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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.
- 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 before being place in the market? 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?
The Netherlands has the decree on Cosmetic Products under the Commodities Act (Warenwetbesluit Cosmetische Producten) which refers to Regulation (EC) No 1223/2009 on cosmetic products (hereinafter “Cosmetic Products Regulation”). The text of the Cosmetic Products Regulation is adopted in its entirety without modification. The Dutch decree includes two specific stipulations for the Dutch market: the product information leaflet should be enclosed in Dutch (for some items Dutch is mandatory) or English; the governing authority in the Netherlands is the Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel en Warenauthoriteit, “NVWA”). Generally, the production, distribution and sale of cosmetic products on the Dutch market must comply with the Cosmetic Products Regulation.
A cosmetic product is classified in Article 2 (1) of the Cosmetic Product Regulation:
- any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
- and a medicinal product is defined in Article 1 (2) of Directive 2001/83/EC as:
- Any substance or combination of substances presented for treating or preventing disease in human beings.
- Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
As mentioned above, the Cosmetic Products Regulation has been adopted in its entirety without modification in the Netherlands. We therefore suffice with a reference to the relevant sections of this Regulation:
- Chapter IV (article 14 and on) provides information on restrictions for certain substances;
- Restrictions for substances are listed in the Annexes of the Regulation (for example in Annex II and III).
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?
Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. The responsible person shall ensure compliance with the relevant obligations set out in the Cosmetic Products Regulation. The obligations of the responsible person are laid out in Article 4 and Article 5 of the Regulation.
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
The cosmetic product must have undergone a safety assessment and the responsible person shall ensure that a safety report of this assessment is made in accordance with Article 10 and Annex I of the Cosmetics Products Regulation.
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
The packaging requirements for cosmetics in the Netherlands are laid out in Article 3 (2), decree on Cosmetic Products under the Commodities Act (Warenwetbesluit Cosmetische Producten):
In any case the indications referred to in Article 19 (1) (b), (c), (d), and (f) and (2) to (4) of the Cosmetics Products Regulation shall be included on the packaging in the Dutch language. All other information may be included in Dutch or English.
It is important to note that the packaging of the products bear specific information in indelible, easily legible and visible lettering. The information which needs to be provided is laid out in Article 19 of the Cosmetic Products Regulation.
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
The Netherlands has a self-regulatory system for advertising that includes labelling, administered by the Advertising Code Foundation (Stichting Reclame Code, “SRC”).
The Dutch rules for advertising are contained in the Dutch Advertising Code (Nederlandse Reclame Code, “NRC”), which is divided into a general section and a section dedicated to special advertising codes. The general section establishes rules that all advertising must comply with, while the section on special codes addresses specific types of advertising, such as the Advertising Code for Cosmetics Products 2023 (Reclamecode Cosmetische Producten 2023, “RCP”).
The RCP sets out the main requirements applicable to advertising for cosmetic products. However, the RCP does not deviate from the rules of the Cosmetic Products Regulation, but rather specifies them.
The RCP contains general rules, rules regarding the substantiation and plausibility of the claimed effect, rules regarding the use of pictures and images, rules regarding testimonials and expert statements, rules regarding children, minors and vulnerable consumers. We will list the general restrictions as listed in article 2 RCP below:
- claims that the product has been authorised or approved by the competent body in the EU are not permitted;
- claims that give the impression that a product offers a specific benefit when it only meets the minimum legal requirements are not allowed;
- when a product states that it contains a specific ingredient, it must actually contain that ingredient;
- claims about the propertied of a specific ingredient shall not create the impression that the finished product also possesses those properties if this is not the case;
- presentation of the performance of a product shall not go beyond what can be substantiated by the available evidence;
- claims may not attribute specific (i.e. unique) characteristics to a particular product if similar products possess the same characteristics;
- if the performance of a product depends on specific conditions such as use in combination with other products, this must be clearly indicated;
- claims must not represent ingredients used in a legal manner;
- claims must be clear and understandable to the average consumer of the cosmetic product;
- new techniques, such as artificial intelligence, must not be used misleadingly when used in support of claims.
