1. Cosmetics & Supplements 
    1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?  
    2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
    3. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
    4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
    5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging? 
    6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?  
    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.
    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. 
    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?  
    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?
    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?
    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? 
    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?
    14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging? 
    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?
    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
    17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
  2. Beauty devices
    1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
    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?
    3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
    4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?  
    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?
    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. 
  3. 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?
    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?
    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?
    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?
    5. Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services? 
    6. Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above. 
    7. 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?
    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. 

Cosmetics & Supplements 

This applies to cosmetic products put on the market for both personal and professional use. Examples include skin care (including “cosmeceuticals”) and dental products such as teeth whitening. 

Supplements (nutraceuticals) are defined broadly and could be something which target cosmetic outcomes e.g., supplement for skin/hair/nails etc. Or something which makes medical claims such as assisting with the side effects of menopause. 

1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?  

In Norway, cosmetic products are regulated under the Cosmetics Act (NO: kosmetikklova). This Act primarily functions as a framework law, enabling the adoption of detailed regulations and the implementation of EU legislation. One of the key regulations under the Act is the Cosmetics Regulations (NO: kosmetikkforskriften), which implements the Cosmetics Regulation (EC) No. 1223/2009 into Norwegian law. 

According to Section 2 of the Cosmetics Act, cosmetic products are defined in line with the EU Cosmetics Regulation as: 

Any substance or mixture intended to come into contact with the external parts of the human body, teeth, or mucous membranes of the oral and nasal cavities, primarily or exclusively to clean, perfume, change their appearance, affect body odours, protect them, or maintain them in good condition.” 

The Cosmetics Act does not apply to substances, mixtures, or devices that fall under the Medicines Act (NO: legemiddelloven) or the Medical Devices Act (NO: lov om medisinsk utstyr). This includes:

  • Medicines, defined as substances, drugs, and preparations intended or marketed for use in preventing, curing, or alleviating diseases, disease symptoms, or pain, influencing physiological functions in humans or animals, or for internal or external use in detecting diseases.
  • Medical devices, which are products that serve a medical purpose (e.g., diagnostics, treatment, or alleviation of disease or injury) where the primary mode of action is not pharmacological, immunological, or metabolic. 

Furthermore, the Act does not apply to foodstuffs regulated under the Food Act (NO: matloven), defined as any substance or product, whether processed, partially processed, or unprocessed, that is intended or reasonably expected to be ingested by humans.

The fundamental difference between cosmetics and medicines/medical devices is that cosmetics only act on the surface of the body and do not possess medical properties, whereas medicines and medical devices are intended to have a therapeutic or diagnostic effect, often involving physiological changes or internal applications.

2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?

Yes, according to Article 14 of Regulation 1223/2009, certain substances are prohibited in cosmetic products (Annex II), while others are subject to restrictions (Annex III). Additionally, there are specific limitations on certain colorants (Annex IV), preservatives (Annex V) and UV-filters (Annex VI). 

Examples of prohibited substances include formaldehyde, antibiotics, and lead. Restricted substances typically have a maximum allowed concentration, and for some substances, a distinction is made between general and professional use. 

Furthermore, Article 15 of Regulation 1223/2009 states that substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) under Regulation (EC) No 1272/2008 are generally prohibited in cosmetics. However, these substances may still be used if they have been evaluated by the Scientific Committee on Consumer Safety (SCCS) and deemed safe for use. 

In addition, the Norwegian Food Safety Authority (NO: Mattilsynet) recommends specific limits for the use of certain pharmacologically active substances in cosmetics. This term refers to substances that are, or could potentially be, active ingredients in medicinal products. The Norwegian Food Safety Authority has reviewed the available information relevant to a broad range of such substances. These substances were selected based on a former national Norwegian regulation, which had to be discontinued with the implementation of the Cosmetics Regulation into Norwegian law. 

According to the Norwegian Food Safety Authority, a review of the risk profiles suggests that nearly all of the pharmacologically active substances should be regulated through limit values, labelling or prohibition to meet the requirement of Article 3 of the Cosmetics Regulation: 

“A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use”. 

