CMS Expert Guide on Beauty in Romania

EU Regulation No 1223/2009 on cosmetic products (“EU Regulation 1223”) and EU Regulation No 655/2013 establishing common criteria for substantiating claims made in relation to cosmetic products (“EU Regulation 655”) are directly applicable in Romania. These EU regulations were implemented by Government Decision no. 147/2015 on the adoption of measures to create a framework for the application of Regulation 1223 and Regulation 655 (“Government Decision 147”).

A cosmetic product is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.  

Products intended to be ingested, inhaled, injected or implanted into the human body are not classified as a cosmetic product. Therefore, products which are ingested but claim to have “cosmetic benefits” i.e. improving skin, hair and nails, would likely fall under the food supplement regime.

Medicinal products defined as any substance or combination of substances either (a) presented for treating or preventing disease in human beings or (b) which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. Medicinal products require marketing authorisation from the National Agency for Medicines and Medical Devices in Romania (AMNDMR).

Where, taking into account all the characteristics of a product, a product may fall both within the definition of a medicinal product and within the definition of a cosmetic product, the provisions on medicinal products shall apply.

EU Regulation 1223 provides for restrictions for substances used in cosmetic products.

Certain substances are prohibited in any circumstances, others are only restricted and may be used provided that certain requirements are met.

Broadly, the EU Regulation 1223 prohibits:

1. all substances listed in Annex II;
2. substances listed in Annex III which are not used in accordance with the restrictions laid down in the that annex;
3. colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that annex;
4. preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that annex;
5. UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that annex.

A variety of restrictions are specified under EU Regulation 1223, for example the concentration of certain chemicals in products for home use and for professional use or the wording of conditions of use and warnings that must be displayed on the label.

EU Regulation 1223 further prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (“CMR substances”) according to EU Regulation No. 1272/2008 on classification, labelling and packaging of substances and mixtures. The use is either absolute or restricted if certain conditions are fulfilled, depending on the category of the CMR substance.

The lists are constantly updated. For example, Butylphenyl Methylpropional (Lilial), a substance which was used in different types of cosmetic products, was prohibited in 2022.

Other restrictions will also apply from 2025, such as related to the maximum concentration of retinol.

According to EU regulation 1223, all cosmetic products available to consumers must have a ‘Responsible Person’ who shall ensure compliance with legal obligations and make sure safety measures are followed.

A Responsible Person can be either:

• the manufacturer,
• the importer,
• the distributor (if it sells the products under its name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected) or
• an appointed company or person (who is named by the manufacturer or the importer).

According to EU Regulation 1223, a safety assessment needs to be performed prior to placing a cosmetic product on the market.

The cosmetic product safety assessment shall be carried out by a qualified person and should take the form of a Cosmetic Product Safety Report (CPSR). The CPSR provides information on the composition of the product, the functions of the component substances, the foreseeable use of the product, undesirable effects etc. Within the safety assessment, tests on the stability of the product and on the preservation should be conducted. In addition, a specific safety assessment is required for cosmetic products intended for use on children under the age of three, and for cosmetic products intended exclusively for use in external intimate hygiene.

Cosmetic products shall be made available on the market only where the container and packaging bear the following information in indelible, easily legible and visible lettering:

• the name or registered name and the address of the responsible person;
• the country of origin for imported cosmetic products;
• the weight or volume, with some exceptions;
• the date until which the cosmetic product, stored;
• the date of minimum durability;
• particular precautions for use;
• the batch number or the reference for identifying the product;
• the function of the cosmetic product, unless it is clear from its presentation;
• the ingredients.

Translation in Romanian of certain information on the labels is mandatory and the Romanian Consumer Protection Authority if very active in sanctioning the companies which do not comply with their obligations, as interpreted broadly, in conjunction with the general consumer protection rules applicable in Romania. 

EU Regulation 655, directly applicable in Romania, lays down the common criteria for the justification of claims used in relation to cosmetic products.

