CMS Expert Guide on Beauty in Poland

• EU Regulation No 1223/2009 on Cosmetic Products (hereinafter: “EU Cosmetics Regulation”)
• EU Regulation No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products (hereinafter: “EU Claims Justification Regulation”)
• The act of 4 October 2018 on cosmetic products (hereinafter: “Act on Cosmetic Products”)

The definition of a cosmetic product in the Act on Cosmetic Products refers directly to the EU Cosmetics Regulation. 

The definition of a cosmetic product in the EU Cosmetics Regulation comprises three parts: a function, field of application, and product composition.

• There are 6 functions of cosmetic products including to clean, perfume, change appearance, protect, keep in good condition and correct body odours;
• The field of application of cosmetic product relates to external parts of the body including the epidermis, hair system, nails, lips, external genital organs, teeth and the mucous membranes of the oral cavity;
• A cosmetic product may be a substance or mixture of a number of substances.

Products that are intended to be ingested, inhaled, injected or implanted are not classified as cosmetic products. Such products may fall under the definition of medicinal products, medical devices or food supplements. A separate group of products are biocidal products, e.g. repellents.

The EU Cosmetics Regulation relates only to cosmetic products. The delimitation follows in particular from the detailed definition of cosmetic products.

In contrast, medicinal products (which are also a substance or mixture of a number of substances) are presented as having properties for the prevention or treatment of a human disease or administered for making a diagnosis, or for restoring, correcting or modifying physiological functions of the body through pharmacological, immunological or metabolic action. Unlike cosmetic products, medicinal products require a marketing authorisation. A cosmetic product cannot be claimed to have medicinal properties.

Restrictions on particular substances in cosmetic products are placed by EU law – Polish law does not indicate separate restrictions. The EU Cosmetics Regulation indicates what substances are prohibited (Annex II), restricted in use (Annex III) and under what terms colorants (Annex IV), preservatives (Annex V) and UV-filters (Annex VI) can be used in cosmetic products.

In terms of substances prohibited in cosmetic products, these include, for example: epinephrine, alkyne alcohols, benzidine, substances with an androgenic effect and antibiotics. According to the latest amendments to the EU Cosmetics Regulation, the list of prohibited substances was supplemented with 4-Methylbenzylidene Camphorl – products containing such substance may not be placed on the EU market from 1 May 2025.

Regarding substances that are restricted in use, such restrictions concern the maximum concentration of substances in a product, special conditions of use and warnings. Examples of restricted substances are ammonia, chloramine-T and hydrogen peroxide. Due to the last changes in EU law, from 1 November 2025 cosmetic products containing substances such as retinol, retinyl acetate and retinyl palmitate must comply with the restrictions implemented for them by the EU Cosmetics Regulation. Otherwise, they should not be placed on the EU market.   

In terms of colourants, preservatives and UV-filters, they may be used in cosmetic products, but only those listed in the Annexes to the EU Cosmetics Regulation and only if used in accordance with the conditions laid down in these Annexes.

In Poland, a fine of up to PLN 100,000 (approx. EUR 23,000) may be imposed for placing on the market a cosmetic product in violation of substance restrictions.

In Poland, only cosmetic products for which a “Responsible Person” is designated within the EU maybe placed on the market. The Responsible Person (natural person or entity) does not have to be designated directly in Poland, but may be designated in any EU country.

For each cosmetic product placed on the market, the Responsible Person must ensure compliance with the relevant obligations set out in the law.

A Responsible Person can be either:

• the manufacturer;
• the importer;
• the person established within the EU designated by the manufacturer or importer by a written mandate; or
• the distributor (when it places a cosmetic product on the market under its name or trademark or modifies a product in such a way that compliance with the applicable requirements may be affected).

The translation of information relating to a cosmetic product already placed on the market is not considered as a modification of such a nature as to affect compliance with the applicable requirements, so that the mere translation of information does not make the distributor a Responsible Person.

