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Cosmetics & Supplements
- How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
- Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
- Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
- Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
- Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
- Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?
- Do the regulations in your jurisdiction specify what can and cannot be put in supplement products?
- Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
- Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards? If so, are there any exceptions/particular extra requirements for certain products?
- Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?
- Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
- Is the advertising and promotion of Supplements allowed in your jurisdiction? If so, under what conditions? Are there any specific requirements or regulations for advertising and promotion?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regards to the supply of supplements
- Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
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Beauty devices
- Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
- Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic devices and their safety placed on the market?
- Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
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Cosmetic (non-surgical) services
- Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
- Are there any rules in your national law which prevent an individual under the age of 18 (or other age as relevant) from receiving a particular non-surgical cosmetic service?
- Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
- Does the (national) law require that businesses and/or practitioners administering these services register with a centralised body? Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services?
- Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above.
- Are there any national laws or regulations which are relevant to the advertising of non-surgical cosmetic services? If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
jurisdiction
Cosmetics & Supplements
1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
They are ruled by the following:
- EU Regulation No 1223/2009 on Cosmetic Products, as amended by EU Regulation 344/2013 and, lastly, by EU Regulation 2024/996;
- Manual of the working group on cosmetic products (sub-group on borderline products established in EU Commission) on the scope of application of the cosmetics EU Regulation No 1223/2009 (art. 2(1)(a)) Version 5.3 (November 2023);
- Italian Legislative Decree No 204/2015;
- Italian Consumer Code, Legislative Decree No 206/2005.
Regarding the classification, the definition of a cosmetic product relies on three elements: its function, its field of application, and its composition. The Regulations specify that:
- the prevalent or only 6 functions are clean, perfume, change appearance, protect, keep them in good condition or correct body smells;
- the field of application relates to external parts of the body e.g., skin, hair, nails, teeth etc.;
- a cosmetic product may be a substance or mixture of a number of substances, and it may come in one or more than one part to be combined by the user.
Art. 2 specifies then that products, which are intended to be ingested, inhaled, injected or implanted, are not classified as cosmetic products. For example, products aimed to be ingested, but claim to have “cosmetic benefits” i.e. improving skin, hair and nails, would likely fall under the food supplement regime.
Differently, medicinal products are those which have properties for treating or preventing disease in human beings or which may be used/administered in order to restore, correct or modify physiological function, trough pharmacological, immunological or metabolic action. Such products would require marketing authorisation from the Italian Medicines Agency (AIFA), who would determine whether a product is medicinal or not.
The cosmetic, therefore, unlike drugs and medical devices, can not be considered a cure, can not intervene in people's state of health, and can only act on the abovementioned fields.
One of the main issue then is to classify borderline products, which are very numerous: on the matter, the European Commission publishes and regularly updates the Cosmetics Working Group Manual (Subgroup on Borderline Products) to help better orientate and facilitate the application of EU legislation in these cases, which reports a list of products and classify them.
As for example, shampoos may be cosmetics or medicines, depending on the constituents and the claims being made. Those mainly intended for hygiene, or are for anti-dandruff, are likely to be cosmetic products. However, if the claims are for the alleviation or treatment of itchy scalp, or dermatitis, then the product would fall to be a medicinal product as it suggests that an underlying medical condition exists.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
The EU Regulations prescribe what substances are prohibited (Annex II) or restricted (Annex III) in producing cosmetic products and which colourants, preservatives and UV filters are prohibited whether not present or conform (Annex IV, V and VI). The latter is then a positive list, meaning only substances listed shall be used.
On the contrary, Annex II contains the list of banned substances that may not be used in cosmetics. Please note that the being of trace amounts of these substances is tolerated as long as it is technically unavoidable.
These specify a variety of restrictions, for example, on the concentration of certain chemicals permitted in products for home use and for professional use. Tooth whitening products which contain or release between 0.1%-6% hydrogen peroxide are only available for professional use. Products containing or releasing less than 0.1% hydrogen peroxide are deemed safe for home use. If colourants, preservatives, or UV-filters are being used any restrictions or prohibitions which apply must be followed.
Please note that recently, as outlined even in Q8, the EU COMMISSION REGULATION (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products has stated that there will be a 0.3% retinol limit for skincare and face products and a 0.05% limit for bodycare going forward. However, it doesn't mean retinol products with higher concentrations will be abolished overnight. Indeed, it has been provided an exemption period of three years for brands to reformulate their existing retinol products should they wish to continue trading in Europe. Indeed, the new rules will be rolled out over 36 months and starting at the end of 2024.
