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Cosmetics & Supplements
- How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
- Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
- Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
- Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
- Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
- Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?
- Do the regulations in your jurisdiction specify what can and cannot be put in supplement products? If so, what are some examples of these restrictions?
- Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
- Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards? If so, are there any exceptions/particular extra requirements for certain products?
- Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?
- Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
- Is the advertising and promotion of Supplements allowed in your jurisdiction? If so, under what conditions? Are there any specific requirements or regulations for advertising and promotion?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regards to the supply of supplements
- Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
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Beauty devices
- Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
- Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic devices and their safety placed on the market?
- Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
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Cosmetic (non-surgical) services
- Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
- Are there any rules in your national law which prevent an individual under the age of 18 (or other age as relevant) from receiving a particular non-surgical cosmetic service?
- Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
- Does the (national) law require that businesses and/or practitioners administering these services register with a centralised body? Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services?
- Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above.
- Are there any national laws or regulations which are relevant to the advertising of non-surgical cosmetic services? If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
jurisdiction
Cosmetics & Supplements
1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
Regulation (EC) No 1223/2009 on Cosmetic Products (“EU Cosmetics Regulation”); German Regulation on Cosmetic Products (“Kosmetik-Verordnung”) which mainly serves to transpose the EU Regulation.
The definition of a cosmetic product in Article 2(1)(a) of the EU Cosmetics Regulation comprises three parts: product composition, field of application, and a function.
- A cosmetic product may be a substance or mixture of a number of substances, and it may come in one or more than one part to be combined by the user.
- The field of application relates to external parts of the body (epidermis, hair system, nails, lips and external genital organs), the teeth and the mucous membranes of the oral cavity.
- The Regulation specifies 6 functions: Cleaning, perfuming, changing the appearance, protecting, keeping in good condition, or correcting body odours.
Products that are intended to be ingested, inhaled, injected or implanted are not classified as cosmetic products. For example, aromatherapy products not intended for use on the skin would not be classified as a cosmetic product. Products which are ingested but claim to have “cosmetic benefits” i.e. improving skin, hair and nails, would likely fall under the food supplement or medicinal products regime.
Medicinal products are those which are presented as having properties for treating or preventing disease in human beings (“medicinal products by presentation”) or which may be used/administered with a view to restoring, correcting or modifying physiological function (pharmacological immunological or metabolic action) (“medicinal products by function”). Such products would require a marketing authorisation from the EU Commission or the German Federal Institute for Medicinal Products and Medical Devices, who would determine if a product is medicinal.
With regard to the classification as a medicinal products by function, the decisive factor to differentiate them from cosmetic products are the pharmacological, immunological or metabolic properties: form the essential basis for assessing whether a product is a medicinal product due to its function. According to the case law of the European Court of Justice, it is sufficient for the existence of a pharmacological effect if the substance in question interacts with cellular components present in the user's organism, such as molecules, bacteria, viruses or parasites, so that physiological functions in humans are restored, corrected or influenced. Excluded from this are completely insignificant effects on the human body. According to both German and European case law, the substance must have a significant effect on the metabolism and thus really influence its functional conditions.
Art. 2(2) of Directive 2001/83/EC provides for a rule of doubt according to which, in cases of doubt where a product, taking into account all its characteristics, may fall both under the definition of "medicinal product" and under the definition of a cosmetic product, the (stricter) rules for medicinal products will apply.
With regard to medicinal products by presentation, it all depends on the main purpose of the product and how it appears, through its presentation (packaging and advertisement), to an average consumer who is reasonably well-informed and observant and circumspect. Shampoos may be cosmetics or medicines, depending on the constituents and the claims being made. Those mainly intended for hygiene, or are for anti-dandruff, are likely to be cosmetic products. However, if the claims are for the alleviation or treatment of itchy scalp, or dermatitis, then the product would fall to be a medicinal product as it suggests that an underlying medical condition exists.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
Articles 14-16 and the Annexes I-VI of EU Cosmetics Regulation prescribe what substances are prohibited or restricted in use in cosmetic products. Cosmetic products shall not contain:
- prohibited substances listed in Annex II;
- restricted substances which are not used in accordance with the restrictions laid down in Annex III;
- colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, or substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;
- preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex, and substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;
- UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex, and substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex;
- substances classified as CMR substances (i) of category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008, (ii) of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (unless certain exceptions apply).
3. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
All cosmetic products available to consumers must have a ‘Responsible Person’ who makes sure safety measures are followed and legal obligations are met (Article 4).
A Responsible Person can be either:
- the manufacturer,
- the importer,
- the distributor, if they label the product as their own (for example, using their brand name), or
- an appointed company or person (who is named by the manufacturer or the importer).
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
Before making a cosmetic product available to consumers, the Responsible Person shall ensure that the cosmetic product has undergone a safety assessment and that a cosmetic product safety report (“CPSR”) is set up in accordance with Annex I of Regulation (EC) No 1272/2008. The CPSR provides evidence of how the product is safe for its intended cosmetic use and takes account of reasonably foreseeable use. In addition, a specific safety assessment is required for cosmetic products intended for use on children under the age of three, and for cosmetic products intended exclusively for use in external intimate hygiene.
The cosmetic product safety assessment shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a EU Member State.
In addition, when a cosmetic product is placed on the market, the Responsible Person shall prepare a product information file for it, and keep such file for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. The file must contain the following information and data (to be updated as necessary): (a) a description of the cosmetic product; (b) the CPSR as referred to above; (c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice; (d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product; (e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
According to section 3 of the German Cosmetic Regulation, any person who manufactures cosmetic products domestically must notify the place of manufacture (or if this place changes) to the competent authority before placing the product on the market. If cosmetic products are imported into the EU, the person responsible for the import shall, before the first import, notify the competent authority of the place where he brings cosmetic products into Germany (or if this place changes).
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
From a German law perspective, packagings for cosmetics are classified as “consumer products” (“Bedarfsgegenstände”) which are regulated by the German Food-, Feed- and Consumer Products Act (“Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch”, LFGB) and the German Regulation on Consumer Products (“Bedarfsgegenständeverordnung”). However, the vast majority of the provisions specifically apply to packaging materials which come into direct contact with food (food contact materials). With regard to packaging materials for other products such as cosmetics, there is only a genera requirement that the packaging material must not be likely to cause damage to health through its composition, in particular through toxicologically active substances.
According to Annex I of the EU Cosmetics Regulation, the CPSR must also contain information on the relevant characteristics of packaging material, in particular purity and stability.
Moreover, a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular:
(a) its presentation, which includes making sure that it cannot be mistaken as food by children; (b) labelling; (c) instructions for use and disposal; (d) any other indication or information provided by the Responsible Person.
The labelling for cosmetic products must be easy to read and must be in the German language (see section 4 of the German Cosmetics Regulation) According to Article 19 of the EU Cosmetics Regulation, the container and any packaging must be labelled with:
- the name and address of the Responsible Person
- the nominal content at the time of packaging, given by weight or by volume
- the date until which the cosmetic product can be used
- any precautions for use
- the batch number of manufacture or the reference for identifying the cosmetic product
- the function of the cosmetic product (i.e. what the cosmetic product does), unless it is clear from its presentation
- a list of the ingredients
It may not be practical to include precautions and ingredients for certain cosmetic products, for example due to available space on packaging. If this is the case, it is important to include this information within the packaging, for example on a leaflet. A symbol should be used to indicate where this information is.
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
Marketing of cosmetics is primarily governed by the main advertising regulations in Germany, in particular by the Act against Unfair Competition (“UWG).
Moreover, Article 20 of the EU Cosmetics Regulation requires that in the marketing of cosmetic products, every Responsible Person must ensure that the wording of any claim in relation to a cosmetic product does not imply that the product has a characteristic or function which it does not have.
