CMS Expert Guide on Beauty in Czech Republic

Key Regulations:

• Regulation EC No. 1223/2009 on cosmetics products
• Act No. 634/1992 Coll., Consumer Protection Act
• Commission Regulation No. 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
• Act. No 258/2000 Coll., on Public Health Protection

Distinction between cosmetic product and medicinal product:

Cosmetic product is defined in Regulation No. 1223/2009 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.

Medicinal product is defined in Act No. 378/2007 Coll., on Pharmaceuticals, as

1. a substance or mixture presented as having properties for treating or preventing disease in human beings or animals or;
2. a substance or mixture which may be used in humans or administered to humans, or used in animals or administered to animals, either to restore, modify or influence physiological functions through a pharmacological, immunological or metabolic effect, or to establish a medical diagnosis.

As a general rule (with certain exceptions), pharmaceuticals need to be registered and obtain marketing authorisation before they can be placed on a market.

Regulation EC No. 1223/2009 on cosmetics products prescribe what substances are prohibited or restricted in use in cosmetic products. Detail on restrictions for substances can be found in Annex II, Annex III, Annex IV, Annex V and Annex VI of the regulation.

These specify for example, the concentration of certain chemicals such as common solvents and excipients, substances considered to be of medical use, maximum concentration of certain substances in the product or the indication of a specific warning/statement on the packaging if these are present in the product.

Presence of certain allergens (e.g. benzyl benzoate, farnesol) must be indicated and labelled on the packaging of cosmetic products where their concentration exceeds a specified value (0,001 % for products that do not rinse, and 0,01 % for rinse-off products).

EU Legislation also regulates the list of prohibited substances that cannot be used in any way in preparations. These are generally corrosive substances (e.g. hydroxide calcium hydroxide) and CMR substances (e.g. petroleum distillates). (e.g. ethylene oxide), mutagenic (e.g. ethylene oxide) and substances toxic to reproduction.

Retinol and products containing retinol:

Retinol and retinol related substances and their content in cosmetics is directly regulated in Regulation 1223/2009. The maximum Retinol concentration is now 0.3% for face products and 0.05% for body products.

Yes, under Regulation 1223/2009 all cosmetic products available to consumers must have a “Responsible Person” who makes sure safety measures are followed and legal obligations are met.

A Responsible Person can be either:

• the manufacturer,
• the importer,
• the distributor, or
• an appointed company or person (who is named by the manufacturer or the importer).

Yes; Before making a cosmetic product available to consumers, its safety must be checked by a qualified safety assessor. The safety assessment must be EU regulations and state regulations compliant. E.g. the safety assessment on EU level can take the form of a Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor. The CPSR provides evidence of how the product is safe for its intended cosmetic use and takes account of reasonably foreseeable use.

In the Czech Republic the entity responsible for safety assessment of cosmetic products is National reference centre for cosmetics which provides analysis and safety assessment of cosmetic products.

In addition, a specific information can be required for cosmetic products intended for use on children under the age of three under Commission Regulation No. 1004/2014.

Yes, the packaging must be labelled in compliance with Regulation No. 1223/2009 and section 27 of Act No. 258/2000 Coll. on Public Health Protection.

All cosmetic products must be labelled in Czech language and carry, in particular, the following information:

• name or registered name and the address of the responsible person
• the weight or volume of the product
• date of minimum durability (not mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer.)
• precautions for use
• function of cosmetic product, unless it is clear from its presentation
• list of ingredients

Cosmetic product which are not packaged can have a separate labelling on a leaflet/card/tape/tag which is provided for consumer.

The marketing/promotion of cosmetics products is regulated by Act. No 40/1995 Coll. Advertisement Act, and Commission Regulation No. 655/2013.

Regulation No. 655/2013 sets out specific rules for claims regarding cosmetic products. In particular, these require that:

• The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product;
• All claims must be truthful;
• Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence;
• Marketing communications shall take into account the capacity of the target audience (population of relevant Member States or segments of the population, e.g. end users of different age and gender);
• Marketing communications shall be clear, precise, relevant and understandable by the target audience.

Although the Advertisement Act does not contain specific cosmetics regulation, it regulates the so called “health-targeted products”.

Under the Advertisement Act, it is prohibited to advertise health-targeted products which are not pharmaceuticals, medical devices or food for special medical purposes and which indicates that the product is a pharmaceutical, medical device or food for special medical purposes.

Advertisement of such products, cannot:

• Imply that the use of the product will improve or maintain the health of the person using it;
• Imply that non-use of the product may adversely affect the health of persons, or
• Recommend the product with reference to the recommendations of scientists, medical experts or persons who are not such experts but who, by virtue of their actual or presumed social status, could support the use of the product.

