Transcript: Understanding the new Listeria rules

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Introduction, Dr Mairéad McCann, Safefood

Good morning, everyone, and welcome to today's webinar on the upcoming Listeria changes that are taking effect in July this year.

We are delighted to see such a strong interest in this important topic, and we hope you find today's session both informative and practical.

So, our first speaker this morning is Dr. Mary Lenahan, and Mary is Senior Technical Executive in the Biological Safety Team at the Food Safety Authority of Ireland. In this role, Mary provides technical guidance to food businesses and regulatory authorities on microbiological compliance, shelf life determination and risk assessment.

So this morning, Mary's presentation will outline the rationale behind the updated legislation, what is currently changing under the EU microbiological criteria, and what food businesses need to demonstrate compliance, or how they need to demonstrate compliance ahead of the July deadline this year.

And then our second speaker, Catherine Coady, is Regional Technical Director at Sofina Foods Europe, and here, Catherine leads the food safety team, quality systems and regulatory compliance across multiple sites in Ireland.

Catherine's talk this morning will guide us through how Listeria monocytogenes is managed within her organisation, how they're preparing for the upcoming changes, along with practical insights for food businesses. So, as Tracy said, we'll begin with Mary's presentation, followed by Catherine, then we'll move into a Q&A session, where Tracy has already mentioned that Kevin Connolly from the Food Standards Agency has kindly agreed to join to answer any specific questions from Northern Ireland food businesses.

Thank you for that, Kevin, and as Tracy also mentioned, if you have any questions throughout the talks, please pop them into the Q&A box that you can see at the bottom of your screen. So I'll hand over to Mary now to get started. Thank you.

Amendment to L. monocytogenes criterion on Food Cat. 1.2, Reg. 2073/2005, Dr Mary Lenehan, FSAI

Overview

Thank you. So good morning, everybody, thank you for joining us today. So I'm going to cover the amendment to the legislation and what it really means for food businesses.

So today, I thought I'd cover what Listeria monocytogenes is, and why it's important that we control this pathogen in ready-to-eat products.

I'm going to cover the legislation and the new amendment, what the current legislation is, what will change and why, what will be the impact for food businesses, and how can they comply, and then we'll go through some of the shelf life studies that are listed under Annex 2 of the legislation, Regulation 2073, where the Listeria microbiological criteria are. And we'll finish up with some information and resources.

What is Listeria monocytogenes?

Listeriosis is an infection that's caused by the pathogen Listeria monocytogenes. It's usually acquired by eating contaminated food.

It is readily killed by thorough cooking.

Usually, infection with Listeria monocytogenes is quite rare, but the reason we're so concerned about Listeria monocytogenes and Listeriosis is there's a very high case fatality rate, and the symptoms can be very severe for those people that do get sick.

On average, in Ireland, we would have between 14 to 22 cases a year. But as I said, people who are in what is considered to be the vulnerable groups – so older adults who are greater than 65 years old, people who have weakened immune systems, for example, people maybe who are living with cancer, and pregnant women – are particularly vulnerable to this pathogen and are more likely to experience more severe symptoms.

There is a lot of information about Listeria monocytogenes on our own website, on the Food Safety Authority of Ireland's website.

And the European Food Safety Authority also have a lovely Listeria monocytogenes story map that really explains it, and this image has come from that. And those links will be sent with the feedback form after the webinar.

Sources of L. monocytogenes

Okay, so Listeria monocytogenes is also a pathogen that's just widely present in the environment, so it's very difficult to control – particularly if it gets into a food processing factory, it can be endemic in that factory and very difficult to eradicate.

Usually, food gets contaminated either from raw materials, or it could be present in food that's already cooked as a result of post-process contamination, or if that food is not heated properly.

Listeria monocytogenes, in particular, grows very slowly at refrigeration temperatures. It survives really well in cold environments.

And it's those conditions that you normally find in food processing factories that are ideal for it to grow and survive.

Chilled, ready-to-eat food is more likely to be contaminated, and we have some examples here on the slide – so things like sandwiches, salads, deli meats, soft cheeses, coleslaw.

Symptoms and vulnerable groups

The illness causes two different types of illness – a non-invasive Listeriosis and an invasive Listeriosis.

For some people, they may actually be asymptomatic and not experience any symptoms, or some very mild symptoms. So they might experience a very mild flu-like symptom with some kind of persistent fever, some aches and pains.

