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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?
A. European Framework on cosmetic products.
Please note that the most important European regulations on cosmetic products, which is directly applicable (i.e., no implementation regulation is required) in Spain are listed below:
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council, of 30 November 2009, on cosmetic products (“Regulation (EU) 1223/2009”).
- Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH”).
- Commission Regulation (EU) No 655/2013, of 10 July, laying down common criteria for the justification of claims used in relation to cosmetic products (“Regulation (EU) 655/2013”).
- Commission Implementing Decision (EU) 2013/674, of November 25, on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.
- Commission Implementing Decision (EU) 2022/677 of 31 March 2022 laying down rules for the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the glossary of common ingredient names for use in the labelling of cosmetic products.
- Among others.
Furthermore, it should be considered the guidelines (soft law) that the European Commission publishes on the cosmetics products.
B. Spanish legal framework on cosmetic products.
The Spanish regulatory framework applicable to cosmetic products consists mainly in:
- Royal Legislative Decree 1/2015, of July 24, approving the revised text of Act on Guarantees and rational use of Medical Products and Medical Devices (“RDL 1/2015”).
- Royal Decree 85/2018, of February 23, regulating cosmetic products (“RD 85/2018”).
- Ministerial Orders on the methods of analysis necessary for the composition of cosmetic products.
- Among others.
Also, the AEMPS publishes informative notes and guidelines in order to clarify how to report on adverse effects of cosmetic products, control measures or any other information that may be relevant for the marketing of cosmetic products in Spain.
Please note that, under article 2 of 85/2018, referring to definition included in article 2 of Regulation (EU) 1223/2009, 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 and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes. This requirement excludes any product that can be ingested, inhaled, injected or implanted into the human body;
- With the exclusive or principal purpose of cleaning, perfuming, modifying their appearance, protecting, maintaining them in good condition or correcting body odours.
The Spanish Agency for Medicines and Medical Products (“AEMPS”) is the authority responsible for determining whether a product is classified as a cosmetic product or not. Regional and local healthcare authorities are the competent to control that the cosmetic products comply with the Spanish regulation applicable. Lastly, the Pharmaceutical Inspection of the Health and Social Policy Areas of (“Pharmaceutical Inspection”) is the competent authority to carry out inspections for the verification and verification of the responsible statement of manufacturing or import activities, as well as border healthcare inspections on imported cosmetic products.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
RD 85/2018 refers to Regulation (EU) 1223/2009 in order to determine the limits applicable to cosmetic products marketed in Spain. In this regard, only cosmetic products that comply with provisions of both the Royal Decree and Regulation 1223/2009 are allowed to be marketed in Spain.
Under no circumstances, the marketing of cosmetics which may pose a risk to public health is allowed by Law.
Particularly, Regulation (EU) 1223/2009 regulates the prohibitions (annex II) and restrictions (annexes III, IV, V and V) on substances listed in the Annexes of the Regulation. For example, various restrictions can be classified as follows:
- Prohibited substances: 2-Acetylamino-5-chlorobenzoxazole, Allyl isothiocyanate, Nalorphine (INN), its salts and ethers, Betaeucaine (INN) and its salts, Zoxazolamine (INN), 4-Methylbenzylidene Camphor (introduced by recent Regulation (EU) 2024/996, of 3 April 2024) among others. Also, CMR substances (i.e. substances classified as carcinogenic, mutagenic or toxic to reproduction) are included in the listed of prohibited substances.
- Restricted substances: that is, substances whose use in cosmetic products is allowed subject to compliance with certain measures authorized by the competent health authority. These include the following: Boric acid, Thioglycolic acid, Esters of thioglycolic acid, Genistein, Daidzein, Kojic Acid, Retinol, Retinyl Acetate, Retinyl Palmitate, Alpha-Arbutin, Arbutin (introduced by recent Regulation (EU) 2024/996, of 3 April 2024), among others. Please note that in the case of cosmetics products containing vitamin A (known as “Retinol”) its use is limited to 0.05% retinol equivalent in body products and 0.3% in all other cases, in order to ensure that its use is safe for the human health.
- Colorants other than those listed in Annex IV are prohibited.
- Preservatives other than those listed in Annex V are prohibited.
- Ultraviolet filters other than those listed in Annex VI are prohibited.
