This article is written to meet the following sections of the Standards:

BRCGS Food Safety Issue 88. High-risk, high-care and ambient high-care production risk zones
BRCGS Packaging Issue 6Not applicable
BRCGS Agents & Brokers Issue 3Not applicable
BRCGS Storage & Distribution Issue 4Not applicable
FSSC22000 Version 5.1No specific clauses
IFS Food Version 74.8.3 Product safety areas
SQF Edition 911.7.1 High-risk processes

Why the BRCGS guidance doesn’t make any sense

Let’s take a simple example, of fresh pasteurised milk. The milk comes in raw, is pasteurised and then is filled into bottles. The packing process is typically enclosed, but the milk is open to the environment for a short space of time  – after filling and before the lid is put on.

Is fresh pasteurised milk high-care?

The BRCGS guideline for understanding high-risk, high-care and ambient high-care on page 28, for pasteurised dairy products – clearly states that fresh pasteurised milk is high-care. However, let’s put it to the test and answer the following questions to see what result we get:

Question 1: Is the product ambient, chilled or frozen?
Answer: Chilled.

Question 2: Is the product open to the environment?
Answer: This is questionable, but let’s say it is, for the sake of this example – that it’s open. We’ll cover enclosed after.

Question 3: Does the product support pathogenic growth?
Answer: Yes, it does.

Question 4: Is the product fully cooked prior to eating?
Answer: No – it’s ready-to-eat.

Question 5: Has the product been heat treated to 70°C for 2 minutes?
Answer: Yes – of course it has, it’s pasteurised.

The result: Fresh pasteurised milk is high-risk.

Decision Tree Example

Click the image to enlarge.

So, the result that’s been returned is that milk isn’t high-care at all. Let’s now answer question 2 on the decision tree as ‘No’ – that the product isn’t open to the environment. BRCGS even give milk in pipework as an example. This means that result is fresh pasteurised milk is enclosed product. This means we’ve gone from a result of high-risk to one that is enclosed product – which seems wrong, so it leaves us thinking that maybe it should be low-risk!

It makes no sense

You can see how a simple product like milk can be complicated. You can manipulate the information to give you the result you want. It makes no sense, and therefore it doesn’t add any value.

What’s the point of high-risk and high-care?

The aim of both of these facilities is to prevent pathogenic cross-contamination. The reason that this is important, is that products in these areas will support pathogenic survival and growth. Which ultimately means, that contamination could result in food poisoning of the consumer.

So, the question is – what’s the difference between high-risk products and high-care products?

High-risk standards

The BRCGS Standard for high-risk and high-care is very similar, but there are a few additional requirements for high-care. From this, we can determine that high-risk products are at greater risk of contamination than high-care products. So now, an understanding is needed of why high-risk, is a higher risk than high-care.

Why are high-risk products riskier?

To do this, let’s look at what differentiates them in the BRCGS decision tree:

QuestionHigh-riskHigh-care
1. Storage conditionsChilled or frozenChilled or frozen
2. Is the product open to the environment?YesYes
3. Does the product support pathogenic growth?YesYes
4. Are the products ready-to-cook?NoNo
5. Have all the materials undergone a treatment which is equivalent to 70°C for 2 minutes?YesNo

So, it’s the treatment described in question 5 that separates high-risk from high-care. If all the materials in the product have undergone a treatment equivalent to 70°C for 2 minutes (6 log reduction in Listeria mono) then the product is high-risk. If not, it’s high-care.

More confusion

However, looking at the BRCGS Guidance document again: Appendix 2 – example products and typical production zones: 8. Cooked meat/fish products (on page 29), it confuses matters again. As it says that if preservatives are added to cooked meat, then they’re high-care and not high-risk. The decision tree doesn’t mention this. So, there’s no reason as to why BRCGS has decided to apply the high-care principle.

Why does the treatment change the risk?

Let’s look at why question 5 determines if the product is high-risk or high-care.

Let’s take two similar products, one which would be defined as high-risk and one that would be defined at high-care.

Ready-to-heat product 1Ready-to-heat product 2
A plain cooked piece of salmon.A cooked piece of salmon, topped with a red pesto.

 

Product 1: Has undergone heat treatment equivalent to 70°C for 2 minutes. Therefore, this product is high-risk.

Product 2: Has undergone the same heat treatment, but the red pesto on top hasn’t. Therefore, this product is high-care.

Question: Why is product 1 more at risk of causing food poisoning than product 2?

In theory, because product 2 with red pesto hasn’t gone through a treatment which is equivalent to a 6 log reduction, this product is more likely to cause food poisoning.

You could argue that the high-risk product is more sterile, so the expiry would be longer and therefore, it’s important that it doesn’t get contaminated. However, surely that would be the case for the high-care product too – that if it was to get contaminated it could cause food poisoning within the shelf life.

