News
16 June 2014

SNE position statement 16 June 2014 - SNE comments on the draft EFSA opinion on essential composition criteria for infant and follow-on formula

Specialised Nutrition Europe (SNE), representing manufacturers of infant and young child nutrition in Europe, welcomes EFSA’s draft scientific opinion on the essential composition of infant and follow-on formulae, which was recently open for public consultation, and which complements the 2013 opinion on nutrient requirements and dietary intakes of infants and young children.

After breastfeeding, our products and services support the best possible start in life. Therefore, SNE has taken the opportunity to participate in this consultation process, and the following statement summarises SNE’s contribution. For more information on the details of the SNE submission, please contact Aurélie Perrichet, Executive Director SNE at .

EFSA RECOGNITION THAT INFANTS AND YOUNG CHILDREN HAVE SPECIFIC NUTRITIONAL NEEDS

SNE welcomes the recognition that infants and young children have specific nutritional needs and agrees that it is both timely and appropriate to review and update the scientific evidence which provides the basis for the essential composition of infant and follow-on formulae.

SNE also welcomes the fact that the draft opinion recognises the specific differences in nutritional requirements for infants 0-6 months compared to older infants over 6 months. The differentiation between infant formula and follow-on formula may help to address the risk of inadequate intakes of iron after 6 months of age.

SNE concurs with the recognition of the specific category ‘young child formulae’. While young children can achieve a balanced diet by eating normal foods such as cow’s milk, the 2013 EFSA opinion [1] demonstrated that across Europe the reality is that many children are unable to achieve a balanced diet with normal foods, and young child formulae represents one way to support those with inadequate intakes or at risk of inadequate status of nutrients.

EFSA RECOGNITION THAT NUTRIENTS AND SUBSTANCES ADDED TO FORMULA ARE STRICTLY REGULATED AND SAFE

SNE welcomes the EFSA’s recognition that the current levels of nutrients and substances added to formulae do not cause any concerns in relation to the safety, growth and development of infants, and that no adverse effects have been reported in relation to use of these ingredients.

The EFSA has also recognised that infant formula and follow-on formula can evolve with respect to the use of new technologies and nutrients. It is therefore disappointing that EFSA has chosen to describe certain nutrients as ‘unnecessary’ rather than ‘optional’ as it is only through their inclusion in formula and subsequent research that their presence can be demonstrated to be beneficial.

Indeed, advancements in science and research allow continuous improvements to formula composition, and ingredients considered ‘optional’ today may be regarded as essential in the future following continued clinical research.[2] The addition of optional ingredients always follows due process, with strict review and approval by independent national scientific bodies.

THE NEED TO MAINTAIN THE CURRENT MAXIMUM LEVELS TO ENSURE safety

SNE notes that Tolerable Upper Intake Levels are not clearly mentioned in the draft Opinion. SNE supports the recommendation not to set new maximum limits and requests that the current maximum values of Directive 2006/141/EC are retained. These ranges are supported by a history of safe use with no adverse effects, and have been proven to support growth and development for infants and young children.

Setting maximum limits that are valid across Europe also helps to maintain a harmonised approach to Member State controls, thereby providing a unique instrument for controlling product suitability.

THE NEED FOR A MINIMUM COMMON STANDARD FOR YOUNG CHILD FORMULA

Currently, there are no harmonised common standards for young child formula. SNE therefore calls upon the EFSA to provide guidance on the nutritional composition of young child formula, which, along with considerations of food safety and quality (among other regulatory considerations) would ensure that there is a minimum standard for these products in the EU within the framework of Regulation (EU) No. 609/2013 on Foods for Specific Groups.

In particular, SNE would welcome consideration by the EFSA and the European Commission that nutritional compositional requirements for young-child formulae may be appropriate to:

  1. Ensure that there are specific minimum levels of nutrients appropriate for young children. This is particularly relevant in the context that reference intakes for adults are not appropriate for young children and reference intakes for infants are different from those for young children (as identified by EFSA in its 2013 opinion referenced above);
  2. Ensure that maximum levels of certain nutrients are not exceeded in foods intended for young children; and
  3. Provide a range between the minimum and maximum levels of nutrients which may allow for differences in composition to reflect the more diversified diet consumed by young children compared to older infants, in addition to national dietary habits.

As a responsible industry dedicated to providing infants and young children with the products they rely on, the European Specialised Nutrition industry takes research and development very seriously, and invests heavily in this area. Scientific substantiation drives formulae development and our products are always manufactured in accordance with the very highest safety and quality standards.

SNE looks forward to seeing how these considerations are taken into account in the EFSA’s final scientific opinion, and how this advice will then be addressed in the context of discussions at EU level on regulating infant, follow-on formulae and young child formulae in a way that ensures the best nutrition during the first years of life and encourages safe innovation based on science.


[1]EFSA Journal 2013;11(10):3408

[2]Choline and inositol were considered ‘optional’ or ’unnecessary’ nutrients before 2006, and are now regarded as essential in infant formulae.