Finally, please note that abovementioned Annexes may provide the utilisation of some of these products or substances exclusively by a professional.
Please note that the use of CBD in food and food supplements is allowed, but the Italian Government’ intention is to prohibit it wholly in the next few months. Nowadays, however, the Italian regulations do not prevent CBD from being used as an ingredient, even in cosmetics. Cosmetics with CBD are marketable in Italy if they are in accordance with the requirements of Regulation (EC) No 1223/2009 on 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?
Pursuant to art. 4 of the EU Regulation No 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, if they label the product as their own (for example, using their brand name); or
- an appointed company or person (who is named by the manufacturer or the importer).
Pursuant to art. 10 the Responsible Person shall ensure that cosmetic products, before being placed on the market, have undergone a safety assessment based on the relevant information and that Cosmetic Product Safety Report (CPSR) has been prepared.
Moreover, pursuant to art.11 the Responsible Person is required to keep a set of data and information related to the cosmetic at the disposal of the control authorities, the so-called "Product Information File" which is referred to by the acronym PIF (Product Information File).
The PIF consists of all information and data on the product to which it relates, among others it includes the following information: the qualitative and quantitative formula of the product, the physicochemical and microbiological specifications of the raw materials and finished product, the method of manufacture, data on the safety evaluation of the product, evidence of claimed effects, and existing data regarding undesirable effects on human health caused by the cosmetic product as a result of its use.
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
Pursuant to art. 8 of EU Regulation No 1223/2009 Good manufacturing practices (UNI EN ISO 22716) shall be complied with in manufacturing of cosmetic products.
Then, before making a cosmetic product available to consumers, its safety must be checked by a qualified safety assessor. The safety assessment should 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 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.
It is under responsibility of the Responsible Person guaranteeing that cosmetic products, before being placed on the market, have been subjected to safety assessment based on relevant information and a cosmetic product safety report has been prepared in accordance with Annex I of the EU Regulation.
Formulation and transparency tests are also required before launch.
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
First, packaging of cosmetic products must be made of suitable materials to ensure their safety and integrity.
Making cosmetic products safe for users also covers how a cosmetic product is presented. It must have clear labelling and have instructions on use and disposal.
The labelling for cosmetic products must be easy to read. The container and any packaging must be labelled with:
- the name and address of the Responsible Person;
- the country of origin if the product is imported to the EU;
- the weight or volume;
- the date which the cosmetic product can be used until;
- any precautions for use;
- an identification number (for example batch number);
- what the cosmetic product does;
- the ingredients - these can be provided solely on the packaging. Note that nanomaterial ingredients must be followed by ‘(nano)’. Please note that in the list, ingredients shall be present in descending order by weight at the time of incorporation into the cosmetic product. However, ingredients of which concentration is less than 1% may be listed in random order, after those present in concentrations greater than 1%.
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.
Consider also any new recycling / plastic packaging claims.
Moreover, according to Italian Consumer Code (art.9), all information for consumers and users must be made at least in Italian.
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
In Italy, advertising is in general terms ruled by Legislative Decree No 145/2007 and Italian Consumer Code, which provides that advertising shall:
- be true and is not likely to distort to an appreciable extent the economic behaviour, in relation to the product, of the consumer:
- be made in such a way that the advertising nature of the message is evident, and the product is clearly identified;
- promote rational use, presenting it objectively and without exaggerating its properties;
- not be misleading;
- objective claims be back by evidence, sometimes scientific evidence (e.g. for reversal of hair loss).
Moreover, art. 23 of the Consumer Code provides a list of business practices considered deceptive in all cases (e.g (lett f. refers to claims which are contrary to the truth or otherwise create the impression that the sale of the product is lawful).
7. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
Article 25 of the Regulation requires Ministry of Health, as designated competent authority, to request the Responsible Person to take corrective action over a product that does not comply with the Regulation. In this case:
- Ministry of Health 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 Ministry of Health must take all appropriate measures itself to stop the product going on the market, or to withdraw or recall products already on the market;
- Ministry of Health has all the powers 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 Ministry of Health, as designated competent authority, 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.
Please refer to Legislative Decree No 204 of 2015 provides different penalties depending on which provision of the regulation is not complied with. In general breach of the Regulation could result in a fine of up to EUR 100.000,00, or imprisonment, or both.