Article 3 of the RCP states that claims concerning cosmetic products, both explicit and implicit, shall be substantiated by sufficient and verifiable evidence, including, where necessary, expert evaluations and other information contained in the product information leaflet referred to in Article 11 of the Cosmetic Products Regulation.
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.
The Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel en Warenauthoriteit "NVWA”) is the designated regulator for the Cosmetic Products Regulation.
The NVWA can impose an administrative fine of up to €1,030,000 (worst case scenario). The NVWA can also impose an order under penalty. Other administrative sanctions include:
- shutting down the business (and taking goods into custody);
- forfeiture of goods;
- publication of the warning, reprimand or judgment;
- under the Economic Offenses Act (Wet economische delicten, "WED"), criminal sanctions can be imposed.
With respect to the enforcement of the advertising regulations, the following applies:
The SRC's Advertising Code Committee ("ACC") and Board of Appeal ("BoA") are responsible for enforcing the self-regulatory advertising system. Anyone who believes that an advertisement violates the NRC may file a complaint with the ACC. If the ACC determines that there has been a violation of the NRC, it will sustain the complaint and recommend that the advertiser discontinues the advertising in question. The claimant or defendant can appeal the decision and bring it before the BoA.
The ACC/BoA cannot grant damages or impose any fines. However, over 95% of all ACC/BoA rulings and recommendations are respected due to the principle of "naming and shaming" – publishing the name of the infringing advertiser on the SRC website with a description of the case.
8. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
No future developments in the field of cosmetics, other than developments to EU legislation that will or might sideways impact the cosmetic industry, for instance expected new EU rules to reduce, reuse and recycle packaging.
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?
- The Dutch regulations that apply for supplements are laid out in:
- Directive 2002/46EG regarding Food supplements;
- Regulation 1925/2006, especially Annex III;
- the Decree on Food Supplements under the Commodities Act (Warenwetbesluit voedingssupplementen);
- Regulation on Food Supplements under the Commodities Act (Warenwetregeling voedingssupplementen); and
- Regulation on Exemption of Food Supplements under the Commodities Act (Warenwetregeling vrijstelling voedingssupplementen).
Food Supplements are defined in article 1 (1) (b) of the Decree on Food Supplements under the Commodities Act (Warenwetbesluit voedingssuplementen). Food supplements are described as food or drink products that:
- are intended to supplement the normal diet;
- are a concentrated source of one or more micronutrients or other substances with a nutritional or physiological effect; and;
- are sold in measured small unit quantities intended for ingestion.
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?
The Regulation on Exemption of Food Supplements under the Commodities Act (Warenwetregeling vrijstelling voedingssupplementen) lists what can and cannot be included in supplement products.
The supplements, for example, can not contain vitamins in amounts that may be harmful to human health (article 3) and for certain food supplements age restrictions/recommendations apply (article 5).
11. Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
Food supplements, fortified foods and herbal preparations must comply with the general (European) requirements for foods. As such, all business operators of food supplements, fortified foods and herbal preparations are responsible for ensuring that only safe products are placed on the market. The Dutch designated regulator, the NVWA, emphasises this in the explanatory Handbook Food Supplements, Fortified Foods and Herbal Preparations.
12. Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards before being place in the market? If so, are there any exceptions/particular extra requirements for certain products?
The (legal) manufacturer is responsible for safety and regulatory compliance. The manufacturer must ensure that their products comply with all the relevant European and Dutch legislation and that they have the necessary documentation to substantiate the safety and quality of their supplements.
Dutch law includes specific safety requirements with respect to mandatory information on the label, including information with respect to the substances contained and the percentage relative to the daily recommended intake. Furthermore, with respect to a number of food supplements, there is a requirement to mention that the food supplement is not suitable for children under the age of 1/3/10/17 years old.
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?
No, Dutch law does not include such a requirement.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
Article 6 of the Decree on Food Supplements to the Commodities Act (Warenwet), lists the information that needs to be included on the label/packaging. The following requirements must be adhered to:
- the designation of the categories of micronutrients or substances characterizing the commodity, or information regarding the nature of these micronutrients or substances;
- the recommended daily portion of the commodity;
- a warning about exceeding the recommended daily portion;
- a statement that dietary supplements are not to be used as a substitute for a diversified diet; and
- a warning that dietary supplements should be kept out of the reach of young children.
