Comprehensive Legal Overview of Beauty Products in Serbia

The Act on Items of General Use (2019)
The Rulebook on Cosmetic Products (2019)

Cosmetic products are substances or mixtures intended to be put in contact with the external parts of the human body (epidermis, hair, nails, lips, external genitalia) or with the teeth and mucous membranes of the oral cavity, exclusively or mainly for the purpose of cleaning, perfuming, altering their appearance, i.e. correcting body odours, i.e. protecting and keeping them in good condition.

The term cosmetic product does not include substances or mixtures intended to be ingested, inhaled, injected or implanted in the human body.

For certain products ("borderline products"), it may not be sufficiently clear, due to their appearance/presentation, composition, area of application, claims and other characteristics, whether they should be categorised as cosmetic products/products for general use within the meaning of this Act, or whether they should meet the requirements of regulations relating to other product categories. The decision on the categorisation of each individual borderline product shall be made by the sanitary inspector on a case-by-case basis, taking into account all product characteristics and applying the recommendations or guidelines used in the European Union.

If the sanitary inspector is unable to classify the product in the course of sanitary supervision and despite the application of the principle referred to in paragraph 1 of this article, he may request the opinion of the special working group of the Ministry of Health for the classification of borderline products.

The opinion of the special working group is binding. The special working group is obliged to issue an opinion within seven working days from the date of receipt of the request for an opinion.

For example, a toothpaste can be a cosmetic product or a medical device, depending on its characteristics.

A (general) medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other product, used alone or in combination, including software, which is intended by its manufacturer to be used for diagnostic or therapeutic purposes and for which software support is necessary for its proper application in human beings in accordance with the manufacturer's instructions, and which is used:

to diagnose, prevent, monitor, predict, prognose, treat or mitigate disease;
to diagnose, monitor, treat, mitigate or replace an injury or disability;
for examination, replacement or modification of anatomical or physiological or pathological functions and conditions;
for providing information through in vitro testing of human blood samples, including organ, blood and tissue donations;
for birth control or assistance;
for cleaning, disinfecting or sterilising medical devices.

Such products would require marketing authorisation from the Agency for Medicines and Medical Devices (ALIMS).

According to the Rulebook on Cosmetic Products, there are substances that may not be present in cosmetic products and substances that may be present but only in limited quantities. This area is further regulated in the Shedules, which are an integral part of the Rulebook on Cosmetic Products.

The cosmetic product must not contain:

substances whose use is prohibited in cosmetic products, listed in Schedule 2.
substances listed in Schedule 3, except under the conditions and with the restrictions listed in this Schedule. (For example, Tri glycolic acid and its salts, which are used in products for curling and straightening hair, the maximum concentration in general use is 8%, while in professional use it is 11%.)
colours that are not listed in Schedule 4, as well as colours from Schedule 4, if they are not used under the conditions specified in that Schedule.
preservatives not listed in Schedule 5, as well as preservatives from Schedule 5, if they are not used under the conditions specified in that Schedule.
UV filters that are not listed in Schedule 6, as well as UV filters from Schedule 6, if they are not used under the conditions specified in that Schedule.

In addition, the use of substances classified as carcinogenic, mutagenic or toxic for reproduction, category 2, under the regulation on the classification, packaging, labelling and advertising of chemicals and certain products, is prohibited in the manufacture of cosmetic products.

All cosmetic products available to consumers must have a responsible person who ensures that each cosmetic product placed on the market complies with the obligations (the Responsible Person).

A Responsible Person can be either:

the manufacturer,
the importer,
the distributor, if they label the product as their own (for example, using their brand name) or when he modifies a product already placed on the market in a way that may affect its compliance with the requirements that apply to him, or
an appointed company or person (who is named by the manufacturer or the importer).

Cosmetic products placed on the market must be safe for human health, if applied under normal or reasonably foreseeable conditions, taking into account in particular:

product appearance including compliance with regulations governing deceptive products in terms of general product safety,
its label,
instructions for use and disposal,
any other data or information provided by the Responsible Person, defined in the law.

In order to prove that the cosmetic product complies with the law, the Responsible Person shall ensure that the cosmetic product has passed a safety assessment based on relevant information before being placed on the market and that a report on the safety of the cosmetic product has been prepared. The safety assessment of the cosmetic product must be carried out by a qualified person.

The information on the label must be indelible, clearly legible and visible. The container and any packaging must be labelled with:

the name and address of the Responsible Person, and the country of origin,
the weight or volume,
the date which the cosmetic product can be used (minimum shelf life of the product),
application conditions and warnings,
production batch number (product control number),
purpose of the product,
list of product ingredients - these can be provided solely on the packaging. Note that nanomaterial ingredients must be followed by ‘(nano)’

It may not be practical to include precautions and ingredients for certain cosmetic products, for example due to available space on packaging. If this is the case, it is important to include this information within the packaging, for example on a leaflet. A symbol should be used to indicate where this information is.

It is forbidden to declare or advertise cosmetic products in such a way as to mislead the consumer as to the actual composition, properties or purpose of such products.