The Responsible Person must ensure, prior to placing a cosmetic product on the EU market (including the Polish market), that:

• it has undergone a safety assessment on the basis of the relevant information; and
• its safety report is set up in accordance with Annex I to the EU Cosmetics Regulation,

to demonstrate that it complies with applicable safety regulations.

The Responsible Person must ensure that:

• the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
• an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;
• the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.

Whoever places a cosmetic product on the Polish market without complying with the above safety assessment requirements may be subject to a fine of up to PLN 100,000 (approx. EUR 23,000).

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

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

The labelling for cosmetic products must be easy to read and provided in the Polish language. The container and any packaging must be labelled with:

• name and address of the Responsible Person;
• country of origin for cosmetic products imported into the EU;
• nominal content (weight or volume), date of minimum durability and the identification number (e.g. batch number);
• precautions to be observed in use;
• function of the cosmetic product, unless this is clear from its presentation;
• ingredients - this information may be indicated on the packaging alone; the list must be preceded by the term “ingredients” and established in descending order of weight.

If the cosmetic product is unpackaged or packaged at the point of sale at the request of the purchaser or pre-packaged for immediate sale, the above information must be displayed on the container or packaging in which the cosmetic product is displayed for sale.

In Poland, a fine of up to PLN 70,000 (approx. EUR 17,000) may be imposed for placing or making available on the market a cosmetic product without complying with the labelling requirements, including the language of labelling.

According to the EU Cosmetics Regulation, when making available on the market and when advertising cosmetic products, in the labelling, text, names, trade marks, pictures and figurative or other signs should not be used to imply that these products have characteristics or functions which they do not have.

As a rule, claims for cosmetic products’ uses in advertising are very restricted by the EU Claims Justification Regulation. Among other things, claims must be supported by adequate and verifiable evidence. Where studies are being used as evidence, they should be relevant to the product and to the benefit claimed, should follow well-designed, well-conducted methodologies and should respect ethical considerations.

Overall, under the EU Claims Justification Regulation, the advertising of cosmetics should comply with the following criteria:

• legal compliance;
• truthfulness;
• evidential support;
• honesty;
• fairness; and
• informed decision-making.

Assessment of the acceptability of a claim should be based on the weight of evidence of all studies, data and information available depending on the nature of the claim and the prevailing general knowledge of the end users.

In Poland, there is additionally a self-regulation “Code of Ethics of the Polish Association of the Cosmetics Industry” which introduces additional requirements, such as, e.g.: advertisements and marketing claims for cosmetic products should not contain sexually offensive language and should avoid any sexual content that may be degrading to women or men. Advertisements should also not contain elements that encourage acts of violence.

According to the Act on Cosmetic Products, anyone who makes a cosmetic product available on the market without complying with the requirements related to product claims set in the EU Cosmetics Regulation may be subject to a fine of up to PLN 20,000 (approx. EUR 4,700).

Furthermore, misleading advertising may be considered a practice that violates the collective interests of consumers, which involves the possibility of imposing a fine under the Competition and Consumer Protection Act of up to 10% of annual turnover.

For each cosmetic product placed on the market, the Responsible Person must ensure compliance with the relevant obligations set out in the EU Cosmetics Regulation. The EU Cosmetics Regulation requires the competent authorities to request the Responsible Person to take corrective action regarding a product that does not comply with the Regulation.

If the Responsible Person does not take the measures within the time limit, or where immediate action is necessary to prevent serious risk to human health, the competent authority may take all appropriate measures itself to stop the product going on the market, or to withdraw or recall products already on the market. Competent authorities have all the powers they need to prevent any further distribution or sale of the product if the Responsible Person is not taking the necessary actions.

Under the Act on Cosmetic Products, breach of the EU Cosmetics Regulation provisions could result in fine of up to PLN 100,000 (approx. EUR 23,000).

Legislative changes and their impact on the cosmetics industry mainly focus on cosmetic ingredients. This is a major challenge for cosmetic product manufacturers, who must keep a close eye on upcoming regulations and adapt their cosmetic product in time. Often, it is also necessary to change the formulation in order to eliminate a banned ingredient from the formula or to adjust its concentration to the regulatory limit.