In addition, Regulation (EU) No. 655/2013 establishes common criteria for the justification of claims made in relation to cosmetic products. This Regulation applies to advertising in any form, irrespective of the medium or marketing instrument used. The Responsible Person must ensure that the wording of advertising claims is consistent with the documentation proving the claimed effect of the cosmetic product, which is part of the product information file, and meets the following criteria:
- compliance with legal provisions,
- truthfulness,
- verifiability,
- honesty,
- fairness, and
- sound decision-making.
According to the criterion of verifiability, the advertiser must be able to prove the accuracy of its claims: Advertising claims about cosmetic products must be substantiated by sufficient and verifiable evidence that takes into account the state of the art, and studies used as evidence must be relevant to the product and the claimed benefit, be based on properly developed and applied methods and take ethical considerations into account. This does not mean that the advertiser may only use advertising claims if they can be regarded as scientifically proven; but mere testimonials from users of the cosmetic product do not meet these requirements.
Finally, the German Healthcare Advertising Code (“Heilmittelwerbegesetz”) also partially applies to advertisement for cosmetic products, provided that the advertisement relates to the elimination or alleviation of diseases, aliments, bodily harm or pathological complaints. (Note that this can only be the case if the elimination or alleviation of diseases, aliments, bodily harm or pathological complaints is not the main purpose of the product in question; otherwise, the product risks to be classified as medicinal product.) The main rules applicable to such advertisements for cosmetic products are:
- prohibition of misleading statements (section 3 Healthcare Advertising Code),
- specific rules for the advertising with expert opinions (section 6 Healthcare Advertising Code),
- specific rules for the provision of promotional gifts (section 7 Healthcare Advertising Code),
- specific restrictions for certain advertisements (such as advertising with recommendations of famous persons or with raffles) in section 11 Healthcare Advertising Code,
- and the prohibition to use statements that refer to the detection, elimination or alleviation of the diseases listed in the appendix to section 12 Healthcare Advertising Code.
7. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products. Is there criminal liability for non-compliance?
Article 25 of the EU Cosmetics Regulation requires competent authorities to request the Responsible Person to take corrective action over a product that does not comply with the Regulation.
- A competent authority must request that the Responsible Person takes all appropriate measures, proportionate to the nature of the risk where there is certain non–compliance including corrective actions aimed at ensuring compliance, or withdrawal or recall, within an expressly mentioned time limit.
- If the Responsible Person does not take the measures within the time limit, or where immediate action is necessary to prevent serious risk to human health, the competent authority must take all appropriate measures itself to stop the product going on the market, or to withdraw or recall products already on the market.
- Competent authorities have all the powers they need to prevent any further distribution or sale of the product if the Responsible Person is not taking the necessary actions.
Article 26 of the Regulation requires competent authorities to take corrective action over a product that does not comply with a distributor's responsibilities under the Regulation, in a similar way to Article 25. Article 27 of the Regulation allows an enforcement authority to take direct provisional action where there is a serious risk to human health, or there are reasonable grounds for concern.
Under the German Cosmetic Regulation, the breach of certain provisions of the EU Cosmetic Regulation (such as the prohibition to place on the market a cosmetic product containing ingredients which are forbidden pursuant to Annex II of the EU Cosmetics Regulation) is a criminal offense. Depending on the respective provision, the penalty can be imprisonment of up to 3 years (or a fine), or imprisonment of up to 1 year (or a fine). The breach of certain provisions of the German Cosmetic Regulation can be prosecuted as an administrative offence (potentially leading to fines).
Moreover, non-compliance with cosmetic laws can also be considered as an act of unfair competition and be pursued by competitors as well as industry and consumer associations before civil courts under the German Act against Unfair Competition (“UWG”).
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.
Due to the increase in substance-related findings, substance restrictions and bans are likely to increase. Concrete changes are partly foreshadowed by adjustments to the CLP Regulation, but may also arise under the EU Cosmetics Regulation.
From 1st September 2025 onwards, there will be a new list of 21 CMR substances in Annex II of the CLP Regulation the use of which will be forbidden in cosmetic products. There will be no difference between placing on the market and making available on the market. It means that, of the application date, non-compliant cosmetic products cannot be sold on the EU market anymore and must be recalled before.
