Regulation R638 Explained: The Complete Guide for South African Food Businesses

If your business handles food anywhere in South Africa, Regulation R638 is the law that decides whether you may legally open your doors — and it is the regulation behind the Certificate of Acceptability every environmental health inspector will ask to see.

What is Regulation R638?

Regulation R638 — formally the Regulations Governing General Hygiene Requirements for Food Premises, the Transport of Food and Related Matters — was published in 2018 under the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). It is the single most important general-hygiene regulation for anyone who handles food in South Africa.

In practical terms, R638 sets the minimum legal standard for three things: how food premises must be built, equipped and kept; how food handlers must behave; and how food must be stored and transported. It also gives municipal Environmental Health Practitioners (EHPs) the authority to inspect premises, issue or refuse a Certificate of Acceptability, and stop food handling where there is a health risk.

R638 is not a voluntary standard or a best-practice guideline — it is enforceable law. Contravening it is a criminal offence under the Act.

R962 to R638: what changed

R638 replaced the older R962 of 2012. The move to R638 modernised and tightened the general hygiene requirements — sharpening expectations around the Certificate of Acceptability, the duties of the person in charge, food-handler hygiene and training, temperature control, and the transport of food. If your compliance documents, signage or training still reference R962, they are out of date and should be updated to R638.

Who must comply with R638?

R638 applies to any person or business that handles food that is not pre-packed and sealed by a manufacturer. If you prepare, process, produce, pack, store, transport, serve or sell food, you are almost certainly covered:

• Restaurants, takeaways, cafés, coffee shops, food trucks and caterers
• Spaza shops, supermarkets, butcheries, bakeries, delis and fruit-and-veg outlets
• Food manufacturers, processors, abattoirs and packhouses
• Cold stores, distribution warehouses and food transport operators
• School, hospital, mine, hotel and workplace canteens
• Home-based food businesses, market stalls and informal traders

What R638 covers

R638 is broad. Rather than one rule, it is a set of connected requirements that together define a hygienic food operation. At a high level it covers:

The Certificate of Acceptability (COA)

The Certificate of Acceptability is the licence that proves your premises meet R638. It is issued by your local authority (municipality) after an EHP has inspected the premises and is satisfied that the hygiene requirements are met.

• It is issued per premises — each physical location needs its own certificate.
• It is not transferable — a new owner or a new location means a new application.
• It must be displayed on the premises and produced on request.
• It can be withdrawn if the premises stop meeting the requirements.

Because the COA is the question inspectors ask first, we have written a dedicated, step-by-step guide: How to get a Certificate of Acceptability in South Africa.

Food-premises requirements

R638 requires food premises to be designed, built and maintained so they can be kept clean and so food is protected from contamination. Inspectors assess the premises across several areas:

Structure and finishes

Floors, walls and ceilings must be smooth, durable, impervious, washable and kept in good repair, with no flaking paint, cracks or gaps that harbour dirt or pests. Junctions should be easy to clean.

Water supply and plumbing

Premises need an adequate supply of potable (drinking-quality) water, with hot and cold water available where food and equipment are washed. Plumbing and drainage must remove waste water hygienically and prevent back-flow or contamination.

Hand-washing and ablution facilities

Dedicated hand-washing facilities must be provided with soap and a hygienic means of drying hands. Sufficient, separate toilet and change-room facilities must be available for staff, kept clean, and must not open directly onto areas where food is handled.

Lighting and ventilation

Adequate natural or artificial lighting must let staff work and clean effectively, and lighting over food should be protected against breakage. Effective ventilation controls heat, steam, condensation and odours.

Equipment and food-contact surfaces

Equipment, containers and surfaces that touch food must be made of non-toxic, corrosion-resistant, cleanable material, kept in good condition, and cleaned and where necessary disinfected.

Storage, drainage and waste

There must be suitable storage for food, packaging, cleaning chemicals (stored separately from food) and waste. Refuse must be controlled in covered, cleanable containers and removed regularly, and drainage must not create a contamination risk.

Food handlers and personal hygiene

People are the biggest contamination risk, so R638 places clear duties on food handlers:

• Wear clean protective clothing suitable for the work being done
• Maintain a high standard of personal hygiene and wash hands properly and often
• Not handle food while suffering from a condition, illness or wound that could contaminate it
• Report relevant illnesses, symptoms and injuries to the person in charge
• Avoid unhygienic practices near food (such as smoking, eating or spitting)
• Be trained in food safety and hygiene, with training records kept and available

Training is where most businesses fall short at inspection. ASC offers accredited food-handler training that satisfies this requirement and produces the certificates inspectors want to see.