There are multiple mechanisms for compliance with regards to the regulations discussed in Q1.

Under Regulation No. 1223/2009 in case of breach of obligations competent authorities request the Responsible Person to take corrective action over a product that does not comply with the Regulation.

• A competent authority must request that the Responsible Person takes all appropriate measures, proportionate to the nature of the risk where there is certain non–compliance including corrective actions aimed at ensuring compliance, or withdrawal or recall, within an expressly mentioned time limit.
• 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 must 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.

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

Article 27 of the Regulation allows an enforcement authority to take direct provisional action where there is a serious risk to human health, or there are reasonable grounds for concern. An enforcement authority must obtain authorisation from the Secretary of State before taking any provisional measures.

On state level the competent authority is based on the character of the breach e.g. in case of breach of Act No. 258/2000 Coll. the breach is of administrative nature and can result in monetary fine.

In extreme cases, a criminal liability may also apply.

No, we do not expect any future development on the state level at the moment.

Key Regulation:

Supplements are regulated on national level alongside with directly applicable EU regulations. 

State level:

Act No. 110/1997 Coll. on foodstuffs and tobacco products

Decree of the Ministry of Agriculture No. 58/2018 Coll., on food supplements and food composition 

EU regulations:

Regulation No. 2015/2283 

Commission Regulation No. 432/2012

Regulation No. 1169/2011

Commission Regulation No. 1170/2009

Directive 2002/46/ES of the European Parliament and of the Council

Supplement definition: 

According to Act. No. 110/1997 Coll., food supplement means foodstuffs the purpose of which is to supplement the normal diet and which is concentrated source of vitamins and minerals or other substances having nutritional or physiological effect, alone or in combination, designed to be taken in measured small unit quantities.

Supplements in the Czech Republic are a separate category of foodstuffs regulated by Act No.:10/1997 Coll., and Decree No. 58/2018 Coll. which is direct transposition of EU Regulation 2002/46

Products classified as food preparations/supplements include:

• Products that do not treat, cure or prevent diseases or ailments are generally classed as food preparations.
• Food or dietary supplements (based on substances like plant extracts, fruit concentrates, honey or fructose) that contain added vitamins.

Yes, the composition of supplements is regulated.

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

Decree No. 58/2018 Coll. on food supplements and foodstuff composition includes a list of plants prohibited in food production and other substances prohibited in food production.

Further, it is not possible to put into food supplements narcotic or psychotropic substances, steroid substances, i.e. substances with anabolic and other hormonal effects, substances of a hormonal nature and other substances which have been shown to have toxic, genotoxic, teratogenic, hallucinogenic, narcotic or other adverse effects on the human body, etc.

In addition, the supplement launched on the market must be compliant with EU Regulation No. 2015/2283 and certain products containing novel foods cannot be sold or marketed unless approved.  

Food business operators are required to notify the supplement to the Ministry and is then responsible for maintaining requirements concerning  composition of food supplements, their labelling and method of use.

As long as supplements comply with EU law (the law specific to food supplements and all other applicable food law) then they are permitted for sale. It is the responsibility of the manufacturer, importer or retailer of the supplements to ensure that they comply with the law.

Food business operators are required to ensure the traceability of food. The concept of traceability means the ability to locate and trace, at all stages of production, processing and distribution, a food, feed, farm animal or substance which is intended or expected to be incorporated into food or feed.

They must be labelled as “food supplement”, and the label / package must include, in particular, the following information:

• the name of the vitamin or mineral or other substance; 
• the portion of the product recommended for daily consumption; 
• a warning not to exceed the stated recommended daily dose and conditions for use; 
• a statement to the effect that food supplements should not be used as a substitute for a varied diet; 
• a statement to the effect that the product should be stored out of the reach of young children; 
• the amount of any vitamin or mineral or other substance with a nutritional or physiological effect which is present in the product;
• a list of ingredients including common allergens which must be emphasised.

The labelling shall not:

• attribute to food supplements properties relating to the prevention, treatment or cure of human disease or refer to such properties; and
• contain any claim stating or implying that a balanced and varied diet cannot provide sufficient nutrients in general.

The information must be on either:

• the packaging;
• a label attached to the packaging; or on a leaflet added to the packaging accessible to the customer.

Yes, it is allowed. The advertisement of supplements is regulated by general rules of advertisement set out in the Advertisement Act. More detailed regulation is enshrined in Regulation No. 1924/2006 on nutrition and health claims made on food.

The special requirements are following:

• Supplements must be labelled as food supplements;
• It is forbidden to advertise supplements as having medicinal effects-it must be clearly communicated that the product is a supplement and has no healing properties;
• Health claims, including reduction of disease risk claims, must be made in line with rules set out primarily in Regulation No. 1924/2006.