Amongst other requirements, claims for cosmetic products shall:

• be truthful, meaning that the ingredients claimed on a product should be deliberately present in the product’s composition;
• be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments;
• be clear and understandable to the average end user;
• contain information allowing the average end user to make an informed choice;
• be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used;
• not create confusion with the product of a competitor.

Also, guidelines for advertising of cosmetic products can be found in the soft law, i.e., the Principles for responsible advertising and marketing communications for cosmetic products issued by the Romanian Advertising Council.

In addition, the general provisions on advertising apply.

Government Decision 147 establishes the enforcement mechanism for compliance with EU Regulation 1223 and EU Regulation 655. Failure to comply with the obligations enacted therein is considered a misdemeanour and is sanctioned with a fine (up to EUR 10,000 for companies, depending on the infringed obligation). Authorities may also impose corrective measures, such as recall or withdrawal from the market.

Depending on the infringed obligation, the competent authority for finding the infringement, sanctioning the company and applying corrective measures is either the Ministry of Health or the National Consumer Protection Authority. These authorities may also samples of the cosmetic product they deem necessary for physical and laboratory verifications.

Government Decision 147 doesn’t provide for criminal liability in case of non-compliance with the cosmetics regulations, but there may be cases in which criminal liability could be engaged, e.g. if altered products affecting health are knowingly sold on the market.

There is no indication of future development in the field in the near future. 

Food supplements are regulated in Romania by Food Supplements Law No. 56/2021 (“Law 56”), which transposed Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements (Food Supplements Directive). Also, the legislation on foodstuffs is also applicable to food supplements.

Under Law 56, food supplements are defined as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with nutritional or physiological effects, either alone or in combination, marketed in dose form, such as capsules, tablets, pills, or other similar forms, sachets of powder, ampoules of liquid, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

Medicinal and aromatic plants and beehive products are separately regulated.

Also, where the product is qualified as a medicinal products, the legislation on medicinal products applies. The delimitation between food supplements and medicines is sometimes difficult to make. In 2022, the Romanian Competition Council emphasized in a report the need to distinguish between the two categories of products in order to avoid misleading consumers. 

Law 56 provides that only vitamins and minerals covered by EU legislation may be used in the manufacture of food supplements. At EU level, the Food Supplements Directive provides that only certain vitamins and minerals listed in Annex I and in the form listed in Annex II may be used in the manufacture of food supplements. Substances not listed in the Directive cannot be used.

To place the food supplement on the Romanian market, the producer, the importer or the person responsible with the placing the product on the market must file for a notification certificate and must comply with the obligations provided by the specific legislation.

Generally, as long as food supplements comply with Romanian and EU law (the law specific to food supplements and all other applicable food law) and a notification certificate is obtained, then they are permitted for sale. The notification procedure with the Public Health Institute is mandatory before placing a food supplement on the market. Food supplements may not be placed on the market before the date of issue of the notification certificate.

Certain food supplements must undergo a prior physico-chemical and microbiological analysis. The resulting report issued by a third party accredited laboratory should be filed when requesting for the notification certificate.

The food supplements legislation doesn’t provide a specific obligation for food supplements operators to keep records in relation to supplements made available to customers. However, general rules on foodstuff, data protection and tax may require so.

The label of food supplements must include the following indications:

• the names of the categories of nutrients or substances that characterise the product or an indication of the nature of these nutrients or substances;
• the recommended daily portion;
• a warning against exceeding the recommended daily portion;
• a warning regarding the avoidance of using dietary supplements as a substitute for a varied diet;
• a warning indicating that these products should be kept out of reach of young children.

On the labels and presentation of food supplements, it is prohibited (a) to attribute to food supplements properties for the prevention, treatment or cure of a human disease or to refer to such properties and (b) to use direct or implying claims that a varied and balanced diet cannot provide adequate amounts of nutrients.

The advertising of supplements is permitted only after the content of the advertising material has been approved by the Public Health Authority within the Ministry of Health, and it cannot make references to treatments, prevention, or diseases.