For some people, that might also be accompanied by gastrointestinal symptoms, so vomiting and diarrhoea.

But for some people in the vulnerable groups, they are more likely to experience the invasive type of Listeriosis, and that usually has a longer incubation period. So people – as I mentioned, older adults in particular, pregnant women, people with diabetes or cancer patients, people who are undergoing certain treatments for different illnesses, pregnant women and their newborn or unborn infants – for those people, they're more likely to experience more severe symptoms, so things like meningitis, septicaemia, and in some very rare cases, potentially, it can be fatal.

For pregnant women in particular, they may experience premature labour, or be at risk of miscarriage or meningitis in the newborn. So it's quite a nasty illness, really.

2023/24 EU trends in Zoonoses

So I wanted to show you some of the trends for Listeriosis in Europe, and this comes from – every year, there's an annual report published by the European Food Safety Authority, EFSA, and the European Centre for Disease Prevention and Control, ECDC. And they produce this joint One Health report, usually towards the end of every calendar year, and it gathers the data from all of the member states across the European Union, where they do testing for official control samples for food, but also they look at the human cases, and they bring that information all together in a nice report.

And looking at that, you can see the trends for Listeriosis over 2023. 2024 is the most recent report, so the 2025 report will be published later this year. And you can see – Listeriosis is the fifth most common infection that's causing foodborne illness.

But you can see highlighted here what I really wanted to show you – in 2023, and then comparing it to 2024, Listeriosis cases are increasing. And in particular, if you note the number of hospitalisations is increasing, so it's becoming more severe.

So, for 1,551 patients that they had information on, there were 1,497 hospitalised in 2023, compared to just over 1,700 they had information from, and 1,715 were hospitalised in that case. So you can see it's quite a high hospitalisation rate.

In addition, there's a very high fatality rate, which again is increasing. So in 2023, there were 335 deaths.

So we had a slight decrease there in 2024, but in terms of outbreaks, we had an increase.

And we had 19 outbreaks and 133 cases in 2023, which resulted in 83 hospitalisations and 11 fatalities.

In 2024, 38 outbreaks, 210 cases, 149 of those were hospitalised, and 17 fatalities. So you can then see that the incidence of Listeriosis is increasing.

Pattern of Listeriosis in Ireland

Looking at the pattern in Ireland, we're quite steady at around 22 cases a year. It's not the pathogen that causes the most illnesses – that would be Campylobacter, followed by Shiga toxin-producing E. coli – so our data is similar to the European trends.

And we're averaging at around 16 cases a year.

But we would expect, potentially, in the future, there may be more cases in Ireland and across Europe. And really looking at the age profile – you know, as health and quality of life is improving, people are living well into their 80s and 90s with good health.

You can see here that in the last 10 years, we have had an increase in Ireland of the number of people who are living to over 65.

And this is set to continue well into 2057. And in particular, what I wanted to highlight here was that the number of people who are living beyond around 80 years and older is set to really increase as time goes on. And really, I know over 65 is a vulnerable group, but particularly when people get to over 75, they're particularly vulnerable to Listeriosis.

So the trend means that there's going to be a larger cohort of people that are potentially more vulnerable to Listeriosis from the food that they eat.

Commission Regulation (EU) 2024/2895 amending Reg. 2073 as regards L. monocytogenes

So, for that reason, it's important that the risk of Listeria monocytogenes contamination in ready-to-eat food is controlled and managed to prevent people becoming sick and to protect public health.

And this brings me to the reason why the European Commission has introduced this amendment. So, Commission Regulation 2024/2895, is amending the legislation in Regulation 2073, as regards Listeria monocytogenes.

I just wanted to bring you back to the legislation that's currently there.

And the legislation for Listeria monocytogenes – the microbiological criteria – is set out in Chapter 1 of Regulation 2073 of 2005.

It has three different microbiological criteria for Listeria monocytogenes.

The first, Category 1.1, is for infants and for foods for special medical purposes, and there's much more stringent criteria there. You have to take 10 samples, and Listeria is not allowed to be in any of those.

Category 1.3 is for foods that are considered not able to support the growth of Listeria monocytogenes. So these are foods that have a shelf life of four days or less, or have a low pH or a low water activity, or if there's some other reason – like, for example, if it's a frozen product.

What I really want to draw your attention to is Category 1.2.

