Lonza’s MemreePS™ Receives Approval for Certain Food Categories in Europe

June 26,2014

Basel, Switzerland, 26 June 2014 – In May 2014, the Finnish Food Safety Authority (EVIRA) approved the use of MemreePS™ beyond dietary supplements. No objections were raised by the Member States of the European Union (EU) within the 60-days period. MemreePS™ can now be used for food applications like yoghurt-based foods and beverages, cereal bars, chocolate-based confectionary and milk powder-based drinks in the EU. MemreePS™ has already been approved for various food categories in the United States by the FDA-GRAS and in China, and for use in supplements in the EU, Switzerland, Russia and other regions/countries.

“The extension of the approval for MemreePS™ to food categories in Europe underlines our strategy of strengthening our product offers to the functional foods industry. We will continuously increase our efforts to position our ingredients in this branch through regulatory channels and scientific development,” said Ilya Zhivkovich, Head of Marketing for Nutrition at Lonza.

The Memree™ brand covers a line of products that includes high-quality, soy-based, phosphatidylserine (PS). PS is an important structural component of cell membranes and is found in concentrated amounts in brain cells. MemreePS™ contains high-quality PS, which can be used for cognitive health applications. PS has been widely studied as a cognitive health ingredient. Research has shown that as people age, the amount of PS in brain cells begins to decline1. While PS is found in dietary sources such as dairy products and organ meats, intake of such products generally decreases as people age. Supplementation with Memree™ can increase dietary intake of PS and help restore levels of PS in brain cells. Numerous studies have also shown that PS helps improve brain functions that decline with age2,3. Specifically, PS has been shown to improve memory retention and support mental concentration. Furthermore, PS is the only cognitive health ingredient for which the FDA allows a qualified health claim4.  

In December 2013 Lonza submitted a Novel Food inquiry to the EVIRA who requested the Finnish food assessment body under Regulation (EC) No 258/97, the Novel Food Board, for opinion. The request concerned the substantial equivalence of the PS preparation MemreePS™ with products described in Commission Decision 2011/513/EU. Based on the information provided, EVIRA is satisfied that PS sold under the brand name MemreePS™ is substantially equivalent with respect to its composition, nutritional value, metabolism, and intended use to PS described in Decision 2011/513/EU. As no objections were raised by any Member State, MemreePS™ can now be sold in the approved food categories throughout the EU.

The Memree™ line of products is produced according to strict safety and quality standards in a state-of-the-art cGMP facility. The production process for Memree™ is carried out by a series of enzymatic reactions, starting with soy-derived phospholipids and cabbage-derived phospholipase D. The enzymatic reaction is done in water and is free of any solvents, which allows for only natural phospholipids to be produced. At the end of the process, Memree™ is extracted and stabilized to a liquid or powder form for use in end-consumer applications.  

1.     Soderberg M et al. (1990) J Neurochem. 54:415-423
2.     Wehrmuller K (2008) ALP Science No. 524
3.     Kato-Kataoka A et al. (2010) J Clin Biochem Nutr 47:246-255
4.     FDA: Phosphatidylserine and Cognitive Function and Dementia Qualified Health Claim. http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm072999.htm
  

 

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