It is important to note that these substances are not currently prohibited under existing regulations. However, the Norwegian Food Safety Authority strongly encourages the industry to follow these specific Norwegian recommendations. During inspections of cosmetics in Norway, the authority will assess the presence of these risk-evaluated substances. If products are found to be potentially unsafe, the industry must provide scientific evidence demonstrating their safety. Should the provided documentation be deemed insufficient, the Norwegian Food Safety Authority will take the necessary actions to ensure consumer safety. 

The Norwegian Food Safety Authority’s risk profiles aimed at industry can be found at the following link (Norwegian only): https://www.mattilsynet.no/kosmetikk-og-kroppspleieprodukter/farmakologisk-aktive-stoffer-i-kosmetikk

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?

Yes, according to Article 4 of Regulation 1223/2009, all cosmetic products made available to consumers must have a designated “responsible person.” The responsible person is generally responsible for meeting most regulatory obligations, with the exception of national language requirements and certain minor details, which fall under the responsibility of national distributors. 

The responsible person can be either;

  • the manufacturer,
  • the importer,
  • the distributor (if they place a cosmetic product on the market under their own name or trademark), or
  • a person appointed by the manufacturer or the importer.

4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?

Yes, according to Article 10 of Regulation 1223/2009, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment, and that a cosmetic report is set up. The responsible person must ensure that the safety report is presented in a language that is easily understood by Norwegian authorities 

The responsible person shall ensure that;

  • the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment,
  • an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources, and that
  • the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.

A safety report consists of two parts:

  • Safety information about the product: This includes all necessary information to demonstrate that the product is safe.
  • Safety assessment of the information in the first part: A qualified expert must assess the product. The expert must provide documentation of their educational qualifications.

5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging? 

According to Article 19 of Regulation 1223/2009, cosmetic products may only be available on the market if their container and packaging include the following information, in clear and legible writing:

  1. Responsible person: name and address of the responsible person, including the country of origin for imported products.
  2. Content: stated weight or volume, except for small packages, samples and single-use items.
  3. Durability: Minimum durability date or the period after opening for products with a shelf life of more than 30 months.
  4. Precautions: Specific usage instructions and warnings, particularly for professional-use products.
  5. Batch number: For traceability, unless impractical for small products.
  6. Function: if not obvious from the product’s presentation
  7. Ingredient list: listed in descending order by weight, including nanomaterials and colorants, using standardized names. 

If practical constraints make labelling difficult, the information in points d) and g) can be provided on an enclosed leaflet, label, or similar. For small items like soap and bath bombs, information can be displayed near the sales unit. 

The information in (d) and (f) must be provided in Norwegian. For products where direct labeling on the packaging is impractical, the information must also be provided in Norwegian. 

The information in (b) and (c) may be provided in Norwegian or in a language similar in meaning and spelling to Norwegian, such as Swedish or Danish.

6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?  

The marketing of cosmetics is regulated by the Cosmetics Act (NO: kosmetikklova), the Marketing Act (NO: markedsføringsloven), the Cosmetics Regulation, and Regulation (EU) 655/2013, which establishes common criteria for the justification of claims used in relation to cosmetic products. 

According to Section 7 of the Cosmetics Act, the labeling, presentation, and advertising of cosmetics must be accurate, provide sufficient information to the consumer, and not be misleading. This means that the information provided must not create false impressions about the product regarding aspects such as origin, properties, nature, quantity, composition, or other factors that may be important to consumers. 

The Marketing Act applies to all advertising and marketing in Norway, including cosmetics. The Marketing Act requires that all marketing must adhere to good marketing practices and must not be misleading or unfair. This implies that claims about a cosmetic product’s properties must be substantiated, and the marketing must not attribute effects to the product that it does not have. 

In addition, there are specific requirements for product claims under Article 20 of Regulation 1223/2009. Under this Article, labels, marketing, and advertisements for cosmetic products must not use text, names, trademarks, images, or symbols to suggest characteristics or functions that the products do not possess. Moreover, a claim that no animal testing has been conducted may only be made if the manufacturer and suppliers have not carried out, commissioned, or used ingredients tested on animals for the purpose of developing new cosmetic products. 

