Compliance Regulations for Skincare Businesses in South Africa

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Compliance Regulations for Skincare Businesses in South Africa

South Africa’s skincare industry is growing steadily, driven by rising consumer demand for locally made beauty and personal care products. However, this growth comes with a strict regulatory framework that many small business owners underestimate when entering the market. From product safety standards to labelling requirements and health authority approvals, skincare businesses must comply with several pieces of legislation before their products can reach store shelves or online marketplaces.

Non-compliance can result in product recalls, fines or reputational damage. It is therefore essential that small to medium-sized enterprise (SME) owners understand their obligations from the outset.

This article breaks down the key compliance regulations governing skincare businesses in South Africa, giving business owners a clear starting point before diving into the numbers shaping the industry today.

South Africa’s Cosmetics Market

South Africa’s skin care market size is expected to grow from $832,76 million in 2025 to $890,81 million in 2026 and is forecast to reach $1 248,38 million by 2031 at 6,97% CAGR over 2026-2031. The industry’s growth is driven by decreased inflation that enables consumers to choose premium formulations and increased demand for derma-cosmetics.

The industry is experiencing significant growth in value and innovation, driven by a consumer base that strongly prefers products that combine dermatological effectiveness with cosmetic benefits. This evolving trend is influencing shopper behaviour and expanding the scope of traditional skin care.

Compliance Regulations for Skincare Businesses in South Africa

Every skincare business operating in South Africa, regardless of size, falls under the Foodstuffs, Cosmetics and Disinfectants Act. This Act regulates foodstuffs, cosmetics and disinfectants. It sets quality standards that manufacturers must comply with and governs the importation and exportation of these products. It remains the primary piece of legislation skincare entrepreneurs must work within and is administered by the National Department of Health (NDoH).

Alongside it is the Consumer Protection Act, which governs how skincare products are marketed, labelled and sold to consumers. The Act aims to promote a fair, accessible and sustainable marketplace for consumer products and services, establish national norms and standards relating to consumer protection, improve standards of consumer information, and prohibit certain unfair marketing and business practices.

Additionally, it established the National Consumer Commission as an enforcement body, which means non-compliant skincare businesses can be held accountable by more than one regulator at once.

Regulatory Bodies for Cosmetics/Skincare

Most people assume there is a single body overseeing cosmetics, but responsibility is actually split between two authorities:

The National Department of Health (NDoH): It deals with general cosmetic safety, labelling accuracy, permitted ingredients and advertising compliance under the CPA. This is the relevant authority for most ordinary skincare products, such as moisturisers, cleansers and serums.

The South African Health Products Regulatory Authority (SAHPRA): SAHPRA only becomes involved when a product is classified as a “borderline product”. This means the product makes a therapeutic or medicinal claim. Products promoting anti-ageing, acne treatment, skin lightening or hair growth effects can be pulled out of the cosmetics category entirely and treated as medicines under the Medicines and Related Substances Act, which triggers a far heavier registration process.

This is one of the most common compliance pitfalls for small skincare brands, as marketing language intended to sound persuasive can inadvertently reclassify an entire product line.

Registration Requirements

Unlike some international markets, South Africa does not require general cosmetic products to undergo pre-market registration or notification before they can be sold. This shifts the compliance burden solely to the business owner, something SMEs must monitor closely.

There is no regulator checking a product before it reaches shelves, which means any errors in formulation, labelling or claims are the manufacturer’s liability from day one and can only be picked up after the fact through complaints, inspections or post-market surveillance.

Labelling Requirements

Labelling is one of the most heavily scrutinised areas of compliance, and the regulations relating to labelling, advertising and composition of cosmetics set out specific mandatory particulars. At a minimum, skincare product labels must include:

1. Product Identity and Net Content Declarations

The product name must accurately describe the item’s function without implying therapeutic benefits. The net content declaration needs metric units placed within the bottom third of the principal display panel. Solid or semi-solid products are declared by mass in grams or kilograms, while liquids use volume in millilitres or litres at 20°C.

Check that your filling equipment accounts for temperature-dependent density variations, so the declared net content never falls below the stated amount during shelf life.

2. Ingredient Listing Conventions and INCI Nomenclature

Ingredients must be listed using standardised International Nomenclature of Cosmetic Ingredients (INCI) names, arranged in descending order of concentration at the point of incorporation. Components present below 1% concentration may appear in any order after those exceeding this threshold, though preservatives and colourants have specific placement rules regardless of concentration.

Botanical ingredients need the Latin binomial name alongside the plant part used and the extract type, to avoid ambiguity between similar species or processing methods. For example, to indicate if it is an oil, extract, or juice, you would use Helianthus Annuus Seed Oil.