This list is included also in the “National Market Monitoring Campaign Final Report 2023: Banned Substances in Cosmetics” (Informe Final de la Campaña Nacional de Control del Mercado 2023: “Sustancias prohibidas en cosméticos), published in 2023 by the AEMPS. The purpose of the guideline is to report the prohibited and limited substances in cosmetic products in Spain. So, in short, Spain applies the same prohibitions and restrictions on cosmetic substances and products as the EU.
Regarding cosmetic products with active ingredients or with nanomaterials, the same rules must be complied with as in the European Union. In particular, in the case of acids, in addition to the composition restrictions imposed by the European Commission (Regulation (EU) 2024/996), the recommendations of the AEMPS must be followed, especially for pregnancy and neuropsychiatric effects.
Finally, it should be noted that Spanish and European Regulation does not differentiate between cosmetics products intended for domestic use and those used by professionals. Notwithstanding the above, it should be noted that the AEMPS may, when the characteristics of the product require it or/and by health protection causes, limit its use to certain professional uses.
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?
Indeed, both Spanish and European regulations refer to the responsible person or entity responsible based in the EU for the marketed cosmetic products in the EU or Spain and their safety (the “Responsible Person”).
RD 85/2018 expressly regulates the procedures for reporting health risks and adverse effects by the Responsible Person and distributors of cosmetic products. Regarding the way of the appointment and obligations of the responsible person in Spain, the regime of Regulation (EU) 1223/2009 is applicable.
Thus, all products marketed in Spain must comply with the requirement of the appointment of a Responsible Person who ensures the safety measures and legal obligations listed in the regulation applicable.
The Responsible Person may be: (a) the manufacturer based in the EU; (b) the importer of the cosmetic product; (c) the distributor, when it introduces a cosmetic product to the market under its name or trademark, or modifies an already marketed product in such a way that compliance with applicable requirements may be affected; or (d) a representative appointed by the manufacturer not based in the EU or the importer.
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
Yes. RD 85/2018 establishes that for the manufacturing and importation of cosmetic products, the compliance with the only annex of said regulation is required. Such annex outlines a series of conditions that must be fulfilled, including those related to product quality. In particular, it requires the following:
- The existence of an up-to-date quality system that sets out responsibilities, processes, and management measures to ensure that the manufacturing of cosmetic products is carried out in accordance with the principles of good manufacturing practices, as referenced in article 8.1 of Regulation 1223/2009; and,
- Requires an organizational structure, with defined responsibilities, appropriate to the size of the company and the type of cosmetic products being manufactured, that can guarantee the quality of the products produced, as well as the execution of relevant controls to document the aspects related to manufacturing.
Moreover, Regulation (EU) 1223/2009 specifies that (i) cosmetic products must undergo safety evaluation; (ii) the Responsible Person must ensure that this is conducted before the product is introduced into the market; and (iii) a cosmetic product safety report must be prepared in accordance with annex I of THIS Regulation.
In this regard, Regulation (EU) 1223/2009 establishes several obligations to the Responsible Person of the cosmetics products:
- The Responsible Person must ensure that the utilisation of the product and the exposure of each particular ingredient is considered during the evaluation.
- The Responsible Person must ensure that an appropriate approach is used to assess the value of the evidence in the evaluation.
- The Responsible Person must ensure that the cosmetic product safety report is kept up-to-date with relevant information.
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
Cosmetic products marketed in Spain must comply, in relation to packaging and labelling, with the requirements established in articles 6 and 7 of RD 85/2018. Article 6 of RD 85/2018, referring to Article 19 of Regulation (EU) 1223/2009, establishes the minimum information that the product cosmetic packaging must contain, namely:
The name or business name and address of the responsible person (a physical address is required; an email address is not accepted). The country of origin must be indicated for imported cosmetics.
- The nominal content.
- The minimum durability date or the period after opening during which the product is safe, as applicable.
- Precautions for use and warnings.
- The batch number.
- The product's intended function.
- The full list of ingredients.
Neither the material manufacturer of the product nor the distributor need be listed.
Furthermore, in accordance with article 6.1. of RD 85/2018, article 19.5 of Regulation (EU) 1223/2009, at least, the following information must appear in Spanish at the labelling of the product:
- The nominal content at the time of packaging.
- The minimum durability date.
- Particular precautions for use.
