EFSA Publishes New Guidance on Infant Formula from Protein Hydrolysates

b6f51552-608e-46a8-be92-02b2c1fa6af2articleimage.jpg

12 May 2017 --- New guidance published by EFSA will assist applicants in preparing and presenting dossiers for authorisation of infant and/or follow-on formulae manufactured from protein hydrolysates. It will also help applicants in preparing dossiers to assess a product’s efficacy in reducing the risk of infants becoming allergic to milk proteins. 

Regulatory rules dating back to 2006 were revised in 2016. The revision was based on scientific advice by EFSA on the need to establish the safety and suitability of each protein hydrolysate used in the manufacture of formula. EFSA had also advised that clinical studies be conducted to demonstrate a formula’s potential to reduce the risk of infants developing allergy to milk proteins. 

What kind of data do applicants need to submit?
EFSA’s technical and scientific guidance details the type of data and information applicants need to provide. The required information should include:

  • Characterisation of the hydrolysed infant or follow-on formulae, including a description of the manufacturing process;
  • Information about the nutritional safety and suitability of the formula, including information on the history of use; and/or
  • Information on the product’s efficacy in reducing the risk of developing an allergy to milk proteins.

The guidance presents a common format for the organisation of the information applicants need to provide. A well-structured application will help the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) to carry out its evaluation and deliver its scientific advice effectively and consistently.

Public Consultation
Prior to finalizing the guidance, EFSA presented the document to the public and invited feedback. EFSA received and considered over 80 comments from seven interested parties including a governmental organization, food business operators and industry associations.

To contact our editorial team please email us at editorial@cnsmedia.com

Related Articles

Nutrition & Health News

Key gut-brain interplays identified, enhancing possibilities for neurological treatments

21 May 2018 --- Steps have been taken toward untangling the complex interplay that allows the byproducts of microorganisms living in the gut to influence the progression of neurodegenerative diseases. Researchers have defined a pathway between the two, coined the gut-brain axis, that may help guide therapies for multiple sclerosis and other neurological diseases. Essentially, some gut microbes were found to activate an anti-inflammatory pathway that can limit neurodegeneration.

Nutrition & Health News

DuPont attains US green light on HMO infant nutrition solution

17 May 2018 --- DuPont Nutrition & Health’s CARE4U human milk oligosaccharide (HMO) is now Generally Recognized as Safe (GRAS) for use in infant and toddler formula following a “No Objection” letter from the US Food and Drug Administration.

Nutrition & Health News

Nestlé for Healthier Kids initiative: “Reach 50 million kids by 2030”  

17 May 2018 --- Nestlé is beefing up their children's nutrition programme with a focus on developing health fortified and sugar and salt reduced products. The move is hoped to offer children more nutritious food options, as part of Nestlé's wider Healthier Kids initiative. Other key goals of the on-going initiative include: “Building knowledge on children’s nutritional needs and inspiring parents & caregivers to raise healthier kids,” a Nestlé spokesperson tells NutritionInsight.

Nutrition & Health News

US safety watchdog to US FDA: “Add warning labels to ginkgo biloba supplements”

16 May 2018 --- The Center for Science in the Public Interest (CSPI) is urging consumers to avoid supplements made with ginkgo biloba, which they claim can be adulterated. They propose that the supplement is ineffective in improving memory and circulation. The agency has compiled a letter to the FDA’s Office of Dietary Supplement Programs requesting warning labels on ginkgo packages.

Nutrition & Health News

Oral health: Natural products rising and good-for-your teeth sweets

15 May 2018 --- In line with the personal care market, oral health products are increasingly marketing themselves from a natural positioning, as well as a cosmetic one. “Beauty from within” claims all contribute to a more holistic understanding of wellbeing and consumers are increasingly looking to inherent health benefits from natural ingredients which convey better-for-you appeal. NutritionInsight covers a range of innovative products and suppliers tapping into the tooth-care market. When it comes to teeth, more than a shiny, white veneer is the goal: strong teeth and a healthy mouth – chemical free, are increasingly in demand. 

More Articles
URL : http://www.nutritioninsight.com:80/news/efsa-publish-new-guidance-on-infant-formula-from-protein-hydrolysates.html