Health Claims for Whey (Protein) Products – A Global Evaluation of Current and Future Opportunities Nigel Baldwin BSc, Csci Director, Scientific and Regulatory Consulting, Europe Intertek Scientific and Regulatory Consultancy

Agenda Claim Categories and Examples of Protein-related Claims European Union United States Canada Australia/New Zealand China South Korea

Claims Permissible in the Labelling and Advertising of Foods Claims Made in Food Labelling and Advertising1 Nutrition Claims Article 13.3 Health Claims Article 13.5 Health Claims Article 14.1 Health Claims (a) Disease Risk Reduction (b) Children’s Health and Development 1 Regulation (EC) No 1924/2006 of the European parliament and of the council of 20 December 2006 on nutrition and health claims made on foods, available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:012:0003:0018:EN:PDF

Examples of Health Claims for Protein* Claim Type Claim Wording Condition for Use of the Claim Article 13.3 Protein contributes to a growth in muscle mass Used only for food which is at least a source of protein (i.e., at least 12% of the energy value of the food is provided by protein) Protein contributes to the maintenance of muscle mass Protein contributes to the maintenance of normal bones Article 14.1(b) Protein is needed for normal growth and development of bone in children *As of September 4, 2014. From the EU Register on nutrition and health claims, available at: http://ec.europa.eu/nuhclaims/

Claims Permissible in the Labelling of Foods Claims Made in Food Labelling Nutrient Content Claims Structure/ Function Claims1 Health Claim2 Authorized3 Qualified4 1 Dietary Supplement Health and Education Act of 1994 (DSHEA) allows structure/function statements. 2 General and specific requirements for health claims are laid out in 21 CFR 101.14 and 21 CFR 101 Subpart E, respectively. 3 The Nutrition Labeling and Education Act of 1990 (NLEA) introduced the use of Authorized Health Claims. 4 Due to a litigation that raised First Amendment challenges (i.e., free-speech) to the significant scientific agreement (SSA) standard, which authorized claims are held to, the U.S FDA announced in 2000 for dietary supplements and in 2002 for conventional foods to exercise its enforcement discretion with certain health claims (i.e., qualified health claims).

Examples of Claims for Protein Claim Type Claim Wording Structure/Function Protein contributes to the maintenance of muscle mass. Authorized Health Claim1 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein. Qualified Health Claim2 For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship." 1 Authorized health claim for soy protein and risk of heart disease (21 CFR 101.82), available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.82 2 Letter of Enforcement Discretion for 100% whey-protein partially hydrolzed infant formula and reduced risk of atopic dermatitis, available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm256731.htm

Claims Permissible in the Labelling and Advertising of Foods Claims Made in Food Labelling and Advertising1 Nutrient Content Claims Health Claims Nutrient Function Other Function Disease Risk-Reduction and Therapeutic 1 Food and Drug Regulations B.01.600 to B.01.603, available at: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/FullText.html; and Canada Food Inspection Agency’s Food Labelling for Industry, available at: http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794

Examples of Claims for Protein Claim Type Claim Wording Nutrient Function1 Protein helps build and repair body tissues. Protein helps build antibodies. Protein helps build strong muscles. Food must be at least a source of protein (protein rating ≥20). Other Function None specific to protein have been endorsed by Health Canada. Possibilities exist if claims can be scientifically substantiated (e.g., satiety, physical performance, body weight/composition, sarcopenia). Disease Risk-Reduction and Therapeutic None specific to protein have been authorized by Health Canada. Possibilities exist if claims can be scientifically substantiated (e.g., reduced risk of certain diseases, treatment of obesity). 1 Acceptable nutrient function claims, available at: http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=8

Claims Permissible in the Labelling and Advertising of Foods Claims Made in Food Labelling and Advertising1 Nutrition Content Claims Health Claims General Level High Level 1 The Australia New Zealand Food Standards Code Standard 1.2.7, available at: http://www.comlaw.gov.au/Details/F2013L00054

