CMS Expert Guide on Beauty in South Africa

Cosmetics in South Africa are primarily governed by the Foodstuffs, Cosmetics, and Disinfectants Act 54 of 1972 (“FCD Act”). This act defines cosmetics broadly as any substance or mixture of substances intended for external application to the human body for purposes such as cleansing, beautifying, enhancing attractiveness, or altering appearance. It applies to products used on the skin, hair, nails, and lips.  1

Notable Exclusions: Products that are intended for therapeutic purposes (such as treating, diagnosing, or preventing diseases) fall under the definition of medicines. 2  The definition of medicine means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or restoring, correcting or modifying any somatic or psychic or organic function in humans; and includes any veterinary medicine 3 . These products must be registered with the South African Health Products Regulatory Authority (“SAHPRA”). 4

In the case of Minister of Health and Another v Alliance of Natural Health Products (South Africa) 5 , the court held that the distinction between complementary medicines that fall within the scope of a medicine and those that do not depends on whether therapeutic claims are made in relation to the product in question. This aligns with the Code of Advertising Practice administered by the Advertising Regulatory Board (“Advertising Codes”), which prohibits the use of claims in relation to cosmetics that “convey the impression, through their overall execution and/or the use of symbols, that the cosmetic product provides medicinal benefits (such as healing or curative properties)” 6

Examples of cosmetics are skin creams, shampoos, deodorants, and perfumes

Cosmetic Products are regulated by the FCD Act. Cosmetic products are intended for external use only and are not intended to have any therapeutic or medical effect.

Medicinal products are regulated under the Medicines and Related Substances Act 101 of 1965 (“MRS Act”). This Act defines medicinal products as substances used or intended for use in the diagnosis, treatment, mitigation, modification, or prevention of disease in humans or animals.

The Regulations relating to the labelling, advertising, and composition of cosmetics (“LACS Regulations”) prescribed:

1. list of substances which must not form part of the composition of cosmetics are listed in the Annexure I, few examples are:
   1. Mercury compounds prohibited due to their toxicity and harmful effects on human health;
   2. Chloroform which is carcinogenic and harmful to human health;
   3. Lead compounds which pose risks of neurotoxicity; and
   4. Hydroquinone prohibited in skin-lightening products except under professional supervision.
2. list of substances which cosmetics must not contain except subject to the restrictions laid down are listed in the Annexure II, few examples are:
   1. Benzoyl Peroxide used for acne treatment, is restricted in concentration of  0.7%
   2. Selenium compounds used in anti-dandruff shampoos, are restricted to a maximum concentration of 1% selenium sulfide.
   3. Formaldehyde permitted only at low concentrations (up to 0.2% in cosmetic products) due to its potential to cause allergic reactions.

Retinoic acid falls under the list of substances prohibited in the LACS Regulation and is classified as a medicine under the MRS Act, as it affects skin structure and function. 7  Products containing retinoic acid must be registered with the (SAHPRA)

Liability of importer, manufacturer, or packer. The individual identified on the label of any cosmetic or disinfectant sold in a sealed package that does not comply with the provisions of this Act shall be presumed to have imported, manufactured, or packed the product in question, as applicable, and may be convicted and sentenced accordingly. 8

No person may sell, manufacture, or import for sale any cosmetic product that could harm human health when used under normal or reasonably expected conditions. Key factors to consider include the product's presentation, composition, labelling, usage and disposal instructions, and any other information provided by the responsible party. Additionally, the responsible person must ensure that the cosmetic and its ingredients have undergone a safety assessment. 9

The product name must be clearly visible and indicate the intended use (e.g., cleanser, moisturizer, etc.) to prevent confusion or misuse.

The Regulation requires that the packaging clearly indicate the function of the cosmetic, where it is not immediately apparent from the name. 10

Prohibition of False or Misleading Advertising, the FCD Act explicitly prohibits the use of false or misleading claims in the advertising or promotion of cosmetic products. This includes any advertisements, labels, or promotions that could deceive consumers about the nature, composition, or effectiveness of the product. 11

In terms of the general standards for marketing of goods or services as contained in the Consumer Protection Act, 2008, a producer, importer, distributor, retailer or service provider must not market any goods or services in a manner that is reasonably likely to imply a false or misleading representation concerning those goods or services or in a manner that is misleading, fraudulent or deceptive in any way, including in respect of, inter alia, the nature, properties, advantages or uses of the goods or services or any other material aspect of the goods or services.

