Regulation R638 — formally the Regulations Governing General Hygiene Requirements for Food Premises, the Transport of Food and Related Matters — is the foundational legal instrument governing food safety in South Africa. Published under the Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972), it applies to any premises where food is manufactured, processed, stored, distributed, or sold.
If you run a food business in South Africa, R638 applies to you. It is not optional, and it is not only for large manufacturers. A home-based baker, a restaurant kitchen, a contract packer, and a cold-storage facility all fall under its scope. Understanding what it requires — and what it does not require — is the starting point for any food safety system.
What R638 actually requires
R638 sets out minimum requirements across premises design, equipment, personal hygiene, food handling practices, waste management, pest control, and the management of food handlers. It requires that every food premises have a designated Person in Charge (PIC) — a person who takes responsibility for food safety on the premises and who has demonstrable knowledge of food hygiene requirements.
The regulation also governs the Certificate of Acceptability (COA) — the permit issued by your local municipality that confirms your premises meets R638 requirements. Without a valid COA, you cannot legally sell food from those premises. Retailers, distributors, and export buyers will ask to see it. Losing it — through a failed inspection or an expired renewal — stops your business.
The Person in Charge: what this means in practice
R638 requires that your Person in Charge understands the food safety risks relevant to your operation and can demonstrate that understanding to an inspector. This does not mean they need a formal qualification. It does mean they need to know what hazards exist in your process, how they are controlled, and what to do when something goes wrong. In practice, this person is often the owner, the production manager, or the head of quality — whoever is on the floor when an inspector arrives.
How R638 connects to HACCP
R638 is the legal floor. HACCP — specifically SANS 10330:2020 in the South African context — is the system you build on top of it. R638 tells you what conditions your premises must meet. HACCP tells you how to identify and control the specific food safety hazards in your product and process. If you only comply with R638 and nothing else, you meet the legal minimum. If you are supplying retailers, export markets, or any buyer with a supplier audit requirement, you will need to go further — and HACCP is where that journey starts.