Jacqui Lowdon
Paediatric
Dietitian, Team
Leader Critical Care, Therapy & Dietetics, RMCH
Presently team leader for Critical Care and Burns, Jacqui previously specialised in gastroenterology and cystic fibrosis. Although her career to date has focused on the acute sector, Jacqui has a great interest in paediatric public health.
The infant and young child formula milk market in the UK is dominated by four major brands. However, there is an increasing range of formulae becoming available even though infant and young child formula milks* are amongst the most strictly regulated foodstuffs. Here, Jacqui Lowdon takes a look at the products on the market and the related legislation and regulations.
Code on Breastmilk Substitutes.2 In 2016, there was an increasing focus on the regulatory arena. In May, a call for banning of advertising of all formulae for the first three years of life was proposed by the World Health Assembly (WHA).3 At the same time, the Royal College of Paediatrics and Child Health (RCPCH) consulted its members on whether the RCPCH should receive any funding from formula milk companies. Later in 2016, a Bill was introduced to the House of Commons, Feeding Products for Babies and Children (Advertising Although “welcomed with appreciation” by its member states, the recent WHA Resolution was not ‘endorsed’, being concluded that its following proposals were too extreme: to prohibit contact between healthcare professionals and to further restrict funding; and to consider foods given to a child up to 36 months as breastmilk
The membership agreed that the RCPCH should continue to accept funding from formula milk companies, obviously within strict, specified They felt that, although any promotion of IF milk over breastfeeding is unacceptable, an open dialogue between manufacturers, researchers and healthcare professionals relating to clinical research and product development, is essential, so long as it is transparent and accountable.
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IMPORTANT NOTICE: Breastfeeding is best for babies. Infant formula should only be used on the advice of a healthcare professional. Good maternal nutrition is important for breastfeeding. Reversing a decision not to breastfeed is difficult and combined breast and bottle feeding in the first weeks of life may reduce the supply of your own breastmilk. Improper use of an infant formula or inappropriate foods or feeding methods may present a health hazard. Please note that Goat Milk formula is not suitable for confirmed cases of cow’s milk protein allergy (CMPA), unless directed by a suitably qualified healthcare professional.
The Bill that was put forward aimed to establish an agency (the ‘Infant and Young Child Nutrition Agency’) to set, monitor and evaluate compositional, safety and quality standards, labelling and nutritional claims for formula milks for babies and young children. However, this would merely duplicate the work already undertaken by existing law.
In February 2016, the European Commission Delegated Regulation (EU) 2016/17,6 which updates the specific compositional and information requirements for IF and FOF, became a legal requirement, being fully applicable by February 2020 (February 2021 for protein
hydrolysate-based formulae). The previous regulations under Directive 2006/141/EC remain in force until repealed at this date. This regulation specifies the nutritional composition of IF and FOF, including labelling and claims specific to this group.
It remains unclear how the UK may determine and enforce regulations as it negotiates an exit from the EU.
In order to reflect the ever-increasing knowledge of infant nutrition, regulations are not fixed, but are subject to change. As would be expected, there is often a time lapse between our scientific knowledge and development.
Table 1: The standard infant and young child milk formulas presently available in the UK (reproduced from First Steps Nutrition, Infant milks in the UK 2017)
IF suitable from birth (cows’ milk-based)
IF suitable from birth (goat milk-based)
IF marketed for hungrier babies, suitable from birth (cows’ milk-based)
Thickened (anti-reflux) IF suitable from birth
Soya protein-based IF suitable from birth
Lactose-free IF suitable from birth
Partially hydrolysed IF suitable from birth
Aptamil 1 First Milk
Aptamil Profutura 1 First Infant Milk
Bebivita 1 First Infant Milk
Cow & Gate 1 First Infant Milk
HiPP Organic Combiotic First Infant Milk
Holle Organic Infant Formula 1
Kendamil First Infant Milk
Kendamil Mehadrin First Infant Milk
Mamia First Infant Milk
Similac First Infant Milk
SMA Pro First Infant Milk
Goat Milk Formula 1
Holle Organic Infant Goat Milk Formula 1
Kabrita Gold 1 Infant milk
NANNYcare First Infant Milk
Aptamil Hungry Milk
Cow & Gate Infant Milk for Hungrier Babies
HiPP Organic Combiotic Hungry Infant Milk
SMA Extra Hungry
Aptamil Anti-reflux
Cow & Gate Anti-reflux
HiPP Organic Combiotic Anti-reflux
SMA Staydown
SMA Wysoy
Aptamil Lactose Free
SMA LF
Aptamil Comfort
Cow & Gate Comfort
HiPP Combiotic Comfort
SMA Comfort
SMA HA
Table 1 continued overleaf
FOF suitable from 6 months of age
FOF suitable from 6 months of age (goat milk-based)
Aptamil 2 Follow-on Milk
Aptamil Profutura 2 Follow-on Milk
Bebivita 2 Follow-on Milk
Cow & Gate 2 Follow-on Milk
HiPP Organic Combiotic Follow-on Milk 2
Holle Organic Infant Follow-on Formula 2
Kendamil Follow-on Milk
Mamia Follow-on Milk
Similac Follow-on Milk
SMA Pro Follow-on Milk
Holle Organic Infant Goat Milk Follow-on
Formula 2
Kabrita Gold 2 Follow-on Milk
NANNYcare Follow-on Milk
Good night milks
Growing-up milks and toddler milks suitable from around 1 year of age (cows’ milk-based)
Growing-up milks suitable from around 1 year of age (goat milk-based)
Soya protein-based growing-up milks and toddler milks suitable from 1 year of age
Growing-up milks and toddler milks suitable from around 2 years
For example, the decision to include DHA (omega-3) in the list of mandatory ingredients from February 2020.7 Clinical research has been ongoing in this area for the last 20 years and has clearly demonstrated the benefits of DHA for non-breastfed infants. This is also an example of where industry collaborating with healthcare professionals has produced an advancement for the benefit of babies who are not fed with breast milk.
