When a product is classified as a medicine or a borderline product, it becomes a hurdle to enter South Africa’s cosmetics market. This is where many companies get stuck with delays in imports, relabeling expenses, and compliance problems.
The primary risk for regulatory and product teams is product claims. Even products sold as cosmetics could be subject to SAHPRA review of anti-aging, acne, skin-lightening, and hair-growth claims. The classification is determined by the intended use, claims, and mode of action of the product, as assessed by the South African regulators.
This guide provides an overview of cosmetic law in South Africa, the role of SAHPRA in borderline products, labelling requirements, restrictions on banned ingredients, and steps that companies need to take prior to market entry.
Regulatory Authorities for Cosmetics in South Africa
The South African Department of Health (DoH) is the main regulatory authority for cosmetics through the Foodstuffs, Cosmetics and Disinfectants Act. The DoH has the responsibility for cosmetic safety, labeling, ingredient restrictions, and advertising compliance.
The South African Health Products Regulatory Authority (SAHPRA) will be involved when the cosmetic product is deemed to be a borderline product, complementary medicine, or medicine.
Cosmetic Product Classification in South Africa
According to SAHPRA, cosmetics are products applied externally to
- Cleanse
- Protect
- perfume, or
- Improve appearance
Products that are
- Ingested
- Inhaled
- Injected, or
- Implanted
are NOT considered cosmetics.
Cosmetics can only exert a “local action” and “temporary action,” which is limited to the area in which it is applied. Products promoting anti-aging, acne treatment, hair growth, and skin lightening effects could be categorized as “borderline” or “medicines” instead.
Compliance Requirements for Cosmetics in South Africa
The Foodstuffs, Cosmetics and Disinfectants Act should apply to cosmetic products sold in South Africa and that should not claim to be medical or therapeutic.
Key compliance requirements include:
- Products are required to stay in the cosmetic category, depending on their use and claims.
- If there is a claim mentioned in acne treatment, anti-aging, skin repair, hair growth or skin lightening, it could subject the product to SAHPRA review.
- The use of ingredients that are prohibited or restricted should not be included in the product.
- Cosmetic labelling in South Africa must be in accordance with the labelling requirements.
- Companies should have product safety and technical records, such as ingredient and quality data.
- The manufacturers and importers should practice GMP and quality control.
- Companies need to keep track of complaints and product safety concerns after markets
Products that are in the scope of the borderline products, medicines or complementary medicines may be further subject to regulatory scrutiny and compliance requirements.
Cosmetics Market Entry Process in South Africa (Step-by-Step)
Companies need to focus on classification, claims, labeling, and import compliance before commercialization.
Step 1: Determine Whether the Product Is a Cosmetic or a Borderline Product
Review the product’s:
- Intended purpose
- Claims
- Ingredient profile
- Mode of action
Products with therapeutic or physiological claims may be exempt from cosmetic compliance and subject to SAHPRA review. It is particularly important for anti-aging, acne treatment, skin lightening, and hair growth products.
Step 2: Submit a Request for Designation (RFD) if Classification Is Unclear
Companies have the option of applying for an RFD application to SAHPRA if there is any doubt about the classification of the product.
The application can contain:
- Cover letter
- Product labelling and packaging
- Instructions for use or brochures
- Material Safety Data Sheet (MSDS)
- Risk assessment and risk management plan
- Classification in other markets
- Proof of payment
Typically, SAHPRA will process an RFD application within 30 working days.
Step 3: Check Ingredient Compliance
Check whether the formulation meets South African cosmetic requirements and whether it contains prohibited or restricted ingredients.
Be mindful of:
- Skin-lightening ingredients
- Mercury compounds
- Hydroquinone
- Restricted preservatives and colors
Step 4: Create Technical and Safety Documentation
Maintain:
- Product formula details
- Ingredient specifications
- Safety and quality information
- Manufacturing information
- Claims substantiation
- Labeling and packaging files
The lack of proper documentation may lead to importer onboarding and customs clearance delays.
Step 5: Make Sure That Labeling and Claims Are Compliant
Check labels and marketing materials to ensure compliance with cosmetic claims.
Verify:
- Ingredient declarations
- Importer details
- Product function
- Required warnings
- Net content
- Batch details
Any claims that suggest treatment, prevention, or changes in physiology could be subject to regulatory review.
Step 6: Designate a Local Importer or Distributor
Foreign cosmetic brands normally have to deal with a South African importer or distributor who will be responsible for:
- Product importation
- Customs coordination
- Product traceability
- Local market compliance
Step 7: Import and Commercialize the Product
Products can be imported and marketed when they comply with applicable cosmetic requirements and do not give rise to any additional SAHPRA concerns.
Step 8: Maintain Post-Market Compliance
Once launched, companies should keep monitoring:
- Consumer complaints
- Adverse reactions
- Label changes
- Advertising claims
- Formula updates
If new claims, packaging, or scientific information alter a product’s regulatory status, SAHPRA may review the product’s classification.
Documents Required for Cosmetic Compliance in South Africa
Companies should maintain technical, safety, and labeling documents to support cosmetic compliance and potential SAHPRA review.
Required documents may include:
- Product formula and ingredient list
- Ingredient specifications
- Product labels and packaging artwork
- Claims and marketing materials
- Safety Data Sheet (SDS/MSDS)
- Stability and safety data
- Manufacturing and quality information
- Claims substantiation documents
- Risk assessment and risk management plan
- Product brochure or instructions for use
- Classification status in other countries (for borderline products)
- Proof of payment for RFD applications, where applicable
Labeling Requirements for Cosmetics in South Africa
Cosmetic labels in South Africa must provide clear product, ingredient, and importer information and should not make misleading or medicinal claims.
Labels should include:
- Product name and function
- Ingredient list
- Net content
- Batch number
- Manufacturer or importer details
- Country of origin
- Directions for use, where applicable
- Required warnings and precautions
Ingredient declarations should follow INCI naming conventions.
Timeline for Market Entry in South Africa
The market entry timeline for cosmetics in South Africa depends mainly on product classification, claims, and whether an SAHPRA review is required.
Typical timelines may include:
- Product classification and claims assessment: 1–2 weeks
- Ingredient and labeling review: 1–3 weeks
- Technical documentation preparation: 2–4 weeks
- Import and customs coordination: 1–2 weeks
Cost of Cosmetic Compliance in South Africa
Cosmetic compliance costs in South Africa vary depending on product category, claims, and classification risk.
Typical cost areas include:
- Ingredient and formula compliance review
- Claims and labeling review
- Technical and safety documentation preparation
- Product testing and stability studies
- Label redesign and artwork updates
- Local importer or distributor support
- Customs and import coordination
Conclusion
It is important for companies to review SAHPRA guidelines so that the products are not classified as borderline products. It is important to be compliant with all the labeling, product classification, and post-market surveillance.
It helps to get in touch with a regulatory expert to ensure your products meet all standards. An expert partner like Artixio can smooth the process for you. Our team of experts can help with borderline product assessment and labeling review to simplify market entry. Know more about our cosmetic commercialization in South Africa at info@artixio.com.