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, advertisement and promotion of supplements is allowed in the Netherlands. However, there are certain restrictions and generally speaking, the advertisement may not be misleading. The Inspection Board for Commentation of Health Products (Keuringsraad) assesses advertisements for food supplements according to the Code for the Commendation of Health Products (Code Aanprijzing Gezondheisproducten “CAG”). Food supplements fall within the scope of the Dutch Commodities Act (Warenwet) and therefore no medical claims may be made for them.
The SRC and the Keuringsraad work together to regulate health product advertising in the Netherlands.
Health claims are allowed, as long as the consumer is not misled and that Regulation 1924/2006 is complied with.
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
The NVWA is the designated regulator for supplements.
The NVWA can impose an administrative fine of up to €1,030,000 (worst case scenario). The NVWA can also impose an order under penalty. Other administrative sanctions include:
- shutting down the business (and taking goods into custody);
- forfeiture of goods;
- publication of the warning, reprimand or judgment;
- under the Economic Offenses Act (Wet economische delicten, "WED"), criminal sanctions can be imposed.
With respect to health claims the following applies: the Keuringsraad is an executive board based on self-regulation and does not enforce and cannot impose fines. However they can address parties if advertisements do not comply. If the party addressed does not want to cooperate, the file can be transferred to the NVWA or the Health and Youth Inspectorate (Inspectie Gezondheidszorg en Jeugd, “IGJ”). These designated authorities can impose fines for violations of advertisement regulations.
The SRC's Advertising Code Committee (ACC) and Board of Appeal (BoA) are responsible for enforcing the advertising codes. Anyone who believes that an advertisement violates the NRC may file a complaint with the ACC. If the ACC determines that there has been a violation of the NRC, it will sustain the complaint and recommend that the advertiser discontinues the advertising in question. The claimant or defendant can appeal the decision and bring it before the BoA.
The ACC/BoA cannot grant damages or impose any fines. However, over 95% of all ACC/BoA rulings and recommendations are respected due to the principle of "naming and shaming" – publishing the name of the infringing advertiser on the SRC website with a description of the case.
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
No future developments in this field that we are aware of.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
Beauty devices such as microneedling, lasers, LED masks and radio frequency devices are subject to various laws and regulations to ensure their safety and efficacy. These regulations are designed to protect consumers and ensure that the devices are used correctly by qualified professionals. It depends on the specific device, the purpose and the use of the device under which regulations it falls.
Depending on the circumstances, a beauty device could either qualify as a cosmetic product (Cosmetic Products Regulation), medical device (Medical Device Regulation, “MDR”), radioactive device (Radiation Protection Act or in Dutch: Kernenergiewet), and/or fall within the general scope of the Regulation (EU) 2023/988 on General Product Safety.
As the MDR is directly applicable in the Netherlands, we refer to the definition of a medical device as laid out in Article 2 (1) MDR:
“medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, (…)”
However, there are a few devices listed in Annex XVI of the MDR without an intended medical purpose that also have to comply with the MDR and are for that purpose equated with a medical device. The devices listed here could in some cases be used as a cosmetic device. The list in Annex XVI includes the following list of products that should comply with the MDR, regardless of a medical purpose or not:
- contact lenses;
- products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings;
- substances, combinations of substances or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection, excluding those for tattooing;
- equipment intended to be used to reduce, remove or destroy adipose tissue;
- high intensity electromagnetic radiation (such as infra-red devices, lasers, tattoo or hair removal devices or other skin treatments); or
- equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
We furthermore confirm that if no specific medical device or cosmetics regulations applies, the Regulation (EU) 2023/988 on General Product Safety functions as a catch-all regulation for the general safety requirements of the products.
