R638 Compliance in South Africa: The Complete Operator’s Guide

Almost every business that handles food for sale in South Africa operates under one regulation, whether they know it or not: Regulation 638 of 2018. It is the national hygiene floor for food premises and the transport of food, and it carries real teeth — a municipal practitioner can prohibit you from trading. Yet most operators meet it without reading it, and many cold chain operators misunderstand what it actually requires.

This guide sets out what R638 is, who it binds, how the Certificate of Acceptability process works, what an inspector checks, and where the regulation ends and your cold chain obligations begin. That last distinction matters more than most operators realise: passing a hygiene inspection is not the same as running a validated cold chain.

What R638 Actually Is

R638 is shorthand for the Regulations Governing General Hygiene Requirements for Food Premises, the Transport of Food and Related Matters, published as Government Notice R638 on 22 June 2018. The Minister of Health made the regulations under section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 — the parent statute that gives the Minister power to regulate how food is produced, handled, transported, stored and sold.

R638 replaced Regulation R962 of 2012, which had itself replaced R918 of 1999. Certificates of Acceptability issued under the repealed regulations expired on 22 June 2019, which means every food premises operating today should hold a certificate issued under R638. The regulation is administered nationally by the Department of Health but enforced locally: it is your municipality’s environmental health department — staffed by Environmental Health Practitioners — that inspects, issues certificates, and acts against non-compliance.

One important boundary: premises controlled under the Meat Safety Act 40 of 2000 — principally abattoirs — fall outside R638, because they are regulated by a separate framework. The transport of meat after it leaves the abattoir, however, is squarely within R638’s scope. For a refrigerated transport operator, that distinction is the whole game.

There Is No “R638 Certificate”

This is the single most common misunderstanding in the market, so it is worth stating plainly. R638 is a regulation. You either comply with it or you do not. There is no certificate that says “R638 certified,” and any provider claiming to issue or hold “R638 certification” is misdescribing the framework.

What does exist is the Certificate of Acceptability — a permit issued to a food premises by the local authority confirming that the premises meets the hygiene standards in the regulation. People informally call it an “R638 certificate,” but the legal instrument is the Certificate of Acceptability, issued in terms of Regulations 5 and 6. Compliance is meeting the legal requirement; certification (ISO 22000, FSSC 22000, HACCP and the like) is separate, voluntary, third-party verification against a published standard. Confusing the two leads operators to over-claim and under-prepare.

Who R638 Applies To

R638 applies to anyone who handles food intended for sale to the public — handling, in this context, covers preparing, processing, packing, storing, transporting, displaying and selling. The net is wide: restaurants, takeaways, caterers, butcheries, manufacturers, retailers, spaza shops, food trucks, home-based food businesses, cold stores, and refrigerated transport operators all fall within it.

The reach comes from how the regulation defines “food premises.” It is not limited to a fixed building. The definition expressly includes any building, structure, stall or vehicle in or from which food is handled. For cold chain operators this is the load-bearing point: a refrigerated delivery vehicle is itself a food premises under R638. The hygiene, cleanliness and protection-from-contamination duties that apply to a cold store apply, in their own form, to the truck that services it.

The Certificate of Acceptability

The Certificate of Acceptability is the legal authorisation to operate a food premises. Without a valid certificate, a food business is trading unlawfully regardless of its size or how long it has been operating.

How it is issued

The certificate is issued by the local authority — in practice, your municipality’s environmental health department — in terms of Regulations 5 and 6, which set the standards for premises and equipment. The process runs roughly as follows:

A written application is submitted to the relevant local authority for the specific premises.
An Environmental Health Practitioner inspects the premises against the requirements of Regulations 5 and 6.
If the practitioner is satisfied that the premises complies, the local authority issues the certificate.
Where it falls short, the practitioner identifies the deficiencies and the premises must remedy them before a certificate is granted.

Fees vary by municipality and are set locally, not nationally. The variance is real: the City of Tshwane has charged a one-time inspection fee in the order of R2 152, while smaller authorities such as the Garden Route District Municipality have charged administrative fees closer to R190. Some authorities issue certificates at no charge. Confirm the fee and the documentation your specific municipality requires before applying — requirements differ in detail across the country.

Validity, display and renewal

The certificate has no fixed statutory expiry date — it does not lapse annually. But it is not “set and forget.” A new certificate is required when material circumstances change, including:

a change of ownership of the food business;
a change in the Person in Charge;
structural alterations or a change in the nature of the food handled.