We already know of several changes in the permitted concentrations of selected substances in cosmetic products in 2025, including vitamin A (Retinol, Retinyl Acetate and Retinyl Palmitate), Alpha-Arbutin and Arbutin, and certain substances with potential endocrine disrupting properties, whose maximum concentration in cosmetic products has been set by Regulation 2024/996.

• Regulation 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 (hereinafter: “EU Food Law Regulation”)
• Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements (hereinafter: “Food Supplements Directive”)
• Regulation No 1169/2011 on the provision of food information to consumers (hereinafter: “EU Food information Regulation”)
• Regulation No 852/2004 on the hygiene of foodstuffs (hereinafter: “Foodstuffs Hygiene Regulation”)
• Act of 25 August 2006 on food and nutrition safety (hereinafter: “Act on Food and Nutrition Safety”)
• Regulation of the Minister of Health of 9 October 2007 on the composition and labelling of food supplements (hereinafter: “PL Food Supplements Regulation”)

According to the Act on Food and Nutrition Safety, a food supplement is a foodstuff which is to supplement the normal diet. Food supplements are a concentrated source of vitamins or minerals or other substances having a nutritional or other physiological effect, alone or in combination, marketed in a dosage form.

Food supplements are marketed after notification in the form of capsules, tablets, dragées and other similar forms, sachets of powder, ampoules of liquid, dropper bottles and other similar forms of liquids and powders intended to be consumed in small, measured unit quantities.

It should be noted that products which have the properties of a medicinal product within the meaning of Polish pharmaceutical legislation (presented as having properties for the prevention or treatment of disease or administered for the purpose of making a diagnosis or for the purpose of restoring, correcting or modifying physiological functions of the body through pharmacological, immunological or metabolic action) are not considered to be food supplements.

Polish law provides that a product that simultaneously meets the criteria of a medicinal product and the criteria of another type of product, in particular a food supplement, a cosmetic product or a medical device (borderline products), is subject – as a medicinal product – to pharmaceutical legislation. 

According to the Act on Food and Nutrition Safety, food supplements may contain vitamins and minerals that naturally occur in and are consumed as part of food, as well as other substances that show a nutritional or other physiological effect.

The maximum permitted level of vitamins and minerals and other substances in food supplements must ensure that the normal use of the food supplement as labelled will be safe for human health and life. The minimum permitted level of vitamins and minerals in a recommended daily portion must not be less than 15% of the reference intakes set out in point 1 of Part A of Annex XIII to the EU Food Information Regulation.

The vitamins (e.g. Vitamin A, Vitamin D, Vitamin K, Pantothenic acid, and Biotin) and minerals (e.g. Calcium, Iron, Sodium, Potassium, Silicon, and Zinc) authorised for use in food supplements are listed at EU level in the Food Supplements Directive.

At the Polish level, authorised vitamins and minerals are listed in the PL Food Supplements Regulation, alongside their authorised chemical forms. The PL Food Supplements Regulation also set outs additional requirements for the content of vitamins and minerals in food supplements, including purity criteria, as well as the level of vitamins and minerals in the food supplement.

In addition, Poland has a Food Supplements Group, which is a consultative and advisory body of the Chief Sanitary Inspector, which issues resolutions mainly concerning daily portions and warnings that should be placed on the product label. The resolutions mainly concern vitamins and minerals, but a few have been dedicated to herbal substances - aloe vera, isoflavones or white mulberry. The resolutions are highly controversial in the industry as they are not a source of law sensu stricto, but the Chief Sanitary Inspector takes them into account when considering food supplement notifications.

It is the responsibility of the person placing the food supplement on the market for the first time to ensure that the food supplement meets the requirements of the law. In order to monitor the products marketed in Poland, a food business operator who introduces or intends to introduce a food supplement to the market for the first time is obliged to submit a notification to the Chief Sanitary Inspector.

The notification must provide data such as:

• the name of the product and its manufacturer;
• the form in which the product is marketed;
• the design of labelling in Polish;
• the qualification/type of foodstuff adopted by the food business operator;
• the qualitative composition including data on the ingredients contained in the product, including active substances;
• the quantitative composition of the ingredients;
• the name, address and tax identification number (NIP) of the notifier of the first placing on the market.