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.
No future developments are going to be enforced in Italy, a part form the one outlined before about CBD, which regards also, but non exclusively, cosmetics and which is only a prevision given by government.
9. Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?
Supplements are governed by:
- Directive 2002/46/CE;
- EU Regulation EC No. 1170/2009 amending Directive 2002/46/EC the lists of vitamins and minerals and their forms that can be added to foods, including food supplements;
- EU General Food Regulation, No 178/2002;
- Implementative Legislative Decree No 169/2004;
- Ministerial Decree of 9th July 2012 on "Regulation of the use in food supplements of herbal substances and preparations" supplementing Legislative Decree No 169/2004.
Food supplements are defined as products intended to supplement the common diet and which constitute a concentrated source of nutrients, such as vitamins and minerals, or other substances having a nutritional or physiological effect, particularly, but not exclusively, amino acids, essential fatty acids, fiber, and extracts of plant origin, whether single- or multi-compound, in pre-dosed forms.
An example of popular cosmetic supplements that would fall under these regulations is vitamin C or D supplement, which pills are ingested. Their packaging often indicates they are beneficial for maintaining general health or wellbeing.
Supplements are not permitted to contain medicinal ingredients. If it contains one or more ingredients, which is/ are regarded as medicinal and indicates a medicinal purpose (i.e. that it can treat, cure or prevent diseases), it is likely to be a medicinal product rather than a supplement. The Italian Medicines Agency (AIFA) is in charge of determining whether a product is medicinal or not.
Essentially, the difference between the medicinal product and cosmetic supplement is that the first one has a pharmacological and curative action, which the second does not have since its aim is to prevent from occurring or worsening, and for health purposes in healthy subjects, who do not have deficiencies, to maintain and improve health.
Please note that in order to be included in supplements, each substance must have a history of significant consumption within Europe as proof of safety, without which the product is classified as a novel food pursuant to Regulation (EU) 2015/2283.
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?
Pursuant to Legislative Decree No 169/ 2004 (art.3), only vitamins and minerals listed in Annex I, in the forms listed in Annex II, shall be used in the manufacture of food supplements (e.g retinol). As consequence, all substances not included cannot be present.
Certain products such as oils rich in omega-3 fatty acids derived from krill, which is classed as a “novel food”, cannot be marketed/sold unless approved.
CBD is not considered novel food as clarified by EU Commission on 2nd June 2023 and therefore no specific authorization by the European Commission according to EU Regulation 2015/2283 is required. The use of CBD in food and food supplements is allowed, but the Italian Government’ intention is to prohibit it wholly in the next few months. Nowadays, however, the Italian regulations do not prevent CBD from being used as an ingredient, even in supplements, with the only THC threshold of 0.5%.
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?
There is no provision for identifying a “Responsible Person”, but it is expected that the manufacturer or the one who places the supplements on the market will initiate a procedure for placing them on the market notifying to the Ministry of Health, which asses compliance with current regulations in order to ensure product safety and proper consumer information, and upon successful completion of which the products are included in a register that the Ministry of Health publishes and periodically updates.
The manufacturer or the one who places the supplements on the market will be legally responsible for all aspects of those goods, including composition, safety and labelling of the products.
Supplements must include a business name and address on the packaging. The label must include name/company name/brand and registered office of the producer or importer established in the European Union.
12. Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards? If so, are there any exceptions/particular extra requirements for certain products?
As long as supplements comply with EU and Italian law (the law specific to the specific ingredients used and all other applicable food law, such as Law No. 283/ 1962, as amended) 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.
The abovementioned regulations on the subject provide for purity requirements for listed substances and maximum quantitative levels of vitamins and minerals in dietary supplements per daily dose. Moreover, it is clear that any other ingredients used must be safe for human consumption and not be injurious to health.
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?
In general, the EU General Food Regulation, No 178/2002 provides that manufacturers (or persons treated as such) must keep track of the substances used and the persons for whom their products were intended.
On the contrary, European and Italian legislation on supplements does not define the specific obligation of manufacturers with regard to safety after being made available to the public.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
EU Regulation and Legislative Decree No 169/2004 set out labelling requirements for supplements. They must be labelled as “food supplement” (or similar) and marked or labelled with the following:
- the name of the category of any vitamin or mineral or other substance with a nutritional or physiological effect which characterises the product or an indication of the nature of that 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;
- a “use by” or “best before” date.