In terms of the Advertising Codes, any cosmetic claims, whether implicit or explicit, must be supported by adequate and appropriate substantiation to demonstrate the veracity of product efficacy and/or performance 12

Example: In respect of hair cosmetic products (as defined in the FCD Act), Appendix B of the Advertising Codes states that medical terms are not permitted to describe specific conditions of the hair and scalp. For example, the following terms should be used: “excess oil” instead of “seborrhoea”; “dandruff” instead of “pityriasis” and “seborrheic dermatitis” and “hair loss” instead of “alopecia”.

Any claim that a hair care product can cure or permanently prevent a specific condition of the hair or scalp that is a symptom of disease, is not permitted. Claims shall be clear that the effect is only observed with regular use of the product in question and is not permanent, e.g. thickens or adds volume.

Any person convicted of violating or failing to comply with these regulations is subject to penalties. For a first conviction, they may face a fine, imprisonment of up to six months, or both. For a second conviction, the penalty increases to a fine, imprisonment of up to twelve months, or both. For a third or subsequent conviction, the individual may be fined, imprisoned for up to twenty-four months, or both. Additionally, anyone convicted is responsible for the cost of destroying non-compliant products. 13

Section 5 of the FCD Act states that any person shall be guilty of an offence if he publishes a false or misleading advertisement of any foodstuff, or for purposes of sale, describes any foodstuff in a manner which is false or misleading as regards to its origin, nature, substance, composition, quality, strength, nutritive value or other properties or the time, mode or place of its manufacture; or sells, or imports for sale any foodstuff described in the manner aforesaid. 

Not aware of any future developments

Supplements are typically classified as complementary medicines or health supplements, depending on their intended use, ingredients, and claims made. 14  They are primarily regulated under the MRS Act and the General Regulations Relating to Medicines and Scheduled Substances (GN R. 859 of 25 August 2017) (“General Regulations”), which set the guidelines for the manufacture, sale, and marketing of supplements.

The General Regulations has the lists of specific prohibited substances that cannot be included in supplements due to safety concerns.  15

The MRS Act mandates that supplements, like other complementary medicines, must be registered with the SAHPRA before being marketed. This ensures that the product meets the necessary safety, efficacy, and quality standards. 16

The person or entity responsible for manufacturing, importing, or packing a supplement is liable for ensuring the product complies with safety regulations. If a supplement is found to be unsafe, mislabelled, or does not comply with the provisions of the Act, the person or entity responsible for placing it on the market may face penalties. 17

In South Africa, supplements must pass specific safety assessment standards before they are placed on the market, particularly if they make medicinal claims or contain active ingredients. Complementary medicines (regulated by the MRS Act) must undergo rigorous evaluation and SAHPRA registration.  18

The General Regulations stipulates that a person who holds a license must maintain a prescription book or permanent record, as specified in regulation 35(1), for medicines that are dispensed or compounded and dispensed, and keep these records for at least 5 years from the date of sale. 19

Every complementary medicine in which is intended for administration to or use by humans is sold shall have a label attached to it on which the following particulars shall appear in clearly legible indelible letters in English and at least one other official language. 20

In terms of the General Regulations issued under the Medicines Act, where the medicine has not received registration with the Medicine Authority the following disclaimer should be included in the advertisement: "This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use."

Medicines which contain a Schedule 0 substance or a substance listed as Schedule 1 of the General Regulations may be advertised to the public. 21

The advertisements must not make false or misleading claims. They should accurately reflect the benefits and uses of the supplement without overstating its effects. Additionally, the advertisements must not claim to treat, prevent, or cure any serious diseases unless there is sufficient scientific evidence to support such claims, and they are approved by SAHPRA. 22

Any person who fails to comply with, contravenes the provisions of or furnishes incorrect information be guilty of an offence and upon conviction be liable to a fine or to imprisonment for a period not exceeding 10 years. 23

Not aware of any future developments. 

In South Africa, cosmetic devices are primarily regulated under the MRS Act. This act governs medical devices, which include certain cosmetic devices that have an effect on the structure or function of the body, particularly those with therapeutic or medical claims.