R638 training courses you can enrol in

R638 requires your food handlers and the person in charge to be trained in food safety and hygiene, with records kept for inspection. These accredited, online, self-paced ASC courses give you exactly that — each ends with a downloadable certificate you can show at your next inspection:

Browse all ASC food safety courses →

Cleaning, sanitation and pest control

A compliant premises is a consistently clean premises. R638 expects effective cleaning of the premises, equipment and food-contact surfaces, and an effective programme to keep pests out. In practice inspectors look for a documented cleaning schedule (what is cleaned, how, how often and by whom), suitable cleaning chemicals stored away from food, and a pest-control programme — often supported by a service provider — with proofing, monitoring and records. Openings to the outside should be screened, and there should be no evidence of pest activity.

Temperature control and food storage

Keeping food out of the danger zone is central to safety. R638 requires food to be stored and handled so it stays safe, which in practice means keeping cold food cold and hot food hot, separating raw and ready-to-eat foods to prevent cross-contamination, protecting food from contamination at all times, and using stock rotation so older stock is used first. Fridges and freezers should be monitored, and temperature records are strong evidence of control at inspection.

Transport of food

R638 also governs how food moves. Vehicles, containers and equipment used to transport food must be clean, in good condition and able to protect food from contamination and — where relevant — keep it at safe temperatures. Raw and ready-to-eat foods must be kept separate, and food may not be transported together with anything (chemicals, non-food loads, live animals) that could contaminate it.

Duties of the person in charge

R638 makes the person in charge of the premises responsible for compliance. That includes making sure the premises and facilities meet the requirements, that food handlers are healthy, hygienic, suitably clothed and trained, that food is protected and kept at safe temperatures, and that the necessary records — training, cleaning, pest control and temperatures — are kept and available. When an inspector visits, it is the person in charge who must be able to show that the system works.

Records inspectors want to see

How R638 relates to HACCP, FSSC 22000 and GFSI

R638 is the legal baseline every food business in South Africa must meet. Food safety standards such as HACCP, FSSC 22000, BRCGS and the wider GFSI standards build on top of that baseline for businesses that need certification — usually to supply retailers or export markets. Meeting R638 does not make you HACCP or FSSC certified, but you cannot achieve those standards without first meeting the general hygiene requirements R638 sets. Many of the prerequisite programmes in a HACCP or FSSC system are, in effect, the same controls R638 already requires. If you are working towards certification, start by making sure your R638 foundation is solid — a gap audit is the quickest way to confirm it.

The 10 most common R638 inspection failures

Most businesses fail on the same avoidable issues. In our experience, these are the ones that come up again and again:

• No valid Certificate of Acceptability on display
• Damaged or unsealed floors, walls or ceilings that cannot be cleaned
• Hand-wash basins missing, blocked, or with no soap or hand drying
• Weak or undocumented pest control, or signs of pest activity
• Fridges and freezers not holding safe temperatures, with no monitoring
• Raw and ready-to-eat foods stored together
• Cleaning chemicals stored with or near food
• Food handlers without training records
• Poor personal hygiene or missing protective clothing
• No cleaning schedule or records to show the system works

R638 compliance checklist

Use this quick self-check before an inspection. If you cannot tick every box with confidence, book a gap audit before the EHP arrives:

Enforcement and penalties

Environmental Health Practitioners enforce R638. If a premises is non-compliant or poses a health risk, an EHP can issue a prohibition order that stops food handling immediately and can effectively close the business until the problems are fixed. Operating without a Certificate of Acceptability, or contravening the regulations, is an offence under the Foodstuffs, Cosmetics and Disinfectants Act and can lead to fines and prosecution. Beyond the legal risk, a failed inspection, a closure, or a foodborne-illness incident can do lasting damage to your brand and to customer trust — which is often far more costly than the fix would have been.

Frequently asked questions

What South African food businesses say about ASC

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This guide is general information to help South African food businesses understand Regulation R638 of 2018 and is not legal advice. Always refer to the current regulations and your local municipality’s environmental health department for requirements specific to your premises.