The supplements must be compliant with the regulations from Q1. Compliance is controlled by competent inspection authorities.

It is an administrative offence. Non-compliance can amount to a monetary fine which varies based on the severity of the breach. 

Relevant supervision authority is Czech Agriculture and Food Inspection Authority. In case of breach of the food supplements regulations, it can take diverse corrective actions such as prohibition of use of packaging and labels, prohibit launch of supplements on the market, order product recall, block web of the supplement seller/distributor and finally award fines.

In extreme cases, criminal liability may also apply.

We are not aware of any developments, at the moment.

Czech law regulates separately cosmetic devices which are professionally used and fall within the category of medical devices. Beauty devices for home use are not specifically regulated. They must comply with General Product safety regulation.

Under Act No. 102/2001 Coll. on General Product Safety, all products must be safe in their normal or reasonably foreseeable usage, must contain information on the usage and provide information for the consumer regarding the properties of the device, longevity, risks of usage etc. All information regarding the product must be in Czech language.

As from 13 December 2024, new EU general product safety regulation should become directly effective in the Czech Republic.

The authority enforcing product safety regulations is Czech Trade Inspection.

Medical device is defined by Act No. 375/2022 referencing EU regulations “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 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.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilisation of above devices.

Under General Product Safety Regulation (i.e. in cases when cosmetic device is not a medical device), the producer or distributor is responsible for the product safety.

Cosmetic devices (which are not medical devices) must comply with General Product Safety Regulation.

Cosmetic devices must comply with the general advertising regulations that apply to all products. In case that the cosmetic device would qualify as a medical device, special rules set out in the Advertisement Act concerning medical devices, would apply.

Enforcement powers of Czech Trade inspection include the ability to enter premises, inspect goods, issue notices, obtain evidence, and request technical documents.

The enforcement measures chosen will be proportionate to the risk and the breach. Measures include:

• Suspension notices
• Requirements to mark / warn
• Service of withdrawal notices
• Recall notices
• Monetary penalty

In extreme cases, criminal liability may apply.

Yes, the EU Commission has now defined “Common Specifications” in the implementing Regulation 2022/2346, which gives requirements for the risk management and labelling for each of the following specified groups of beauty devices:

• Liposuction, lipolysis, and lipoplasty devices
• Light emitting equipment, such as lasers or intense pulse light (IPL) devices for hair or tattoo removal, skin resurfacing, or other skin treatments

Under these procedures are listed 2 sub-groups:

1. medical procedures (further regulated by Act No. 372/2011, Coll. on medical care);
2. cosmetic procedures influencing the skin integrity regulated by Trade Act No. 455/1991 Coll.

Procedures such as injection of Botulinum toxins / Fillers, Vitamin drips/ Vitamin injections, weight loss injections etc. can be administered or prescribed only by a licensed doctor practicing in the relevant field of medicine.

IPL and laser treatments also must follow Regulation of the Czech Government 291/2015 Coll., on Protection of health against non-ionising radiation.

For administration of cosmetics procedures which influence the integrity of skin it is mandatory to have special higher cosmetology education and have proper trade licensing under Trade Act No. 455/1991 Coll. Cosmetologists are allowed to perform only minor procedures interfering with skin integrity such as semi-permanent make up, whole body cryotherapy, certain IPL and laser treatments.

IPL and laser treatments are classified under Czech legislation into categories based on the “strength” of the laser/IPL. If the IPL/laser falls within category 2 and higher of norm ČSN EN 60825-1:2007 only qualified medical practitioners are allowed to provide treatment using these.

As a general rule, the Civil Code sets out that children under the age of 18 may consent to a procedure on his or her own body in the usual cases, if it is appropriate to the minor's mental maturity and if it is a procedure that does not have permanent or serious consequences. In other cases, it would be likely required to have the consent of the children’s legal representatives (parents).

It is a prescription only drug and only certified doctors from relevant field of expertise can prescribe the drug and administer it.  

To prescribe and administer BT the doctor must have completed a master´s cycle of MD education, followed a relevant practice, be licensed in the relevant field and be registered In the Czech Medical Chamber.

Yes, doctors administering these services must be, among other things, licensed and registered in Czech Medical Chamber. This body administers disciplinary complaints, Members can be removed from the chamber for breaching the professional codes of conduct.

Cosmetologists administering procedures intervening with skin integrity are not obliged to be registered within a specific professional body, however, they need to hold the relevant trade license. 

The consequences for malpractice and or non-compliance with the relevant regulation varies based on the severity of breach.

It can include a civil law liability (in case of damage to health of person), administrative sanctions (in case of breach of public law regulations), or even a criminal law liability.

No, the advertisement must comply with general legislation regarding advertisements set out under the Advertisement Act.

We are not aware of any developments, at the moment.