Regulatory Pathway for Food Products and Dietary Supplements in South Africa

As the demand for food products and dietary supplements grows in South Africa, ensuring Regulatory compliance becomes crucial. The country boasts a robust Regulatory framework designed to protect consumers and guarantee the safety and quality of these products. This blog is a comprehensive guide for businesses navigating South Africa’s Regulatory landscape.

Regulatory Framework for Food Products in South Africa

In South Africa, the central Regulatory bodies overseeing food products are the Department of Health (DOH), the South African Bureau of Standards (SABS), and the National Regulator for Compulsory Specifications (NRCS). The DOH is responsible for ensuring the safety and quality of food products and dietary supplements. The SABS develops and maintains standards for these products, while the NRCS ensures compliance with mandatory specifications.

The Foodstuffs, Cosmetics, and Disinfectants Act is a pivotal legislation that regulates the manufacturing, sale, and distribution of food products and dietary supplements in South Africa. Complementing this Act, the regulations on the labeling and advertising of food products set specific requirements for labeling and advertising. These regulations mandate accurate product names, ingredient lists, allergen information, country of origin, batch identification numbers, use by dates, and nutritional information.

Regulatory Framework for Dietary Supplements in South Africa

Dietary supplements in South Africa fall under the Medicines and Related Substances Act, and they are classified as a subcategory of Complementary Medicines (Category D). This classification underscores that dietary supplements are intended to supplement your regular diet with additional nutrients, vitamins, or minerals rather than serve as substitutes for a balanced diet. The South African Health Products Regulatory Authority (SAHPRA) is responsible for ensuring the safety and quality of these products. Dietary supplements must be registered with the SAHPRA and comply with stringent labeling and advertising regulations.

The classification of dietary supplements in South Africa also affects marketing and sales approaches. While dietary supplements are not regulated as medicines, they must meet the same labeling and advertising standards. The standards ensure that consumers receive accurate and understandable information, thus maintaining high standards of consumer protection.

Steps for Ensuring Compliance

• Product Registration:. In South Africa, food products and dietary supplements must be registered with distinct procedures. Food products have to be registered with the Department of Agriculture, Forestry, and Fisheries (DAFF), while dietary supplements must be registered with the SAHPRA. The necessary documentation for registration includes a detailed product description, accurate labeling, and packaging information.
• Good Manufacturing Practices (GMP): Adherence to GMP is vital for ensuring product safety and quality. GMP guidelines cover food handling, storage, transportation, and control of contaminants in food products. For dietary supplements, GMP includes guidelines for manufacturing, packaging, and labeling.
• Regular Inspections and Audits: Regulatory inspections of manufacturing facilities ensure ongoing compliance with standards. Manufacturers must prepare for audits by maintaining accurate documentation and meeting all the Regulatory requirements. Handling audits professionally minimizes risks and ensures continuous compliance.

Labeling Requirements

• General Labeling Requirements: Labels must include the product name, ingredients list, net weight, country of origin, manufacture and expiry dates, batch number, and product size or weight. All information must be in English to ensure clarity and readability.
• Specific Requirements for Food Products: Food product labels must feature a nutritional information panel and allergen declarations, ensuring that consumers have all the essential dietary information.
• Specific Requirements for Dietary Supplements: Labels must include an ingredient listing and Recommended Daily Allowance (RDA) information if a nutritional claim is made. This information helps consumers make informed choices about their dietary supplements.

Importance of a Legal Representative (LR)

The role of a Legal Representative (LR) in the registration of food and dietary supplements in South Africa is vital. Here are some of the key functions of an LR:

• Compliance with Regulations: An LR ensures that the company complies with all relevant regulations, including the Foodstuffs, Cosmetics and Disinfectants Act, the Medicines and Related Substances Act, and the SAHPRA regulations.
• Submission of Registration Applications: They assist companies in submitting registration applications to the SAHPRA, ensuring that they submit all necessary documents and checking into the accuracy of the documentation.
• Label and Claims Review: An LR reviews labeling and claims to ensure compliance and avoid potential legal issues.
• Product Classification: They help classify the product correctly, ensuring proper registration under the correct category.
• GMP Audit Support: An LR provides support during GMP audits, ensuring compliance with the Regulatory requirements.
• Regulatory Updates: They keep the company informed about updates Regulatory guidelines and standards updates.
• Food Import Guidance: An LR offers guidance on importing food products, ensuring that all the necessary documentation and procedures are followed.
• Common Technical Document (ZA-CTD) Dossier Gap Analysis and Compilation: They assist in compiling the CTD dossier in the latest version, ZA-CTD, ensuring completeness and accuracy.
• Regulatory Pathway Report: They provide a Regulatory pathway report that outlines the steps required for product registration and highlights potential Regulatory issues.
• Legal Representation (LR) Services: They protect the company in case of legal disputes.

SAHPRA’s Food Import Guidance

Importing food and dietary supplements into South Africa involves several critical steps, as outlined by SAHPRA’s guidance on food import:

• Labeling Requirements: Food products must be labeled with specific information, including the product name, ingredients, nutritional information, country of origin, and shelf-life. Compliance with these requirements ensures transparency and consumer safety.
• Regulatory Compliance: Imported food products must adhere to the Foodstuffs, Cosmetics, and Disinfectants Act and related regulations, which ensures compliance with local safety and quality standards.
• Import Permits: Import permits from the Department of Agriculture, Forestry, and Fisheries (DAFF) are required for all food products, including dietary supplements. This step ensures that only safe and compliant products enter the South African market.
• Food Safety and Quality: The DOH oversees the safety and quality of imported food products, ensuring they are safe for consumption.
• Product Classification: Accurate classification of products as either food or health supplements is crucial for ensuring correct registration and compliance.
• Label and Claims Review: Reviewing labels and claims ensures that imported products do not mislead consumers and meet Regulatory standards.
• GMP Audit Support: Importers must comply with GMP standards, ensuring that products are manufactured under safe and sanitary conditions.
• Regulatory Updates: Keeping abreast of Regulatory changes helps maintain compliance and adapt to new requirements.
• CTD Dossier Compilation: Importers must compile a CTD dossier, including all the necessary information for product registration.
• LR Services: An LR can offer crucial support throughout the import process, such as ensuring compliance and addressing legal issues.

To sum up, ensuring Regulatory compliance for food products and dietary supplements in South Africa is crucial for businesses since it helps them avoid legal issues and product recalls. Freyr can help food businesses understand the South African Regulatory framework, provide LR services, and assist with food imports, labeling requirements, and claims. This support ensures that products meet the necessary standards and are safe for consumption. By adhering to these guidelines and leveraging expert assistance, businesses can successfully navigate the Regulatory landscape, contribute to consumer safety, and efficiently launch their food products and dietary supplements in South Africa. Contact us now!