- The function of the cosmetic product.
The Spanish authorities pay particular attention that all product ingredients are included in the labelling of the cosmetic product and that, in turn, the public is not misled as to the composition of the product.
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
The Spanish Act 34/1988, of 11 November, on Advertising, in its Article 5, establishes that products, goods, or services that may pose risks to health may be subject to special regulations or to a regime of prior administrative authorization.
With regard to the specific regulation on cosmetic product advertising, this is addressed in RDL 1/2015, which establishes as a serious infringement the use of texts, trademarks, images, or any other symbol in the labelling, marketing, or advertising of cosmetic products that attribute characteristics or functions to these products which they do not possess, or that violate the common criteria established. This is consistent with the provisions of article 20 of Regulation (EU) 1223/2009, which governs the advertising of cosmetic products and the claims made regarding their functions. In this sense, article 20 of Regulation (EU) 1223/2009 establishes that:
"In the labeling, marketing, and advertising of cosmetic products, no text, names, trademarks, images, or other figurative or non-figurative symbols shall be used to imply characteristics or functions that the products do not have."
These claims are further regulated under Regulation (EU) 655/2013, which states that the Responsible Person must ensure that the wording of any claims regarding cosmetic products complies with the common criteria established in annex I of the aforementioned Regulation and is consistent with the supporting documentation included in the cosmetic product information file. Annex I addresses the following marketing and advertising common criteria that all the cosmetics products must comply with:
- Compliance with legislation.
- Truthfulness.
- Supporting data for the claim.
- Honesty.
- Fairness.
- Informed decision-making.
In summary, any information provided in the advertising of cosmetic products must adhere to the principles of legality, truthfulness, and be supported by appropriate and verifiable evidence, including, where applicable, expert evaluations. Failure to comply with these requirements is classified as a serious infringement under article 113.1.b of RDL 1/2015, punishable with an infringement of €30,000 to €90,000.
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?
In Spain, enforcement of regulations regarding cosmetic products is governed by article 13 of RD 85/2018, which outlines the following key measures:
- Health Protection Measures: competent authorities are responsible for implementing health protection measures in accordance with the decree and applicable laws.
- Preventive Measures: if a serious health risk is detected or reasonably suspected, authorities may take precautionary measures such as limiting, prohibiting, or imposing special conditions on the manufacture, import, marketing, distribution, or use of cosmetic products. These measures can include quarantining, withdrawing products from the market, or recalling them.
- Corrective Actions: if a responsible person fails to comply with cosmetic regulations, authorities will require corrective actions, such as product recall or market withdrawal, within a specified time frame proportional to the risk.
- Distributor Compliance: distributors must also comply with regulatory obligations, and authorities can mandate corrective measures or recall of products in case of non-compliance.
- Manufacturing and Importation Cease Orders: regional health authorities may order the cessation or suspension of cosmetic manufacturing or importation activities if it is found that these operations are being conducted without submitting the required declaration of responsibility or failing to meet the necessary regulatory requirements for importers or manufacturers.
- Communication with AEMPS: regional and local health authorities must inform the AEMPS about measures taken. AEMPS will, in turn, communicate these actions to the European Commission and other member states, as well as to relevant regional authorities through national alert networks if health risks or serious undesirable effects are involved.
Furthermore, under Spanish law, there is a system of Cosmetovigilance regulated in article 16 of RD 85/2018, which establishes a control system for cosmetic products placed on the market.
Specifically, Cosmetovigilance is defined as the activity aimed at collecting, evaluating, and monitoring information regarding undesirable effects observed as a consequence of the normal or reasonably foreseeable use of cosmetic products.
This control is overseen by the AEMPS. The system is structured to include various activities carried out by the health authorities of the autonomous communities and by healthcare professionals. These activities involve the reporting, collection, evaluation, and monitoring of adverse effects caused by cosmetic products, as well as the adoption of measures and dissemination of information related to such effects.
Consumers may also participate in this process. Both consumers and professionals who use or apply cosmetic products may report adverse effects either by informing healthcare professionals or by reporting directly to the health authorities of the autonomous communities or to the AEMPS, which provides a form for this purpose on its website.
