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Legislative changes to infant formulations

New legislation¹ has been introduced affecting all infant formula, follow-on formula and infant food for special medical purposes by 22 February 2020* to enhance existing regulations and to reflect the latest scientific advances in nutrition².

These updates may result in:

  • Changes to the product label
  • A slight difference in smell, appearance and/or taste of the formulation.

Why do you need to know about the legislation changes to all infant milks?

Parents may look to healthcare professionals for reassurance, so it’s important that you are aware of the changes to support parents of combination or bottle-fed infants.

When will the change take place?

*From 22 February 2020, all infant formula, follow-on formula (EU Delegated Regulation 2016/127) and infant food for special medical purposes (EU Delegated Regulation 2016/128) must comply with the changes. Until then, manufacturers are allowed to sell products which are compliant with either the current or new legislation. Infant formula manufactured from protein hydrolysates must be compliant by 22 February 2021.

Download a summary of the legislation changes here.

Composition

Changes in mandatory, minimum and maximum nutrient levels.

  • Mandatory addition of the omega-3 fatty acid, docosahexaenoic acid (DHA) in the range 20-50mg DHA/100 kcal
  • New maximum limit for the essential fatty acid, alpha-linolenic acid of 100mg/100 kcal.
  • Increase in the minimum amount of some nutrients e.g. Vitamin A, Iodine, Selenium, Vitamin D¹.

The changes referred to in this update relate only to those required by the latest EU regulations.

We will be updating our infant formula, follow-on formula and infant food for special medical purposes for formulations in line with the new regulations.

Manufacturers will continue to innovate and/or update products with the voluntary addition of ingredients in line with scientific research and inform Healthcare Professionals accordingly.

 

Labelling

Changes in the presentation of the nutrition table and ingredients list.

  • Unit changes for some nutrients
  • Re-labelling of some nutrients e.g. Folic acid will be listed as Folate
  • Order of ingredients in the ingredients list may change due to updated recommended levels of nutrients added

Communication to consumers

Further restrictions on claims.

  • The only nutrition claims permitted on infant formula are ‘Contains DHA’ and ‘Lactose only’/’Lactose-free’ where applicable
  • For infant food for special medical purposes, information on the properties/characteristics of the product (e.g. nutrients, ingredients or processing) relevant to the medical condition should be provided. No nutrition and health claims are permitted
  • The removal of nutrient claims may prompt parents to believe that nutrients have been omitted. Healthcare professionals can reassure them by using the nutrition table

 

*From 22 February 2020, all infant formula, follow-on formula (EU Delegated Regulation 2016/127) and infant food for special medical purposes (EU Delegated Regulation 2016/128) must comply with the changes. Until then, manufacturers are allowed to sell products which are compliant with either the current or new legislation. Infant formula manufactured from protein hydrolysates must be compliant by 22 February 2021.

References: 1. These are given as examples. For further information on changes see EU Delegated Regulation 2016/127 (Infant formula and Follow-On Formula) http://data.europa.eu/eli/reg_del/2016/127/oj and EU Delegated Regulation 2016/128 (Food for special medical purposes) http://data.europa.eu/eli/reg_del/2016/128/oj [Accessed May 2019]. 2. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the essential composition of infant and follow-on formulae. EFSA Journal 2014;12(7):3760, 106 pp.
doi:10.2903/j.efsa.2014.3760 Available online: http://www.efsa.europa.eu/efsajournal [Accessed April 2019].