The commercial communications for the promotion of food supplements must also comply with the general provisions on advertising.

Only the information present on the label of the food supplement, analysed within the notification certification procedure by the National Institute of Public Health, in accordance with the provisions of national/European legislation in force, shall be used.

In marketing communications relating to food supplements, it is prohibited (a) to attribute to food supplements properties for the prevention, treatment or cure of a human disease or to refer to such properties and (b) to use direct or implying claims that a varied and balanced diet cannot provide adequate amounts of nutrients.

Moreover, guidelines for marketing/promotion of food supplements can be found in the soft law, such as the Guide for communication related to food supplements – Annex to the Code for interactions with the healthcare professional and general public, issued by RASCI.

In addition, the general provisions on advertising apply.

The supervision and market control of supplements are carried out by state health inspectors from the county-level state health inspections and the Bucharest municipal state health inspection.

The authority responsible with the control of the labelling and advertising of food supplements is the Consumer Protection Authority.

Non-compliance with the legal obligations is considered a misdemeanour sanctioned with a fine up to EUR 3,000. Complementary sanctions such as suspension of activities may also be applied by the competent authorities.

Additionally, the act of preparing or manufacturing counterfeit dietary supplements, as well as introducing, offering, selling, or distributing such supplements while knowing they are counterfeit, constitutes a criminal offense and is punishable according to the provisions of the Criminal Code.

Under Law 56, the Government should have adopted a set of technical rules for the manufacture, marketing, advertising and use of food supplements. While the deadline has been long surpassed, the adoption of such set of rules is awaited. The new set of rules might should change and supplement the current legal framework on food supplements. 

Also, there is a draft law including food supplements marketed exclusively within the agricultural and food supply chain in the scope of Law 81/2022 on commercial practices in the agricultural and food supply chain (transposing the EU UTP Directive 2019/633) which has the potential to hugely impact the relations between buyers and suppliers of food supplements.             

The notion of cosmetic devices is not regulated as such in Romania.

Medical devices are regulated separately from cosmetic products. While cosmetic products fall under the Regulation 1223, some cosmetic devices fall under the scope of the EU Medical Devices Regulation No. 2017/745 (“MDR”).

The MDR covers devices intended for medical purposes, as well as certain devices without an intended medical purpose, listed in Annex XVI of the MDR. Lasers, microneedling, LED light masks and radio frequency devices would qualify as devices under MDR’s scope of application.

On a national level, medical devices are also regulated by Government Emergency Ordinance No. 46/2021 on establishing the institutional framework and measures for the implementation of the MDR (“GEO 46”) and by the Law No. 95/2006 on healthcare reform.

The National Agency for Medicines and Medical Devices (“ANMDMR”) oversees the regulation of the medical devices.

Where the devices do not fall within the scope of the MDR, the general provisions on the sale of products, general product safety and consumer protection should apply.

Medical device manufacturers must ensure that their devices are designed and manufactured in accordance with EU requirements when they are placed on the market or put into service. In addition, they must implement a risk management system.

If the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer appoints a single authorized representative.

Import, distribution, and service activities in the field of medical devices, including the remote sale of medical devices via information society services, are subject to control and require authorization. The exception to this requirement applies to activities carried out by the manufacturer of the medical devices subject to such activities. The authorization is issued by the ANMDMR.

In addition, manufacturers are required to have within their organization at least one person responsible for regulatory compliance, who possesses the necessary expertise in the field of medical devices.

Generally, a device should meet the general safety and performance requirements set out in Annex I of the MDR which apply to it, taking into account its intended purpose. The conformity with the relevant general safety and performance requirements under the normal conditions of the intended use of the device should be based on clinical data providing sufficient clinical evidence. In this respect, a clinical evaluation shall be performed.