In addition, a food business operator (which markets or trades food supplements) can start operations after its establishment has been approved by the Chief Sanitary Inspector (as a rule) or after it has been entered in the register of establishments (e.g. pharmacies, herbal shops, mail order entrepreneurs).

Placing a food supplement on the market for the first time without having submitted a notification is punishable by a fine. Operating without submitting an application for an entry in the register of establishments or for approval of an establishment and entry in the register of establishments (when it is required) is subject to a fine of up to 30 times the average monthly salary (currently around PLN 210,000, which is approx. EUR 50,000).

According to current legislation, food supplements are subject to food law and are defined as foodstuffs. Only microbiological testing and testing for maximum levels of contaminants in food (depending on the composition of the food supplement, these will include, for example, heavy metals, citrinin, or pyrrolizidine alkaloids) are required before a food supplement can be marketed. The production or marketing of a food supplement harmful to human health or life (for example, when failing to meet microbiological requirements) is punishable by a fine, restriction of liberty or imprisonment for up to three years.

To market the food supplement, it is necessary to submit a notification to the Chief Sanitary Inspector. Upon receipt of the notification, the Chief Sanitary Inspector may carry out an investigation to clarify whether the notified product is a food supplement in view of its composition, the properties of its individual ingredients and its intended use.

According to EU Food Law Regulation, food (including food supplements) placed or likely to be placed on the market in the EU should be appropriately labelled or marked with appropriate documentation or information to facilitate traceability.

Additionally, according to the Foodstuffs Hygiene Regulation, food business operators must keep and maintain records relating to actions taken to control hazards (HACCP).

There are no specific provisions for food supplements only, related to record-keeping obligations. However, according to the Act on Food and Nutrition Safety, the Chief Sanitary Inspector has the right to carry out an investigation to check if the supplement meets the legal requirements and is entitled to require the entity to document that the supplement meets the conditions laid down in the regulations, in particular to provide an opinion from a scientific body.

In addition, the Chief Sanitary Inspector himself keeps a register of products covered by the notification of first placing on the market on the territory of Poland (including food supplements). The register of products is kept in electronic form. The data from the register is published on the website of the Chief Sanitary Inspectorate.

Food supplements must comply with general food labelling regulations, i.e. labels must be clear and easy to understand for the consumer, must be written in Polish, and must not be misleading.

Additionally, according to the PL Food Supplements Regulation, food supplements placed on the market must be labelled with the following information on the packaging:

• the term ‘supplement’;
• the names of the categories of nutrients or substances characterising the product or an indication of the nature of those substances;
• the portion of the product recommended for consumption per day;
• a warning not to exceed the recommended daily portion;
• a statement that the supplements must not be used as a substitute (replacement) for a varied diet;
• a statement that the supplements should be kept out of the reach of young children.

The content of vitamins and minerals and other substances with a nutritional or other physiological effect present in a supplement must be stated on the labelling in numerical form.

The declared content of vitamins and minerals and other substances with a nutritional or other physiological effect in the labelling must be expressed per daily portion recommended for consumption by the manufacturer.

The labelling and presentation of food supplements must not contain information stating or implying that a balanced and varied diet cannot provide sufficient nutrients for the body. A failure to comply with food labelling requirements is punishable by a fine of up to 30 times the average monthly salary (currently around PLN 210,000, which is approx. EUR 50,000).

Yes, however there are certain limitations. As a main rule, advertising of food supplements must not contain information stating or implying that a balanced and varied diet cannot provide sufficient nutrients for the body.

Additionally, advertising must not attribute to food supplements properties for the prevention, treatment or cure of human disease or refer to such properties. However, registered health claims may be used in advertising, but only when they comply with EU regulations, including not being ambiguous, untrue or misleading or exploiting customers’ fears through drastic images or text.

At the moment in Poland, apart from the above rule, regulations related to the advertising of food in general and self-regulations, there are no specific regulations related to advertising and promotion of food supplements.

