Appendix VIII. Proposed Draft Guidelines for Use of Nutrition and Health Claims (Proposed Draft Recommendations for the Use of Health Claims)[30]

(At Step 3 of the Procedure)

Nutrition claims should be consistent with national nutrition policy and support that policy. Only nutrition claims that support national nutrition policy should be allowed.

Health claims must be consistent with national health policy, including nutrition policy, and support such policies. Health claims should supported by specific consumer education. Claims of the type described in section 3.4 of the Codex General Guidelines on Claims are prohibited.

1. SCOPE

1.1 These guidelines relate to the use of nutrition and health claims in food labelling.

1.2 These guidelines apply to all foods for which nutrition and health claims are made without prejudice to specific provisions under Codex standards or Guidelines relating to Foods for Special Dietary Uses and Foods for Special Medical Purposes.

1.3 These guidelines are intended to supplement the Codex General Guidelines on Claims and do not supersede any prohibitions contained therein.

1.4 Health claims are not permitted for foods for infants and young children unless specifically provided for in relevant Codex standards.

2. DEFINITIONS

2.1 Nutrition claim[31] means any representation which states, suggests or implies that a food has particular nutritional properties including but not limited to the energy value and to the content of protein, fat and carbohydrates, as well as the content of vitamins and minerals. The following do not constitute nutrition claims:

(a) the mention of substances in the list of ingredients;

(b) the mention of nutrients as a mandatory part of nutrition labelling;

(c) quantitative or qualitative declaration of certain nutrients or ingredients on the label if required by national legislation.

(Examples:[32] “source of calcium”; “high in fibre and low in fat”;)

2.1.2 Comparative claim is a claim that compares the nutrient levels and/or energy value of two or more foods.

(Examples: “reduced”; “less than”; “fewer”; “increased”; “more than”.)

2.2 Health claim means any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health. Health claims include the following:

2.2.1 Nutrient Function Claims - a nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body[33].

[Examples:

“Calcium aids in the development of strong bones and teeth”;
“Protein helps build and repair body tissues”;
“Iron is a factor in red blood cell formation”;
“Vitamin E protects the fat in body tissues from oxidation”.
“Contains folic acid: folic acid contributes to the normal growth of the fetus”]

Such claims relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health.

[Examples:

“Certain non-digestible oligosaccharides improve the growth of specific bacterial flora in the gut”

“Folate can help reduce plasma homocysteine levels”

“X may assist in increasing alertness”]

1) Information on an accepted diet-health relationship; followed by

2) Information on the composition of the product relevant to the relationship unless the relationship is based on a whole food or foods whereby the research does not link to specific constituents of the food.

[Examples:

“Iron can help reduce the risk of anaemia. Food A is a high source of iron.”;

“A diet low in saturated fat may reduce the risk of heart disease. Food B is low in saturated fat.”;

“Folate may reduce a woman’s risk of having a child with neural tube defects. Food C is high in folate.”

“Sufficient calcium intake may reduce the risk of osteoporosis in later life. Food D is high in calcium.”]

Any food for which a nutrition or health claim is made should be labelled with a nutrient declaration in accordance with Section 3 of the Codex Guidelines on Nutrition Labelling.

4. NUTRITION CLAIMS

4.1 The only nutrition claims permitted shall be those relating to energy, protein, carbohydrate, and fat and components thereof, fibre, sodium and vitamins and minerals for which Nutrient Reference Values (NRVs) have been laid down in the Codex Guidelines for Nutrition Labelling.

5. NUTRIENT CONTENT CLAIMS

5.1 When a nutrient content claim that is listed in the Table to these Guidelines or a synonymous claim is made, the conditions specified in the Table for that claim should apply.

5.2 Where a food is by its nature low in or free of the nutrient that is the subject of the claim, the term describing the level of the nutrient should not immediately precede the name of the food but should be in the form “a low (naming the nutrient) food” or “a (naming the nutrient)-free food”.