Non-compliance with cosmetic product regulations is governed by articles 113 and 114 of RDL 1/2015. It includes very serious, serious, and minor infringements, with fines ranging from €6,000 to €1,000,000 depending on the conduct developed, the classification of the infringement and other circumstances. In some cases, these amounts may exceed this range, reaching up to five times the value of the products or services subject to the infraction.
Please note that, under Spanish law, there is no specific criminal penalties for the manufacturing, commercialisation or advertising of cosmetic products. However, in the case of intentionally endangering public health by manufacturing harmful substances that do not comply with regulations, it could be considered a criminal offense by articles 359 and 360 of the Spanish Criminal Code.
Furthermore, it shall be considered the application of administrative sanctions may still apply in the event of non-compliance with applicable regulations.
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. The Spanish authorities have not recently announced any regulatory reforms relevant to cosmetic products.
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 in Spain are regulated under Royal Decree 1487/2009, of 26 September, on food supplements ("RD 1487/2009"), which transposes Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (“Directive 2002/46/EC”). In line with Directive 2002/46/EC, the RD 1487/2009 defines food supplements as "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities."
According to this definition, the difference between food supplements and medicines is that medicines are intended for the treatment or prevention of diseases in humans to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to establish a medical diagnosis. On the other hand, the purpose of food supplements is to complement the normal diet, i.e., they are not intended for the treatment or prevention of diseases or physiological pathologies. In addition, both products are regulated by different regulatory regimes and legal requirements.
In Spain, the same restrictions or prohibitions of substances and nutrients that may be used in the manufacturing of food supplements will apply as in the European Union. Therefore, annexes I and II of Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamins and minerals and their forms that may be added to foods, including food supplements (“Regulation (EU) 1170/2009”), apply in order to determine what substances are allowed to be manufactured and marketed in Spain.
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?
RD 1487/2009 stipulates that only the vitamins and minerals listed in annex I and annex II of Regulation (EU) 1170/2009 may be used in the manufacture of food supplements.
In this regard, it establishes a limitation whereby only those substances expressly mentioned in Regulation 1170/2009 are allowed. The annex lists several vitamins and minerals that may be used to produce these products. Some of these are:
- Vitamins: Vitamin A, Vitamin B1, Vitamin K, Vitamin E (…)
- Minerals: Calcium acetate, Calcium L-ascorbate, Magnesium carbonate, Magnesium chloride, Sodium fluoride (…).
It should also be noted that the Spanish food authority (AESAN) periodically publishes information alerts on supplements or substances that do not comply with the applicable law.
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?
Directive 2002/46/EC explicitly addresses this aspect in Article 10, stating that Member States may require the manufacturer or the Responsible Person for placing the product on the market within their territory to notify the competent authorities by sending them a copy of the product label.
In this regard, Royal Decree 1487/2009, in Article 9, mandates the identification of a responsible party who must notify the relevant authorities of the product’s placement on the national market by providing a copy of the product label either prior to or simultaneously with its first market entry.
This mandatory notification must be carried out by the manufacturer, the party responsible for first placing the product on the market, or the importer in the case of third-country products.
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?
Food supplements must comply with both Spanish and European regulations. In addition to this, food supplements are subject to official control by the food competent authorities (in particular, the AESAN). During the manufacture of food supplements, the rules of Good Manufacturing Practice must be complied with by the manufacturer.
Likewise, the manufacturer or Responsible person for the marketing of the product in Spain or the importer must notify the first marketing of the product in Spain to the competent authorities (AESAN), providing them with a copy of the label of the product. If, once the label has been delivered, the authority considers it necessary to submit the product to specific quality and hygienic controls, it will be necessary to comply with these controls.
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 accordance with article 8 of RD 1487/2009, Companies responsible for the production, processing, packaging, storage, distribution, importation and marketing of the products are obliged to register themselves and the products marketed in Spain in the Spanish General Sanitary Food Registry (“Registro General Sanitario de Alimentos”). This register is public and interested parties may consult it to find out all the information on the marketing company or manufacturer and on the food supplement.
Also note that, as a foodstuff, it will be subject to the traceability regime of Regulation (EC) No. 178/2002, which lays down the general principles and requirements of food law, establishes in Article 18 the traceability requirements for food and stipulates that food business operators must be able to identify any person from whom they have received a food product or any substance intended for the production of food.