Examples of self-regulation include the ‘Code of Ethics for Advertising’ of the Union of Associations Advertising Council, which includes rules for advertising food supplements directed at medical professionals and the rules for the use of labels in advertising (e.g. claims to confirm product quality and safety), a very widely understood definition of advertising of supplement (including messages made available on the Internet on a website or in social media), a ban on misleading advertising (including suggestions that a food supplement is a medicinal product, a medical device, a cosmetic product or another food category), and the ban on advertising supplements upon the first placement on the market when notifications have not been made in accordance with regulations.

The Chief Sanitary Inspector may conduct a procedure to clarify whether the notified food supplement is in fact a food supplement - in view of its composition, the properties of its individual ingredients and its intended use.

If it is suspected that a food supplement does not meet the requirements for a supplement, the sanitary inspector makes a decision to temporarily suspend its marketing or withdraw it from the market until the procedure is completed.

The same decision is also made in the event that the notified product is found to meet the requirements of a medicinal product or a medical device. The food business operator is notified in writing of the results of the conducted proceedings.

Additionally, there are various enforcement mechanisms for compliance, e.g. the penalty for marketing a spoiled or adulterated food supplement is a fine, restriction of liberty or imprisonment of up to one year, while the penalty for marketing a food supplement after the best-before date or minimum durability date is a fine.

A draft Act amending the Act on Food and Nutrition Safety was published in 2023. The draft provides for a clarification of the rules regarding the presentation or advertising of food supplements.

The draft brings the legislation on advertising of food supplements closer to the legislation on advertising of medicinal products. Among other things, the draft proposes a provision for a mandatory message when presenting or advertising a food supplement, i.e. ‘A food supplement is a foodstuff whose purpose is to supplement the normal diet. A food supplement has no medicinal properties.’. The draft also provides for restrictions on how and where presentations or advertising of food supplements may be carried out, for example the ban on the use of doctors’ images in advertising. At present, there is no information on whether the draft will proceed further and when it will do so.                

• Directive No 2001/95/EC on general product safety (hereinafter: “General Product Safety Directive”).
• Regulation No 2023/988 on general product safety (hereinafter: “GPSR”).
• Act of 12 December 2003 on general product safety (hereinafter: “Act on General Product Safety”).
• Regulation No 2017/745 on medical devices (hereinafter: “MDR”).
• Act of 7 April 2022 on medical devices (hereinafter: “Act on Medical Devices”).

Cosmetic devices are regulated separately from cosmetic products, which may be only a substance or mixture of a number of substances.

Cosmetic devices are subject to general product safety regulations, or medical device regulations if the cosmetic device qualifies as a medical device.

According to the MDR, a medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
• providing information by means of an in vitro examination of specimens derived from the human body, including organ, blood and tissue donations;
• and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Medical devices are also products specifically intended for the cleaning, disinfection or sterilisation of devices.

As a rule, medical devices are intended by the manufacturer to be used for one or more of the specific medical purposes, but they also cover products without an intended medical purpose. According to Annex XVI to the MDR, cosmetic devices without medical purpose which will qualify as medical devices are, for example:

• equipment for liposuction, lipolysis or lipoplasty;
• laser or intense pulsed light devices for hair removal or skin treatment.

If a cosmetic device cannot be qualified as medical device it is required to adhere to general product safety rules.

The question of the person or entity responsible for a cosmetic device will vary depending on whether the device falls under the general product safety regime or the medical device legislation.

For cosmetic devices which are medical devices it is the responsibility of medical device manufacturers to ensure that devices are designed and manufactured in compliance with the legal requirements. Where the manufacturer of the product is not established in the EU, the device may only be placed on the market in the EU if the manufacturer appoints an authorised representative, who will be held liable under the conditions laid down for the manufacturer, on the basis of medical device regulations.

Nevertheless, the MDR introduces the position of a person responsible for regulatory compliance. Such person needs to possess the requisite expertise in the field of medical devices. This person’s responsibilities include ensuring that:

• the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
• the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
• the post-market surveillance obligations are complied with the law;
• the reporting obligations are fulfilled.