In January this year, the EFSA Panel on Dietetic Products, Nutrition and Allergies produced a draft scientific opinion on ‘The safety and suitability for use by infants of
HiPP Organic Good Night Milk
Aptamil 3 Growing Up Milk 1-2 Years
Aptamil Profutura 3 Growing Up Milk
Bebivita 3 Growing Up Milk
Cow & Gate 3 Growing Up Milk 1-2 Years
HiPP Organic Combiotic Growing Up Milk 3
Holle Organic Growing Up Milk 3
Kendamil Toddler Milk
Kendamil Mehadrin Toddler Milk
PaediaSure Shake
Similac Growing Up Milk
SMA Pro Toddler Milk
Holle Organic Infant Goat Milk Follow-on
Formula 3
Kabrita Gold 3 Toddler Milk
NANNYcare Growing Up Milk
Alpro Soya +1 Complete Care
Aptamil 4 Growing Up Milk 2-3 Years
Cow & Gate 4 Growing Up Milk 2-3 Years
HiPP Combiotic Growing Up Milk 4
follow-on formulae with a protein content of at least 1.6g/100kcal’. The level of protein discussed represents a minimum protein content of around 1.1g/100ml. This is lower than the average for follow-on milk products currently available in the UK. It was concluded that the use of FOF with a protein content of at least 1.6g/100kcal from either cows’ milk protein or goat milk protein and complying with EU legislation is safe and suitable for infants living in Europe with access to complementary foods of a sufficient quality. The safety and suitability of FOF made from either protein hydrolysates or soya protein isolates could not be established with the available data.8
It is essential that health professionals keep themselves updated on the various formulae now available, in order to best advise parents.
Within certain Clinical Commissioning Groups (CCGs), prescriptions of IF are at risk of being restricted. Proposals have included restrictions to soya-based IF, thickened IF, formulae for lactose intolerance and for cows’ milk protein allergy (CMPA). It is imperative that children with CMPA are diagnosed and managed with the most appropriate formula, be that an aminoacid based formula (AAF,) or extensively hydrolysed formula (eHF), as stated by NICE and the MAP Guideline.9,10 Already in some areas, CCGs are removing certain formulae from being prescribed. The risk is that shortterm financial savings may negatively impact on patient outcomes and effectively cost the NHS more money in the long term.
A recent systematic review by The Food Standards Agency11 concluded that there was no consistent evidence that partially hydrolysed formula reduces the risk of allergic disease. Furthermore, ESPGHAN working group consensus12 also concluded that evidence on efficacy of partially hydrolysed formula on prevention of atopic
disease is limited and highlighted the lack of any evidence on long-term metabolic consequences and outcomes of using these products.
The NICE Quality Standard (QS112, NICE 2016) outlines how gastro-oesophageal reflux should be diagnosed and managed in infants. Regurgitation is a common and normal occurrence in infants, not normally requiring any investigation or treatment. Where there may be significant symptoms of frequent regurgitation with distress, a thickener added to milk or a prethickened formula can be recommended.
It is essential that health professionals keep themselves updated on the various formulae now available, in order to best advise parents. It is also essential that we understand and are knowledgeable on the legislation and regulation of these formulae to reassure parents on their suitability.
* In this article, the term ‘infant formula milks’ is used generically to include infant formula, followon formula, young child formula and infant foods for special medical purposes (iFSMPs).