Examples of Health Claims for Protein Claim Type Claim Wording Conditions for Use General Level1 Protein is necessary for tissue building and repair Protein contributes to the growth of muscle mass Protein contributes to the maintenance of muscle mass Protein contributes to the maintenance of normal bones Food must meet the general conditions for making a nutrition content claim for protein (at least 5 g of protein per serving) Protein is necessary for normal growth and development of bone For children and adolescents aged 4 years and over Protein is necessary for normal growth and development For children aged 4 years and over Food must be a food for infants For infants aged 6 to 12 months 1 From the Australia New Zealand Food Standards Code Standard 1.2.7, available at: http://www.comlaw.gov.au/Details/F2013L00054

Claims Permissible in the Labelling and Advertising of Functional Foods According to the Guidelines for Registration for Functional Foods, the functional (health) food referred to a food that has special health functions or is able to supply vitamins and minerals. It is suitable for consumption by special groups of people, aiming to regulate human body functions, but is not used for therapeutic purposes. Must demonstrate safety and efficacy Two categories: Function Healthy Foods include substances such as fish oil, ginseng, etc. and can make health claims or structure/function claims. Nutritional supplements include vitamins and minerals and can only make nutrient content claims. Functional food claims are product-specific (not ingredient-specific). Function Healthy Foods can bear 1 or several of the 27 established functions. Product-specific testing must be conducted according to pre-defined research protocols at a qualified testing agency in China.

Functional Claims for Function Healthy Foods 27 categories of product-specific health claims Function-related or refers to reduction of disease risk Maximum of 2 claims per product Those in red likely to be cancelled Those in green likely to be combined

Example of Claim for Protein Product Product Name Image Price Key Claims Unit Sales in 30 Days Protein Powder 160 RMB 450g Enhancing Immune Function 23,519

Nutrient Content and Nutrient Function Claims Nutrient content claim criteria for protein are: Source of protein: ≥10 % NRV per 100 g;  ≥5 % NRV or per 100ml; ≥5 % NRV per 420 kJ High, or rich in protein: ≥20 % NRV per 100 g;  ≥10 % NRV or per 100ml; ≥10 % NRV per 420 kJ Approved nutrient function claims are: Protein is the main component of body and could provide various kinds of amino acids. Protein is essential to human life activities, as well as contributing to tissue formation and growth. Protein helps constituting or repairing human tissue. Protein helps with tissue formation and growth. Protein is an essential nutrient for tissue formation and growth.

Claims Permissible in the Labelling and Advertising of Foods Food Claims1 Usefulness Claims Health Functional Food Claims2 Generic Claims Nutrient Functional Ingredients Product Specific Claims 1 Food Sanitation Act and subordinate legislations. 2 Health Functional Food Act and subordinate legislations.

Examples of Claims for Protein Products Description Conditions Generic Nutrient Claims & Usefulness Claims1 Protein is a component of physical tissues such as muscle and connective tissue Single-dosage forms:  12 g/day Foods: at least a source of protein Protein is required for the normal formation of enzymes, hormones and antibodies Protein is required for the transport and storage of essential nutrients or active materials in the body Protein is required for the maintenance of fluid balance and acid-base balance Protein is required for the synthesis of energy, glucose, and lipids 1 From the Health Functional Food Code.

Examples of Claims for Protein Products Description Conditions Generic Functional Ingredient Claim1 Soy protein helps maintain blood cholesterol Single-dosage forms:  15 g/day Product Specific Claims Lactoferrin helps reduce body fat  300 mg/day Milk protein hydrosylate (Lactium®) helps reduce stress-induced anxiety Single dosage forms:  150mg/day 1 From the Health Functional Food Code. 2 From the Approved Product-Specific Ingredient register, available at: http://www.foodnara.go.kr/hfoodi/industry/

Thank you! Email: nigel.baldwin@intertek.com Website: www.intertek.com/food/consulting NOTE:   "Intertek Cantox" is now "Intertek Scientific & Regulatory Consultancy".