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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? If so, what are some examples of these restrictions?
- 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?
Regulation (EC) No. 1223/2009 on Cosmetic Products.
Article 3 of the French Law No. 2014-201 of 24 February 2014 modifying the French Public Health Code (in particular Articles L. 5131-1 to L. 5131-8 and L. 5431-1 to L. 5431-9 of the French Public Health Code).
Article L. 5131-1 of the French Public Health Code defines “cosmetic products” as any substance or mixture intended to be placed in contact with the superficial parts of the human body (epidermis, hair system, nails, lips and external genial organs) or with the teeth and oral mucous membranes, 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.
Article 2(a) of Regulation No. 1223/2009 on Cosmetic Products provides for a similar definition.
Products that are intended to be ingested, inhaled, injected or implanted are not classified as cosmetic products. Products which are ingested but claim to have “cosmetic benefits” i.e. improving skin, hair and nails, would be considered as food.
Medicinal products are those which are presented as having properties for treating or preventing disease in human beings or which may be used/administered with a view to restoring, correcting or modifying physiological function (pharmacological immunological or metabolic action) (as per the Regulation and Article L. 5111-1 of the French Public Health Code).
In France, medicinal products would require marketing authorisation from the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé).
For example, products for spots are usually considered as cosmetics products, as long as the claimed effects of the product are to only affect the appearance of comedones but are not aimed to prevent or treat acne. On the contrary, products for acne, which is a medical condition characterized by an inflammation and skin damage, tend to be considered as medicinal products.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
Regulation (EC) No. 1223/2009 on Cosmetic Products provides at Article 14 what substances are prohibited (Annex II of the Regulation) and what substances are restricted in use in cosmetics products (Annex III of the Regulation).
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 colorants, preservatives, or UV-filters are being used, any restrictions or prohibitions which apply must be followed. This is a positive list, meaning only substances listed in Annex IV, Annex V or Annex VI may be used.
Moreover, the use in cosmetic products classified as CMR substances are usually prohibited (Article 15 of the Regulation). The use of nanomaterials in cosmetic products is also regulated (Article 16 of the Regulation).
There is an amendment to the EU Cosmetics Regulation of 3 April 2024 which restricts concentrations of retinol, retinyl acetate and retinyl palmitate.
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?
All cosmetic products available to consumers must have a ‘Responsible Person’ who makes sure safety measures are followed and legal obligations are met (Article 4 of the Regulation and Article L. 5431-2 et seq. of the French Public Health Code).
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).
More information about the steps that need to be accomplished by the responsible person in France (e.g. notification prior to placing the cosmetic product on the market; communication of serious undesirable effects) can be found here.
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
According to Article 10 and Annex I of the Regulation, 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.
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
[See Article 19 of the Regulation].
The labelling for cosmetic products must bear information in indelible, easily legible and visible lettering. 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 France;
- 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 or reference);
- the function of the cosmetic product;
- the ingredients - these can be provided solely on the packaging. Note that nanomaterial ingredients must be followed by ‘(nano)’ in brackets.
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 or a tag. A symbol should be used to indicate where this information is.
The labelling information on cosmetic products must include a list of ingredients. The EU Commission implemented a decision 2022/677 of 31 March 2022 which is laying down rules for the application of Regulation (EC) No. 1223/2009 as regards to the glossary of common ingredient names for use in the labelling of cosmetic products.
According to Article R. 5131-4 of the French Public Health Code, the weight or volume, the date until which the cosmetic product must be used, the particular precautions for use and the function of the cosmetic product must written in French.
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
There is no specific law relating to the advertising of cosmetic products in France.
However, at the EU level, the Regulation No. 655/2013 of 10 July 2013 provides for some common criteria for the justification of claims used in relation to cosmetic products. For example, presentations of a product’s performance shall not go beyond the available supporting evidence.
Article 20 of the Regulation No. 1223/2009 requires that in the marketing of cosmetic products, every Responsible Person must ensure that the wording of any claim in relation to a cosmetic product does not imply that the product has a characteristic or function which it does not have.
The French Consumer Code also prohibits unfair commercial practices relating to the nature or composition of the product (see Article L. 121-1 of the French Consumer Code). Therefore, the information on packaging of cosmetics must not mislead consumers about the product properties.
The ANSM and the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) have drafted guidance related to “free from” claims made for cosmetic products.