3. Batch Coding, Expiry Dating and Storage Instructions

Traceability of products relies on indelible batch codes that link each unit to specific manufacturing records, raw material lots, and quality control test results. Expiry dating must reflect validated stability testing evidence rather than arbitrary estimates, particularly for products containing volatile actives or natural preservatives prone to degradation. Storage instructions become mandatory when specific conditions are needed to maintain product integrity until the stated expiry date, such as protection from direct sunlight or from temperatures above 30°C.

Our product label checklist can help guide you on what information needs to be on a product label. 

Restricted and Banned Substances

The cosmetics regulations gazette includes detailed annexes listing substances that may not form part of any cosmetic product, as well as substances that are permitted only under strict concentration limits.

For example, formaldehyde – a colourless, flammable gas with a strong odour – is only allowed at very low concentrations due to its potential to cause allergic reactions, while certain active ingredients, such as retinoic acid, are excluded from the cosmetics category altogether and classified as medicines requiring separate registration.

SME formulators need to check their raw material suppliers’ documentation carefully, since liability for a non-compliant ingredient rests with whoever is named on the product label, not the raw material supplier.

Advertising and Marketing Cosmetic Products

Advertising claims for skincare products are governed by both the CPA and the self-regulatory Advertising Regulatory Board (ARB), whose Code of Advertising Practice includes a dedicated Cosmetic Code developed in conjunction with the Cosmetic, Toiletry and Fragrance Association of South Africa.

The code governs all claims made in text, imagery, symbols or trademarks and is intended to ensure consumers are not misled about a product’s safety or efficacy. Because the Cosmetic Code applies the same definition of “cosmetic” used in the CPA, any advertising claim that strays into therapeutic territory carries the same reclassification risk discussed above, making marketing copy just as much a compliance issue as the product formulation itself.

Practical Compliance Steps for SMEs

If you are looking to start a cosmetic business or already have one and want to launch a product, you need to ensure you are prepared to meet all compliance requirements. Use the following steps to help you remain within the law.

Step 1: Conduct a Thorough Formula Review

This step is a prerequisite for the preparation of the cosmetic product safety report (CPSR) and the verification of the product label. The formula review is a meticulous review of your cosmetics formula to ensure that all ingredients are safe for their intended use and comply with the FCDA and CTFA.

It is based on the composition expressed in the raw material trade names. The documentation of each raw material is reviewed to verify its regulatory compliance, and the impurity profile is highlighted.

Preliminary calculations and investigations are conducted to ensure that each ingredient and impurity is safe, given the cosmetic product type, its intended use and the targeted population.

A formula review can also be performed on its own.

This first step includes doing the following:

  • Verification of the regulatory and safety compliance of the ingredients (eventual restricted or prohibited ingredients).
  • Establishment of the INCI list or ingredients list.
  • Confirmation and validation of the mandatory laboratory tests performed on the finished product.

Step 2: Creating a Cosmetic Product Safety Report

The CPSR is a comprehensive document prepared by a qualified toxicologist. It is intended to support and confirm the safe use of the cosmetic product, taking into consideration all available information, such as toxicological profiles of each ingredient and impurity, test results, certificates, declarations, and raw materials documentation.
The report takes the form of two sections, Part A and -B.

Part A: Cosmetic Product Safety Information

This part of the report contains all the data needed for the evaluation of the cosmetic product.

Part B: Cosmetic Product Safety Assessment

This includes an evaluation of the product’s safety and conclusions. Part B is essential, as it certifies the effectiveness and safety of a product before being placed on the South African market.
Introducing a product with a high-quality report can be a serious offence that can lead to the withdrawal of the product from the market, significant financial penalties and serious damage to the cosmetic brand’s reputation.

Step 3: Ensure Accurate Labels and Claims

A legible label is crucial for helping customers in their purchasing decisions and safeguarding their health. All pertinent information must be accessible, legible and comprehensible at the point of purchase.

The principle is clear: the end-consumer must have a clear understanding of the product they are purchasing upon inspection.

Lungile Msomi - author photo

Written by
Lungile Msomi

Meet Lungile Msomi, is the digital content specialist for SME South Africa with a Media Studies and Communication degree from the University of the Free State. With experience ranging from journalism to copywriting—and now steering the ship as Startup.Africa’s editor—she transforms ideas into captivating stories. When she’s not busy turning words into art, you’ll find her vibing to music, exploring tech trends, or reading literally anything. Passionate about technology, music, fashion, and, of course, writing, Lungile adds a fun twist to every project 😁

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