Archives

Following the International Life Science Institute (ILSI) for Mesoamerica’s first webinar reviewing the different concepts and definitions regarding foods for special dietary uses (FSDU) and food supplements (FS), ILSI organised a second webinar (EN, ES) on Labelling and Claims of Foods for Special Dietary Uses and Food Supplements on 21 July.

ISDI Vice-President Xavier Lavigne presented the Codex framework for FSDU labelling and claims on behalf of ISDI (watch the full webinar below).

The panel was also composed of David Pineda (Managing Director, DPE International Consulting), a regulatory expert on food supplements, and Basil Mathioudakis (Consultant, Food Legislation and Nutrition, Basil Mathioudakis Consulting).

In December 2021, 7 years after ISDI asked JECFA – the Joint FAO/WHO Expert Committee on Food Additives – to evaluate the use of xanthan gum in formulas for special medical purposes for infants, its inclusion in the General Standard for Food Additives (GSFA) was finally adopted at the 44th session of the Codex Alimentarius Commission (CAC44).

We spoke to Dr Paul Hanlon Ph.D., DABT, Director of Regulatory Affairs at Abbott Nutrition and Chair of the ISDI Food Safety and Food Additives Working Groups about how it happened and why it matters.

When did the whole xanthan gum story start and why?

Standard infant formulas rely on intact proteins from high quality sources such as milk or soy. Unfortunately, some infants are born with conditions such as allergies to intact proteins that make them unable to consume these products. For these infants, infant formulas produced with hydrolysed proteins are an option, but only if those products can be manufactured in a manner that ensures the consistent delivery of the nutrition that infants need. The nature of hydrolysed proteins results in products that cannot maintain homogeneity during standard storage and use conditions without the help of food additives.

Several food additives have been demonstrated to be able to achieve the technological effect of maintaining the homogeneity of infant formula products that rely on hydrolysed protein. The effectivity of different additives in a product is influenced by many factors specific to a product, including the product format, manufacturing conditions, and the formulation. In some products, xanthan gum has been demonstrated to perform better than other available additives in maintaining the homogeneity of these products.

While xanthan gum has been approved for use in countries for many years and has been used in marketed infant formula FSMP products in many countries, xanthan gum had not been authorised for use in infant formula by Codex until 2021.

What about the safety assessment of xanthan gum? How did that happen and what were the results?

One of the foundations of Codex is creating food standards focused on ensuring the safety of food, and this is an element that is applied to the consideration of all food additives. JECFA, the scientific risk assessment body for Codex, conducts a safety evaluation of all food additives prior to their authorisation. The JECFA safety evaluation considers everything about the additive, including how it is manufactured, what products it will be used in, the concentration it is used in those products and which individuals consume those products.

For xanthan gum, the JECFA safety assessment considered that this additive was going to be in products intended for consumption by infants, including those under 16 weeks of age. Infants of this age have been identified as an especially sensitive population, and because of that the safety of this additive was supported by data that is typically not included in safety assessments of additives used only in non-infant products, such as a study conducted in new-born piglets, as well as outcomes from clinical studies in human infants.

After reviewing all of the data for xanthan gum, JECFA concluded at their 82nd meeting in 2016 that “the consumption of xanthan gum in infant formula or formula for special medical purposes intended for infants is of no safety concern at the maximum proposed use level of 1000 mg/L.”

From there, how did the discussions start in CCNFSDU?

The conclusions from the JECFA safety assessment were published in June 2016. In December that year, the positive outcome of the JECFA safety assessment was raised at the CCNFSDU meeting, and ISDI submitted a Conference Room Document (CRD) in advance of the meeting providing the technological justification for the use of this additive in specific infant formula products.

At the 2016 CCNFSDU meeting, the committee determined that there had not been enough time for Codex members to consider the technological justification provided by ISDI. Furthermore, the committee agreed that it would be beneficial to develop a more structured framework for judging whether an additive met the criteria for technological need. CCNFSDU therefore set up a working group to develop this new framework, and xanthan gum was identified as one of the additives that would be used to pilot these criteria.