According to Article 5 of the French Law No. 2023-451 of 9 June 2023 aimed at regulating commercial influence and combating the abuses of influencers on social networks, influencers must also add the words “Retouched images” when publishing images that have been altered by any image processing process in order to refine or thicken their silhouettes or change the appearance of their faces.
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 competent authorities to request the Responsible Person to take corrective action over a product that does not comply with the Regulation.
In France, the competent authority is the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (“DGCCRF”) (see Article L. 5131-3 of the French Public Health Code and Articles L. 522-1 and R. 522-1 of the French Consumer Code).
- A competent authority must request that the Responsible Person takes all appropriate measures, proportionate to the nature of the risk where there is certain non–compliance including corrective actions aimed at ensuring compliance, or withdrawal or recall, within an expressly mentioned time limit.
- If the Responsible Person does not take the measures within the time limit, or where immediate action is necessary to prevent serious risk to human health, the competent authority must take all appropriate measures itself to stop the product going on the market, or to withdraw or recall products already on the market.
- Competent authorities have all the powers they need to prevent any further distribution or sale of the product if the Responsible Person is not taking the necessary actions.
Article 26 of the Regulation requires competent authorities to take corrective action over a product that does not comply with a distributor's responsibilities under the Regulation, in a similar way to Article 25.
Article 27 of the Regulation allows an enforcement authority to take direct provisional action where there is a serious risk to human health, or there are reasonable grounds for concern.
Under the Articles L. 5431-2 et seq. of the French Public Health Code, breach of the Regulation could result in a fine of up to €30,000 for natural persons and up to €150,000 for legal entities, or in imprisonment of up to 2 years, or both (see for example Article L. 5431-8 of the French Public Health Code for breach by the Responsible Person of its obligation to communicate serious undesirable effects referred to in Article 23 of the Regulation).
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.
The Amendment to the EU Cosmetics Regulation of 3 April 2024 which restricts concentrations of retinol, retinyl acetate and retinyl palmitate.
This Amendment add new restricted and banned substances such as 3-(4′-methylbenzylidene)-camphor which becomes a banned substance. It means that from 1 May 2025, products containing that substance shall not be placed on the EU market.
Products containing retinol or retinol equivalent must have a percentage of retinol of 0.05 % for body lotions and 0.3 % in face and hand products. From 1 November 2025, cosmetic products containing that substance and not complying with the conditions shall not be placed on the EU market.
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?
Food supplements are subject to all the general provisions of food law, as well as to the specific rules defined by Directive 2002/46/EC of June 10, 2002 relating to food supplements, transposed into French law by Decree no. 2006-352 on food supplements.
On the basis of this decree, the following orders apply:
- Order of 9 May 2006 relating to the nutrients that may be used in the manufacture of food supplements;
- Order of 24 June 2014 establishing the list of plants, other than mushrooms, authorized in food supplements and the conditions of their use;
- Order of 26 September 2016 establishing the list of substances with nutritional or physiological purposes authorized in food supplements and the conditions of their use.
Article 2 of the Decree 2006-352 defines food supplements as “foodstuffs whose purpose is to supplement the normal diet and which constitute a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, i.e. presentation forms such as capsules, pastilles, tablets, pills and other similar forms, as well as sachets of powder, ampoules of liquid, dropper bottles and other similar forms of liquid or powder preparations intended to be taken in measured units of small quantities.”
In particular, supplements may be distinguished from regular food products through 3 criteria, according to the Ministry of Economics:
- Their purpose, i.e. complementing the diet, without substituting for regular diet.
- Their composition, i.e. essentially made up of ingredients with a nutritional or physiological effect (plants, nutrients...), and not made up of a food matrix, i.e. a complex physical structure combining macronutrients (carbohydrates, lipids and proteins).
- Their presentation, i.e. sold in doses, with a measurable unit of intake and of small quantity, compared to the quantities of food usually consumed.
Supplements should also be distinguished from medical products:
- Placing on the market: Unlike medicinal products, supplements do not require marketing authorization, but are solely subject to declarations to the French Directorate General for Competition Policy, Consumer Affairs and Fraud Control (“DGCCRF”).
- Promoting on the market: If the presentation might be similar to medicinal products (e.g. capsules or lozenges), supplements cannot claim any therapeutic effect. However, a limited number of health claims may be permitted according to the European Commission’s list.
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?