Furthermore, Regulation 655/2013, which is implemented in Norwegian law through the Cosmetics Regulations, establishes common criteria for cosmetic product claims to ensure they are truthful, clear, and substantiated, protecting consumers from misleading information. The regulation outlines six main criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. 

Overall, claims about cosmetic products must reflect the product’s actual characteristics, be supported by evidence, and avoid exaggeration or ambiguity.

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.

In Norway, the enforcement mechanism for ensuring compliance with regulations concerning the supply of cosmetic products is governed by the Cosmetics Act Chapter III, with the Norwegian Food Safety Authority (NO: Mattilsynet) serving as the supervisory authority. The authority oversees compliance and can take measures such as prohibiting the development, production, import, distribution, export, and sale of non-compliant products. It can also seize, destroy products, or close businesses when necessary. 

Businesses may also be required to pay fees to cover the costs of inspections, certifications, and other regulatory services. Additionally, the Norwegian Food Safety Authority can impose coercive fines, which may be either one-time fines or recurring daily fines, on businesses that fail to meet the deadlines for enforcement orders. 

Intentional or negligent violations of the Cosmetics Act or its associated regulations can lead to penalties, including fines or imprisonment for up to one year.

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. 

If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced. 

At the end of 2024, Norway incorporated Regulations (EU) 2024/858 and (EU) 2024/996 into Norwegian law.

Regulation 2024/858 introduces bans and restrictions on the use of specific nanomaterials in cosmetic products. Regulation 2024/996 sets restrictions on the use of Vitamin A, Alpha-Arbutin, Arbutin, and certain substances with potential endocrine disrupting properties in cosmetics.

These changes mean that cosmetic products containing these substances, or not complying with the new restrictions, cannot be placed on the market from February 1, 2025. Additionally, from November 1, 2024, such products cannot be made available on the market.

9. Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?  

In Norwegian law, supplements are classified as food products rather than cosmetics or pharmaceuticals, even though they are often used as part of beauty routines. Supplements are primarily regulated by the Food Act (NO: matloven) and the Regulation on Dietary Supplements (NO: Forskrift om kosttilskudd), which implement EU legislation, especially Directive 2002/46/EC. 

Supplements is defined in the Regulation on Dietary Supplements as foodstuffs which;

  • are intended to supplement the diet, and
  • are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect, alone or in combination, and
  • are put into circulation in pre-packaged and dosed form intended to be ingested in small measured quantities; such as capsules, lozenges, tablets, pills, powder sachets, ampoules, dropper bottles and similar forms of liquids and powders.

10. Do the regulations in your jurisdiction specify what can and cannot be put in supplement products? If so, what are some examples of these restrictions?

Yes, the Regulation on Dietary Supplements regulates which vitamins and minerals may be included in supplements, either naturally or by addition. The amount of vitamins and minerals may also be within set limits.

Additionally, there are regulations on which compounds of vitamins and minerals are permitted to be added to a supplement. 

Other substances, beyond vitamins and minerals, may also be added, in accordance with the Regulation on the addition of vitamins, minerals and certain other substances to foodstuffs, describing which substances may be added and further conditions for the addition of these substances.

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?

It is a requirement that those who operates businesses that falls within the scope of the Norwegian Food Act and the regulations derived from it, such as the Regulation on Dietary Supplements must notify the Norwegian Food Authority (NO: Mattilsynet). Cosmetic and personal care businesses that must register in accordance with the Cosmetics Act are the following: 

  • Producers, importers, wholesalers and distributors of cosmetic and personal care products and online businesses selling cosmetic and personal care businesses. 

Businesses that must register in accordance with the Food Act are among others the following: 

  • Producers, importers, exporters, wholesalers and distributors of food and beverages (which includes supplements), as well as grocery stores and supermarkets, restaurants, cafes and catering companies. This includes online businesses.

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? 