What was the appraisal process for evaluating the technological need of xanthan gum in infant formula and FSMPs?

The evaluation of the technological need for xanthan gum evolved as the CCNFSDU working group developed the criteria. That work started in the summer of 2017, when the first draft of the criteria was circulated for comment. The criteria were refined over several rounds of comments in electronic working groups and discussions at the CCNFSDU plenary sessions in 2017 and 2018. The criteria were finalised in 2019 after a highly effective physical meeting of the working group that was held the day before the CCNFSDU plenary.

Throughout that process, the technological justification for xanthan gum was adapted to align with the developing criteria, although the underlying rationale never changed. Infant formula products, especially those produced with ingredients like hydrolysed proteins, represent a huge technological challenge, especially when considering that the resulting products must be able to consistently provide the same nutrition over the life of the product and under all potential use scenarios.

We demonstrated through a set of experiments that under our particular product conditions (including production method, product format and product composition) xanthan gum was able to maintain homogeneity at a lower concentration than other additives. Infant formula manufacturers strive to minimise the amount of food additives in the products we produce, and having a variety of food additives authorised within the same technological function allows manufacturers to optimise products by using the additives that are the most effective at the lowest amount possible.

Once the provisions were adopted in the standards, what were the next steps?

At the same meeting where the working group finalised the criteria for evaluating the technological need, the working group also concluded that xanthan gum met these criteria. The recommendation from this working group was then reviewed at the CCNFSDU plenary session, where the committee aligned to this assessment and made the recommendation to add this authorisation to the Codex Infant Formula Standard (Codex Stan 72-1981). From there, the Codex procedure took over with the Codex Alimentarius Commission adopting the recommendation to amend the Infant Formula Standard in 2020, and with the Codex Committee on Food Additives (CCFA) then updating the General Standard for Food Additives (Codex Stan 192-1995) in 2021.

What is next for infant formula additives at Codex?

The work at Codex is never done, and the good news is that after the hard work over the last few years on establishing processes for reviewing additives we have a clear infrastructure in place to review infant formula additives. In fact, there is already another infant formula additive that has begun moving through the process. Similar to the  story of xanthan gum, we have found another stabiliser/thickener called gellan gum is able to accomplish the technological need of maintaining homogeneity in certain products at concentrations lower than other additives. Gellan gum was determined by JECFA to be safe for consumption by infants less than 12 weeks of age in their 87th meeting in 2019, so it has already met some of the criteria for authorising its use.

Unfortunately, the safety determination for gellan gum was published at the last in-person CCNFSDU meeting and right before the pandemic hit. It was identified as the next additive to test the newly established criteria for evaluating technological need, but with the pandemic disruption of many Codex activities, discussions have stalled. The technological justification for gellan gum, including comparisons with other additives showing its superiority at lower concentrations, was shared with Codex members who are participating in the electronic working group that was initiated in 2020, and at this point we are waiting for the endorsement of that group so that it can be discussed at the next CCNFSDU plenary.

From there, we will have several good examples (xanthan gum, gellan gum, pectins) of how additives proceed through the process. This will be a big help, since we won’t have to carve out the path next time, just follow it. When infant formula manufacturers have more scientific advances that identify safe food additives that are effective at even lower concentrations, this will make it easier to get those additives authorised at Codex and help make these advances so that we can continually reduce the amount of food additives needed in these products.

Summary

The xanthan gum story actually started a few years before the work at Codex began with its addition to the JECFA priority list in 2015. A lot of work was conducted prior to this to build up the science that was needed to demonstrate the safety of that additive, and many of those studies were conducted years before addition to the JECFA priority list.

Overall, xanthan gum was quite an adventure at Codex, but an adventure that demonstrates the robustness of the Codex processes. Xanthan gum wasn’t approved until after all questions about the safety and technological need were thoroughly evaluated by experts from around the world. The discussion of xanthan gum at Codex stretched over 7 years, required collaboration between both CCNFSDU and CCFA, and even helped with the development of criteria for demonstrating technological need.