In the labelling of cosmetic products (for the purpose of placing on the market and advertising), no text, names, trademarks, images or other signs may be used with the aim of attributing to the specified product characteristics which it does not possess.

The Ministry of Health, through the sanitary inspectors, supervises the implementation of this law.

The sanitary inspector, in the course of the inspection supervision, in order to establish the decisive facts, in addition to the direct inspection in the facility or other places of control, carries out a review of the documentation, a physical or sensory inspection of the characteristics of items of general use, and takes samples for laboratory testing if necessary, i.e. if it is not possible to establish the correctness of the product in any other way, taking into account the established principles of risk assessment, the request of the party, objections and other available information.

A legal entity will be fined RSD 300,000 to RSD 3,000,000 (approx. EUR 2,550 to EUR 25,600) for an economic offence if it places a product on the market in the Republic of Serbia that is not medically correct, i.e. safe, i.e. in conformity with the regulations. The responsible person in the legal entity will be fined from RSD 50,000 to RSD 200,000 (approx. EUR 430 to EUR 1,700).

In addition, a legal entity will be fined RSD 300,000 (approx. EUR 2,550) and the responsible person in the legal entity will be fined RSD 30,000 (approx. EUR 260) for a violation of the specified obligations under the Act on Items of General Use.

We have no information in this respect.

The Food Safety Act (2009)
The Rulebook on Nutritional Supplements (2022)

Nutritional supplements are foods intended to supplement the usual diet and which are concentrated sources of nutrients or other ingredients with a nutritional or physiological effect, individually or in combination, and which are marketed in dosage forms such as capsules, lozenges, tablets and the like, sachets of powder, liquid ampoules, dropper bottles and other similar forms of liquids and powders intended to be taken in small doses.

Nutritional supplements are classified as foodstuffs and not as cosmetic products (although they may have a cosmetic outcome).

Yes. There are rules on the vitamins and minerals that can be used in the manufacture of nutritional supplements, their chemical forms and the maximum amounts allowed in the daily dose of the nutritional supplement for adults.

There are also rules on the maximum levels of certain chemical contaminants in foods and microbiological criteria.

There are restrictions on the use of plants, parts of plants or plant preparations in food supplements.

The food business operator is the one responsible for the product it puts on the market.

A food business operator is required to have a responsible person with appropriate professional training for the implementation of good production and hygiene practices and the application of HACCP in a permanent employment relationship.

Before placing a nutritional supplements on the market, the food business operator shall, inter alia, obtain:

an opinion and an analytical report from a health institution on the safety of the food supplement;
a certificate from the competent authority that the nutritional supplement has been produced in accordance with the principles of HACCP and/or GMP and GHP;
a declaration by the manufacturer that the food supplement does not contain GMOs and does not contain raw materials associated with the risk of bovine spongiform encephalopathy and other transmissible spongiform encephalopathies (BSE/TSE);
a photocopy of the decision, i.e. the record of the sanitary inspector on the fulfilment of the general and specific sanitary and hygiene conditions for the manufacture of nutritional supplements and that the nutritional supplement has been manufactured in accordance with the principles of HACCP, for manufacturers in the Republic of Serbia.

Food business operator shall ensure that food supplements comply with the relevant microbiological criteria set out in the relevant Annex of the Rulebook on Nutritional Supplements.

The Food Safety Act stipulates that food business operators at all stages of the production, processing and trade of food under their control are obliged to ensure that the food meets the conditions laid down by law and other special regulations, and to provide evidence of compliance with these conditions. It also specifies that the legal entity must have systems and procedures in place to ensure the availability of traceability data.

Food that is placed on the market or is likely to be placed on the market in the territory of the Republic of Serbia must be appropriately marked and recorded for the purpose of identification and traceability of the food.

Nutritional supplements shall be labelled as 'nutritional supplements' and shall be marked or labelled with (in addition to the general labelling requirements for foods):

the names of the categories of nutrients or substances that characterise the product or a description of the nature of the nutrients or substances;
the amount of the product recommended for daily consumption;
a warning that the recommended daily amount should not be exceeded;
state that food supplements are not a substitute for a varied diet;
a statement that the product should be kept out of the reach of young children;
instructions on how to use the nutritional supplement; restrictions on use and special warnings for potentially high-risk categories: children, pregnant women, nursing mothers, people suffering from chronic diseases, etc.

The label may, where appropriate, include information on the intended purpose of the product without misleading the consumer. The declaration, labelling and advertising of nutritional supplements shall not attribute to them the properties of preventing, treating or curing disease or refer to such properties.

The declaration, labelling and advertising of nutritional supplements shall not contain any statement suggesting or claiming that a balanced and varied diet cannot provide adequate amounts of nutrients.

Advertising is allowed, but in a way that does not mislead the consumer. Advertising for nutritional supplements must not imply or refer to the prevention, treatment or cure of disease.

Advertising for nutritional supplements must not suggest or claim that a balanced and varied diet cannot provide adequate amounts of nutrients.