The information must be on either:
- the packaging;
- a label attached to the packaging; or
- a label which is clearly visible through the packaging.
Labelling for vitamin and mineral supplements must also (in addition to the above) include the percentage of the relevant Recommended Daily Allowance (RDA).
More generally, the labelling, presentation and advertising do not attribute therapeutic properties or the ability to prevent or cure human disease to dietary supplements or otherwise refer to such properties. In addition, no wording is included that states or implies that a balanced and varied diet is generally unable to provide the nutrients in sufficient quantities.
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?
Yes. EU Regulation and Legislative Decree No 169/2004, rule the advertising. As outlined in Q14 advertising do not attribute therapeutic properties or the ability to prevent or cure human disease to dietary supplements or otherwise refer to such properties. In addition, no wording is included that states or implies that a balanced and varied diet is generally unable to provide the nutrients in sufficient quantities.
Moreover, marketing communications for supplements include:
- in the case of supplements touted in any way as adjuncts to low-calorie dietary regimes aimed at weight reduction, no reference to the timing or amount of weight loss resulting from their use is permitted;
- marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified in the applicable register. claims must be presented clearly and without exaggeration;
- only nutrition claims listed in the applicable register may be used in marketing communications;
- only health claims listed as authorised in the applicable register, or claims that would have the same meaning to the consumer, may be used in marketing communications;
- marketers must not state or imply that a balanced or varied diet cannot provide appropriate quantities of nutrients in general. Individuals should not be encouraged to swap a healthy diet for supplementation, and without well-established proof, no marketing communication may suggest that a widespread vitamin or mineral deficiency exists.
Marketing communications for foods must not claim to treat clinical vitamin or mineral deficiency
Then, as for Q6, in Italy, advertising is ruled by Legislative Decree No 145/2007 and Consumer Code, which provides that advertising shall:
- be true and is not likely to distort to an appreciable extent the economic behaviour, in relation to the product, of the consumer:
- be made in such a way that the advertising nature of the message is evident and the product is clearly identified;
- promote rational use, presenting it objectively and without exaggerating its properties;
- not be misleading;
Please, see also art. 23 of the Italian Consumer Code which provides a list of business practices considered deceptive in all cases (e.g lett f. state, contrary to the truth, or otherwise create the impression that the sale of the product is lawful).
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
Pursuant to Legislative Decree No 169/2004 offences and penalties for selling any supplements, which are not marked or labelled in accordance with the regulations, vary depending on the specific offense, the fine for which can be up to EUR 20.000,00, unless it constitutes a more serious crime.
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
A meeting was recently held at the Italian Chamber of Deputies on Food Supplements and the possibility of reformulating and adapting the current European and Italian regulatory framework to the market. However, no concrete proposal is in place.
Moreover, as outlined before, the subject may be involved in cannabis regulation developments.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
In general, it can be said that cosmetic devices are regulated separately from cosmetic products, even though the products in question are often bordeline products, straddling the qualification of cosmetic and medical device.
In general, the subject matter is regulated by the MDR, as Art.1 par.2 provides that this Regulation also applies to groups of products without an intended medical purpose that are listed in Annex XVI of the MDR, taking into account the state of the art, and in particular existing harmonised standards for similar devices with a medical purpose, based on similar technology. Annex XVI products include High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. Therefore, as far as they are under the Medical Device category, the regulatory body in responsible for managing cosmetic devices in Italy is the Ministry of Health.
Please note that for these products listed in Annex XVI there are common specifications which shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety. These common specifications are contained in Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down, as from 22 June 2023, common specifications for product groups listed in Annex XVI indicating, specifically for each of the product listed, the application of risk management and clinical safety evaluation.
By virtue of the fact that borderline products are often involved, please note that the distinction with respect to cosmetic products is not always straightforward and therefore, except in the cases explicitly provided for, it is often necessary to refer to a case-by-case qualification. However, on this issue, it is important to refer to the case law of the Court of Justice (e.g. Case C-321/14), which has provided clear interpretative criteria for defining the scope of application of cosmetic products, and thus for excluding them from being understood or not within the MDs.
In particular, reference must be made to the definition of cosmetic and assess:
- the nature of the product: is it a substance or a mixture?
- the part of the human body on which the product is intended to be applied: does the part of the body fall within the exhaustive list of Art. 2(1)(a)?