The authority concerned with medical devices is the Health and Youth Care Inspectorate ( Inspectie Gezondheidszorg en Jeugd, "IGJ"). The authority concerned with cosmetic products and general product safety is the Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel en Warenautoriteit, "NVWA"). The authority concerned with radioactive devices is the Nuclear Safety and Radiation Protection Authority (Autoriteit Nucleaire Veilgheid en Stralingsbescherming).
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?
Yes, from the General Product Safety Regulation it follows that the manufacturer should appoint a responsible person for products placed on the Union market.
Under specific regulations, there can be additional requirements. For example, the MDR also requires a “person responsible for regulatory compliance”.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
From the General Product Safety Regulation it follows that manufacturers must ensure their products are safe for consumers to use and conduct proper safety assessments before placing the devices on the market.
Specific regulations can impose additional requirements. For example, the manufacturer of a medical device will need to follow Annex I of the MDR and conduct a risk assessment and the medical device must bear the CE mark.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
The Dutch Civil Code includes the general advertisement regulations. The main principles for advertisement are that they may not be misleading or aggressive. In addition to that, there are several more detailed self-regulating codes for advertisement of cosmetic products, medical devices, self-care medical products and health claims.
The Advertising Code for Cosmetic Products (Reclamecode Cosmetische Producten 2023, "RCP") applies to advertising specifically aimed at cosmetic products marketed in the Netherlands.
For medical devices there is a self-regulating code of conduct for medical devices 2024 (GMH). This Code includes compliance regulation about medical devices in the broadest sense, including advertisement.
Relevant in this respect could be the advertising code for self-care medical products (CMH) 2019 (Code Reclame voor Medische zelfzorg Hulpmiddelen 2019, "CMH").
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?
This depends on the type of product involved and the applicable legislation. The authority concerned with medical devices is the IGJ. The authority concerned with cosmetic products and general product safety is the NVWA. The authority concerned with radioactive devices is the Nuclear Safety and Radiation Protection Authority (Autoriteit Nucleaire Veilgheid en Stralingsbescherming).
The enforcement mechanisms vary from a warning to a substantial fine and the order to remove the products from the market. In some cases, criminal liability for non-compliance is possible, however, that depends on the specific circumstances of the case.
6. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
No future developments in this field that we are aware of.
Cosmetic (non-surgical) services
1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
In the Netherlands, the administration of services is regulated to varying degrees depending on the risks associated with the procedure. A specific list of procedures is, by law, exclusively reserved for physicians, dentists, midwives, physician assistants, clinical technologists and specific, by law appointed specialised nurses. This (limitative) group will hereinafter be referred to as “authorized person(s)”. The restricted or “reserved activities” are regulated in the Healthcare Professionals Act (Wet op de beroepen in de individuele gezondheidszorg “Wet BIG”).
The restricted activities that may be performed solely by an authorized person are listed in article 36 Wet BIG. The activities that might be relevant in relation to the cosmetic services listed in this questionnaire will be highlighted and mentioned below:
- The performance of surgical operations, defined as operations in the field of medicine, whereby the cohesion of body tissues is disrupted and not immediately restored;
- Administering injections;
- Performing punctures;
- The performance of acts of individual healthcare, using radioactive substances or devices emitting ionising radiation;
- Applying electroconvulsive therapy.
While it is rather clear for some cosmetic services whether it would be considered a reserved activity that may only be performed by an authorized person (for instance, Botox may only be performed by or under the supervision of an independently authorized person), for some cosmetic services this is not always (as) clear.
This is especially the case for services that involve new cosmetic treatments that have not been discussed by the authorities before. The Dutch National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, "RIVM"), at the request of the IGJ, conducted a study to gain more clarity on the potential risks associated with the use of the hyaluron pen and the mesogun. As a result of this study, the use of the hyaluron pen and the mesogun, were qualified as injections, and therefore, as reserved activities.
The general law that applies to all cosmetic services (and as well to other healthcare activities) is the Healthcare Quality, Complaints, and Disputes Act (“Wkkgz”). The providers of cosmetic care must comply with the Wkkgz. NB: The Wkkgz does not apply to services by beauticians and make-up artists when they cleanse the skin and apply skin-care creams or apply (non-permanent) makeup.