Competent inspectors may establish violations of legal obligations and initiate proceedings for economic offences or misdemeanours in court.

A legal entity is fined from RSD 300,000 to RSD 3,000,000 (approx. EUR 2,550 to EUR 25,600) for economic offences stipulated in the Food Safety Act. The responsible person in the legal entity will be fined from RSD 50,000 to RSD 200,000 (approx. EUR 430 to EUR 1,700).

A legal entity will be fined from RSD 150,000 to RSD 1,000,000 (approx. EUR 1,300 and EUR 8,500) for an misdemeanours under the Food Safety Act. The responsible person in the legal entity will be fined between RSD 20,000 and RSD 50,000 (approx. EUR 170 and EUR 1,700).

We have no information in this respect.

No. The same rules apply to cosmetic devices classified as cosmetic products, unless they are actually medical devices, in which case different rules apply.

N/A

The Healthcare Act (2019),
The Rulebook on Detailed Conditions and Methods for Health Technology Assessment (“the Rulebook on Anti-aging Medicine”),
The Sanitary Supervision Act (2004),
The Rulebook on Special Sanitary Standards for Facilities Providing Services for the Hygiene, Care and Beautification of the Face and Body (2019)

The Rulebook on Anti-aging Medicine defines anti-aging medicine methods as new health technologies and includes methods and procedures for the prevention, diagnosis, treatment and rehabilitation of age-related changes, i.e. methods whose application has a beneficial effect on health and physical appearance.

Aesthetic anti-age medicine methods and procedures can be carried out in a health institution or other legal entity authorised by law to provide health services, or in a private practice (the “healthcare institutions”).

Procedures in the field of aesthetic "anti-age" medicine are as follows:

techniques to replenish the volume of the skin, subcutaneous tissue and mucous membranes to eliminate signs of ageing (injection of dermal fillers),
botulinum toxin application - wrinkle correction,
minimally invasive face lifting techniques - thread lifting,
platelet enriched blood plasma injection technique in aesthetic medicine - removal of signs of aging on the skin of the face and body,
mesotherapy - application in aesthetic "anti-aging" medicine and application for therapeutic purposes,
chemical peeling - medium and deep,
electromagnetic radiation and lasers - use in aesthetic medicine:
1. laser application in aesthetic medicine,
2. Intense Pulsed Light (IPL) procedures,
3. radiofrequency devices, devices based on energies that heat tissue above 42°C,
4. plasma energy.

Other services from the list may be provided in accordance with the special sanitary standards for facilities providing services for the hygiene, care and beautification of the face and body and after obtaining a sanitary permit prior to commencing the provision of services (e.g. what rooms must be available, the temperature in the facility, how the floors and walls must be made, etc.).

It should be decided on a case-by-case basis what rules should apply in relation to the type of service provided.

According to the Patient Rights Act, a person up to the age of 18 is considered a child.

The law states that if the patient is a child or deprived of legal capacity, medical treatment may be given with the consent of the patient's legal representative.

No, but it can only be administered in a healthcare institution that is registered to provide this type of service.

These services may be provided by health care institutions that fulfil the legal requirements for providing health care services and are registered in the Register of Healthcare Institutions.

The Health Inspectorate supervises the work of health care institutions.

Other cosmetic services are subject to the general rules on registration of companies/entrepreneurs.

A healthcare institution or other legal entity will be fined RSD 300,000 to RSD 1,000,000 (approx. EUR 2,550 to EUR 25,600) for a misdemeanour if it fails to comply with the obligations set out in the Healthcare Act. The responsible person in the legal entity will be fined from RSD 50,000 to RSD 150,000 (approx. EUR 430 to EUR 1,300).

Criminal liability is also provided for in certain cases. Anyone providing treatment or other medical services without appropriate professional qualifications will be fined or imprisoned for up to three years.

The legal entity or organisation will be fined from RSD 250,000 to RSD 1,000,000 (approx. EUR 2,100 to EUR 25,600) for violations of sanitary regulations. The responsible person in the legal entity or organisation will be fined from RSD 15,000 to RSD 50,000 (approx. EUR 130 to EUR 430).

In accordance with the Healthcare Act, it is permitted to advertise health care services, professional medical procedures and health care methods performed in a health care institution in accordance with the decision of the Ministry of Health on the fulfilment of the prescribed conditions for the performance of health care activities, as well as methods and procedures of complementary medicine in accordance with the permit of the Ministry of Health for the performance of certain methods and procedures of complementary medicine, and the contact details of the health care institution, for the purpose of informing the patient.

Other services that do not fall under health services are subject to the general rules on advertising.

The law does not provide for, i.e. regulate, the possibility of booking healthcare or other services via third-party platforms.

We have no information in this respect.

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CMS Expert Guide on Beauty in Serbia

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Cosmetics & Supplements

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Beauty devices

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

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

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

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

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

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

Cosmetic (non-surgical) services

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

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

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

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

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

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

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

Last updated · 06 Jan 2025

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