Regulation R638, made under the Foodstuffs, Cosmetics and Disinfectants Act, sets the hygiene requirements for handling food in South Africa, and it applies to any business that prepares, handles or sells food, not only large manufacturers. Understanding it properly protects both your customers and your ability to keep trading legally.
These are the areas the regulation actually covers.
Premises and equipment requirements
Food preparation areas must be kept clean, properly maintained, and designed to prevent contamination, with adequate ventilation, running water and correctly functioning refrigeration where perishable food is stored.
Equipment and surfaces that contact food need to be made of materials that can be properly cleaned and sanitised, and cleaning needs to happen on a genuine schedule, not only when something looks visibly dirty.
Personal hygiene for anyone handling food
Anyone handling food needs to follow basic hygiene practice: proper handwashing, clean protective clothing, and staying away from food handling when ill with anything transmissible. This is a legal requirement, not a suggestion.
Staff training on these requirements needs to be genuine and ongoing, since a single induction session does not create a lasting habit, and inspectors assess actual practice, not just whether a policy document exists.
Getting a Certificate of Acceptability
A Certificate of Acceptability from the local municipal health department confirms the premises meets these requirements, and trading without one where required is a compliance failure regardless of how good your actual hygiene practice is.
Our guide to submitting a food licence application covers this process step by step, since the certificate and the licence are handled through the same municipal inspection process in most areas.
What inspection and enforcement actually look like
Environmental health practitioners inspect premises periodically, and non-compliance can result in a range of responses from a corrective notice through to closure for serious or repeated hygiene failures.
The full regulation is published by the South African government, and confirming your specific obligations against the actual text is safer than relying on a summary, including this one.
Build compliance into daily operations, not a once-off checklist
A hygiene system that only gets attention before an inspection is a warning sign, both to an inspector and to the business itself. Daily checks on temperature control, cleaning schedules and staff hygiene practice should be routine enough that an unannounced visit changes nothing.
Keep simple written records of cleaning schedules and temperature checks. Beyond satisfying an inspector, this record is genuinely useful for catching a developing problem, such as a fridge slowly losing its seal, before it becomes a food safety incident.
Frequently asked questions
Who does Regulation R638 apply to?
Any business that prepares, handles or sells food, not only large manufacturers, including small food businesses and home kitchens trading commercially.
What does it require of premises?
Cleanliness, proper maintenance, adequate ventilation and running water, and refrigeration that functions correctly for perishable food.
What personal hygiene practices are required?
Proper handwashing, clean protective clothing, and staying away from food handling when ill with anything transmissible.
What is a Certificate of Acceptability?
Confirmation from the local municipal health department that your premises meets the hygiene requirements, required before trading in most areas.
What happens if a business does not comply?
Responses range from a corrective notice through to closure for serious or repeated hygiene failures, depending on severity.
