1. 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

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

3. 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:

4. 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, From the EU Register on nutrition and health claims, available at:

5. 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 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).

6. 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 ), available at:
2 Letter of Enforcement Discretion for 100% whey-protein partially hydrolzed infant formula and reduced risk of atopic dermatitis, available at:

7. 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 to B , available at: and Canada Food Inspection Agency’s Food Labelling for Industry, available at:

8. 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:

9. 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:

10. 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:

11. 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.

12. 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

13. 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

14. 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.

15. 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.

16. 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.

17. 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:

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