And this is for Listeria monocytogenes in ready-to-eat food that is able to support the growth of Listeria monocytogenes. And this is where the amendment will take place. So, looking at the current legislation, this criteria is unusual in that it kind of has two sub-criteria in there. You can refer to them as Category 1.2A, for which the limit is 100 CFU per gram, and 1.2B – not detected in 25 grams.

The reason there are two different limits is that there are two different methods associated with those.

For the 100 CFU per gram limit, the method that's used is the enumeration method, and this is a less sensitive method when testing for Listeria monocytogenes.

The food sample is taken and put into a diluent, and it is put on special chromogenic agar, and the laboratory are able to count how many Listeria are actually in that sample.

When it comes to the detection method, the sample is actually put into a special buffer, and this buffer helps the Listeria monocytogenes, if it's present, to recover and start growing to a level that the lab is able to detect if it's there or not. So for that reason, the first method is a quantitative method, but the second method is a qualitative method. So it will give you a detected or not detected result.

For food businesses that are able to show that Listeria monocytogenes – if it was in their product – might grow, but it won't grow beyond 100 CFU per gram throughout the shelf life of their products, as written in footnotes 5 and 7, they can comply with this 100 CFU per gram for products placed on the market during their shelf life.

Currently, in the legislation, that not detected in 25 grams limit ends – in the legislation, it says – before the food has left the immediate control of the food business operator who has produced it. But essentially, what that means is at the end of manufacturing.

So basically, for food businesses – in accordance with footnote 7 – that are not able to show that if Listeria monocytogenes is in their food it won't grow beyond 100 CFU per gram, they can comply with this more stringent limit.

But that limit currently finishes at the end of manufacturing, so it means there's a legislative gap there. So for these foods, when they're on the market, the criteria defaults back to 100 CFU per gram, which is less sensitive.

So currently, if a food is found to have Listeria monocytogenes detected in it when it's placed on the market, because there is no criteria to assess that result, the risk is assessed under Article 14 for unsafe food in General Food Law Regulation 178 of 2002.

Legislative amendment to food category 1.2

So this amendment has been introduced really to plug that gap. The consultation period for this amendment was way back, between April and May of 2024, and industry groups and food businesses and regulators were given a month to give their comments on the introduction of this amendment.

The Commission took into consideration those consultation periods and the comments they received, and then the final amendment was published on the 20th of November 2024.

The Commission allowed an 18-month transitional period for food businesses to allow them sufficient time to adapt their practices and procedures to implement the new legislative requirement. So we're currently in that transitional period now, and that's set to end soon. There is an implementation date for this legislation on the 1st of July 2026.

And as I said, it will be applicable to that not detected in 25 grams criteria in food Category 1.2.

What will change?

So basically a very small change, really, at the end of the day. The wording "before the food has left the immediate control of the food business operator that has produced it" will be substituted with the wording "products placed on the market during their shelf life."

And the associated footnotes will still be there – footnotes 5 and 7 – around showing that if Listeria is in your product, how it will grow.

Why?

As I already mentioned, the reason that this amendment has been introduced is to plug that regulatory gap.

So currently, that 100 CFU per gram limit only applies when the food business operator can show how Listeria would grow in their product, and that it wouldn't grow beyond 100 CFU per gram throughout their products during the shelf life.

So, at the moment, there's no limit, actually, where a food business can't show that Listeria monocytogenes won't grow beyond 100 CFU per gram when that product is placed on the market.

So the reason the Commission has introduced this legislation, as I said, is to close the gap, but more importantly, it's to ensure consistent control of Listeria monocytogenes across the entire chain.

What changes from 1 July 2026?

So, from the 1st of July, the qualitative, more sensitive detection method will be used to test those Category 1.2 foods when the food business is unable to show that the Listeria monocytogenes in that product won't grow beyond 100 CFU per gram throughout its shelf life.

And these will apply to products placed on the market – so when they're tested at manufacturing, but also at wholesale, retail, and import control.

I suppose one of the big changes – currently in the Republic of Ireland, if official control samples for Listeria monocytogenes are taken for ready-to-eat foods, they are tested using the enumeration method, because there's no criteria to assess that result, unless there's some reason – for example, if we thought it was associated with an outbreak.

So currently we use the enumeration method. From the 1st of July, those official samples will be tested using the detection method, and that result will be assessed for compliance against the new criterion limit that's extended to the end of shelf life.