- the purpose for which the product is intended to be used: is the product intended to clean, perfume, change appearance, protect or maintain, etc.?
Moreover, safety standard shall be compliant with the abovementioned Italian Consumer Code (artt.102 – 113), which is applied only in case that for those aspects and risks or risk categories not subject to such safety requirements prescribed by EU legislation or other Italian law addressed specifically on that product.
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?
Regardless the product is classified as cosmetic or medical device, Eu law (MDR or EU Regulation No 1223/2009) and implementing Italian decrees require a person or entity to be responsible for the cosmetic devices, and their safety, placed on the market.
Please note that even Italian Consumer Code does not provide the election of a responsible person/entity, it is established that the manufacturer of the product established in the Community and any other person presenting himself as the manufacturer by affixing his name, trade mark or other distinctive sign to the product, or the person refurbishing the product/the manufacturer's representative if the latter is not established in the Community or, if there is no representative established in the Community the importer of the product/other professionals in the marketing chain insofar as their activity may affect the safety properties of the products, has an obligation to place only safe products on the market and to provide the consumer with all relevant information to assess and prevent risks arising from normal or reasonably foreseeable use of the product, if they are not immediately apparent without adequate warnings, and to prevent such risks.
Furthermore, he must take measures proportionate to the characteristics of the product supplied to enable the consumer to be informed of the risks associated with its use and to take appropriate action to avoid such risks, including withdrawing the product from the market, recalling it and providing appropriate and effective information to consumers.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
Regardless the product is classified as cosmetic or medical device, EU law (and consequently Italian implementing decrees) demands that cosmetic devices shall adhere or pass certain safety assessment standards pursuant to Art.8 of the MDR or art. 8 of Cosmetic Regulation, depending on the given qualification.
Whether none of the abovementioned regulations or other EU law is applied, Italian Consumer Code provides that safety assessment standards are envisaged by specific national regulation depending on the nature, how the product works and how to apply it.
It may be the case for electrical equipment (considering cosmetic devices such as at home lasers). The subject is ruled by Legislative Decree no 86/2016, which sets out the essential safety requirements that electrical equipment must have in order to be made available on the EU market, in order to offer a high degree of health protection.
It is envisaged that when placing their electrical equipment on the market or putting it into service, manufacturers shall ensure that it has been designed and manufactured in accordance with the safety objectives set out in Article 1, paragraphs 2 and 3, and set out in Annex I of the abovementioned Decree. In particular, the safety objectives relate to hazards and external causes which may affect the end product.
Manufacturers shall draw up the technical documentation referred to in Annex III and carry out or have carried out the conformity assessment procedure referred to in the same Annex III and shall also provide for the marking and EU declaration of conformity.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
Advertising regulation relies on the classification of the cosmetic device as cosmetic product or medical device.
In the first case please refer to Q6 (cosmetic product). On the contrary, in second case, in the scenario where MDR is applied and consequently in advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
- ascribing functions and properties to the device which the device does not have;
- creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
- failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
- suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
Please note that regardless the classification of the product, in Italy, advertising is generally ruled by Legislative Decree No 145/2007 and Italian Consumer Code, which provides that advertising shall:
- be true and is not likely to distort to an appreciable extent the economic behaviour, in relation to the product, of the consumer:
- be made in such a way that the advertising nature of the message is evident and the product is clearly identified;
- promote rational use, presenting it objectively and without exaggerating its properties;
- not be misleading;
- objective claims be back by evidence, sometimes scientific evidence (e.g. for reversal of hair loss).
Please, see also art. 23 of the Consumer Code which provides a list of business practices considered deceptive in all cases. (e.g (lett f. state, contrary to the truth, or otherwise create the impression that the sale of the product is lawful).
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?
Non-compliance consequences rely on the classification of the cosmetic device as cosmetic product or medical device.
As for the first case please refer to Q7 (section: cosmetic), while for the second hypothesis there may be a fine up to EUR 145.000,00, unless the conduct does not constitute a crime and therefore leads to a criminal liability.
Whether none of the abovementioned regulations or other EU law is applied, Italian Consumer Code provides that enforcement mechanism for compliance consists mainly in fines, unless the conduct does not constitute a criminal offence and therefore leads to a criminal liability.
Generally, compliance is tracked by EU and Italian authorities which have powers, to investigate allegations of non-compliance that are national, novel or contentious in scope.