The local authority must be informed of such changes in advance and in writing. The certificate must also be displayed prominently on the premises for which it was issued; where display is impractical — as on a vehicle — it must be produced immediately on request by a practitioner or member of the public.

Duties by Role: Operator, Facility, Individual

R638 spreads its obligations across the business, the premises and the people. Reading it through that lens makes it far easier to apply than working through the clauses sequentially.

The food business and the Person in Charge

Every food premises must have a designated Person in Charge. Under Section 10(1), that person must be trained in food safety by an accredited training provider, or hold a relevant qualification (such as a chef or food technologist qualification). The business carries the overarching duty: it may not handle food, or allow food to be handled, in a manner contrary to the regulations. It must hold a valid Certificate of Acceptability, maintain the premises to standard, and keep the records that demonstrate ongoing compliance.

Food handlers

Individuals who handle food carry personal hygiene duties: wearing clean protective clothing, maintaining personal cleanliness, not handling food while suffering from a condition that could contaminate it, and following hygienic handling practices. Food handlers must be instructed and trained appropriately for the work they do. The duty is not abstract — an inspector will look for evidence that handlers know and apply it.

The premises and equipment

Regulations 5 and 6 set the structural and equipment standards: cleanable surfaces and finishes, adequate lighting and ventilation, a safe water supply, hand-washing and sanitation facilities, effective waste handling, pest control, and the separation of activities and products to prevent cross-contamination. Equipment and containers that contact food must be constructed and maintained so they can be effectively cleaned.

Transport operators

Because a vehicle is a food premises, refrigerated transport operators inherit the hygiene logic directly. Vehicles and containers used to carry food must be kept clean and maintained in good condition, designed and used so food is protected from contamination, and operated so that incompatible products are not transported together in a way that risks cross-contamination. Perishable food must be carried under conditions that keep it from becoming a health hazard — which is where R638 hands off to temperature control, discussed below.

Operators transporting meat carry additional obligations. Section 6(8) and Annexure F deal with the cleaning of meat-handling equipment, and require proof that handlers are trained in those cleaning procedures.

Where R638 Ends and the Cold Chain Begins

Here is the distinction that trips up otherwise diligent operators. R638 is a general hygiene regulation. It requires that perishable and potentially hazardous food be handled, stored and transported under conditions that prevent it from becoming unsafe. It does not function as a numeric cold chain temperature schedule. R638 will not hand you a table that says “carry this product at this temperature for this duration.”

Those specific temperature regimes come from elsewhere: product-specific regulations (meat, dairy), national standards, the Good Distribution Practice requirements that govern pharmaceutical distribution, export rules administered by the Perishable Products Export Control Board, and — very often — the contractual specifications your customer imposes. R638 is the legal hygiene floor. The cold chain you actually run sits on top of it.

The practical consequence is blunt: an Environmental Health Practitioner can clear your hygiene and issue your Certificate of Acceptability while your cold chain remains entirely unvalidated. Those are two different problems. A spotless, certificated vehicle that loses 4°C of control over a long Karoo leg in summer has passed its R638 inspection and still ruined the load. Hygiene compliance and thermal performance are not the same achievement, and treating the certificate as proof of the latter is how compliant operators still lose product — and customers.

South African conditions sharpen the point. Maintaining temperature through load shedding, holding setpoint across long high-ambient routes, and producing the monitoring records that prove you did so are all part of keeping food from becoming unsafe — and therefore part of operating lawfully under R638’s general duty, even though the regulation does not spell out the engineering. The documentation trail is what converts “we kept it cold” into “we can demonstrate we kept it cold.”

Inspection and Enforcement

Environmental Health Practitioners are empowered to enter and inspect food premises, including vehicles. They can prohibit the handling or transport of food where they judge it unsafe, impose hygiene measures beyond the baseline where circumstances warrant, and — within the framework — grant exemptions. Enforcement is not theoretical; an inspector who finds a serious failure can stop you trading on the spot.

What an inspector typically checks

A practitioner working through a premises or vehicle will generally look at:

a valid Certificate of Acceptability, displayed or producible on request;
structural and surface condition, lighting, ventilation and water supply;
protective clothing, hand-washing and general handler hygiene;
training records for the Person in Charge and food handlers;
pest control and waste handling;
separation of incompatible products and prevention of cross-contamination;
temperature control of perishables and the supporting monitoring records;
cleanliness and condition of vehicles and food-contact equipment.

Running this list as a quarterly self-audit is the cheapest insurance available against an unannounced inspection.