Placement of a supplement (food product) on the market is on the condition of it being safe. A supplement is considered unsafe if it is harmful to health or unfit for consumption. In determining whether a food product is unsafe, consideration must be given to consumers’ normal use of the food at each stage of production, processing and distribution, and the information provided to consumers, including labelling or other public information on how to avoid specific adverse health effects.  

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?

The responsible entity is obliged to send the following information to the Norwegian Food Safety Authority before being placed on the market:

  • Name and address of the notifier and manufacturer.
  • All constituent ingredients, including compounds of added vitamins and minerals.
  • The dietary supplement's total content (the sum of naturally occurring and added amounts) of all vitamins and minerals per recommended daily dose. 

The Norwegian Food Safety Authority must be notified of all changes to the information provided and any withdrawal of products from the market. 

The Norwegian Food Safety Authority may require further information and documentation, although the regulation does not specify the details on which information they may request. As such, is it probably wise to keep records for a certain time period, to comply with potential inquiries under their broad authority.

14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging? 

Yes, the Regulation on Dietary Supplements provides that supplements must be labeled in accordance with applicable regulations on the labeling of foodstuffs. 

It is not permitted in the labeling or marketing of dietary supplements to claim or give the impression that a balanced and varied diet generally does not provide a sufficient supply of vitamins and minerals. Furthermore, it is not permitted in labeling or marketing to claim or give the impression that a dietary supplement prevents, heals or relieves disease, disease symptoms or pain.

Specifically, the following information must be included in the labelling/packaging:

  • The name of the categories of nutrients or other substances with a nutritional or physiological effect that characterize the product, or an indication of their nature.
  • The recommended daily dose.
  • A warning against consuming more than the recommended daily dose.
  • Information that food supplements should not be used as a substitute for a varied diet
  • Information that the products should be kept out of the reach of children. 

Food supplements must be labeled with the amount of nutrients or other substances with a nutritional or physiological effect expressed in numbers per recommended daily dose.

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 Supplements is allowed. 

The responsible entity must ensure that labelling, presentation, advertising and marketing are correct, provide the recipient with sufficient information and are not likely to mislead. 

It is not permitted in the labelling or marketing of supplements to claim or give the impression that a balanced and varied diet generally does not provide a sufficient supply of vitamins and minerals. 

It is not permitted in labelling or marketing to claim or give the impression that a supplement prevents, heals or relieves illness, disease symptoms or pain.

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 Norwegian Food Safety Authority is responsible for supervision and makes decision to ensure compliance with regulations regarding supplements, including closure or coercive fines, and fines or imprisonment in severe cases.

17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?

We expect minor changes regarding implementation of recent minor changes to Directive 2002/46/EC. It is important to note that these regulations are subject to constant evolution, however we have no indication of any major changes or reforms in the near future.


Beauty devices

1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?

Yes. As described under section 1, question 1, cosmetic products are regulated under the Cosmetics Act (NO: kosmetikklova). 

Cosmetic devices, however, may fall either under the general Regulation (EU) 2023/988 on general product safety (“Product Safety Regulation”), or under the Regulation (EU) 2017/745 on medical devices (“MDR”). MDR Annex XVI mentions several products that fall under MDR, such as laser equipment etc. 

Products which fall under MDR are regulated by the Medical Devices Act (NO: lov om medisinsk utstyr). The definitions in the Medical Devices Act references MDR, and products that fall under MDR is therefore regulated by the Medical Devices Act. For these products, the regulatory body is NOMA – Norwegian Medical Products Agency (NO: Direktoratet for Medisinske Produkter). 

Cosmetic devices not covered by MDR, and thus not regulated by the Medical Devices Act, are regulated by the Product Control Act (NO: produktkontrolloven). The Product Control Act is based on the previous Directive 2001/95/EC on general product safety (“Product Safety Directive”), as Norway has yet to implement the Product Safety Regulation. 

If there is uncertainty whether a product falls under MDR or not, NOMA is given the authority to decide if a device is to be considered a medical device. 

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?

If the device falls under MDR, the person responsible for the cosmetic device and its safety is primarily the manufacturer (defined as “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark”). Where the manufacturer of a device is not established within the EEA, the device may only be placed on the market if the manufacturer designates a sole authorized representative. 