This necessarily implies that the responsible parties must maintain records that allow the traceability of the origin of ingredients, the production process, and the distribution of products, thereby facilitating the identification of products in the event of a food safety incident.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
As a general rule, food supplements must comply with the labelling requirements set forth in Regulation (EU) (EU) 1169/2011, since they are considered "food" under European law.
However, there are specific labelling requirements regulated by RD 1487/2009 and Royal Decree 1334/1999, of 31 July, which approves the General Standard for the labeling, presentation, and advertising of food products ("RD 1334/1999").
Article 5 of RD 1487/2009 establishes that:
- the labelling, presentation, and advertising of food supplements must not include any statement suggesting that a balanced and varied diet cannot provide adequate amounts of nutrients in general;
- the labelling, presentation, and advertising must not attribute the ability to prevent, treat, or cure a human disease to supplements, nor should they reference such properties; and
- the following information must be included in the label:
- the categories of nutrients or substances that characterize the product, or a description of the nature of such nutrients or substances;
- the recommended daily dose of the product;
- a warning not to exceed the expressly recommended daily dose;
- a statement that food supplements should not be used as a substitute for a balanced diet;
- an indication that the product should be kept out of the reach of young children; and
- the safety warnings established in the third column of the annex of the RD 1487/2009.
Furthermore, RD 1334/1999 stipulates that the labelling or promotional methods for a food supplement, and the way in which such promotion is carried out, must not be misleading to the consumer, particularly in relation to:
- The characteristics of the food product, specifically its nature, identity, qualities, composition, quantity, shelf life, origin, or production methods.
- Attributing to the food product effects or properties it does not possess.
- Suggesting that the food product has particular characteristics when all similar products possess the same characteristics.
- Attributing to the food product preventive, therapeutic, or curative properties for a human disease, or referring to such properties, except for applicable provisions relating to natural mineral waters and food products intended for special dietary use.
These prohibitions also apply to the presentation of foodstuff (especially the shape or appearance of the product or its packaging, the materials used for packaging, and the way they are arranged, as well as the environment in which they are displayed) and to advertising.
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, the advertising and promotion of food supplements are allowed in Spain. We refer to Q.1.14 above.
Moreover, in relation to the advertising of food supplements, the regulations governing the use of nutrition and health claims on foods are also highly relevant. Specifically, Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (“Regulation 1924/2006”).
In this regard, the Spanish Agency for Food Safety and Nutrition (AESAN) provides a search tool for "Nutrition and Health Claims," which includes all authorized claims under Regulation 1924/2006.
Besides, another significant prohibition regarding the promotion of food supplements is set out in article 44.3 of Act 17/2011, of 5 July, on Food Safety and Nutrition, which prohibits any reference, in the advertising or direct or indirect promotion of food products, including food supplements, "to their use in healthcare facilities or their distribution through pharmacies."
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
Regulation (EC) 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, allows competent authorities to take measures such as the recall of foodstuffs from the market if they are found to pose a risk to public health. In severe cases, they may order the suspension of activities or temporarily halt the production or distribution of food until compliance with safety standards is ensured.
Additionally, Regulation imposes strict obligations regarding the traceability of food products. Food business operators must be able to identify and record the origin and destination of each product throughout the entire supply chain. This includes having systems in place for the quick tracking of food and its ingredients, and providing this information to authorities when necessary for product recalls or other food safety controls.
The sanctioning regime for non-compliance with obligations related to food supplements is generally governed by Act 14/1986, of April 25, on General Health regime.
Finally, it should be noted that RD 1487/2009 specifically considers as a serious infringement the failure to comply with the obligations set out in Article 9 of the aforementioned regulation, regarding the information on the commercialization of products, as well as the failure to comply with the labelling regulations under RD 1334/1999. Sanctions in this respect range from €3,005.07 to €15,025.30, with the possibility of exceeding this amount up to five times the value of the products or services involved in the violation.
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
None at the moment, given that the competent food authority in Spain (AESAN) has not recently announced any relevant reforms.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
In Spain, beauty devices (such as microneedling, microdermabrasion, LED masks, laser hair removal devices, radiofrequency devices, etc.) do not fall under the definition of medical device of Regulation (EU) 2017/745, of 5 April 2017, of the European Parliament and of the Council on medical devices (“Regulation 2017/745”) and Spanish Royal Decree 192/2023, 21 March, on medical devices. However, these products shall be subject to the common specifications of Article 9 of Regulation 2017/745. In this regard, Implementing Commission (EU) 2022/2346, of 1 December 2022 (“Regulation (EU) 2022/2356”) sets out common specifications for such groups of products without a medical purpose listed in Annex XVI of Regulation (EU) 2017/745.