Manufacturers and authorised representatives must have available within their organisation at least one person responsible for regulatory compliance.

If a cosmetic device is not a medical device it is subject to general product safety regulations. Until December 2024, it is the producers who are obliged to market only safe products. According to the General Product Safety Directive, the producer means the manufacturer of the product, the manufacturer’s representative or other professionals in the supply chain, insofar as their activities may affect the safety properties of a product. There is no obligation to establish a responsible person or entity.

As of December 2024, the GPSR will apply, according to which there must be a person responsible for products placed on the EU market. According to the GPSR, the responsible person is the entity whose duty it is to ensure that products comply with the safety requirements set out in the GPSR.

If the cosmetic device is a medical device, manufacturers or authorised representatives must establish, document, implement and maintain a system for risk management. For a medical device to be placed on the market and put into use, it must meet the requirements specified for it, i.e. the manufacturer or its authorised representative must ensure that the devices, in their design and manufacture, comply with the general safety and performance requirements set out in Annex I of the MDR.

If the cosmetic device is not a medical device, it must comply with general product safety rules, and no specific safety assessment is required. According to the Act on General Product Safety, in the absence of specific EU regulations on the safety of a particular product, a product placed on the Polish market is deemed safe if it meets specific product safety requirements set out in separate Polish regulations (such specific regulations may apply to electronic cosmetic products, for example).

The marketing and promotion of cosmetic devices which are not medical devices is governed by the main advertising regulations in Poland, such as the prohibition on misleading advertising to consumers.

When a cosmetic device is a medical device, then the rules for advertising medical devices will apply.

The rules for the advertising of medical devices include:

• the advertising of a device to the public must be formulated in a way that can be understood by a layperson;
• the advertising of a device to the public may not: use the image of medical professionals; contain a direct appeal to children to purchase the advertised devices; refer to devices intended for use by users other than laypersons.

Therefore, if a cosmetic device is a medical device intended for professional use, its advertising may not be directed to the public.

With regard to cosmetic devices that are not medical devices, at the time of writing this guide (September 2024), the trade inspectorate has inspection powers. If the findings of the inspection indicate a substantial likelihood that the product does not meet the general safety requirements, the President of the Office of Competition and Consumer Protection, which is the supervisory authority, initiates administrative proceedings.

If the President of the Office of Competition and Consumer Protection finds that a product placed on the market is not safe, he may issue a decision to:

• eliminate the hazards posed by the product;
• immediately withdraw the product from the market;
• warn consumers, specifying the time limit and form of the warning;
• recall the product from consumers and destroy it.

The penalty for a failure to comply with the above-mentioned decision or for placing a product on the market which does meet safety requirements is a fine of up to PLN 100,000 (approx. EUR 23,000).

It should be noted that, following the entry into force of the GPSR, a draft of a new General Product Safety Act has already emerged in Poland, which will introduce changes to the competences of the authorities and the level of penalties (see more in response to Q6).

As far as cosmetic devices which are medical devices are concerned, the legislation on medical devices applies to them. Therefore, the supervisory authority is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (President of the URPL). The President of the URPL cooperates with other authorities, including the Chief Pharmaceutical Inspector, the Chief Sanitary Inspector and the President of the Office of Competition and Consumer Protection. These authorities notify the President of the URPL about irregularities found concerning medical devices, systems or treatment kits.

The President of the URPL is authorised to carry out inspections, including inspections of economic operators and their suppliers or subcontractors, and of the conformity of characteristics and performance of medical devices.  The inspection is carried out by persons authorised in writing by the President of the URPL. The penalty in Poland for placing on the market or putting into use a medical device that does not comply with the legal requirements is a fine of between PLN 20,000 and PLN 5,000,000 (approx. EUR 4,500 – 1,170,000).

As the GPSR regulation will start to apply from December 2024, legislative work has been undertaken in Poland on a new General Product Safety Act.