6. COMPARATIVE CLAIMS

Comparative claims should be permitted subject to the following conditions and based on the food as sold, taking into account further preparation required for consumption according to the instructions for use on the label:

6.1 The foods being compared should be different versions of the same food or similar foods. The foods being compared should be clearly identified.

6.2 A statement of the amount of difference in the energy value or nutrient content should be given. The following information should appear in close proximity to the comparative claim:

6.2.1 The amount of difference related to the same quantity, expressed as a percentage, fraction, or an absolute amount. Full details of the comparison should be given.

6.2.2 The identity of the food(s) to which the food is being compared. The food(s) should be described in such a manner that it (they) can be readily identified by consumers.

6.4 The use of the word “light” should follow the same criteria as for “reduced” and include an indication of the characteristics which make the food “light”.

7. HEALTH CLAIMS

7.1 Health claims should be permitted provided that the following conditions are met:

7.1.1 Health claims must be based on current relevant scientific substantiation and the level of proof must be sufficient to substantiate the type of claimed effect as recognised by generally accepted scientific review of the data and the scientific substantiation should be reviewed as new knowledge becomes available.[34]

7.1.2 Any health claim must be accepted by or be acceptable to the competent authorities of the country where the product is sold. Only health claims that support national health policy and goals should be allowed.

7.1.3 The claim about a food or food constituent must be stated within the context of the total diet.

7.1.4 The claimed benefit should arise from the consumption of a reasonable quantity of the food or food constituent in the context of a normal diet.

7.1.5 If the claimed benefit is attributed to a constituent in the food, the food in question should be:

(i) - a significant or high source of the constituent in the case where increased consumption is recommended; or,

(ii) - low in, reduced in, or free of the constituent in the case where reduced consumption is recommended. Where appropriate, the conditions for nutrient content claims and comparative claims will be used to determine the levels for “high”, “low”, “reduced”, and “free”.[35]

7.1.6 Only those nutrients for which a Nutrient Reference Value (NRV) has been established in the Codex Guidelines on Nutrition Labelling or those nutrients which are mentioned in officially recognized dietary guidelines of the national authority having jurisdiction, should be the subject of a nutrient function claim.[36]

7.2 Health claims should have a clear framework for qualifying and/or disqualifying conditions for eligibility to use the specific claim, including the ability of competent national authorities to prohibit claims made for foods that contain nutrients or constituents in amounts that increase the risk of disease or an adverse health-related condition. The health claim should not be made if it encourages or condones excessive consumption of any food or disparages good dietary practice.

7.3 If the claimed effect is attributed to a constituent of the food, there must be a validated method to quantify the food constituent that forms the basis of the claim.

7.4 The impact of health claims on consumers’ eating behaviours and dietary patterns should be monitored.

7.5 The following information should appear on the label or labelling of the food bearing health claims:

7.5.1 A statement of the quantity of any nutrient or other constituent of the food that is the subject of the claim.

7.5.2 Information on the target group, if appropriate.

7.5.3 Information on how to use the food to obtain the claimed benefit, if appropriate.

7.5.4 If appropriate, advice to vulnerable groups on how to use the food and to groups, if any, who need to avoid the food.

7.5.5 Maximum safe intake of the food where necessary.

Claims that relate to dietary guidelines or “healthy diets” should be permitted subject to the following conditions:

8.1 Only claims related to the pattern of eating contained in dietary guidelines officially recognized by the appropriate national authority.

8.2 Flexibility in the wording of claims is acceptable, provided the claims remain faithful to the pattern of eating outlined in the dietary guidelines.

8.3 Claims related to a “healthy diet” or any synonymous term are considered to be claims about the pattern of eating contained in dietary guidelines and should be consistent with the guidelines.

8.4 Foods which are described as part of a healthy diet, healthy balance, etc., should not be based on selective consideration of one or more aspects of the food. They should satisfy certain minimum criteria for other major nutrients related to dietary guidelines.