In fact, the microbial load of the high-care product would more than likely be higher in the first place (because the pesto isn’t 6 log treated), and therefore it’s more important to stop it from becoming even more contaminated and reaching a level which would cause food poisoning.

So, in conclusion, there doesn’t seem to be a reason why high-risk is riskier than high-care.

How to work out if your product is high-risk or high-care

Given what we’ve already said, our advice would be – that if your product is chilled or frozen, expect it to be high-risk as default. Then work back from there.

You’ll then need to think about your justification as to why your product should be high-care and not high-risk. And if you think that your product shouldn’t even be high-care, then your justification needs to be even more rigorous. Your justification needs to establish the following aspects.

  • Is the product at risk of pathogenic contamination? If so, which pathogen(s) and why?
  • If the product was to become contaminated by the pathogens you’ve defined, would they survive and would the product support growth? This question should be the key driver. The lower the risk of growth, the more justified the reasoning is to opt for high-care over high-risk. However, what’s the point at which the risk switches from one to the other – there’s no guidance or reasoning for this.
  • All of the materials that are used to make up the product in the area must be treated. It’s essential that all materials that go into the area are free from pathogenic contamination. This must be at least a 2 log reduction, but ideally the equivalent of a 6 log reduction in Listeria monocytogenes. The auditor will want to see the validation of the treatments used as it’s a key aspect of how BRCGS define whether something is high-risk or high-care.
  • Although, how sterile the material is – to some degree is not important, as the shelf life of the product will have been validated based on this level of contamination. And also tested to prove that the environment in which it was produced, is acceptable.
  • Your justification for high-care then has to be made and if all of your materials in your product are treated to a 6 log reduction, then your case needs to be why growth won’t occur during the shelf life. For example, because of the short shelf life or the addition of shelf life extenders.

Justifying your risk rating

Gather all that information and then justify your reasoning for the risk rating that you’ve decided on. Add as much evidence and historical data as possible.

Please note, that even though you’ve done this – it doesn’t mean that you won’t get a non-conformance if your auditor doesn’t agree. Because the Standard is so confusing and the information can be manipulated to get a range of results, this means your auditor has the ammunition that they need to give you a non-conformance. So be prepared for this and be prepared for a fight!

Do you want to know our view?

In our opinion it doesn’t need to be this complicated. The only difference between the Standard for high-risk and high-care is that you have to have positive air pressure and filtration in high-risk. And anything going into high-risk has to have undergone the equivalent of a 6 log Listeria mono reduction.

Although having positive air pressure and filtration has its costs implications, it doesn’t seem worth the hassle of arguing whether high-risk or high-care is the right risk rating. And for us, good practice would be to have the right level of air filtration in place anyway. The level of filtration can be determined by risk, so that the right solution is applied.

It’s our view that this is just another example of BRCGS making things more complicated than they need to be. And this view (in our opinion) would seem to be aligned with our view when you look at the retailer standards. As they state that the standards for managing high-risk and high-care areas are the same.

The most important aspect is segregating contaminated product with decontaminated product, to reduce the risk of cross-contamination. We’re not sure why it has to be any more complicated than that.

BRCGS definition of high-risk and high-care areas

The BRCGS state that the difference between these areas is:

  • The aim of a high-risk area is to prevent the risk of pathogenic contamination.
  • The aim of a high-care area is to minimise the risk of pathogenic contamination.

So – basically, you can contaminate products in the high-care area with small amounts of pathogens. But you must not do this to product in high-risk areas. That makes sense – NOT!

Definition of a high-risk product

The UK Food Standards Agency states:

“Products may be considered high-risk if they contain, for example, contaminants such as mycotoxins, pesticides, salmonella.”

Therefore, a high-risk product is one which is known to contain a contaminant which has the potential to cause harm.

However, the BRCGS definition of a high-risk product is:

“A chilled or frozen ready-to-eat/ready-to-heat product or food where there is a high-risk of growth of pathogenic micro-organisms.” – BRCGS Food Safety Issue 8

You can see here, BRCGS are talking about the product after treatment. Whereas the FSA are referring to the product before treatment. Very confusing!

Definition of a high-care product

The BRCGS state that a high-care product is:

“A product that requires chilling or freezing during storage, is vulnerable to the growth of pathogens, has received a process to reduce microbiological contamination to safe levels (typically 1-2 log reduction) and is ready to eat or heat.” – BRCGS Food Safety Issue 8

So, again this supports the theory that what happens to the product before it goes into the area – is what defines whether it’s high-risk or high-care. A greater log reduction (6 log) would be high-risk and a lower log reduction is high-care. Why, this makes a difference to how much contamination the product can withstand when the product is actually in the area – we’re not sure.

Ambient high-care

To confuse matters even further we also have the term ‘ambient high-care’. This is basically a high-care product that doesn’t have to be stored in a chilled or frozen environment.