The special dietary foods industries are proud to provide people with the essential safe and ‎nutritious foods they need to live, grow and thrive, as well as support the Sustainable ‎Development Goals of zero hunger, good health and wellbeing through building partnerships ‎for food safety. The quality and safety of food products is, and remains, an absolute priority ‎for our industry.‎

Foods for special dietary uses (FSDU) – from infant formula, complementary foods and foods for special medical purposes (FSMP) to dietetic nutrition, gluten-free foods and sport foods – are scientifically developed to cater for the specific nutritional requirements of people with special dietary needs. These safe and highly nutritious solutions support people throughout all stages of life, from the healthy growth and development of infants and young children to the dietary management of the elderly.

As an industry, we are committed to enforcing the strictest standards and our members take pride in producing foods based on the latest scientific information, accredited food production and manufacturing operations and other global food management systems.

Since 1973, ISDI has supported the work of Codex Alimentarius in establishing science-based ‎food standards, guidelines and codes of practice that ensure food safety and quality. As an ‎international organisation, we are committed to continue working with regulators, policy-‎makers and other stakeholders to improve the health and wellbeing of current and future ‎generations, and enhance food security. ‎

Our members around the world work together with national authorities to ensure safe and ‎nutritious foods are available for people with special dietary needs, providing support in ‎regulating food safety along the entire food chain and ensuring international standards are ‎met or even surpassed. Our industry goes further in supporting food security by using ‎sustainably managed and renewable resources, more efficient operations, waste ‎management and environmentally-friendly packaging. Moreover, ISDI members form ‎partnerships for sustainable food production and encourage their partners to adopt best ‎practices.‎

We welcome the fourth World Food Safety Day as an opportunity to recognise the people who ‎help keep our food safe and celebrate the role of safe and nutritious food in providing for the ‎health and wellbeing of people around the world.

Kate M. Forde BSc MPH RD is Specialised Nutrition Executive – Foods for Special Medical Purposes at Dairy Industry Ireland, and is an experienced dietitian.

She answered our questions ahead of the release of a series of videos and factsheets on adult malnutrition and Oral Nutritional Supplements (ONS).

What is malnutrition and why is it important?‎

Malnutrition is a serious condition that occurs when a person’s diet does not contain enough nutrients to meet the demands of their body. This can affect growth, physical health, mood, behaviour and many of the functions of the body, including its ability to heal or repair. You can also become malnourished if your diet does not contain the right balance of nutrients. It is possible to eat a diet high in calories but containing few vitamins and minerals. This means you can become malnourished, regardless of your body size¹.

Weight loss and malnutrition can increase a person’s risk of serious but potentially avoidable complications. It is associated with poorer response to therapy and poorer outcomes, which can really impact a person’s overall quality of life. That is why it is so important. It also has a particularly negative impact on older people as it can adversely affect their function, mobility and independence².

People who are considered malnourished experience more complications than those that are well-nourished. For instance, the risk of infection is greater in hospitalised malnourished patients and, in the community, malnourished patients are likely to visit their family doctors more often. The annual healthcare costs associated with malnutrition are enormous, estimated at €170bn³ across Europe, for example. However, malnutrition is usually relatively simple and inexpensive to treat, especially if detected early. Research has shown that raising awareness of malnutrition, effective screening programmes and early treatment leads to better patient outcomes³.

Who is at risk of being malnourished and what are the risk factors?‎

Anyone is at risk of becoming malnourished at some point in their lifetime and it can often be difficult to recognise as there are many factors that could contribute to that risk. A loss of appetite coupled with unintentional weight loss signal that an individual has an inadequate intake of energy, protein and other nutrients, which contributes to the risk of becoming malnourished.