Enforcement powers 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. Measures include:
- Fines
- Suspension notices
- Requirements to mark / warn
- Service of withdrawal notices
- Recall notices
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.
No upcoming future developments in this field that we are aware of.
Cosmetic (non-surgical) services
1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
Yes, it is regulated as aesthetic medicine, meaning the one which aims to improve a person's psychophysical wellbeing through non-invasive interventions aimed at resolving an aesthetic blemish. Aesthetic medicine therefore stands at a complementary level and not an alternative to aesthetic surgery, since it deals with prevention and then correction of minor defects by non-surgical means, referring those situations that can only be resolved with a surgical approach to the plastic-aesthetic surgeon.
However, please note that there is no specific regulation then on cosmetic treatments, which are carried out for non-medical reasons, usually for aesthetic purposes, and which consequently fall under Italian law no. 833 of 1978, often qualified as precautional medical services.
Please note, then, that as far as cosmetic surgical services are considered, aesthetic medicine interventions are even included in free services (LEAs), and therefore are provided by the National Health Service, but only in the case when they are necessary (“functional aesthetic medicine) as a result of accidents or due to congenital or acquired malformations.
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?
From May 2012 it is not allowed to undergo breast augmentation surgery before the age of 18. This prohibition only applies to breast augmentation surgery and not to other types of cosmetic plastic surgery, such as rhinoplasty, which can also be performed on underage patients, but only with parental consent.
There are, however, exceptions: plastic breast surgery on a minor may, for example, be considered in the case of illnesses, malformations and situations of severe asymmetry that can worsen the patient's self-esteem.
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?
Yes, BTs are prescription only medicines and can only be prescribed by a designated medical prescriber to a named patient and intended to be used directly by the specialist during the out-patient visit.
Please note that only Neurologist (neuropsychiatrist), Neuropsychiatrist child, Physician specialising in physical medicine and rehabilitation, Neurophysiopathologist, Ophthalmologist, Orthopaedist, Urologist, Dermatologist can prescribe it as of Resolution of 16th February 2017 by Italian Medicines Agency (AIFA).
There is an obligation to ensure that the premises in which the procedures are carried out in are assessed to ensure that they meet the required standards. The prescriber is required to assure themselves that the person to whom they have issued the prescription to is safe to administer the toxin.
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?
Aesthetic medicine (non-surgical) treatments may be performed by a doctor provided that he or she has a university degree and is duly registered with the Order of Physicians of his or her province. Consequently, the Council of the Order shall ensure that the doctor has the necessary skills and knowledge to be registered and function within their scope of practice.
Moreover, please note that several Bars in Italy established a specific registry for professionals who perform aesthetic medicine. Coherently, the registration is often subject to show evidence of a two-year Master's degree in Aesthetic Medicine, a diploma from a four-year public school or similar requirements, and continuing education certificates.
Please note that every physician shall comply with good clinical and care practices and recommendations as set out in the national guidelines and the healthcare professionals' code of ethics.
The complaints in relation to non-surgical cosmetic services are not handled by a centralised body, but directed to the physician himself/herself and/or the healthcare facilities.
On the contrary, please note that for surgical services there is the need of a specialised surgeon, who is a doctor having undertaken a further five years of specialised training in the field of Plastic, Reconstructive and Aesthetic Surgery.
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.
The non-compliance may entail criminal and/or civil liability for the physician (e.g. malpractice or injuries) and the healthcare facilities. It could lead to imprisonment up to 3 years (as for the physician), the payment of a high fine up to EUR 50.000,00, the prohibition or disqualification from the professional, etc.
Moreover, there could be supplementary sanctions for both, especially for healthcare facilities whether they are public entities and they pay a fine.
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?
It is allowed (Law No 145/2018) for health professionals and facilities to make informative communications, directly or via third party, according to criteria of transparency and truthfulness of the message"(...)functional to ensure the safety of health treatments, containing only:
- titles;
- professional specialisations;
- characteristics of the service offered;
- the price;
- the overall costs of the services.
Therefore, any element of an attractive nature is excluded, respecting the free and conscious determination of the patient, in order to protect public health, the dignity of the person and his right to correct health information.
However, not every attractive and suggestive element is prohibited, but only that which could lead to the improper use of health treatments.
7. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
No upcoming future developments in this field that we are aware of.