At the national level, Royal Decree 192/2023 of 21 March, which regulates medical devices (“RD 192/2023”), implements the provisions of the European regulations, also referring to products without a medical purpose.
The centralized regulatory authority responsible for the beauty devices in Spain is the AEMPS.
According to European regulations, it can be found that the distinction between a beauty device and a medical device is based on the product's intended purpose. A medical device must have a specific medical purpose, whereas beauty devices listed in Annex XVI of Regulation 2017/745 are expressly identified as products without a medical purpose.
Regarding product safety regulations, the requirements set out in Annex I of Regulation 2017/745 as well as those provided in Regulation 2022/2356 must apply.
Nevertheless, according to RD 192/2023, products that qualify as "machines" under Royal Decree 1644/2008, of 10 October, which establishes the rules for the commercialization and commissioning of machines, must also comply with the essential health and safety requirements stipulated therein, provided that such essential health and safety requirements are more specific than the general safety and performance requirements set out by the aforementioned European regulations.
Additionally, depending on the characteristics of the beauty device, it may also be necessary to ensure its electromagnetic compatibility in accordance with the requirements established in Royal Decree 186/2016, of May 6, which regulates the electromagnetic compatibility of electrical and electronic equipment.
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?
Under Regulation (EU) 2017/745, the manufacturer holds the primary responsibility for ensuring the safety and compliance of medical devices placed on the market. This includes ensuring the device's design, risk management, clinical evaluation, and post-market surveillance. Manufacturers must have robust systems in place to guarantee that their devices meet all regulatory requirements and safety standards.
If the manufacturer is located in a third country, it must appoint an authorized representative within the EU, which is responsible of ensuring the product's compliance with the regulation and shares legal responsibility for defective products with the manufacturer if the latter fails to comply.
Importers must ensure that products entering the EU market are compliant. They shall verify that the device bears the CE mark and the manufacturer’s conformity documentation is complete, and ensure proper labelling and storage conditions.
Distributors must verify the product’s compliance before making it available on the market, ensure proper storage and transport conditions and notify authorities of any non-compliance or safety risks.
Importers or distributors take on manufacturer responsibilities if they:
- Market the product under their own brand or commercial name.
- Modify the device or its intended use in ways that may affect compliance.
In summary, the manufacturer is primarily responsible for device safety and compliance, but authorized representatives, importers, and distributors also play crucial roles in ensuring compliance within the EU market, with their respective obligations outlined in the regulation.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
We refer to Q.2.1 above regarding product safety regulations.
In this regard, compliance with the general safety and performance requirements for beauty devices must be subjected to a clinical evaluation as set out in Regulation (EU) 2017/745 and RD 192/2023, in accordance with the requirements established therein as well as in Regulation 2022/2346.
Specifically, in the case of products without a medical purpose, the requirement to demonstrate a "clinical benefit" should be understood as the requirement to demonstrate the performance of the product. As such, the clinical evaluations of these products will be based on relevant safety data, including post-market surveillance data, specific post-market clinical follow-up, and where applicable, specific clinical investigations. Clinical investigations will be carried out for such products unless reliance on existing clinical data for an analogous medical device is duly justified.
Notwithstanding the above, when it is not deemed appropriate to demonstrate compliance with general safety and performance requirements based on clinical data, the justification for any exception must be grounded on the results of the manufacturer's risk management process, the specific interaction between the product and the human body, the intended clinical performance, and the manufacturer’s claims.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
A draft of a Spanish Royal Decree regulating the advertising of medical devices, as well as beauty devices listed in Annex XVI of Regulation 2017/745, is currently under process of approval.
Notwithstanding the above, there is no national specific regulation governing promotion or marketing of beauty devices listed in Annex XVI of Regulation 2017/745.
