulations of the MDR (and e.g. has to undergo a clinical trial).
The EU Commission may extend the list of medical devices without intended medical purpose in future by means of delegated acts and add new product groups.
If the cosmetic product is not considered a medical device, the general product safety rules apply.
The answers to the following questions only relate to cosmetic devices that are not considered as medical devices.
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?
Yes. According to the Product Safety Act (PSG) manufacturers and importers must take appropriate measures in the context of their respective business activities, proportionate to the product concerned, in order to recognise any risks posed by their products and to take appropriate precautions to avoid them, including, if necessary, the withdrawal from the market, appropriate and effective warning to consumers and, if necessary, recall from consumers.
Such measures may include, for example:
- Appropriate labelling that enables the product to be identified and traced back to the manufacturer
- Labelling of the production batch
- Carrying out spot checks on the products placed on the market, investigating complaints and, if necessary, keeping a complaints log and informing distributors of the results of these activities
Distributors must contribute to compliance with the applicable safety requirements, in particular by not supplying products which they know or should know, on the basis of the information available to them with reasonable care, do not fulfil these requirements.
Within the scope of their respective business activities, they must contribute to monitoring the safety of the products placed on the market, in particular by:
- passing on information about hazards posed by the products
- keeping and providing the documentation required to trace products
- cooperating in measures taken by manufacturers and competent authorities to prevent hazards.
As part of their business activities, they must facilitate effective co-operation with other distributors, consumers and authorities.
Distributors who place the products on the market must co-operate with the competent authorities with regard to measures to prevent risks. In particular, they are obliged to:
- Provide information to these authorities (e.g. about upstream suppliers and distribution channels)
- Provide product documentation, test certificates and other suitable documents that enable the risk assessment of products
- To make products available for testing, in particular products that have caused harm to persons; modifications to the products in question must be refrained from
- To make suggestions as to how a danger can be averted.
If the cosmetic device is considered a medical device under the MDR, the provisions of the MDR apply. Furthermore, the provisions of the Austrian MPG are applicable.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
No there is no certain safety assessment that cosmetic devices have to adhere or pass.
According to the General Product Safety Act, a product is considered safe when there are no hazards or only the minimum compatible risks compatible with the product's use, considering a high level of protection for the safety and health of persons. The use also includes the period of use and, where applicable, putting into service, installation and maintenance requirements.
A product is deemed dangerous if it does not meet the requirements set forth in the Product Safety Act. The possibility of obtaining higher levels of protection or the availability of other products presenting a lesser degree of risk do not make a product dangerous.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
There are no specific advertising restrictions for cosmetic devices in Austria that go beyond the general requirements for advertising (Austrian Unfair Competition Act).
As such misleading and comparative advertising is forbidden. This means that advertising must not be misleading and must not contain false or unfounded claims about the performance or advantages of cosmetic devices.
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?
If the safety requirements under the Austrian Product Safety Act are not met by the distributors, the competent federal minister can take measures, which may be addressed to the distributors or, if necessary to avert the danger, to any other person in order to ensure a high level of consumer health and safety protection.
Measures include prohibitions or restrictions on the placement of the product on the market, prohibitions or restrictions on the export of the product, the obligation to immediately withdraw the product from the market or to conduct an immediate and efficient recall of the product or batch of products already placed on the market. The enforcement measures chosen will be proportionate to the risk.
A person who places dangerous products on the market, the potential danger of which was known at the time of placing on the market or should have been recognized with reasonable care and which pose a serious risk to the life and health of consumers, commits an administrative offence which is punishable by the district administrative authority with a fine of up to EUR 25,000 or, with a substitute custodial sentence of up to six weeks.
The marketing of medical devices as cosmetic devices constitutes a breach of UWG (breach of law) and MPG:
For offences against the advertising provisions of the MPG - provided that the actions are not subject to criminal sanctions – administrative penalties of EUR 25,000, in the repetition case of EUR 50,000 may be imposed.
Violation of UWG may result in claims for injunctive relief, removal, damages and publication of judgements as well as reimbursement of costs. These claims may be asserted by competitors and certain organisations.
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.
The General Product Safety Regulation (EU) 2023/988 (GPSR) will apply from 13.12.2024, making the appointment of a responsible person for products placed on the Union market obligatory, as well as setting out stricter requirements for product safety.
Therefore a new national Product Safety Act is expected to enter into force in the Beginning of 2025.
For environmental claims in relation to such products please see chapter 1 question 17.
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?