Devices that do not have therapeutic claims and are strictly for beautification or aesthetic purposes may not be regulated as medical devices but must comply with general consumer safety regulations under the Consumer Protection Act 68 of 2008 (“CPA”) defined as goods. 24

Therefore, cosmetic devices that are not classified as medical devices would be regulated under the CPA. The act ensures that these devices meet product safety standards and protect consumers from harm. 25

The CPA establishes strict liability for any harm caused by unsafe or defective products, including cosmetic devices. The liability applies to:

• The producer or manufacturer of the product.
• The importer of the product into South Africa.
• The distributor or retailer who sells the product.

All these parties can be held liable for any harm caused by defects in the product, whether due to a lack of safety, inadequate instructions, or insufficient warnings. 26

If the device is unsafe, defective, or causes harm, any of these parties can be held liable for damages. This creates a strong framework for consumer protection regarding product safety in South Africa.

Medical devices, including cosmetic devices with therapeutic claims, must undergo safety and efficacy evaluations to demonstrate that they are safe for their intended use. The device must be registered with the SAHPRA. 27

The South African Bureau of Standards ("SABS") is a leading business services provider to organizations worldwide, offering a range of services for management system certification, product testing and certification, and standardization.

SABS may require product (cosmetic device) to meet specific safety and quality standards. This could involve testing and certification processes to ensure your product is safe for consumers.

The suppliers must ensure that the goods or services provided are safe, of good quality, and meet the expectations of the consumer as per the standards required by law. This section emphasizes the duty of suppliers to inform consumers of any risks associated with the goods or services and to take necessary steps to ensure consumer safety. If a supplier fails to comply with these requirements, they may be held liable for any harm or loss suffered by the consumer. This section is a fundamental part of the Act, aiming to uphold the safety and rights of consumers in transactions. 28

The producer, importer, distributor, or retailer of goods is liable for any harm caused, whether wholly or partially, by supplying unsafe goods, a product failure, defect, or hazard in the goods, or by providing inadequate instructions or warnings related to any hazard associated with using the goods. This liability applies regardless of whether the harm resulted from negligence on the part of the producer, importer, distributor, or retailer, emphasizing strict liability without the need for proof of negligence. 29

The CPA prohibits misleading advertising, requiring that all claims made in advertisements must be truthful, clear, and not misleading to consumers 30

It further stipulates that supplier must not advertise any particular goods or services as being available at a specified price in a manner that may result in consumers being misled or deceived in any respect relating to the actual availability of those goods or services from that supplier, at that advertised price. 31

Anyone convicted of an offence under the CPA may, in the case of a violation, face a fine, imprisonment for up to 10 years, or both. For any other offence, they may be fined, imprisoned for up to 12 months, or both. 32

Not aware of any future developments.

The FCD Act plays a critical role in safeguarding public health by regulating the quality, safety, and advertising of foodstuffs, cosmetics, and disinfectants in South Africa. It prevents harmful products from reaching consumers and ensures that all products are safe, appropriately labelled, and manufactured according to approved standards.

The Foodstuffs, Cosmetics and Disinfectants Act No. 54 of 1972 applies.

The legislation is silent about national preventing individuals under 18 from receiving non-surgical cosmetic services, providers are bound by general consent and consumer protection laws, requiring parental approval for minors and ensuring the safety of any procedure provided.

Botulinum toxin (BT) is a prescription only drug in South Africa. 33

A practitioner, nurse or a person registered under the Health Professions Act No. 56 of 1974 (“HPA”) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Authority, to patients under his/her care. 34

 Practitioners must be registered with the Health Professions Council of South Africa (HPCSA) is a statutory body, established in terms of the HPA and is committed to protecting the public and guiding the professions.

Any person who fails to comply with, contravenes the provisions of or furnishes incorrect information be guilty of an offence and upon conviction be liable to a fine or to imprisonment for a period not exceeding 10 years. 35

The CPA prohibits misleading advertising, requiring that all claims made in advertisements must be truthful, clear, and not misleading to consumers 36

It further stipulates that supplier must not advertise any particular goods or services as being available at a specified price in a manner that may result in consumers being misled or deceived in any respect relating to the actual availability of those goods or services from that supplier, at that advertised price. 37

Not aware of any future developments.