On the contrary, Regulation 2017/745 stipulates that, in the advertising of such products, the use of texts, names, trademarks, photographs, images, or other signs that may mislead the user or patient regarding the intended purpose, safety, or performance of the product is prohibited by any of the following means:
- Attributing functions and properties to the product that it does not possess;
- Creating a false impression about treatment or diagnosis, functions, or properties that the product does not have;
- Failing to inform the user or patient of the possible risks associated with the use of the product in accordance with its intended purpose; and,
- Suggesting uses for the product other than those indicated as part of the intended purpose for which conformity assessment was conducted.
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?
In Spain, the enforcement mechanisms for compliance with regulations regarding beauty devices are primarily governed by RD 192/2023 and Regulation 2017/745. Those regulations include the following measures:
- Market Control Activities: the AEMPS coordinates market control activities in collaboration with the regional health authorities.
- Health Protection Measures: if a product presents an unacceptable risk to health or safety, the AEMPS and other health authorities will adopt precautionary measures in accordance with Article 95 of Regulation 2017/745. These measures may include restrictions, prohibitions, or conditions on the manufacturing, import, marketing, and distribution of the devices. Products may also be quarantined, withdrawn, or recalled from the market if deemed necessary.
- Corrective and Preventive Actions: when a product does not comply with regulatory requirements, the AEMPS can impose corrective measures, including recalls or market withdrawals. In this regard, manufacturers are required to take the necessary actions within a specified timeframe to rectify non-compliance. Also preventive health measures can be adopted if a product poses a potential risk.
- Post-Market Surveillance: the manufacturers must implement post-market surveillance systems in accordance with Articles 83 and 84 of Regulation 2017/745. This includes the collection, analysis, and reporting of data on the quality, safety, and performance of the product throughout its lifecycle. Any serious incidents or corrective actions must be reported to the relevant authorities, and if necessary, immediate action must be taken to ensure public safety.
- Communication with Competent Authorities: any measures taken by health authorities, particularly those adopted by regional authorities, must be communicated to the AEMPS. The AEMPS is responsible for informing the European Commission and other member states about these measures through established electronic systems.
Please note that, under Spanish law, there is no specific criminal penalties for the manufacturing, commercialisation or advertising of cosmetic products. However, in the case of intentionally endangering public health by manufacturing harmful substances that do not comply with regulations, it could be considered a criminal offense by articles 359 and 360 of the Spanish Criminal Code.
Furthermore, it shall be considered the application of administrative sanctions may still apply in the event of non-compliance with applicable regulations.
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.
A draft of a Spanish Royal Decree regulating the advertising of medical devices, as well as beauty devices listed in Annex XVI of Regulation 2017/745, is currently under consideration.
The proposed reform is expected to be approved in 2024 and aims to provide a comprehensive framework for the regulation of advertising related to medical devices as well as beauty devices listed in Annex XVI of Regulation 2017/745.
We summary below key highlights of the regulation amendment:
- The draft introduces a wide definition of advertising, covering any informative offer, prospecting, or incitement made by a physical or legal entity, whether public or private, aimed at promoting products directly or indirectly through any communication channels, digital or non-digital. This scope includes advertisements on social media and applies to both public-facing and professional-targeted promotions.
- It prohibits exaggerated or misleading references to real or fictional patient testimonials and exaggeration of a product's effects. This restriction also applies to influencers promoting these products. Advertising must present the product devices objectively, without overstating their properties. Furthermore, the regulation prohibits exaggerated visual representations of human body conditions or the effects of products on the body.
- The draft clarifies that advertising of medical or beauty procedures linked to the use of a specific product must comply with the rules for advertising medical and beauty devices. However, it distinguishes between advertising the technique itself and the product, stating that advertising techniques under generic names is considered distinct from product-specific promotion.
- Advertising targeted at healthcare professionals does not require prior authorization from health authorities, nor the submission of a responsible declaration. Promotional content must appear in scientific media aimed at healthcare professionals and must include contraindications and possible side effects. While incentives and bonuses are generally prohibited, sponsorship of scientific meetings and presentations of non-conforming products in exhibitions are allowed under specific conditions.
- There are notable changes in the rules for advertising medical or beauty devices to the general public. Certain products, listed in Annex II of the draft of decree, do not require prior authorization for advertising, with a responsible declaration being sufficient. Examples include home-use intense pulsed light (IPL) photoepilation laser, contact lenses, nasal breathing aids or bandages. Additionally, the draft of decree mandates that public advertisements shall include disclaimers about potential side effects and contraindications, along with references to product information on official websites.
