EFSA adopts essential infant formula composition opinion

By Annie Harrison-Dunn

- Last updated on GMT

 We agree that sucrose increases risk of dental caries, but there is no evidence that lactose is less cariogenic than other sugars, says NDA panel.
We agree that sucrose increases risk of dental caries, but there is no evidence that lactose is less cariogenic than other sugars, says NDA panel.

Related tags Infant Nutrition Milk European food safety authority

EFSA has adopted its opinion on the essential infant formula composition following a period of public consultation which saw nearly 400 comments stream in on the likes of omega-3 form DHA (docosahexaenoic acid), probiotics, fluoride and sucrose's effect on dental health.

The European Food Safety Authority (EFSA) received 377 comments during the six-week period from 31 different parties. Two of the interested parties were universities, five were government organisations, eight non-government organisations (NGOs), one medical society and 15 members of the food industry. 

The Dietetic Products, Nutrition and Allergies (NDA) panel said many of the suggestions went beyond its remit as a scientific board, into that of policy makers and regulators like the European Commission and European Parliament. However the panel did engage on some of the points, although most did not result in significant changes to the draft document​. 

The changes were agreed and adopted by the panel on Thursday at a plenary open to observers such as press, trade associations, NGOs and companies, with the final draft yet to be published.

Organisations that submitted comments:

Abbott Nutrition – US

ANDI (Asociación Nacional Fabricantes 

de Productos de Dietética Infantil) – ES

Balchem Corporation – US

Comité de Nutrition de la Société Française de Pédiatrie – FR

Croatian Food Agency – HR

Danone Nutricia Early Life Nutrition – NL

DSM Nutritional Products – US

Early Nutrition Academy – DE

ELC (Federation of European Speciality Food Ingredients Industries) – BE

ENSA (European Natural Soy and Plant Based Manufacturers Organisation) – BE

First Steps Nutrition Trust – UK

Food Safety Authority of Ireland – IE

Belgian FPS (Federal Public Service) Public Health Food Safety and Environment – BE

GOED (Global Organisation for EPA and DHA Omega-3s) – US

“Healthy eating from the start!” – AT

IBFAN Baby Feeding Law Group – UK

Initiativ Liewensufank – LU

Intertek Scientific & Regulatory Consultancy – UK

Lactalis – FR + ES

LIFIB (The Lancashire Infant Feeding Information Board) – UK

Mead Johnson Nutrition – NL

New Zealand Ministry for Primary Industries – NZ

Swedish National Food Agency – SE

NCT (National Childbirth Trust) – UK

Nestlé SA – CH

NutriKids- IE

Sedan – DK

SFAE (Syndicat Français des Aliments de l’Enfance) – FR

SNE (Specialised Nutrition Europe) – BE

Université Paris-Sud – FR

University of Illinois – US 

DHA funding

On DHA content, EFSA responded that it would remain "prudent"​ in light of there being as yet "no scientific evidence"​ for the long term benefits or effects of its inclusion in formula.

One commentator said that a statement that there was, “no convincing evidence of DHA benefits beyond infancy on any functional outcomes​ was unnecessary as evaluation of effects of formula consumption should be limited to infancy only, with later effects being irrelevant as long as adequate infant development and compositional similarity to breast milk were ensured.

The panel responded that: "All long term effects are relevant and we cannot neglect this evidence when available."

Among the observers was Dr Adriano Cattaneo, there representing the breast milk lobby group International Baby Food Action Network (IBFAN). As one of the groups that submitted comments to EFSA, Cattaneo told NutraIngredients that he was disappointed but not surprised by the outcome.

Cattaneo said it was important to consider who funded the research, a point he put to the panel later when the floor was opened up to the observers.  

However, the panel responded to his question that alleged an inherent bias of industry-led research by saying whether or not research was funded by corporations was "not a concern" ​of EFSA.​ Speaking later the panel's chair said that as a scientific organisation like EFSA must be, "blind to the needs of the industry and blind to the needs of the consumers".

Later, one member of the panel told NutraIngredients that he thought NGOs knew what did and did not sit within EFSA's remit, but that these pointed questions were used to raise a point.

Phrasing probiotics

The panel made some changes to the probiotics and synbiotics section of the opinion. In the meeting they discussed their use of quotation marks around the terms – which they said qualified this as borrowed terminology as opposed to something they were necessarily endorsing.

They also added in the clarifications "in humans"​ as well as "doses"​ and "at the conditions of use"​ in response to the suggestion that the panel should conclude not on probiotics and synbiotics in general but refer to individual strains.

On panel member said: "This could be an important question in the future."

Sweet-toothed babies

Discussing the inclusion of digestible (glycaemic) carbohydrates, one commentator contested the panel’s retention of existing maximum permitted amounts of sucrose or glucose.

EFSA said there was no evidence that the addition of these sugars would camouflage the taste of the formula and influence acceptability and the mother’s choice of such formulae, as suggested by the commentator. Although the panel did agree that sucrose and glucose were not “necessary​ components of formula.

It was also suggested that a statement made by the panel in the original draft that sucrose and fructose could be "tolerated"​ in follow-on formula was contrary to national and international infant feeding recommendations, referencing in particular possible negative effects on dental health.

The NDA panel responded saying that it “agreed that sucrose increased risk of dental caries, but there was no evidence that lactose was less cariogenic than others”.

Fluoride is not an essential nutrient

EFSA said that fluoride was not an essential nutrient and it was therefore not necessary to propose minimum contents, as suggested by the feedback. However “for clarity and completeness​ it added a section with this conclusion as well highlighting that fluoride content of ready-to-feed formulae depended on the fluoride content of the water used for preparation and therefore water quality was “of importance”.

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