Other factors that can contribute to malnutrition are¹:

• If someone has eaten little or nothing for the last five days
• Or if they are likely to eat little or nothing for the next five days or more due to certain medical conditions
• If the body is unable to absorb nutrients from the diet or normal foods as expected
• Some underlying conditions can mean your body is likely to need additional nutrients than it did previously
• If teeth are in a poor condition, eating can be difficult or painful
• If swallowing food is difficult or painful (the medical term for this is dysphagia and there are a range of causes, such as a blockage in your throat, damage to the nerves used in swallowing or sores in the mouth)
• A loss of appetite as a result of losing your sense of smell and taste
• Physical disability or other impairments could make it difficult for you to cook for yourself
• Taking many different types of medication at the same time can disrupt the body’s ability to absorb and use nutrients efficiently
• The body may have an increased demand for energy at times, e.g. if it is trying to heal itself after a serious injury or surgery
• Social factors can also contribute, such as low income, living alone and being socially isolated, having reduced mobility and lack of transport with restricted access to amenities
• Mental health conditions may affect your ability to look after yourself
• Older people may become malnourished gradually if poor health begins to affect their ability to feed themselves properly. Malnutrition then, in turn, makes their health worse.

These are just some of the considerations that will be taken into account during a nutritional assessment by a healthcare professional. Malnutrition can develop rapidly during periods of acute illness or more gradually, depending on the circumstances. This highlights the importance of nutrition screening, which takes less than 5 minutes and can identify those at risk².

How is malnutrition identified and treated?‎

A diagnosis of malnutrition is usually made following a nutritional assessment by a trained healthcare professional, based on factors such as weight, unintentional weight loss, or whether something, such as a health condition, has impacted a person’s ability to absorb nutrients from their diet. Any other medical conditions or investigations a person may be undergoing are also taken into account¹.

There are validated screening tools that use a practical, simple method as the first step in identifying people who are at risk of being or becoming malnourished and who are likely to require a nutritional intervention². There are many nutrition screening tools available, but the most commonly used validated screening tools are the ‘Malnutrition Universal Screening Tool’ (MUST) or the ‘Mini Nutrition Assessment’ (MNA). The MUST is a five-step screening tool to identify adults with malnutrition used in all healthcare settings. The MNA is a validated nutrition screening and assessment tool comprised of six questions that is specially used for those aged 65 and above².

Screening should be undertaken in all healthcare settings, such as on admission to hospital both as an inpatient and outpatient appointments and weekly thereafter if there is a clinical concern. All residents of care and nursing homes should be screened on admission, with screening repeated monthly given the high prevalence of malnutrition in these populations. Moreover, screening should be carried out at initial registration in GP surgeries, repeated where there is a clinical concern and at other opportunities, such as health checks or vaccinations⁴.

Screening, however, is only ever designed to be a quick way of identifying those who are at significant risk of nutritional problems so that further detailed nutritional assessment can be undertaken by a trained healthcare professional, such as a registered dietitian².

The main treatment option for somebody identified by these screening tools is to increase the energy calorie and protein content of their diet. Consideration is also given to the need for the right balance of vitamins and minerals. Calories in food are what give your body energy. Protein is known as the ‘building block’ of the body, helping it build, repair and maintain strength¹.

A dietitian or other healthcare professional will discuss what changes can be made to a person’s diet to increase the energy calorie and protein content. They will develop a recommended diet plan depending on individual circumstances and food preferences. They will also provide someone with support to make these dietary changes, with the aim to ensure nutritional adequacy of their diet over long periods. In addition to these dietary changes, depending on the circumstances, oral nutritional supplements (ONS) may also be recommended to achieve a person’s nutritional requirements.

What are Foods for Special Medical Purposes (FSMPs), such as Oral Nutritional Supplements (ONS)?

Foods for Special Medical Purposes (FSMPs) are designed to meet nutritional needs arising from a wide range of medical conditions that affect people of all ages, from infancy to old age. They are food products created for the dietary management of people suffering from a disease, disorder or medical condition that either temporarily or permanently affects their ability to achieve a suitable nutritional intake using normal foods⁵.