If Listeria monocytogenes is found on those products, we will contact the food business and see if they have evidence to show that it won't grow beyond 100 CFU per gram throughout the shelf life, in accordance with footnotes 5 and 7. And if they're unable to show that, those results will be designated as unsatisfactory, and there will be appropriate risk management action taken.

While I know the introduction of this amendment will seem to be a little bit controversial to some food businesses, really it's clarifying a change – or a requirement – that was already there, particularly in the footnotes. So currently, food businesses, according to footnotes 5 and 7, could only comply with this 100 CFU per gram if they were able to show that Listeria monocytogenes would not grow beyond 100 CFU per gram during the shelf life.

So, at the moment, if Listeria monocytogenes is found in a product that's placed on the market using the detection method, that gap is risk assessed using Article 14 of Regulation 178.

But I think for the future, you know, it'll be clearer to food businesses to understand what the criteria is, and that both of them go to the same stage.

Impact of the legislation change on food businesses

So, I suppose for food businesses after the 1st of July, the implications for them – food businesses can still continue to use that not detected in 25 grams criteria to assess compliance when they're testing their foods at the end of manufacturing, which is what a lot of food businesses that fall into Category 1.2 are doing currently anyway.

But it should be noted for official control samples – and maybe if you are supplying customers and you have some kind of customer specifications where there are agreements about testing – that not detected in 25 grams limit will also apply beyond the manufacturing level.

We may see some non-compliance for some food businesses if they don't have robust control programmes in place to control the risk of Listeria monocytogenes contamination in their ready-to-eat foods. And Catherine is going to speak a little bit from the food industry perspective and some of the things that they do in their food businesses to control this risk.

But I think in terms of public health overall, it will be a better outcome for consumers in terms of controlling that Listeriosis risk. And in particular, we can see the age profile of the population is set to increase. So, you know, it's important that we protect our consumers.

Challenges

I just wanted to talk a little bit about the challenges that some food businesses face, and we can understand that for a lot of food businesses, there's a lot of food legislation, food safety legislation – it can be very overwhelming. But I would like to remind food businesses that it is their responsibility to produce safe food, under Regulation 178.

For some small to medium-sized food businesses, they might struggle to understand or comply with the legislation for Listeria monocytogenes, and they may also have limited resources, or staff, or floor space, maybe some limited funds.

Key message

But the key message I would like you to take away today is that while the food business operator might be small, the risk of Listeria monocytogenes to your operation and to public health can be large. It's really important as a food business that you understand the risk profile for the ready-to-eat food that you produce.

You know, understanding its physicochemical characteristics, such as its pH and water activity, understanding your process, understanding whether the type of food that you produce has been linked to outbreaks in the past for Listeriosis.

And really, while the operation might differ and the level of technical knowledge might differ etc., the principles of implementing a good food safety management system remain the same. And it's up to the food business to tailor the situation to your own business and your own operation, and what will work for you.

What can food businesses do to ensure compliance?

So what can food businesses do to ensure compliance? And I see a lot of the time it's really the basics that are keeping that Listeria monocytogenes risk under control. So, it is critical to implement a robust supplier control programme, and a Listeria monocytogenes environmental monitoring programme, and really acting – if you find Listeria monocytogenes in your products or in your environment – that you have corrective actions already laid out, and you follow those, and you get to the root cause of that problem.

I would advise for businesses to spend – and they might have limited funds – but to spend those wisely. Really have a solid prerequisite programme and HACCP-based procedures. So really have a strong food safety management system – good staff training, a good hygiene programme, a good environmental monitoring programme, knowing the risk that may potentially be associated with raw materials.

And really just understanding the characteristics of your product, and how Listeria monocytogenes might grow in your product if it gets in there. And you can do that by following the studies in Annex 2 of Regulation 2073.

Annex II – Spend resources wisely

So in 2073, there are five different shelf life studies listed, but I would see them as kind of a Part A and a Part B. So 1 and 2 fall into Part A, and these are things that every food business must do.

Part B, which is 3, 4, and 5 – on the next slide – these are things that food businesses might do if they feel they're necessary, but they're not obliged to do them.

So the things that you must do is really understanding your product – characterising your product in terms of its physicochemical characteristics, so its pH, its water activity, you might use salt in there, you might use preservatives. These are the types of things that you'll probably already have listed in your specification.

