PHARMALYS
PHARMALYS
Moving to the new EU regulation for infant formula
A new regulation for infant formula is coming into force in the EU and Switzerland. The changed requirements for nutrients and packaging has meant a re-development of our EU portfolio. HOCHDORF is in now in the final stages of change. From February 2020, infant formula intended for Switzerland and the EU can only be produced in line with the new regulation.
The composition of infant and follow-on formula is strictly regulated by law.
Any infant formula sold in the European Union must comply with the European Parliament's regulations. In September 2015, the EU adopted a supplement (Regulation (EU) 2016/128) to the existing regulation on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. (1)
Composition changes and new packaging information
The supplementary regulation lays down new minimum and/or maximum limits for several nutrients such as minerals and vitamins in the composition of infant and follow-on formula. It also sets requirements for contaminants in food and declarations on food labelling. This has created the need to adapt the formulations and packaging for infant formula produced in the EU from 2020. The new regulation applies in Switzerland too. The regulation of the Federal Department of Home Affairs (FDHA) on foods for persons with special nutritional requirements (VLBE) is harmonised with the EU regulation with regard to infant and follow-on formula. (2)
New HOCHDORF formulations
HOCHDORF is also affected by the new regulation for infant formula and follow-on formula and has had to adjust its portfolio accordingly. The specifications of several nutrients have changed, requiring the development of new formulations. HOCHDORF has developed all its customer formulations in line with the new specifications. The company's own portfolio has also been adjusted in line with the new ordinance and HOCHDORF has used the opportunity to optimise its own formulations too. Certain nutrients and ingredients have been modified as a result, on the basis of new scientific findings and in order to optimise the production process.

This includes the introduction of a clean label, awarded to products free from certain ingredients that consumers consider to be unwanted. Additives such as artificial flavours, sweeteners or colourings are not included in infant formula by law. The clean label project also made it possible to reduce the amount of allergens from three to two: the allergen soy lecithin was replaced by sunflower lecithin as the vegetable emulsifier.
Transition phase for manufacturing ends in February 2020
Manufacturers of infant formula have had four years since the adoption of the new law to adjust their formulations. The old law and the new regulation have been in place during this transition phase, which ends on 22 February 2020. From then, infant formula intended for Switzerland and the EU can only be produced in line with the new regulation. The change will be gradual from the end consumer's perspective: it will still be possible to sell and use any formula manufactured up to 22 February 2020 till the expiry date.
Written by Janny Vedder

Sources

  • Official Journal of the European Union; Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes. 2.2.2016.
  • Federal Department of Home Affairs (FDHA); Federal Food Safety and Veterinary Office FSVO; Explanation of the Ordinance of the Federal Department of Home Affairs (FDHA) on foodstuffs for persons with special nutritional requirements.
  • https://inside.hochdorf.com/en
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