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4. Infant formula legislation

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4. Infant formula legislation

Based on the latest evidence, refinements to the composition and informational requirements for infant formulas and follow-on formulas will come into force in February 2020

The content of infant formula is tightly regulated and based on the scientific advice of European Food Safety Authority experts, with the legislation then being approved by the European Parliament and Member States, including the UK Government. This ensures that the appropriate nutrients are provided for babies in appropriate amounts.

The Commission Delegated Regulation (EU) 2016/127 supplementing Regulation (EU) 609/2013 has led to further refinements to the composition and informational requirements for infant formulas and follow-on formulas based on the latest evidence.

What’s new?

The changes update, but largely retain, the existing rules, however there are three main changes to the nutritional composition of formulas:

  • They require lower maximum levels of protein
  • There is a mandatory requirement to add docosahexaenoic acid (DHA), which was previously voluntary
  • They require a higher level of vitamin D and changes to maximum and minimum levels of other vitamins and minerals.

The timeline

These changes need to be made by 22 February 2020 and by 21 February 2021 for protein hydrolysate formulas. 

Changes are being implemented now, but the law is very restrictive about what can and cannot be communicated. As such, manufacturers of formula milks introducing the new recipes are typically flagging this with stickers to highlight that the formula has changed and directing customers with concerns to their careline.

The impact

As the regulations require the reformulation of some infant formulas, there will be updated nutritional declarations on product labels.

In addition, there may be changes to the taste and smell of products, which may result in “settling” issues with the new formulations. However, if this does occur, it should only be temporary and minimal. Vicky Pennington, nutritionist at Boots UK, comments that settling issues are “normal and in my experience it’s not unusual when complaints that a product has ‘made my baby sick’ increase with a labelling design change, let alone a change to the formulation.”

Parents should be reassured that the formulation changes are based on the latest scientific evidence and made for the benefit of their baby’s nutrition and that settling issues are normal. Any concerned parents should be signposted to the manufacturer’s careline or their healthcare professional.

A new code of practice

UK manufacturers of formula milks have committed to adhere to a new Code of Practice called the Infant Nutrition Industry (INI) Code. This has been developed by the British Specialist Nutrition Association, whose members include Danone, Nestlé, Abbott, HiPP and Mead Johnson. 

The Code will be regulated by the new and independent Code of Practice Authority (INICPA), which will investigate any complaints made and have the power to require any company found to be in breach of the INI Code to take appropriate steps to correct it.

The updates

1 Lower maximum levels of protein

2 Mandatory requirement to add docosahexaenoic acid (DHA), which was previously voluntary

3 Higher level of vitamin D and changes to maximum and minimum levels of other vitamins and minerals.

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