What's new in the hygiene regulations R638

By Linda Jackson on 14 October 2019

Updated at 18 October 2019

Despite the wording in the regulation relating to the continued validity of COAs issued under R962/918, the official interpretation of this requirement according to Ms. Penny Campbell (Directorate Food Control, National Department of Health) is as follows:

Based on the new requirements of R638,
a new certificate will be required after 22 June 2019.

For more information, please watch this webinar on this topic,
presented by Ms.Penny Campbell on 17 October 2019

View the full Interview with Penny Campbell
click here to view



What is the purpose of the regulation?

This regulation defined the basic hygiene requirements that EVERY food handling business should have in place to ensure minimum legal compliance. This is what we refer to as the entry level regulation. Your certificate of acceptability(COA) is issued under this regulation. This regulation defines the legal physical must-haves for a hygienic environment.


So what is new?

The entire regulation has been re-formatted and the grammar revised. It makes a LOT more sense!. A new word MUST has replaced all the “SHALL’s” underlining that this is a mandatory requirement that MUST be met.


Your certificate of acceptability (COA)

The good news is that you DON’T need to reapply for your COA. That is provided the person in charge, the site address or the products and processes haven’t changed since the issue of the last one!

However, the regulation now more clearly states that if you may not make any changes to your facility without informing the local authority first. We have one year from 22 June to sort out any issues you may have with your current certificates so I would definitely have a good look at the old ones!

What needs to change in your premises?

The standards for buildings remain the same. Regulation 3(c ) iv now also requires a controlled refuse area.

We finally have clarification on hot and/or cold water! You must have HOT where possible!

Standards and requirements for facilities on food premises

Additional requirements for the heat treatment of milk and bulk milk storage tankers used in retail are also addressed specifically to improve the safety of bulk milk sales – look out: there is a WHOLE page of requirements.

If you were wondering why the emphasis on meat and butchery, there are now specific detailed cleaning instructions in Annexure F of the regulation. Documented cleaning procedures including disassembly are required.

Standards and requirements for the display, storage and temperatures of food

When handling ready-to-eat non-packaged foods, these must now also be protected against contact by bare hands. This is a significant change and will mean we see many more gloves? Or will it?

The surface temperature of frozen foods that may be re-frozen has been lowered to 5 degrees, previously 7 degrees. More detailed requirements are given for thawing practices too. Frozen fish is also addressed.

Previously the regulation prohibited food that was 2 degrees above or below the regulated storage temperatures for more than 1 hour from being sold. This has been increased to 4 hours – the thinking behind this is to try and reduce food waste.

Standards and requirements for protective clothing

You will now be required to provide clothing for visitors too.

Duties of the person in charge of food premises

You should sit up as this section represents the most significant changes in my opinion. The person in charge( this should be the person who is able to supervise food handling practices on a day to day basis, and who will be liable for any criminal acts) must now be able to demonstrate that he/she is suitably qualified and/or trained in principles and practices of food safety and hygiene. This should be accredited training or provided by the inspector. No definition is given for accredited.

The person in charge must then still ensure all food handlers are now trained in principles and practices of food safety and hygiene. In addition to training, the person in charge must evaluate the effectiveness of the training through assessments (again no definition) and arrange for follow up training if required. Finally records of training must be kept and training programmes must be updated.

The person in charge must ensure that persons under his control, who handle food, meet the standards and requirements of the regulations.

In addition to this requirement for training, the person in charge must demonstrate compliance with the regulations by keeping records of processing, production and distribution. These should be kept for at least 6 months after the shelf life of the product. One could argue that previously the only way one could show compliance was using records as proof, but now this requirement has been clearly stated.

A traceability system is now required and a recall procedure must be in place. A recall activation must be now be formally reported to the local inspector and the National Directorate: Food Control. No definition has been provided for recall but the definition of the CPA should be considered.

Duties of the food handler

There is now an additional requirement to wash hands after handling allergens to avoid cross contamination.


In general

The order of some of the regulations has been changed to flow more logically and the wording and formatting of the document is much more user friendly.

The additional Codex documents for the transport of bulk food and bottled water have been removed.

The temperature for storing heated products is now 60 degrees and perishable products have been reduced to 5 degrees.


When do the changes come into effect?

You have 12 months to become qualified and ensure your bulk milk tank is correct.

For the rest the implementation is immediate.





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