This was added into the BRCGS Standard in Issue 7, as a response to pathogenic contamination of ambient products, such as chocolate. However, because these products are ambient stored, they didn’t fit into the existing high-risk and high-care definitions. So, a new category of ambient high-care was introduced.

Time for change?

Looking back through the old versions of the BRC Food Standard, it looks like the term high-care was introduced in 2005. Perhaps 17 years on it might be time to review the need for high-care and ambient high-care. Wouldn’t it be simpler and less confusing if there was only high-risk and low-risk? We’d happily update our compliance documentation pack for you in a heartbeat!

As always, we’d love to know your thoughts on this subject, just leave us a comment below.

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Have your say…

8 thoughts on “Is your product high-risk, high-care or ambient high-care?

  1. There is a difference between high risk/care AREAS and the foods themselves.

    In production zone standards the word ‘risk’ refers to that presented BY the production AREA to the food, not the food itself.

    A RTE/RTRH food that is fully cooked (min 70/2) but not processed in-pack needs to be handled post-process under particularly rigorous hygiene conditions to protect it from environmental contamination, ie HRA.

    RTE/RTRH food with a raw component has not been treated to 70/2 throughout so is inherently at greater risk of carrying micro contamination. (Note that CFA guidelines require raw components such as produce to have undergone a decontamination process but this is not equiv to 6-log reduction of target organisms. More like 1-2 logs). High hygiene standards are of course required for handling open product, but it is recognised that the presence in the food of non-70/2 component(s) means that there is less benefit in applying full HRA conditions, hence HCA is appropriate.

    A non-RTE/RTRH food that is completely raw (all components <70/2) is inherently greater micro risk to a GMP standard production environment than vice versa.

    For something like pasteurised milk risk assessment of the area hygiene and duration of exposure to the environment post-pasteurisation would be appropriate to determine the hygiene area standard required.

    1. Hi Karin,
      Thanks for this – unfortunately your view of RTE/RTRH doesn’t align with high-risk and high-care. A sandwich is RTE but generally produced in a high-care area….
      What is the benefit in having different standards for high-risk and high-care areas, producing RTE products – in your view?
      Kassy

  2. A very interesting and useful article, Kassy, and it is very helpful to compare BRCGS with FSSC 22000 v5, for example. Your key question is “why make it so complicated and how does that help?” and I think it really is a good question to ask. With the definitions varying from one source to another (e.g. BRCGS from FSA), I can see that it really is time for a rethink. For example, I am also not sure how we class cut up fruit which is ready to eat, and salads?

    1. Hi Susan
      OK thanks – I’ll do that. I’ve not looked at FSSC – I had assumed (and you know what that does!) that FSSC wouldn’t give us much info, becuase it’s such an open and flexible standard.
      On your question about cut up fruit and salads – they would typically be high care.
      Kassy

  3. The risk issue also comes up in the BRC Agents & Brokers and Storage & Distribution Standards. This time it is what do you define as Low Risk? If your product is low risk you can get away without GFSI or site audits which is a big issue for some. I can’t find any criteria to help the definition, so it is a case of auditor interpretation against mine.

  4. Just to add a few thoughts to this:
    Regarding milk pasteurisation, this is high-care rather than high-risk. The answer to question 5 was incorrect, which is why the wrong conclusion was drawn. Milk has not been heat-treated to 70°C for 2 minutes. It has been heat-treated, but for less than this (typically 72.6°C for 15 seconds) which is why this would come up as high-care. The answer to question 5 would be no.

    There are some pretty significant differences between high-risk, high-care and ambient high-care.

    Ambient high-care is only 2 clauses (8.1.1 and 8.1.4), the rest of section 8 is not applicable.

    High-risk requires practices to minimise contamination during transfer (e.g. disinfection of materials on entry) where as high-care doesn’t. In fact high-care doesn’t actually need physical barriers at all and would be perfectly acceptable to have other risk based controls such as time or space segregation, as well as the other things you’ve mentioned.

    That said, I think it would be beneficial for the requirements of risk zoning to be made simpler and clearer and whilst I don’t think it should be just high-risk vs low-risk, I think there could be some benefit for the site to determine which risk based controls they need from section 8, depending on the product. Perhaps something like how BRCGS Packaging Materials (issue 6) now works with the risk-based deviations.

  5. I think it also adds complication as BRC specifies “Heat Treatment” to have 6 log reduction, however there are other technologies that can achieve this reduction with validation in place such as HPP.
    How would this work during an audit if you use ingredients that have been treated with validated 6 log reduction HPP step in High Risk production?

    Thank you

    1. Hi Reni
      In theory, if you can prove it through a 6-log validation it shouldn’t be a problem. However, an auditor would be sceptical, so your validation would have to be really robust.
      Kassy

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