Oral Nutritional Supplements (ONS) are a type of FSMP that are tailor-made food products with specific amounts of energy (calories), protein, fat, carbohydrates, vitamins and minerals⁵. There are many different types of ONS:

• Powders that can be made up into drinks using fresh milk or water or added to drinks and/or foods and recipes
• Ready-to-drink milk-based or juice-style drinks
• Pudding type ONS for those who may have a difficulty swallowing  

ONS are available in a choice of flavours and textures, so that anyone who needs them is able to find a product that suits them. This promotes enjoyment of the products, thereby encouraging better compliance and ensuring that they are adequately nourished. A healthcare professional will help someone to decide which one is best for their needs and preferences.

ONS are an effective and non-invasive solution to tackle malnutrition and provide functional benefits in those who are typically able to consume some normal food, but not enough to meet all of their nutritional needs³. These products are consumed across all healthcare settings – in hospitals, care homes, clinics and in private homes, but should only be used based on the recommendation of, and used under the supervision of, a healthcare professional. This necessary and continued supervision by a healthcare professional clearly distinguishes FSMPs, including ONS, from other food types³.

How do ONS address malnutrition and how do they fit into a patient’s nutrition management or care ‎plan?‎

ONS are foods that contain specific amounts of energy, protein, vitamins and minerals that you would normally get from a healthy balanced diet. They are specifically designed for people who may not be able to eat enough food to meet their needs through their regular diet alone. They are designed to improve the amount of nutrients you get to help maintain your body weight or to help cope better with illness and recover more quickly.

There are several reasons why ONS may be prescribed in addition to dietary changes. For example, a person may have unintentionally lost weight due to illness as they find it more difficult to eat normal foods because of their symptoms. Certain conditions can impact a person’s appetite, cause taste changes or make it difficult to swallow normal foods, making it too difficult for them to increase their intake of normal foods.

The supervising healthcare professional will help decide which ONS is best suited to the person and their condition. Importantly, they should explain the need to take ONS, how many to take and for how long they will be needed. In most cases, they will only be needed while someone is having difficulty eating a normal diet or until they have reached a healthy weight. The healthcare professional should regularly review their progress while they are taking ONS, taking factors such as weight and how the person is managing with the recommended ONS into consideration, and they will ask questions about what the person is managing to eat. Regular reviews are important to make sure they are getting the maximum benefit from the ONS and that they are only taken for as long as they are needed.

It is also very important that they ensure ONS are taken alongside normal foods and are not used as a replacement for normal food or the recommended diet plan as advised by a dietitian. The purpose of ONS is to help boost a person’s current dietary intake and not replace it, so it is important that they only take the recommended dose each day. They may be taken between meals like a snack, first thing in the morning or before bed-time. Some people find that taking small amounts regularly throughout the day also helps. ONS are also very versatile and can be incorporated in favourite recipes or meals, for example in porridge for breakfast. However, it is still important that any dietary advice or changes are made under the supervision of a trained healthcare professional.

References

1. HSE. Malnutrition in Ireland. Available: https://www.hse.ie/eng/services/list/2/primarycare/community-funded-schemes/nutrition-supports/malnutrition-in-ireland/ (accessed 5 April 2022).
2. IrSPEN. UNDERSTANDING MALNUTRITION. Available: https://www.irspen.ie/malnutrition/understanding-malnutrition/ (accessed 5 April 2022).
3. MNI (2018). Better care through better nutrition: Value and effects of Medical Nutrition. Brussels: Medical Nutrition Industry International.
4. BSNA. Medical Foods Q&A. Available: https://bsna.co.uk/pages/about-specialist-nutrition/medical-oral-nutritional-supplements/faqs (accessed 5 April 2022)
5. SNE. Food for Special Medical Purposes. Available: https://www.specialisednutritioneurope.eu/specialised-nutrition/food-for-special-medical-purposes/ (accessed 5 April 2022)