It is important for responsible persons under the EU Cosmetics Regulation to maintain or establish comprehensive and forward-looking substance-related monitoring.
9. Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?
Supplements are governed by the German Regulation on Food Supplements (“Verordnung über Nahrungsergänzungsmittel”) and by the general German and EU rules on food, in particular the Regulation (EC) No 178/2002 (“General Food Law Regulation”) and the Regulation (EU) No 1169/2011 on food information.
Food supplements are defined as a food which is (1) intended to supplement the general diet, (2) a concentrate of nutrients or other substances with a nutritional or physiological effect, alone or in combination, and (3) in a dosage form, particularly in in the form of capsules, lozenges, tablets, pills and other similar forms of administration, sachets of powder, ampoules of liquids, bottles with droppers and other similar forms of administration of liquids and powders for taking in small, measured quantities.
Since supplements are very often administered in an identical way as pharmaceuticals, and since they contain vitamins, minerals and/or other substances in concentrated form with an effect on the body, the differentiation from medicinal products can be difficult. Unlike medicines, supplements may only supplement the normal diet, i.e. they must not have any medicinal effect. The main criterion to distinguish between supplements and medicinal products is that the supplement may not (i) be presented as having properties for treating or preventing disease in human beings (otherwise it would be a “medicinal products by presentation”), or (ii) be used/administered with a view to restoring, correcting or modifying physiological function, i.e it shall only have a nutritional or physiological, but not a pharmacological, immunological or metabolic effect (in which case the product would be classified as a “medicinal products by function”).
Products classified as food preparations/supplements include:
- Products that do not treat, cure or prevent diseases or ailments are generally classed as food preparations.
- Food or dietary supplements (based on substances like plant extracts, fruit concentrates, honey or fructose) that contain added vitamins. The packaging often indicates they are beneficial for maintaining general health or wellbeing.
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?
According to section 3 of the Food Supplements Regulation, supplements may only contain the vitamins and minerals listed in Annex I to EU Directive 2002/46/EC on food supplements, and only in the form as listed in Annex II to the Directive.
Certain products such as CBD which is classed as a ‘novel food’ cannot be marketed/sold unless approved. The EU Commission is responsible for authorising ‘novel foods’ (foods that were not used for human consumption to a significant degree within the EU before 15 May 1997), and CBD food and drink including CBD oils, capsules, sprays, CBD gummies, soft drinks and snacks would need to be authorised.
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 a food business operator must register with their local authority. A “food business operator” is anyone carrying out any of the activities related to any stage of production, processing and distribution of food (which includes supplements). This also includes online retailers, as well as businesses specializing in the food trade (brokers, dealers) that organize the transport of food between suppliers or to retail outlets, but whose premises are not used for the handling or storage of food.
The food business operator is personally responsible for complying with all food law provisions and for ensuring that the supplements they produce, transport, store and/or distribute are safe.
12. Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards? If so, are there any exceptions/particular extra requirements for certain products?
Any person who, as a manufacturer or importer, intends to place a food supplement on the market shall notify the German Federal Office of Consumer Protection and Food Safety (“Bundesamt für Verbraucherschutz und Lebensmittelsicherheit”), submitting a sample of the label used for the product. If the food supplement has already been placed on the market in another EU Member State, and if the law applicable in that Member State provides for a notification requirement, the manufacturer/importer still needs to notify the German authority if the product shall be placed on the market in Germany and the notification must additionally state the authority of the other Member State with which the first notification was made.
Other than that, there is no specific authorisation or safety assessment requirement: As long as supplements comply with EU and German law (the law specific to food supplements and all other applicable food law) they are permitted for sale. It is the responsibility of the manufacturer, importer or retailer of the supplements to ensure that they comply with the law.
13. Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?
Food business operators dealing with supplements must keep records to ensure the traceability of the supplements at all stages of production, processing and distribution. They must therefore be able to identify any person from whom they have been supplied with a supplement (or an ingredient thereof), and to whom their products have been supplied, and have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
The Regulation (EU) No 1169/2011 on food information governs most food labelling in Germany, and the German Food Supplements Regulation sets out additional labelling requirements for food supplements.
