Peptigen IF-3080 is one of only a few milk protein hydrolysate ingredients to receive a positive opinion from the European Food Safety Authority (EFSA) in accordance with new safety regulations.
Following full approval, Peptigen IF-3080 will be permitted for use in infant and follow-on formula sold in the EU.
In the meantime, Arla Foods can continue to supply EU customers for the development of new infant formula brands. Formulas that are not approved have to be removed from the market.
Anders Steen Jørgensen, Head of SBU Paediatric, Arla Foods Ingredients, said: “We are delighted by this opinion, which supports our reputation for having the industry’s highest levels of quality, innovation and food safety.”
New rules on infant and follow-on formula manufactured from protein hydrolysates apply from February 22 and are set out in the EU’s Delegated Regulation (EU) 2016/17.
All established and novel hydrolysed proteins for infant and follow-on formula have to be assessed for conformity to the latest nutritional safety and suitability guidelines.
Each application must be approved by experts from each Member State and scrutinised by the European Parliament and Council, which can take up to two months. The World Trade Organisation is also notified and if there are no objections approvals are published in the EU Official Journal.
Manufacturers have to comply with strict compositional and ingredient requirements and achieve minimal levels of pesticide residue. Nutrition and health claims are not permitted under the latest terms.
The EU regulations outline specific minerals and vitamins that must be included in the nutritional declaration, although it is not necessary to include salt, fat, carbohydrate, or protein content.
Labelling, presentation and advertising of infant formula and follow-on formula must be designed to avoid risk of confusion between formula types and make a clear distinction between products.
Other articles relate to promotional and commercial activity and requirements on information relating to infant and young child feeding, such as the compulsory inclusion of declarations on the benefits of breastfeeding.
Arla Foods Ingredients launched Peptigen for infant and follow-on formula in the late 90s. Hydrolysates in the formula are produced by enzymatic hydrolysis of milk proteins and designed for formulas that target allergies and reduce gastrointestinal discomfort.
Consuming partial hydrolysates induces oral tolerance to intact proteins to prevent allergic reactions and is crucial in the first few months of infant development. They also facilitate protein digestion and absorption and increase plasma amino acid availability.
Hydrolysed casein and whey proteins also feature in the company’s portfolio of infant formulas for allergy treatment and digestive comfort.