The Wkkgz stipulates what is considered to be "good care", specifies what should happen if people have a complaint about the care they have received and includes provisions on enforcement mechanisms.
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?
Whether or not a non-surgical cosmetic service may be provided to a minor, depends on the question whether the service is considered to be a reserved activity.
For cosmetic services that do not qualify as a reserved activity, the general rule applies in relation to legal acts performed by children: Minors may perform legal acts only with the consent of their legal representative(s). However, consent is presumed to have been granted if it involves legal acts which it is customary in society for minors of this age to perform independently.
For medical treatments in general, and thus for reserved activities, this principle is further elaborated on in the Medical Treatment Contract Act (Wet op de geneeskundige behandelingsovereenkomst, "WGBO"):
- For children under 12 years of age, the consent of the parents/guardians is required. Consent of the child is not required, but the child has a right to information. The physician must tailor the information to the child's comprehension;
- For adolescents aged 12 to 16, the consent of the parents/guardians and of the adolescent himself is required. In two exceptional cases, the consent of the young person alone is sufficient;
- Adolescents 16 years and older decide independently and have an independent right to information.
However, the Cosmetic Care Quality Framework (Kwaliteitskader Cosmetische Zorg) describes the national agreements and quality requirements in relation to what is considered to be "good care" in relation to cosmetic care. The Framework is intended for all healthcare providers and healthcare institutions performing cosmetic or aesthetic medicine treatments in the Netherlands. The Framework stipulates that healthcare providers only treat clients with a cosmetic care requirement if they are 18 years and older.
The professional association of cosmetic doctors has conformed to a guideline issued by plastic surgeons. That reads that they maintain a minimum age of 18 for cosmetic procedures without medical necessity, except for special (uninsured but not considered cosmetic) indications. For example, if a patient suffers psychologically due to his or her appearance/and has a recurring desire to have this corrected. This includes, for example, excessive hair growth. In these cases, parent(s) or guardian(s) must give consent prior to treatment. To this end, the “informed consent” is co-signed by parent(s) or guardian(s).
The Professional Code for Skin Therapists (Beroepscode voor de Huidterapeut) contains a similar provision: For patients with a request for help, which requires risky or irreversible treatment, the skin therapist only treats patients aged 18 and over. In special circumstances, the skin therapist may deviate from this.
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, botulinum toxin (BT) is a prescription only drug in the Netherlands.
The Individual Healthcare Professions Act (Wet BIG) specifies which professionals are authorized to prescribe prescriptions for UR drugs. Traditionally, these are three professions: doctors, dentists and obstetricians. They may prescribe UR drugs within their own area of expertise and to the extent that they are competent to do so. Physician assistants and nursing specialists may also prescribe UR drugs within their own area of expertise. They may only do so insofar as this involves less complex, routine prescriptions, the risks of which can be assessed. In doing so, they must act in accordance with nationally applicable guidelines, standards and protocols.
Administering BT to a patient may only be performed by or under the supervision of an independently authorized person.
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?
There is no requirement to register these type of services with a centralised body. There is however, a broader obligation: Any healthcare provider that provides (or arranges for the provision of) specialist medical care (which includes, among others, dermatology and plastic surgery) or any healthcare provider that provides (or arranges for the provision of) care with 11 or more care providers (to the extent such care is defined in the Healthcare Insurance Act (Zorgverzekeringswet) or the Long-Term Care Act (Wet Langdurige Zorg) must have a permit (and/or registration) under the Healthcare and Care Providers (Accreditation) Act (Wet toetreding zorgaanbieders, "WTZa").
The WTZa includes a number of exceptions in relation to the obligation to have a permit. For instance, independently operating healthcare providers (private persons) and beauticians do not have to apply for a permit.
With regard to complaints: the Netherlands has the so called National Healthcare Report Centre (Landelijk Meldpunt Zorg, "LMZ") which registers healthcare-related complaints. The LMZ gives information and advice to citizens on what to do with a complaint. The LMZ also registers the complaint. This allows the IGJ to use it in its supervision responsibilities. The LMZ is part of the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, "IGJ").