Pursuant to Regulation (EU) No 1169/2011, the following information is mandatory on any food products:
- the name of the food (for supplements, the legal designation is “Food supplement” (“Nahrungsergänzungsmittel”),
- the list of ingredients,
- any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II to the Regulation causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form,
- the quantity of certain ingredients or categories of ingredients,
- the net quantity of the food,
- the date of minimum durability or the ‘use by’ date,
- any special storage conditions and/or conditions of use,
- the name or business name and address of the food business operator,
- instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions,
- a nutrition declaration.
In addition to these, the German Food Supplement Regulation requires the following information:
- the names of the categories of nutrients or other substances that characterize the product, or an indication of these nutrients or other substances,
- the recommended daily intake in portions of the product,
- the warning “The stated recommended daily intake should not be exceeded”,
- a statement that food supplements should not be used as a substitute for a balanced and varied diet,
- a statement that the products should be stored out of reach of young children,
- the quantity of nutrients or other substances with a nutritional or physiological effect in the food supplement, based on the daily intake stated on the label in accordance with the amounts stated in Annex I to Directive 2002/46/EC, in the units of measurement stated in each case, as average values based on the analysis of the product,
- the vitamins and minerals present in the food supplement indicated as a percentage of the reference values given in Part A of Annex XIII to Regulation (EU) No 1169/2011, where reference values are set for these substances in that Annex.
The information listed above must appear directly on the package or on a label attached thereto, and be easily visible and clearly legible. It shall not in any way be hidden, obscured, detracted from or interrupted by any other written or pictorial matter or any other intervening material. The information shall be printed in characters using a font size where the x-height is equal to or greater than 1.2 mm; in case of packaging or containers the largest surface of which has an area of less than 80 cm2, the x-height of the font size shall be equal to or greater than 0.9 mm.
Regarding the packaging as such, if the packaging is in direct contact with the supplement itself (i.e. the capsule, the tablet etc.), there are specific rules which apply to so-called food contact materials. These are regulated in the EU Regulation (EC) No 1935/2004 , in the German Food, Feed and Consumer Products Act (“Lebensmittel-, Futtermittel und Bedarfsgegenstände-Gesetzbuch”, LFGB) as well as in the German Regulation for Consumer Products (“Bedarfsgegenständeverordnung”).
Food contact materials must be manufactured in accordance with good manufacturing practice. Under normal or foreseeable conditions of use, they must not transfer any components to food that endanger human health, cause an unjustifiable change in the composition of the food or impair the organoleptic properties (smell, taste, appearance) of the food.
Food contact materials must be labeled before they are first placed on the with the following information:
- “For food contact” or a special note on the intended use or with the glass-fork symbol (unless the intended use as food contact materials is obvious);
- special conditions of use for safe and proper use;
- name and address or registered office of the manufacturer, processor or a seller established in the EU.
The above labeling elements must be clearly and indelibly marked on the article itself or on its packaging or on a label attached to the article or packaging when it is supplied to the end consumer.
Moreover, a conformity assessment and declaration is required for food contact materials made of plastic, regenerated cellulose and ceramic. This means that these items may only be placed on the market if they are accompanied by a written declaration in German. This declaration must be issued by the manufacturer or the person responsible for the first placing on the market and must contain information in accordance with Annex 12 of the Consumer Goods Ordinance. In addition, suitable documents must be made available to the competent authorities on request to prove that the food contact materials meet the legal requirements. These are suitability certificates and information from upstream stages, recipes, documentation of good manufacturing practice, analysis results and migration values, risk assessments and worst-case scenarios.
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.
Marketing of supplements is primarily governed by the main advertising regulations in Germany, in particular by the Act against Unfair Competition (“UWG”). Moreover, the Regulation (EU) No 1169/2011 on food information and the German Food Supplements Regulation set the most relevant specific requirements for the advertisement for food and food supplements.
