This article is written to meet the following sections of the Standards:
|BRCGS Food Safety Issue 8||8. High-risk, high-care and ambient high-care production risk zones|
|BRCGS Packaging Issue 6||Not applicable|
|BRCGS Agents & Brokers Issue 3||Not applicable|
|BRCGS Storage & Distribution Issue 4||Not applicable|
|FSSC22000 Version 5.1||No specific clauses|
|IFS Food Version 7||4.8.3 Product safety areas|
|SQF Edition 9||11.7.1 High-risk processes|
- Why the BRCGS guidance doesn’t make any sense
- What’s the point of high-risk and high-care?
- Why does the treatment – change the risk?
- How to work out if your product is high-risk or high-care
- Do you want to know our view?
- BRCGS definition of high-risk and high-care areas
- Definition of a high-risk product
- Definition of a high-care product
- Ambient high-care
- Time for change?
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?
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.
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?
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:
|1. Storage conditions||Chilled or frozen||Chilled or frozen|
|2. Is the product open to the environment?||Yes||Yes|
|3. Does the product support pathogenic growth?||Yes||Yes|
|4. Are the products ready-to-cook?||No||No|
|5. Have all the materials undergone a treatment which is equivalent to 70°C for 2 minutes?||Yes||No|
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.
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.
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 1||Ready-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.
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.