The MDR requires certain safety related standards to be complied with by the manufacturers:

• Risk Management System: Manufacturers must establish, document, implement, and manage a risk management system.
• Clinical Evaluation: Manufacturers must conduct a clinical evaluation including the Post-Market Clinical Follow-up (PMCF).
• Technical Documentation: Manufacturers of devices, other than custom-made devices, are required to prepare and maintain up-to-date technical documentation that allows for the assessment of conformity with the regulation.
• Custom-Made Devices: Manufacturers of custom-made devices must prepare, update, and make available to the competent authorities the documentation to allow the conformity of the device with the requirements of the regulation to be assessed.
• Declaration of Conformity and CE Marking: Once compliance with applicable requirements has been demonstrated through the appropriate conformity assessment procedure, manufacturers (except those of custom-made devices or devices under investigation) must draw up an EU Declaration of Conformity and affix the CE marking.
• UDI and Registration Obligations: Manufacturers must comply with the obligations related to the UDI (Unique Device Identification) system.

Specific obligations are provided additionally depending on the classification of the devices. For example, for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.

GEO 46 provides for specific rules for the advertising of medical devices for both the general public and for healthcare professionals.

Advertising intended for the general public must be submitted to the ANMDMR for approval and can be distributed only after obtaining advertising clearance from the authority.

Advertising of a medical device intended for health professionals, when it belongs to the category of medical devices with a high degree of risk to the health of the population, must be notified in advance to the ANMDMR, as a matter of urgency.

As a general rule, advertising for medical devices must be objective, accurate, and not misleading, providing clear information for both the public and healthcare professionals. Claims must be supported by clinical evidence, and all ads must align with product instructions.

Public advertising is prohibited for devices needing medical recommendations. However, advertising is allowed for the medical devices intended to be used without the intervention of qualified medical personnel, where pharmacists’ advice may suffice.

On a high level, advertising for medical devices directed at the general public must clearly identify the product as a medical device and provide essential information, including its name, intended use, and usage instructions. It must not mislead or imply guaranteed results, negate the need for medical consultation, or target children. Additionally, endorsements from celebrities or non-experts, and comparisons to cosmetics or other products, are prohibited. Advertisements must not exaggerate claims, mislead regarding safety or efficacy, or depict alarming visuals of health conditions or device effects.

Advertising for medical devices intended for health professionals must be tailored to the recipients and must contain particular information.

There are also guidelines for marketing/promotion of medical devices found in the soft law, such as the Guide for communication of medical devices – Annex to the Code for interactions with the healthcare professional and general public, issued by RASCI.

In addition, the general provisions on advertising apply.

Non-compliance with the obligations set forth by the specific regulations on medical devices are considered misdemeanours, unless there are classified as crimes under criminal law.

The competent authority may apply fined up to EUR 5,000, as well as complementary measures such as withdrawal of non-compliant medical devices from the market, prohibition to use and/or to place the product on the market. The severity of penalties varies based on the specific contravention and the party responsible. Repeated violations can lead to further sanctions, including suspension of operational licenses.

GEO 46 doesn’t provide for criminal liability specifically applicable in case of non-compliance with the medical devices regulations, but there may be cases in which criminal liability could be engaged under criminal law.

The Ministry of Health published in 2022 a draft order for the approval of Methodological Rules on the advertising of medical devices. However, the draft order has not been adopted yet and there is no information as to whether the adoption was dropped by the authority.

Also, the draft law for approving GEO 46 is currently pending before the Parliament. After a constitutionality re-examination, the draft law amended certain provisions of the GEO 46 on the advertising of medical devices.  

Some of the above-mentioned cosmetic services are regulated by Order No. 1648/2024 for the approval of Hygiene Rules for beauty salons and tattoo, piercing and dermal implantation salons (“Hygiene Rules”), as enacted by the Romanian Ministry of Health. From a consumer protection perspective, the provision of these services should also comply with the general legislation on consumer protection.

The Hygiene Rules do not include the procedures implying the usage of certain medical devices (for example, a medical device used for the injection of Botulinum toxins, Fillers, Vitamin injections etc).