Furthermore, the Healthcare Quality, Complaints and Disputes Act (Wet kwaliteit, klachten en geschillen zorg , "Wkkgz") is of importance. The Wkkgz applies to both healthcare institutions and independent healthcare providers and thus extends to all healthcare providers, regardless of their size or form of cooperation. This Act obliges healthcare providers, among others, to make arrangements for effective and accessible reception and handling of complaints and obliges them to be affiliated with a recognized dispute settlement body that can issue binding rulings and award damages up to a certain amount.
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.
There are enforcement mechanisms aimed at the individual healthcare provider as well as mechanisms aimed at healthcare institutions.
Enforcement mechanisms for individual healthcare professionals
Healthcare professionals who are registered in the BIG-register are subject to self-regulatory disciplinary rules with respect to any act or omission contrary to the care that such professional should exercise.
The disciplinary board may impose one of the following disciplinary measures with respect to a person subject to disciplinary action:
- warning;
- reprimand;
- fine not exceeding €4,500;
- suspension of the authority to exercise the powers associated with the healthcare professional's BIG-registration for up to one year;
- partial disqualification from practicing the profession in question;
- removal from the BIG-register;
- binding to special conditions to practice the profession for which the professional is registered in the BIG-register.
The inspector of the IGJ monitors a professional's compliance with the disciplinary measures under d-f above.
A case may be brought to the appropriate regional disciplinary board by the filing of a complaint by:
- a patient;
- person who has given an assignment to the accused;
- the person with whom or the board of an institution at which the accused is employed or registered to provide individual healthcare;
- the inspector of the IGJ.
Punitive measures, such as imprisonment or fines up to €25,750,- are also possible.
Enforcement mechanisms for individual healthcare institutions
Supervision of healthcare institutions in relation to their compliance with the WTZa and the Wkkgz is carried out by the IGJ.
The measures that the IGJ can impose on healthcare providers who fail to meet their obligations under the Wkkgz or the Wtza are to:
- give a written designation to comply/become compliant within a specified period;
- (in urgent situations) impose an order that must be complied with immediately and may entail, for example, the immediate cessation of certain healthcare activities;
- apply administrative coercion if a healthcare provider does not comply with a given indication or order. This means that the IGJ itself can take the necessary measures at the healthcare provider's expense;
- impose an order under penalty to force the healthcare provider to take the necessary measures;
- impose an administrative fine for violations of the Wkkgz, such as failure to report calamities or violence in the healthcare relationship;
- take (other) appropriate measures, including informing judicial authorities if there is a serious threat to the safety of clients or care.
The IGJ can also institute enhanced supervision if the quality of care falls seriously short.
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?
The Code of Medical Cosmetic Treatments Performed by Physicians (Code medische Cosmetische Behandelingen uitgevoerd door Artsen, "CCBA") applies to advertising of medical cosmetic treatments performed by physicians and to advertising of such treatments in clinics.
This Code is without prejudice to the regulation of misleading advertising as mentioned in articles 7 and 8 of the general part of the Dutch Advertising Code, the Code for the Advertising of Medicinal Products to the General Public (Code Publieksreclame voor Geneesmiddelen, "CPG"), the Code for the Advertising of self-medication products (Code Reclame voor medische Zelfzorgmiddelen, "CMH") and the articles in the Media Act on advertising, sponsorship and product placement for medical treatments (Mediawet inzake reclame, sponsoring en productplacement voor medische behandelingen), that also contain provisions that are relevant in respect to the advertising of non-surgical cosmetic services. While perhaps more indirectly, the Code for the Advertisement of Cosmetic Products (Reclamecode Cosmetische Producten 2023, "RCP") may also be relevant.
As such, this party booking platforms which allow consumers to book non-surgical cosmetic services are not prohibited. However, such booking platforms shall adhere to the advertising codes and may thus, for instance, not promote the rational use of medical cosmetic treatment is not permitted. It is therefore also prohibited to include or suggest any form of time pressure and to conduct promotions involving a commitment to purchase or treatment.
7. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
No future developments in this field that we are aware of.