Pursuant to section 4(4) of the German Food Supplements Regulation, a food supplement may not be marketed under names, information or packaging or advertised with images or other statements claiming or implying that a balanced, varied diet is generally unable to provide adequate quantities of nutrients.
Pursuant to Article 36(2) of Regulation (EU) No 1169/2011, advertisements for food shall not mislead the consumer, it shall not be ambiguous or confusing for the consumer, and it shall, where appropriate, be based on the relevant scientific data. In particular, it shall not be misleading (i) as to the characteristics of the food, (ii) by attributing to the food effects or properties which it does not possess, (iii) by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics, in particular by specifically emphasising the presence or absence of certain ingredients and/or nutrients, (iv) by suggesting, the presence of a particular food or an ingredient, while in reality a component naturally present or an ingredient normally used in that food has been substituted with a different component or a different ingredient.
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
In Germany, food law is primarily monitored and enforced by the respective responsible local food authorities. Enforcement powers include the ability to enter premises, inspect goods, issue notices, obtain evidence, and request technical documents. Measures also include suspension notices, requirements to mark / warn, service of withdrawal notices and recall orders.
In addition to these authorities conducting audits and investigations and issuing any necessary orders as well as ordering fines, certain breaches are also a criminal offence and can be pursued by criminal authorities.
Moreover, non-compliance with food law can also be considered as an act of unfair competition and be pursued by competitors as well as industry and consumer associations before civil courts under the German Act against Unfair Competition (“UWG”).
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
No upcoming future developments in this field that we are aware of.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
Since the EU definition of cosmetic products only encompasses “substances or mixtures of substances”, the EU Cosmetics Regulation does not apply to cosmetic devices.
Rather, cosmetic devices 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”) Regulation).
The Product Safety Regulation requires that economic operators – i.e. in particular manufacturers, importers, authorized representatives and distributors – shall place or make available on the market only safe products, and provides for several specific duties, in particular for manufacturers.
Certain cosmetic devices, however, fall under the Regulation (EU) 2017/745 on medical devices (“MDR”), even if they do not have an intended medical purpose: According to Annex XVI, Paragraph 5, intense pulsed light (IPL) and laser equipment fall under the category of “High intensity electromagnetic radiation equipment.” These devices are intended for use on the human body and include sources like infrared, visible light, and ultraviolet light, used for various skin treatments, such as skin renewal, tattooing, and hair removal.
In addition, in Germany, there is the Regulation for Protection against Non-ionizing Radiation when Used on Humans ("Verordnung zum Schutz gegen die nichtionisierende Strahlung bei der Anwendung am Menschen", NiSV), regulating the use of devices that emit non-ionizing radiation. This includes many cosmetic treatment devices that are frequently used in beauty salons.
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 does not fall under the MDR, the provisions of the EU Product Safety Regulation apply. This Regulation provides for various obligations for “economic operators”, i.e. “the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with this Regulation”. However, the person mainly responsible for the safety of a device under the Regulation is the manufacturer. To name a few of the most important duties, the manufacturer must conduct a product specific risk assessment before placing the product on the market, he must ensure that each product bears a type, batch or serial number enabling the identification of the product, and must indicate their name or trade mark/name, their postal and electronic address on the product (or, where that is not possible, on its packaging or in a document accompanying the product), and he also must report accidents caused by their product to the competent authorities without delay via the Safety Business Gateway
If the device falls under the MDR, the person responsible for the cosmetic devic 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 EU, the device may only be placed on the market if the manufacturer designates a sole authorised 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.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
If the device does not fall under the MDR, the provisions of the EU Product Safety Regulation apply. Under this Regulation, manufacturers must carry out an internal risk analysis for each product, taking into account all relevant aspects of a product, including, for example, physical, mechanical and chemical properties, as well as the product's packaging and its effect on consumers (adults, children), and create a corresponding technical documentation. This technical documentation must be kept for at least 10 years after the product has been placed on the market and must be kept up to date.
If the device is an IPL or laser device, it falls under the MDR. Under the 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, fr 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.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
Marketing of cosmetic devices is primarily governed by the main advertising regulations in Germany, in particular by the Act against Unfair Competition (“UWG”).
