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
1
www.intertek.com
Agenda
Claim Categories and Examples of Protein-related Claims
• European Union
• United States
• Canada
• Australia/New Zealand
• China
• South Korea
2
www.intertek.com
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
1
(b) Children’s
Health and
Development
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
3
www.intertek.com
Examples of Health Claims for Protein*
Claim
Type
Claim Wording
Condition for Use of
the Claim
Protein contributes to a growth in muscle
mass
Article
13.3
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
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)
*As of September 4, 2014. From the EU Register on nutrition and health claims,
available at: http://ec.europa.eu/nuhclaims/
4
www.intertek.com
Claims Permissible in the Labelling of Foods
Claims Made
in Food
Labelling
Nutrient
Content
Claims
Structure/
Function
Claims1
Authorized3
Health
Claim2
Qualified4
1 Dietary
Supplement Health and Education Act of 1994 (DSHEA) allows structure/function statements.
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).
2
5
www.intertek.com
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
6
www.intertek.com
Claims Permissible in the Labelling and
Advertising of Foods
Claims Made in
Food Labelling
and
Advertising1
Nutrient
Content Claims
Nutrient
Function
Health Claims
Other
Function
Disease RiskReduction and
Therapeutic
1
Food and Drug Regulations B.01.600 to B.01.603, available at: http://lawslois.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/healthclaims/eng/1392834838383/1392834887794
7
www.intertek.com
Examples of Claims for Protein
Claim Type
Nutrient Function1
Claim Wording
- 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 RiskReduction 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/healthclaims/eng/1392834838383/1392834887794?chap=8
8
www.intertek.com
Claims Permissible in the Labelling and
Advertising of Foods
Claims Made in
Food Labelling
and Advertising1
Nutrition
Content Claims
Health Claims
General Level
1
High Level
The Australia New Zealand Food Standards Code Standard 1.2.7, available at: http://www.comlaw.gov.au/Details/F2013L00054
9
www.intertek.com
Examples of Health Claims for Protein
Claim Type
General
Level1
Claim Wording
Conditions for Use
• 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
• Food must meet the general conditions for
making a nutrition content claim for protein
(at least 5 g of protein per serving)
• For children and adolescents aged 4
years and over
• Protein is necessary for normal growth
and development
• Food must meet the general conditions for
making a nutrition content claim for protein
(at least 5 g of protein per serving)
• For children aged 4 years and over
• Protein is necessary for normal growth
and development
• 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
10
www.intertek.com
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.
11
www.intertek.com
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
12
www.intertek.com
Example of Claim for Protein Product
Product Name
Protein Powder
13
Image
Price
Key
Claims
160 RMB
450g
Enhancing
Immune
Function
Unit Sales
in 30
Days
23,519
www.intertek.com
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.
14
www.intertek.com
Claims Permissible in the Labelling
and Advertising of Foods
Food
Health
Functional
Food Claims2
Claims1
Usefulness
Claims
Generic
Claims
Nutrient
Functional
Ingredients
Product
Specific
Claims
Functional
Ingredients
1 Food
2
Sanitation Act and subordinate legislations.
Health Functional Food Act and subordinate legislations.
15
www.intertek.com
Examples of Claims for Protein Products
Claims
Generic
Nutrient
Claims &
Usefulness
Claims1
Description
• Protein is a component of physical
tissues such as muscle and
connective tissue
• Protein is required for the normal
formation of enzymes, hormones and
antibodies
Conditions
Single-dosage forms:  12
g/day
Foods: at least a source of
protein
• 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 acidbase balance
• Protein is required for the synthesis
of energy, glucose, and lipids
1
From the Health Functional Food Code.
16
www.intertek.com
Examples of Claims for Protein Products
Claims
Generic
Functional
Ingredient
Claim1
Description
• Soy protein helps maintain
blood cholesterol
Conditions
Single-dosage forms:
 15 g/day
Product
• Lactoferrin helps reduce body
Specific Claims fat
Single-dosage forms:
 300 mg/day
• Milk protein hydrosylate
(Lactium®) helps reduce stressinduced 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/
17
www.intertek.com
Thank you!
Email: nigel.baldwin@intertek.com
Website: www.intertek.com/food/consulting
NOTE: "Intertek Cantox" is now "Intertek Scientific &
Regulatory Consultancy".
18
www.intertek.com