Yes, pursuant to Article 4 of the Decree no. 2006-352, only the following may be put in supplement products:
- Nutrients, i.e. vitamins and minerals (e.g. vitamin C or zinc);
- Substances with nutritional or physiological purposes, i.e. chemically defined substances other than vitamins and minerals;
- Plants and plant preparations (e.g. mushrooms, algae, microalgae...);
- Other ingredients whose use in human food is traditional or recognized as such within the meaning of Regulation (EU) No. 2015/2283 on novel foods, or authorized in accordance with this regulation;
- Additives, flavors and processing aids authorized for use in food.
In addition, each of these components may be subject to specific restrictions under the aforementioned Orders, which establish positive lists of authorized substances.
Certain products such as CBD cannot be marketed/sold unless approved, since they do not have history of consumption, as stated in the European Commission's CPVADAAA Novel Food and Toxicology report of February 27, 2023.
Finally, no substance may be used in the composition of a dietary supplement if its properties are exclusively pharmacological, i.e. intended for medicinal use.
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?
As for food products, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a product placed on the market is safe and complies with regulations, in terms of both safety and consumer information.
In this regard, the prior declaration must specify the identity of the manufacturer or importer.
In particular, pursuant to Article 16 of the Decree 2016-352, the first placing on the French market of a supplement containing a substance with a nutritional or physiological purpose, a plant or a plant preparation, not listed in the Decree but legally manufactured or marketed in the EU/EEA gives rise to a declaration to the Minister responsible for agriculture by the importer or manufacturer of the supplement.
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?
Any supplement must be declared to the relevant authorities, in accordance with the requirements of Articles 15 and 16 of Decree no. 2006-352. Since 2023, this declaration should be made to the Ministry of Agriculture, via the teleservice “Compl’alim”.
In this regard, general obligations of food law, defined by EU Regulation no. 178/2002, apply to companies in the food supplements sector: safety (product prevention and monitoring), compliance (self-monitoring), traceability, cooperation, fair trading and consumer information.
Requirements of the EU Regulation no. 852/2004 on food hygiene are also applicable (e.g. implementation of food safety management systems covering prerequisite programs (PRPs) and procedures based on the HACCP principles).
In terms of health safety, food supplements must comply with the provisions applicable to food products: microbiological criteria, chemical contaminants, food enhancers. In some cases, special thresholds are set for these products (e.g. heavy metals).
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?
Food business operators must keep records so that they are able to identify businesses they have bought food supplements from and who they have sold them to. They must retain documents such as invoices and delivery notes so that information can be produced if requested by enforcement authorities.
In addition, since 2009, the nutrivigilance system set up by the ANSES encourages manufacturers or distributors, but also doctors and pharmacists, as well as private individuals to report undesirable effects linked to the consumption of supplements.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
Yes, there are several labelling requirements under French law.
On one hand, under Article 9 of EU Regulation No. 1169/2011 on the provision of food information to consumers (INCO Regulation), mandatory information are required for any food labelling:
- The name of the food;
- The list of ingredients;
- Allergens, highlighted in the list of ingredients, either in bold or underlined;
- The quantity of the food;
- The date of minimum durability or the ‘use by’ date;
- Any special storage conditions and/or conditions of use;
- The name or business name and address of the food business operator
- The country of origin or place of provenance;
- Instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions;
- With respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume;
- A nutrition declaration.
On the other hand, under Decree 2016-352 relating to food supplements, the following information must be included on the labelling:
- The name of the nutrients or substances characterizing the supplement;
- The recommended daily dose and a warning about exceeding this dose;
- A statement to prevent food supplements from being used as substitutes for a varied diet;
- A warning to keep food supplements out of the reach of young children.
In addition, Article 9 requires that dietary supplements be sold under this name only, and a nutritional declaration must be displayed in accordance with Article 12 of the decree.
Please note that supplements may also display other warnings, depending on the substances they contain.
Finally, while the packaging of a dietary supplement may mention the health benefits induced by its consumption, it cannot claim an ability to prevent or treat a disease.
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. General rules of the French Consumer Code are applicable, especially Article L.121-1 to L.121-5 on unfair and misleading practices. For instance, the Ministry of Economics specifies that it is strictly forbidden to:
- claim to prevent, treat or cure human disease,
- refer to the rate or extent of weight loss,
- refer to recommendations issued by a doctor or other health professional,
- suggest that a balanced and varied diet is insufficient, or that the consumer runs a risk by not consuming the dietary supplement.