If the device is an IPL or laser device and therefore falls under the MDR, the specific provision of Article 7 of the MDR applies according to which it is prohibited, in the labelling, instructions for use, the distribution and advertising of devices, to use text or figurative communication which may mislead the user or the patient with regard to the device's intended purpose, safety and performance by ascribing functions and properties to the device, or by creating a false impression regarding treatment or diagnosis, functions or properties, which the device does not have, by failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose, or by suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
In addition, if the device falls under the MDR, the strict provisions of the German Healthcare Advertising Code (“Heilmittelwerbegesetz”) apply.
But even if the device does not fall under the MDR, several provisions of the German Healthcare Advertising Code would still need to be observed, provided that the advertisement for the device relates to the elimination or alleviation of diseases, aliments, bodily harm or pathological complaints.
The main rules are:
- prohibition of misleading statements (section 3 Healthcare Advertising Code)
- specific rules for the advertising with expert opinions (section 6 Healthcare Advertising Code)
- specific rules for the provision of promotional gifts (section 7 Healthcare Advertising Code)
- specific restrictions for certain advertisements (such as advertising with recommendations of famous persons or with raffles) in section 11 Healthcare Advertising Code and the prohibition to use statements that refer to the detection, elimination or alleviation of the diseases listed in the appendix to section 12 Healthcare Advertising Code.
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 Germany, the rules applicable to cosmetic devices are primarily monitored and enforced by the respective responsible local consumer protection or health authorities. Enforcement powers include the ability to enter premises, inspect goods, issue notices, obtain evidence, and request technical documents. Measures also include suspension notices, requirements to mark / warn, service of withdrawal notices and recall orders.
In addition to these authorities conducting audits and investigations and issuing any necessary orders as well as ordering fines, certain breaches are also a criminal offence and can be pursued by criminal authorities.
Moreover, non-compliance with the relevant laws and regulations can also be considered as an act of unfair competition and be pursued by competitors as well as industry and consumer associations before civil courts under the German Act against Unfair Competition (“UWG”).
6. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
No upcoming future developments in this field that we are aware of.
Cosmetic (non-surgical) services
1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
The administration of cosmetic (non-surgical) services is only partially regulated by laws and regulations in Germany:
The work of beauticians is officially recognized as a profession called “Kosmetiker/Kosmetikerin”. This training is legally not obligatory to offer cosmetic services but for quality and liability reasons strongly recommended, and required in order to use the professional name “Kosmetiker/Kosmetikerin”. The training lasts for 3 years and is regulated by the Regulation on the Training to become a beautician (“Verordnung über die Berufsausbildung zum Kosmetiker/zur Kosmetikerin”). This Regulation defines duration, structure, content, aims and exams of the training.
A further relevant set of rules the Regulation for Protection against Non-ionizing Radiation when Used on Humans ("Verordnung zum Schutz gegen die nichtionisierende Strahlung bei der Anwendung am Menschen", NiSV), regulating the use of devices that emit non-ionizing radiation. This includes many cosmetic treatment devices that are frequently used in beauty salons. According to this Regulation, beauticians must be able to present a successfully completed certificate of competence through a special training in order to be allowed to use certain cosmetic treatment devices. This is to protect customers from damage caused by incorrect use of radiation. The Regulation describes exactly which treatment devices require a certificate of competence through a special NiSV training:
- Laser devices of different classes
- Intense pulsed light (“IPL”) devices with the aim of an effect on the target tissue
- ultrasonic devices (with more than 50 milliwatts per cm2 on the eye, more than 100 milliwatts per cm2 on the rest of the body)
- high-frequency devices (from 100 kilohertz to 100 gigahertz)
- low-frequency devices (from 1 hertz to 100 kilohertz)
- direct current devices (from 8 milliamperes per cm2)
- Magnetic field devices (with more than 400 millitesla).