Manufacturers must ensure that the device has been designed and manufactured in accordance with the requirements of the MDR and have to observe various obligations and duties. Amongst many others, manufacturers must establish, document, implement and maintain a system for risk management, they must conduct a clinical evaluation of the device and draw up and keep up to date technical documentation for those devices.

If the device does not fall under the MDR, the provisions of the Product Control Act apply. This Regulation provides for various obligations for several involved parties i.e. the manufacturer, the authorized representative, and the importer. However, the person mainly responsible for the safety of a device under the Regulation is the manufacturer.

3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?

If the device falls under MDR, these devices are categorized into the risk classes Class IIa or Class IIb. Manufacturers of these devices must ensure compliance with both general safety and performance requirements outlined in MDR. Moreover, for the product to be legally marketed, it must undergo a conformity assessment leading to the award of a CE mark. This assessment of compliance and safety is checked by an independent, so-called Notified Body. The Notified Body thoroughly examines whether the product meets all the legal requirements and safety standards along with manufacturing activities and QMS. Once the Notified Body certifies the conformity of the product with all applicable MDR rules, it receives the CE mark, signifying its compliance, and can then be placed on the market. 

If the device does not fall under the MDR, the provisions of the Product Control Act apply. This Act does not have specific safety assessment standards, other than the general requirements for the manufacturer. However, all products must be considered safe, which is the responsibility of the manufacturer. Products are presumed to be “safe” if the product complies with the requirements of a harmonized standard, which is defined as a European standard drawn up in accordance with a mandate from the European Commission and EFTA and published in the Official Journal and the EEA Supplement thereto. If no harmonized standard exists for the relevant product, the product’s safety must be assessed based on broader criteria, such as possible national standards, codes of good practice, state of the art technology, level of safety than can reasonably be expected, etc.

4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?  

If the device falls under MDR, article 7 of the directive regulates marketing/promotion. Under MDR art. 7, marketing/promotional materials must not:

  • Use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient regarding the device's intended purpose, safety and performance.
  • Ascribe functions and properties to the device which the device does not have.
  • Create a false impression regarding treatment or diagnosis, functions or properties which the device does not have.
  • Fail to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose.
  • Suggest uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. 

If the device does not fall under MDR, the general Marketing Control Act (NO: markedsføringsloven) applies. Under this Act, all commercial practices considered misleading, i.e. false information, deceiving information, is prohibited. Additionally, misleading omission, i.e. unclear, ambiguous, or otherwise omitted or hidden information, is prohibited.

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?

If the product falls under MDR, the relevant competent authority, NOMA, has been given broad powers to inspect goods and premises, request necessary documentation etc. Measures may include coercive fines, infringement fees and possible criminal liability charges in severe cases. 

If the product does not fall under MDR, the relevant authority depends on the products nature, e.g. Norwegian Environment Agency, the Norwegian Electricity Authority and the Ministry of Children and Families. The Ministry of Children and Families are responsible for general safety and health, unless the product is covered by any of the more specific public authorities. Measures may include coercive fines, infringement fees and possible criminal liability charges in severe cases.

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. 

We expect minor changes regarding prohibited contents of cosmetic products, but no foreseeable changes to legislation regarding cosmetic devices. It is important to note that these regulations are subject to constant evolution, however we have no indication of any major changes or reforms in the near future.


Cosmetic (non-surgical) services 

1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?

Yes, depending on the risk that administering or providing the cosmetic treatment, procedure, injection etc. exposes the person being treated to. If it is the case that the treatment may pose a risk of serious injury, illness, complications or side effects, the treatment must be carried out by a qualified healthcare professional.  Individuals under the age of 18 cannot undergo cosmetic procedures that pose serious risks unless medically justified according to the Patient and User Rights Act § 4-5 a and the Health Personnel Act § 4 b. 

Following regulations may apply:

  • Health Personnel Act
  • Patient and User Rights Act
  • The Medicinal Products Act 

"Cosmetic surgery/procedures" generally require medical doctor competence. The term covers cosmetic and plastic surgery but may also include non-surgical activities with similar risks and side effects. 