Yes. Depending on the cosmetic service, the following regulations can apply:
- Austrian Act on the Performance of Aesthetic Treatments and Operations (ÄsthOpG)
- Austrian Law on Doctors (ÄrzteG)
- Medicinal Products Act (AMG)
- Regulation (EU) 2017/745 on Medical Devices
The Administration of such cosmetic services in most cases falls under the Austrian Act on the Performance of Aesthetic Treatments and Operations (ÄsthOpG) and is therefore also subject to the Austrian Law on Doctors 1998 (ÄrzteG) as aesthetic treatments and operations without medical indication are considered medical activities and may only be carried out by physicians who are specialised in certain medical fields.
‘Aesthetic treatment’ means any treatment using methods other than surgical procedures, in particular by means of medicinal products and minimally invasive methods, to bring about a subjectively perceived improvement in the visual appearance or beautification of the human body or an aesthetic change in physical appearance, including the treatment of age-related external changes to the body without medical indication.
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?
According to Art 7 ÄsthOpG Aesthetic treatments or surgery on individuals who have not yet reached the age of 16 is not permitted.
Individuals who have reached the age of 16 and have not yet reached the age of 18 can undergo aesthetic treatments or surgery, only when:
- The consent of the legal guardians has been verifiably given in writing or
- The consent of the patient, who is able to understand the nature, significance, extent and risks of the aesthetic treatment or operation and to determine his or her will accordingly, has been given in writing and appropriate comprehensive and verifiable medical information has been provided.
3. Is botulinum toxin (BT) a prescription only drug in your jurisdiction?mIf so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
Botulinum toxin is a prescription only drug in Austria. It can therefore only be prescribed by physicians.
As the administration of BT is a cosmetic non-surgical service, it is subject to the Federal Act on the Performance of Aesthetic Treatments and Operations (ÄsthOpG). Aesthetic treatments may be carried out by physicians within the framework of their general professional rights; general practitioners as well as medical specialists may carry out aesthetic treatments within the framework of their respective specialist field and the generally applicable specialist restrictions.
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?
There is no requirement for physicians to additionally register with a centralised body when administering aesthetic treatments.
If it is suspected that an incorrectly performed aesthetic treatment or operation has led to an illness or other complication, according to Art 10 ÄsthOpG, the physicians who performed the aesthetic treatment or operation and any other physicians providing follow-up treatment must forward the relevant information to the statutory health insurance, the health care institution or the statutory pension insurance for the purpose of examining a possible recourse claim, provided that the follow-up treatment is a service that is reimbursable under social insurance law.
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.
Anyone who acts in contravention of one or more of the instructions or prohibitions according to the ÄsthOpG commits an administrative offence (provided that the act does not constitute a criminal offence) and is punishable by a fine of up to EUR 15,000 (EUR 25,000 in the event of a repeat offence).
The ÄsthOpG sets out strict requirements for consent and information that go beyond the general rules on consent to medical treatments (e.g. waiting period between information and consent, special consideration of certain circumstances such as psychiatric illnesses). Every aesthetic treatment and operation constitute an encroachment on physical integrity and therefore require the patient's informed consent. Violation of this regulation may result in criminal prosecution, such as for bodily harm under §§ 83 ff of the Austrian Criminal Code (StGB).
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?
Art 8 ÄsthOpG sets out Advertising restrictions and a general prohibition of commission for aesthetic treatments.
Physicians must refrain from any discriminatory, unobjective, untrue or self-promotion, or advertising that is detrimental to the reputation of the profession by advertising his or her person or services in an advertising-like manner.
In particular, the following may not be used to advertise aesthetic treatments or operations:
- Stating that the aesthetic treatment or operation is medically, dentally or otherwise professionally recommended or tested or used
- Stating that the aesthetic treatment or operation is particularly low-priced or offering free consultations
- Advertising by means of promotional lectures
- Advertising by means of advertising measures that are directed exclusively or predominantly at minors
- Advertising by means of competitions, games, prize draws or comparable procedures
These advertising rules also apply to platforms.
According to the Austrian Law on Doctors and the ÄsthOpG, a physician may not promise, give, or accept the promise of any remuneration for referring patients to him or through him (Provisionsverbot). Legal transactions that violate this prohibition are null and void. Fees paid for such legal transactions can be reclaimed. Business models involving referral of patients to doctors for non-surgical cosmetic services must observe these restrictions. Although the legal prohibition is addressed to doctors, platforms not obeying these rules may be held liable for inducement of doctors to infringe their obligations under Austrian professional law.
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 upcoming future developments in this field that we are aware of.