Penalties

Offences and penalties flow from the parent statute, the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972, which provides for fines and, in serious cases, imprisonment. Beyond the criminal exposure, the immediate operational risks are the ones that hurt a business fastest: prohibition of handling or transport, and the inability to trade lawfully without a valid Certificate of Acceptability.

R638 in Relation to Other Frameworks

R638 is the general hygiene baseline. Several other frameworks sit alongside it, and operators frequently carry obligations under more than one at once.

Framework	Scope	Status
R638 of 2018	General hygiene for all food premises and food transport	Mandatory (law)
Meat Safety Act 40 of 2000	Abattoirs and primary meat processing	Mandatory (law) — replaces R638 for those premises
Good Distribution Practice	Pharmaceutical and healthcare product distribution	Mandatory for licensed distributors
PPECB control	Export of perishable products	Mandatory for regulated exports
ISO 22000 / FSSC 22000 / HACCP	Food safety management systems	Voluntary, often customer-required

For a full mapping of which framework applies to which operator type, see the certifications guidance linked at the foot of this page.

Frequently Asked Questions

Is there an "R638 certificate"?

No. R638 is a regulation you comply with. The legal document issued to a compliant premises is the Certificate of Acceptability. The phrase “R638 certificate” is informal shorthand for that certificate, not a separate certification scheme.

Does my refrigerated delivery vehicle need to comply?

Yes. R638 defines a vehicle used to handle food as a food premises, so the hygiene, cleanliness and protection-from-contamination duties apply to it. Confirm with your local authority how the Certificate of Acceptability requirement is applied to vehicles in your jurisdiction, as practice varies.

Does the Certificate of Acceptability expire?

It has no fixed statutory expiry date, but you must apply for a new one when ownership changes, the Person in Charge changes, or the premises is structurally altered or changes the food it handles. The local authority must be told of such changes in advance and in writing.

What temperatures does R638 require?

R638 does not publish a numeric temperature schedule. It requires perishable food to be kept under conditions that prevent it becoming a health hazard. The specific temperatures you run come from product-specific regulations, national standards, Good Distribution Practice (for pharmaceuticals), export rules, and your customer’s contractual requirements.

Who issues the certificate and what does it cost?

Your local municipality’s environmental health department issues it, after an inspection by an Environmental Health Practitioner. Fees are set locally and range from no charge to a few thousand rand depending on the authority.

How is R638 compliance different from ISO 22000 or HACCP?

R638 compliance is a legal minimum, verified by a municipal practitioner. ISO 22000, FSSC 22000 and HACCP are voluntary management-system standards verified by independent certification bodies. Many customers require the latter contractually, but they sit on top of R638 rather than replacing it.

What happens if I operate without a valid certificate?

You are trading unlawfully. An Environmental Health Practitioner can prohibit you from handling or transporting food, and the parent Act provides for fines and, in serious cases, imprisonment.

Sources & References

Regulation R638 of 2018 — Notice No. 638 — Department of Health notice promulgating the regulations under section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act, 22 June 2018.
Regulations Governing General Hygiene Requirements for Food Premises and the Transport of Food (InforMEA) — Summary of scope, certificate of acceptability provisions and food-handler duties under R638.
R638 of 2018 (UNEP Law and Environment Assistance Platform) — Legislative summary covering premises, persons, equipment standards and the local-authority certificate requirement.
Garden Route District Municipality — Certificate of Acceptability process — Municipal explanation of the application process, Regulations 5 and 6, display requirements and the R918/R962 transition.
City of Tshwane — Registration and certification of food premises — Municipal notice illustrating mandatory adherence to R638 and an example inspection fee.
National Institute for Occupational Health — Food Control Requirements — Presentation summarising R638 scope, the food-premises definition including vehicles, the Meat Safety Act carve-out and local-authority enforcement powers.
Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 — Parent statute defining offences, inspector powers and the Minister’s regulation-making authority.

All sources verified as of June 2026 and reflect the most current publicly available information on R638. Fees, municipal procedures and supporting requirements vary by local authority and may change; confirm current requirements with your municipality before applying.

Related Resources

This guide is published by ColdChainSA, South Africa’s dedicated cold chain intelligence platform. It is sponsored by The Frozen Food Courier, a refrigerated courier operating across Gauteng and the Western Cape, whose operational experience informs the cold chain commentary in this article. The guide provides general regulatory information and is not legal advice; confirm your specific obligations with your local authority or a qualified Environmental Health Practitioner.