"Cosmetic injections" mainly refer to injecting drugs or substances like fillers into the skin. These can be performed by other healthcare personnel, either independently or assisting a doctor. 

"Cosmetic treatment" includes non-surgical cosmetic activities often performed by non-healthcare personnel, aimed at aesthetic improvements but not classified as "cosmetic surgery/procedures" or "cosmetic injections." 

If so, what national laws apply? 

  • Botulinum toxins / Fillers

Yes. Botulinum toxin (Botox) can only be prescribed by doctors for human medical use, according to Health Personnel Act §§ 4 and 11. Treatment with Botox must be carried out by qualified healthcare personnel, cf. the Health Personnel Act § 4 a. Nurses can administer Botox as the doctor's assistant, provided they have received sufficient training, and the responsible doctor has ensured their competence. The doctor must be available for guidance and supervision during the procedure, cf. Health Personnel Act § 5. 

Certain fillers does not count as a medicinal product, but only health personnel may administer these fillers because it counts as a cosmetic injection, and the receiver must be 18 years of age.  

  • Vitamin drips and injections

This depends on the risk posed by drips/injections.

  • Weight loss injections

No, but this is prescription based in Norway.

  • Laser, LED and IPL skin treatments (hair removal, skin rejuvenation, weight loss)

Companies must report class 4 lasers or IPLs to DSA and register the lasers/IPLs in the electronic reporting system. the Health Personnel Act contains provisions regulating the use of lasers for hair removal in Norway. Specifically, Section 4a is relevant, as it sets competence requirements for cosmetic procedures, including laser treatments. According to this section, only authorized health personnel are permitted to perform cosmetic procedures, injections, or treatments that could cause serious harm, illness, complications, or side effects to the patient.

  • Microneedling
  • Mesotherapy
  • Chemical Skin peels
  • Micro dermabrasion
  • Dermarolling / Dermaplaning
  • Professional Skin lightening
  • Infrared skin treatments
  • Vampire facials/platelet-rich plasma (PRP)
  • Whole body cryotherapy
  • Semi-permanent make up 

Whether the abovementioned treatments are subject to Norwegian laws and regulations depends on the risk that the respective treatment poses for the person being treated to. In general, invasive treatments – both surgery/procedures and injections – are subject to the Health Personnel Act. For treatments performed with medical equipment, the Medicinal Products Act will also apply.

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?

The Health Personnel Act § 4 b states that cosmetic procedures, injections or any treatment without a medical or odontological need that may risk serious injury, illness, complications or side effects, shall not be performed on patients under 18 years of age. 

The 18-year age limit is absolute and applies irrespective of whether the patient consents to such treatments, or whether the patient's parents or others with parental responsibility for the patient gives their consent on behalf of the patient. 

Cosmetic procedures, injections or treatments that are not covered by this provision will fall outside the scope of the Health Personnel Act, if performed by someone who is not a healthcare professional. This will apply to cosmetic treatments with low risks, typically skin care and similar treatments. For these procedures, the 18-year age limit will therefore not apply if it is performed by someone other than a healthcare professional. However, the age limit will still apply to treatments performed by healthcare professionals.

3. Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?

Botulinum toxin (Botox) can only be prescribed by doctors for human medical use, according to Health Personnel Act §§ 4 and 11. Treatment with Botox must be carried out by qualified healthcare personnel, cf. the Health Personnel Act § 4 a.

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 general, health personnel practitioners must obtain an authorization from the Norwegian Directorate of Health. This process includes verifying medical qualifications and proficiency in the Norwegian language. The Norwegian Board of Health Supervision oversees healthcare services, including non-surgical cosmetic procedures like Botox treatments. They are responsible for ensuring that practitioners comply with established standards and regulations. 

4.1 Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services? 

In Norway, complaints about Botox treatments are primarily handled by the County Governor (NO: Statsforvalteren), which serves as both a supervisory authority and a complaints body for health and care services, including cosmetic procedures like Botox.