Currently, the draft is at the governmental stage - so there is no certainty as whether the proposed law, available at this point, will enter into force in its proposed form. Nevertheless, the general direction of the changes can already be outlined, including setting out detailed rules and procedures for inspections, both on-site and online, as well as rules for administrative investigations and a system of sanctions to be imposed for non-compliance with the GPSR.

Among other things, the draft provides for an administrative fine of up to PLN 1,000,000 (approx. EUR 230,000) to be imposed on a manufacturer for placing on the market a product which does not comply with a general safety requirement.

The administration of cosmetic (non-surgical) services that are not related to the treatment of illness, is not regulated under Polish law. The specific provisions for the provision of such services mainly concern the hygiene and sanitary requirements for beauty salons.

It is worth noting that, under Polish law, aesthetic-repair medicine is included in a doctor's qualification as a condition for applying for a certificate of professional competence. However, aesthetic services are not exclusively reserved for medical practitioners. Nevertheless, there are some cases where the provision of a service by someone other than a medical practitioner is debatable, such as the administration of botulinum toxin.

There are no specific rules in Poland that prevent an individual under the age of 18 from receiving a particular non-surgical cosmetic service.

However, in the case of more permanent body modification techniques such as semi-permanent make up and tattoos, these are usually not performed on people under the age of 18 without their legal representative’s consent (as such persons do not have full legal capacity).

Botulinum toxin (BT) is a prescription only medicinal product and as a general rule can be prescribed only by a doctor.

There are views, that as it is a medicinal product, it should be administrated only by a medical practitioner. According to this view, the administration of botulinum toxin by a person other than a medical practitioner (e.g. a beautician) should be subject to criminal liability (a fine, and in the case of acting for financial gain – a fine, restriction of freedom or imprisonment). However, it is common practice in Poland for beauticians to administer botulinum toxin.

For services which do not require a medical practitioner – there is no need for a business or practitioner administering these services to register with a centralised body.

When services require a medical practitioner, such practitioner needs to obtain an entry in the register of healthcare providers. Regarding medical entities providing aesthetic medicine services, they should also be registered as a healthcare provider.

Medical entities providing aesthetic medicine services must comply with a number of obligations arising from legal requirements, such as:

• the obligation to have insurance;
• the obligation to keep medical records in accordance with the applicable rules;
• the obligation to have organisational bylaws of the treatment entity;
• compliance with the requirements for the processing of personal data;
• the premises and equipment of the treatment entity must meet the applicable requirements.

The above-mentioned obligations for medical entities and medical practitioner do not apply to cosmetology surgeries. The legal requirements for running a cosmetology practice are considerably more relaxed than those for medical entities.

In particular, cosmetologists are not obliged to keep medical records. Similarly, cosmetology practices are not required to adopt and publish office regulations along the lines of those provided for medical entities.

As stated above, beauticians and beauty salons are not required to register and are therefore not subject to penalties for non-registration.

Regarding medical practitioners and medical entities, the penalty for practising without being registered is arrest, restriction of liberty or a fine.

In addition, the body keeping the register is entitled to inspect the entities performing therapeutic activities on the compliance of the performed activities with the regulations defining the conditions for performing therapeutic activities.

Entities conducting therapeutic activity or operating a medical establishment may not make available public information on the scope and types of health services provided that has the form and content of advertising. Such action is punishable by arrest, restriction of freedom or a fine. Therefore, any information on the services provided by such entities should be purely informative.

Beauty salons and persons providing cosmetic (non-medical) services have no such restrictions - they may advertise their services. However, it should be highlighted that if the advertising concerns services performed with medical devices (such as hair removal lasers), restrictions apply. Inter alia, any advertisement for aesthetic services should include the name or trade name of the service and the names of the medical devices used in the procedure.

If this medical device is intended for professional use only, advertising to the public is not allowed at all. Therefore, if a beauty salon provides services with a medical device for professional use only, only basic information such as the name of the service, name of the medical device and price should be given.

A lot of discussion is taking place as to whether non-surgical cosmetic services should only be provided by qualified personnel. Although no imminent regulation is on the horizon, the matter should be kept under review.