Where, procedures are considered medical interventions – such as the injections with botulinum toxins/fillers, these are subject to specific rules on healthcare (the main enactment being Law No. 95/2006 on healthcare reform).

It should also be taken into consideration that depending on their qualification, some procedures may be regulated under specific acts, such as Vampire facials/platelet-rich plasma which may be subject to specific rules on the use of substances of human origin intended for human application.

The Hygiene Rules state that it is forbidden to perform body piercing and dermal implant procedures on persons under the age of 16, except for piercing in the ear area for which the consent of the parent/guardian is required.

The same rules also prohibit the performance of cosmetic and artistic tattooing procedures or genital piercing on persons under the age of 18.

Where procedures are considered medical interventions, these cannot be performed on persons under the age of 18 without parental consent, except for certain limited cases.

Botulinum toxin is a prescription drug in Romania. Medical prescriptions can be issued by doctors only.

As the injection of the botulinum toxin is considered a specific medical intervention, only physicians should be able to do it. Even more, the physicians should have a particular specialty, certification or training to be able to perform this procedure.

In certain cases, such as completing complementary studies, dentists may also administer the botulinum toxin.

According to the Hygiene Rules, the operator/ aesthetician/ aesthetic operator/ technician is represented by a person who is trained and qualified, following the completion of an accredited specialization course. These persons are not registered at a centralised body.

In respect of physicians, they must be registered with the Romanian College of Physicians with a license to practice.

If a patient is dissatisfied with the services received from a physician or considers it was subject to medical malpractice, he or she has several options to complain. One option is to file a complaint with the College of Physicians, who is authorized to analyse cases of deviations from the rules of professional ethics, medical deontology and the rules of good professional practice, as a body of professional jurisdiction. The same is valid with complaints against dentists, filed with the College of Dentists.

Another option would be to file a claim in court based on civil liability – please see answer to Question 5 for more information.

Healthcare professional shall be liable under civil law for damage:

• caused by error, including negligence, recklessness or insufficient medical knowledge in the exercise of their profession, by individual acts in the course of preventive, diagnostic or treatment procedures.
• arising from failure to comply with norms on confidentiality, informed consent and duty to provide healthcare.
• arising out of the exercise of their profession and when exceeding the limits of their competence, except in emergencies where medical personnel with the necessary competence are not available.

Persons may file complaints directly in court claiming damages based on the above, or with the College of Physicians/Dentists, which can start disciplinary actions against the physicians.

If the act that caused the damage constitutes a criminal offense under the law, criminal liability may also be incurred

Additionally, under the Romanian Criminal Code, practicing without right a profession or activity for which the law requires authorization or the practice of such activities in conditions other than those prescribed by law, if the special law provides that the commission of such acts is punishable under criminal law, is punishable by imprisonment from 3 months to one year or a fine. Therefore, performing procedures which require administration by a physician, without being a physician may be subject to criminal charges.

Regarding the provisions of the Hygiene Rules, the General Directorate of Public Health, together with the State Sanitary Inspectorate of the Ministry of Health and the Public Health Directorates of the Counties and Bucharest Municipality, public and private establishments in the field represent the empowered authorities to verify the compliance with such provisions.

The Code of Medical Ethics of the Romanian College of Physicians provides for specific rules applicable to advertising of medical activities (surgical or non-surgical).

Generally, advertising must be truthful, not misleading, respect professional secrecy and be carried out with dignity and prudence.

The Code expressly regulates rules and restrictions for advertising, the accepted means of advertising, the prohibition of unfair competition (including by way of advertising), as well as the content and presentation of a web page on medical activities.

Otherwise, advertising must comply with the provisions of general advertising legislation, such as Law No. 158/2008 on misleading and comparative advertising.

Third-party booking platforms which allow consumers to book non-surgical cosmetic services should also take into consideration these advertising regulations. Under Advertising Law No. 148/2000, the author, the advertiser and the legal representative of the broadcaster are jointly and severally liable with the person who advertises, in case of violation of the provisions of the advertising law.

There is no indication of future development in the field in the near future.