Moreover, the following devices may not be used by beauticians:
- Ablative laser applications, such as the removal of tattoos or laser treatments for vascular or pigmented skin changes
- Procedures to reduce adipose tissue (lypolysis) using any technology
- highly focused ultrasound (HIFU), which violates the integrity of the epidermis as a protective barrier.
These devices may only be applied by physicians.
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?
There is no specific rule in Germany preventing an individual under the age of 18 from receiving a particular non-surgical cosmetic service. However, several cosmetic services, such as the administration of botulinum toxin or filler injections for cosmetic purposes, or tattoos, might legally be considered as an act of bodily harm requiring a sufficient consent of the affected person. A legally sufficient consent requires that the person is at least 14 years old and is mentally sufficiently mature to fully assess the meaning and consequences of a consent. As a matter of fact, the legal uncertainty in this respect often leads to beauticians requesting that a patient is 18 years old or provides proof of a consent from the responsible parent(s) of a minor patient.
3. Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
Yes, BTs are prescription only medicines (POMs) and can only be prescribed and administered by a fully approved physician to a named patient.
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?
If a beautician wants to open an establishment for cosmetic services (e.g. “beauty salon”), this needs to be registered with the relevant local authority (“Gewerberegister”). However, this registration is not specifically cosmetics- or health-related but applies to any company offering commercial services to the public. The local authority does not specifically handle complaints but would be entitled to forbid the commercial offering of cosmetic services if there is evidence that the owner of the business does not prove to be “sufficiently reliable” (for example due to repeated non-payment of taxes and/or social security charges, the committing of criminal offences which are related to the business etc.). Again, this applies to any business owner in Germany and not to cosmetic practitioners in particular.
Other than that, there is no registration requirement under German law.
There are several voluntary industry associations within the aesthetic industry for non-healthcare professionals. These include the:
- Bundesberufsverband der KosmetikerInnen in Deutschland e.V. (BBVKD) and the
- Bundesberufsverband der Fachkosmetiker/innen in Deutschland e. V. (BfD)
5. Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above.
The local authority would be entitled to forbid the commercial offering of cosmetic services if there is evidence that the practitioner/owner of the business does not prove to be “sufficiently reliable” (for example due to repeated non-payment of taxes and/or social security charges, the committing of criminal offences which are related to the business etc.). Again, this applies to any business owner in Germany and not to cosmetic practitioners in particular.
If the practitioner commits professional mistakes when administering cosmetic services, he/she might be held liable under civil law by the affected patient for malpractice. Potentially, the practitioner might also be held criminally liable for bodily injury (for example if a treatment is being done without sufficient consent).
If the practitioner violates applicable rules under the Healthcare Advertising Code, or otherwise involves in misleading advertising (for example by presenting him-/herself as “officially recognized beautician” without having undergone the official training), he/she an be held liable by competitors and consumer/industry associations under the German Act against Unfair Competition (“UWG”).
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?
Marketing of cosmetics is primarily governed by the main advertising regulations in Germany, in particular by the Act against Unfair Competition (“UWG).
The advertisement for cosmetic services can also fall under the German Healthcare Advertising Code (“Heilmittelwerbegesetz”), provided that the advertisement for the device relates to the elimination or alleviation of diseases, aliments, bodily harm or pathological complaints. The main rules under the Code are:
prohibition of misleading statements (section 3 Healthcare Advertising Code)
- specific rules for the advertising with expert opinions (section 6 Healthcare Advertising Code)
- specific rules for the provision of promotional gifts (section 7 Healthcare Advertising Code)
- specific restrictions for certain advertisements (such as advertising with recommendations of famous persons or with raffles) in section 11 Healthcare Advertising Code and the prohibition to use statements that refer to the detection, elimination or alleviation of the diseases listed in the appendix to section 12 Healthcare Advertising Code.
Third party booking platforms which allow consumers to book non-surgical cosmetic services are usually not caught by these advertising laws, unless they actively participate in any misleading advertising or use or endorse misleading information/statements stemming of the practitioner/business on their platform although they have reasons to believe that the information/statements are misleading.
7. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
No upcoming future developments in this field that we are aware of.