The Norwegian Board of Health Supervision (NO: Statens helsetilsyn) oversees health personnel and services, intervening in cases of improper execution of medical procedures.

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. 

In Norway, the Health Personnel Act outlines various sanctions and measures that can be imposed on healthcare professionals who breach its provisions.

These reactions vary in severity and scope, including:

  1. Professional Order (§ 56): Supervisory authorities can mandate healthcare professionals to implement measures to enhance their competence.
  2. Revocation of Authorization, License, or Specialist Approval (§ 57): In cases of serious breaches, a healthcare professional's authorization, license, or specialist approval may be revoked.
  3. Prohibition from Providing Healthcare Services for Formerly Authorized Professionals (§ 57a): Formerly authorized healthcare professionals may be prohibited from providing healthcare services if they no longer meet the necessary requirements.
  4. Limited and Full Suspension of Authorization, License, and Specialist Approval (§ 58): Suspension can be imposed as a temporary measure when there is suspicion of a breach of the law.
  5. Suspension Due to Breach of Duty to Inform (§ 58a): Healthcare professionals can be suspended if they fail to fulfill their duty to inform.
  6. Restriction of Authorization (§ 59): Authorization can be limited to specific tasks or areas in the event of a breach.
  7. Order for Expert Examination (§ 60): Supervisory authorities can mandate healthcare professionals to undergo an expert assessment.
  8. Voluntary Relinquishment of Authorization, License, or Specialist Approval (§ 61): Healthcare professionals may voluntarily relinquish their authorization or license.
  9. New Authorization or License (§ 62): Formerly authorized healthcare professionals can apply for new authorization or license after a certain period.
  10. Order to Submit Patient Record Archives (§ 62a): Healthcare professionals can be required to submit patient records in the event of a breach.
  11. Loss of Right to Prescribe Certain Medications (§ 63): The right to prescribe certain medications can be revoked following a breach.
  12. Suspension of Prescribing Rights (§ 64): Prescribing rights can be suspended in the event of a breach.
  13. Reduction of Period for Loss of Prescribing Rights (§ 65): The period for losing prescribing rights can be shortened following a breach.
  14. Reactions Towards Temporary Practitioners (§ 65a): Temporary practitioners can face reactions in the event of a breach.
  15. Information to Employer and Other Countries (§ 66): Supervisory authorities can inform employers and authorities in other countries about breaches.
  16. Criminal Sanctions (§ 67): Serious breaches can lead to criminal sanctions.

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?

Yes, several regulations, including the Medicines Act, Health Personnel Act, Marketing Act, and regulations on cosmetic procedures and medical equipment. 

This is an overview of the basic rules for marketing cosmetic procedures on social media and websites in Norway: 

Prescription Medications: It is prohibited to market prescription medications to the public. Examples include Botox, Azzalure, Vistabel, and Belkyra. It is also illegal to promote the use of drugs outside their approved applications. 

Medical Equipment: The marketing of medical equipment must align with the manufacturer's instructions. This includes items like fillers, threads for facelifts, laser hair removal equipment, liposuction devices, and needles for cosmetic procedures. Misleading customers, making false claims, or failing to disclose potential side effects and complications is not allowed. 

Prohibited Marketing Practices:

  • No before-and-after photos
  • No offensive, harmful, or body-shaming content
  • No use of negative terms or promoting unrealistic body standards (e.g., “bunny lines” or “turkey neck”)
  • No offers for consumer loans 

Protection for Minors: Children under 18 have special protection from marketing that exploits social insecurity or contributes to body pressure. Marketing of cosmetic procedures is often illegal on platforms popular with minors, especially for more invasive procedures. 

  • What to Avoid:
    • Appeals to children, such as discounts or contests
    • Marketing related to issues particularly relevant to young people, like acne scars
    • Encouraging early preventive treatments
    • Direct calls to purchase or share marketing materials 

If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations? 

Yes, the rules prohibiting marketing are aimed at the advertisement itself, and not necessarily who is offering the service.

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. 

It is important to note that these regulations are subject to constant evolution. However, the most recent updates to the regulations in Norway were implemented relatively recently.