More specifically, advertising and promotions concerning nutrition and health are subject to the provisions of Regulation (EC) n°1924/2006 on nutrition and health claims made on foods. In practice, operators wishing to promote the benefits of their dietary supplements must use an authorized claim, i.e. one that appears on the positive lists (annex to regulation (EC) n°1924/2006 for nutritional claims and European register for health claims) or, in the absence of authorization, submit an application to the EU.
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
There are several sanctions mechanisms in case of non-compliance to the applicable regulations.
For instance, under the French Consumer Code, any infringement of the labelling requirements under Regulation INCO are punishable by a fine up to €1,500 and €7,500 for legal entities and can be applied as many times as the number of offences committed. In the event of a repeat offence within 1 year, the fine can be up to €3,000 and €15,000 for legal entities (Articles L412-1 & R451-1).
Moreover, in case of breach of advertising rules, deceptive commercial practices are punishable by 2 years' imprisonment and a fine of €1,500,000 for legal entities. Since 2024, when the offence is committed using an online public communication service or via a digital or electronic medium, the penalties are increased to 5 years' imprisonment and a fine of €3,750,000 (Article L132-2).
In respect of enforcement, the DGCCRF is usually responsible for enforcing and executing the regulations from the French Consumer Code. However, please note that since 1st January 2024, food safety is now the responsibility of the Directorate General for Food of the French Ministry of Agriculture and Food Sovereignty.
Additionally, competitors could bring an unfair competition claim against a company which infringes the applicable regulation. If successful, such claim may give rise to a court order which will (i) prohibit the concerned infringement (ii) allocate damages to the claimant and (iii) possibly publication measures of the order.
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
On 17 July 2024, a warning from the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) was addressed to athletes, coaches and healthcare professionals on the risks induced by the consumption of dietary supplements and foods enriched with proteins, amino acids or plant extracts aimed at building muscle mass or reducing body fat. In particular, between 2016 and 2024, 154 new cases of adverse reactions were reported to the nutrivigilance system, including 2 deaths and 4 people with their prognosis threatened. As a consequence, the ANSES decided to initiate a risk assessment on this topic, which may lead to new recommendations in the coming months.
Furthermore, on 2023, the ANSES published an opinion on herbal food supplements and consumer safety, which notably recommends that manufacturers explicitly mention any restrictions on use linked to the presence of plants, in the leaflet or on the packaging. The Agency also recommends that health professionals in charge of advising and selling food supplements receive training in the safety and use of plants contained in food supplements. These recommendations are only soft law, but we cannot totally exclude compulsory requirements in the future.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
Cosmetic devices such as microneedling, LED masks, laser hair removal devices or microcurrent do not fall under the definition of a cosmetic product laid out in Regulation No. 1223/2009 on Cosmetic Products, since such devices are not substances nor mixtures.
For medical devices - Despite the fact that cosmetic devices do not have an intended medical purpose, cosmetic devices such as lasers and pulsed light equipment, for skin resurfacing, hair removal or other skin treatment are considered as medical devices according to Article 1(2) and Annex XVI of Regulation No. 2017/745 of 5 April 2017 on medical devices and Article L. 5211-1 of the French Public Health Code.
General – Directive 2001/95/EC of 3 December 2001 on general product safety and Article L. 421-3 of the French Consumer Code apply to products intended for or likely, under reasonably foreseeable conditions, to be used by consumers.
Articles L. 423-1 et seq. of the French Consumer Code require all products to be safe in their normal or reasonably foreseeable usage, provide information for the consumer to be able to assess the inherent risk in a 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?
For medical devices – Yes. Pursuant to Article 10 and seq of the Regulation No. 2017/745, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a device placed on the market is safe and complies with the Regulation, in terms of both safety and consumer information. Moreover, manufacturers of devices shall report to the relevant competent authorities any serious incident involving devices and any field safety corrective action in respect of devices (Article 87 of the Regulation).
General – According to Article 1245 of the French Civil Code, the manufacturer is liable for any damage caused by a defect in its product, whether or not it has a contractual relationship with the victim. If the manufacturer cannot be identified, the supplier or importer might be liable.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
For medical devices – According to Article 61 of the Regulation No. 2017/745, there is a requirement to demonstrate the performance of the medical device. Clinical evaluations of those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.