8.5 Foods should not be described as “healthy” or be represented in a manner that implies that a food in and of itself will impart health.

8.6 Foods may be described as part of a “healthy diet” provided that the label carries a statement relating the food to the pattern of eating described in the dietary guidelines.

TABLE OF CONDITIONS FOR NUTRIENT CONTENTS

COMPONENT	CLAIM	CONDITIONS
		NOT MORE THAN
Energy	Low	40 kcal (170 kJ) per 100 g (solids) or 20 kcal (80 kJ) per 100 ml (liquids)
	Free	4 kcal per 100 ml (liquids)
Fat	Low	3g per 100 g (solids) 1.5 g per 100 ml (liquids)
	Free	0.5 g per 100 g (solids) or 100 ml (liquids)
Saturated Fat	Low[37]	1.5 g per 100 g (solids) 0.75 g per 100 ml (liquids) and 10% of energy
	Free	0.1 g per 100 g (solids) 0.1 g per 100 ml (liquids)
Cholesterol	Low8	0.02 g per 100 g (solids) 0.01 g per 100 ml (liquids)
	Free	0.005 g per 100 g (solids) 0.005 g per 100 ml (liquids)
		and, for both claims, less than: 1.5 g saturated fat per 100 g (solids) 0.75 g saturated fat per 100 ml (liquids) and 10% of energy of saturated fat
Sugars	Free	0.5 g per 100 g or 100 ml
Sodium	Low	0.12 g per 100 g
	Very Low	0.04 g per 100 g
	Free	0.005 g per 100 g

DIFFERENT TYPES OF CLAIMS SUBJECT TO THE CONDITIONS IN THESE GUIDELINES

The purpose of these examples is only to illustrate the differences between different types of health and nutrition claims. Special conditions for use of these claims are found in the guidelines.

COMPONENT	TYPE OF CLAIM	CLAIM
Calcium	Nutrient content claim	Food A is a source of calcium
	Comparative claim	Food A contains x% more calcium than...
	Nutrient function claim	Calcium aids in the development of strong bones and teeth. Food A is a source of/rich in calcium.
	Enhanced function claim	Calcium may help to improve bone density. Food A is a source of/rich in calcium.
	Reduction of disease risk claim	Sufficient calcium intake may reduce the risk of osteoporosis in later life. Food A is high in calcium.
Iron	Nutrient content claim	Food B is a source of iron
	Comparative claim	Food B contains increased contents of iron
	Nutrient function claim	Iron is a factor in red blood cell formation. Food B is a source of/rich in iron.
	Enhanced function claim	A good iron status may promote endurance. Food B is a source of/rich in iron.
	Reduction of disease risk claim	Iron deficiency is common among women, but good dietary habits can reduce the risk for iron deficiency. B is an important source of the type of iron that is readily absorbed by the body.
Folic acid	Nutrient content claim	Food C is a source of folic acid
	Comparative claim	Food C contains x% more folic acid than...
	Nutrient function claim	Folic acid contributes to the normal growth of the fetus. Food C contains folic acid
	Nutrient function claim	Folate may help to normalise plasma homocysteine levels. Food C is a source of/rich in folic acid.
	Reduction of disease risk claim	Folate may reduce a woman’s risk of having a child with neural tube defects. Food C is high in folate.
General Examples	Nutrient content claim	Food D is high in fibre Food D is low in fat
	Comparative claim	Component X has been reduced in Food E Food E contains less component X than...
	Nutrient function claim	Protein helps build and repair body tissues Vitamin E protects the fat in body tissues from oxidation
	Nutrient function claim	Certain non-digestible oligosaccharides improve the growth of specific bacterial flora in the gut Food F may assist in increasing alertness
	Reduction of disease risk claim	A diet low in saturated fat may reduce the risk of heart disease. Food G is low in saturated fat