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?
The relevant aesthetic/cosmetic (non-surgical) services described within the scope of this section 3 (“Aesthetic Services”) are generally governed by Royal Decree 1277/2003 of October 10, which establishes the general framework for the authorization of healthcare centers, services, and establishments ("RD 1277/2003").
Under this regulation, aesthetic medicine is categorized as healthcare service U.48, defined as a "healthcare unit where a licensed doctor is responsible for performing non-surgical treatments aimed at improving body or facial aesthetics." Consequently, the applicable legal requirements must be fulfilled.
Aesthetic Services must be performed under the responsibility of a licensed doctor, which entails the doctor's continuous presence at the center.
In this regard, article 403 of the Spanish Criminal Code imposes penalties for engaging in activities reserved for professionals (such as the Aesthetic Services described within the scope of this section 3) without proper qualifications, with penalties of up to two years in prison.
Finally, please note that the most recent amendment to RD 1277/2003 has introduced the requirement for specialization in order to perform aesthetic surgery (surgical procedures), but not for aesthetic medicine (non-surgical procedures) under U-48, which only requires a medical degree. However, many regional authorities, within the scope of their territory, have been further developing U-48 by requiring specific training in aesthetic medicine for the performance of such activities.
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?
While other countries have prohibited non-surgical aesthetic treatments for minors under 18 years, there is no such prohibition in Spain, aside from any specific restrictions that may be established in the technical datasheets of the medical product used in the treatment.
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, authorized drugs (medical products) containing Botulinum Toxin Type A for aesthetic purposes are subject to medical prescription in Spain.
According to the AEMPS Informative Circular No. 2/2010 (soft law) on the conditions for prescription, dispensing, and use of medical products containing Botulinum Toxin Type A for aesthetic purposes, the administration of such medical products can only be performed by doctors with appropriate qualification, experience in the treatment, and access to the necessary equipment or instruments. In this regard, these treatments can only be carried out in duly authorized healthcare establishments or centers.
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?
In Spain, healthcare centers, establishments, and services must be registered in the General Registry of Healthcare Centers, Services, and Establishments (“REGCESS”). Established by Order SCO/3866/2007, of December 18, this registry provides a public and informative platform allowing users to access information regarding healthcare centers, services, and establishments authorized by the relevant regional health authorities.
Please note that REGCESS is updated based on data provided by the corresponding registers of the regional health authorities. Thus, the service, center or establishment must be registered before the registry of the relevant regional health authorities, which will then forward the information to the centralized registry (REGCESS).
The REGCESS does not handle complaints related to non-surgical cosmetic services, as it is a purely informational registry. Its purpose is to provide public access to information on authorized healthcare centers, services, and establishments, but it does not have a role in managing or addressing consumer complaints.
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.
We refer to frameworks described in Q.1.7 regarding cosmetic products and Q.2.7. regarding beauty devices.
Enforcement of regulations regarding medical products is governed in Spain by RDL 1/2015:
- In cases where there is an imminent and serious risk to public health, the health authorities may adopt precautionary measures as outlined in Article 109 of RDL 1/2015. These measures include the quarantine, market withdrawal, and prohibition of use of medical products, as well as the suspension of activities, advertising, and temporary closure of facilities.
- Additionally, sanctions for non-compliance are categorized as minor, serious, or very serious, with fines ranging from €6,000 to €1,000,000, depending on the severity of the infraction and the harm caused. For very serious infractions, additional sanctions may include the temporary closure of the establishment for up to five years. Moreover, any illicit profits gained from the infraction may be confiscated by the Treasury.
- The authorities are also empowered to impose non-punitive measures, such as the closure of facilities that do not meet the required health authorizations or the confiscation of expired or unauthorized medical products.
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?
There is no specific regulation governing the advertising of non-surgical aesthetic services, and therefore, they are subject to the general rules on service advertising, Royal Legislative Decree 1/2007, of 16 November, of the General Law for the Protection of Consumers and Users and other complementary laws.
However, if cosmetic services are advertised alongside medical devices, cosmetic products, or medical products, compliance with the relevant advertising regulations for medical devices, cosmetic products, or medical products, as applicable, will be required.
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.
None at the moment, given that the competent authorities in Spain have not recently announced any relevant reforms.