General – Articles L. 421-5 et seq. of the French Consumer Code provides that a product is deemed to satisfy the general safety requirement when it complies with the specific regulations applicable to it for the protection of consumer health and safety. There are no currently specific regulations for cosmetic devices in France.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
For medical devices - Article R. 5213-1 of the French Public Health Code outlines the requirements for advertising medical devices to the general public. It emphasizes that the advertisement must clearly identify the product as a medical device and include the following information:
- The commercial name or reference of the medical device;
- The intended use as specified by the manufacturer;
- The manufacturer’s or representative’s name;
- Necessary information for proper use;
- An explicit invitation to read the instructions in the accompanying leaflet or labelling:
- A cautionary message and advice to consult a healthcare professional, depending on the device’s risk level;
- The statement: “This medical device is a regulated health product that bears the CE marking;
- An internal reference number, if applicable.
According to Article 4 of the French Law No. 2023-451 of 9 June 2023 aimed at regulating commercial influence and combating the abuses of influencers on social networks, an influencer is also prohibited from directly or indirectly promoting products, acts, processes, techniques and methods presented as comparable, preferable or substitutable to therapeutic acts, protocols or prescriptions, as well as aesthetic acts, processes, techniques and methods relating to products covered by Annex XVI of Regulation (EU) 2017/745.
General - Article L. 121-1 of the French Consumer Code prohibits unfair commercial practices relating to the nature or composition of the product.
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?
For medical devices - According to Article L. 5211-2 of the French Public Health Code, the competent authority for controlling medical devices mentioned in the Annex XVI of Regulation No. 2017/745 of 5 April 2017 is the DGCCRF, the Regional Directorates for Business, Competition, Consumer Affairs, Labour and Employment (DIRECCTE, now DREETS) and the Departmental Directorates for the Protection of Populations (DDPP or DDETSPP, depending on the department).
According to Article L. 5461-3 of the French Public Health Code, breach of Article 19 of Regulation No. 2017/745 (EU declaration of conformity), of Article 20 of the Regulation (product bears the CE marking of conformity), of Article 56 of the Regulation (certificates of conformity) and of the General Safety and Performance Requirements mentioned in the Annex I of the Regulation, could result in a fine of up to €375,000, and imprisonment of up to 5 years.
General – From 13 December 2024, if a manufacturer or an importer, who considers or has reason to believe that a product placed on the market is dangerous and fails to take corrective measures (withdrawal or recall of the product), to inform consumers and the market surveillance authorities, such a manufacturer or importer could be fined up to €600,000 and imprisoned up to 5 years (new Article L. 452-5-1 of the French Consumer Code).
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.
The General Product Safety Regulation (GPSR) of 10 May 2023 is a new key instrument in the EU product safety legal framework, which will replace, from 13 December 2024, the current General Product Safety Directive of 3 December 2001. The French Law No. 2024-364 of 22 April 2024 will implement the Directive and will modify the provisions of the French Consumer Code accordingly.
This new EU Regulation will add specific rules on how to handle product safety recalls, including a mandatory recall notice template, and right to remedy for consumers, and a list of aspects to be taken into account when assessing the safety of the products, including for new technologies.
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?
According to the Ministry of Economics, several types of personal care need to be distinguished:
- healthcare (medical or paramedical): procedures designed to assess, maintain or restore a patient's state of health, reserved for doctors and medical auxiliaries (e.g. lymphatic drainage, ultrasound electrotherapy);
- aesthetic medicine: procedures designed to improve a person's physical appearance, or to reduce or delay the effects of ageing; they are carried out exclusively by doctors, using more or less invasive techniques (e.g. botulinum toxin or lipolaser injections);
- esthetics: procedures designed to maintain, preserve or improve the condition of the body or skin performed exclusively by qualified estheticians (e.g. skin cleansing, waxing, application of cosmetic products);
- well-being: this type of treatment is designed to enhance a person's well-being, notably through a beautifying or comfort-enhancing action (e.g. non-therapeutic massages, false eyelashes or nails, spas).
The “Hospital, Patients, Health and Territories” Law of 21 July 2009 (“HPST Law”) provides a framework for cosmetic services presenting serious risks to people's health, and prohibiting those presenting serious dangers or suspected serious dangers (Articles L.1151-2 and L.1151-3 of the French Public Health Code).
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?
No.