It should be relatively inexpensive for you to gather that information and file it all together to get a good view of what your product is. And particularly, it's important that you build up a profile about the variability of that product. So, you know, maybe taking a pH of every batch – you could buy your own pH meter, once you train the staff to use that properly, and make sure that it's calibrated.

And you kind of build up a profile, so you have an idea of what the variability is in your process, in your product. And then using that worst-case scenario, you might use that for some of the studies, like predictive microbiology, on the next slide.

Then secondly, looking at the scientific literature and the research data, and maybe data about foodborne outbreaks for Listeriosis, and understanding the risk profile for the product that you're producing.

So, you know, is it likely that Listeria monocytogenes will grow in your product? Has there been similar products involved in Listeriosis cases previously?

And one thing I would say – if you're looking at other products on the market, particularly in terms of how long the shelf life is on those products, make sure you're comparing like with like.

So, you know, you might have a product that you pack in air, but your competitor packs it in modified atmosphere packaging, and they're getting a longer shelf life, or you're using a preservative and they're not using a preservative in their product.

So these are the two steps that really every food business must gather.

And you'll be doing this anyway – you should be doing it anyway – for developing your shelf life studies.

And then we have these three other studies that, again, food businesses don't have to do them, but you may choose to do some of them, depending on your product and your process.

In particular, I think predictive microbiology is something that we're seeing a bit more food businesses turning to. There are a few tools available, and as a competent authority, we don't have a preference for the tool that you use, once you know how to use it properly, or if you're using a consultant, that they know how to use it properly.

So if we are presented with a predictive microbiology study to evaluate, we'll be looking at the tool used, and if that tool was used properly – what were the input values, how was that result interpreted, was that result interpretation justified based on the information that you put in?

So I would say, if you are looking to do some work using predictive microbiology, you need to be competent and understand how to use that tool, or if you're outsourcing that work to a third party, ensure that they are competent and understand how to use that tool.

Some of the information that you've gathered from Steps 1 and 2 will feed into that if you're going to do predictive microbiology, particularly around the physicochemical characteristics.

Study 4 is basically a challenge test. That's basically where you deliberately inoculate a strain that's relevant for your food product, or a combination of strains, into your food products, and it is held at different temperature profiles to reflect reasonably foreseeable conditions of distribution, storage, and use. And you see how that Listeria monocytogenes might grow over that shelf life that you've assigned to that product, and will it grow beyond 100 CFU per gram?

The laboratories that do that are very specialised.

In the Republic of Ireland, we don't have any laboratories that are currently offering this service. There are some commercial laboratories in Britain, and also in mainland Europe.

Food businesses are not obliged to carry this out, but they may choose to do it because the type of product that they have – maybe there are some problems they can't get control over with Listeria monocytogenes contamination in that product, and they want to show that if Listeria monocytogenes is in that, it won't grow beyond 100 CFU per gram. So really, it's a business decision for the food business about whether they get that done or not. But I would say, maybe try doing predictive microbiology first to see if it's worth going to this. And for some food products, there is no point in spending money and getting a challenge test done, because it's just going to show you what you already know from Steps 1 and 2, and probably from Step 3, that Listeria monocytogenes will grow in that product.

And then lastly, we have durability studies.

Durability studies is where – if you had a naturally occurring contamination with Listeria monocytogenes in your product – again, that could be stored over reasonably foreseeable conditions of distribution, storage, and use to see how that Listeria will grow in your product.

Again, you'd have to work with a lab that's competent in carrying out the study, and would be able to help you interpret the results.

One thing for durability studies – they're more suitable for verification, and the reason for that is because the distribution of bacteria is not uniform.

Sometimes you might do a lot of testing and actually not find Listeria monocytogenes in your product. So you need to do a lot of testing to find a product that has Listeria monocytogenes in it, and then you need to have a laboratory set up and ready to go, because the logistics of actually carrying out the study can be quite complicated.

For both the challenge tests and the durability studies, the European Union Reference Laboratory for Listeria monocytogenes has a document where they specify the protocol that is to be carried out for both of those studies, and that will be used by the competent authority when assessing any studies that are provided to us as evidence that Listeria monocytogenes won't grow beyond 100 CFU per gram.