Cosmetic services performed by doctors - Pursuant to Article L1111-2 of the French Public Health Code, the right to consent to medical acts belongs to the holders of parental authority. That being said, minors have the right to receive information themselves and to participate in decision-making concerning them, in a manner appropriate to their degree of maturity.
On top of that, the law requires that the minor be involved in the decision, and his or her consent must be systematically sought if he or she has sufficient capacity for discernment (Article L1111-4 of the French Public Health Code).
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?
Botulinum toxin-based products are prescription-only drugs and require a marketing authorization (AMM) before being marketed. (ANSM, 2021).
Only a doctor can perform an injection. (Ministry of Economics, 2024). Therefore, the practice of aesthetic injections by beauticians and non-health professionals is illegal.
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?
Cosmetic services performed by doctors – The French National Order of Doctors (Conseil national de l’Ordre des médecins, “CNOM”) is the centralised body responsible handle complaints.
Three conditions are necessary to practice medicine in France (Article L.4111-1 of the French Public Health Code):
- Diplomas: at a minimum, a French state diploma of doctor of medicine;
- Nationality, as the case may be;
- Registration on the register of the Order of Doctors.
General - In accordance with Article L121-1 of the French Crafts Code, regardless of the legal status and characteristics of the company, aesthetic personal care other than medical and paramedical care, and aesthetic comfort modelling without a medical purpose, may only be carried out by a professionally qualified person or under the effective and permanent supervision of such a person.
In particular, the qualified person must hold a professional certificate or a diploma or title of equal or higher level, approved or registered. (Article R121-1 of the French Crafts Code).
Please note that the AFNOR developed a standard SPEC X50-1231 “Beauty and wellness centers - Requirements and recommendations for hygiene and the prevention of health risks” to guide professionals in their practice during health crises.
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.
Pursuant to Article L1151-3 of the French Public Health Code, cosmetic services that present a serious danger or suspected serious danger to human health may be banned by decree, after consultation with the High Authority for Health.
Moreover, several authorities can be involved in the enforcement mechanism. For instance, on 2016, the General Directorate for Health (DGS), the General Directorate for Labour (DGT), the General Directorate for Risk Prevention (DGPR) and the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCRF) requested the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) to carry out an assessment of the health risks associated with the use of some devices intended for cosmetic services, especially hair removal and lipolysis.
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?
Cosmetic services performed by doctors - When it comes to advertising with reference to doctors (even for non-surgical cosmetic services such as BT injection), doctor’s ethic rules will apply.
Since Decree No. 2020-1662 of 22 December 2020 amending the code of ethics of doctors, the strict prohibition of medical advertising has been repealed in the French Public Health Code (former Article R4127-19 of the French Public Health Code). However, if « doctors are free to communicate to the public, by any means, including on a website, information likely to contribute to the patient's free choice of practitioner, relating in particular to his or her professional skills and practices, career path and conditions of practice.”, such advertising “does not use third party testimonials, is not based on comparisons with other doctors or establishments (…) » (Article R.4127-19-1 of the French Public Health Code).
General - General rules of the French Consumer Code are applicable, especially Article L.121-1 to L.121-5 on unfair and misleading practices. For instance, it is forbidden (i) to falsely claim that a product or service is likely to cure diseases, dysfunctions or malformations, or (ii) to disseminate or have disseminated by another legal or natural person false consumer opinions or recommendations, or to modify consumer opinions or recommendations in order to promote products.
Any operator who advertises cosmetic services must comply with these provisions, including the third-party booking platform. In case of breach of advertising rules, deceptive commercial practices are punishable by 2 years' imprisonment and a fine of €1,500,000 for legal entities. Since 2024, when the offence is committed using an online public communication service or via a digital or electronic medium, the penalties are increased to 5 years' imprisonment and a fine of €3,750,000 (Article L132-2).
Besides, pursuant to the French Influencer Law (Law no. 2023-451 of 9 June 2023), please note that influencers must not promote aesthetic acts, procedures, techniques and methods (Article 4).
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.
The Decree no. 2024-470 of 24 May 2024 on non-therapeutic intense pulsed light and laser hair removal procedures recently extended the scope of professionals to nurses and aestheticians (i.e. persons professionally qualified, or under the effective and permanent supervision of such persons, for aesthetic personal care other than medical and paramedical under Article L121-1 of the French Crafts Code), other than doctors.