How to manage risk for ready-to-eat food that supports Listeria monocytogenes growth

So, for food businesses – if you have a product that Listeria monocytogenes might occasionally be on, and you know that it might grow beyond 100 CFU per gram – what can you do?

Firstly, I suppose, focus on the basic principles about not letting that product get contaminated with Listeria monocytogenes in the first place.

So, making sure that you tick all the basics and get those right – your hygiene programme, cleaning and disinfection, that that will remove it. Don't let it establish itself through poor fabric or equipment, or poor hygiene design.

Implement robust supplier controls, have a good hygiene programme, staff training, and an environmental and food sampling programme.

Act immediately if you find Listeria monocytogenes in either a raw material, an end product, or the environment. So root cause analysis and risk management is critical.

And then just to highlight – if you have Listeria monocytogenes in a product and it's not at retail level, it may be suitable for further processing to remove that Listeria monocytogenes risk.

And Article 7 of Regulation 2073 permits that, once it's authorised by the competent authority. So you might be able to heat treat it and make it into a new product, for example.

Other longer-term options

Longer-term options include maybe reformulating the product – you might be able to reduce the pH, or maybe use some kind of preservative, or reduce the water activity, and that would lower the probability for growth.

Make sure that the cold chain is maintained to at least less than 5 degrees Celsius, which is the best practice temperature. So, while Listeria monocytogenes will grow slowly at refrigeration temperatures, the lower the temperature, the less it will grow.

You could implement what's known as a multiple hurdle approach – so maybe, depending on your recipe, you can't drop the pH right down or the water activity right down, but maybe you could use a combination of those things that will reduce the growth, plus maybe storage at 4 degrees Celsius while it's under the FBO's control.

For some businesses, potentially it's suitable to reduce the shelf life to four days or less, and that would drop you into Category 1.3, and you'd be complying with the less stringent limit of 100 CFU per gram.

Or maybe you could reduce the shelf life slightly and combine it with that multiple hurdle approach, so basically lowering the impact if Listeria monocytogenes was in your product, and the potential for growth.

Information and resources

So, finishing up now, just with some information and resources.

So I was on the working group that worked at the European Commission and the European Reference Laboratory to write quite a comprehensive document. It's a guidance document for food businesses, but also official authorities can use it, and also third parties – maybe consultants, laboratories.

And it goes through in much more detail what I covered today, and why the amendment was introduced, and what food businesses can do to comply, and how they can understand the Listeria monocytogenes risk profile for their food.

FSAI recently published Guidance Note 45. And this is showing you how to implement a robust environmental monitoring programme in your facility, and what corrective actions to take if you find Listeria monocytogenes in your product.

And Catherine, who's joining me after this talk, was one of the food industry people that fed into this document – so we had a big working group that wrote this document. And I think it's quite a nice resource.

The European Reference Laboratory for Listeria monocytogenes on their website have a lot of different resources, so I'd recommend going to that website and having a look. And in particular, they have some nice videos showing how to take swabs for Listeria monocytogenes. And then I thought I'd just mention Guidance Note 44, which is our one on food safety culture, because I think that also really feeds into ticking the basics and the prerequisite requirements, the HACCP-based procedures, and having a food safety culture that really makes sure that the staff understand the risk of Listeria monocytogenes, and why the procedures are in place, and why they need to follow them.

And then, of course, Safefood and FSAI always have different webinars and things that you might be interested in, so if you subscribe to the updates, you'll see those coming up.

And then lastly, the Food Safety Authority of Ireland have a learning portal, and you can get there by the QR link.

And this has a lot of different resources, a lot of different e-learnings and webinars, and if you haven't been on it, I'd recommend that you join up to it.

Summary

So, in summary, all food businesses are responsible for producing safe food, and while the size of the operation, the level of technical knowledge, etc. might vary, the principles of the food safety management system are the same, and the operation should tailor the plan to their own situation.

Spend the resources wisely to address the Listeria monocytogenes risk, and really build on those as the years go on.

Make sure you have the basics right – good supplier control programme, good hygiene programme, good staff training, and a Listeria monocytogenes environmental monitoring programme, etc.

Understand your product and what the risk profile is, and how Listeria monocytogenes might grow in your product by following those studies in the legislation. And then, I suppose, just continuously improving and striving to build on existing knowledge to manage and control the risk over the long term.

And maybe look at some of the more long-term options you might be able to take for your product.

Okay, so that's me finished, so I am going to hand over to Catherine.